british association for nutrition and lifestyle medicine – bant - … · 2017. 5. 24. · i am...
TRANSCRIPT
the Regional Co-ordinators programme
This will be an excellent help for students
as they prepare for practice and a useful
tool to grow their businesses once qualified
I am making a new BANT presentation for
Training Providers to help improve our
reputation and image amongst NT students
The PR and Marketing team continues to
work on generating ideas to raise the profile
of BANT and Nutritional Therapy to the
public and the health professionals I will let
you know more as the project develops
So please keep reading
Catherine Honeywell
Chair BANT Council
Chairlsquos Report and Update
British Association for Applied Nutrition and Nutritional Therapy ISSUE 28 bull SEP 2011
27 Old Gloucester Street
London WC1N 3XX
T 0870 606 1284
F 0870 606 1284
wwwbantorguk
theadministratorbantorguk
Standing Orders If you currently have a standing order set up to pay
us and have not yet cancelled it please can you
contact your bank as soon as possible to cancel this
arrangement If you are registered to do online banking
you will be able to cancel the standing order via your
online bank account
We have already sent out 4 email reminders and many
of you have not yet responded We are unable to cancel
this arrangement for you as a standing order is in your
control
It is essential that you cancel the standing order as
soon as possible and send an email to me to confirm
that you have done this If you do not cancel the
standing order and your account is debited it will NOT
mean that your membership has been renewed It will
however mean that we will have to spend valuable time
refunding your payment at a cost to BANT
Thank you for your co-operation in the matter
Melanie de Grooth
BANT AdministratorGeneral Manager
Functional Medicine Pathology BANT Practitioner Special Offer (25 discount)
Updated BIOLAB Osteoporosis Profile
or our Mineral amp Vitamin Screen (valid from August to September quote BANT-2511)
BIOLAB offers a comprehensive range of pathology investigations
of micronutrient amp antioxidant status essential fatty acids toxic
metals gut dysbiosis amp permeability allergy tests and others (all at
affordable prices)
Register on-line to receive our introduction pack for latest news
and to see our multimedia educational resources or contact us
directly to discuss your requirements
9 Weymouth Street London W1W 6DB
Telephone (+44) 020 7636-5959 E-mail infobiolabcouk
STANDING ORDERS 1
MEMBER INFORMATION 1
CNHCNTC REGISTRATION 1
REGIONAL CO-ORDINATORS 2
RECIPE OF THE MONTH 2
ARC UPDATE 3
CPD UPDATE 3
PPC UPDATE 4
CNHC UPDATE 4
LEARNING ZONE
CHALLENGE 4
ONLINE RENEWALS 5
DICKEN WEATHERBY ON
CV HEALTH 6
MONTHLY REPORTSNEWS
PODCASTSWEBINARS 8
ANH RULES AND REGS DVD 9
BANT RULES AND REGS
PRESENTATION 9
PHARM TO FORK ARTICLE 10
MONTHLY ARTICLESPAPERS 13
Inside This Issue
DISCLAIMER - BANT does not endorse any products
services jobs or seminars advertised in the newsletter
Evidence-based Live Activated Multi Strain Probiotic ndash totally different
to any other probiotic available today wwwsymprovecom
CNHCNTC Registration Is your CNHC registration up to date If not you need to
contact the CNHC to renew it or let BANT know that you
are no longer registered with the CNHC
Donlsquot forget to email the administrator i f you would like
to indicate on your BANT profile that you are either
registered with the CNHC or NTC or both
Member Information In order to make sure that all BANT members
are complying with the new ASA rules and the Rules
and Regulations affecting NT practice please check
your information in relation to the documentation we
have released over the last few months
In October all full members will be sent an email
containing the information you have listed under the
sections Special Interests and Further Information
Please can you ensure that you check that your
information is correct and up to date
Please use these resource links for checking your
information
ASA rules
wwwbantorgukbantjspmemberASARulesfaces
Rules and Regulations
wwwbantorgukbantjspmember
rulesRegulationfaces
Once you have checked your information carefully
please email the changes to the administrator as
you would like them to appear ndash
theadministratorbantorguk
Please note that we cannot check your
individual entries We have provided all the
documentation for you to make this process as
easy as possible
It is your responsibility to ensure that the
information on your BANT profile is correct and
in line with the rules and regulations that affect
NT practice
Dear Members
August can be a quiet month but welsquove still
managed to put together another informative
and interesting issue with the topic of month
being Cardiovascular Health
Our featured article has been written by
Dr Dicken Weatherby and you will have an
chance to see him and Dr Kara Fitzgerald
speak at the BANTNutrition Geeks seminar
on CARDIOVASCULAR HEALTH amp STRESS - A
FUNCTIONAL PERSPECTIVE being held in
October httpcvdandstresseventbritecom
Thanks to the hard work of Ann Sinclair we
have been able to launch a new networking
group specifically for student members within
Page 2 of 13 Regional Co-ordinators Update Overall August has been a quieter month for many
practitioners due to the holiday season Next regional
co-ordinator group meetings are planned for Sept
A new round of conference calls for co-ordinators only
has been scheduled to share updates and exchange
information (you should have received an email
on 19th July 2011 from Lara Just on
pr-regionsbantorguk)
Option 1 Thursday 1st Sept 2011 730-830pm
- Still available
Option 2 Saturday 3rd Sept 2011 1000-1100am
- Still available
Option 3 Tuesday 20th Sept 2011 730-830pm
- Full
Option 4 Wednesday 21st Sept 2011 730-830pm
- 2 places left
If regional co-ordinators have not signed up for one of
them please get back to us
Practitioners are advised to see these regional
groups as opportunities to collaborate and share their
extended networks of contacts These meetings are
not obligatory but it is recommended that you try to
attend at least two meetings per year Ideally try to
aim for 4 times per year (quarterly) Not all regions
are represented We have currently 45 regional
co-ordinators (including student co-ordinators)
BANT Student Members - Preparing for Practice
BANT is pleased to launch a new networking group
specifically for student members within the Regional
Co-ordinators programme The aim of the group is to
help NT students prepare for practice - by building a
network of contacts in the profession sharing
concerns ideas and knowledge about the practical
challenges of setting up a practice and finding work
It also hopes to involve other healthcare professionals
to help students understand how to build and utilise
networks of contacts outside NT to help grow their
businesses when they qualify The group is being
set up by Ann Sinclair a University of Westminster
student member of BANT who volunteered to be part
of the Regional Co-ordinator team last year Nearly
100 student members have already indicated their
interest in getting involved in the group with initial
discussions now taking place to design a programme
of activities and events to meet their needs as they
study and prepare to qualify If you are interested
in finding out more or would like to share your
experience of setting up practice or your expertise in
a particular area of nutritional therapy with the group
please email Ann Sinclair at studentsbantorguk
for more information
If you would like to find the co-ordinator nearest to
your region please go to
wwwbantorgukbantjspregionalCoordinatorsfaces
If you donlsquot have a group near you and you would like
to become a BANT regional co-ordinator please
contact pr-regionsbantorguk
Lara Just
Head of BANT Regional Co-ordinators
Recipe of the Month If you would like to send us a good recipe preferably with a picture to feature in our e -newsletter
please email theadministratorbantorguk
FREE FROM PRAWN AND MONKFISH WITH LEMONGRASS
Recipe taken from the Free From website at the following link
wwwfreefromrecipesmattercomrecipesfm_fishprawn_monkfishhtml
Wheat gluten corn nightshade soya
dairy amp egg free
Serves 6
2 tbsp olive oil
1 large2 medium onions very finely
chopped
75g 3oz small button mushrooms finely
sliced
400g 14oz jasmine or basmati rice
Approx 1 litre 34fl oz glutenwheat -free
vegetable or fish stock
50g 2oz baby spinach leaves
sea salt and freshly ground black pepper
1 stick fresh lemon grass cut in half
lengthways
400ml 13 12fl oz coconut milk
juice 2 limes
400g 14oz monkfish cut in large cubes
200g 7oz fresh large prawns (shrimp)
Handful fresh coriander (cilantro) chopped coarsely
Heat the oil in a wide pan and add the onions Cook very gently for at least 5 minutes or until the
onions are starting to soften
Add the mushrooms and continue to cook very gently for a further 5ndash6 minutes
Add the rice stir around well and then cover with the stock
Cook fairly briskly for 10ndash15 minutes or until the liquid has been absorbed Add extra stock if
need be
Just before all the liquid is absorbed scatter the baby spinach leaves over the rice and gently mix
them in ndash they will wilt and cook in the heat of the rice
Season to taste set aside and keep warm
Meanwhile in another wide pan heat the lemon grass in the coconut milk Simmer very gently to
allow the lemon grass to infuse the coconut milk thoroughly
Add the lime juice the monkfish and the prawns (shrimps) and continue to cook gently for 3ndash4
minutes or until they are cooked ndash do not over cook
Adjust the seasoning of the sauce to taste then serve with the rice scattering the chopped
coriander (cilantro) over both
Naturally occurring with a breakthrough patented water-based delivery
system to support gut and immune health wwwsymprovecom
Page 3 of 13 CPD Committee Update
New BANT CPD Committee Members
We would like to welcome Jacqui Merridew to the CPD committee
Jacqui Merridew is a nutritional therapist who has been involved in the
governmentlsquos Change4Lifelsquo program and also works as a trainer and
lecturer in nutritional therapy
We look forward to working with them
CPD Events
Currently the BANT Members web page has over 40 events at various
locations for our members to attend You can access all seminars
conferencesDVDs at
wwwbantorgukbantjspmemberCPDandconferencesfaces
Too busy to travel
Then why not increase your CPD hours by watching a DVD we currently
have four to choose from
Dont forget
The BANT members web page is regularly updated so keep checking for
new events
So if you have not yet logged CPD for 2011 take a look at the BANT
web pages and start recording your CPD today
If you do need help using the log for the first time or if you would like more
information as to why CPD is an important part of your professional
practice then please refer to the documents located on your BANT home
page you can access when you log in to the BANT website
wwwbantorgukbantjsploginfaces
We also welcome your feedback on all aspects of CPD so please email
cpdbantorguk
Jeraldine Curran Chair of CPD Committee
cpdbantorguk
The toolkit notes have now been out for over four months plus you have the
more recently published rules and regulations slides so lots of information to
digest and take on board
We are still receiving regular requests from members asking ARC to review
or check copy This isnlsquot something that we can offer to members As with all
the BANT committees the work we do is mainly voluntary so we simply donlsquot
have the manpower to offer a tailored copy advice service You can however
use the FREE copy advice service offered by CAP
httpcopyadviceorgukAd-AdviceBespoke-Copy-Adviceaspx
We used this service extensively in putting together the guidelines You will
have to register on their website to do so but we really recommend that you
do Some members have expressed concern that by registering on the CAP
website it will in some way put them on the radar and open their website to
greater scrutiny From all our dealings with CAP and the ASA we would say
this simply isnlsquot the case In fact the more advice queries that are raised
with CAP the more they will see us as a responsible profession Whatlsquos
more if you can let us know what advice was received what was allowed
and what was disallowed this will enable us to build a more accurate picture
of what CAP are thinking and to know where precedents have been set and
if there is ever contradictory advice This will be very helpful to ARC in our
future dealings with the ASA on your behalf and we can build a greater
knowledge bank and add to the FAQs we already have
We do want to reiterate that members have a responsibility to check their
own websites social media sites leaflets and any other marketing materials
and to change them to make sure that they comply with the ASA rules We
are aware that there are still many websites that donlsquot yet comply which
is going to leave you as individuals and us as a profession open to
unwarranted criticism Letlsquos lead by example whether we agree with the
rules or not letlsquos show that we are a responsible profession How about we
all give ourselves a deadline of the end of September to have everything
updated and in order
Angela Walker - Chair of ARC
ARC Update
Lactose and Gluten Free Symprove is breaking new ground in the way next
generation probiotics support digestive wellbeing wwwsymprovecom
Page 4 of 13 News from the Professional Practice Committee Professional Practice FAQs
The Professional Practice Committee (PPC) is currently working to prepare a set of Professional Practice FAQs to post on the PPC page of the BANT
website We are often asked the same or similar questions more than once and rather than repeatedly sending out the same answers we feel that it
would make sense for members to able to check on the website first before having to approach us It also means that if we do receive duplicate queries
we can very quickly direct members to where the answer is available Then as further suitable queries come in we will add them to the FAQs and so
build a body of information to support the guidelines laid out in the Code of Professional Practice We expect the Professional Practice FAQ page to go
live some time towards the end of September and we will inform members when this has happened
PPC September FAQ
We have been approached a number of times by members who are concerned that a complaint may be about to be lodged against them asking whether
there are any particular measures they need to take
If you feel for some reason that a client or past client is likely to lodge a complaint against you the PPC would suggest that you make sure your case
notes relating to that client are in good order and that you keep copies of all correspondence that you have with the client making a signed note of
anything that is said on the telephone We would also suggest that you inform your insurer that you are concerned that a client may be preparing a
complaint against you
A direct approach made to a client as soon as possible asking what it is they are not happy about can often calm things down and avert a formal
complaint An offer of a refund or a further consultation if you feel it is justified may help to rectify the situation
Alison Belsham - Chair of Professional Practice Committee
CNHC Appoints New CEO CNHC has appointed a new Chief Executive From 1 September 2011 Margaret Coats takes up post as Interim CEO and Registrar Her immediate past
position was as CEO at the General Chiropractic Council a position she held for eleven years Prior to that her roles includ ed that of CEO of the
Occupational Standards Council for Health amp Social Care and Head of the NHS Open Learning Unit
Margaret brings a wealth of experience to her new role from both the health and occupational standards sectors Having been w orking until recently in
the statutory arm of professional regulation she looks forward to the challenges and rewards associated with managing a volun tary regulator Maggy
Wallace CNHC Chair said ―I know that I can speak on behalf of the whole Board of Directors when I say how pleased we are that Margaret is joining us
CNHC is moving into new phase of its evolution and we anticipate benefitting hugely from Margaretlsquos knowledge and experience All organisations benefit
from fresh eyes and approaches to help move them forward especially at times of significant political and regulatory change such as those we are
currently experiencing
Margaretlsquos experience will be particularly valuable in supporting CNHClsquos on -going involvement with the Council for Healthcare Regulatory Excellence
(CHRE) as that body develops its own new role as the Professional Standards Authority (PSA) for Health and Social Care CHRElsquo s remit is to bring all
of health care regulation under the wing of the PSA CNHC is already actively participating in the current discussions with i nterested parties as it has
valuable experience to share from its work with and experience in the complementary healthcare sector Margaretlsquos knowledge and experience will
enhance that which has already been acquired
Maggy Wallace CNHC Chair also expressed thanks to Maggie Dunn who steps down as CEO on 31 August ―Maggielsquos unstinting com mitment to
getting CNHC up and running as an effective body has been exemplary Maggie has been a real pleasure to work with and we are delighted that she
remains on the Board of Directors and will continue to build and maintain links with professional colleagues
REMINDER - Learning Zone Challenge to BANT Members The BANT Learning Zone challenge for full members
So you think you know Functional Medicine (FM) and its approaches Test your knowledge at the Learning Zone
as a way of enhancing your knowledge or just seeing what you know maybe over a cup of coffee or with friends
No two tests are the same so each time you take a test you will get a fresh approach to teasing your brain cells
The BANT Learning Zone challenge for student members
SO you think you know FM and your training providers have prepared you for its challenges Well we dare you to
find out how much you know or even to find out how much you may still need to learn about FM
At no time will there be a recording in any shape or form of either the number of attempts made to pass the
modules or any of your scores below the pass rate of 80 Your result is only recorded when you pass a module
at which point you will receive a certificate of achievement If the unthinkable happens no one will know other than
you so WHY NOT TAKE THE LEARNING ZONE CHALLENGE and get a certificate that really means something
The online Learning Zone was launched on the 1st of July 2011 containing 3 FM modules These 3 FM modules
are compulsory for Associate Members as they form a critical part of the APLAPEL assessment process However these online modules are
currently voluntary for full and student members of BANT
These online modules should be viewed as a resource for BANT practitioners to show a) they are up to date and b) a tool which BANT can use for
assessing new membership applications In the light of the criticisms over nutritional therapists using genetic testing BANT did assure the Human
Genetics Commission that those using these tests would be up to date As practice changes we need to have mechanisms in place to get everyone
together if BANT has to organise its own courses in post-genome nutrition It is envisaged that many more carefully chosen modules will be developed
and added to the Learning Zone over the next few years
In time the modules should be seen as a resource to be used for revalidation There is no requirement for revalidation yet particularly for those who have
gone through the NTC Grandparenting process
1 in 10 of you will need Symprove at some stage in your life Many people
already know what Symprove does for them wwwsymprovecom
Page 5 of 13
Help contribute to the content of the e-Newsletter
We are looking for members who have specialised experience
in dealing with certain health conditions
You would be able submit a lead article on the subject
Provide references to articles and papers on the subject
Useful websites and links that cover the subject
Webinars podcasts or videos on the subject
Any other useful information on the subject
If you feel that you would like to help us by contributing please contact us
Melanie at theadministratorbantorguk or Catherine at bantchairbantorguk for more details
Get Involved - Contribute to the BANT e-Newsletter
REMINDER - Online Renewals to be Implemented 1st October 2011
BANT is working hard to develop online renewal processing in time for 1 October 2011 The system will initially be rolled out for membership renewals
and we will then be looking at processing all membership applications online by 1 October 2012 The online renewal system wil l only take card payments
and it will be essential for all members to have an active email address and also have registered their details to access the members only section The
link to register your details can be found at wwwbantorgukbantjspregister faces
For those of you who have a standing order set up to pay BANT each year please can you contact your bank as soon as possible to cancel the
arrangement We are unable to do this for you as a standing order is entirely under your control If you do not cancel your standing order the
payment will be still debited from your account but this will NOT mean that you have renewed your membership It will however take up a lot of
our time and complicate our financial records if we need to refund standing order payments that have not been cancelled Over the next few weeks we
will be emailing all members who have an existing standing order to remind them to cancel the arrangement
From this renewal year all student members will also be required to renew their membership each year for a fee of pound20 We are delighted to inform you
that we will keeping our full member renewal fees at pound75 ndash this will be the 8th consecutive year that BANT has kept the full member fee at pound75
Interested in being part of this exciting new technology First 100 to
contactsymprovecom receive a free bottle wwwsymprovecom
Page 6 of 13
Statin Drugs Cholesterol and Heart Disease Myth versus Reality
By Dicken Weatherby ND and Donald R Yance MH CN
Pfizer and Merck are continuing their efforts to have the commonly prescribed Statin medications Lipitor and Mevacor approved for over the counter use
Currently these drugs are made available in the US only with a physicianlsquos prescription In the US the Food and Drug Adminis tration or FDA has turned
down three times Mercklsquos application to make Mevacor one of the first statin drugs available without a prescription The pa nel that made this decision
the third time raised concerns that patients would turn to statin drugs instead of seeking a physicianlsquos care Itlsquos good news that the FDA isnlsquot giving the
green light to widespread over-the-counter drug use despite the heavy sway of advertising that would have people believe statin drugs are a safe
panacea for preventing cardiovascular disease We know most of you reading this already understand the misinformation being f oisted on the public
regarding statin drugs but we thought welsquod take this opportunity to review some the myths and the realities behind this issue so you can properly consult
with your patients and clients
Dispelling some of the myths regarding statin drugs cholesterol and heart disease
MYTH 1
ldquoHigh cholesterol (and LDL) is the number-one cause of heart disease in the Westrdquo
Wrong High cholesterol is among the risk factors for heart disease but is not the leading risk factor The most prevalent r isk factor is low HDL along
with small LDL particles which commonly occur together In fact of every 100 people with coronary heart disease 60-70 will have low HDL and small
LDL particles but fewer than 30 will have high LDL If this is the case why do we not hear more about low HDL and small LDL particles The answer is
simple because treating these is not as profitable for drug companies But just waitmdashwhen a profitable drug becomes available to treat this more
prevalent risk factor for heart disease we can expect to hear about an ―epidemic that will justify billions of dollars in new drug expenditures1-4
What qualifies as low HDL National guidelines say it is a level of less than 40 mgdL for men and less than 45 mgdL for wom en5 In fact a level of
less than 60 mgdL is probably very significant6 HDL is already a standard measure in everyday cholesterol panels Small LDL particles on the other
hand need to be measured specifically The medical world focuses on statin therapy for LDL while the most prevalent risk factor for heart disease goes
untreated in the great majority of cases
MYTH 2
ldquoIf I take a statin agent I wonrsquot have a heart attackrdquo
This is simply untrue Lowering cholesterol (even to rock-bottom levels) reduces but does not eliminate the risk of heart attacks Many heart attacks still
occur in people with low cholesterol levels whether or not they take cholesterol-lowering drugs7 We must consider that there are other risk factors for
heart disease besides cholesterol such as small LDL particles low HDL high fibrinogen high homocysteine and high insulin levels Results from the
most recent National Health and Nutritional Survey show that 47 million US adults have metabolic syndrome (low HDL high trig lycerides high blood
pressure excess abdominal fat) which substantially heightens the risk of heart disease even in the presence of low cholesterol levels8
MYTH 3
ldquoI feel fine and my stress test was normal My doctor says I donrsquot have heart diseaserdquo
This is among the most widely propagated fallacies spread by many primary care physicians and even cardiologists First lack of symptoms should not
be reassuring as most heart disease is silentmdashwithout symptoms and undetectable by conventional means such as electrocardiograms and cholesterol
testing Second stress testing is a miserable failure for screening asymptomatic people Most future deaths and heart attack s in fact occur in people
with normal stress tests (when symptoms are not present) The net result of this misperception is that most future heart -attack victims are walking around
feeling fine and unaware of their risk9 Cholesterol can be high low or in between but all too frequently fails to shed light on this murky situation
Cholesterol the lipid with a bad reputation
Hyperlipidemia refers to elevated blood levels of lipids (fats) including cholesterol and triglycerides Most people with hy perlipidemia have no symptoms
However hyperlipidemia is a contributing factor associated with an increased risk of coronary heart disease (CHD) a thicken ing or hardening of the
arteries that supply blood to the heart muscle CHD in turn can result in angina pectoris (chest pain) a heart attack or both Although hyperlipidemia is
considered a risk factor to heart disease it is one of many risk factors and what actually causes hyperlipidemia is a debatable issue It not as simple as
foods that contain cholesterol elevate lipids
Another important risk factor which has been largely overlooked is the oxidation of low -density lipoprotein (LDL) cholesterol caused from a lack of
antioxidant-rich foods herbs and nutrients andor a large intake of foods and chemicals that contains damaging free radicals Chronic inflammation also
contributes to oxidative stress and an increase in CHD When LDL cholesterol oxidizes it promotes atherosclerosis by a proc ess referred to as the
macrophage-foam cell mechanism particularly in the presence of stressors like cortisol and insulin Cortisol and insulin together act as a dynamic
duel causing all kinds of disruptions including an increased oxidative and inflammatory state These are the real underline causes to chronic disease
Inflammation is also involved in the process of LDL oxidation and contributes to the development of vascular disease 10-13 Ideally LDL levels should be
kept under 120 mgdL and you should monitor your patients for oxidative activity especially lipid peroxidation
The production of C-reactive protein is an essential part of the inflammatory process and the measurement of this substance reflects the level of
inflammatory activity deep within the body It appears that certain conditions create a state of excessive inflammation withi n the circulatory system High
C-reactive protein levels are evidence of this type of inflammation 14-17 Ideally it is best to keep C-reactive protein levels below 055 mgL in men and 15
Featured Article by Dicken Weatherby on Cardiovascular Health
Page 7 of 13
mgL in women Please note that the reference ranges above refer to the High Sensitivity CRP or hs -CRP test
Multiple risk markers for atherosclerosis and cardiovascular disease act in a synergistic way through inflammatory pathways The following lists the
different factors that have been identified as risk factors for CHD and arterial damage
Elevated CRP
Elevated LDL
Excess Insulin
Low HDL
High Glucose
Nitric Oxide Deficit
Excess Triglycerides
Low Free Testosterone
Excess Fibrinogen
Excess Homocysteine
Hypertension
Low Vitamin K
Excess Cholesterol
There are many key inflammatory biochemical risk markers for cardiovascular disease in particular the role of three basic c ell types affected by
these risk markers (endothelial cells smooth muscle cells and immune cells) the crucial role of inflammatory mediators ni tric oxide balance in
cardiovascular pathology and the use of nutrients (flavanoids carotenoids sterols vitamin C and E Omega 3 fatty acids et c) to circumvent several of
these inflammatory pathways Most of the above risk markers for cardiovascular disease have a pro -inflammatory component which stimulates the
release of a number of active molecules such as inflammatory mediators reactive oxygen species nitric oxide and peroxynitr ite from endothelial
vascular smooth muscle and immune cells in response to injury Nitric oxide plays a pivotal role in preventing the progressi on of atherosclerosis through
its ability to induce vasodilation suppress vascular smooth muscle proli feration and reduce vascular lesion formation Nutr ients such as arginine
antioxidants (OPCs vitamins C and E lipoic acid selenium glutathione) and enzyme cofactors (vitamins B2 and B3 B6 B12 folate zinc) help to
elevate nitric oxide levels and may play an important role in the management of cardiovascular disease Other dietary components such as DHAEPA
from fish oil tocotrienols vitamins B6 and B12 and quercetin contribute further to mitigating the inflammatory process 18
Within the broad range of cholesterol levels from 180 to 240 there is little to no evidence that this alone correlates with h eart disease Below 180 there is
increased risk of hemorrhagic stroke depression and suicide Above 240 there is increased risk of cardiovascular disease an d ischemic stroke Over age
70 elevated cholesterol and cardiovascular events no longer correlate All told total serum cholesterol alone is a poor ind icator of cardiovascular disease
Half of all heart attack patients have normal total cholesterol levels
So not only do statin drugs have their inherent drawbacks but in some ways they are treating a fabricated problem based on misunderstood and
misrepresented ―research As natural health care providers we know that we must be wary of the current cholesterol hysteria we must be able to
explain the real evidence and we must help our patients understand the facts so they can make educated health choices
Dicken Weatherby ND is originally from Oxfordshire in the UK and is based in Ashland Oregon USA A graduate of the National College of Natural
Medicine Dicken is author of the bestselling book Blood Chemistry and CBC Analysis -Clinical Laboratory Testing from a Functional Perspective He
has self-published seven other books in the field of alternative medical diagnosis has created numerous information products and runs a number of
successful Web sites including wwwFMTowncom an online membership community for practitioners interested in Functional Medicine and
Functional Diagnosis Dr Weatherby is the creator of the ldquoFoundations of Functional Diagnosis Training Programrdquo at wwwFunctionalDiagnosiscom and
the ldquoFoundations of Functional Blood Chemistry Analysisrdquo Training Program at wwwBloodChemistryTrainingcom
Donald R Yance CN MH RH is an internationally known herbalist and nutritionist He is the founder and medical director of the Centre for Natural
Healing in Ashland Ore Through extensive research and clinical practice he has developed his Triphasic system which forms the cornerstone of his
clinical approach Donald is the founder and formulator of Natura Health Products and founder and president of The Mederi Fo undation whose
programs promote health education and clinical research on the use of natural medicine with an emphasis in the field of integrative oncology
References
1 Gardner CD Fortmann SP Krauss RM Association of small low-density lipoprotein particles with the incidence of coronary artery disease in
men and women JAMA 1996 Sep 18276(11)875-81
2 Stampfer MJ Krauss RM Ma J et al A prospective study of triglyceride level low- density lipoprotein particle diameter and risk of myocardial
infarction JAMA 1996 Sep 18276(11)882-88
3 Lamarche B Tchernof A Moorjani S et al Small dense low-density lipoprotein particles as a predictor of the risk of ischemic heart disease in
men Prospective results from the Quebec Cardiovascular Study Circulation 1997 Jan 795(1)69 -75
4 Kuller L Tracy P Arnold A et al Nuclear magnetic resonance spectroscopy of lipoproteins and risk of coronary heart diseas e in the
cardiovascular health study Arterioscler Thromb Vasc Biol 2002 Jul 122(7)1175 -80
5 Expert Panel on Detection Evaluation and Treatment of High Blood Cholesterol in Adults Executive summary of the third report of the national
cholesterol education program (NCEP) expert panel on detection evaluation and treatment of high blood cholesterol in adults (Adult Treatment
Panel III) JAMA 2001 May 16285(19)2486-97
Featured Article by Dicken Weatherby on Cardiovascular Health
BANT - the seal of excellence for nutrition health professionals
We are pleased to let you all know that Dicken will be speaking at our seminar on 29th October 2011 - donrsquot miss it or you will
miss out Book your tickets now as they are selling fast wwwbantorgukbantjspNGseminarvideosfaces
Page 8 of 13
6 Gotto AM Brinton EA Assessing low levels of high-density lipoprotein cholesterol as a risk factor in coronary heart disease J Am Coll Cardiol
2004 Mar 343(5)717-24
7 van Lennep JE Westerveld HT Van Lennep HW Zwinderman AH Erkelens DW van der Wall EE Apolipoprotein concentrations durin g treat
ment and recurrent coronary artery disease events Arterioscler Thromb Vasc Biol 2000 Nov20(11)2408 -13
8 Ford ES Giles WH Dietz WH Prevalence of the metabolic syndrome among US adults findings from the third National Health an d Nutrition
Examination Survey JAMA 2002 Jan 16287(3)356-9
9 Taylor AJ Merz CN Udelson JE 34th Bethesda Conference ―Can atherosclerosis imaging techniques improve the detection of pa tients at risk
for ischemic heart disease J Amer Coll Cardiol 2003 Jun 4(11)411860 -2
10 Rifai N Ridker PM Inflammatory markers and coronary heart disease Curr Opin Lipidol 2002 Aug13(4)383-9
11 Albert CM et al Prospective study of C-reactive protein homocysteine and plasma lipid levels as predictors of sudden cardiac death
Circulation 2002 Jun 4105 (22)2595-9
12 Bermudez EA Ridker PM C-reactive protein statins and the primary prevention of atherosclerotic cardiovascular disease Prev Cardiol 2002
Winter5(1)42-6
13 Schroecksnadel K Frick B Winkler C Fuchs D Crucial role of interferon-gamma and stimulated macrophages in cardiovascular disease Curr
Vasc Pharmacol 2006 Jul4(3)205-13
14 Rifai N Ridker PM Inflammatory markers and coronary heart disease Curr Opin Lipidol 2002 Aug13(4)383-9
15 Albert CM et al Prospective study of C-reactive protein homocysteine and plasma lipid levels as predictors of sudden cardiac death
Circulation 2002 Jun 4105 (22)2595-9
16 Bermudez EA Ridker PM C-reactive protein statins and the primary prevention of atherosclerotic cardiovascular disease Prev Cardiol 2002
Winter5(1)42-6
17 Blake GJ Ridker PM Inflammatory mechanisms in atherosclerosis from laboratory evidence to clinical application Ital Heart J 2001 Nov2
(11)796-800
18 Osiecki HE The role of chronic inflammation in cardiovascular disease and its regulation by nutrients Altern Med Rev 2004 Mar9(1)32-53
Conversion Table This will help you to convert the markers in this article from US units into units used on UK blood tests
Reference ranges given are typical but may vary depending on lab used Eg Biolab given reference range for cholesterol is that target should be below
4 to 5 depending on clinical factors
Featured Article by Dicken Weatherby on Cardiovascular Health
Studies
CHIA SEEDS MAY OFFER OMEGA-3 HEART AND LIVER BENEFITS STUDY
wwwnutraingredients-usacomHealth-condition-categoriesCardiovascular-
healthChia-seeds-may-offer-omega-3-heart-and-liver-benefits-Study
c=TRR9CYYlHK48nEzv7WRu8CTrplNtVNvfamputm_source=Newsletter_Productampu
tm_medium=emailamputm_campaign=Newsletter2BProduct
DORMANT ANTIOXIDANT HAS lsquoUNPARALLELEDrsquo BENEFITS
wwwnutraingredients-usacomHealth-condition-categoriesCardiovascular-
healthDormant -antioxidant-has-unparalleled-benefits
WHOLE MANGOSTEEN FRUIT AND ITS BENEFITS
wwwthewholefruitcomstructure_functionphp
The early research on the whole mangosteen fruit and its numerous
nutritional components is both promising and precise Feel like digging in
Herelsquos a snapshotmdashjust a small samplemdashof the studies that back the
impressive edge of whole mangosteen formulation and supplementation
Neutralizes Free Radicals
Supports a Healthy Cardiovascular System
Supports Cartilage and Joint Function
Strengthens the Immune System
Promotes a Healthy Seasonal Respiratory System
Maintains Intestinal Health
Other Supportive Papers
Monthly ReportsStudiesWebinarsVideocasts
Publications
Destination 2020 - A Plan for Cardiac and Vascular Health
wwwbhforgukpublicationsview-publicationaspxps=1000855
Webinars
You need to register your details before you can access these webi-
nars FREE OF CHARGE
2010 State-of-the-Art Webinar Series in Cardiovascular Disease
Webinar I
Webinar II
Webinar III
Videocasts
Vitamin D cardiovascular disease and cancer emerging evi-
dence [electronic resource] JoAnn E Manson
httpvideocastnihgovlaunchasp15689
Heart failure in women
httpvideocastnihgovlaunchasp15838
Demystifying Medicine - Cardiovascular disease in the eras of
imaging and stem cells
httpvideocastnihgovlaunchasp16573
Demystifying Medicine - Arteriosclerotic cardiovascular disease
Number one killer and the Framingham experience
httpvideocastnihgovlaunchasp14936
US reference range To convert from US to UK UK units
Cholesterol 150-220 mgdL Multiple by 002586 336-52 mmoll
HDL 40-90 mgdL Multiple by 002586 103-232 mmol
LDL 60-130 mgdL Multiple by 002586 155 ndash 336 mmoll
BANT sponsors a 2 day seminar on cPNI on 8-9 of Sep 2011
organised by Bonusan under the auspices of the Natura Foundation
wwwbantorgukbantjspmemberpdfseminarsBONUSAN_CPNIpdf
Page 9 of 13
On Saturday 21st May the Alliance for Natural Health International supported by the GNC and BANT held its first
training and education day for practitioners helping them through the minefield of legislative requirements facing the
natural health sector The conference was well attended by over 240 practitioners whose feedback confirms that the
information was critical to their ability to manage their practices compliantly in the future and was summed up succinctly
by one of the delegates
I think the conference today really hits the mark in terms of tak ing a very complex set of regulations and putting it into a
digestible form for practitioners laying out not only the regulations but also the practical side of how we live within thi s
new regulatory environment
Kathleen Devereaux
We understand that many were not able to attend the conference in person but as promised we have now produced a full download of the daylsquos
sessions in video format which includes the pre-reading pack sent to delegates a comprehensive delegate volume of notes covering the days event and
an extensive reference list of supporting documentation We know its been a few weeks since the event but it takes time to p rofessionally edit the raw
footage so we hope that youll now feel part of it as if you had actually been there with us
Having attended the ANH conference I was able to get a real picture about the Rules and Regulations NTs are up against Understanding this legislation
and how it affects NT practice is an important part of being a responsible NT We need to learn the language of these new rul es and in doing so feel
empowered and in control of our work environment This conference DVD and info should be an essential part of your NT toolk it
Melanie de Grooth BANT AdministratorGeneral Manager
This comprehensive package costs pound40 with proceeds going to the ANH campaign fund and is available to practitioners and student practitioners only
Those practitioners who are going to be successful in this new environment will need to uniquely express themselves according to their qualifications and
experience A me too approach where everyone says the same things is not going to allow you to stand out from the crowd At the heart of this is an
understanding of the principles behind the rules and regulations as well as solutions allowing you to not fall foul of it Provided in the printed and video
outputs from our seminar are all the basics youll need to move confidently forward in this difficult and confusing regulatory climate and we will be
following up with more support in due course
As NT practitioners we are facing a maze of rules and regulations that will affect how we work in the future I therefore urge you all to purchase the must
have DVD from the recent excellent ANH training conference entitled Rules and Regulations in Clinical Practice Developing your Practice in Spite of the
EU Regulatory Juggernaut This is an extremely useful toolk it for your practice and will assist you in understanding these l egislative changes
Catherine Honeywell - Chair BANT Council
PURCHASE DOWNLOAD - wwwanh-europeorgrules-and-regulations-training-buy-download We also invite you to sign up for our regular
eAlerts wwwanh-europeorguserregister and to check out our practitioner pages - wwwanh-europeorgpractitioners
Thank you ANH-Intl
ANH-Intl Rules and Regulations DVD Now on Sale
BANT Page on Rules and Regulations If you have not already done so please make sure you access the presentations we have
provided on Rule and Regulations Affecting NT Practice and Understanding the Scope and
Definition for Medicinal Claims
An incredible amount of time and effort has gone into this project and we are sure that you will
now easily be able to navigate your way through the complicated array of rules and regulations
that impact on our practise of Nutritional Therapy
We would like to thank ANH-Intl and give credit to them for auditing and contributing the source
materials which BANT has interpreted and presented in this unique format The format and
presentation are the copyright of BANT and should not be reproduced without prior permission
We would also like to give a special thank you to Louise Carder who tirelessly gave of her time
and expertise to help BANT produce these slides ndash thank you Louise
You can access these slides at the following link wwwbantorgukbantjspmemberrulesRegulation faces
They have been designed for best use online You can of course print them out but you will then not be able to benefit from using the hyperlinks for
navigation Please take some time out of your busy schedules to carefully work and read through these slides This informati on is an essential part of
you Nutritional Therapy toolkit and will help you to be a better and more responsible practitioner
Understanding these Rules and Regulations will not only empower you as a practitioner but will
also demonstrate your level of commitment to your clients and the profession
From time to time we will update the content of the slides but will always let you know when this
has been done
IMPORTANT
After the renewals in October all full members will be emailed a copy of what you currently state
on you BANT profile under Special Interests and Further Information It will be your responsi-
bility to check the information is correct in relation to the ASA Rules and the Rules and
Regulations affecting NT practice Use this link to access the ARC Toolkit and FAQs on the
ASA rules wwwbantorgukbantjspmemberASARulesfaces
Page 10 of
FoodInfo Online Features 1 April 2011
httpwwwfoodsciencecentralcomfscixid16088
copy IFIS Publishing 2011 - All Rights Reserved
From pharm to fork in the nutrigenomic era is it food or medicine
Susan A McGinty and Dominic Man
London South Bank University 103 Borough Road London SE1 0AA
1 Introduction
The foodmedicine boundary has long been opaque with responsibility for medicines and food regulation coming under different European Commission
directorates This has led to a lack of integration at the EU level between food and medicine which has been further exacerbat ed by a lack of
harmonisation of implementation at Member State level of EU food law From 1 May the EU Traditional and Herbal Medicines Products Directive
(THMPD) comes fully into force and the elements of a perfect stormlsquo may be moving into place Manufacturers will no longer be able to supply
unlicensed herbal medicines to the public The European Medicines Agencylsquos (EMEA) has a database of medicinal herbs which includes inter
alia sage thyme garlic onion cinnamon pumpkin seed linseed juniper berry peppermint leaf and aniseed The UKlsquos Medicines and Healthcare
Products Regulatory Agency (MHRA) has published its own list of herbs and classifies them as medicinefoodcosmetic - also reflecting the problem of
the regulation of products and claims for cosmeceuticals From May 2011 ―it is the competence and responsibility of national authorities to decide on a
case by case basis whether a herbal product fulfils the definition of medicinal product A survey of the fundamental definitions clarifications by the
European Court of Justice (ECJ) and an examination of the European Councillsquos homeostasis model spotlights areas which may nee d to be reconciled if
the overall regulatory framework is capable of adapting to the era of systems biology and personalised medicinenutrition i ncluding dermagenetics
2 The devil in the detail the definitions
21 Food
Article 2 of EC 1782002 defines food including supplements as ―any substance or product whether processed partially processed or unprocessed
intended to be or reasonably expected to be ingested by humans This definition is straightforward but allows interpretation of reasonably expectedlsquo to
determine a medicinal product where dosagelsquo may be seen as a critical element ndash see later
22 Medicine bdquoform‟ and bdquofunction‟
Directive 200183EC of 6 November 2001 defined a medicine as either ―any substance or combination of substances presented for treating or
preventing disease in human beings or ―any substance or combination of substances which may be administered to human beings with a view to making
a diagnosis or to restoring correcting or modifying physiological balance in human beings This linked marketing activities and intention of consumption
to medicinal functionality In 2004 Directive 200427EC amended the definition of a medicine to ―any substance or combination of substances
presented as having properties for treating or preventing disease in human beings or any substance or combination of substances which may be used
in or administered to human beings either with a view to restoring correcting or modifying physiological functions by exerting a pharmacological
immunological or metabolic action or to making a medical diagnosis Article 22 of the 2004 Directive goes on to state ―In cases of doubt where
taking into account all its characteristics a product may fall within the definition of a medicinal productlsquo and within the definition of a product covered by
other Community legislation the provisions of this Directive shall apply
This definition had the technical effect of making all bioactive food components meet the medicinal standard by function if not by presentation and has
left Member State medicines regulators the EMEA and the European Commissionlsquos Directorate General Enterprise and Industry (DGEI) in the driving
seat as to determining product status and enforcement Nonetheless the ECJ ruled in C-31905 Commission of the European Communities v Federal
Republic of Germany of 15 November 2007 that the definition of a medicinal product by function should be interpreted restrictively since it was des igned
to cover only products whose pharmacological properties have been scientifically observed and not substances which while ha ving an effect on the
human body do not significantly affect the metabolism and thus do not strictly modify the way in which it functions
The formlsquo of a medicine versus a food supplement was also tested in C-31905 in which the Commission accused the Federal Republic of Germany of
breach of its obligations under Articles 28 and 30 of the EC Treaty (free movement of goods) by classifying a garlic preparat ion in capsule form as a
medicinal product The ECJ held that a capsule form was not of itself sufficient to decide whether a product was medicinal that the capsule form is not
exclusive to medicinal products and the product in question only contained natural garlic and could not have any additional e ffects (positive or negative)
compared to garlic in its natural state A medicinal product must have the function of preventing or treating disease beneficial effects for health in general
are not sufficient
The ECJ clarifications pose a fundamental problem for Member State medicines regulators consistently using formlsquo and functi onlsquo as theirbenchmark
standards Pillcapsuletincture forms regularity of consumption defined posology and ADME (absorption distribution metabolism and excretion) and
the accompanying claims have long been the determinants in borderline product adjudications
23 Prevention or disease-risk reduction
The EU has no definition of diseaselsquo in any of its regulatory instruments except for medically diagnosed conditions or using w ider public health
frameworks for measuring disease prevention in terms ofQuality of Life Years (QALYs) and Disability Adjusted Life Years (DALY s) for example It has not
From Pharm to Fork in the Nutrigenomic Era Is It Food or Medicine
BANT - the seal of excellence for nutrition health professionals
Page 11 of From Pharm to Fork in the Nutrigenomic Era Is It Food or Medicine- Cont
adopted a fully transparent and credible suite of biomarkers surrogate or end-markers to establish healthdisease status and bi ofunctionality In the UK
The Medicines Act 1968 (as amended) defines disease as something which ―includes any injury ailment or adverse condition whether of body or
mind The lack of a clear legal definition has been recognised by the ECJ where disease has been intrinsically linked to the definition of a medicinal
product The Court determined in C-36988 on whether eye lotion was a medicinal product or cosmetic (a cosmetic being external but being able to
protectlsquo or keep in good conditionlsquo) that on the basis of scientific knowledge ―it is for the national authorities to dete rmine whether products presented as
counter-acting certain conditions of sensations such as hunger heaviness in the legs tiredness or itching constitute a medic al product
The United States Food and Drug Administration (FDA) in its health claims legislation defines disease as
―Damage to an organ part or structure or system of the body such that it does not function properly (eg cardiovascular dis ease) or a state of health
leading to such dysfunctioning (eg hypertension) except that diseases resulting from essential nutrient deficiencies (eg scurvy pellagra) are not
included in this definition
Proposals for health claims legislation being framed by Food Standards Australia and New Zealand (FSANZ) include definitions for diseaselsquo and serious
diseaselsquo which distinguish in terms both of severity of condition and of level of claim
Disease an unhealthy condition characterised by clinically significant signs or symptoms
Serious disease or condition forms of disease conditions ailments or defects which are generally accepted to be beyond the ability of the
average consumer to evaluate accurately and to treat safely without regular supervision by a suitably qualified health care professional
Where disease-risk reduction relates to one of a number of factors in the aetiology of disease the concept of preventionlsquo itse lf poses a number
of difficulties as like diseaselsquo it is not clearly defined in law
Coppens et al 2001 survey use of preventionlsquo in relation to the first EU Medicines Directive 6565 where prevention has had a history of use in terms
of vaccination and infectious diseases Prevention is a word with an absolute indication and its use is clear and distinct in nature and includes some
statistical certainty nonetheless with chronic diseases there is an overlap where reduction of disease risk pertains to one factor sufficient to prevent the
occurrence likely to be based on epidemiological evidence from studies of population cohorts Coppens et al propose that prevention has three facets
a) Prevention of disease occurrence where
the disease is not (yet) present
the therapy can prevent the occurrence of the disease with substantial statistical certainty
b) Prevention of episodes of the disease where
the disease is present
the therapy decreases the number duration or severity of disease episodes with a substantial statistical certainty
c) Prevention of progression of the patientlsquos underlying disease where
the disease is present
the therapy has been shown to delay the progression of the disease with a substantial statistical certainty
At the other end of the spectrum treatlsquo denotes a purpose of action intention therefore becomes a key determinant in claim status Intention in
consumption is important for the enforcement of health claims where (average) consumer understanding is a factor Consumption of supplemental vitamin
D3 to support bone health or with a substantiated claim reduce the risk of osteoporosis comes under the food domain However consumption of
supplemental vitamin D3 for the purposes of immune-modulation would be medicinal
The principle of disease risk reduction (DRR) as distinct from prevention was incorporated into EU law in EC 19242006 on nutrition and health claims
on food (NHCR) which requires that all structurefunction and DRR claims on food including supplements must be preapproved by the EU Commission
and meet a standard of substantial scientific agreement While the DRR paradigm recognises that chronic disease conditions are the product of multiple
gene-environment influences it nonetheless still must be predicated on what diseaselsquo is in biological terms The EU-funded PASSCLAIM projec t was
tasked with establishing how health claims would be substantiated and to identify functional biomarkers or surrogate end-point markers for use in the
assessment process PASSCLAIM working groups produced reports on diet -related cardiovascular disease bone health and osteoporosis physical
performance and fitness mental state and performance body weight insulin sensitivity and diabetes diet -related cancer and gut health and
immunity At January 2011 the European Food Safety Authority (EFSA) charged with the process of assessing claims is yet to fully clarify its
assessment criteria
24 Functional foods food bioactives and nutraceuticals
While the EU regulates foods containing plant sterolsstanols there is no formal definition of functional foodlsquo The EU FUFOSE project used a working
definition of functional foods that ―affect beneficially one or more target functions in the body beyond adequate nutriti onal effects in a way that is
relevant to either an improved state of health and well -being andor reduction of risk of disease FUFOSE noted that a functional food can be a natural
food one to which a component has been added or removed where a component has been modified or its bioavailability modifie d or any combination or
multiples of all the possibilities Therefore functional foods in the EU must be foods with health claims as defined by the NHCR
BANT sponsors a 2 day seminar on cPNI on 8-9 of Sep 2011
organised by Bonusan under the auspices of the Natura Foundation
wwwbantorgukbantjspmemberpdfseminarsBONUSAN_CPNIpdf
Page 12 of
Although in 2006 the US FDA proposed that the term functional foodlsquo be regulated (21 Code of Federal Regulations Part 101 and Part 170)it still has no
formal definition of that or of nutraceuticallsquo Earlier in 2004 the US Department of Health and Human Services (DHHS) launch ed a consultation on a
proposed definition of bioactive food componentslsquo In its supplementary information to the proposal the DHHS stated that bioactives may have multiple
sites of action may interact with one or more dietary constituents and may act directly or indirectly to produce a functional outcome citing as examples
lycopene long-chain omega-3 fatty acids isoflavones sulphorophane and resveratrol Establishing a definition of a food bioactive was a first step
towards evaluating their significance in promoting health and disease prevention then guiding research priorities and science-based information to help
guide public health policylsquo The definition proposed was
―Bioactive food components are constituents in foods or dietary supplements other than those needed to meet basic human nutr itional needs that are
responsible for changes in health status
As of early 2011 the work on defining food bioactives has not progressed Respondents to the 2004 consultation made strong representations about a
definition of bioactivity which excluded nutrients arguably the most important bioactive category of food components Seventeen written responses were
received in response to the consultation a number of which proposed alternate definitions Common themes in those alternate definitions include use of
the term physiologically activelsquo or physiological benefitlsquo reference to structure functionlsquo and disease -risk reductionlsquo and (ILSI North America) ―as
measured through utilizing appropriate methodology and biomarkers
In January 2011 the US National Academies of Science publishedPerspectives on Biomarker and Surrogate Endpoint Evaluation with recommendations
for establishing a framework for harmonising biomarker use across all areas including drugs and foods
3 Dosage and the homeostasis model what is lsquonormalrsquo
The ECJ Judgement C-8807 of 5 March 2009 determined that substances ―which while having an effect on the human body do not significantly
affect the metabolism and thus do not strictly modify the way in which it functions should not be classified as medicinal products by function
(see Commission v Germany paragraph 60 and Hecht-Pharma paragraph 41) Dosage therefore is a key criterion in determining food from medicine
of botanicals and from May 2011 is likely to be used by national authorities in enforcement This complements the homeostasis model produced by
the European Council in 2008 to distinguish foods and medicinal products The model incorporates the notion of intended use of the product and the
nature of the induced effect food induces the physiological effects characterised by maintainsupportoptimiselsquo and medicine induces the physiological
functions characterised by restorecorrectmodifylsquo It is a self-contained integrated approach but is predicated on the definition of homeostasis being
defined as ldquothe status of a person whose physiological parameters function within the limits considered as normal But while normal
physiological parameters may be defined by (sometimes quite large) reference ranges nutritional prerequisites or dietary ref erence intakes are not fully
harmonised throughout the EU nor do they take account of ancestral or inter-individual variation which characterise different sub-populations The lack
of harmonisation means some EU Member States regard supra -RDA vitamin and mineral supplements as medicines where others including the UK
have taken a more liberal approach The EU-funded EurRECA network of excellence is tasked with developing methodologies and recommendations to
standardise the process of setting pan-EU micronutrient recommendations This will inform progress in setting maximum permitted levels of vitamins and
minerals in food supplements However the extent of inter-individuality may prove problematic in 2007 the UK Committee on Toxicity in its working
group report on variability and uncertainty stated that for vitamins and minerals ―variability in the response of individuals has the potential to result in a
situation which a given level of exposure could be essential for some but toxic for others
What is normallsquo in dietary requirements underpins the basis on which both medicinal and health claims are evaluated namely that a healthy balanced
diet is generally able to provide all micronutrient requirements by normal healthy individuals for health maintenance Two signi ficant sub-populations
however threaten to undermine that approach In the UK the Healthy Start programme administered by statutory instrument by the Department
of Health and National Health Service provides two bespoke Healthy Start-branded vitamin supplements for low income beneficiaries for women free
during pregnancy and up until their baby is one year old and for children from 6 months of age until their fourth birthday Non-beneficiaries can
purchase Healthy Start-branded supplements at low cost from health clinics Health professionals are encouraged to make sure that mothers and
children ―get two important vitamins that they may not be getting in adequate quantities ndash even from a healthy balanced diet These are vitamins A and D
for children and vitamin D and folic acid for women While it is prohibited under the NHCR to claim that a healthy balanced diet cannot in general
provide all nutrients needed there is no such prohibition under medicinal law and the Healthy Startvitamins are marketed under a UK medicines
licence [PL015110003] This conflict adds to the problems of robust implementation of the NHCR which is already stymied by the lack of
A credible transparent system of scientific assessment
An agreed nutrient profiling system
A harmonised pan-EU characterisation of a healthy balanced diet
4 Going forward
Added to the woes of the NHCR looms a new era of personal genomicmetabolomic profiling and personalised nutrition in the for m of P4
medicinelsquo (personalised predictive preventive participatory) In its essence nutrigenomicslsquo incorporates two aspects
The effect of food components on the genome and epigenome
The extent of ancestral and individual variation
If disease can be classified at the molecular level what effect does this have on the meaning of homeostasislsquo and medicine lsquo These key terms need full
and comprehensive definition both in biology and law so that the food -medicine continuum is fully resolved and the foundation is laid for the successful
application of both personalised medicine and personalised nutrition Innovation and continued investment in wellness products by the food industry
depend on a clear consistent and transparent system of claims assessment
From Pharm to Fork in the Nutrigenomic Era Is It Food or Medicine- Cont
Page 13 of 13 Topic of the Month - Cardiovascular Health
Nutri Link Clinical Education - wwwnleducationcouk
They believe in supporting the health care professionals who count on them for
effective nutritional solutions Their team of CAM-leading experts are committed to
providing you with the latest unbiased scientific research and clinical support plus a
vast array of continuing education opportunitieshellipbecause as practitioners they
understand that knowledge is the key to positive patient results
FM Town - wwwfmtowncom
Its all about relevancy Being in a 100 Functional Medicine environment will give
you an opportunity to get direct and immediate access to all the information that is
most relevant to you FMTown is private and highly relevant in its scope of focus
Get connected to an amazing online resource which can grow with you and support
your Functional Medicine Journey
Institute for Functional Medicine - wwwfunctionalmedicineorg
IFM Membership is your gateway to a community of like-minded clinicians and
researchers It is primarily aimed at clinicians and scientists whose interest in
functional medicine is deeply connected to examining the emerging research
attending CME courses discussing issues and patients with colleagues and so
forth Membership helps to build a network of practitioners from many disciplines
who are using and studying functional medicine every day
Food Science Central - wwwfoodsciencecentralcom
Food Science Central is the home of IFIS Publishing on the web Here you can
learn about products and services and access FREE articles on many topics in food
science food technology and nutrition
Monthly ArticlesPapers
ANXIETY AND CARDIOVASCULAR RISK REVIEW OF
EPIDEMIOLOGICAL AND CLINICAL EVIDENCE
O Olafiranye G Jean-Louis F Zizi J Nunes and MT Vincent
wwwncbinlmnihgovpmcarticlesPMC3150179pdfnihms-
301210pdf
POST-TRAUMATIC STRESS DISORDER AND
CARDIOVASCULAR DISEASE
Steven S Coughlin
wwwncbinlmnihgovpmcarticlesPMC3141329pdfTOCMJ-5-
164pdf
STUDIES OF GENE VARIANTS RELATED TO INFLAMMATION
OXIDATIVE STRESS DYSLIPIDEMIA AND OBESITY
IMPLICATIONS FOR A NUTRIGENETIC APPROACH
Maira Ladeia R Curti Patrıcia Jacob Maria Carolina Borges
Marcelo Macedo Rogero and Sandra Roberta G Ferreir
wwwncbinlmnihgovpmcarticlesPMC3136190pdfJOBES2011-
497401pdf
EFFECT OF AN OFFICE WORKSITE-BASED YOGA
PROGRAM ON HEART RATE VARIABILITY A RANDOMIZED
CONTROLLED TRIAL
Birinder S Cheema Paul W Marshall Dennis Chang Ben
Colagiuri and Bianca Machliss
wwwncbinlmnihgovpmcarticlesPMC3154869pdf1471-2458-
11-578pdf
CARDIOVASCULAR COMPLICATIONS IN CKD PATIENTS
ROLE OF OXIDATIVE STRESS
Elvira O Gosmanova and Ngoc-Anh Le
wwwncbinlmnihgovpmcarticlesPMC3022166pdfCRP2011-
156326pdf
TARGETING STEM CELL NICHES AND TRAFFICKING FOR
CARDIOVASCULAR THERAPY
Nicolle Kraumlnkel Gaia Spinetti Silvia Amadesi and Paolo Madeddu
wwwncbinlmnihgovpmcarticlesPMC3017934pdfukmss-
33677pdf
INTERACTION OF SLEEP QUALITY AND PSYCHOS OCIAL
STRESS ON OBESITY IN AFRICAN AMERICANS THE
CARDIOVASCULAR HEALTH EPIDEMIOLOGY STUDY (CHES)
Aurelian Bidulescu Rebecca Din-Dzietham Dorothy L Coverson
Zhimin Chen Yuan-Xiang Meng Sarah G Buxbaum Gary H Gib-
bons Verna L Welch
wwwbiomedcentralcomcontentpdf1471-2458-10-581pdf
PATHOPHYSIOLOGIC MECHANISMS LINKING IMPAIRED
CARDIOVASCULAR HEALTH AND NEUROLOGIC
DYSFUNCTION THE YEAR IN REVIEW
Ki E Park Carl J Pepine
wwwccjmorgcontent77Suppl_3S40fullpdf+html
BERRIES EMERGING IMPACT ON CARDIOVASCULAR
HEALTH
Arpita Basu Michael Rhone and Timothy J Lyons
wwwncbinlmnihgovpmcarticlesPMC3068482pdf
nihms171310pdf
THE PLACENTA IS A PROGRAMMING AGENT FOR
CARDIOVASCULAR DISEASE
KL Thornburg PF OlsquoTierney and S Louey
wwwncbinlmnihgovpmcarticlesPMC2846089pdf
nihms177889pdf
Useful Websites
BANT - the seal of excellence for nutrition health professionals
Page 2 of 13 Regional Co-ordinators Update Overall August has been a quieter month for many
practitioners due to the holiday season Next regional
co-ordinator group meetings are planned for Sept
A new round of conference calls for co-ordinators only
has been scheduled to share updates and exchange
information (you should have received an email
on 19th July 2011 from Lara Just on
pr-regionsbantorguk)
Option 1 Thursday 1st Sept 2011 730-830pm
- Still available
Option 2 Saturday 3rd Sept 2011 1000-1100am
- Still available
Option 3 Tuesday 20th Sept 2011 730-830pm
- Full
Option 4 Wednesday 21st Sept 2011 730-830pm
- 2 places left
If regional co-ordinators have not signed up for one of
them please get back to us
Practitioners are advised to see these regional
groups as opportunities to collaborate and share their
extended networks of contacts These meetings are
not obligatory but it is recommended that you try to
attend at least two meetings per year Ideally try to
aim for 4 times per year (quarterly) Not all regions
are represented We have currently 45 regional
co-ordinators (including student co-ordinators)
BANT Student Members - Preparing for Practice
BANT is pleased to launch a new networking group
specifically for student members within the Regional
Co-ordinators programme The aim of the group is to
help NT students prepare for practice - by building a
network of contacts in the profession sharing
concerns ideas and knowledge about the practical
challenges of setting up a practice and finding work
It also hopes to involve other healthcare professionals
to help students understand how to build and utilise
networks of contacts outside NT to help grow their
businesses when they qualify The group is being
set up by Ann Sinclair a University of Westminster
student member of BANT who volunteered to be part
of the Regional Co-ordinator team last year Nearly
100 student members have already indicated their
interest in getting involved in the group with initial
discussions now taking place to design a programme
of activities and events to meet their needs as they
study and prepare to qualify If you are interested
in finding out more or would like to share your
experience of setting up practice or your expertise in
a particular area of nutritional therapy with the group
please email Ann Sinclair at studentsbantorguk
for more information
If you would like to find the co-ordinator nearest to
your region please go to
wwwbantorgukbantjspregionalCoordinatorsfaces
If you donlsquot have a group near you and you would like
to become a BANT regional co-ordinator please
contact pr-regionsbantorguk
Lara Just
Head of BANT Regional Co-ordinators
Recipe of the Month If you would like to send us a good recipe preferably with a picture to feature in our e -newsletter
please email theadministratorbantorguk
FREE FROM PRAWN AND MONKFISH WITH LEMONGRASS
Recipe taken from the Free From website at the following link
wwwfreefromrecipesmattercomrecipesfm_fishprawn_monkfishhtml
Wheat gluten corn nightshade soya
dairy amp egg free
Serves 6
2 tbsp olive oil
1 large2 medium onions very finely
chopped
75g 3oz small button mushrooms finely
sliced
400g 14oz jasmine or basmati rice
Approx 1 litre 34fl oz glutenwheat -free
vegetable or fish stock
50g 2oz baby spinach leaves
sea salt and freshly ground black pepper
1 stick fresh lemon grass cut in half
lengthways
400ml 13 12fl oz coconut milk
juice 2 limes
400g 14oz monkfish cut in large cubes
200g 7oz fresh large prawns (shrimp)
Handful fresh coriander (cilantro) chopped coarsely
Heat the oil in a wide pan and add the onions Cook very gently for at least 5 minutes or until the
onions are starting to soften
Add the mushrooms and continue to cook very gently for a further 5ndash6 minutes
Add the rice stir around well and then cover with the stock
Cook fairly briskly for 10ndash15 minutes or until the liquid has been absorbed Add extra stock if
need be
Just before all the liquid is absorbed scatter the baby spinach leaves over the rice and gently mix
them in ndash they will wilt and cook in the heat of the rice
Season to taste set aside and keep warm
Meanwhile in another wide pan heat the lemon grass in the coconut milk Simmer very gently to
allow the lemon grass to infuse the coconut milk thoroughly
Add the lime juice the monkfish and the prawns (shrimps) and continue to cook gently for 3ndash4
minutes or until they are cooked ndash do not over cook
Adjust the seasoning of the sauce to taste then serve with the rice scattering the chopped
coriander (cilantro) over both
Naturally occurring with a breakthrough patented water-based delivery
system to support gut and immune health wwwsymprovecom
Page 3 of 13 CPD Committee Update
New BANT CPD Committee Members
We would like to welcome Jacqui Merridew to the CPD committee
Jacqui Merridew is a nutritional therapist who has been involved in the
governmentlsquos Change4Lifelsquo program and also works as a trainer and
lecturer in nutritional therapy
We look forward to working with them
CPD Events
Currently the BANT Members web page has over 40 events at various
locations for our members to attend You can access all seminars
conferencesDVDs at
wwwbantorgukbantjspmemberCPDandconferencesfaces
Too busy to travel
Then why not increase your CPD hours by watching a DVD we currently
have four to choose from
Dont forget
The BANT members web page is regularly updated so keep checking for
new events
So if you have not yet logged CPD for 2011 take a look at the BANT
web pages and start recording your CPD today
If you do need help using the log for the first time or if you would like more
information as to why CPD is an important part of your professional
practice then please refer to the documents located on your BANT home
page you can access when you log in to the BANT website
wwwbantorgukbantjsploginfaces
We also welcome your feedback on all aspects of CPD so please email
cpdbantorguk
Jeraldine Curran Chair of CPD Committee
cpdbantorguk
The toolkit notes have now been out for over four months plus you have the
more recently published rules and regulations slides so lots of information to
digest and take on board
We are still receiving regular requests from members asking ARC to review
or check copy This isnlsquot something that we can offer to members As with all
the BANT committees the work we do is mainly voluntary so we simply donlsquot
have the manpower to offer a tailored copy advice service You can however
use the FREE copy advice service offered by CAP
httpcopyadviceorgukAd-AdviceBespoke-Copy-Adviceaspx
We used this service extensively in putting together the guidelines You will
have to register on their website to do so but we really recommend that you
do Some members have expressed concern that by registering on the CAP
website it will in some way put them on the radar and open their website to
greater scrutiny From all our dealings with CAP and the ASA we would say
this simply isnlsquot the case In fact the more advice queries that are raised
with CAP the more they will see us as a responsible profession Whatlsquos
more if you can let us know what advice was received what was allowed
and what was disallowed this will enable us to build a more accurate picture
of what CAP are thinking and to know where precedents have been set and
if there is ever contradictory advice This will be very helpful to ARC in our
future dealings with the ASA on your behalf and we can build a greater
knowledge bank and add to the FAQs we already have
We do want to reiterate that members have a responsibility to check their
own websites social media sites leaflets and any other marketing materials
and to change them to make sure that they comply with the ASA rules We
are aware that there are still many websites that donlsquot yet comply which
is going to leave you as individuals and us as a profession open to
unwarranted criticism Letlsquos lead by example whether we agree with the
rules or not letlsquos show that we are a responsible profession How about we
all give ourselves a deadline of the end of September to have everything
updated and in order
Angela Walker - Chair of ARC
ARC Update
Lactose and Gluten Free Symprove is breaking new ground in the way next
generation probiotics support digestive wellbeing wwwsymprovecom
Page 4 of 13 News from the Professional Practice Committee Professional Practice FAQs
The Professional Practice Committee (PPC) is currently working to prepare a set of Professional Practice FAQs to post on the PPC page of the BANT
website We are often asked the same or similar questions more than once and rather than repeatedly sending out the same answers we feel that it
would make sense for members to able to check on the website first before having to approach us It also means that if we do receive duplicate queries
we can very quickly direct members to where the answer is available Then as further suitable queries come in we will add them to the FAQs and so
build a body of information to support the guidelines laid out in the Code of Professional Practice We expect the Professional Practice FAQ page to go
live some time towards the end of September and we will inform members when this has happened
PPC September FAQ
We have been approached a number of times by members who are concerned that a complaint may be about to be lodged against them asking whether
there are any particular measures they need to take
If you feel for some reason that a client or past client is likely to lodge a complaint against you the PPC would suggest that you make sure your case
notes relating to that client are in good order and that you keep copies of all correspondence that you have with the client making a signed note of
anything that is said on the telephone We would also suggest that you inform your insurer that you are concerned that a client may be preparing a
complaint against you
A direct approach made to a client as soon as possible asking what it is they are not happy about can often calm things down and avert a formal
complaint An offer of a refund or a further consultation if you feel it is justified may help to rectify the situation
Alison Belsham - Chair of Professional Practice Committee
CNHC Appoints New CEO CNHC has appointed a new Chief Executive From 1 September 2011 Margaret Coats takes up post as Interim CEO and Registrar Her immediate past
position was as CEO at the General Chiropractic Council a position she held for eleven years Prior to that her roles includ ed that of CEO of the
Occupational Standards Council for Health amp Social Care and Head of the NHS Open Learning Unit
Margaret brings a wealth of experience to her new role from both the health and occupational standards sectors Having been w orking until recently in
the statutory arm of professional regulation she looks forward to the challenges and rewards associated with managing a volun tary regulator Maggy
Wallace CNHC Chair said ―I know that I can speak on behalf of the whole Board of Directors when I say how pleased we are that Margaret is joining us
CNHC is moving into new phase of its evolution and we anticipate benefitting hugely from Margaretlsquos knowledge and experience All organisations benefit
from fresh eyes and approaches to help move them forward especially at times of significant political and regulatory change such as those we are
currently experiencing
Margaretlsquos experience will be particularly valuable in supporting CNHClsquos on -going involvement with the Council for Healthcare Regulatory Excellence
(CHRE) as that body develops its own new role as the Professional Standards Authority (PSA) for Health and Social Care CHRElsquo s remit is to bring all
of health care regulation under the wing of the PSA CNHC is already actively participating in the current discussions with i nterested parties as it has
valuable experience to share from its work with and experience in the complementary healthcare sector Margaretlsquos knowledge and experience will
enhance that which has already been acquired
Maggy Wallace CNHC Chair also expressed thanks to Maggie Dunn who steps down as CEO on 31 August ―Maggielsquos unstinting com mitment to
getting CNHC up and running as an effective body has been exemplary Maggie has been a real pleasure to work with and we are delighted that she
remains on the Board of Directors and will continue to build and maintain links with professional colleagues
REMINDER - Learning Zone Challenge to BANT Members The BANT Learning Zone challenge for full members
So you think you know Functional Medicine (FM) and its approaches Test your knowledge at the Learning Zone
as a way of enhancing your knowledge or just seeing what you know maybe over a cup of coffee or with friends
No two tests are the same so each time you take a test you will get a fresh approach to teasing your brain cells
The BANT Learning Zone challenge for student members
SO you think you know FM and your training providers have prepared you for its challenges Well we dare you to
find out how much you know or even to find out how much you may still need to learn about FM
At no time will there be a recording in any shape or form of either the number of attempts made to pass the
modules or any of your scores below the pass rate of 80 Your result is only recorded when you pass a module
at which point you will receive a certificate of achievement If the unthinkable happens no one will know other than
you so WHY NOT TAKE THE LEARNING ZONE CHALLENGE and get a certificate that really means something
The online Learning Zone was launched on the 1st of July 2011 containing 3 FM modules These 3 FM modules
are compulsory for Associate Members as they form a critical part of the APLAPEL assessment process However these online modules are
currently voluntary for full and student members of BANT
These online modules should be viewed as a resource for BANT practitioners to show a) they are up to date and b) a tool which BANT can use for
assessing new membership applications In the light of the criticisms over nutritional therapists using genetic testing BANT did assure the Human
Genetics Commission that those using these tests would be up to date As practice changes we need to have mechanisms in place to get everyone
together if BANT has to organise its own courses in post-genome nutrition It is envisaged that many more carefully chosen modules will be developed
and added to the Learning Zone over the next few years
In time the modules should be seen as a resource to be used for revalidation There is no requirement for revalidation yet particularly for those who have
gone through the NTC Grandparenting process
1 in 10 of you will need Symprove at some stage in your life Many people
already know what Symprove does for them wwwsymprovecom
Page 5 of 13
Help contribute to the content of the e-Newsletter
We are looking for members who have specialised experience
in dealing with certain health conditions
You would be able submit a lead article on the subject
Provide references to articles and papers on the subject
Useful websites and links that cover the subject
Webinars podcasts or videos on the subject
Any other useful information on the subject
If you feel that you would like to help us by contributing please contact us
Melanie at theadministratorbantorguk or Catherine at bantchairbantorguk for more details
Get Involved - Contribute to the BANT e-Newsletter
REMINDER - Online Renewals to be Implemented 1st October 2011
BANT is working hard to develop online renewal processing in time for 1 October 2011 The system will initially be rolled out for membership renewals
and we will then be looking at processing all membership applications online by 1 October 2012 The online renewal system wil l only take card payments
and it will be essential for all members to have an active email address and also have registered their details to access the members only section The
link to register your details can be found at wwwbantorgukbantjspregister faces
For those of you who have a standing order set up to pay BANT each year please can you contact your bank as soon as possible to cancel the
arrangement We are unable to do this for you as a standing order is entirely under your control If you do not cancel your standing order the
payment will be still debited from your account but this will NOT mean that you have renewed your membership It will however take up a lot of
our time and complicate our financial records if we need to refund standing order payments that have not been cancelled Over the next few weeks we
will be emailing all members who have an existing standing order to remind them to cancel the arrangement
From this renewal year all student members will also be required to renew their membership each year for a fee of pound20 We are delighted to inform you
that we will keeping our full member renewal fees at pound75 ndash this will be the 8th consecutive year that BANT has kept the full member fee at pound75
Interested in being part of this exciting new technology First 100 to
contactsymprovecom receive a free bottle wwwsymprovecom
Page 6 of 13
Statin Drugs Cholesterol and Heart Disease Myth versus Reality
By Dicken Weatherby ND and Donald R Yance MH CN
Pfizer and Merck are continuing their efforts to have the commonly prescribed Statin medications Lipitor and Mevacor approved for over the counter use
Currently these drugs are made available in the US only with a physicianlsquos prescription In the US the Food and Drug Adminis tration or FDA has turned
down three times Mercklsquos application to make Mevacor one of the first statin drugs available without a prescription The pa nel that made this decision
the third time raised concerns that patients would turn to statin drugs instead of seeking a physicianlsquos care Itlsquos good news that the FDA isnlsquot giving the
green light to widespread over-the-counter drug use despite the heavy sway of advertising that would have people believe statin drugs are a safe
panacea for preventing cardiovascular disease We know most of you reading this already understand the misinformation being f oisted on the public
regarding statin drugs but we thought welsquod take this opportunity to review some the myths and the realities behind this issue so you can properly consult
with your patients and clients
Dispelling some of the myths regarding statin drugs cholesterol and heart disease
MYTH 1
ldquoHigh cholesterol (and LDL) is the number-one cause of heart disease in the Westrdquo
Wrong High cholesterol is among the risk factors for heart disease but is not the leading risk factor The most prevalent r isk factor is low HDL along
with small LDL particles which commonly occur together In fact of every 100 people with coronary heart disease 60-70 will have low HDL and small
LDL particles but fewer than 30 will have high LDL If this is the case why do we not hear more about low HDL and small LDL particles The answer is
simple because treating these is not as profitable for drug companies But just waitmdashwhen a profitable drug becomes available to treat this more
prevalent risk factor for heart disease we can expect to hear about an ―epidemic that will justify billions of dollars in new drug expenditures1-4
What qualifies as low HDL National guidelines say it is a level of less than 40 mgdL for men and less than 45 mgdL for wom en5 In fact a level of
less than 60 mgdL is probably very significant6 HDL is already a standard measure in everyday cholesterol panels Small LDL particles on the other
hand need to be measured specifically The medical world focuses on statin therapy for LDL while the most prevalent risk factor for heart disease goes
untreated in the great majority of cases
MYTH 2
ldquoIf I take a statin agent I wonrsquot have a heart attackrdquo
This is simply untrue Lowering cholesterol (even to rock-bottom levels) reduces but does not eliminate the risk of heart attacks Many heart attacks still
occur in people with low cholesterol levels whether or not they take cholesterol-lowering drugs7 We must consider that there are other risk factors for
heart disease besides cholesterol such as small LDL particles low HDL high fibrinogen high homocysteine and high insulin levels Results from the
most recent National Health and Nutritional Survey show that 47 million US adults have metabolic syndrome (low HDL high trig lycerides high blood
pressure excess abdominal fat) which substantially heightens the risk of heart disease even in the presence of low cholesterol levels8
MYTH 3
ldquoI feel fine and my stress test was normal My doctor says I donrsquot have heart diseaserdquo
This is among the most widely propagated fallacies spread by many primary care physicians and even cardiologists First lack of symptoms should not
be reassuring as most heart disease is silentmdashwithout symptoms and undetectable by conventional means such as electrocardiograms and cholesterol
testing Second stress testing is a miserable failure for screening asymptomatic people Most future deaths and heart attack s in fact occur in people
with normal stress tests (when symptoms are not present) The net result of this misperception is that most future heart -attack victims are walking around
feeling fine and unaware of their risk9 Cholesterol can be high low or in between but all too frequently fails to shed light on this murky situation
Cholesterol the lipid with a bad reputation
Hyperlipidemia refers to elevated blood levels of lipids (fats) including cholesterol and triglycerides Most people with hy perlipidemia have no symptoms
However hyperlipidemia is a contributing factor associated with an increased risk of coronary heart disease (CHD) a thicken ing or hardening of the
arteries that supply blood to the heart muscle CHD in turn can result in angina pectoris (chest pain) a heart attack or both Although hyperlipidemia is
considered a risk factor to heart disease it is one of many risk factors and what actually causes hyperlipidemia is a debatable issue It not as simple as
foods that contain cholesterol elevate lipids
Another important risk factor which has been largely overlooked is the oxidation of low -density lipoprotein (LDL) cholesterol caused from a lack of
antioxidant-rich foods herbs and nutrients andor a large intake of foods and chemicals that contains damaging free radicals Chronic inflammation also
contributes to oxidative stress and an increase in CHD When LDL cholesterol oxidizes it promotes atherosclerosis by a proc ess referred to as the
macrophage-foam cell mechanism particularly in the presence of stressors like cortisol and insulin Cortisol and insulin together act as a dynamic
duel causing all kinds of disruptions including an increased oxidative and inflammatory state These are the real underline causes to chronic disease
Inflammation is also involved in the process of LDL oxidation and contributes to the development of vascular disease 10-13 Ideally LDL levels should be
kept under 120 mgdL and you should monitor your patients for oxidative activity especially lipid peroxidation
The production of C-reactive protein is an essential part of the inflammatory process and the measurement of this substance reflects the level of
inflammatory activity deep within the body It appears that certain conditions create a state of excessive inflammation withi n the circulatory system High
C-reactive protein levels are evidence of this type of inflammation 14-17 Ideally it is best to keep C-reactive protein levels below 055 mgL in men and 15
Featured Article by Dicken Weatherby on Cardiovascular Health
Page 7 of 13
mgL in women Please note that the reference ranges above refer to the High Sensitivity CRP or hs -CRP test
Multiple risk markers for atherosclerosis and cardiovascular disease act in a synergistic way through inflammatory pathways The following lists the
different factors that have been identified as risk factors for CHD and arterial damage
Elevated CRP
Elevated LDL
Excess Insulin
Low HDL
High Glucose
Nitric Oxide Deficit
Excess Triglycerides
Low Free Testosterone
Excess Fibrinogen
Excess Homocysteine
Hypertension
Low Vitamin K
Excess Cholesterol
There are many key inflammatory biochemical risk markers for cardiovascular disease in particular the role of three basic c ell types affected by
these risk markers (endothelial cells smooth muscle cells and immune cells) the crucial role of inflammatory mediators ni tric oxide balance in
cardiovascular pathology and the use of nutrients (flavanoids carotenoids sterols vitamin C and E Omega 3 fatty acids et c) to circumvent several of
these inflammatory pathways Most of the above risk markers for cardiovascular disease have a pro -inflammatory component which stimulates the
release of a number of active molecules such as inflammatory mediators reactive oxygen species nitric oxide and peroxynitr ite from endothelial
vascular smooth muscle and immune cells in response to injury Nitric oxide plays a pivotal role in preventing the progressi on of atherosclerosis through
its ability to induce vasodilation suppress vascular smooth muscle proli feration and reduce vascular lesion formation Nutr ients such as arginine
antioxidants (OPCs vitamins C and E lipoic acid selenium glutathione) and enzyme cofactors (vitamins B2 and B3 B6 B12 folate zinc) help to
elevate nitric oxide levels and may play an important role in the management of cardiovascular disease Other dietary components such as DHAEPA
from fish oil tocotrienols vitamins B6 and B12 and quercetin contribute further to mitigating the inflammatory process 18
Within the broad range of cholesterol levels from 180 to 240 there is little to no evidence that this alone correlates with h eart disease Below 180 there is
increased risk of hemorrhagic stroke depression and suicide Above 240 there is increased risk of cardiovascular disease an d ischemic stroke Over age
70 elevated cholesterol and cardiovascular events no longer correlate All told total serum cholesterol alone is a poor ind icator of cardiovascular disease
Half of all heart attack patients have normal total cholesterol levels
So not only do statin drugs have their inherent drawbacks but in some ways they are treating a fabricated problem based on misunderstood and
misrepresented ―research As natural health care providers we know that we must be wary of the current cholesterol hysteria we must be able to
explain the real evidence and we must help our patients understand the facts so they can make educated health choices
Dicken Weatherby ND is originally from Oxfordshire in the UK and is based in Ashland Oregon USA A graduate of the National College of Natural
Medicine Dicken is author of the bestselling book Blood Chemistry and CBC Analysis -Clinical Laboratory Testing from a Functional Perspective He
has self-published seven other books in the field of alternative medical diagnosis has created numerous information products and runs a number of
successful Web sites including wwwFMTowncom an online membership community for practitioners interested in Functional Medicine and
Functional Diagnosis Dr Weatherby is the creator of the ldquoFoundations of Functional Diagnosis Training Programrdquo at wwwFunctionalDiagnosiscom and
the ldquoFoundations of Functional Blood Chemistry Analysisrdquo Training Program at wwwBloodChemistryTrainingcom
Donald R Yance CN MH RH is an internationally known herbalist and nutritionist He is the founder and medical director of the Centre for Natural
Healing in Ashland Ore Through extensive research and clinical practice he has developed his Triphasic system which forms the cornerstone of his
clinical approach Donald is the founder and formulator of Natura Health Products and founder and president of The Mederi Fo undation whose
programs promote health education and clinical research on the use of natural medicine with an emphasis in the field of integrative oncology
References
1 Gardner CD Fortmann SP Krauss RM Association of small low-density lipoprotein particles with the incidence of coronary artery disease in
men and women JAMA 1996 Sep 18276(11)875-81
2 Stampfer MJ Krauss RM Ma J et al A prospective study of triglyceride level low- density lipoprotein particle diameter and risk of myocardial
infarction JAMA 1996 Sep 18276(11)882-88
3 Lamarche B Tchernof A Moorjani S et al Small dense low-density lipoprotein particles as a predictor of the risk of ischemic heart disease in
men Prospective results from the Quebec Cardiovascular Study Circulation 1997 Jan 795(1)69 -75
4 Kuller L Tracy P Arnold A et al Nuclear magnetic resonance spectroscopy of lipoproteins and risk of coronary heart diseas e in the
cardiovascular health study Arterioscler Thromb Vasc Biol 2002 Jul 122(7)1175 -80
5 Expert Panel on Detection Evaluation and Treatment of High Blood Cholesterol in Adults Executive summary of the third report of the national
cholesterol education program (NCEP) expert panel on detection evaluation and treatment of high blood cholesterol in adults (Adult Treatment
Panel III) JAMA 2001 May 16285(19)2486-97
Featured Article by Dicken Weatherby on Cardiovascular Health
BANT - the seal of excellence for nutrition health professionals
We are pleased to let you all know that Dicken will be speaking at our seminar on 29th October 2011 - donrsquot miss it or you will
miss out Book your tickets now as they are selling fast wwwbantorgukbantjspNGseminarvideosfaces
Page 8 of 13
6 Gotto AM Brinton EA Assessing low levels of high-density lipoprotein cholesterol as a risk factor in coronary heart disease J Am Coll Cardiol
2004 Mar 343(5)717-24
7 van Lennep JE Westerveld HT Van Lennep HW Zwinderman AH Erkelens DW van der Wall EE Apolipoprotein concentrations durin g treat
ment and recurrent coronary artery disease events Arterioscler Thromb Vasc Biol 2000 Nov20(11)2408 -13
8 Ford ES Giles WH Dietz WH Prevalence of the metabolic syndrome among US adults findings from the third National Health an d Nutrition
Examination Survey JAMA 2002 Jan 16287(3)356-9
9 Taylor AJ Merz CN Udelson JE 34th Bethesda Conference ―Can atherosclerosis imaging techniques improve the detection of pa tients at risk
for ischemic heart disease J Amer Coll Cardiol 2003 Jun 4(11)411860 -2
10 Rifai N Ridker PM Inflammatory markers and coronary heart disease Curr Opin Lipidol 2002 Aug13(4)383-9
11 Albert CM et al Prospective study of C-reactive protein homocysteine and plasma lipid levels as predictors of sudden cardiac death
Circulation 2002 Jun 4105 (22)2595-9
12 Bermudez EA Ridker PM C-reactive protein statins and the primary prevention of atherosclerotic cardiovascular disease Prev Cardiol 2002
Winter5(1)42-6
13 Schroecksnadel K Frick B Winkler C Fuchs D Crucial role of interferon-gamma and stimulated macrophages in cardiovascular disease Curr
Vasc Pharmacol 2006 Jul4(3)205-13
14 Rifai N Ridker PM Inflammatory markers and coronary heart disease Curr Opin Lipidol 2002 Aug13(4)383-9
15 Albert CM et al Prospective study of C-reactive protein homocysteine and plasma lipid levels as predictors of sudden cardiac death
Circulation 2002 Jun 4105 (22)2595-9
16 Bermudez EA Ridker PM C-reactive protein statins and the primary prevention of atherosclerotic cardiovascular disease Prev Cardiol 2002
Winter5(1)42-6
17 Blake GJ Ridker PM Inflammatory mechanisms in atherosclerosis from laboratory evidence to clinical application Ital Heart J 2001 Nov2
(11)796-800
18 Osiecki HE The role of chronic inflammation in cardiovascular disease and its regulation by nutrients Altern Med Rev 2004 Mar9(1)32-53
Conversion Table This will help you to convert the markers in this article from US units into units used on UK blood tests
Reference ranges given are typical but may vary depending on lab used Eg Biolab given reference range for cholesterol is that target should be below
4 to 5 depending on clinical factors
Featured Article by Dicken Weatherby on Cardiovascular Health
Studies
CHIA SEEDS MAY OFFER OMEGA-3 HEART AND LIVER BENEFITS STUDY
wwwnutraingredients-usacomHealth-condition-categoriesCardiovascular-
healthChia-seeds-may-offer-omega-3-heart-and-liver-benefits-Study
c=TRR9CYYlHK48nEzv7WRu8CTrplNtVNvfamputm_source=Newsletter_Productampu
tm_medium=emailamputm_campaign=Newsletter2BProduct
DORMANT ANTIOXIDANT HAS lsquoUNPARALLELEDrsquo BENEFITS
wwwnutraingredients-usacomHealth-condition-categoriesCardiovascular-
healthDormant -antioxidant-has-unparalleled-benefits
WHOLE MANGOSTEEN FRUIT AND ITS BENEFITS
wwwthewholefruitcomstructure_functionphp
The early research on the whole mangosteen fruit and its numerous
nutritional components is both promising and precise Feel like digging in
Herelsquos a snapshotmdashjust a small samplemdashof the studies that back the
impressive edge of whole mangosteen formulation and supplementation
Neutralizes Free Radicals
Supports a Healthy Cardiovascular System
Supports Cartilage and Joint Function
Strengthens the Immune System
Promotes a Healthy Seasonal Respiratory System
Maintains Intestinal Health
Other Supportive Papers
Monthly ReportsStudiesWebinarsVideocasts
Publications
Destination 2020 - A Plan for Cardiac and Vascular Health
wwwbhforgukpublicationsview-publicationaspxps=1000855
Webinars
You need to register your details before you can access these webi-
nars FREE OF CHARGE
2010 State-of-the-Art Webinar Series in Cardiovascular Disease
Webinar I
Webinar II
Webinar III
Videocasts
Vitamin D cardiovascular disease and cancer emerging evi-
dence [electronic resource] JoAnn E Manson
httpvideocastnihgovlaunchasp15689
Heart failure in women
httpvideocastnihgovlaunchasp15838
Demystifying Medicine - Cardiovascular disease in the eras of
imaging and stem cells
httpvideocastnihgovlaunchasp16573
Demystifying Medicine - Arteriosclerotic cardiovascular disease
Number one killer and the Framingham experience
httpvideocastnihgovlaunchasp14936
US reference range To convert from US to UK UK units
Cholesterol 150-220 mgdL Multiple by 002586 336-52 mmoll
HDL 40-90 mgdL Multiple by 002586 103-232 mmol
LDL 60-130 mgdL Multiple by 002586 155 ndash 336 mmoll
BANT sponsors a 2 day seminar on cPNI on 8-9 of Sep 2011
organised by Bonusan under the auspices of the Natura Foundation
wwwbantorgukbantjspmemberpdfseminarsBONUSAN_CPNIpdf
Page 9 of 13
On Saturday 21st May the Alliance for Natural Health International supported by the GNC and BANT held its first
training and education day for practitioners helping them through the minefield of legislative requirements facing the
natural health sector The conference was well attended by over 240 practitioners whose feedback confirms that the
information was critical to their ability to manage their practices compliantly in the future and was summed up succinctly
by one of the delegates
I think the conference today really hits the mark in terms of tak ing a very complex set of regulations and putting it into a
digestible form for practitioners laying out not only the regulations but also the practical side of how we live within thi s
new regulatory environment
Kathleen Devereaux
We understand that many were not able to attend the conference in person but as promised we have now produced a full download of the daylsquos
sessions in video format which includes the pre-reading pack sent to delegates a comprehensive delegate volume of notes covering the days event and
an extensive reference list of supporting documentation We know its been a few weeks since the event but it takes time to p rofessionally edit the raw
footage so we hope that youll now feel part of it as if you had actually been there with us
Having attended the ANH conference I was able to get a real picture about the Rules and Regulations NTs are up against Understanding this legislation
and how it affects NT practice is an important part of being a responsible NT We need to learn the language of these new rul es and in doing so feel
empowered and in control of our work environment This conference DVD and info should be an essential part of your NT toolk it
Melanie de Grooth BANT AdministratorGeneral Manager
This comprehensive package costs pound40 with proceeds going to the ANH campaign fund and is available to practitioners and student practitioners only
Those practitioners who are going to be successful in this new environment will need to uniquely express themselves according to their qualifications and
experience A me too approach where everyone says the same things is not going to allow you to stand out from the crowd At the heart of this is an
understanding of the principles behind the rules and regulations as well as solutions allowing you to not fall foul of it Provided in the printed and video
outputs from our seminar are all the basics youll need to move confidently forward in this difficult and confusing regulatory climate and we will be
following up with more support in due course
As NT practitioners we are facing a maze of rules and regulations that will affect how we work in the future I therefore urge you all to purchase the must
have DVD from the recent excellent ANH training conference entitled Rules and Regulations in Clinical Practice Developing your Practice in Spite of the
EU Regulatory Juggernaut This is an extremely useful toolk it for your practice and will assist you in understanding these l egislative changes
Catherine Honeywell - Chair BANT Council
PURCHASE DOWNLOAD - wwwanh-europeorgrules-and-regulations-training-buy-download We also invite you to sign up for our regular
eAlerts wwwanh-europeorguserregister and to check out our practitioner pages - wwwanh-europeorgpractitioners
Thank you ANH-Intl
ANH-Intl Rules and Regulations DVD Now on Sale
BANT Page on Rules and Regulations If you have not already done so please make sure you access the presentations we have
provided on Rule and Regulations Affecting NT Practice and Understanding the Scope and
Definition for Medicinal Claims
An incredible amount of time and effort has gone into this project and we are sure that you will
now easily be able to navigate your way through the complicated array of rules and regulations
that impact on our practise of Nutritional Therapy
We would like to thank ANH-Intl and give credit to them for auditing and contributing the source
materials which BANT has interpreted and presented in this unique format The format and
presentation are the copyright of BANT and should not be reproduced without prior permission
We would also like to give a special thank you to Louise Carder who tirelessly gave of her time
and expertise to help BANT produce these slides ndash thank you Louise
You can access these slides at the following link wwwbantorgukbantjspmemberrulesRegulation faces
They have been designed for best use online You can of course print them out but you will then not be able to benefit from using the hyperlinks for
navigation Please take some time out of your busy schedules to carefully work and read through these slides This informati on is an essential part of
you Nutritional Therapy toolkit and will help you to be a better and more responsible practitioner
Understanding these Rules and Regulations will not only empower you as a practitioner but will
also demonstrate your level of commitment to your clients and the profession
From time to time we will update the content of the slides but will always let you know when this
has been done
IMPORTANT
After the renewals in October all full members will be emailed a copy of what you currently state
on you BANT profile under Special Interests and Further Information It will be your responsi-
bility to check the information is correct in relation to the ASA Rules and the Rules and
Regulations affecting NT practice Use this link to access the ARC Toolkit and FAQs on the
ASA rules wwwbantorgukbantjspmemberASARulesfaces
Page 10 of
FoodInfo Online Features 1 April 2011
httpwwwfoodsciencecentralcomfscixid16088
copy IFIS Publishing 2011 - All Rights Reserved
From pharm to fork in the nutrigenomic era is it food or medicine
Susan A McGinty and Dominic Man
London South Bank University 103 Borough Road London SE1 0AA
1 Introduction
The foodmedicine boundary has long been opaque with responsibility for medicines and food regulation coming under different European Commission
directorates This has led to a lack of integration at the EU level between food and medicine which has been further exacerbat ed by a lack of
harmonisation of implementation at Member State level of EU food law From 1 May the EU Traditional and Herbal Medicines Products Directive
(THMPD) comes fully into force and the elements of a perfect stormlsquo may be moving into place Manufacturers will no longer be able to supply
unlicensed herbal medicines to the public The European Medicines Agencylsquos (EMEA) has a database of medicinal herbs which includes inter
alia sage thyme garlic onion cinnamon pumpkin seed linseed juniper berry peppermint leaf and aniseed The UKlsquos Medicines and Healthcare
Products Regulatory Agency (MHRA) has published its own list of herbs and classifies them as medicinefoodcosmetic - also reflecting the problem of
the regulation of products and claims for cosmeceuticals From May 2011 ―it is the competence and responsibility of national authorities to decide on a
case by case basis whether a herbal product fulfils the definition of medicinal product A survey of the fundamental definitions clarifications by the
European Court of Justice (ECJ) and an examination of the European Councillsquos homeostasis model spotlights areas which may nee d to be reconciled if
the overall regulatory framework is capable of adapting to the era of systems biology and personalised medicinenutrition i ncluding dermagenetics
2 The devil in the detail the definitions
21 Food
Article 2 of EC 1782002 defines food including supplements as ―any substance or product whether processed partially processed or unprocessed
intended to be or reasonably expected to be ingested by humans This definition is straightforward but allows interpretation of reasonably expectedlsquo to
determine a medicinal product where dosagelsquo may be seen as a critical element ndash see later
22 Medicine bdquoform‟ and bdquofunction‟
Directive 200183EC of 6 November 2001 defined a medicine as either ―any substance or combination of substances presented for treating or
preventing disease in human beings or ―any substance or combination of substances which may be administered to human beings with a view to making
a diagnosis or to restoring correcting or modifying physiological balance in human beings This linked marketing activities and intention of consumption
to medicinal functionality In 2004 Directive 200427EC amended the definition of a medicine to ―any substance or combination of substances
presented as having properties for treating or preventing disease in human beings or any substance or combination of substances which may be used
in or administered to human beings either with a view to restoring correcting or modifying physiological functions by exerting a pharmacological
immunological or metabolic action or to making a medical diagnosis Article 22 of the 2004 Directive goes on to state ―In cases of doubt where
taking into account all its characteristics a product may fall within the definition of a medicinal productlsquo and within the definition of a product covered by
other Community legislation the provisions of this Directive shall apply
This definition had the technical effect of making all bioactive food components meet the medicinal standard by function if not by presentation and has
left Member State medicines regulators the EMEA and the European Commissionlsquos Directorate General Enterprise and Industry (DGEI) in the driving
seat as to determining product status and enforcement Nonetheless the ECJ ruled in C-31905 Commission of the European Communities v Federal
Republic of Germany of 15 November 2007 that the definition of a medicinal product by function should be interpreted restrictively since it was des igned
to cover only products whose pharmacological properties have been scientifically observed and not substances which while ha ving an effect on the
human body do not significantly affect the metabolism and thus do not strictly modify the way in which it functions
The formlsquo of a medicine versus a food supplement was also tested in C-31905 in which the Commission accused the Federal Republic of Germany of
breach of its obligations under Articles 28 and 30 of the EC Treaty (free movement of goods) by classifying a garlic preparat ion in capsule form as a
medicinal product The ECJ held that a capsule form was not of itself sufficient to decide whether a product was medicinal that the capsule form is not
exclusive to medicinal products and the product in question only contained natural garlic and could not have any additional e ffects (positive or negative)
compared to garlic in its natural state A medicinal product must have the function of preventing or treating disease beneficial effects for health in general
are not sufficient
The ECJ clarifications pose a fundamental problem for Member State medicines regulators consistently using formlsquo and functi onlsquo as theirbenchmark
standards Pillcapsuletincture forms regularity of consumption defined posology and ADME (absorption distribution metabolism and excretion) and
the accompanying claims have long been the determinants in borderline product adjudications
23 Prevention or disease-risk reduction
The EU has no definition of diseaselsquo in any of its regulatory instruments except for medically diagnosed conditions or using w ider public health
frameworks for measuring disease prevention in terms ofQuality of Life Years (QALYs) and Disability Adjusted Life Years (DALY s) for example It has not
From Pharm to Fork in the Nutrigenomic Era Is It Food or Medicine
BANT - the seal of excellence for nutrition health professionals
Page 11 of From Pharm to Fork in the Nutrigenomic Era Is It Food or Medicine- Cont
adopted a fully transparent and credible suite of biomarkers surrogate or end-markers to establish healthdisease status and bi ofunctionality In the UK
The Medicines Act 1968 (as amended) defines disease as something which ―includes any injury ailment or adverse condition whether of body or
mind The lack of a clear legal definition has been recognised by the ECJ where disease has been intrinsically linked to the definition of a medicinal
product The Court determined in C-36988 on whether eye lotion was a medicinal product or cosmetic (a cosmetic being external but being able to
protectlsquo or keep in good conditionlsquo) that on the basis of scientific knowledge ―it is for the national authorities to dete rmine whether products presented as
counter-acting certain conditions of sensations such as hunger heaviness in the legs tiredness or itching constitute a medic al product
The United States Food and Drug Administration (FDA) in its health claims legislation defines disease as
―Damage to an organ part or structure or system of the body such that it does not function properly (eg cardiovascular dis ease) or a state of health
leading to such dysfunctioning (eg hypertension) except that diseases resulting from essential nutrient deficiencies (eg scurvy pellagra) are not
included in this definition
Proposals for health claims legislation being framed by Food Standards Australia and New Zealand (FSANZ) include definitions for diseaselsquo and serious
diseaselsquo which distinguish in terms both of severity of condition and of level of claim
Disease an unhealthy condition characterised by clinically significant signs or symptoms
Serious disease or condition forms of disease conditions ailments or defects which are generally accepted to be beyond the ability of the
average consumer to evaluate accurately and to treat safely without regular supervision by a suitably qualified health care professional
Where disease-risk reduction relates to one of a number of factors in the aetiology of disease the concept of preventionlsquo itse lf poses a number
of difficulties as like diseaselsquo it is not clearly defined in law
Coppens et al 2001 survey use of preventionlsquo in relation to the first EU Medicines Directive 6565 where prevention has had a history of use in terms
of vaccination and infectious diseases Prevention is a word with an absolute indication and its use is clear and distinct in nature and includes some
statistical certainty nonetheless with chronic diseases there is an overlap where reduction of disease risk pertains to one factor sufficient to prevent the
occurrence likely to be based on epidemiological evidence from studies of population cohorts Coppens et al propose that prevention has three facets
a) Prevention of disease occurrence where
the disease is not (yet) present
the therapy can prevent the occurrence of the disease with substantial statistical certainty
b) Prevention of episodes of the disease where
the disease is present
the therapy decreases the number duration or severity of disease episodes with a substantial statistical certainty
c) Prevention of progression of the patientlsquos underlying disease where
the disease is present
the therapy has been shown to delay the progression of the disease with a substantial statistical certainty
At the other end of the spectrum treatlsquo denotes a purpose of action intention therefore becomes a key determinant in claim status Intention in
consumption is important for the enforcement of health claims where (average) consumer understanding is a factor Consumption of supplemental vitamin
D3 to support bone health or with a substantiated claim reduce the risk of osteoporosis comes under the food domain However consumption of
supplemental vitamin D3 for the purposes of immune-modulation would be medicinal
The principle of disease risk reduction (DRR) as distinct from prevention was incorporated into EU law in EC 19242006 on nutrition and health claims
on food (NHCR) which requires that all structurefunction and DRR claims on food including supplements must be preapproved by the EU Commission
and meet a standard of substantial scientific agreement While the DRR paradigm recognises that chronic disease conditions are the product of multiple
gene-environment influences it nonetheless still must be predicated on what diseaselsquo is in biological terms The EU-funded PASSCLAIM projec t was
tasked with establishing how health claims would be substantiated and to identify functional biomarkers or surrogate end-point markers for use in the
assessment process PASSCLAIM working groups produced reports on diet -related cardiovascular disease bone health and osteoporosis physical
performance and fitness mental state and performance body weight insulin sensitivity and diabetes diet -related cancer and gut health and
immunity At January 2011 the European Food Safety Authority (EFSA) charged with the process of assessing claims is yet to fully clarify its
assessment criteria
24 Functional foods food bioactives and nutraceuticals
While the EU regulates foods containing plant sterolsstanols there is no formal definition of functional foodlsquo The EU FUFOSE project used a working
definition of functional foods that ―affect beneficially one or more target functions in the body beyond adequate nutriti onal effects in a way that is
relevant to either an improved state of health and well -being andor reduction of risk of disease FUFOSE noted that a functional food can be a natural
food one to which a component has been added or removed where a component has been modified or its bioavailability modifie d or any combination or
multiples of all the possibilities Therefore functional foods in the EU must be foods with health claims as defined by the NHCR
BANT sponsors a 2 day seminar on cPNI on 8-9 of Sep 2011
organised by Bonusan under the auspices of the Natura Foundation
wwwbantorgukbantjspmemberpdfseminarsBONUSAN_CPNIpdf
Page 12 of
Although in 2006 the US FDA proposed that the term functional foodlsquo be regulated (21 Code of Federal Regulations Part 101 and Part 170)it still has no
formal definition of that or of nutraceuticallsquo Earlier in 2004 the US Department of Health and Human Services (DHHS) launch ed a consultation on a
proposed definition of bioactive food componentslsquo In its supplementary information to the proposal the DHHS stated that bioactives may have multiple
sites of action may interact with one or more dietary constituents and may act directly or indirectly to produce a functional outcome citing as examples
lycopene long-chain omega-3 fatty acids isoflavones sulphorophane and resveratrol Establishing a definition of a food bioactive was a first step
towards evaluating their significance in promoting health and disease prevention then guiding research priorities and science-based information to help
guide public health policylsquo The definition proposed was
―Bioactive food components are constituents in foods or dietary supplements other than those needed to meet basic human nutr itional needs that are
responsible for changes in health status
As of early 2011 the work on defining food bioactives has not progressed Respondents to the 2004 consultation made strong representations about a
definition of bioactivity which excluded nutrients arguably the most important bioactive category of food components Seventeen written responses were
received in response to the consultation a number of which proposed alternate definitions Common themes in those alternate definitions include use of
the term physiologically activelsquo or physiological benefitlsquo reference to structure functionlsquo and disease -risk reductionlsquo and (ILSI North America) ―as
measured through utilizing appropriate methodology and biomarkers
In January 2011 the US National Academies of Science publishedPerspectives on Biomarker and Surrogate Endpoint Evaluation with recommendations
for establishing a framework for harmonising biomarker use across all areas including drugs and foods
3 Dosage and the homeostasis model what is lsquonormalrsquo
The ECJ Judgement C-8807 of 5 March 2009 determined that substances ―which while having an effect on the human body do not significantly
affect the metabolism and thus do not strictly modify the way in which it functions should not be classified as medicinal products by function
(see Commission v Germany paragraph 60 and Hecht-Pharma paragraph 41) Dosage therefore is a key criterion in determining food from medicine
of botanicals and from May 2011 is likely to be used by national authorities in enforcement This complements the homeostasis model produced by
the European Council in 2008 to distinguish foods and medicinal products The model incorporates the notion of intended use of the product and the
nature of the induced effect food induces the physiological effects characterised by maintainsupportoptimiselsquo and medicine induces the physiological
functions characterised by restorecorrectmodifylsquo It is a self-contained integrated approach but is predicated on the definition of homeostasis being
defined as ldquothe status of a person whose physiological parameters function within the limits considered as normal But while normal
physiological parameters may be defined by (sometimes quite large) reference ranges nutritional prerequisites or dietary ref erence intakes are not fully
harmonised throughout the EU nor do they take account of ancestral or inter-individual variation which characterise different sub-populations The lack
of harmonisation means some EU Member States regard supra -RDA vitamin and mineral supplements as medicines where others including the UK
have taken a more liberal approach The EU-funded EurRECA network of excellence is tasked with developing methodologies and recommendations to
standardise the process of setting pan-EU micronutrient recommendations This will inform progress in setting maximum permitted levels of vitamins and
minerals in food supplements However the extent of inter-individuality may prove problematic in 2007 the UK Committee on Toxicity in its working
group report on variability and uncertainty stated that for vitamins and minerals ―variability in the response of individuals has the potential to result in a
situation which a given level of exposure could be essential for some but toxic for others
What is normallsquo in dietary requirements underpins the basis on which both medicinal and health claims are evaluated namely that a healthy balanced
diet is generally able to provide all micronutrient requirements by normal healthy individuals for health maintenance Two signi ficant sub-populations
however threaten to undermine that approach In the UK the Healthy Start programme administered by statutory instrument by the Department
of Health and National Health Service provides two bespoke Healthy Start-branded vitamin supplements for low income beneficiaries for women free
during pregnancy and up until their baby is one year old and for children from 6 months of age until their fourth birthday Non-beneficiaries can
purchase Healthy Start-branded supplements at low cost from health clinics Health professionals are encouraged to make sure that mothers and
children ―get two important vitamins that they may not be getting in adequate quantities ndash even from a healthy balanced diet These are vitamins A and D
for children and vitamin D and folic acid for women While it is prohibited under the NHCR to claim that a healthy balanced diet cannot in general
provide all nutrients needed there is no such prohibition under medicinal law and the Healthy Startvitamins are marketed under a UK medicines
licence [PL015110003] This conflict adds to the problems of robust implementation of the NHCR which is already stymied by the lack of
A credible transparent system of scientific assessment
An agreed nutrient profiling system
A harmonised pan-EU characterisation of a healthy balanced diet
4 Going forward
Added to the woes of the NHCR looms a new era of personal genomicmetabolomic profiling and personalised nutrition in the for m of P4
medicinelsquo (personalised predictive preventive participatory) In its essence nutrigenomicslsquo incorporates two aspects
The effect of food components on the genome and epigenome
The extent of ancestral and individual variation
If disease can be classified at the molecular level what effect does this have on the meaning of homeostasislsquo and medicine lsquo These key terms need full
and comprehensive definition both in biology and law so that the food -medicine continuum is fully resolved and the foundation is laid for the successful
application of both personalised medicine and personalised nutrition Innovation and continued investment in wellness products by the food industry
depend on a clear consistent and transparent system of claims assessment
From Pharm to Fork in the Nutrigenomic Era Is It Food or Medicine- Cont
Page 13 of 13 Topic of the Month - Cardiovascular Health
Nutri Link Clinical Education - wwwnleducationcouk
They believe in supporting the health care professionals who count on them for
effective nutritional solutions Their team of CAM-leading experts are committed to
providing you with the latest unbiased scientific research and clinical support plus a
vast array of continuing education opportunitieshellipbecause as practitioners they
understand that knowledge is the key to positive patient results
FM Town - wwwfmtowncom
Its all about relevancy Being in a 100 Functional Medicine environment will give
you an opportunity to get direct and immediate access to all the information that is
most relevant to you FMTown is private and highly relevant in its scope of focus
Get connected to an amazing online resource which can grow with you and support
your Functional Medicine Journey
Institute for Functional Medicine - wwwfunctionalmedicineorg
IFM Membership is your gateway to a community of like-minded clinicians and
researchers It is primarily aimed at clinicians and scientists whose interest in
functional medicine is deeply connected to examining the emerging research
attending CME courses discussing issues and patients with colleagues and so
forth Membership helps to build a network of practitioners from many disciplines
who are using and studying functional medicine every day
Food Science Central - wwwfoodsciencecentralcom
Food Science Central is the home of IFIS Publishing on the web Here you can
learn about products and services and access FREE articles on many topics in food
science food technology and nutrition
Monthly ArticlesPapers
ANXIETY AND CARDIOVASCULAR RISK REVIEW OF
EPIDEMIOLOGICAL AND CLINICAL EVIDENCE
O Olafiranye G Jean-Louis F Zizi J Nunes and MT Vincent
wwwncbinlmnihgovpmcarticlesPMC3150179pdfnihms-
301210pdf
POST-TRAUMATIC STRESS DISORDER AND
CARDIOVASCULAR DISEASE
Steven S Coughlin
wwwncbinlmnihgovpmcarticlesPMC3141329pdfTOCMJ-5-
164pdf
STUDIES OF GENE VARIANTS RELATED TO INFLAMMATION
OXIDATIVE STRESS DYSLIPIDEMIA AND OBESITY
IMPLICATIONS FOR A NUTRIGENETIC APPROACH
Maira Ladeia R Curti Patrıcia Jacob Maria Carolina Borges
Marcelo Macedo Rogero and Sandra Roberta G Ferreir
wwwncbinlmnihgovpmcarticlesPMC3136190pdfJOBES2011-
497401pdf
EFFECT OF AN OFFICE WORKSITE-BASED YOGA
PROGRAM ON HEART RATE VARIABILITY A RANDOMIZED
CONTROLLED TRIAL
Birinder S Cheema Paul W Marshall Dennis Chang Ben
Colagiuri and Bianca Machliss
wwwncbinlmnihgovpmcarticlesPMC3154869pdf1471-2458-
11-578pdf
CARDIOVASCULAR COMPLICATIONS IN CKD PATIENTS
ROLE OF OXIDATIVE STRESS
Elvira O Gosmanova and Ngoc-Anh Le
wwwncbinlmnihgovpmcarticlesPMC3022166pdfCRP2011-
156326pdf
TARGETING STEM CELL NICHES AND TRAFFICKING FOR
CARDIOVASCULAR THERAPY
Nicolle Kraumlnkel Gaia Spinetti Silvia Amadesi and Paolo Madeddu
wwwncbinlmnihgovpmcarticlesPMC3017934pdfukmss-
33677pdf
INTERACTION OF SLEEP QUALITY AND PSYCHOS OCIAL
STRESS ON OBESITY IN AFRICAN AMERICANS THE
CARDIOVASCULAR HEALTH EPIDEMIOLOGY STUDY (CHES)
Aurelian Bidulescu Rebecca Din-Dzietham Dorothy L Coverson
Zhimin Chen Yuan-Xiang Meng Sarah G Buxbaum Gary H Gib-
bons Verna L Welch
wwwbiomedcentralcomcontentpdf1471-2458-10-581pdf
PATHOPHYSIOLOGIC MECHANISMS LINKING IMPAIRED
CARDIOVASCULAR HEALTH AND NEUROLOGIC
DYSFUNCTION THE YEAR IN REVIEW
Ki E Park Carl J Pepine
wwwccjmorgcontent77Suppl_3S40fullpdf+html
BERRIES EMERGING IMPACT ON CARDIOVASCULAR
HEALTH
Arpita Basu Michael Rhone and Timothy J Lyons
wwwncbinlmnihgovpmcarticlesPMC3068482pdf
nihms171310pdf
THE PLACENTA IS A PROGRAMMING AGENT FOR
CARDIOVASCULAR DISEASE
KL Thornburg PF OlsquoTierney and S Louey
wwwncbinlmnihgovpmcarticlesPMC2846089pdf
nihms177889pdf
Useful Websites
BANT - the seal of excellence for nutrition health professionals
Page 3 of 13 CPD Committee Update
New BANT CPD Committee Members
We would like to welcome Jacqui Merridew to the CPD committee
Jacqui Merridew is a nutritional therapist who has been involved in the
governmentlsquos Change4Lifelsquo program and also works as a trainer and
lecturer in nutritional therapy
We look forward to working with them
CPD Events
Currently the BANT Members web page has over 40 events at various
locations for our members to attend You can access all seminars
conferencesDVDs at
wwwbantorgukbantjspmemberCPDandconferencesfaces
Too busy to travel
Then why not increase your CPD hours by watching a DVD we currently
have four to choose from
Dont forget
The BANT members web page is regularly updated so keep checking for
new events
So if you have not yet logged CPD for 2011 take a look at the BANT
web pages and start recording your CPD today
If you do need help using the log for the first time or if you would like more
information as to why CPD is an important part of your professional
practice then please refer to the documents located on your BANT home
page you can access when you log in to the BANT website
wwwbantorgukbantjsploginfaces
We also welcome your feedback on all aspects of CPD so please email
cpdbantorguk
Jeraldine Curran Chair of CPD Committee
cpdbantorguk
The toolkit notes have now been out for over four months plus you have the
more recently published rules and regulations slides so lots of information to
digest and take on board
We are still receiving regular requests from members asking ARC to review
or check copy This isnlsquot something that we can offer to members As with all
the BANT committees the work we do is mainly voluntary so we simply donlsquot
have the manpower to offer a tailored copy advice service You can however
use the FREE copy advice service offered by CAP
httpcopyadviceorgukAd-AdviceBespoke-Copy-Adviceaspx
We used this service extensively in putting together the guidelines You will
have to register on their website to do so but we really recommend that you
do Some members have expressed concern that by registering on the CAP
website it will in some way put them on the radar and open their website to
greater scrutiny From all our dealings with CAP and the ASA we would say
this simply isnlsquot the case In fact the more advice queries that are raised
with CAP the more they will see us as a responsible profession Whatlsquos
more if you can let us know what advice was received what was allowed
and what was disallowed this will enable us to build a more accurate picture
of what CAP are thinking and to know where precedents have been set and
if there is ever contradictory advice This will be very helpful to ARC in our
future dealings with the ASA on your behalf and we can build a greater
knowledge bank and add to the FAQs we already have
We do want to reiterate that members have a responsibility to check their
own websites social media sites leaflets and any other marketing materials
and to change them to make sure that they comply with the ASA rules We
are aware that there are still many websites that donlsquot yet comply which
is going to leave you as individuals and us as a profession open to
unwarranted criticism Letlsquos lead by example whether we agree with the
rules or not letlsquos show that we are a responsible profession How about we
all give ourselves a deadline of the end of September to have everything
updated and in order
Angela Walker - Chair of ARC
ARC Update
Lactose and Gluten Free Symprove is breaking new ground in the way next
generation probiotics support digestive wellbeing wwwsymprovecom
Page 4 of 13 News from the Professional Practice Committee Professional Practice FAQs
The Professional Practice Committee (PPC) is currently working to prepare a set of Professional Practice FAQs to post on the PPC page of the BANT
website We are often asked the same or similar questions more than once and rather than repeatedly sending out the same answers we feel that it
would make sense for members to able to check on the website first before having to approach us It also means that if we do receive duplicate queries
we can very quickly direct members to where the answer is available Then as further suitable queries come in we will add them to the FAQs and so
build a body of information to support the guidelines laid out in the Code of Professional Practice We expect the Professional Practice FAQ page to go
live some time towards the end of September and we will inform members when this has happened
PPC September FAQ
We have been approached a number of times by members who are concerned that a complaint may be about to be lodged against them asking whether
there are any particular measures they need to take
If you feel for some reason that a client or past client is likely to lodge a complaint against you the PPC would suggest that you make sure your case
notes relating to that client are in good order and that you keep copies of all correspondence that you have with the client making a signed note of
anything that is said on the telephone We would also suggest that you inform your insurer that you are concerned that a client may be preparing a
complaint against you
A direct approach made to a client as soon as possible asking what it is they are not happy about can often calm things down and avert a formal
complaint An offer of a refund or a further consultation if you feel it is justified may help to rectify the situation
Alison Belsham - Chair of Professional Practice Committee
CNHC Appoints New CEO CNHC has appointed a new Chief Executive From 1 September 2011 Margaret Coats takes up post as Interim CEO and Registrar Her immediate past
position was as CEO at the General Chiropractic Council a position she held for eleven years Prior to that her roles includ ed that of CEO of the
Occupational Standards Council for Health amp Social Care and Head of the NHS Open Learning Unit
Margaret brings a wealth of experience to her new role from both the health and occupational standards sectors Having been w orking until recently in
the statutory arm of professional regulation she looks forward to the challenges and rewards associated with managing a volun tary regulator Maggy
Wallace CNHC Chair said ―I know that I can speak on behalf of the whole Board of Directors when I say how pleased we are that Margaret is joining us
CNHC is moving into new phase of its evolution and we anticipate benefitting hugely from Margaretlsquos knowledge and experience All organisations benefit
from fresh eyes and approaches to help move them forward especially at times of significant political and regulatory change such as those we are
currently experiencing
Margaretlsquos experience will be particularly valuable in supporting CNHClsquos on -going involvement with the Council for Healthcare Regulatory Excellence
(CHRE) as that body develops its own new role as the Professional Standards Authority (PSA) for Health and Social Care CHRElsquo s remit is to bring all
of health care regulation under the wing of the PSA CNHC is already actively participating in the current discussions with i nterested parties as it has
valuable experience to share from its work with and experience in the complementary healthcare sector Margaretlsquos knowledge and experience will
enhance that which has already been acquired
Maggy Wallace CNHC Chair also expressed thanks to Maggie Dunn who steps down as CEO on 31 August ―Maggielsquos unstinting com mitment to
getting CNHC up and running as an effective body has been exemplary Maggie has been a real pleasure to work with and we are delighted that she
remains on the Board of Directors and will continue to build and maintain links with professional colleagues
REMINDER - Learning Zone Challenge to BANT Members The BANT Learning Zone challenge for full members
So you think you know Functional Medicine (FM) and its approaches Test your knowledge at the Learning Zone
as a way of enhancing your knowledge or just seeing what you know maybe over a cup of coffee or with friends
No two tests are the same so each time you take a test you will get a fresh approach to teasing your brain cells
The BANT Learning Zone challenge for student members
SO you think you know FM and your training providers have prepared you for its challenges Well we dare you to
find out how much you know or even to find out how much you may still need to learn about FM
At no time will there be a recording in any shape or form of either the number of attempts made to pass the
modules or any of your scores below the pass rate of 80 Your result is only recorded when you pass a module
at which point you will receive a certificate of achievement If the unthinkable happens no one will know other than
you so WHY NOT TAKE THE LEARNING ZONE CHALLENGE and get a certificate that really means something
The online Learning Zone was launched on the 1st of July 2011 containing 3 FM modules These 3 FM modules
are compulsory for Associate Members as they form a critical part of the APLAPEL assessment process However these online modules are
currently voluntary for full and student members of BANT
These online modules should be viewed as a resource for BANT practitioners to show a) they are up to date and b) a tool which BANT can use for
assessing new membership applications In the light of the criticisms over nutritional therapists using genetic testing BANT did assure the Human
Genetics Commission that those using these tests would be up to date As practice changes we need to have mechanisms in place to get everyone
together if BANT has to organise its own courses in post-genome nutrition It is envisaged that many more carefully chosen modules will be developed
and added to the Learning Zone over the next few years
In time the modules should be seen as a resource to be used for revalidation There is no requirement for revalidation yet particularly for those who have
gone through the NTC Grandparenting process
1 in 10 of you will need Symprove at some stage in your life Many people
already know what Symprove does for them wwwsymprovecom
Page 5 of 13
Help contribute to the content of the e-Newsletter
We are looking for members who have specialised experience
in dealing with certain health conditions
You would be able submit a lead article on the subject
Provide references to articles and papers on the subject
Useful websites and links that cover the subject
Webinars podcasts or videos on the subject
Any other useful information on the subject
If you feel that you would like to help us by contributing please contact us
Melanie at theadministratorbantorguk or Catherine at bantchairbantorguk for more details
Get Involved - Contribute to the BANT e-Newsletter
REMINDER - Online Renewals to be Implemented 1st October 2011
BANT is working hard to develop online renewal processing in time for 1 October 2011 The system will initially be rolled out for membership renewals
and we will then be looking at processing all membership applications online by 1 October 2012 The online renewal system wil l only take card payments
and it will be essential for all members to have an active email address and also have registered their details to access the members only section The
link to register your details can be found at wwwbantorgukbantjspregister faces
For those of you who have a standing order set up to pay BANT each year please can you contact your bank as soon as possible to cancel the
arrangement We are unable to do this for you as a standing order is entirely under your control If you do not cancel your standing order the
payment will be still debited from your account but this will NOT mean that you have renewed your membership It will however take up a lot of
our time and complicate our financial records if we need to refund standing order payments that have not been cancelled Over the next few weeks we
will be emailing all members who have an existing standing order to remind them to cancel the arrangement
From this renewal year all student members will also be required to renew their membership each year for a fee of pound20 We are delighted to inform you
that we will keeping our full member renewal fees at pound75 ndash this will be the 8th consecutive year that BANT has kept the full member fee at pound75
Interested in being part of this exciting new technology First 100 to
contactsymprovecom receive a free bottle wwwsymprovecom
Page 6 of 13
Statin Drugs Cholesterol and Heart Disease Myth versus Reality
By Dicken Weatherby ND and Donald R Yance MH CN
Pfizer and Merck are continuing their efforts to have the commonly prescribed Statin medications Lipitor and Mevacor approved for over the counter use
Currently these drugs are made available in the US only with a physicianlsquos prescription In the US the Food and Drug Adminis tration or FDA has turned
down three times Mercklsquos application to make Mevacor one of the first statin drugs available without a prescription The pa nel that made this decision
the third time raised concerns that patients would turn to statin drugs instead of seeking a physicianlsquos care Itlsquos good news that the FDA isnlsquot giving the
green light to widespread over-the-counter drug use despite the heavy sway of advertising that would have people believe statin drugs are a safe
panacea for preventing cardiovascular disease We know most of you reading this already understand the misinformation being f oisted on the public
regarding statin drugs but we thought welsquod take this opportunity to review some the myths and the realities behind this issue so you can properly consult
with your patients and clients
Dispelling some of the myths regarding statin drugs cholesterol and heart disease
MYTH 1
ldquoHigh cholesterol (and LDL) is the number-one cause of heart disease in the Westrdquo
Wrong High cholesterol is among the risk factors for heart disease but is not the leading risk factor The most prevalent r isk factor is low HDL along
with small LDL particles which commonly occur together In fact of every 100 people with coronary heart disease 60-70 will have low HDL and small
LDL particles but fewer than 30 will have high LDL If this is the case why do we not hear more about low HDL and small LDL particles The answer is
simple because treating these is not as profitable for drug companies But just waitmdashwhen a profitable drug becomes available to treat this more
prevalent risk factor for heart disease we can expect to hear about an ―epidemic that will justify billions of dollars in new drug expenditures1-4
What qualifies as low HDL National guidelines say it is a level of less than 40 mgdL for men and less than 45 mgdL for wom en5 In fact a level of
less than 60 mgdL is probably very significant6 HDL is already a standard measure in everyday cholesterol panels Small LDL particles on the other
hand need to be measured specifically The medical world focuses on statin therapy for LDL while the most prevalent risk factor for heart disease goes
untreated in the great majority of cases
MYTH 2
ldquoIf I take a statin agent I wonrsquot have a heart attackrdquo
This is simply untrue Lowering cholesterol (even to rock-bottom levels) reduces but does not eliminate the risk of heart attacks Many heart attacks still
occur in people with low cholesterol levels whether or not they take cholesterol-lowering drugs7 We must consider that there are other risk factors for
heart disease besides cholesterol such as small LDL particles low HDL high fibrinogen high homocysteine and high insulin levels Results from the
most recent National Health and Nutritional Survey show that 47 million US adults have metabolic syndrome (low HDL high trig lycerides high blood
pressure excess abdominal fat) which substantially heightens the risk of heart disease even in the presence of low cholesterol levels8
MYTH 3
ldquoI feel fine and my stress test was normal My doctor says I donrsquot have heart diseaserdquo
This is among the most widely propagated fallacies spread by many primary care physicians and even cardiologists First lack of symptoms should not
be reassuring as most heart disease is silentmdashwithout symptoms and undetectable by conventional means such as electrocardiograms and cholesterol
testing Second stress testing is a miserable failure for screening asymptomatic people Most future deaths and heart attack s in fact occur in people
with normal stress tests (when symptoms are not present) The net result of this misperception is that most future heart -attack victims are walking around
feeling fine and unaware of their risk9 Cholesterol can be high low or in between but all too frequently fails to shed light on this murky situation
Cholesterol the lipid with a bad reputation
Hyperlipidemia refers to elevated blood levels of lipids (fats) including cholesterol and triglycerides Most people with hy perlipidemia have no symptoms
However hyperlipidemia is a contributing factor associated with an increased risk of coronary heart disease (CHD) a thicken ing or hardening of the
arteries that supply blood to the heart muscle CHD in turn can result in angina pectoris (chest pain) a heart attack or both Although hyperlipidemia is
considered a risk factor to heart disease it is one of many risk factors and what actually causes hyperlipidemia is a debatable issue It not as simple as
foods that contain cholesterol elevate lipids
Another important risk factor which has been largely overlooked is the oxidation of low -density lipoprotein (LDL) cholesterol caused from a lack of
antioxidant-rich foods herbs and nutrients andor a large intake of foods and chemicals that contains damaging free radicals Chronic inflammation also
contributes to oxidative stress and an increase in CHD When LDL cholesterol oxidizes it promotes atherosclerosis by a proc ess referred to as the
macrophage-foam cell mechanism particularly in the presence of stressors like cortisol and insulin Cortisol and insulin together act as a dynamic
duel causing all kinds of disruptions including an increased oxidative and inflammatory state These are the real underline causes to chronic disease
Inflammation is also involved in the process of LDL oxidation and contributes to the development of vascular disease 10-13 Ideally LDL levels should be
kept under 120 mgdL and you should monitor your patients for oxidative activity especially lipid peroxidation
The production of C-reactive protein is an essential part of the inflammatory process and the measurement of this substance reflects the level of
inflammatory activity deep within the body It appears that certain conditions create a state of excessive inflammation withi n the circulatory system High
C-reactive protein levels are evidence of this type of inflammation 14-17 Ideally it is best to keep C-reactive protein levels below 055 mgL in men and 15
Featured Article by Dicken Weatherby on Cardiovascular Health
Page 7 of 13
mgL in women Please note that the reference ranges above refer to the High Sensitivity CRP or hs -CRP test
Multiple risk markers for atherosclerosis and cardiovascular disease act in a synergistic way through inflammatory pathways The following lists the
different factors that have been identified as risk factors for CHD and arterial damage
Elevated CRP
Elevated LDL
Excess Insulin
Low HDL
High Glucose
Nitric Oxide Deficit
Excess Triglycerides
Low Free Testosterone
Excess Fibrinogen
Excess Homocysteine
Hypertension
Low Vitamin K
Excess Cholesterol
There are many key inflammatory biochemical risk markers for cardiovascular disease in particular the role of three basic c ell types affected by
these risk markers (endothelial cells smooth muscle cells and immune cells) the crucial role of inflammatory mediators ni tric oxide balance in
cardiovascular pathology and the use of nutrients (flavanoids carotenoids sterols vitamin C and E Omega 3 fatty acids et c) to circumvent several of
these inflammatory pathways Most of the above risk markers for cardiovascular disease have a pro -inflammatory component which stimulates the
release of a number of active molecules such as inflammatory mediators reactive oxygen species nitric oxide and peroxynitr ite from endothelial
vascular smooth muscle and immune cells in response to injury Nitric oxide plays a pivotal role in preventing the progressi on of atherosclerosis through
its ability to induce vasodilation suppress vascular smooth muscle proli feration and reduce vascular lesion formation Nutr ients such as arginine
antioxidants (OPCs vitamins C and E lipoic acid selenium glutathione) and enzyme cofactors (vitamins B2 and B3 B6 B12 folate zinc) help to
elevate nitric oxide levels and may play an important role in the management of cardiovascular disease Other dietary components such as DHAEPA
from fish oil tocotrienols vitamins B6 and B12 and quercetin contribute further to mitigating the inflammatory process 18
Within the broad range of cholesterol levels from 180 to 240 there is little to no evidence that this alone correlates with h eart disease Below 180 there is
increased risk of hemorrhagic stroke depression and suicide Above 240 there is increased risk of cardiovascular disease an d ischemic stroke Over age
70 elevated cholesterol and cardiovascular events no longer correlate All told total serum cholesterol alone is a poor ind icator of cardiovascular disease
Half of all heart attack patients have normal total cholesterol levels
So not only do statin drugs have their inherent drawbacks but in some ways they are treating a fabricated problem based on misunderstood and
misrepresented ―research As natural health care providers we know that we must be wary of the current cholesterol hysteria we must be able to
explain the real evidence and we must help our patients understand the facts so they can make educated health choices
Dicken Weatherby ND is originally from Oxfordshire in the UK and is based in Ashland Oregon USA A graduate of the National College of Natural
Medicine Dicken is author of the bestselling book Blood Chemistry and CBC Analysis -Clinical Laboratory Testing from a Functional Perspective He
has self-published seven other books in the field of alternative medical diagnosis has created numerous information products and runs a number of
successful Web sites including wwwFMTowncom an online membership community for practitioners interested in Functional Medicine and
Functional Diagnosis Dr Weatherby is the creator of the ldquoFoundations of Functional Diagnosis Training Programrdquo at wwwFunctionalDiagnosiscom and
the ldquoFoundations of Functional Blood Chemistry Analysisrdquo Training Program at wwwBloodChemistryTrainingcom
Donald R Yance CN MH RH is an internationally known herbalist and nutritionist He is the founder and medical director of the Centre for Natural
Healing in Ashland Ore Through extensive research and clinical practice he has developed his Triphasic system which forms the cornerstone of his
clinical approach Donald is the founder and formulator of Natura Health Products and founder and president of The Mederi Fo undation whose
programs promote health education and clinical research on the use of natural medicine with an emphasis in the field of integrative oncology
References
1 Gardner CD Fortmann SP Krauss RM Association of small low-density lipoprotein particles with the incidence of coronary artery disease in
men and women JAMA 1996 Sep 18276(11)875-81
2 Stampfer MJ Krauss RM Ma J et al A prospective study of triglyceride level low- density lipoprotein particle diameter and risk of myocardial
infarction JAMA 1996 Sep 18276(11)882-88
3 Lamarche B Tchernof A Moorjani S et al Small dense low-density lipoprotein particles as a predictor of the risk of ischemic heart disease in
men Prospective results from the Quebec Cardiovascular Study Circulation 1997 Jan 795(1)69 -75
4 Kuller L Tracy P Arnold A et al Nuclear magnetic resonance spectroscopy of lipoproteins and risk of coronary heart diseas e in the
cardiovascular health study Arterioscler Thromb Vasc Biol 2002 Jul 122(7)1175 -80
5 Expert Panel on Detection Evaluation and Treatment of High Blood Cholesterol in Adults Executive summary of the third report of the national
cholesterol education program (NCEP) expert panel on detection evaluation and treatment of high blood cholesterol in adults (Adult Treatment
Panel III) JAMA 2001 May 16285(19)2486-97
Featured Article by Dicken Weatherby on Cardiovascular Health
BANT - the seal of excellence for nutrition health professionals
We are pleased to let you all know that Dicken will be speaking at our seminar on 29th October 2011 - donrsquot miss it or you will
miss out Book your tickets now as they are selling fast wwwbantorgukbantjspNGseminarvideosfaces
Page 8 of 13
6 Gotto AM Brinton EA Assessing low levels of high-density lipoprotein cholesterol as a risk factor in coronary heart disease J Am Coll Cardiol
2004 Mar 343(5)717-24
7 van Lennep JE Westerveld HT Van Lennep HW Zwinderman AH Erkelens DW van der Wall EE Apolipoprotein concentrations durin g treat
ment and recurrent coronary artery disease events Arterioscler Thromb Vasc Biol 2000 Nov20(11)2408 -13
8 Ford ES Giles WH Dietz WH Prevalence of the metabolic syndrome among US adults findings from the third National Health an d Nutrition
Examination Survey JAMA 2002 Jan 16287(3)356-9
9 Taylor AJ Merz CN Udelson JE 34th Bethesda Conference ―Can atherosclerosis imaging techniques improve the detection of pa tients at risk
for ischemic heart disease J Amer Coll Cardiol 2003 Jun 4(11)411860 -2
10 Rifai N Ridker PM Inflammatory markers and coronary heart disease Curr Opin Lipidol 2002 Aug13(4)383-9
11 Albert CM et al Prospective study of C-reactive protein homocysteine and plasma lipid levels as predictors of sudden cardiac death
Circulation 2002 Jun 4105 (22)2595-9
12 Bermudez EA Ridker PM C-reactive protein statins and the primary prevention of atherosclerotic cardiovascular disease Prev Cardiol 2002
Winter5(1)42-6
13 Schroecksnadel K Frick B Winkler C Fuchs D Crucial role of interferon-gamma and stimulated macrophages in cardiovascular disease Curr
Vasc Pharmacol 2006 Jul4(3)205-13
14 Rifai N Ridker PM Inflammatory markers and coronary heart disease Curr Opin Lipidol 2002 Aug13(4)383-9
15 Albert CM et al Prospective study of C-reactive protein homocysteine and plasma lipid levels as predictors of sudden cardiac death
Circulation 2002 Jun 4105 (22)2595-9
16 Bermudez EA Ridker PM C-reactive protein statins and the primary prevention of atherosclerotic cardiovascular disease Prev Cardiol 2002
Winter5(1)42-6
17 Blake GJ Ridker PM Inflammatory mechanisms in atherosclerosis from laboratory evidence to clinical application Ital Heart J 2001 Nov2
(11)796-800
18 Osiecki HE The role of chronic inflammation in cardiovascular disease and its regulation by nutrients Altern Med Rev 2004 Mar9(1)32-53
Conversion Table This will help you to convert the markers in this article from US units into units used on UK blood tests
Reference ranges given are typical but may vary depending on lab used Eg Biolab given reference range for cholesterol is that target should be below
4 to 5 depending on clinical factors
Featured Article by Dicken Weatherby on Cardiovascular Health
Studies
CHIA SEEDS MAY OFFER OMEGA-3 HEART AND LIVER BENEFITS STUDY
wwwnutraingredients-usacomHealth-condition-categoriesCardiovascular-
healthChia-seeds-may-offer-omega-3-heart-and-liver-benefits-Study
c=TRR9CYYlHK48nEzv7WRu8CTrplNtVNvfamputm_source=Newsletter_Productampu
tm_medium=emailamputm_campaign=Newsletter2BProduct
DORMANT ANTIOXIDANT HAS lsquoUNPARALLELEDrsquo BENEFITS
wwwnutraingredients-usacomHealth-condition-categoriesCardiovascular-
healthDormant -antioxidant-has-unparalleled-benefits
WHOLE MANGOSTEEN FRUIT AND ITS BENEFITS
wwwthewholefruitcomstructure_functionphp
The early research on the whole mangosteen fruit and its numerous
nutritional components is both promising and precise Feel like digging in
Herelsquos a snapshotmdashjust a small samplemdashof the studies that back the
impressive edge of whole mangosteen formulation and supplementation
Neutralizes Free Radicals
Supports a Healthy Cardiovascular System
Supports Cartilage and Joint Function
Strengthens the Immune System
Promotes a Healthy Seasonal Respiratory System
Maintains Intestinal Health
Other Supportive Papers
Monthly ReportsStudiesWebinarsVideocasts
Publications
Destination 2020 - A Plan for Cardiac and Vascular Health
wwwbhforgukpublicationsview-publicationaspxps=1000855
Webinars
You need to register your details before you can access these webi-
nars FREE OF CHARGE
2010 State-of-the-Art Webinar Series in Cardiovascular Disease
Webinar I
Webinar II
Webinar III
Videocasts
Vitamin D cardiovascular disease and cancer emerging evi-
dence [electronic resource] JoAnn E Manson
httpvideocastnihgovlaunchasp15689
Heart failure in women
httpvideocastnihgovlaunchasp15838
Demystifying Medicine - Cardiovascular disease in the eras of
imaging and stem cells
httpvideocastnihgovlaunchasp16573
Demystifying Medicine - Arteriosclerotic cardiovascular disease
Number one killer and the Framingham experience
httpvideocastnihgovlaunchasp14936
US reference range To convert from US to UK UK units
Cholesterol 150-220 mgdL Multiple by 002586 336-52 mmoll
HDL 40-90 mgdL Multiple by 002586 103-232 mmol
LDL 60-130 mgdL Multiple by 002586 155 ndash 336 mmoll
BANT sponsors a 2 day seminar on cPNI on 8-9 of Sep 2011
organised by Bonusan under the auspices of the Natura Foundation
wwwbantorgukbantjspmemberpdfseminarsBONUSAN_CPNIpdf
Page 9 of 13
On Saturday 21st May the Alliance for Natural Health International supported by the GNC and BANT held its first
training and education day for practitioners helping them through the minefield of legislative requirements facing the
natural health sector The conference was well attended by over 240 practitioners whose feedback confirms that the
information was critical to their ability to manage their practices compliantly in the future and was summed up succinctly
by one of the delegates
I think the conference today really hits the mark in terms of tak ing a very complex set of regulations and putting it into a
digestible form for practitioners laying out not only the regulations but also the practical side of how we live within thi s
new regulatory environment
Kathleen Devereaux
We understand that many were not able to attend the conference in person but as promised we have now produced a full download of the daylsquos
sessions in video format which includes the pre-reading pack sent to delegates a comprehensive delegate volume of notes covering the days event and
an extensive reference list of supporting documentation We know its been a few weeks since the event but it takes time to p rofessionally edit the raw
footage so we hope that youll now feel part of it as if you had actually been there with us
Having attended the ANH conference I was able to get a real picture about the Rules and Regulations NTs are up against Understanding this legislation
and how it affects NT practice is an important part of being a responsible NT We need to learn the language of these new rul es and in doing so feel
empowered and in control of our work environment This conference DVD and info should be an essential part of your NT toolk it
Melanie de Grooth BANT AdministratorGeneral Manager
This comprehensive package costs pound40 with proceeds going to the ANH campaign fund and is available to practitioners and student practitioners only
Those practitioners who are going to be successful in this new environment will need to uniquely express themselves according to their qualifications and
experience A me too approach where everyone says the same things is not going to allow you to stand out from the crowd At the heart of this is an
understanding of the principles behind the rules and regulations as well as solutions allowing you to not fall foul of it Provided in the printed and video
outputs from our seminar are all the basics youll need to move confidently forward in this difficult and confusing regulatory climate and we will be
following up with more support in due course
As NT practitioners we are facing a maze of rules and regulations that will affect how we work in the future I therefore urge you all to purchase the must
have DVD from the recent excellent ANH training conference entitled Rules and Regulations in Clinical Practice Developing your Practice in Spite of the
EU Regulatory Juggernaut This is an extremely useful toolk it for your practice and will assist you in understanding these l egislative changes
Catherine Honeywell - Chair BANT Council
PURCHASE DOWNLOAD - wwwanh-europeorgrules-and-regulations-training-buy-download We also invite you to sign up for our regular
eAlerts wwwanh-europeorguserregister and to check out our practitioner pages - wwwanh-europeorgpractitioners
Thank you ANH-Intl
ANH-Intl Rules and Regulations DVD Now on Sale
BANT Page on Rules and Regulations If you have not already done so please make sure you access the presentations we have
provided on Rule and Regulations Affecting NT Practice and Understanding the Scope and
Definition for Medicinal Claims
An incredible amount of time and effort has gone into this project and we are sure that you will
now easily be able to navigate your way through the complicated array of rules and regulations
that impact on our practise of Nutritional Therapy
We would like to thank ANH-Intl and give credit to them for auditing and contributing the source
materials which BANT has interpreted and presented in this unique format The format and
presentation are the copyright of BANT and should not be reproduced without prior permission
We would also like to give a special thank you to Louise Carder who tirelessly gave of her time
and expertise to help BANT produce these slides ndash thank you Louise
You can access these slides at the following link wwwbantorgukbantjspmemberrulesRegulation faces
They have been designed for best use online You can of course print them out but you will then not be able to benefit from using the hyperlinks for
navigation Please take some time out of your busy schedules to carefully work and read through these slides This informati on is an essential part of
you Nutritional Therapy toolkit and will help you to be a better and more responsible practitioner
Understanding these Rules and Regulations will not only empower you as a practitioner but will
also demonstrate your level of commitment to your clients and the profession
From time to time we will update the content of the slides but will always let you know when this
has been done
IMPORTANT
After the renewals in October all full members will be emailed a copy of what you currently state
on you BANT profile under Special Interests and Further Information It will be your responsi-
bility to check the information is correct in relation to the ASA Rules and the Rules and
Regulations affecting NT practice Use this link to access the ARC Toolkit and FAQs on the
ASA rules wwwbantorgukbantjspmemberASARulesfaces
Page 10 of
FoodInfo Online Features 1 April 2011
httpwwwfoodsciencecentralcomfscixid16088
copy IFIS Publishing 2011 - All Rights Reserved
From pharm to fork in the nutrigenomic era is it food or medicine
Susan A McGinty and Dominic Man
London South Bank University 103 Borough Road London SE1 0AA
1 Introduction
The foodmedicine boundary has long been opaque with responsibility for medicines and food regulation coming under different European Commission
directorates This has led to a lack of integration at the EU level between food and medicine which has been further exacerbat ed by a lack of
harmonisation of implementation at Member State level of EU food law From 1 May the EU Traditional and Herbal Medicines Products Directive
(THMPD) comes fully into force and the elements of a perfect stormlsquo may be moving into place Manufacturers will no longer be able to supply
unlicensed herbal medicines to the public The European Medicines Agencylsquos (EMEA) has a database of medicinal herbs which includes inter
alia sage thyme garlic onion cinnamon pumpkin seed linseed juniper berry peppermint leaf and aniseed The UKlsquos Medicines and Healthcare
Products Regulatory Agency (MHRA) has published its own list of herbs and classifies them as medicinefoodcosmetic - also reflecting the problem of
the regulation of products and claims for cosmeceuticals From May 2011 ―it is the competence and responsibility of national authorities to decide on a
case by case basis whether a herbal product fulfils the definition of medicinal product A survey of the fundamental definitions clarifications by the
European Court of Justice (ECJ) and an examination of the European Councillsquos homeostasis model spotlights areas which may nee d to be reconciled if
the overall regulatory framework is capable of adapting to the era of systems biology and personalised medicinenutrition i ncluding dermagenetics
2 The devil in the detail the definitions
21 Food
Article 2 of EC 1782002 defines food including supplements as ―any substance or product whether processed partially processed or unprocessed
intended to be or reasonably expected to be ingested by humans This definition is straightforward but allows interpretation of reasonably expectedlsquo to
determine a medicinal product where dosagelsquo may be seen as a critical element ndash see later
22 Medicine bdquoform‟ and bdquofunction‟
Directive 200183EC of 6 November 2001 defined a medicine as either ―any substance or combination of substances presented for treating or
preventing disease in human beings or ―any substance or combination of substances which may be administered to human beings with a view to making
a diagnosis or to restoring correcting or modifying physiological balance in human beings This linked marketing activities and intention of consumption
to medicinal functionality In 2004 Directive 200427EC amended the definition of a medicine to ―any substance or combination of substances
presented as having properties for treating or preventing disease in human beings or any substance or combination of substances which may be used
in or administered to human beings either with a view to restoring correcting or modifying physiological functions by exerting a pharmacological
immunological or metabolic action or to making a medical diagnosis Article 22 of the 2004 Directive goes on to state ―In cases of doubt where
taking into account all its characteristics a product may fall within the definition of a medicinal productlsquo and within the definition of a product covered by
other Community legislation the provisions of this Directive shall apply
This definition had the technical effect of making all bioactive food components meet the medicinal standard by function if not by presentation and has
left Member State medicines regulators the EMEA and the European Commissionlsquos Directorate General Enterprise and Industry (DGEI) in the driving
seat as to determining product status and enforcement Nonetheless the ECJ ruled in C-31905 Commission of the European Communities v Federal
Republic of Germany of 15 November 2007 that the definition of a medicinal product by function should be interpreted restrictively since it was des igned
to cover only products whose pharmacological properties have been scientifically observed and not substances which while ha ving an effect on the
human body do not significantly affect the metabolism and thus do not strictly modify the way in which it functions
The formlsquo of a medicine versus a food supplement was also tested in C-31905 in which the Commission accused the Federal Republic of Germany of
breach of its obligations under Articles 28 and 30 of the EC Treaty (free movement of goods) by classifying a garlic preparat ion in capsule form as a
medicinal product The ECJ held that a capsule form was not of itself sufficient to decide whether a product was medicinal that the capsule form is not
exclusive to medicinal products and the product in question only contained natural garlic and could not have any additional e ffects (positive or negative)
compared to garlic in its natural state A medicinal product must have the function of preventing or treating disease beneficial effects for health in general
are not sufficient
The ECJ clarifications pose a fundamental problem for Member State medicines regulators consistently using formlsquo and functi onlsquo as theirbenchmark
standards Pillcapsuletincture forms regularity of consumption defined posology and ADME (absorption distribution metabolism and excretion) and
the accompanying claims have long been the determinants in borderline product adjudications
23 Prevention or disease-risk reduction
The EU has no definition of diseaselsquo in any of its regulatory instruments except for medically diagnosed conditions or using w ider public health
frameworks for measuring disease prevention in terms ofQuality of Life Years (QALYs) and Disability Adjusted Life Years (DALY s) for example It has not
From Pharm to Fork in the Nutrigenomic Era Is It Food or Medicine
BANT - the seal of excellence for nutrition health professionals
Page 11 of From Pharm to Fork in the Nutrigenomic Era Is It Food or Medicine- Cont
adopted a fully transparent and credible suite of biomarkers surrogate or end-markers to establish healthdisease status and bi ofunctionality In the UK
The Medicines Act 1968 (as amended) defines disease as something which ―includes any injury ailment or adverse condition whether of body or
mind The lack of a clear legal definition has been recognised by the ECJ where disease has been intrinsically linked to the definition of a medicinal
product The Court determined in C-36988 on whether eye lotion was a medicinal product or cosmetic (a cosmetic being external but being able to
protectlsquo or keep in good conditionlsquo) that on the basis of scientific knowledge ―it is for the national authorities to dete rmine whether products presented as
counter-acting certain conditions of sensations such as hunger heaviness in the legs tiredness or itching constitute a medic al product
The United States Food and Drug Administration (FDA) in its health claims legislation defines disease as
―Damage to an organ part or structure or system of the body such that it does not function properly (eg cardiovascular dis ease) or a state of health
leading to such dysfunctioning (eg hypertension) except that diseases resulting from essential nutrient deficiencies (eg scurvy pellagra) are not
included in this definition
Proposals for health claims legislation being framed by Food Standards Australia and New Zealand (FSANZ) include definitions for diseaselsquo and serious
diseaselsquo which distinguish in terms both of severity of condition and of level of claim
Disease an unhealthy condition characterised by clinically significant signs or symptoms
Serious disease or condition forms of disease conditions ailments or defects which are generally accepted to be beyond the ability of the
average consumer to evaluate accurately and to treat safely without regular supervision by a suitably qualified health care professional
Where disease-risk reduction relates to one of a number of factors in the aetiology of disease the concept of preventionlsquo itse lf poses a number
of difficulties as like diseaselsquo it is not clearly defined in law
Coppens et al 2001 survey use of preventionlsquo in relation to the first EU Medicines Directive 6565 where prevention has had a history of use in terms
of vaccination and infectious diseases Prevention is a word with an absolute indication and its use is clear and distinct in nature and includes some
statistical certainty nonetheless with chronic diseases there is an overlap where reduction of disease risk pertains to one factor sufficient to prevent the
occurrence likely to be based on epidemiological evidence from studies of population cohorts Coppens et al propose that prevention has three facets
a) Prevention of disease occurrence where
the disease is not (yet) present
the therapy can prevent the occurrence of the disease with substantial statistical certainty
b) Prevention of episodes of the disease where
the disease is present
the therapy decreases the number duration or severity of disease episodes with a substantial statistical certainty
c) Prevention of progression of the patientlsquos underlying disease where
the disease is present
the therapy has been shown to delay the progression of the disease with a substantial statistical certainty
At the other end of the spectrum treatlsquo denotes a purpose of action intention therefore becomes a key determinant in claim status Intention in
consumption is important for the enforcement of health claims where (average) consumer understanding is a factor Consumption of supplemental vitamin
D3 to support bone health or with a substantiated claim reduce the risk of osteoporosis comes under the food domain However consumption of
supplemental vitamin D3 for the purposes of immune-modulation would be medicinal
The principle of disease risk reduction (DRR) as distinct from prevention was incorporated into EU law in EC 19242006 on nutrition and health claims
on food (NHCR) which requires that all structurefunction and DRR claims on food including supplements must be preapproved by the EU Commission
and meet a standard of substantial scientific agreement While the DRR paradigm recognises that chronic disease conditions are the product of multiple
gene-environment influences it nonetheless still must be predicated on what diseaselsquo is in biological terms The EU-funded PASSCLAIM projec t was
tasked with establishing how health claims would be substantiated and to identify functional biomarkers or surrogate end-point markers for use in the
assessment process PASSCLAIM working groups produced reports on diet -related cardiovascular disease bone health and osteoporosis physical
performance and fitness mental state and performance body weight insulin sensitivity and diabetes diet -related cancer and gut health and
immunity At January 2011 the European Food Safety Authority (EFSA) charged with the process of assessing claims is yet to fully clarify its
assessment criteria
24 Functional foods food bioactives and nutraceuticals
While the EU regulates foods containing plant sterolsstanols there is no formal definition of functional foodlsquo The EU FUFOSE project used a working
definition of functional foods that ―affect beneficially one or more target functions in the body beyond adequate nutriti onal effects in a way that is
relevant to either an improved state of health and well -being andor reduction of risk of disease FUFOSE noted that a functional food can be a natural
food one to which a component has been added or removed where a component has been modified or its bioavailability modifie d or any combination or
multiples of all the possibilities Therefore functional foods in the EU must be foods with health claims as defined by the NHCR
BANT sponsors a 2 day seminar on cPNI on 8-9 of Sep 2011
organised by Bonusan under the auspices of the Natura Foundation
wwwbantorgukbantjspmemberpdfseminarsBONUSAN_CPNIpdf
Page 12 of
Although in 2006 the US FDA proposed that the term functional foodlsquo be regulated (21 Code of Federal Regulations Part 101 and Part 170)it still has no
formal definition of that or of nutraceuticallsquo Earlier in 2004 the US Department of Health and Human Services (DHHS) launch ed a consultation on a
proposed definition of bioactive food componentslsquo In its supplementary information to the proposal the DHHS stated that bioactives may have multiple
sites of action may interact with one or more dietary constituents and may act directly or indirectly to produce a functional outcome citing as examples
lycopene long-chain omega-3 fatty acids isoflavones sulphorophane and resveratrol Establishing a definition of a food bioactive was a first step
towards evaluating their significance in promoting health and disease prevention then guiding research priorities and science-based information to help
guide public health policylsquo The definition proposed was
―Bioactive food components are constituents in foods or dietary supplements other than those needed to meet basic human nutr itional needs that are
responsible for changes in health status
As of early 2011 the work on defining food bioactives has not progressed Respondents to the 2004 consultation made strong representations about a
definition of bioactivity which excluded nutrients arguably the most important bioactive category of food components Seventeen written responses were
received in response to the consultation a number of which proposed alternate definitions Common themes in those alternate definitions include use of
the term physiologically activelsquo or physiological benefitlsquo reference to structure functionlsquo and disease -risk reductionlsquo and (ILSI North America) ―as
measured through utilizing appropriate methodology and biomarkers
In January 2011 the US National Academies of Science publishedPerspectives on Biomarker and Surrogate Endpoint Evaluation with recommendations
for establishing a framework for harmonising biomarker use across all areas including drugs and foods
3 Dosage and the homeostasis model what is lsquonormalrsquo
The ECJ Judgement C-8807 of 5 March 2009 determined that substances ―which while having an effect on the human body do not significantly
affect the metabolism and thus do not strictly modify the way in which it functions should not be classified as medicinal products by function
(see Commission v Germany paragraph 60 and Hecht-Pharma paragraph 41) Dosage therefore is a key criterion in determining food from medicine
of botanicals and from May 2011 is likely to be used by national authorities in enforcement This complements the homeostasis model produced by
the European Council in 2008 to distinguish foods and medicinal products The model incorporates the notion of intended use of the product and the
nature of the induced effect food induces the physiological effects characterised by maintainsupportoptimiselsquo and medicine induces the physiological
functions characterised by restorecorrectmodifylsquo It is a self-contained integrated approach but is predicated on the definition of homeostasis being
defined as ldquothe status of a person whose physiological parameters function within the limits considered as normal But while normal
physiological parameters may be defined by (sometimes quite large) reference ranges nutritional prerequisites or dietary ref erence intakes are not fully
harmonised throughout the EU nor do they take account of ancestral or inter-individual variation which characterise different sub-populations The lack
of harmonisation means some EU Member States regard supra -RDA vitamin and mineral supplements as medicines where others including the UK
have taken a more liberal approach The EU-funded EurRECA network of excellence is tasked with developing methodologies and recommendations to
standardise the process of setting pan-EU micronutrient recommendations This will inform progress in setting maximum permitted levels of vitamins and
minerals in food supplements However the extent of inter-individuality may prove problematic in 2007 the UK Committee on Toxicity in its working
group report on variability and uncertainty stated that for vitamins and minerals ―variability in the response of individuals has the potential to result in a
situation which a given level of exposure could be essential for some but toxic for others
What is normallsquo in dietary requirements underpins the basis on which both medicinal and health claims are evaluated namely that a healthy balanced
diet is generally able to provide all micronutrient requirements by normal healthy individuals for health maintenance Two signi ficant sub-populations
however threaten to undermine that approach In the UK the Healthy Start programme administered by statutory instrument by the Department
of Health and National Health Service provides two bespoke Healthy Start-branded vitamin supplements for low income beneficiaries for women free
during pregnancy and up until their baby is one year old and for children from 6 months of age until their fourth birthday Non-beneficiaries can
purchase Healthy Start-branded supplements at low cost from health clinics Health professionals are encouraged to make sure that mothers and
children ―get two important vitamins that they may not be getting in adequate quantities ndash even from a healthy balanced diet These are vitamins A and D
for children and vitamin D and folic acid for women While it is prohibited under the NHCR to claim that a healthy balanced diet cannot in general
provide all nutrients needed there is no such prohibition under medicinal law and the Healthy Startvitamins are marketed under a UK medicines
licence [PL015110003] This conflict adds to the problems of robust implementation of the NHCR which is already stymied by the lack of
A credible transparent system of scientific assessment
An agreed nutrient profiling system
A harmonised pan-EU characterisation of a healthy balanced diet
4 Going forward
Added to the woes of the NHCR looms a new era of personal genomicmetabolomic profiling and personalised nutrition in the for m of P4
medicinelsquo (personalised predictive preventive participatory) In its essence nutrigenomicslsquo incorporates two aspects
The effect of food components on the genome and epigenome
The extent of ancestral and individual variation
If disease can be classified at the molecular level what effect does this have on the meaning of homeostasislsquo and medicine lsquo These key terms need full
and comprehensive definition both in biology and law so that the food -medicine continuum is fully resolved and the foundation is laid for the successful
application of both personalised medicine and personalised nutrition Innovation and continued investment in wellness products by the food industry
depend on a clear consistent and transparent system of claims assessment
From Pharm to Fork in the Nutrigenomic Era Is It Food or Medicine- Cont
Page 13 of 13 Topic of the Month - Cardiovascular Health
Nutri Link Clinical Education - wwwnleducationcouk
They believe in supporting the health care professionals who count on them for
effective nutritional solutions Their team of CAM-leading experts are committed to
providing you with the latest unbiased scientific research and clinical support plus a
vast array of continuing education opportunitieshellipbecause as practitioners they
understand that knowledge is the key to positive patient results
FM Town - wwwfmtowncom
Its all about relevancy Being in a 100 Functional Medicine environment will give
you an opportunity to get direct and immediate access to all the information that is
most relevant to you FMTown is private and highly relevant in its scope of focus
Get connected to an amazing online resource which can grow with you and support
your Functional Medicine Journey
Institute for Functional Medicine - wwwfunctionalmedicineorg
IFM Membership is your gateway to a community of like-minded clinicians and
researchers It is primarily aimed at clinicians and scientists whose interest in
functional medicine is deeply connected to examining the emerging research
attending CME courses discussing issues and patients with colleagues and so
forth Membership helps to build a network of practitioners from many disciplines
who are using and studying functional medicine every day
Food Science Central - wwwfoodsciencecentralcom
Food Science Central is the home of IFIS Publishing on the web Here you can
learn about products and services and access FREE articles on many topics in food
science food technology and nutrition
Monthly ArticlesPapers
ANXIETY AND CARDIOVASCULAR RISK REVIEW OF
EPIDEMIOLOGICAL AND CLINICAL EVIDENCE
O Olafiranye G Jean-Louis F Zizi J Nunes and MT Vincent
wwwncbinlmnihgovpmcarticlesPMC3150179pdfnihms-
301210pdf
POST-TRAUMATIC STRESS DISORDER AND
CARDIOVASCULAR DISEASE
Steven S Coughlin
wwwncbinlmnihgovpmcarticlesPMC3141329pdfTOCMJ-5-
164pdf
STUDIES OF GENE VARIANTS RELATED TO INFLAMMATION
OXIDATIVE STRESS DYSLIPIDEMIA AND OBESITY
IMPLICATIONS FOR A NUTRIGENETIC APPROACH
Maira Ladeia R Curti Patrıcia Jacob Maria Carolina Borges
Marcelo Macedo Rogero and Sandra Roberta G Ferreir
wwwncbinlmnihgovpmcarticlesPMC3136190pdfJOBES2011-
497401pdf
EFFECT OF AN OFFICE WORKSITE-BASED YOGA
PROGRAM ON HEART RATE VARIABILITY A RANDOMIZED
CONTROLLED TRIAL
Birinder S Cheema Paul W Marshall Dennis Chang Ben
Colagiuri and Bianca Machliss
wwwncbinlmnihgovpmcarticlesPMC3154869pdf1471-2458-
11-578pdf
CARDIOVASCULAR COMPLICATIONS IN CKD PATIENTS
ROLE OF OXIDATIVE STRESS
Elvira O Gosmanova and Ngoc-Anh Le
wwwncbinlmnihgovpmcarticlesPMC3022166pdfCRP2011-
156326pdf
TARGETING STEM CELL NICHES AND TRAFFICKING FOR
CARDIOVASCULAR THERAPY
Nicolle Kraumlnkel Gaia Spinetti Silvia Amadesi and Paolo Madeddu
wwwncbinlmnihgovpmcarticlesPMC3017934pdfukmss-
33677pdf
INTERACTION OF SLEEP QUALITY AND PSYCHOS OCIAL
STRESS ON OBESITY IN AFRICAN AMERICANS THE
CARDIOVASCULAR HEALTH EPIDEMIOLOGY STUDY (CHES)
Aurelian Bidulescu Rebecca Din-Dzietham Dorothy L Coverson
Zhimin Chen Yuan-Xiang Meng Sarah G Buxbaum Gary H Gib-
bons Verna L Welch
wwwbiomedcentralcomcontentpdf1471-2458-10-581pdf
PATHOPHYSIOLOGIC MECHANISMS LINKING IMPAIRED
CARDIOVASCULAR HEALTH AND NEUROLOGIC
DYSFUNCTION THE YEAR IN REVIEW
Ki E Park Carl J Pepine
wwwccjmorgcontent77Suppl_3S40fullpdf+html
BERRIES EMERGING IMPACT ON CARDIOVASCULAR
HEALTH
Arpita Basu Michael Rhone and Timothy J Lyons
wwwncbinlmnihgovpmcarticlesPMC3068482pdf
nihms171310pdf
THE PLACENTA IS A PROGRAMMING AGENT FOR
CARDIOVASCULAR DISEASE
KL Thornburg PF OlsquoTierney and S Louey
wwwncbinlmnihgovpmcarticlesPMC2846089pdf
nihms177889pdf
Useful Websites
BANT - the seal of excellence for nutrition health professionals
Page 4 of 13 News from the Professional Practice Committee Professional Practice FAQs
The Professional Practice Committee (PPC) is currently working to prepare a set of Professional Practice FAQs to post on the PPC page of the BANT
website We are often asked the same or similar questions more than once and rather than repeatedly sending out the same answers we feel that it
would make sense for members to able to check on the website first before having to approach us It also means that if we do receive duplicate queries
we can very quickly direct members to where the answer is available Then as further suitable queries come in we will add them to the FAQs and so
build a body of information to support the guidelines laid out in the Code of Professional Practice We expect the Professional Practice FAQ page to go
live some time towards the end of September and we will inform members when this has happened
PPC September FAQ
We have been approached a number of times by members who are concerned that a complaint may be about to be lodged against them asking whether
there are any particular measures they need to take
If you feel for some reason that a client or past client is likely to lodge a complaint against you the PPC would suggest that you make sure your case
notes relating to that client are in good order and that you keep copies of all correspondence that you have with the client making a signed note of
anything that is said on the telephone We would also suggest that you inform your insurer that you are concerned that a client may be preparing a
complaint against you
A direct approach made to a client as soon as possible asking what it is they are not happy about can often calm things down and avert a formal
complaint An offer of a refund or a further consultation if you feel it is justified may help to rectify the situation
Alison Belsham - Chair of Professional Practice Committee
CNHC Appoints New CEO CNHC has appointed a new Chief Executive From 1 September 2011 Margaret Coats takes up post as Interim CEO and Registrar Her immediate past
position was as CEO at the General Chiropractic Council a position she held for eleven years Prior to that her roles includ ed that of CEO of the
Occupational Standards Council for Health amp Social Care and Head of the NHS Open Learning Unit
Margaret brings a wealth of experience to her new role from both the health and occupational standards sectors Having been w orking until recently in
the statutory arm of professional regulation she looks forward to the challenges and rewards associated with managing a volun tary regulator Maggy
Wallace CNHC Chair said ―I know that I can speak on behalf of the whole Board of Directors when I say how pleased we are that Margaret is joining us
CNHC is moving into new phase of its evolution and we anticipate benefitting hugely from Margaretlsquos knowledge and experience All organisations benefit
from fresh eyes and approaches to help move them forward especially at times of significant political and regulatory change such as those we are
currently experiencing
Margaretlsquos experience will be particularly valuable in supporting CNHClsquos on -going involvement with the Council for Healthcare Regulatory Excellence
(CHRE) as that body develops its own new role as the Professional Standards Authority (PSA) for Health and Social Care CHRElsquo s remit is to bring all
of health care regulation under the wing of the PSA CNHC is already actively participating in the current discussions with i nterested parties as it has
valuable experience to share from its work with and experience in the complementary healthcare sector Margaretlsquos knowledge and experience will
enhance that which has already been acquired
Maggy Wallace CNHC Chair also expressed thanks to Maggie Dunn who steps down as CEO on 31 August ―Maggielsquos unstinting com mitment to
getting CNHC up and running as an effective body has been exemplary Maggie has been a real pleasure to work with and we are delighted that she
remains on the Board of Directors and will continue to build and maintain links with professional colleagues
REMINDER - Learning Zone Challenge to BANT Members The BANT Learning Zone challenge for full members
So you think you know Functional Medicine (FM) and its approaches Test your knowledge at the Learning Zone
as a way of enhancing your knowledge or just seeing what you know maybe over a cup of coffee or with friends
No two tests are the same so each time you take a test you will get a fresh approach to teasing your brain cells
The BANT Learning Zone challenge for student members
SO you think you know FM and your training providers have prepared you for its challenges Well we dare you to
find out how much you know or even to find out how much you may still need to learn about FM
At no time will there be a recording in any shape or form of either the number of attempts made to pass the
modules or any of your scores below the pass rate of 80 Your result is only recorded when you pass a module
at which point you will receive a certificate of achievement If the unthinkable happens no one will know other than
you so WHY NOT TAKE THE LEARNING ZONE CHALLENGE and get a certificate that really means something
The online Learning Zone was launched on the 1st of July 2011 containing 3 FM modules These 3 FM modules
are compulsory for Associate Members as they form a critical part of the APLAPEL assessment process However these online modules are
currently voluntary for full and student members of BANT
These online modules should be viewed as a resource for BANT practitioners to show a) they are up to date and b) a tool which BANT can use for
assessing new membership applications In the light of the criticisms over nutritional therapists using genetic testing BANT did assure the Human
Genetics Commission that those using these tests would be up to date As practice changes we need to have mechanisms in place to get everyone
together if BANT has to organise its own courses in post-genome nutrition It is envisaged that many more carefully chosen modules will be developed
and added to the Learning Zone over the next few years
In time the modules should be seen as a resource to be used for revalidation There is no requirement for revalidation yet particularly for those who have
gone through the NTC Grandparenting process
1 in 10 of you will need Symprove at some stage in your life Many people
already know what Symprove does for them wwwsymprovecom
Page 5 of 13
Help contribute to the content of the e-Newsletter
We are looking for members who have specialised experience
in dealing with certain health conditions
You would be able submit a lead article on the subject
Provide references to articles and papers on the subject
Useful websites and links that cover the subject
Webinars podcasts or videos on the subject
Any other useful information on the subject
If you feel that you would like to help us by contributing please contact us
Melanie at theadministratorbantorguk or Catherine at bantchairbantorguk for more details
Get Involved - Contribute to the BANT e-Newsletter
REMINDER - Online Renewals to be Implemented 1st October 2011
BANT is working hard to develop online renewal processing in time for 1 October 2011 The system will initially be rolled out for membership renewals
and we will then be looking at processing all membership applications online by 1 October 2012 The online renewal system wil l only take card payments
and it will be essential for all members to have an active email address and also have registered their details to access the members only section The
link to register your details can be found at wwwbantorgukbantjspregister faces
For those of you who have a standing order set up to pay BANT each year please can you contact your bank as soon as possible to cancel the
arrangement We are unable to do this for you as a standing order is entirely under your control If you do not cancel your standing order the
payment will be still debited from your account but this will NOT mean that you have renewed your membership It will however take up a lot of
our time and complicate our financial records if we need to refund standing order payments that have not been cancelled Over the next few weeks we
will be emailing all members who have an existing standing order to remind them to cancel the arrangement
From this renewal year all student members will also be required to renew their membership each year for a fee of pound20 We are delighted to inform you
that we will keeping our full member renewal fees at pound75 ndash this will be the 8th consecutive year that BANT has kept the full member fee at pound75
Interested in being part of this exciting new technology First 100 to
contactsymprovecom receive a free bottle wwwsymprovecom
Page 6 of 13
Statin Drugs Cholesterol and Heart Disease Myth versus Reality
By Dicken Weatherby ND and Donald R Yance MH CN
Pfizer and Merck are continuing their efforts to have the commonly prescribed Statin medications Lipitor and Mevacor approved for over the counter use
Currently these drugs are made available in the US only with a physicianlsquos prescription In the US the Food and Drug Adminis tration or FDA has turned
down three times Mercklsquos application to make Mevacor one of the first statin drugs available without a prescription The pa nel that made this decision
the third time raised concerns that patients would turn to statin drugs instead of seeking a physicianlsquos care Itlsquos good news that the FDA isnlsquot giving the
green light to widespread over-the-counter drug use despite the heavy sway of advertising that would have people believe statin drugs are a safe
panacea for preventing cardiovascular disease We know most of you reading this already understand the misinformation being f oisted on the public
regarding statin drugs but we thought welsquod take this opportunity to review some the myths and the realities behind this issue so you can properly consult
with your patients and clients
Dispelling some of the myths regarding statin drugs cholesterol and heart disease
MYTH 1
ldquoHigh cholesterol (and LDL) is the number-one cause of heart disease in the Westrdquo
Wrong High cholesterol is among the risk factors for heart disease but is not the leading risk factor The most prevalent r isk factor is low HDL along
with small LDL particles which commonly occur together In fact of every 100 people with coronary heart disease 60-70 will have low HDL and small
LDL particles but fewer than 30 will have high LDL If this is the case why do we not hear more about low HDL and small LDL particles The answer is
simple because treating these is not as profitable for drug companies But just waitmdashwhen a profitable drug becomes available to treat this more
prevalent risk factor for heart disease we can expect to hear about an ―epidemic that will justify billions of dollars in new drug expenditures1-4
What qualifies as low HDL National guidelines say it is a level of less than 40 mgdL for men and less than 45 mgdL for wom en5 In fact a level of
less than 60 mgdL is probably very significant6 HDL is already a standard measure in everyday cholesterol panels Small LDL particles on the other
hand need to be measured specifically The medical world focuses on statin therapy for LDL while the most prevalent risk factor for heart disease goes
untreated in the great majority of cases
MYTH 2
ldquoIf I take a statin agent I wonrsquot have a heart attackrdquo
This is simply untrue Lowering cholesterol (even to rock-bottom levels) reduces but does not eliminate the risk of heart attacks Many heart attacks still
occur in people with low cholesterol levels whether or not they take cholesterol-lowering drugs7 We must consider that there are other risk factors for
heart disease besides cholesterol such as small LDL particles low HDL high fibrinogen high homocysteine and high insulin levels Results from the
most recent National Health and Nutritional Survey show that 47 million US adults have metabolic syndrome (low HDL high trig lycerides high blood
pressure excess abdominal fat) which substantially heightens the risk of heart disease even in the presence of low cholesterol levels8
MYTH 3
ldquoI feel fine and my stress test was normal My doctor says I donrsquot have heart diseaserdquo
This is among the most widely propagated fallacies spread by many primary care physicians and even cardiologists First lack of symptoms should not
be reassuring as most heart disease is silentmdashwithout symptoms and undetectable by conventional means such as electrocardiograms and cholesterol
testing Second stress testing is a miserable failure for screening asymptomatic people Most future deaths and heart attack s in fact occur in people
with normal stress tests (when symptoms are not present) The net result of this misperception is that most future heart -attack victims are walking around
feeling fine and unaware of their risk9 Cholesterol can be high low or in between but all too frequently fails to shed light on this murky situation
Cholesterol the lipid with a bad reputation
Hyperlipidemia refers to elevated blood levels of lipids (fats) including cholesterol and triglycerides Most people with hy perlipidemia have no symptoms
However hyperlipidemia is a contributing factor associated with an increased risk of coronary heart disease (CHD) a thicken ing or hardening of the
arteries that supply blood to the heart muscle CHD in turn can result in angina pectoris (chest pain) a heart attack or both Although hyperlipidemia is
considered a risk factor to heart disease it is one of many risk factors and what actually causes hyperlipidemia is a debatable issue It not as simple as
foods that contain cholesterol elevate lipids
Another important risk factor which has been largely overlooked is the oxidation of low -density lipoprotein (LDL) cholesterol caused from a lack of
antioxidant-rich foods herbs and nutrients andor a large intake of foods and chemicals that contains damaging free radicals Chronic inflammation also
contributes to oxidative stress and an increase in CHD When LDL cholesterol oxidizes it promotes atherosclerosis by a proc ess referred to as the
macrophage-foam cell mechanism particularly in the presence of stressors like cortisol and insulin Cortisol and insulin together act as a dynamic
duel causing all kinds of disruptions including an increased oxidative and inflammatory state These are the real underline causes to chronic disease
Inflammation is also involved in the process of LDL oxidation and contributes to the development of vascular disease 10-13 Ideally LDL levels should be
kept under 120 mgdL and you should monitor your patients for oxidative activity especially lipid peroxidation
The production of C-reactive protein is an essential part of the inflammatory process and the measurement of this substance reflects the level of
inflammatory activity deep within the body It appears that certain conditions create a state of excessive inflammation withi n the circulatory system High
C-reactive protein levels are evidence of this type of inflammation 14-17 Ideally it is best to keep C-reactive protein levels below 055 mgL in men and 15
Featured Article by Dicken Weatherby on Cardiovascular Health
Page 7 of 13
mgL in women Please note that the reference ranges above refer to the High Sensitivity CRP or hs -CRP test
Multiple risk markers for atherosclerosis and cardiovascular disease act in a synergistic way through inflammatory pathways The following lists the
different factors that have been identified as risk factors for CHD and arterial damage
Elevated CRP
Elevated LDL
Excess Insulin
Low HDL
High Glucose
Nitric Oxide Deficit
Excess Triglycerides
Low Free Testosterone
Excess Fibrinogen
Excess Homocysteine
Hypertension
Low Vitamin K
Excess Cholesterol
There are many key inflammatory biochemical risk markers for cardiovascular disease in particular the role of three basic c ell types affected by
these risk markers (endothelial cells smooth muscle cells and immune cells) the crucial role of inflammatory mediators ni tric oxide balance in
cardiovascular pathology and the use of nutrients (flavanoids carotenoids sterols vitamin C and E Omega 3 fatty acids et c) to circumvent several of
these inflammatory pathways Most of the above risk markers for cardiovascular disease have a pro -inflammatory component which stimulates the
release of a number of active molecules such as inflammatory mediators reactive oxygen species nitric oxide and peroxynitr ite from endothelial
vascular smooth muscle and immune cells in response to injury Nitric oxide plays a pivotal role in preventing the progressi on of atherosclerosis through
its ability to induce vasodilation suppress vascular smooth muscle proli feration and reduce vascular lesion formation Nutr ients such as arginine
antioxidants (OPCs vitamins C and E lipoic acid selenium glutathione) and enzyme cofactors (vitamins B2 and B3 B6 B12 folate zinc) help to
elevate nitric oxide levels and may play an important role in the management of cardiovascular disease Other dietary components such as DHAEPA
from fish oil tocotrienols vitamins B6 and B12 and quercetin contribute further to mitigating the inflammatory process 18
Within the broad range of cholesterol levels from 180 to 240 there is little to no evidence that this alone correlates with h eart disease Below 180 there is
increased risk of hemorrhagic stroke depression and suicide Above 240 there is increased risk of cardiovascular disease an d ischemic stroke Over age
70 elevated cholesterol and cardiovascular events no longer correlate All told total serum cholesterol alone is a poor ind icator of cardiovascular disease
Half of all heart attack patients have normal total cholesterol levels
So not only do statin drugs have their inherent drawbacks but in some ways they are treating a fabricated problem based on misunderstood and
misrepresented ―research As natural health care providers we know that we must be wary of the current cholesterol hysteria we must be able to
explain the real evidence and we must help our patients understand the facts so they can make educated health choices
Dicken Weatherby ND is originally from Oxfordshire in the UK and is based in Ashland Oregon USA A graduate of the National College of Natural
Medicine Dicken is author of the bestselling book Blood Chemistry and CBC Analysis -Clinical Laboratory Testing from a Functional Perspective He
has self-published seven other books in the field of alternative medical diagnosis has created numerous information products and runs a number of
successful Web sites including wwwFMTowncom an online membership community for practitioners interested in Functional Medicine and
Functional Diagnosis Dr Weatherby is the creator of the ldquoFoundations of Functional Diagnosis Training Programrdquo at wwwFunctionalDiagnosiscom and
the ldquoFoundations of Functional Blood Chemistry Analysisrdquo Training Program at wwwBloodChemistryTrainingcom
Donald R Yance CN MH RH is an internationally known herbalist and nutritionist He is the founder and medical director of the Centre for Natural
Healing in Ashland Ore Through extensive research and clinical practice he has developed his Triphasic system which forms the cornerstone of his
clinical approach Donald is the founder and formulator of Natura Health Products and founder and president of The Mederi Fo undation whose
programs promote health education and clinical research on the use of natural medicine with an emphasis in the field of integrative oncology
References
1 Gardner CD Fortmann SP Krauss RM Association of small low-density lipoprotein particles with the incidence of coronary artery disease in
men and women JAMA 1996 Sep 18276(11)875-81
2 Stampfer MJ Krauss RM Ma J et al A prospective study of triglyceride level low- density lipoprotein particle diameter and risk of myocardial
infarction JAMA 1996 Sep 18276(11)882-88
3 Lamarche B Tchernof A Moorjani S et al Small dense low-density lipoprotein particles as a predictor of the risk of ischemic heart disease in
men Prospective results from the Quebec Cardiovascular Study Circulation 1997 Jan 795(1)69 -75
4 Kuller L Tracy P Arnold A et al Nuclear magnetic resonance spectroscopy of lipoproteins and risk of coronary heart diseas e in the
cardiovascular health study Arterioscler Thromb Vasc Biol 2002 Jul 122(7)1175 -80
5 Expert Panel on Detection Evaluation and Treatment of High Blood Cholesterol in Adults Executive summary of the third report of the national
cholesterol education program (NCEP) expert panel on detection evaluation and treatment of high blood cholesterol in adults (Adult Treatment
Panel III) JAMA 2001 May 16285(19)2486-97
Featured Article by Dicken Weatherby on Cardiovascular Health
BANT - the seal of excellence for nutrition health professionals
We are pleased to let you all know that Dicken will be speaking at our seminar on 29th October 2011 - donrsquot miss it or you will
miss out Book your tickets now as they are selling fast wwwbantorgukbantjspNGseminarvideosfaces
Page 8 of 13
6 Gotto AM Brinton EA Assessing low levels of high-density lipoprotein cholesterol as a risk factor in coronary heart disease J Am Coll Cardiol
2004 Mar 343(5)717-24
7 van Lennep JE Westerveld HT Van Lennep HW Zwinderman AH Erkelens DW van der Wall EE Apolipoprotein concentrations durin g treat
ment and recurrent coronary artery disease events Arterioscler Thromb Vasc Biol 2000 Nov20(11)2408 -13
8 Ford ES Giles WH Dietz WH Prevalence of the metabolic syndrome among US adults findings from the third National Health an d Nutrition
Examination Survey JAMA 2002 Jan 16287(3)356-9
9 Taylor AJ Merz CN Udelson JE 34th Bethesda Conference ―Can atherosclerosis imaging techniques improve the detection of pa tients at risk
for ischemic heart disease J Amer Coll Cardiol 2003 Jun 4(11)411860 -2
10 Rifai N Ridker PM Inflammatory markers and coronary heart disease Curr Opin Lipidol 2002 Aug13(4)383-9
11 Albert CM et al Prospective study of C-reactive protein homocysteine and plasma lipid levels as predictors of sudden cardiac death
Circulation 2002 Jun 4105 (22)2595-9
12 Bermudez EA Ridker PM C-reactive protein statins and the primary prevention of atherosclerotic cardiovascular disease Prev Cardiol 2002
Winter5(1)42-6
13 Schroecksnadel K Frick B Winkler C Fuchs D Crucial role of interferon-gamma and stimulated macrophages in cardiovascular disease Curr
Vasc Pharmacol 2006 Jul4(3)205-13
14 Rifai N Ridker PM Inflammatory markers and coronary heart disease Curr Opin Lipidol 2002 Aug13(4)383-9
15 Albert CM et al Prospective study of C-reactive protein homocysteine and plasma lipid levels as predictors of sudden cardiac death
Circulation 2002 Jun 4105 (22)2595-9
16 Bermudez EA Ridker PM C-reactive protein statins and the primary prevention of atherosclerotic cardiovascular disease Prev Cardiol 2002
Winter5(1)42-6
17 Blake GJ Ridker PM Inflammatory mechanisms in atherosclerosis from laboratory evidence to clinical application Ital Heart J 2001 Nov2
(11)796-800
18 Osiecki HE The role of chronic inflammation in cardiovascular disease and its regulation by nutrients Altern Med Rev 2004 Mar9(1)32-53
Conversion Table This will help you to convert the markers in this article from US units into units used on UK blood tests
Reference ranges given are typical but may vary depending on lab used Eg Biolab given reference range for cholesterol is that target should be below
4 to 5 depending on clinical factors
Featured Article by Dicken Weatherby on Cardiovascular Health
Studies
CHIA SEEDS MAY OFFER OMEGA-3 HEART AND LIVER BENEFITS STUDY
wwwnutraingredients-usacomHealth-condition-categoriesCardiovascular-
healthChia-seeds-may-offer-omega-3-heart-and-liver-benefits-Study
c=TRR9CYYlHK48nEzv7WRu8CTrplNtVNvfamputm_source=Newsletter_Productampu
tm_medium=emailamputm_campaign=Newsletter2BProduct
DORMANT ANTIOXIDANT HAS lsquoUNPARALLELEDrsquo BENEFITS
wwwnutraingredients-usacomHealth-condition-categoriesCardiovascular-
healthDormant -antioxidant-has-unparalleled-benefits
WHOLE MANGOSTEEN FRUIT AND ITS BENEFITS
wwwthewholefruitcomstructure_functionphp
The early research on the whole mangosteen fruit and its numerous
nutritional components is both promising and precise Feel like digging in
Herelsquos a snapshotmdashjust a small samplemdashof the studies that back the
impressive edge of whole mangosteen formulation and supplementation
Neutralizes Free Radicals
Supports a Healthy Cardiovascular System
Supports Cartilage and Joint Function
Strengthens the Immune System
Promotes a Healthy Seasonal Respiratory System
Maintains Intestinal Health
Other Supportive Papers
Monthly ReportsStudiesWebinarsVideocasts
Publications
Destination 2020 - A Plan for Cardiac and Vascular Health
wwwbhforgukpublicationsview-publicationaspxps=1000855
Webinars
You need to register your details before you can access these webi-
nars FREE OF CHARGE
2010 State-of-the-Art Webinar Series in Cardiovascular Disease
Webinar I
Webinar II
Webinar III
Videocasts
Vitamin D cardiovascular disease and cancer emerging evi-
dence [electronic resource] JoAnn E Manson
httpvideocastnihgovlaunchasp15689
Heart failure in women
httpvideocastnihgovlaunchasp15838
Demystifying Medicine - Cardiovascular disease in the eras of
imaging and stem cells
httpvideocastnihgovlaunchasp16573
Demystifying Medicine - Arteriosclerotic cardiovascular disease
Number one killer and the Framingham experience
httpvideocastnihgovlaunchasp14936
US reference range To convert from US to UK UK units
Cholesterol 150-220 mgdL Multiple by 002586 336-52 mmoll
HDL 40-90 mgdL Multiple by 002586 103-232 mmol
LDL 60-130 mgdL Multiple by 002586 155 ndash 336 mmoll
BANT sponsors a 2 day seminar on cPNI on 8-9 of Sep 2011
organised by Bonusan under the auspices of the Natura Foundation
wwwbantorgukbantjspmemberpdfseminarsBONUSAN_CPNIpdf
Page 9 of 13
On Saturday 21st May the Alliance for Natural Health International supported by the GNC and BANT held its first
training and education day for practitioners helping them through the minefield of legislative requirements facing the
natural health sector The conference was well attended by over 240 practitioners whose feedback confirms that the
information was critical to their ability to manage their practices compliantly in the future and was summed up succinctly
by one of the delegates
I think the conference today really hits the mark in terms of tak ing a very complex set of regulations and putting it into a
digestible form for practitioners laying out not only the regulations but also the practical side of how we live within thi s
new regulatory environment
Kathleen Devereaux
We understand that many were not able to attend the conference in person but as promised we have now produced a full download of the daylsquos
sessions in video format which includes the pre-reading pack sent to delegates a comprehensive delegate volume of notes covering the days event and
an extensive reference list of supporting documentation We know its been a few weeks since the event but it takes time to p rofessionally edit the raw
footage so we hope that youll now feel part of it as if you had actually been there with us
Having attended the ANH conference I was able to get a real picture about the Rules and Regulations NTs are up against Understanding this legislation
and how it affects NT practice is an important part of being a responsible NT We need to learn the language of these new rul es and in doing so feel
empowered and in control of our work environment This conference DVD and info should be an essential part of your NT toolk it
Melanie de Grooth BANT AdministratorGeneral Manager
This comprehensive package costs pound40 with proceeds going to the ANH campaign fund and is available to practitioners and student practitioners only
Those practitioners who are going to be successful in this new environment will need to uniquely express themselves according to their qualifications and
experience A me too approach where everyone says the same things is not going to allow you to stand out from the crowd At the heart of this is an
understanding of the principles behind the rules and regulations as well as solutions allowing you to not fall foul of it Provided in the printed and video
outputs from our seminar are all the basics youll need to move confidently forward in this difficult and confusing regulatory climate and we will be
following up with more support in due course
As NT practitioners we are facing a maze of rules and regulations that will affect how we work in the future I therefore urge you all to purchase the must
have DVD from the recent excellent ANH training conference entitled Rules and Regulations in Clinical Practice Developing your Practice in Spite of the
EU Regulatory Juggernaut This is an extremely useful toolk it for your practice and will assist you in understanding these l egislative changes
Catherine Honeywell - Chair BANT Council
PURCHASE DOWNLOAD - wwwanh-europeorgrules-and-regulations-training-buy-download We also invite you to sign up for our regular
eAlerts wwwanh-europeorguserregister and to check out our practitioner pages - wwwanh-europeorgpractitioners
Thank you ANH-Intl
ANH-Intl Rules and Regulations DVD Now on Sale
BANT Page on Rules and Regulations If you have not already done so please make sure you access the presentations we have
provided on Rule and Regulations Affecting NT Practice and Understanding the Scope and
Definition for Medicinal Claims
An incredible amount of time and effort has gone into this project and we are sure that you will
now easily be able to navigate your way through the complicated array of rules and regulations
that impact on our practise of Nutritional Therapy
We would like to thank ANH-Intl and give credit to them for auditing and contributing the source
materials which BANT has interpreted and presented in this unique format The format and
presentation are the copyright of BANT and should not be reproduced without prior permission
We would also like to give a special thank you to Louise Carder who tirelessly gave of her time
and expertise to help BANT produce these slides ndash thank you Louise
You can access these slides at the following link wwwbantorgukbantjspmemberrulesRegulation faces
They have been designed for best use online You can of course print them out but you will then not be able to benefit from using the hyperlinks for
navigation Please take some time out of your busy schedules to carefully work and read through these slides This informati on is an essential part of
you Nutritional Therapy toolkit and will help you to be a better and more responsible practitioner
Understanding these Rules and Regulations will not only empower you as a practitioner but will
also demonstrate your level of commitment to your clients and the profession
From time to time we will update the content of the slides but will always let you know when this
has been done
IMPORTANT
After the renewals in October all full members will be emailed a copy of what you currently state
on you BANT profile under Special Interests and Further Information It will be your responsi-
bility to check the information is correct in relation to the ASA Rules and the Rules and
Regulations affecting NT practice Use this link to access the ARC Toolkit and FAQs on the
ASA rules wwwbantorgukbantjspmemberASARulesfaces
Page 10 of
FoodInfo Online Features 1 April 2011
httpwwwfoodsciencecentralcomfscixid16088
copy IFIS Publishing 2011 - All Rights Reserved
From pharm to fork in the nutrigenomic era is it food or medicine
Susan A McGinty and Dominic Man
London South Bank University 103 Borough Road London SE1 0AA
1 Introduction
The foodmedicine boundary has long been opaque with responsibility for medicines and food regulation coming under different European Commission
directorates This has led to a lack of integration at the EU level between food and medicine which has been further exacerbat ed by a lack of
harmonisation of implementation at Member State level of EU food law From 1 May the EU Traditional and Herbal Medicines Products Directive
(THMPD) comes fully into force and the elements of a perfect stormlsquo may be moving into place Manufacturers will no longer be able to supply
unlicensed herbal medicines to the public The European Medicines Agencylsquos (EMEA) has a database of medicinal herbs which includes inter
alia sage thyme garlic onion cinnamon pumpkin seed linseed juniper berry peppermint leaf and aniseed The UKlsquos Medicines and Healthcare
Products Regulatory Agency (MHRA) has published its own list of herbs and classifies them as medicinefoodcosmetic - also reflecting the problem of
the regulation of products and claims for cosmeceuticals From May 2011 ―it is the competence and responsibility of national authorities to decide on a
case by case basis whether a herbal product fulfils the definition of medicinal product A survey of the fundamental definitions clarifications by the
European Court of Justice (ECJ) and an examination of the European Councillsquos homeostasis model spotlights areas which may nee d to be reconciled if
the overall regulatory framework is capable of adapting to the era of systems biology and personalised medicinenutrition i ncluding dermagenetics
2 The devil in the detail the definitions
21 Food
Article 2 of EC 1782002 defines food including supplements as ―any substance or product whether processed partially processed or unprocessed
intended to be or reasonably expected to be ingested by humans This definition is straightforward but allows interpretation of reasonably expectedlsquo to
determine a medicinal product where dosagelsquo may be seen as a critical element ndash see later
22 Medicine bdquoform‟ and bdquofunction‟
Directive 200183EC of 6 November 2001 defined a medicine as either ―any substance or combination of substances presented for treating or
preventing disease in human beings or ―any substance or combination of substances which may be administered to human beings with a view to making
a diagnosis or to restoring correcting or modifying physiological balance in human beings This linked marketing activities and intention of consumption
to medicinal functionality In 2004 Directive 200427EC amended the definition of a medicine to ―any substance or combination of substances
presented as having properties for treating or preventing disease in human beings or any substance or combination of substances which may be used
in or administered to human beings either with a view to restoring correcting or modifying physiological functions by exerting a pharmacological
immunological or metabolic action or to making a medical diagnosis Article 22 of the 2004 Directive goes on to state ―In cases of doubt where
taking into account all its characteristics a product may fall within the definition of a medicinal productlsquo and within the definition of a product covered by
other Community legislation the provisions of this Directive shall apply
This definition had the technical effect of making all bioactive food components meet the medicinal standard by function if not by presentation and has
left Member State medicines regulators the EMEA and the European Commissionlsquos Directorate General Enterprise and Industry (DGEI) in the driving
seat as to determining product status and enforcement Nonetheless the ECJ ruled in C-31905 Commission of the European Communities v Federal
Republic of Germany of 15 November 2007 that the definition of a medicinal product by function should be interpreted restrictively since it was des igned
to cover only products whose pharmacological properties have been scientifically observed and not substances which while ha ving an effect on the
human body do not significantly affect the metabolism and thus do not strictly modify the way in which it functions
The formlsquo of a medicine versus a food supplement was also tested in C-31905 in which the Commission accused the Federal Republic of Germany of
breach of its obligations under Articles 28 and 30 of the EC Treaty (free movement of goods) by classifying a garlic preparat ion in capsule form as a
medicinal product The ECJ held that a capsule form was not of itself sufficient to decide whether a product was medicinal that the capsule form is not
exclusive to medicinal products and the product in question only contained natural garlic and could not have any additional e ffects (positive or negative)
compared to garlic in its natural state A medicinal product must have the function of preventing or treating disease beneficial effects for health in general
are not sufficient
The ECJ clarifications pose a fundamental problem for Member State medicines regulators consistently using formlsquo and functi onlsquo as theirbenchmark
standards Pillcapsuletincture forms regularity of consumption defined posology and ADME (absorption distribution metabolism and excretion) and
the accompanying claims have long been the determinants in borderline product adjudications
23 Prevention or disease-risk reduction
The EU has no definition of diseaselsquo in any of its regulatory instruments except for medically diagnosed conditions or using w ider public health
frameworks for measuring disease prevention in terms ofQuality of Life Years (QALYs) and Disability Adjusted Life Years (DALY s) for example It has not
From Pharm to Fork in the Nutrigenomic Era Is It Food or Medicine
BANT - the seal of excellence for nutrition health professionals
Page 11 of From Pharm to Fork in the Nutrigenomic Era Is It Food or Medicine- Cont
adopted a fully transparent and credible suite of biomarkers surrogate or end-markers to establish healthdisease status and bi ofunctionality In the UK
The Medicines Act 1968 (as amended) defines disease as something which ―includes any injury ailment or adverse condition whether of body or
mind The lack of a clear legal definition has been recognised by the ECJ where disease has been intrinsically linked to the definition of a medicinal
product The Court determined in C-36988 on whether eye lotion was a medicinal product or cosmetic (a cosmetic being external but being able to
protectlsquo or keep in good conditionlsquo) that on the basis of scientific knowledge ―it is for the national authorities to dete rmine whether products presented as
counter-acting certain conditions of sensations such as hunger heaviness in the legs tiredness or itching constitute a medic al product
The United States Food and Drug Administration (FDA) in its health claims legislation defines disease as
―Damage to an organ part or structure or system of the body such that it does not function properly (eg cardiovascular dis ease) or a state of health
leading to such dysfunctioning (eg hypertension) except that diseases resulting from essential nutrient deficiencies (eg scurvy pellagra) are not
included in this definition
Proposals for health claims legislation being framed by Food Standards Australia and New Zealand (FSANZ) include definitions for diseaselsquo and serious
diseaselsquo which distinguish in terms both of severity of condition and of level of claim
Disease an unhealthy condition characterised by clinically significant signs or symptoms
Serious disease or condition forms of disease conditions ailments or defects which are generally accepted to be beyond the ability of the
average consumer to evaluate accurately and to treat safely without regular supervision by a suitably qualified health care professional
Where disease-risk reduction relates to one of a number of factors in the aetiology of disease the concept of preventionlsquo itse lf poses a number
of difficulties as like diseaselsquo it is not clearly defined in law
Coppens et al 2001 survey use of preventionlsquo in relation to the first EU Medicines Directive 6565 where prevention has had a history of use in terms
of vaccination and infectious diseases Prevention is a word with an absolute indication and its use is clear and distinct in nature and includes some
statistical certainty nonetheless with chronic diseases there is an overlap where reduction of disease risk pertains to one factor sufficient to prevent the
occurrence likely to be based on epidemiological evidence from studies of population cohorts Coppens et al propose that prevention has three facets
a) Prevention of disease occurrence where
the disease is not (yet) present
the therapy can prevent the occurrence of the disease with substantial statistical certainty
b) Prevention of episodes of the disease where
the disease is present
the therapy decreases the number duration or severity of disease episodes with a substantial statistical certainty
c) Prevention of progression of the patientlsquos underlying disease where
the disease is present
the therapy has been shown to delay the progression of the disease with a substantial statistical certainty
At the other end of the spectrum treatlsquo denotes a purpose of action intention therefore becomes a key determinant in claim status Intention in
consumption is important for the enforcement of health claims where (average) consumer understanding is a factor Consumption of supplemental vitamin
D3 to support bone health or with a substantiated claim reduce the risk of osteoporosis comes under the food domain However consumption of
supplemental vitamin D3 for the purposes of immune-modulation would be medicinal
The principle of disease risk reduction (DRR) as distinct from prevention was incorporated into EU law in EC 19242006 on nutrition and health claims
on food (NHCR) which requires that all structurefunction and DRR claims on food including supplements must be preapproved by the EU Commission
and meet a standard of substantial scientific agreement While the DRR paradigm recognises that chronic disease conditions are the product of multiple
gene-environment influences it nonetheless still must be predicated on what diseaselsquo is in biological terms The EU-funded PASSCLAIM projec t was
tasked with establishing how health claims would be substantiated and to identify functional biomarkers or surrogate end-point markers for use in the
assessment process PASSCLAIM working groups produced reports on diet -related cardiovascular disease bone health and osteoporosis physical
performance and fitness mental state and performance body weight insulin sensitivity and diabetes diet -related cancer and gut health and
immunity At January 2011 the European Food Safety Authority (EFSA) charged with the process of assessing claims is yet to fully clarify its
assessment criteria
24 Functional foods food bioactives and nutraceuticals
While the EU regulates foods containing plant sterolsstanols there is no formal definition of functional foodlsquo The EU FUFOSE project used a working
definition of functional foods that ―affect beneficially one or more target functions in the body beyond adequate nutriti onal effects in a way that is
relevant to either an improved state of health and well -being andor reduction of risk of disease FUFOSE noted that a functional food can be a natural
food one to which a component has been added or removed where a component has been modified or its bioavailability modifie d or any combination or
multiples of all the possibilities Therefore functional foods in the EU must be foods with health claims as defined by the NHCR
BANT sponsors a 2 day seminar on cPNI on 8-9 of Sep 2011
organised by Bonusan under the auspices of the Natura Foundation
wwwbantorgukbantjspmemberpdfseminarsBONUSAN_CPNIpdf
Page 12 of
Although in 2006 the US FDA proposed that the term functional foodlsquo be regulated (21 Code of Federal Regulations Part 101 and Part 170)it still has no
formal definition of that or of nutraceuticallsquo Earlier in 2004 the US Department of Health and Human Services (DHHS) launch ed a consultation on a
proposed definition of bioactive food componentslsquo In its supplementary information to the proposal the DHHS stated that bioactives may have multiple
sites of action may interact with one or more dietary constituents and may act directly or indirectly to produce a functional outcome citing as examples
lycopene long-chain omega-3 fatty acids isoflavones sulphorophane and resveratrol Establishing a definition of a food bioactive was a first step
towards evaluating their significance in promoting health and disease prevention then guiding research priorities and science-based information to help
guide public health policylsquo The definition proposed was
―Bioactive food components are constituents in foods or dietary supplements other than those needed to meet basic human nutr itional needs that are
responsible for changes in health status
As of early 2011 the work on defining food bioactives has not progressed Respondents to the 2004 consultation made strong representations about a
definition of bioactivity which excluded nutrients arguably the most important bioactive category of food components Seventeen written responses were
received in response to the consultation a number of which proposed alternate definitions Common themes in those alternate definitions include use of
the term physiologically activelsquo or physiological benefitlsquo reference to structure functionlsquo and disease -risk reductionlsquo and (ILSI North America) ―as
measured through utilizing appropriate methodology and biomarkers
In January 2011 the US National Academies of Science publishedPerspectives on Biomarker and Surrogate Endpoint Evaluation with recommendations
for establishing a framework for harmonising biomarker use across all areas including drugs and foods
3 Dosage and the homeostasis model what is lsquonormalrsquo
The ECJ Judgement C-8807 of 5 March 2009 determined that substances ―which while having an effect on the human body do not significantly
affect the metabolism and thus do not strictly modify the way in which it functions should not be classified as medicinal products by function
(see Commission v Germany paragraph 60 and Hecht-Pharma paragraph 41) Dosage therefore is a key criterion in determining food from medicine
of botanicals and from May 2011 is likely to be used by national authorities in enforcement This complements the homeostasis model produced by
the European Council in 2008 to distinguish foods and medicinal products The model incorporates the notion of intended use of the product and the
nature of the induced effect food induces the physiological effects characterised by maintainsupportoptimiselsquo and medicine induces the physiological
functions characterised by restorecorrectmodifylsquo It is a self-contained integrated approach but is predicated on the definition of homeostasis being
defined as ldquothe status of a person whose physiological parameters function within the limits considered as normal But while normal
physiological parameters may be defined by (sometimes quite large) reference ranges nutritional prerequisites or dietary ref erence intakes are not fully
harmonised throughout the EU nor do they take account of ancestral or inter-individual variation which characterise different sub-populations The lack
of harmonisation means some EU Member States regard supra -RDA vitamin and mineral supplements as medicines where others including the UK
have taken a more liberal approach The EU-funded EurRECA network of excellence is tasked with developing methodologies and recommendations to
standardise the process of setting pan-EU micronutrient recommendations This will inform progress in setting maximum permitted levels of vitamins and
minerals in food supplements However the extent of inter-individuality may prove problematic in 2007 the UK Committee on Toxicity in its working
group report on variability and uncertainty stated that for vitamins and minerals ―variability in the response of individuals has the potential to result in a
situation which a given level of exposure could be essential for some but toxic for others
What is normallsquo in dietary requirements underpins the basis on which both medicinal and health claims are evaluated namely that a healthy balanced
diet is generally able to provide all micronutrient requirements by normal healthy individuals for health maintenance Two signi ficant sub-populations
however threaten to undermine that approach In the UK the Healthy Start programme administered by statutory instrument by the Department
of Health and National Health Service provides two bespoke Healthy Start-branded vitamin supplements for low income beneficiaries for women free
during pregnancy and up until their baby is one year old and for children from 6 months of age until their fourth birthday Non-beneficiaries can
purchase Healthy Start-branded supplements at low cost from health clinics Health professionals are encouraged to make sure that mothers and
children ―get two important vitamins that they may not be getting in adequate quantities ndash even from a healthy balanced diet These are vitamins A and D
for children and vitamin D and folic acid for women While it is prohibited under the NHCR to claim that a healthy balanced diet cannot in general
provide all nutrients needed there is no such prohibition under medicinal law and the Healthy Startvitamins are marketed under a UK medicines
licence [PL015110003] This conflict adds to the problems of robust implementation of the NHCR which is already stymied by the lack of
A credible transparent system of scientific assessment
An agreed nutrient profiling system
A harmonised pan-EU characterisation of a healthy balanced diet
4 Going forward
Added to the woes of the NHCR looms a new era of personal genomicmetabolomic profiling and personalised nutrition in the for m of P4
medicinelsquo (personalised predictive preventive participatory) In its essence nutrigenomicslsquo incorporates two aspects
The effect of food components on the genome and epigenome
The extent of ancestral and individual variation
If disease can be classified at the molecular level what effect does this have on the meaning of homeostasislsquo and medicine lsquo These key terms need full
and comprehensive definition both in biology and law so that the food -medicine continuum is fully resolved and the foundation is laid for the successful
application of both personalised medicine and personalised nutrition Innovation and continued investment in wellness products by the food industry
depend on a clear consistent and transparent system of claims assessment
From Pharm to Fork in the Nutrigenomic Era Is It Food or Medicine- Cont
Page 13 of 13 Topic of the Month - Cardiovascular Health
Nutri Link Clinical Education - wwwnleducationcouk
They believe in supporting the health care professionals who count on them for
effective nutritional solutions Their team of CAM-leading experts are committed to
providing you with the latest unbiased scientific research and clinical support plus a
vast array of continuing education opportunitieshellipbecause as practitioners they
understand that knowledge is the key to positive patient results
FM Town - wwwfmtowncom
Its all about relevancy Being in a 100 Functional Medicine environment will give
you an opportunity to get direct and immediate access to all the information that is
most relevant to you FMTown is private and highly relevant in its scope of focus
Get connected to an amazing online resource which can grow with you and support
your Functional Medicine Journey
Institute for Functional Medicine - wwwfunctionalmedicineorg
IFM Membership is your gateway to a community of like-minded clinicians and
researchers It is primarily aimed at clinicians and scientists whose interest in
functional medicine is deeply connected to examining the emerging research
attending CME courses discussing issues and patients with colleagues and so
forth Membership helps to build a network of practitioners from many disciplines
who are using and studying functional medicine every day
Food Science Central - wwwfoodsciencecentralcom
Food Science Central is the home of IFIS Publishing on the web Here you can
learn about products and services and access FREE articles on many topics in food
science food technology and nutrition
Monthly ArticlesPapers
ANXIETY AND CARDIOVASCULAR RISK REVIEW OF
EPIDEMIOLOGICAL AND CLINICAL EVIDENCE
O Olafiranye G Jean-Louis F Zizi J Nunes and MT Vincent
wwwncbinlmnihgovpmcarticlesPMC3150179pdfnihms-
301210pdf
POST-TRAUMATIC STRESS DISORDER AND
CARDIOVASCULAR DISEASE
Steven S Coughlin
wwwncbinlmnihgovpmcarticlesPMC3141329pdfTOCMJ-5-
164pdf
STUDIES OF GENE VARIANTS RELATED TO INFLAMMATION
OXIDATIVE STRESS DYSLIPIDEMIA AND OBESITY
IMPLICATIONS FOR A NUTRIGENETIC APPROACH
Maira Ladeia R Curti Patrıcia Jacob Maria Carolina Borges
Marcelo Macedo Rogero and Sandra Roberta G Ferreir
wwwncbinlmnihgovpmcarticlesPMC3136190pdfJOBES2011-
497401pdf
EFFECT OF AN OFFICE WORKSITE-BASED YOGA
PROGRAM ON HEART RATE VARIABILITY A RANDOMIZED
CONTROLLED TRIAL
Birinder S Cheema Paul W Marshall Dennis Chang Ben
Colagiuri and Bianca Machliss
wwwncbinlmnihgovpmcarticlesPMC3154869pdf1471-2458-
11-578pdf
CARDIOVASCULAR COMPLICATIONS IN CKD PATIENTS
ROLE OF OXIDATIVE STRESS
Elvira O Gosmanova and Ngoc-Anh Le
wwwncbinlmnihgovpmcarticlesPMC3022166pdfCRP2011-
156326pdf
TARGETING STEM CELL NICHES AND TRAFFICKING FOR
CARDIOVASCULAR THERAPY
Nicolle Kraumlnkel Gaia Spinetti Silvia Amadesi and Paolo Madeddu
wwwncbinlmnihgovpmcarticlesPMC3017934pdfukmss-
33677pdf
INTERACTION OF SLEEP QUALITY AND PSYCHOS OCIAL
STRESS ON OBESITY IN AFRICAN AMERICANS THE
CARDIOVASCULAR HEALTH EPIDEMIOLOGY STUDY (CHES)
Aurelian Bidulescu Rebecca Din-Dzietham Dorothy L Coverson
Zhimin Chen Yuan-Xiang Meng Sarah G Buxbaum Gary H Gib-
bons Verna L Welch
wwwbiomedcentralcomcontentpdf1471-2458-10-581pdf
PATHOPHYSIOLOGIC MECHANISMS LINKING IMPAIRED
CARDIOVASCULAR HEALTH AND NEUROLOGIC
DYSFUNCTION THE YEAR IN REVIEW
Ki E Park Carl J Pepine
wwwccjmorgcontent77Suppl_3S40fullpdf+html
BERRIES EMERGING IMPACT ON CARDIOVASCULAR
HEALTH
Arpita Basu Michael Rhone and Timothy J Lyons
wwwncbinlmnihgovpmcarticlesPMC3068482pdf
nihms171310pdf
THE PLACENTA IS A PROGRAMMING AGENT FOR
CARDIOVASCULAR DISEASE
KL Thornburg PF OlsquoTierney and S Louey
wwwncbinlmnihgovpmcarticlesPMC2846089pdf
nihms177889pdf
Useful Websites
BANT - the seal of excellence for nutrition health professionals
Page 5 of 13
Help contribute to the content of the e-Newsletter
We are looking for members who have specialised experience
in dealing with certain health conditions
You would be able submit a lead article on the subject
Provide references to articles and papers on the subject
Useful websites and links that cover the subject
Webinars podcasts or videos on the subject
Any other useful information on the subject
If you feel that you would like to help us by contributing please contact us
Melanie at theadministratorbantorguk or Catherine at bantchairbantorguk for more details
Get Involved - Contribute to the BANT e-Newsletter
REMINDER - Online Renewals to be Implemented 1st October 2011
BANT is working hard to develop online renewal processing in time for 1 October 2011 The system will initially be rolled out for membership renewals
and we will then be looking at processing all membership applications online by 1 October 2012 The online renewal system wil l only take card payments
and it will be essential for all members to have an active email address and also have registered their details to access the members only section The
link to register your details can be found at wwwbantorgukbantjspregister faces
For those of you who have a standing order set up to pay BANT each year please can you contact your bank as soon as possible to cancel the
arrangement We are unable to do this for you as a standing order is entirely under your control If you do not cancel your standing order the
payment will be still debited from your account but this will NOT mean that you have renewed your membership It will however take up a lot of
our time and complicate our financial records if we need to refund standing order payments that have not been cancelled Over the next few weeks we
will be emailing all members who have an existing standing order to remind them to cancel the arrangement
From this renewal year all student members will also be required to renew their membership each year for a fee of pound20 We are delighted to inform you
that we will keeping our full member renewal fees at pound75 ndash this will be the 8th consecutive year that BANT has kept the full member fee at pound75
Interested in being part of this exciting new technology First 100 to
contactsymprovecom receive a free bottle wwwsymprovecom
Page 6 of 13
Statin Drugs Cholesterol and Heart Disease Myth versus Reality
By Dicken Weatherby ND and Donald R Yance MH CN
Pfizer and Merck are continuing their efforts to have the commonly prescribed Statin medications Lipitor and Mevacor approved for over the counter use
Currently these drugs are made available in the US only with a physicianlsquos prescription In the US the Food and Drug Adminis tration or FDA has turned
down three times Mercklsquos application to make Mevacor one of the first statin drugs available without a prescription The pa nel that made this decision
the third time raised concerns that patients would turn to statin drugs instead of seeking a physicianlsquos care Itlsquos good news that the FDA isnlsquot giving the
green light to widespread over-the-counter drug use despite the heavy sway of advertising that would have people believe statin drugs are a safe
panacea for preventing cardiovascular disease We know most of you reading this already understand the misinformation being f oisted on the public
regarding statin drugs but we thought welsquod take this opportunity to review some the myths and the realities behind this issue so you can properly consult
with your patients and clients
Dispelling some of the myths regarding statin drugs cholesterol and heart disease
MYTH 1
ldquoHigh cholesterol (and LDL) is the number-one cause of heart disease in the Westrdquo
Wrong High cholesterol is among the risk factors for heart disease but is not the leading risk factor The most prevalent r isk factor is low HDL along
with small LDL particles which commonly occur together In fact of every 100 people with coronary heart disease 60-70 will have low HDL and small
LDL particles but fewer than 30 will have high LDL If this is the case why do we not hear more about low HDL and small LDL particles The answer is
simple because treating these is not as profitable for drug companies But just waitmdashwhen a profitable drug becomes available to treat this more
prevalent risk factor for heart disease we can expect to hear about an ―epidemic that will justify billions of dollars in new drug expenditures1-4
What qualifies as low HDL National guidelines say it is a level of less than 40 mgdL for men and less than 45 mgdL for wom en5 In fact a level of
less than 60 mgdL is probably very significant6 HDL is already a standard measure in everyday cholesterol panels Small LDL particles on the other
hand need to be measured specifically The medical world focuses on statin therapy for LDL while the most prevalent risk factor for heart disease goes
untreated in the great majority of cases
MYTH 2
ldquoIf I take a statin agent I wonrsquot have a heart attackrdquo
This is simply untrue Lowering cholesterol (even to rock-bottom levels) reduces but does not eliminate the risk of heart attacks Many heart attacks still
occur in people with low cholesterol levels whether or not they take cholesterol-lowering drugs7 We must consider that there are other risk factors for
heart disease besides cholesterol such as small LDL particles low HDL high fibrinogen high homocysteine and high insulin levels Results from the
most recent National Health and Nutritional Survey show that 47 million US adults have metabolic syndrome (low HDL high trig lycerides high blood
pressure excess abdominal fat) which substantially heightens the risk of heart disease even in the presence of low cholesterol levels8
MYTH 3
ldquoI feel fine and my stress test was normal My doctor says I donrsquot have heart diseaserdquo
This is among the most widely propagated fallacies spread by many primary care physicians and even cardiologists First lack of symptoms should not
be reassuring as most heart disease is silentmdashwithout symptoms and undetectable by conventional means such as electrocardiograms and cholesterol
testing Second stress testing is a miserable failure for screening asymptomatic people Most future deaths and heart attack s in fact occur in people
with normal stress tests (when symptoms are not present) The net result of this misperception is that most future heart -attack victims are walking around
feeling fine and unaware of their risk9 Cholesterol can be high low or in between but all too frequently fails to shed light on this murky situation
Cholesterol the lipid with a bad reputation
Hyperlipidemia refers to elevated blood levels of lipids (fats) including cholesterol and triglycerides Most people with hy perlipidemia have no symptoms
However hyperlipidemia is a contributing factor associated with an increased risk of coronary heart disease (CHD) a thicken ing or hardening of the
arteries that supply blood to the heart muscle CHD in turn can result in angina pectoris (chest pain) a heart attack or both Although hyperlipidemia is
considered a risk factor to heart disease it is one of many risk factors and what actually causes hyperlipidemia is a debatable issue It not as simple as
foods that contain cholesterol elevate lipids
Another important risk factor which has been largely overlooked is the oxidation of low -density lipoprotein (LDL) cholesterol caused from a lack of
antioxidant-rich foods herbs and nutrients andor a large intake of foods and chemicals that contains damaging free radicals Chronic inflammation also
contributes to oxidative stress and an increase in CHD When LDL cholesterol oxidizes it promotes atherosclerosis by a proc ess referred to as the
macrophage-foam cell mechanism particularly in the presence of stressors like cortisol and insulin Cortisol and insulin together act as a dynamic
duel causing all kinds of disruptions including an increased oxidative and inflammatory state These are the real underline causes to chronic disease
Inflammation is also involved in the process of LDL oxidation and contributes to the development of vascular disease 10-13 Ideally LDL levels should be
kept under 120 mgdL and you should monitor your patients for oxidative activity especially lipid peroxidation
The production of C-reactive protein is an essential part of the inflammatory process and the measurement of this substance reflects the level of
inflammatory activity deep within the body It appears that certain conditions create a state of excessive inflammation withi n the circulatory system High
C-reactive protein levels are evidence of this type of inflammation 14-17 Ideally it is best to keep C-reactive protein levels below 055 mgL in men and 15
Featured Article by Dicken Weatherby on Cardiovascular Health
Page 7 of 13
mgL in women Please note that the reference ranges above refer to the High Sensitivity CRP or hs -CRP test
Multiple risk markers for atherosclerosis and cardiovascular disease act in a synergistic way through inflammatory pathways The following lists the
different factors that have been identified as risk factors for CHD and arterial damage
Elevated CRP
Elevated LDL
Excess Insulin
Low HDL
High Glucose
Nitric Oxide Deficit
Excess Triglycerides
Low Free Testosterone
Excess Fibrinogen
Excess Homocysteine
Hypertension
Low Vitamin K
Excess Cholesterol
There are many key inflammatory biochemical risk markers for cardiovascular disease in particular the role of three basic c ell types affected by
these risk markers (endothelial cells smooth muscle cells and immune cells) the crucial role of inflammatory mediators ni tric oxide balance in
cardiovascular pathology and the use of nutrients (flavanoids carotenoids sterols vitamin C and E Omega 3 fatty acids et c) to circumvent several of
these inflammatory pathways Most of the above risk markers for cardiovascular disease have a pro -inflammatory component which stimulates the
release of a number of active molecules such as inflammatory mediators reactive oxygen species nitric oxide and peroxynitr ite from endothelial
vascular smooth muscle and immune cells in response to injury Nitric oxide plays a pivotal role in preventing the progressi on of atherosclerosis through
its ability to induce vasodilation suppress vascular smooth muscle proli feration and reduce vascular lesion formation Nutr ients such as arginine
antioxidants (OPCs vitamins C and E lipoic acid selenium glutathione) and enzyme cofactors (vitamins B2 and B3 B6 B12 folate zinc) help to
elevate nitric oxide levels and may play an important role in the management of cardiovascular disease Other dietary components such as DHAEPA
from fish oil tocotrienols vitamins B6 and B12 and quercetin contribute further to mitigating the inflammatory process 18
Within the broad range of cholesterol levels from 180 to 240 there is little to no evidence that this alone correlates with h eart disease Below 180 there is
increased risk of hemorrhagic stroke depression and suicide Above 240 there is increased risk of cardiovascular disease an d ischemic stroke Over age
70 elevated cholesterol and cardiovascular events no longer correlate All told total serum cholesterol alone is a poor ind icator of cardiovascular disease
Half of all heart attack patients have normal total cholesterol levels
So not only do statin drugs have their inherent drawbacks but in some ways they are treating a fabricated problem based on misunderstood and
misrepresented ―research As natural health care providers we know that we must be wary of the current cholesterol hysteria we must be able to
explain the real evidence and we must help our patients understand the facts so they can make educated health choices
Dicken Weatherby ND is originally from Oxfordshire in the UK and is based in Ashland Oregon USA A graduate of the National College of Natural
Medicine Dicken is author of the bestselling book Blood Chemistry and CBC Analysis -Clinical Laboratory Testing from a Functional Perspective He
has self-published seven other books in the field of alternative medical diagnosis has created numerous information products and runs a number of
successful Web sites including wwwFMTowncom an online membership community for practitioners interested in Functional Medicine and
Functional Diagnosis Dr Weatherby is the creator of the ldquoFoundations of Functional Diagnosis Training Programrdquo at wwwFunctionalDiagnosiscom and
the ldquoFoundations of Functional Blood Chemistry Analysisrdquo Training Program at wwwBloodChemistryTrainingcom
Donald R Yance CN MH RH is an internationally known herbalist and nutritionist He is the founder and medical director of the Centre for Natural
Healing in Ashland Ore Through extensive research and clinical practice he has developed his Triphasic system which forms the cornerstone of his
clinical approach Donald is the founder and formulator of Natura Health Products and founder and president of The Mederi Fo undation whose
programs promote health education and clinical research on the use of natural medicine with an emphasis in the field of integrative oncology
References
1 Gardner CD Fortmann SP Krauss RM Association of small low-density lipoprotein particles with the incidence of coronary artery disease in
men and women JAMA 1996 Sep 18276(11)875-81
2 Stampfer MJ Krauss RM Ma J et al A prospective study of triglyceride level low- density lipoprotein particle diameter and risk of myocardial
infarction JAMA 1996 Sep 18276(11)882-88
3 Lamarche B Tchernof A Moorjani S et al Small dense low-density lipoprotein particles as a predictor of the risk of ischemic heart disease in
men Prospective results from the Quebec Cardiovascular Study Circulation 1997 Jan 795(1)69 -75
4 Kuller L Tracy P Arnold A et al Nuclear magnetic resonance spectroscopy of lipoproteins and risk of coronary heart diseas e in the
cardiovascular health study Arterioscler Thromb Vasc Biol 2002 Jul 122(7)1175 -80
5 Expert Panel on Detection Evaluation and Treatment of High Blood Cholesterol in Adults Executive summary of the third report of the national
cholesterol education program (NCEP) expert panel on detection evaluation and treatment of high blood cholesterol in adults (Adult Treatment
Panel III) JAMA 2001 May 16285(19)2486-97
Featured Article by Dicken Weatherby on Cardiovascular Health
BANT - the seal of excellence for nutrition health professionals
We are pleased to let you all know that Dicken will be speaking at our seminar on 29th October 2011 - donrsquot miss it or you will
miss out Book your tickets now as they are selling fast wwwbantorgukbantjspNGseminarvideosfaces
Page 8 of 13
6 Gotto AM Brinton EA Assessing low levels of high-density lipoprotein cholesterol as a risk factor in coronary heart disease J Am Coll Cardiol
2004 Mar 343(5)717-24
7 van Lennep JE Westerveld HT Van Lennep HW Zwinderman AH Erkelens DW van der Wall EE Apolipoprotein concentrations durin g treat
ment and recurrent coronary artery disease events Arterioscler Thromb Vasc Biol 2000 Nov20(11)2408 -13
8 Ford ES Giles WH Dietz WH Prevalence of the metabolic syndrome among US adults findings from the third National Health an d Nutrition
Examination Survey JAMA 2002 Jan 16287(3)356-9
9 Taylor AJ Merz CN Udelson JE 34th Bethesda Conference ―Can atherosclerosis imaging techniques improve the detection of pa tients at risk
for ischemic heart disease J Amer Coll Cardiol 2003 Jun 4(11)411860 -2
10 Rifai N Ridker PM Inflammatory markers and coronary heart disease Curr Opin Lipidol 2002 Aug13(4)383-9
11 Albert CM et al Prospective study of C-reactive protein homocysteine and plasma lipid levels as predictors of sudden cardiac death
Circulation 2002 Jun 4105 (22)2595-9
12 Bermudez EA Ridker PM C-reactive protein statins and the primary prevention of atherosclerotic cardiovascular disease Prev Cardiol 2002
Winter5(1)42-6
13 Schroecksnadel K Frick B Winkler C Fuchs D Crucial role of interferon-gamma and stimulated macrophages in cardiovascular disease Curr
Vasc Pharmacol 2006 Jul4(3)205-13
14 Rifai N Ridker PM Inflammatory markers and coronary heart disease Curr Opin Lipidol 2002 Aug13(4)383-9
15 Albert CM et al Prospective study of C-reactive protein homocysteine and plasma lipid levels as predictors of sudden cardiac death
Circulation 2002 Jun 4105 (22)2595-9
16 Bermudez EA Ridker PM C-reactive protein statins and the primary prevention of atherosclerotic cardiovascular disease Prev Cardiol 2002
Winter5(1)42-6
17 Blake GJ Ridker PM Inflammatory mechanisms in atherosclerosis from laboratory evidence to clinical application Ital Heart J 2001 Nov2
(11)796-800
18 Osiecki HE The role of chronic inflammation in cardiovascular disease and its regulation by nutrients Altern Med Rev 2004 Mar9(1)32-53
Conversion Table This will help you to convert the markers in this article from US units into units used on UK blood tests
Reference ranges given are typical but may vary depending on lab used Eg Biolab given reference range for cholesterol is that target should be below
4 to 5 depending on clinical factors
Featured Article by Dicken Weatherby on Cardiovascular Health
Studies
CHIA SEEDS MAY OFFER OMEGA-3 HEART AND LIVER BENEFITS STUDY
wwwnutraingredients-usacomHealth-condition-categoriesCardiovascular-
healthChia-seeds-may-offer-omega-3-heart-and-liver-benefits-Study
c=TRR9CYYlHK48nEzv7WRu8CTrplNtVNvfamputm_source=Newsletter_Productampu
tm_medium=emailamputm_campaign=Newsletter2BProduct
DORMANT ANTIOXIDANT HAS lsquoUNPARALLELEDrsquo BENEFITS
wwwnutraingredients-usacomHealth-condition-categoriesCardiovascular-
healthDormant -antioxidant-has-unparalleled-benefits
WHOLE MANGOSTEEN FRUIT AND ITS BENEFITS
wwwthewholefruitcomstructure_functionphp
The early research on the whole mangosteen fruit and its numerous
nutritional components is both promising and precise Feel like digging in
Herelsquos a snapshotmdashjust a small samplemdashof the studies that back the
impressive edge of whole mangosteen formulation and supplementation
Neutralizes Free Radicals
Supports a Healthy Cardiovascular System
Supports Cartilage and Joint Function
Strengthens the Immune System
Promotes a Healthy Seasonal Respiratory System
Maintains Intestinal Health
Other Supportive Papers
Monthly ReportsStudiesWebinarsVideocasts
Publications
Destination 2020 - A Plan for Cardiac and Vascular Health
wwwbhforgukpublicationsview-publicationaspxps=1000855
Webinars
You need to register your details before you can access these webi-
nars FREE OF CHARGE
2010 State-of-the-Art Webinar Series in Cardiovascular Disease
Webinar I
Webinar II
Webinar III
Videocasts
Vitamin D cardiovascular disease and cancer emerging evi-
dence [electronic resource] JoAnn E Manson
httpvideocastnihgovlaunchasp15689
Heart failure in women
httpvideocastnihgovlaunchasp15838
Demystifying Medicine - Cardiovascular disease in the eras of
imaging and stem cells
httpvideocastnihgovlaunchasp16573
Demystifying Medicine - Arteriosclerotic cardiovascular disease
Number one killer and the Framingham experience
httpvideocastnihgovlaunchasp14936
US reference range To convert from US to UK UK units
Cholesterol 150-220 mgdL Multiple by 002586 336-52 mmoll
HDL 40-90 mgdL Multiple by 002586 103-232 mmol
LDL 60-130 mgdL Multiple by 002586 155 ndash 336 mmoll
BANT sponsors a 2 day seminar on cPNI on 8-9 of Sep 2011
organised by Bonusan under the auspices of the Natura Foundation
wwwbantorgukbantjspmemberpdfseminarsBONUSAN_CPNIpdf
Page 9 of 13
On Saturday 21st May the Alliance for Natural Health International supported by the GNC and BANT held its first
training and education day for practitioners helping them through the minefield of legislative requirements facing the
natural health sector The conference was well attended by over 240 practitioners whose feedback confirms that the
information was critical to their ability to manage their practices compliantly in the future and was summed up succinctly
by one of the delegates
I think the conference today really hits the mark in terms of tak ing a very complex set of regulations and putting it into a
digestible form for practitioners laying out not only the regulations but also the practical side of how we live within thi s
new regulatory environment
Kathleen Devereaux
We understand that many were not able to attend the conference in person but as promised we have now produced a full download of the daylsquos
sessions in video format which includes the pre-reading pack sent to delegates a comprehensive delegate volume of notes covering the days event and
an extensive reference list of supporting documentation We know its been a few weeks since the event but it takes time to p rofessionally edit the raw
footage so we hope that youll now feel part of it as if you had actually been there with us
Having attended the ANH conference I was able to get a real picture about the Rules and Regulations NTs are up against Understanding this legislation
and how it affects NT practice is an important part of being a responsible NT We need to learn the language of these new rul es and in doing so feel
empowered and in control of our work environment This conference DVD and info should be an essential part of your NT toolk it
Melanie de Grooth BANT AdministratorGeneral Manager
This comprehensive package costs pound40 with proceeds going to the ANH campaign fund and is available to practitioners and student practitioners only
Those practitioners who are going to be successful in this new environment will need to uniquely express themselves according to their qualifications and
experience A me too approach where everyone says the same things is not going to allow you to stand out from the crowd At the heart of this is an
understanding of the principles behind the rules and regulations as well as solutions allowing you to not fall foul of it Provided in the printed and video
outputs from our seminar are all the basics youll need to move confidently forward in this difficult and confusing regulatory climate and we will be
following up with more support in due course
As NT practitioners we are facing a maze of rules and regulations that will affect how we work in the future I therefore urge you all to purchase the must
have DVD from the recent excellent ANH training conference entitled Rules and Regulations in Clinical Practice Developing your Practice in Spite of the
EU Regulatory Juggernaut This is an extremely useful toolk it for your practice and will assist you in understanding these l egislative changes
Catherine Honeywell - Chair BANT Council
PURCHASE DOWNLOAD - wwwanh-europeorgrules-and-regulations-training-buy-download We also invite you to sign up for our regular
eAlerts wwwanh-europeorguserregister and to check out our practitioner pages - wwwanh-europeorgpractitioners
Thank you ANH-Intl
ANH-Intl Rules and Regulations DVD Now on Sale
BANT Page on Rules and Regulations If you have not already done so please make sure you access the presentations we have
provided on Rule and Regulations Affecting NT Practice and Understanding the Scope and
Definition for Medicinal Claims
An incredible amount of time and effort has gone into this project and we are sure that you will
now easily be able to navigate your way through the complicated array of rules and regulations
that impact on our practise of Nutritional Therapy
We would like to thank ANH-Intl and give credit to them for auditing and contributing the source
materials which BANT has interpreted and presented in this unique format The format and
presentation are the copyright of BANT and should not be reproduced without prior permission
We would also like to give a special thank you to Louise Carder who tirelessly gave of her time
and expertise to help BANT produce these slides ndash thank you Louise
You can access these slides at the following link wwwbantorgukbantjspmemberrulesRegulation faces
They have been designed for best use online You can of course print them out but you will then not be able to benefit from using the hyperlinks for
navigation Please take some time out of your busy schedules to carefully work and read through these slides This informati on is an essential part of
you Nutritional Therapy toolkit and will help you to be a better and more responsible practitioner
Understanding these Rules and Regulations will not only empower you as a practitioner but will
also demonstrate your level of commitment to your clients and the profession
From time to time we will update the content of the slides but will always let you know when this
has been done
IMPORTANT
After the renewals in October all full members will be emailed a copy of what you currently state
on you BANT profile under Special Interests and Further Information It will be your responsi-
bility to check the information is correct in relation to the ASA Rules and the Rules and
Regulations affecting NT practice Use this link to access the ARC Toolkit and FAQs on the
ASA rules wwwbantorgukbantjspmemberASARulesfaces
Page 10 of
FoodInfo Online Features 1 April 2011
httpwwwfoodsciencecentralcomfscixid16088
copy IFIS Publishing 2011 - All Rights Reserved
From pharm to fork in the nutrigenomic era is it food or medicine
Susan A McGinty and Dominic Man
London South Bank University 103 Borough Road London SE1 0AA
1 Introduction
The foodmedicine boundary has long been opaque with responsibility for medicines and food regulation coming under different European Commission
directorates This has led to a lack of integration at the EU level between food and medicine which has been further exacerbat ed by a lack of
harmonisation of implementation at Member State level of EU food law From 1 May the EU Traditional and Herbal Medicines Products Directive
(THMPD) comes fully into force and the elements of a perfect stormlsquo may be moving into place Manufacturers will no longer be able to supply
unlicensed herbal medicines to the public The European Medicines Agencylsquos (EMEA) has a database of medicinal herbs which includes inter
alia sage thyme garlic onion cinnamon pumpkin seed linseed juniper berry peppermint leaf and aniseed The UKlsquos Medicines and Healthcare
Products Regulatory Agency (MHRA) has published its own list of herbs and classifies them as medicinefoodcosmetic - also reflecting the problem of
the regulation of products and claims for cosmeceuticals From May 2011 ―it is the competence and responsibility of national authorities to decide on a
case by case basis whether a herbal product fulfils the definition of medicinal product A survey of the fundamental definitions clarifications by the
European Court of Justice (ECJ) and an examination of the European Councillsquos homeostasis model spotlights areas which may nee d to be reconciled if
the overall regulatory framework is capable of adapting to the era of systems biology and personalised medicinenutrition i ncluding dermagenetics
2 The devil in the detail the definitions
21 Food
Article 2 of EC 1782002 defines food including supplements as ―any substance or product whether processed partially processed or unprocessed
intended to be or reasonably expected to be ingested by humans This definition is straightforward but allows interpretation of reasonably expectedlsquo to
determine a medicinal product where dosagelsquo may be seen as a critical element ndash see later
22 Medicine bdquoform‟ and bdquofunction‟
Directive 200183EC of 6 November 2001 defined a medicine as either ―any substance or combination of substances presented for treating or
preventing disease in human beings or ―any substance or combination of substances which may be administered to human beings with a view to making
a diagnosis or to restoring correcting or modifying physiological balance in human beings This linked marketing activities and intention of consumption
to medicinal functionality In 2004 Directive 200427EC amended the definition of a medicine to ―any substance or combination of substances
presented as having properties for treating or preventing disease in human beings or any substance or combination of substances which may be used
in or administered to human beings either with a view to restoring correcting or modifying physiological functions by exerting a pharmacological
immunological or metabolic action or to making a medical diagnosis Article 22 of the 2004 Directive goes on to state ―In cases of doubt where
taking into account all its characteristics a product may fall within the definition of a medicinal productlsquo and within the definition of a product covered by
other Community legislation the provisions of this Directive shall apply
This definition had the technical effect of making all bioactive food components meet the medicinal standard by function if not by presentation and has
left Member State medicines regulators the EMEA and the European Commissionlsquos Directorate General Enterprise and Industry (DGEI) in the driving
seat as to determining product status and enforcement Nonetheless the ECJ ruled in C-31905 Commission of the European Communities v Federal
Republic of Germany of 15 November 2007 that the definition of a medicinal product by function should be interpreted restrictively since it was des igned
to cover only products whose pharmacological properties have been scientifically observed and not substances which while ha ving an effect on the
human body do not significantly affect the metabolism and thus do not strictly modify the way in which it functions
The formlsquo of a medicine versus a food supplement was also tested in C-31905 in which the Commission accused the Federal Republic of Germany of
breach of its obligations under Articles 28 and 30 of the EC Treaty (free movement of goods) by classifying a garlic preparat ion in capsule form as a
medicinal product The ECJ held that a capsule form was not of itself sufficient to decide whether a product was medicinal that the capsule form is not
exclusive to medicinal products and the product in question only contained natural garlic and could not have any additional e ffects (positive or negative)
compared to garlic in its natural state A medicinal product must have the function of preventing or treating disease beneficial effects for health in general
are not sufficient
The ECJ clarifications pose a fundamental problem for Member State medicines regulators consistently using formlsquo and functi onlsquo as theirbenchmark
standards Pillcapsuletincture forms regularity of consumption defined posology and ADME (absorption distribution metabolism and excretion) and
the accompanying claims have long been the determinants in borderline product adjudications
23 Prevention or disease-risk reduction
The EU has no definition of diseaselsquo in any of its regulatory instruments except for medically diagnosed conditions or using w ider public health
frameworks for measuring disease prevention in terms ofQuality of Life Years (QALYs) and Disability Adjusted Life Years (DALY s) for example It has not
From Pharm to Fork in the Nutrigenomic Era Is It Food or Medicine
BANT - the seal of excellence for nutrition health professionals
Page 11 of From Pharm to Fork in the Nutrigenomic Era Is It Food or Medicine- Cont
adopted a fully transparent and credible suite of biomarkers surrogate or end-markers to establish healthdisease status and bi ofunctionality In the UK
The Medicines Act 1968 (as amended) defines disease as something which ―includes any injury ailment or adverse condition whether of body or
mind The lack of a clear legal definition has been recognised by the ECJ where disease has been intrinsically linked to the definition of a medicinal
product The Court determined in C-36988 on whether eye lotion was a medicinal product or cosmetic (a cosmetic being external but being able to
protectlsquo or keep in good conditionlsquo) that on the basis of scientific knowledge ―it is for the national authorities to dete rmine whether products presented as
counter-acting certain conditions of sensations such as hunger heaviness in the legs tiredness or itching constitute a medic al product
The United States Food and Drug Administration (FDA) in its health claims legislation defines disease as
―Damage to an organ part or structure or system of the body such that it does not function properly (eg cardiovascular dis ease) or a state of health
leading to such dysfunctioning (eg hypertension) except that diseases resulting from essential nutrient deficiencies (eg scurvy pellagra) are not
included in this definition
Proposals for health claims legislation being framed by Food Standards Australia and New Zealand (FSANZ) include definitions for diseaselsquo and serious
diseaselsquo which distinguish in terms both of severity of condition and of level of claim
Disease an unhealthy condition characterised by clinically significant signs or symptoms
Serious disease or condition forms of disease conditions ailments or defects which are generally accepted to be beyond the ability of the
average consumer to evaluate accurately and to treat safely without regular supervision by a suitably qualified health care professional
Where disease-risk reduction relates to one of a number of factors in the aetiology of disease the concept of preventionlsquo itse lf poses a number
of difficulties as like diseaselsquo it is not clearly defined in law
Coppens et al 2001 survey use of preventionlsquo in relation to the first EU Medicines Directive 6565 where prevention has had a history of use in terms
of vaccination and infectious diseases Prevention is a word with an absolute indication and its use is clear and distinct in nature and includes some
statistical certainty nonetheless with chronic diseases there is an overlap where reduction of disease risk pertains to one factor sufficient to prevent the
occurrence likely to be based on epidemiological evidence from studies of population cohorts Coppens et al propose that prevention has three facets
a) Prevention of disease occurrence where
the disease is not (yet) present
the therapy can prevent the occurrence of the disease with substantial statistical certainty
b) Prevention of episodes of the disease where
the disease is present
the therapy decreases the number duration or severity of disease episodes with a substantial statistical certainty
c) Prevention of progression of the patientlsquos underlying disease where
the disease is present
the therapy has been shown to delay the progression of the disease with a substantial statistical certainty
At the other end of the spectrum treatlsquo denotes a purpose of action intention therefore becomes a key determinant in claim status Intention in
consumption is important for the enforcement of health claims where (average) consumer understanding is a factor Consumption of supplemental vitamin
D3 to support bone health or with a substantiated claim reduce the risk of osteoporosis comes under the food domain However consumption of
supplemental vitamin D3 for the purposes of immune-modulation would be medicinal
The principle of disease risk reduction (DRR) as distinct from prevention was incorporated into EU law in EC 19242006 on nutrition and health claims
on food (NHCR) which requires that all structurefunction and DRR claims on food including supplements must be preapproved by the EU Commission
and meet a standard of substantial scientific agreement While the DRR paradigm recognises that chronic disease conditions are the product of multiple
gene-environment influences it nonetheless still must be predicated on what diseaselsquo is in biological terms The EU-funded PASSCLAIM projec t was
tasked with establishing how health claims would be substantiated and to identify functional biomarkers or surrogate end-point markers for use in the
assessment process PASSCLAIM working groups produced reports on diet -related cardiovascular disease bone health and osteoporosis physical
performance and fitness mental state and performance body weight insulin sensitivity and diabetes diet -related cancer and gut health and
immunity At January 2011 the European Food Safety Authority (EFSA) charged with the process of assessing claims is yet to fully clarify its
assessment criteria
24 Functional foods food bioactives and nutraceuticals
While the EU regulates foods containing plant sterolsstanols there is no formal definition of functional foodlsquo The EU FUFOSE project used a working
definition of functional foods that ―affect beneficially one or more target functions in the body beyond adequate nutriti onal effects in a way that is
relevant to either an improved state of health and well -being andor reduction of risk of disease FUFOSE noted that a functional food can be a natural
food one to which a component has been added or removed where a component has been modified or its bioavailability modifie d or any combination or
multiples of all the possibilities Therefore functional foods in the EU must be foods with health claims as defined by the NHCR
BANT sponsors a 2 day seminar on cPNI on 8-9 of Sep 2011
organised by Bonusan under the auspices of the Natura Foundation
wwwbantorgukbantjspmemberpdfseminarsBONUSAN_CPNIpdf
Page 12 of
Although in 2006 the US FDA proposed that the term functional foodlsquo be regulated (21 Code of Federal Regulations Part 101 and Part 170)it still has no
formal definition of that or of nutraceuticallsquo Earlier in 2004 the US Department of Health and Human Services (DHHS) launch ed a consultation on a
proposed definition of bioactive food componentslsquo In its supplementary information to the proposal the DHHS stated that bioactives may have multiple
sites of action may interact with one or more dietary constituents and may act directly or indirectly to produce a functional outcome citing as examples
lycopene long-chain omega-3 fatty acids isoflavones sulphorophane and resveratrol Establishing a definition of a food bioactive was a first step
towards evaluating their significance in promoting health and disease prevention then guiding research priorities and science-based information to help
guide public health policylsquo The definition proposed was
―Bioactive food components are constituents in foods or dietary supplements other than those needed to meet basic human nutr itional needs that are
responsible for changes in health status
As of early 2011 the work on defining food bioactives has not progressed Respondents to the 2004 consultation made strong representations about a
definition of bioactivity which excluded nutrients arguably the most important bioactive category of food components Seventeen written responses were
received in response to the consultation a number of which proposed alternate definitions Common themes in those alternate definitions include use of
the term physiologically activelsquo or physiological benefitlsquo reference to structure functionlsquo and disease -risk reductionlsquo and (ILSI North America) ―as
measured through utilizing appropriate methodology and biomarkers
In January 2011 the US National Academies of Science publishedPerspectives on Biomarker and Surrogate Endpoint Evaluation with recommendations
for establishing a framework for harmonising biomarker use across all areas including drugs and foods
3 Dosage and the homeostasis model what is lsquonormalrsquo
The ECJ Judgement C-8807 of 5 March 2009 determined that substances ―which while having an effect on the human body do not significantly
affect the metabolism and thus do not strictly modify the way in which it functions should not be classified as medicinal products by function
(see Commission v Germany paragraph 60 and Hecht-Pharma paragraph 41) Dosage therefore is a key criterion in determining food from medicine
of botanicals and from May 2011 is likely to be used by national authorities in enforcement This complements the homeostasis model produced by
the European Council in 2008 to distinguish foods and medicinal products The model incorporates the notion of intended use of the product and the
nature of the induced effect food induces the physiological effects characterised by maintainsupportoptimiselsquo and medicine induces the physiological
functions characterised by restorecorrectmodifylsquo It is a self-contained integrated approach but is predicated on the definition of homeostasis being
defined as ldquothe status of a person whose physiological parameters function within the limits considered as normal But while normal
physiological parameters may be defined by (sometimes quite large) reference ranges nutritional prerequisites or dietary ref erence intakes are not fully
harmonised throughout the EU nor do they take account of ancestral or inter-individual variation which characterise different sub-populations The lack
of harmonisation means some EU Member States regard supra -RDA vitamin and mineral supplements as medicines where others including the UK
have taken a more liberal approach The EU-funded EurRECA network of excellence is tasked with developing methodologies and recommendations to
standardise the process of setting pan-EU micronutrient recommendations This will inform progress in setting maximum permitted levels of vitamins and
minerals in food supplements However the extent of inter-individuality may prove problematic in 2007 the UK Committee on Toxicity in its working
group report on variability and uncertainty stated that for vitamins and minerals ―variability in the response of individuals has the potential to result in a
situation which a given level of exposure could be essential for some but toxic for others
What is normallsquo in dietary requirements underpins the basis on which both medicinal and health claims are evaluated namely that a healthy balanced
diet is generally able to provide all micronutrient requirements by normal healthy individuals for health maintenance Two signi ficant sub-populations
however threaten to undermine that approach In the UK the Healthy Start programme administered by statutory instrument by the Department
of Health and National Health Service provides two bespoke Healthy Start-branded vitamin supplements for low income beneficiaries for women free
during pregnancy and up until their baby is one year old and for children from 6 months of age until their fourth birthday Non-beneficiaries can
purchase Healthy Start-branded supplements at low cost from health clinics Health professionals are encouraged to make sure that mothers and
children ―get two important vitamins that they may not be getting in adequate quantities ndash even from a healthy balanced diet These are vitamins A and D
for children and vitamin D and folic acid for women While it is prohibited under the NHCR to claim that a healthy balanced diet cannot in general
provide all nutrients needed there is no such prohibition under medicinal law and the Healthy Startvitamins are marketed under a UK medicines
licence [PL015110003] This conflict adds to the problems of robust implementation of the NHCR which is already stymied by the lack of
A credible transparent system of scientific assessment
An agreed nutrient profiling system
A harmonised pan-EU characterisation of a healthy balanced diet
4 Going forward
Added to the woes of the NHCR looms a new era of personal genomicmetabolomic profiling and personalised nutrition in the for m of P4
medicinelsquo (personalised predictive preventive participatory) In its essence nutrigenomicslsquo incorporates two aspects
The effect of food components on the genome and epigenome
The extent of ancestral and individual variation
If disease can be classified at the molecular level what effect does this have on the meaning of homeostasislsquo and medicine lsquo These key terms need full
and comprehensive definition both in biology and law so that the food -medicine continuum is fully resolved and the foundation is laid for the successful
application of both personalised medicine and personalised nutrition Innovation and continued investment in wellness products by the food industry
depend on a clear consistent and transparent system of claims assessment
From Pharm to Fork in the Nutrigenomic Era Is It Food or Medicine- Cont
Page 13 of 13 Topic of the Month - Cardiovascular Health
Nutri Link Clinical Education - wwwnleducationcouk
They believe in supporting the health care professionals who count on them for
effective nutritional solutions Their team of CAM-leading experts are committed to
providing you with the latest unbiased scientific research and clinical support plus a
vast array of continuing education opportunitieshellipbecause as practitioners they
understand that knowledge is the key to positive patient results
FM Town - wwwfmtowncom
Its all about relevancy Being in a 100 Functional Medicine environment will give
you an opportunity to get direct and immediate access to all the information that is
most relevant to you FMTown is private and highly relevant in its scope of focus
Get connected to an amazing online resource which can grow with you and support
your Functional Medicine Journey
Institute for Functional Medicine - wwwfunctionalmedicineorg
IFM Membership is your gateway to a community of like-minded clinicians and
researchers It is primarily aimed at clinicians and scientists whose interest in
functional medicine is deeply connected to examining the emerging research
attending CME courses discussing issues and patients with colleagues and so
forth Membership helps to build a network of practitioners from many disciplines
who are using and studying functional medicine every day
Food Science Central - wwwfoodsciencecentralcom
Food Science Central is the home of IFIS Publishing on the web Here you can
learn about products and services and access FREE articles on many topics in food
science food technology and nutrition
Monthly ArticlesPapers
ANXIETY AND CARDIOVASCULAR RISK REVIEW OF
EPIDEMIOLOGICAL AND CLINICAL EVIDENCE
O Olafiranye G Jean-Louis F Zizi J Nunes and MT Vincent
wwwncbinlmnihgovpmcarticlesPMC3150179pdfnihms-
301210pdf
POST-TRAUMATIC STRESS DISORDER AND
CARDIOVASCULAR DISEASE
Steven S Coughlin
wwwncbinlmnihgovpmcarticlesPMC3141329pdfTOCMJ-5-
164pdf
STUDIES OF GENE VARIANTS RELATED TO INFLAMMATION
OXIDATIVE STRESS DYSLIPIDEMIA AND OBESITY
IMPLICATIONS FOR A NUTRIGENETIC APPROACH
Maira Ladeia R Curti Patrıcia Jacob Maria Carolina Borges
Marcelo Macedo Rogero and Sandra Roberta G Ferreir
wwwncbinlmnihgovpmcarticlesPMC3136190pdfJOBES2011-
497401pdf
EFFECT OF AN OFFICE WORKSITE-BASED YOGA
PROGRAM ON HEART RATE VARIABILITY A RANDOMIZED
CONTROLLED TRIAL
Birinder S Cheema Paul W Marshall Dennis Chang Ben
Colagiuri and Bianca Machliss
wwwncbinlmnihgovpmcarticlesPMC3154869pdf1471-2458-
11-578pdf
CARDIOVASCULAR COMPLICATIONS IN CKD PATIENTS
ROLE OF OXIDATIVE STRESS
Elvira O Gosmanova and Ngoc-Anh Le
wwwncbinlmnihgovpmcarticlesPMC3022166pdfCRP2011-
156326pdf
TARGETING STEM CELL NICHES AND TRAFFICKING FOR
CARDIOVASCULAR THERAPY
Nicolle Kraumlnkel Gaia Spinetti Silvia Amadesi and Paolo Madeddu
wwwncbinlmnihgovpmcarticlesPMC3017934pdfukmss-
33677pdf
INTERACTION OF SLEEP QUALITY AND PSYCHOS OCIAL
STRESS ON OBESITY IN AFRICAN AMERICANS THE
CARDIOVASCULAR HEALTH EPIDEMIOLOGY STUDY (CHES)
Aurelian Bidulescu Rebecca Din-Dzietham Dorothy L Coverson
Zhimin Chen Yuan-Xiang Meng Sarah G Buxbaum Gary H Gib-
bons Verna L Welch
wwwbiomedcentralcomcontentpdf1471-2458-10-581pdf
PATHOPHYSIOLOGIC MECHANISMS LINKING IMPAIRED
CARDIOVASCULAR HEALTH AND NEUROLOGIC
DYSFUNCTION THE YEAR IN REVIEW
Ki E Park Carl J Pepine
wwwccjmorgcontent77Suppl_3S40fullpdf+html
BERRIES EMERGING IMPACT ON CARDIOVASCULAR
HEALTH
Arpita Basu Michael Rhone and Timothy J Lyons
wwwncbinlmnihgovpmcarticlesPMC3068482pdf
nihms171310pdf
THE PLACENTA IS A PROGRAMMING AGENT FOR
CARDIOVASCULAR DISEASE
KL Thornburg PF OlsquoTierney and S Louey
wwwncbinlmnihgovpmcarticlesPMC2846089pdf
nihms177889pdf
Useful Websites
BANT - the seal of excellence for nutrition health professionals
Page 6 of 13
Statin Drugs Cholesterol and Heart Disease Myth versus Reality
By Dicken Weatherby ND and Donald R Yance MH CN
Pfizer and Merck are continuing their efforts to have the commonly prescribed Statin medications Lipitor and Mevacor approved for over the counter use
Currently these drugs are made available in the US only with a physicianlsquos prescription In the US the Food and Drug Adminis tration or FDA has turned
down three times Mercklsquos application to make Mevacor one of the first statin drugs available without a prescription The pa nel that made this decision
the third time raised concerns that patients would turn to statin drugs instead of seeking a physicianlsquos care Itlsquos good news that the FDA isnlsquot giving the
green light to widespread over-the-counter drug use despite the heavy sway of advertising that would have people believe statin drugs are a safe
panacea for preventing cardiovascular disease We know most of you reading this already understand the misinformation being f oisted on the public
regarding statin drugs but we thought welsquod take this opportunity to review some the myths and the realities behind this issue so you can properly consult
with your patients and clients
Dispelling some of the myths regarding statin drugs cholesterol and heart disease
MYTH 1
ldquoHigh cholesterol (and LDL) is the number-one cause of heart disease in the Westrdquo
Wrong High cholesterol is among the risk factors for heart disease but is not the leading risk factor The most prevalent r isk factor is low HDL along
with small LDL particles which commonly occur together In fact of every 100 people with coronary heart disease 60-70 will have low HDL and small
LDL particles but fewer than 30 will have high LDL If this is the case why do we not hear more about low HDL and small LDL particles The answer is
simple because treating these is not as profitable for drug companies But just waitmdashwhen a profitable drug becomes available to treat this more
prevalent risk factor for heart disease we can expect to hear about an ―epidemic that will justify billions of dollars in new drug expenditures1-4
What qualifies as low HDL National guidelines say it is a level of less than 40 mgdL for men and less than 45 mgdL for wom en5 In fact a level of
less than 60 mgdL is probably very significant6 HDL is already a standard measure in everyday cholesterol panels Small LDL particles on the other
hand need to be measured specifically The medical world focuses on statin therapy for LDL while the most prevalent risk factor for heart disease goes
untreated in the great majority of cases
MYTH 2
ldquoIf I take a statin agent I wonrsquot have a heart attackrdquo
This is simply untrue Lowering cholesterol (even to rock-bottom levels) reduces but does not eliminate the risk of heart attacks Many heart attacks still
occur in people with low cholesterol levels whether or not they take cholesterol-lowering drugs7 We must consider that there are other risk factors for
heart disease besides cholesterol such as small LDL particles low HDL high fibrinogen high homocysteine and high insulin levels Results from the
most recent National Health and Nutritional Survey show that 47 million US adults have metabolic syndrome (low HDL high trig lycerides high blood
pressure excess abdominal fat) which substantially heightens the risk of heart disease even in the presence of low cholesterol levels8
MYTH 3
ldquoI feel fine and my stress test was normal My doctor says I donrsquot have heart diseaserdquo
This is among the most widely propagated fallacies spread by many primary care physicians and even cardiologists First lack of symptoms should not
be reassuring as most heart disease is silentmdashwithout symptoms and undetectable by conventional means such as electrocardiograms and cholesterol
testing Second stress testing is a miserable failure for screening asymptomatic people Most future deaths and heart attack s in fact occur in people
with normal stress tests (when symptoms are not present) The net result of this misperception is that most future heart -attack victims are walking around
feeling fine and unaware of their risk9 Cholesterol can be high low or in between but all too frequently fails to shed light on this murky situation
Cholesterol the lipid with a bad reputation
Hyperlipidemia refers to elevated blood levels of lipids (fats) including cholesterol and triglycerides Most people with hy perlipidemia have no symptoms
However hyperlipidemia is a contributing factor associated with an increased risk of coronary heart disease (CHD) a thicken ing or hardening of the
arteries that supply blood to the heart muscle CHD in turn can result in angina pectoris (chest pain) a heart attack or both Although hyperlipidemia is
considered a risk factor to heart disease it is one of many risk factors and what actually causes hyperlipidemia is a debatable issue It not as simple as
foods that contain cholesterol elevate lipids
Another important risk factor which has been largely overlooked is the oxidation of low -density lipoprotein (LDL) cholesterol caused from a lack of
antioxidant-rich foods herbs and nutrients andor a large intake of foods and chemicals that contains damaging free radicals Chronic inflammation also
contributes to oxidative stress and an increase in CHD When LDL cholesterol oxidizes it promotes atherosclerosis by a proc ess referred to as the
macrophage-foam cell mechanism particularly in the presence of stressors like cortisol and insulin Cortisol and insulin together act as a dynamic
duel causing all kinds of disruptions including an increased oxidative and inflammatory state These are the real underline causes to chronic disease
Inflammation is also involved in the process of LDL oxidation and contributes to the development of vascular disease 10-13 Ideally LDL levels should be
kept under 120 mgdL and you should monitor your patients for oxidative activity especially lipid peroxidation
The production of C-reactive protein is an essential part of the inflammatory process and the measurement of this substance reflects the level of
inflammatory activity deep within the body It appears that certain conditions create a state of excessive inflammation withi n the circulatory system High
C-reactive protein levels are evidence of this type of inflammation 14-17 Ideally it is best to keep C-reactive protein levels below 055 mgL in men and 15
Featured Article by Dicken Weatherby on Cardiovascular Health
Page 7 of 13
mgL in women Please note that the reference ranges above refer to the High Sensitivity CRP or hs -CRP test
Multiple risk markers for atherosclerosis and cardiovascular disease act in a synergistic way through inflammatory pathways The following lists the
different factors that have been identified as risk factors for CHD and arterial damage
Elevated CRP
Elevated LDL
Excess Insulin
Low HDL
High Glucose
Nitric Oxide Deficit
Excess Triglycerides
Low Free Testosterone
Excess Fibrinogen
Excess Homocysteine
Hypertension
Low Vitamin K
Excess Cholesterol
There are many key inflammatory biochemical risk markers for cardiovascular disease in particular the role of three basic c ell types affected by
these risk markers (endothelial cells smooth muscle cells and immune cells) the crucial role of inflammatory mediators ni tric oxide balance in
cardiovascular pathology and the use of nutrients (flavanoids carotenoids sterols vitamin C and E Omega 3 fatty acids et c) to circumvent several of
these inflammatory pathways Most of the above risk markers for cardiovascular disease have a pro -inflammatory component which stimulates the
release of a number of active molecules such as inflammatory mediators reactive oxygen species nitric oxide and peroxynitr ite from endothelial
vascular smooth muscle and immune cells in response to injury Nitric oxide plays a pivotal role in preventing the progressi on of atherosclerosis through
its ability to induce vasodilation suppress vascular smooth muscle proli feration and reduce vascular lesion formation Nutr ients such as arginine
antioxidants (OPCs vitamins C and E lipoic acid selenium glutathione) and enzyme cofactors (vitamins B2 and B3 B6 B12 folate zinc) help to
elevate nitric oxide levels and may play an important role in the management of cardiovascular disease Other dietary components such as DHAEPA
from fish oil tocotrienols vitamins B6 and B12 and quercetin contribute further to mitigating the inflammatory process 18
Within the broad range of cholesterol levels from 180 to 240 there is little to no evidence that this alone correlates with h eart disease Below 180 there is
increased risk of hemorrhagic stroke depression and suicide Above 240 there is increased risk of cardiovascular disease an d ischemic stroke Over age
70 elevated cholesterol and cardiovascular events no longer correlate All told total serum cholesterol alone is a poor ind icator of cardiovascular disease
Half of all heart attack patients have normal total cholesterol levels
So not only do statin drugs have their inherent drawbacks but in some ways they are treating a fabricated problem based on misunderstood and
misrepresented ―research As natural health care providers we know that we must be wary of the current cholesterol hysteria we must be able to
explain the real evidence and we must help our patients understand the facts so they can make educated health choices
Dicken Weatherby ND is originally from Oxfordshire in the UK and is based in Ashland Oregon USA A graduate of the National College of Natural
Medicine Dicken is author of the bestselling book Blood Chemistry and CBC Analysis -Clinical Laboratory Testing from a Functional Perspective He
has self-published seven other books in the field of alternative medical diagnosis has created numerous information products and runs a number of
successful Web sites including wwwFMTowncom an online membership community for practitioners interested in Functional Medicine and
Functional Diagnosis Dr Weatherby is the creator of the ldquoFoundations of Functional Diagnosis Training Programrdquo at wwwFunctionalDiagnosiscom and
the ldquoFoundations of Functional Blood Chemistry Analysisrdquo Training Program at wwwBloodChemistryTrainingcom
Donald R Yance CN MH RH is an internationally known herbalist and nutritionist He is the founder and medical director of the Centre for Natural
Healing in Ashland Ore Through extensive research and clinical practice he has developed his Triphasic system which forms the cornerstone of his
clinical approach Donald is the founder and formulator of Natura Health Products and founder and president of The Mederi Fo undation whose
programs promote health education and clinical research on the use of natural medicine with an emphasis in the field of integrative oncology
References
1 Gardner CD Fortmann SP Krauss RM Association of small low-density lipoprotein particles with the incidence of coronary artery disease in
men and women JAMA 1996 Sep 18276(11)875-81
2 Stampfer MJ Krauss RM Ma J et al A prospective study of triglyceride level low- density lipoprotein particle diameter and risk of myocardial
infarction JAMA 1996 Sep 18276(11)882-88
3 Lamarche B Tchernof A Moorjani S et al Small dense low-density lipoprotein particles as a predictor of the risk of ischemic heart disease in
men Prospective results from the Quebec Cardiovascular Study Circulation 1997 Jan 795(1)69 -75
4 Kuller L Tracy P Arnold A et al Nuclear magnetic resonance spectroscopy of lipoproteins and risk of coronary heart diseas e in the
cardiovascular health study Arterioscler Thromb Vasc Biol 2002 Jul 122(7)1175 -80
5 Expert Panel on Detection Evaluation and Treatment of High Blood Cholesterol in Adults Executive summary of the third report of the national
cholesterol education program (NCEP) expert panel on detection evaluation and treatment of high blood cholesterol in adults (Adult Treatment
Panel III) JAMA 2001 May 16285(19)2486-97
Featured Article by Dicken Weatherby on Cardiovascular Health
BANT - the seal of excellence for nutrition health professionals
We are pleased to let you all know that Dicken will be speaking at our seminar on 29th October 2011 - donrsquot miss it or you will
miss out Book your tickets now as they are selling fast wwwbantorgukbantjspNGseminarvideosfaces
Page 8 of 13
6 Gotto AM Brinton EA Assessing low levels of high-density lipoprotein cholesterol as a risk factor in coronary heart disease J Am Coll Cardiol
2004 Mar 343(5)717-24
7 van Lennep JE Westerveld HT Van Lennep HW Zwinderman AH Erkelens DW van der Wall EE Apolipoprotein concentrations durin g treat
ment and recurrent coronary artery disease events Arterioscler Thromb Vasc Biol 2000 Nov20(11)2408 -13
8 Ford ES Giles WH Dietz WH Prevalence of the metabolic syndrome among US adults findings from the third National Health an d Nutrition
Examination Survey JAMA 2002 Jan 16287(3)356-9
9 Taylor AJ Merz CN Udelson JE 34th Bethesda Conference ―Can atherosclerosis imaging techniques improve the detection of pa tients at risk
for ischemic heart disease J Amer Coll Cardiol 2003 Jun 4(11)411860 -2
10 Rifai N Ridker PM Inflammatory markers and coronary heart disease Curr Opin Lipidol 2002 Aug13(4)383-9
11 Albert CM et al Prospective study of C-reactive protein homocysteine and plasma lipid levels as predictors of sudden cardiac death
Circulation 2002 Jun 4105 (22)2595-9
12 Bermudez EA Ridker PM C-reactive protein statins and the primary prevention of atherosclerotic cardiovascular disease Prev Cardiol 2002
Winter5(1)42-6
13 Schroecksnadel K Frick B Winkler C Fuchs D Crucial role of interferon-gamma and stimulated macrophages in cardiovascular disease Curr
Vasc Pharmacol 2006 Jul4(3)205-13
14 Rifai N Ridker PM Inflammatory markers and coronary heart disease Curr Opin Lipidol 2002 Aug13(4)383-9
15 Albert CM et al Prospective study of C-reactive protein homocysteine and plasma lipid levels as predictors of sudden cardiac death
Circulation 2002 Jun 4105 (22)2595-9
16 Bermudez EA Ridker PM C-reactive protein statins and the primary prevention of atherosclerotic cardiovascular disease Prev Cardiol 2002
Winter5(1)42-6
17 Blake GJ Ridker PM Inflammatory mechanisms in atherosclerosis from laboratory evidence to clinical application Ital Heart J 2001 Nov2
(11)796-800
18 Osiecki HE The role of chronic inflammation in cardiovascular disease and its regulation by nutrients Altern Med Rev 2004 Mar9(1)32-53
Conversion Table This will help you to convert the markers in this article from US units into units used on UK blood tests
Reference ranges given are typical but may vary depending on lab used Eg Biolab given reference range for cholesterol is that target should be below
4 to 5 depending on clinical factors
Featured Article by Dicken Weatherby on Cardiovascular Health
Studies
CHIA SEEDS MAY OFFER OMEGA-3 HEART AND LIVER BENEFITS STUDY
wwwnutraingredients-usacomHealth-condition-categoriesCardiovascular-
healthChia-seeds-may-offer-omega-3-heart-and-liver-benefits-Study
c=TRR9CYYlHK48nEzv7WRu8CTrplNtVNvfamputm_source=Newsletter_Productampu
tm_medium=emailamputm_campaign=Newsletter2BProduct
DORMANT ANTIOXIDANT HAS lsquoUNPARALLELEDrsquo BENEFITS
wwwnutraingredients-usacomHealth-condition-categoriesCardiovascular-
healthDormant -antioxidant-has-unparalleled-benefits
WHOLE MANGOSTEEN FRUIT AND ITS BENEFITS
wwwthewholefruitcomstructure_functionphp
The early research on the whole mangosteen fruit and its numerous
nutritional components is both promising and precise Feel like digging in
Herelsquos a snapshotmdashjust a small samplemdashof the studies that back the
impressive edge of whole mangosteen formulation and supplementation
Neutralizes Free Radicals
Supports a Healthy Cardiovascular System
Supports Cartilage and Joint Function
Strengthens the Immune System
Promotes a Healthy Seasonal Respiratory System
Maintains Intestinal Health
Other Supportive Papers
Monthly ReportsStudiesWebinarsVideocasts
Publications
Destination 2020 - A Plan for Cardiac and Vascular Health
wwwbhforgukpublicationsview-publicationaspxps=1000855
Webinars
You need to register your details before you can access these webi-
nars FREE OF CHARGE
2010 State-of-the-Art Webinar Series in Cardiovascular Disease
Webinar I
Webinar II
Webinar III
Videocasts
Vitamin D cardiovascular disease and cancer emerging evi-
dence [electronic resource] JoAnn E Manson
httpvideocastnihgovlaunchasp15689
Heart failure in women
httpvideocastnihgovlaunchasp15838
Demystifying Medicine - Cardiovascular disease in the eras of
imaging and stem cells
httpvideocastnihgovlaunchasp16573
Demystifying Medicine - Arteriosclerotic cardiovascular disease
Number one killer and the Framingham experience
httpvideocastnihgovlaunchasp14936
US reference range To convert from US to UK UK units
Cholesterol 150-220 mgdL Multiple by 002586 336-52 mmoll
HDL 40-90 mgdL Multiple by 002586 103-232 mmol
LDL 60-130 mgdL Multiple by 002586 155 ndash 336 mmoll
BANT sponsors a 2 day seminar on cPNI on 8-9 of Sep 2011
organised by Bonusan under the auspices of the Natura Foundation
wwwbantorgukbantjspmemberpdfseminarsBONUSAN_CPNIpdf
Page 9 of 13
On Saturday 21st May the Alliance for Natural Health International supported by the GNC and BANT held its first
training and education day for practitioners helping them through the minefield of legislative requirements facing the
natural health sector The conference was well attended by over 240 practitioners whose feedback confirms that the
information was critical to their ability to manage their practices compliantly in the future and was summed up succinctly
by one of the delegates
I think the conference today really hits the mark in terms of tak ing a very complex set of regulations and putting it into a
digestible form for practitioners laying out not only the regulations but also the practical side of how we live within thi s
new regulatory environment
Kathleen Devereaux
We understand that many were not able to attend the conference in person but as promised we have now produced a full download of the daylsquos
sessions in video format which includes the pre-reading pack sent to delegates a comprehensive delegate volume of notes covering the days event and
an extensive reference list of supporting documentation We know its been a few weeks since the event but it takes time to p rofessionally edit the raw
footage so we hope that youll now feel part of it as if you had actually been there with us
Having attended the ANH conference I was able to get a real picture about the Rules and Regulations NTs are up against Understanding this legislation
and how it affects NT practice is an important part of being a responsible NT We need to learn the language of these new rul es and in doing so feel
empowered and in control of our work environment This conference DVD and info should be an essential part of your NT toolk it
Melanie de Grooth BANT AdministratorGeneral Manager
This comprehensive package costs pound40 with proceeds going to the ANH campaign fund and is available to practitioners and student practitioners only
Those practitioners who are going to be successful in this new environment will need to uniquely express themselves according to their qualifications and
experience A me too approach where everyone says the same things is not going to allow you to stand out from the crowd At the heart of this is an
understanding of the principles behind the rules and regulations as well as solutions allowing you to not fall foul of it Provided in the printed and video
outputs from our seminar are all the basics youll need to move confidently forward in this difficult and confusing regulatory climate and we will be
following up with more support in due course
As NT practitioners we are facing a maze of rules and regulations that will affect how we work in the future I therefore urge you all to purchase the must
have DVD from the recent excellent ANH training conference entitled Rules and Regulations in Clinical Practice Developing your Practice in Spite of the
EU Regulatory Juggernaut This is an extremely useful toolk it for your practice and will assist you in understanding these l egislative changes
Catherine Honeywell - Chair BANT Council
PURCHASE DOWNLOAD - wwwanh-europeorgrules-and-regulations-training-buy-download We also invite you to sign up for our regular
eAlerts wwwanh-europeorguserregister and to check out our practitioner pages - wwwanh-europeorgpractitioners
Thank you ANH-Intl
ANH-Intl Rules and Regulations DVD Now on Sale
BANT Page on Rules and Regulations If you have not already done so please make sure you access the presentations we have
provided on Rule and Regulations Affecting NT Practice and Understanding the Scope and
Definition for Medicinal Claims
An incredible amount of time and effort has gone into this project and we are sure that you will
now easily be able to navigate your way through the complicated array of rules and regulations
that impact on our practise of Nutritional Therapy
We would like to thank ANH-Intl and give credit to them for auditing and contributing the source
materials which BANT has interpreted and presented in this unique format The format and
presentation are the copyright of BANT and should not be reproduced without prior permission
We would also like to give a special thank you to Louise Carder who tirelessly gave of her time
and expertise to help BANT produce these slides ndash thank you Louise
You can access these slides at the following link wwwbantorgukbantjspmemberrulesRegulation faces
They have been designed for best use online You can of course print them out but you will then not be able to benefit from using the hyperlinks for
navigation Please take some time out of your busy schedules to carefully work and read through these slides This informati on is an essential part of
you Nutritional Therapy toolkit and will help you to be a better and more responsible practitioner
Understanding these Rules and Regulations will not only empower you as a practitioner but will
also demonstrate your level of commitment to your clients and the profession
From time to time we will update the content of the slides but will always let you know when this
has been done
IMPORTANT
After the renewals in October all full members will be emailed a copy of what you currently state
on you BANT profile under Special Interests and Further Information It will be your responsi-
bility to check the information is correct in relation to the ASA Rules and the Rules and
Regulations affecting NT practice Use this link to access the ARC Toolkit and FAQs on the
ASA rules wwwbantorgukbantjspmemberASARulesfaces
Page 10 of
FoodInfo Online Features 1 April 2011
httpwwwfoodsciencecentralcomfscixid16088
copy IFIS Publishing 2011 - All Rights Reserved
From pharm to fork in the nutrigenomic era is it food or medicine
Susan A McGinty and Dominic Man
London South Bank University 103 Borough Road London SE1 0AA
1 Introduction
The foodmedicine boundary has long been opaque with responsibility for medicines and food regulation coming under different European Commission
directorates This has led to a lack of integration at the EU level between food and medicine which has been further exacerbat ed by a lack of
harmonisation of implementation at Member State level of EU food law From 1 May the EU Traditional and Herbal Medicines Products Directive
(THMPD) comes fully into force and the elements of a perfect stormlsquo may be moving into place Manufacturers will no longer be able to supply
unlicensed herbal medicines to the public The European Medicines Agencylsquos (EMEA) has a database of medicinal herbs which includes inter
alia sage thyme garlic onion cinnamon pumpkin seed linseed juniper berry peppermint leaf and aniseed The UKlsquos Medicines and Healthcare
Products Regulatory Agency (MHRA) has published its own list of herbs and classifies them as medicinefoodcosmetic - also reflecting the problem of
the regulation of products and claims for cosmeceuticals From May 2011 ―it is the competence and responsibility of national authorities to decide on a
case by case basis whether a herbal product fulfils the definition of medicinal product A survey of the fundamental definitions clarifications by the
European Court of Justice (ECJ) and an examination of the European Councillsquos homeostasis model spotlights areas which may nee d to be reconciled if
the overall regulatory framework is capable of adapting to the era of systems biology and personalised medicinenutrition i ncluding dermagenetics
2 The devil in the detail the definitions
21 Food
Article 2 of EC 1782002 defines food including supplements as ―any substance or product whether processed partially processed or unprocessed
intended to be or reasonably expected to be ingested by humans This definition is straightforward but allows interpretation of reasonably expectedlsquo to
determine a medicinal product where dosagelsquo may be seen as a critical element ndash see later
22 Medicine bdquoform‟ and bdquofunction‟
Directive 200183EC of 6 November 2001 defined a medicine as either ―any substance or combination of substances presented for treating or
preventing disease in human beings or ―any substance or combination of substances which may be administered to human beings with a view to making
a diagnosis or to restoring correcting or modifying physiological balance in human beings This linked marketing activities and intention of consumption
to medicinal functionality In 2004 Directive 200427EC amended the definition of a medicine to ―any substance or combination of substances
presented as having properties for treating or preventing disease in human beings or any substance or combination of substances which may be used
in or administered to human beings either with a view to restoring correcting or modifying physiological functions by exerting a pharmacological
immunological or metabolic action or to making a medical diagnosis Article 22 of the 2004 Directive goes on to state ―In cases of doubt where
taking into account all its characteristics a product may fall within the definition of a medicinal productlsquo and within the definition of a product covered by
other Community legislation the provisions of this Directive shall apply
This definition had the technical effect of making all bioactive food components meet the medicinal standard by function if not by presentation and has
left Member State medicines regulators the EMEA and the European Commissionlsquos Directorate General Enterprise and Industry (DGEI) in the driving
seat as to determining product status and enforcement Nonetheless the ECJ ruled in C-31905 Commission of the European Communities v Federal
Republic of Germany of 15 November 2007 that the definition of a medicinal product by function should be interpreted restrictively since it was des igned
to cover only products whose pharmacological properties have been scientifically observed and not substances which while ha ving an effect on the
human body do not significantly affect the metabolism and thus do not strictly modify the way in which it functions
The formlsquo of a medicine versus a food supplement was also tested in C-31905 in which the Commission accused the Federal Republic of Germany of
breach of its obligations under Articles 28 and 30 of the EC Treaty (free movement of goods) by classifying a garlic preparat ion in capsule form as a
medicinal product The ECJ held that a capsule form was not of itself sufficient to decide whether a product was medicinal that the capsule form is not
exclusive to medicinal products and the product in question only contained natural garlic and could not have any additional e ffects (positive or negative)
compared to garlic in its natural state A medicinal product must have the function of preventing or treating disease beneficial effects for health in general
are not sufficient
The ECJ clarifications pose a fundamental problem for Member State medicines regulators consistently using formlsquo and functi onlsquo as theirbenchmark
standards Pillcapsuletincture forms regularity of consumption defined posology and ADME (absorption distribution metabolism and excretion) and
the accompanying claims have long been the determinants in borderline product adjudications
23 Prevention or disease-risk reduction
The EU has no definition of diseaselsquo in any of its regulatory instruments except for medically diagnosed conditions or using w ider public health
frameworks for measuring disease prevention in terms ofQuality of Life Years (QALYs) and Disability Adjusted Life Years (DALY s) for example It has not
From Pharm to Fork in the Nutrigenomic Era Is It Food or Medicine
BANT - the seal of excellence for nutrition health professionals
Page 11 of From Pharm to Fork in the Nutrigenomic Era Is It Food or Medicine- Cont
adopted a fully transparent and credible suite of biomarkers surrogate or end-markers to establish healthdisease status and bi ofunctionality In the UK
The Medicines Act 1968 (as amended) defines disease as something which ―includes any injury ailment or adverse condition whether of body or
mind The lack of a clear legal definition has been recognised by the ECJ where disease has been intrinsically linked to the definition of a medicinal
product The Court determined in C-36988 on whether eye lotion was a medicinal product or cosmetic (a cosmetic being external but being able to
protectlsquo or keep in good conditionlsquo) that on the basis of scientific knowledge ―it is for the national authorities to dete rmine whether products presented as
counter-acting certain conditions of sensations such as hunger heaviness in the legs tiredness or itching constitute a medic al product
The United States Food and Drug Administration (FDA) in its health claims legislation defines disease as
―Damage to an organ part or structure or system of the body such that it does not function properly (eg cardiovascular dis ease) or a state of health
leading to such dysfunctioning (eg hypertension) except that diseases resulting from essential nutrient deficiencies (eg scurvy pellagra) are not
included in this definition
Proposals for health claims legislation being framed by Food Standards Australia and New Zealand (FSANZ) include definitions for diseaselsquo and serious
diseaselsquo which distinguish in terms both of severity of condition and of level of claim
Disease an unhealthy condition characterised by clinically significant signs or symptoms
Serious disease or condition forms of disease conditions ailments or defects which are generally accepted to be beyond the ability of the
average consumer to evaluate accurately and to treat safely without regular supervision by a suitably qualified health care professional
Where disease-risk reduction relates to one of a number of factors in the aetiology of disease the concept of preventionlsquo itse lf poses a number
of difficulties as like diseaselsquo it is not clearly defined in law
Coppens et al 2001 survey use of preventionlsquo in relation to the first EU Medicines Directive 6565 where prevention has had a history of use in terms
of vaccination and infectious diseases Prevention is a word with an absolute indication and its use is clear and distinct in nature and includes some
statistical certainty nonetheless with chronic diseases there is an overlap where reduction of disease risk pertains to one factor sufficient to prevent the
occurrence likely to be based on epidemiological evidence from studies of population cohorts Coppens et al propose that prevention has three facets
a) Prevention of disease occurrence where
the disease is not (yet) present
the therapy can prevent the occurrence of the disease with substantial statistical certainty
b) Prevention of episodes of the disease where
the disease is present
the therapy decreases the number duration or severity of disease episodes with a substantial statistical certainty
c) Prevention of progression of the patientlsquos underlying disease where
the disease is present
the therapy has been shown to delay the progression of the disease with a substantial statistical certainty
At the other end of the spectrum treatlsquo denotes a purpose of action intention therefore becomes a key determinant in claim status Intention in
consumption is important for the enforcement of health claims where (average) consumer understanding is a factor Consumption of supplemental vitamin
D3 to support bone health or with a substantiated claim reduce the risk of osteoporosis comes under the food domain However consumption of
supplemental vitamin D3 for the purposes of immune-modulation would be medicinal
The principle of disease risk reduction (DRR) as distinct from prevention was incorporated into EU law in EC 19242006 on nutrition and health claims
on food (NHCR) which requires that all structurefunction and DRR claims on food including supplements must be preapproved by the EU Commission
and meet a standard of substantial scientific agreement While the DRR paradigm recognises that chronic disease conditions are the product of multiple
gene-environment influences it nonetheless still must be predicated on what diseaselsquo is in biological terms The EU-funded PASSCLAIM projec t was
tasked with establishing how health claims would be substantiated and to identify functional biomarkers or surrogate end-point markers for use in the
assessment process PASSCLAIM working groups produced reports on diet -related cardiovascular disease bone health and osteoporosis physical
performance and fitness mental state and performance body weight insulin sensitivity and diabetes diet -related cancer and gut health and
immunity At January 2011 the European Food Safety Authority (EFSA) charged with the process of assessing claims is yet to fully clarify its
assessment criteria
24 Functional foods food bioactives and nutraceuticals
While the EU regulates foods containing plant sterolsstanols there is no formal definition of functional foodlsquo The EU FUFOSE project used a working
definition of functional foods that ―affect beneficially one or more target functions in the body beyond adequate nutriti onal effects in a way that is
relevant to either an improved state of health and well -being andor reduction of risk of disease FUFOSE noted that a functional food can be a natural
food one to which a component has been added or removed where a component has been modified or its bioavailability modifie d or any combination or
multiples of all the possibilities Therefore functional foods in the EU must be foods with health claims as defined by the NHCR
BANT sponsors a 2 day seminar on cPNI on 8-9 of Sep 2011
organised by Bonusan under the auspices of the Natura Foundation
wwwbantorgukbantjspmemberpdfseminarsBONUSAN_CPNIpdf
Page 12 of
Although in 2006 the US FDA proposed that the term functional foodlsquo be regulated (21 Code of Federal Regulations Part 101 and Part 170)it still has no
formal definition of that or of nutraceuticallsquo Earlier in 2004 the US Department of Health and Human Services (DHHS) launch ed a consultation on a
proposed definition of bioactive food componentslsquo In its supplementary information to the proposal the DHHS stated that bioactives may have multiple
sites of action may interact with one or more dietary constituents and may act directly or indirectly to produce a functional outcome citing as examples
lycopene long-chain omega-3 fatty acids isoflavones sulphorophane and resveratrol Establishing a definition of a food bioactive was a first step
towards evaluating their significance in promoting health and disease prevention then guiding research priorities and science-based information to help
guide public health policylsquo The definition proposed was
―Bioactive food components are constituents in foods or dietary supplements other than those needed to meet basic human nutr itional needs that are
responsible for changes in health status
As of early 2011 the work on defining food bioactives has not progressed Respondents to the 2004 consultation made strong representations about a
definition of bioactivity which excluded nutrients arguably the most important bioactive category of food components Seventeen written responses were
received in response to the consultation a number of which proposed alternate definitions Common themes in those alternate definitions include use of
the term physiologically activelsquo or physiological benefitlsquo reference to structure functionlsquo and disease -risk reductionlsquo and (ILSI North America) ―as
measured through utilizing appropriate methodology and biomarkers
In January 2011 the US National Academies of Science publishedPerspectives on Biomarker and Surrogate Endpoint Evaluation with recommendations
for establishing a framework for harmonising biomarker use across all areas including drugs and foods
3 Dosage and the homeostasis model what is lsquonormalrsquo
The ECJ Judgement C-8807 of 5 March 2009 determined that substances ―which while having an effect on the human body do not significantly
affect the metabolism and thus do not strictly modify the way in which it functions should not be classified as medicinal products by function
(see Commission v Germany paragraph 60 and Hecht-Pharma paragraph 41) Dosage therefore is a key criterion in determining food from medicine
of botanicals and from May 2011 is likely to be used by national authorities in enforcement This complements the homeostasis model produced by
the European Council in 2008 to distinguish foods and medicinal products The model incorporates the notion of intended use of the product and the
nature of the induced effect food induces the physiological effects characterised by maintainsupportoptimiselsquo and medicine induces the physiological
functions characterised by restorecorrectmodifylsquo It is a self-contained integrated approach but is predicated on the definition of homeostasis being
defined as ldquothe status of a person whose physiological parameters function within the limits considered as normal But while normal
physiological parameters may be defined by (sometimes quite large) reference ranges nutritional prerequisites or dietary ref erence intakes are not fully
harmonised throughout the EU nor do they take account of ancestral or inter-individual variation which characterise different sub-populations The lack
of harmonisation means some EU Member States regard supra -RDA vitamin and mineral supplements as medicines where others including the UK
have taken a more liberal approach The EU-funded EurRECA network of excellence is tasked with developing methodologies and recommendations to
standardise the process of setting pan-EU micronutrient recommendations This will inform progress in setting maximum permitted levels of vitamins and
minerals in food supplements However the extent of inter-individuality may prove problematic in 2007 the UK Committee on Toxicity in its working
group report on variability and uncertainty stated that for vitamins and minerals ―variability in the response of individuals has the potential to result in a
situation which a given level of exposure could be essential for some but toxic for others
What is normallsquo in dietary requirements underpins the basis on which both medicinal and health claims are evaluated namely that a healthy balanced
diet is generally able to provide all micronutrient requirements by normal healthy individuals for health maintenance Two signi ficant sub-populations
however threaten to undermine that approach In the UK the Healthy Start programme administered by statutory instrument by the Department
of Health and National Health Service provides two bespoke Healthy Start-branded vitamin supplements for low income beneficiaries for women free
during pregnancy and up until their baby is one year old and for children from 6 months of age until their fourth birthday Non-beneficiaries can
purchase Healthy Start-branded supplements at low cost from health clinics Health professionals are encouraged to make sure that mothers and
children ―get two important vitamins that they may not be getting in adequate quantities ndash even from a healthy balanced diet These are vitamins A and D
for children and vitamin D and folic acid for women While it is prohibited under the NHCR to claim that a healthy balanced diet cannot in general
provide all nutrients needed there is no such prohibition under medicinal law and the Healthy Startvitamins are marketed under a UK medicines
licence [PL015110003] This conflict adds to the problems of robust implementation of the NHCR which is already stymied by the lack of
A credible transparent system of scientific assessment
An agreed nutrient profiling system
A harmonised pan-EU characterisation of a healthy balanced diet
4 Going forward
Added to the woes of the NHCR looms a new era of personal genomicmetabolomic profiling and personalised nutrition in the for m of P4
medicinelsquo (personalised predictive preventive participatory) In its essence nutrigenomicslsquo incorporates two aspects
The effect of food components on the genome and epigenome
The extent of ancestral and individual variation
If disease can be classified at the molecular level what effect does this have on the meaning of homeostasislsquo and medicine lsquo These key terms need full
and comprehensive definition both in biology and law so that the food -medicine continuum is fully resolved and the foundation is laid for the successful
application of both personalised medicine and personalised nutrition Innovation and continued investment in wellness products by the food industry
depend on a clear consistent and transparent system of claims assessment
From Pharm to Fork in the Nutrigenomic Era Is It Food or Medicine- Cont
Page 13 of 13 Topic of the Month - Cardiovascular Health
Nutri Link Clinical Education - wwwnleducationcouk
They believe in supporting the health care professionals who count on them for
effective nutritional solutions Their team of CAM-leading experts are committed to
providing you with the latest unbiased scientific research and clinical support plus a
vast array of continuing education opportunitieshellipbecause as practitioners they
understand that knowledge is the key to positive patient results
FM Town - wwwfmtowncom
Its all about relevancy Being in a 100 Functional Medicine environment will give
you an opportunity to get direct and immediate access to all the information that is
most relevant to you FMTown is private and highly relevant in its scope of focus
Get connected to an amazing online resource which can grow with you and support
your Functional Medicine Journey
Institute for Functional Medicine - wwwfunctionalmedicineorg
IFM Membership is your gateway to a community of like-minded clinicians and
researchers It is primarily aimed at clinicians and scientists whose interest in
functional medicine is deeply connected to examining the emerging research
attending CME courses discussing issues and patients with colleagues and so
forth Membership helps to build a network of practitioners from many disciplines
who are using and studying functional medicine every day
Food Science Central - wwwfoodsciencecentralcom
Food Science Central is the home of IFIS Publishing on the web Here you can
learn about products and services and access FREE articles on many topics in food
science food technology and nutrition
Monthly ArticlesPapers
ANXIETY AND CARDIOVASCULAR RISK REVIEW OF
EPIDEMIOLOGICAL AND CLINICAL EVIDENCE
O Olafiranye G Jean-Louis F Zizi J Nunes and MT Vincent
wwwncbinlmnihgovpmcarticlesPMC3150179pdfnihms-
301210pdf
POST-TRAUMATIC STRESS DISORDER AND
CARDIOVASCULAR DISEASE
Steven S Coughlin
wwwncbinlmnihgovpmcarticlesPMC3141329pdfTOCMJ-5-
164pdf
STUDIES OF GENE VARIANTS RELATED TO INFLAMMATION
OXIDATIVE STRESS DYSLIPIDEMIA AND OBESITY
IMPLICATIONS FOR A NUTRIGENETIC APPROACH
Maira Ladeia R Curti Patrıcia Jacob Maria Carolina Borges
Marcelo Macedo Rogero and Sandra Roberta G Ferreir
wwwncbinlmnihgovpmcarticlesPMC3136190pdfJOBES2011-
497401pdf
EFFECT OF AN OFFICE WORKSITE-BASED YOGA
PROGRAM ON HEART RATE VARIABILITY A RANDOMIZED
CONTROLLED TRIAL
Birinder S Cheema Paul W Marshall Dennis Chang Ben
Colagiuri and Bianca Machliss
wwwncbinlmnihgovpmcarticlesPMC3154869pdf1471-2458-
11-578pdf
CARDIOVASCULAR COMPLICATIONS IN CKD PATIENTS
ROLE OF OXIDATIVE STRESS
Elvira O Gosmanova and Ngoc-Anh Le
wwwncbinlmnihgovpmcarticlesPMC3022166pdfCRP2011-
156326pdf
TARGETING STEM CELL NICHES AND TRAFFICKING FOR
CARDIOVASCULAR THERAPY
Nicolle Kraumlnkel Gaia Spinetti Silvia Amadesi and Paolo Madeddu
wwwncbinlmnihgovpmcarticlesPMC3017934pdfukmss-
33677pdf
INTERACTION OF SLEEP QUALITY AND PSYCHOS OCIAL
STRESS ON OBESITY IN AFRICAN AMERICANS THE
CARDIOVASCULAR HEALTH EPIDEMIOLOGY STUDY (CHES)
Aurelian Bidulescu Rebecca Din-Dzietham Dorothy L Coverson
Zhimin Chen Yuan-Xiang Meng Sarah G Buxbaum Gary H Gib-
bons Verna L Welch
wwwbiomedcentralcomcontentpdf1471-2458-10-581pdf
PATHOPHYSIOLOGIC MECHANISMS LINKING IMPAIRED
CARDIOVASCULAR HEALTH AND NEUROLOGIC
DYSFUNCTION THE YEAR IN REVIEW
Ki E Park Carl J Pepine
wwwccjmorgcontent77Suppl_3S40fullpdf+html
BERRIES EMERGING IMPACT ON CARDIOVASCULAR
HEALTH
Arpita Basu Michael Rhone and Timothy J Lyons
wwwncbinlmnihgovpmcarticlesPMC3068482pdf
nihms171310pdf
THE PLACENTA IS A PROGRAMMING AGENT FOR
CARDIOVASCULAR DISEASE
KL Thornburg PF OlsquoTierney and S Louey
wwwncbinlmnihgovpmcarticlesPMC2846089pdf
nihms177889pdf
Useful Websites
BANT - the seal of excellence for nutrition health professionals
Page 7 of 13
mgL in women Please note that the reference ranges above refer to the High Sensitivity CRP or hs -CRP test
Multiple risk markers for atherosclerosis and cardiovascular disease act in a synergistic way through inflammatory pathways The following lists the
different factors that have been identified as risk factors for CHD and arterial damage
Elevated CRP
Elevated LDL
Excess Insulin
Low HDL
High Glucose
Nitric Oxide Deficit
Excess Triglycerides
Low Free Testosterone
Excess Fibrinogen
Excess Homocysteine
Hypertension
Low Vitamin K
Excess Cholesterol
There are many key inflammatory biochemical risk markers for cardiovascular disease in particular the role of three basic c ell types affected by
these risk markers (endothelial cells smooth muscle cells and immune cells) the crucial role of inflammatory mediators ni tric oxide balance in
cardiovascular pathology and the use of nutrients (flavanoids carotenoids sterols vitamin C and E Omega 3 fatty acids et c) to circumvent several of
these inflammatory pathways Most of the above risk markers for cardiovascular disease have a pro -inflammatory component which stimulates the
release of a number of active molecules such as inflammatory mediators reactive oxygen species nitric oxide and peroxynitr ite from endothelial
vascular smooth muscle and immune cells in response to injury Nitric oxide plays a pivotal role in preventing the progressi on of atherosclerosis through
its ability to induce vasodilation suppress vascular smooth muscle proli feration and reduce vascular lesion formation Nutr ients such as arginine
antioxidants (OPCs vitamins C and E lipoic acid selenium glutathione) and enzyme cofactors (vitamins B2 and B3 B6 B12 folate zinc) help to
elevate nitric oxide levels and may play an important role in the management of cardiovascular disease Other dietary components such as DHAEPA
from fish oil tocotrienols vitamins B6 and B12 and quercetin contribute further to mitigating the inflammatory process 18
Within the broad range of cholesterol levels from 180 to 240 there is little to no evidence that this alone correlates with h eart disease Below 180 there is
increased risk of hemorrhagic stroke depression and suicide Above 240 there is increased risk of cardiovascular disease an d ischemic stroke Over age
70 elevated cholesterol and cardiovascular events no longer correlate All told total serum cholesterol alone is a poor ind icator of cardiovascular disease
Half of all heart attack patients have normal total cholesterol levels
So not only do statin drugs have their inherent drawbacks but in some ways they are treating a fabricated problem based on misunderstood and
misrepresented ―research As natural health care providers we know that we must be wary of the current cholesterol hysteria we must be able to
explain the real evidence and we must help our patients understand the facts so they can make educated health choices
Dicken Weatherby ND is originally from Oxfordshire in the UK and is based in Ashland Oregon USA A graduate of the National College of Natural
Medicine Dicken is author of the bestselling book Blood Chemistry and CBC Analysis -Clinical Laboratory Testing from a Functional Perspective He
has self-published seven other books in the field of alternative medical diagnosis has created numerous information products and runs a number of
successful Web sites including wwwFMTowncom an online membership community for practitioners interested in Functional Medicine and
Functional Diagnosis Dr Weatherby is the creator of the ldquoFoundations of Functional Diagnosis Training Programrdquo at wwwFunctionalDiagnosiscom and
the ldquoFoundations of Functional Blood Chemistry Analysisrdquo Training Program at wwwBloodChemistryTrainingcom
Donald R Yance CN MH RH is an internationally known herbalist and nutritionist He is the founder and medical director of the Centre for Natural
Healing in Ashland Ore Through extensive research and clinical practice he has developed his Triphasic system which forms the cornerstone of his
clinical approach Donald is the founder and formulator of Natura Health Products and founder and president of The Mederi Fo undation whose
programs promote health education and clinical research on the use of natural medicine with an emphasis in the field of integrative oncology
References
1 Gardner CD Fortmann SP Krauss RM Association of small low-density lipoprotein particles with the incidence of coronary artery disease in
men and women JAMA 1996 Sep 18276(11)875-81
2 Stampfer MJ Krauss RM Ma J et al A prospective study of triglyceride level low- density lipoprotein particle diameter and risk of myocardial
infarction JAMA 1996 Sep 18276(11)882-88
3 Lamarche B Tchernof A Moorjani S et al Small dense low-density lipoprotein particles as a predictor of the risk of ischemic heart disease in
men Prospective results from the Quebec Cardiovascular Study Circulation 1997 Jan 795(1)69 -75
4 Kuller L Tracy P Arnold A et al Nuclear magnetic resonance spectroscopy of lipoproteins and risk of coronary heart diseas e in the
cardiovascular health study Arterioscler Thromb Vasc Biol 2002 Jul 122(7)1175 -80
5 Expert Panel on Detection Evaluation and Treatment of High Blood Cholesterol in Adults Executive summary of the third report of the national
cholesterol education program (NCEP) expert panel on detection evaluation and treatment of high blood cholesterol in adults (Adult Treatment
Panel III) JAMA 2001 May 16285(19)2486-97
Featured Article by Dicken Weatherby on Cardiovascular Health
BANT - the seal of excellence for nutrition health professionals
We are pleased to let you all know that Dicken will be speaking at our seminar on 29th October 2011 - donrsquot miss it or you will
miss out Book your tickets now as they are selling fast wwwbantorgukbantjspNGseminarvideosfaces
Page 8 of 13
6 Gotto AM Brinton EA Assessing low levels of high-density lipoprotein cholesterol as a risk factor in coronary heart disease J Am Coll Cardiol
2004 Mar 343(5)717-24
7 van Lennep JE Westerveld HT Van Lennep HW Zwinderman AH Erkelens DW van der Wall EE Apolipoprotein concentrations durin g treat
ment and recurrent coronary artery disease events Arterioscler Thromb Vasc Biol 2000 Nov20(11)2408 -13
8 Ford ES Giles WH Dietz WH Prevalence of the metabolic syndrome among US adults findings from the third National Health an d Nutrition
Examination Survey JAMA 2002 Jan 16287(3)356-9
9 Taylor AJ Merz CN Udelson JE 34th Bethesda Conference ―Can atherosclerosis imaging techniques improve the detection of pa tients at risk
for ischemic heart disease J Amer Coll Cardiol 2003 Jun 4(11)411860 -2
10 Rifai N Ridker PM Inflammatory markers and coronary heart disease Curr Opin Lipidol 2002 Aug13(4)383-9
11 Albert CM et al Prospective study of C-reactive protein homocysteine and plasma lipid levels as predictors of sudden cardiac death
Circulation 2002 Jun 4105 (22)2595-9
12 Bermudez EA Ridker PM C-reactive protein statins and the primary prevention of atherosclerotic cardiovascular disease Prev Cardiol 2002
Winter5(1)42-6
13 Schroecksnadel K Frick B Winkler C Fuchs D Crucial role of interferon-gamma and stimulated macrophages in cardiovascular disease Curr
Vasc Pharmacol 2006 Jul4(3)205-13
14 Rifai N Ridker PM Inflammatory markers and coronary heart disease Curr Opin Lipidol 2002 Aug13(4)383-9
15 Albert CM et al Prospective study of C-reactive protein homocysteine and plasma lipid levels as predictors of sudden cardiac death
Circulation 2002 Jun 4105 (22)2595-9
16 Bermudez EA Ridker PM C-reactive protein statins and the primary prevention of atherosclerotic cardiovascular disease Prev Cardiol 2002
Winter5(1)42-6
17 Blake GJ Ridker PM Inflammatory mechanisms in atherosclerosis from laboratory evidence to clinical application Ital Heart J 2001 Nov2
(11)796-800
18 Osiecki HE The role of chronic inflammation in cardiovascular disease and its regulation by nutrients Altern Med Rev 2004 Mar9(1)32-53
Conversion Table This will help you to convert the markers in this article from US units into units used on UK blood tests
Reference ranges given are typical but may vary depending on lab used Eg Biolab given reference range for cholesterol is that target should be below
4 to 5 depending on clinical factors
Featured Article by Dicken Weatherby on Cardiovascular Health
Studies
CHIA SEEDS MAY OFFER OMEGA-3 HEART AND LIVER BENEFITS STUDY
wwwnutraingredients-usacomHealth-condition-categoriesCardiovascular-
healthChia-seeds-may-offer-omega-3-heart-and-liver-benefits-Study
c=TRR9CYYlHK48nEzv7WRu8CTrplNtVNvfamputm_source=Newsletter_Productampu
tm_medium=emailamputm_campaign=Newsletter2BProduct
DORMANT ANTIOXIDANT HAS lsquoUNPARALLELEDrsquo BENEFITS
wwwnutraingredients-usacomHealth-condition-categoriesCardiovascular-
healthDormant -antioxidant-has-unparalleled-benefits
WHOLE MANGOSTEEN FRUIT AND ITS BENEFITS
wwwthewholefruitcomstructure_functionphp
The early research on the whole mangosteen fruit and its numerous
nutritional components is both promising and precise Feel like digging in
Herelsquos a snapshotmdashjust a small samplemdashof the studies that back the
impressive edge of whole mangosteen formulation and supplementation
Neutralizes Free Radicals
Supports a Healthy Cardiovascular System
Supports Cartilage and Joint Function
Strengthens the Immune System
Promotes a Healthy Seasonal Respiratory System
Maintains Intestinal Health
Other Supportive Papers
Monthly ReportsStudiesWebinarsVideocasts
Publications
Destination 2020 - A Plan for Cardiac and Vascular Health
wwwbhforgukpublicationsview-publicationaspxps=1000855
Webinars
You need to register your details before you can access these webi-
nars FREE OF CHARGE
2010 State-of-the-Art Webinar Series in Cardiovascular Disease
Webinar I
Webinar II
Webinar III
Videocasts
Vitamin D cardiovascular disease and cancer emerging evi-
dence [electronic resource] JoAnn E Manson
httpvideocastnihgovlaunchasp15689
Heart failure in women
httpvideocastnihgovlaunchasp15838
Demystifying Medicine - Cardiovascular disease in the eras of
imaging and stem cells
httpvideocastnihgovlaunchasp16573
Demystifying Medicine - Arteriosclerotic cardiovascular disease
Number one killer and the Framingham experience
httpvideocastnihgovlaunchasp14936
US reference range To convert from US to UK UK units
Cholesterol 150-220 mgdL Multiple by 002586 336-52 mmoll
HDL 40-90 mgdL Multiple by 002586 103-232 mmol
LDL 60-130 mgdL Multiple by 002586 155 ndash 336 mmoll
BANT sponsors a 2 day seminar on cPNI on 8-9 of Sep 2011
organised by Bonusan under the auspices of the Natura Foundation
wwwbantorgukbantjspmemberpdfseminarsBONUSAN_CPNIpdf
Page 9 of 13
On Saturday 21st May the Alliance for Natural Health International supported by the GNC and BANT held its first
training and education day for practitioners helping them through the minefield of legislative requirements facing the
natural health sector The conference was well attended by over 240 practitioners whose feedback confirms that the
information was critical to their ability to manage their practices compliantly in the future and was summed up succinctly
by one of the delegates
I think the conference today really hits the mark in terms of tak ing a very complex set of regulations and putting it into a
digestible form for practitioners laying out not only the regulations but also the practical side of how we live within thi s
new regulatory environment
Kathleen Devereaux
We understand that many were not able to attend the conference in person but as promised we have now produced a full download of the daylsquos
sessions in video format which includes the pre-reading pack sent to delegates a comprehensive delegate volume of notes covering the days event and
an extensive reference list of supporting documentation We know its been a few weeks since the event but it takes time to p rofessionally edit the raw
footage so we hope that youll now feel part of it as if you had actually been there with us
Having attended the ANH conference I was able to get a real picture about the Rules and Regulations NTs are up against Understanding this legislation
and how it affects NT practice is an important part of being a responsible NT We need to learn the language of these new rul es and in doing so feel
empowered and in control of our work environment This conference DVD and info should be an essential part of your NT toolk it
Melanie de Grooth BANT AdministratorGeneral Manager
This comprehensive package costs pound40 with proceeds going to the ANH campaign fund and is available to practitioners and student practitioners only
Those practitioners who are going to be successful in this new environment will need to uniquely express themselves according to their qualifications and
experience A me too approach where everyone says the same things is not going to allow you to stand out from the crowd At the heart of this is an
understanding of the principles behind the rules and regulations as well as solutions allowing you to not fall foul of it Provided in the printed and video
outputs from our seminar are all the basics youll need to move confidently forward in this difficult and confusing regulatory climate and we will be
following up with more support in due course
As NT practitioners we are facing a maze of rules and regulations that will affect how we work in the future I therefore urge you all to purchase the must
have DVD from the recent excellent ANH training conference entitled Rules and Regulations in Clinical Practice Developing your Practice in Spite of the
EU Regulatory Juggernaut This is an extremely useful toolk it for your practice and will assist you in understanding these l egislative changes
Catherine Honeywell - Chair BANT Council
PURCHASE DOWNLOAD - wwwanh-europeorgrules-and-regulations-training-buy-download We also invite you to sign up for our regular
eAlerts wwwanh-europeorguserregister and to check out our practitioner pages - wwwanh-europeorgpractitioners
Thank you ANH-Intl
ANH-Intl Rules and Regulations DVD Now on Sale
BANT Page on Rules and Regulations If you have not already done so please make sure you access the presentations we have
provided on Rule and Regulations Affecting NT Practice and Understanding the Scope and
Definition for Medicinal Claims
An incredible amount of time and effort has gone into this project and we are sure that you will
now easily be able to navigate your way through the complicated array of rules and regulations
that impact on our practise of Nutritional Therapy
We would like to thank ANH-Intl and give credit to them for auditing and contributing the source
materials which BANT has interpreted and presented in this unique format The format and
presentation are the copyright of BANT and should not be reproduced without prior permission
We would also like to give a special thank you to Louise Carder who tirelessly gave of her time
and expertise to help BANT produce these slides ndash thank you Louise
You can access these slides at the following link wwwbantorgukbantjspmemberrulesRegulation faces
They have been designed for best use online You can of course print them out but you will then not be able to benefit from using the hyperlinks for
navigation Please take some time out of your busy schedules to carefully work and read through these slides This informati on is an essential part of
you Nutritional Therapy toolkit and will help you to be a better and more responsible practitioner
Understanding these Rules and Regulations will not only empower you as a practitioner but will
also demonstrate your level of commitment to your clients and the profession
From time to time we will update the content of the slides but will always let you know when this
has been done
IMPORTANT
After the renewals in October all full members will be emailed a copy of what you currently state
on you BANT profile under Special Interests and Further Information It will be your responsi-
bility to check the information is correct in relation to the ASA Rules and the Rules and
Regulations affecting NT practice Use this link to access the ARC Toolkit and FAQs on the
ASA rules wwwbantorgukbantjspmemberASARulesfaces
Page 10 of
FoodInfo Online Features 1 April 2011
httpwwwfoodsciencecentralcomfscixid16088
copy IFIS Publishing 2011 - All Rights Reserved
From pharm to fork in the nutrigenomic era is it food or medicine
Susan A McGinty and Dominic Man
London South Bank University 103 Borough Road London SE1 0AA
1 Introduction
The foodmedicine boundary has long been opaque with responsibility for medicines and food regulation coming under different European Commission
directorates This has led to a lack of integration at the EU level between food and medicine which has been further exacerbat ed by a lack of
harmonisation of implementation at Member State level of EU food law From 1 May the EU Traditional and Herbal Medicines Products Directive
(THMPD) comes fully into force and the elements of a perfect stormlsquo may be moving into place Manufacturers will no longer be able to supply
unlicensed herbal medicines to the public The European Medicines Agencylsquos (EMEA) has a database of medicinal herbs which includes inter
alia sage thyme garlic onion cinnamon pumpkin seed linseed juniper berry peppermint leaf and aniseed The UKlsquos Medicines and Healthcare
Products Regulatory Agency (MHRA) has published its own list of herbs and classifies them as medicinefoodcosmetic - also reflecting the problem of
the regulation of products and claims for cosmeceuticals From May 2011 ―it is the competence and responsibility of national authorities to decide on a
case by case basis whether a herbal product fulfils the definition of medicinal product A survey of the fundamental definitions clarifications by the
European Court of Justice (ECJ) and an examination of the European Councillsquos homeostasis model spotlights areas which may nee d to be reconciled if
the overall regulatory framework is capable of adapting to the era of systems biology and personalised medicinenutrition i ncluding dermagenetics
2 The devil in the detail the definitions
21 Food
Article 2 of EC 1782002 defines food including supplements as ―any substance or product whether processed partially processed or unprocessed
intended to be or reasonably expected to be ingested by humans This definition is straightforward but allows interpretation of reasonably expectedlsquo to
determine a medicinal product where dosagelsquo may be seen as a critical element ndash see later
22 Medicine bdquoform‟ and bdquofunction‟
Directive 200183EC of 6 November 2001 defined a medicine as either ―any substance or combination of substances presented for treating or
preventing disease in human beings or ―any substance or combination of substances which may be administered to human beings with a view to making
a diagnosis or to restoring correcting or modifying physiological balance in human beings This linked marketing activities and intention of consumption
to medicinal functionality In 2004 Directive 200427EC amended the definition of a medicine to ―any substance or combination of substances
presented as having properties for treating or preventing disease in human beings or any substance or combination of substances which may be used
in or administered to human beings either with a view to restoring correcting or modifying physiological functions by exerting a pharmacological
immunological or metabolic action or to making a medical diagnosis Article 22 of the 2004 Directive goes on to state ―In cases of doubt where
taking into account all its characteristics a product may fall within the definition of a medicinal productlsquo and within the definition of a product covered by
other Community legislation the provisions of this Directive shall apply
This definition had the technical effect of making all bioactive food components meet the medicinal standard by function if not by presentation and has
left Member State medicines regulators the EMEA and the European Commissionlsquos Directorate General Enterprise and Industry (DGEI) in the driving
seat as to determining product status and enforcement Nonetheless the ECJ ruled in C-31905 Commission of the European Communities v Federal
Republic of Germany of 15 November 2007 that the definition of a medicinal product by function should be interpreted restrictively since it was des igned
to cover only products whose pharmacological properties have been scientifically observed and not substances which while ha ving an effect on the
human body do not significantly affect the metabolism and thus do not strictly modify the way in which it functions
The formlsquo of a medicine versus a food supplement was also tested in C-31905 in which the Commission accused the Federal Republic of Germany of
breach of its obligations under Articles 28 and 30 of the EC Treaty (free movement of goods) by classifying a garlic preparat ion in capsule form as a
medicinal product The ECJ held that a capsule form was not of itself sufficient to decide whether a product was medicinal that the capsule form is not
exclusive to medicinal products and the product in question only contained natural garlic and could not have any additional e ffects (positive or negative)
compared to garlic in its natural state A medicinal product must have the function of preventing or treating disease beneficial effects for health in general
are not sufficient
The ECJ clarifications pose a fundamental problem for Member State medicines regulators consistently using formlsquo and functi onlsquo as theirbenchmark
standards Pillcapsuletincture forms regularity of consumption defined posology and ADME (absorption distribution metabolism and excretion) and
the accompanying claims have long been the determinants in borderline product adjudications
23 Prevention or disease-risk reduction
The EU has no definition of diseaselsquo in any of its regulatory instruments except for medically diagnosed conditions or using w ider public health
frameworks for measuring disease prevention in terms ofQuality of Life Years (QALYs) and Disability Adjusted Life Years (DALY s) for example It has not
From Pharm to Fork in the Nutrigenomic Era Is It Food or Medicine
BANT - the seal of excellence for nutrition health professionals
Page 11 of From Pharm to Fork in the Nutrigenomic Era Is It Food or Medicine- Cont
adopted a fully transparent and credible suite of biomarkers surrogate or end-markers to establish healthdisease status and bi ofunctionality In the UK
The Medicines Act 1968 (as amended) defines disease as something which ―includes any injury ailment or adverse condition whether of body or
mind The lack of a clear legal definition has been recognised by the ECJ where disease has been intrinsically linked to the definition of a medicinal
product The Court determined in C-36988 on whether eye lotion was a medicinal product or cosmetic (a cosmetic being external but being able to
protectlsquo or keep in good conditionlsquo) that on the basis of scientific knowledge ―it is for the national authorities to dete rmine whether products presented as
counter-acting certain conditions of sensations such as hunger heaviness in the legs tiredness or itching constitute a medic al product
The United States Food and Drug Administration (FDA) in its health claims legislation defines disease as
―Damage to an organ part or structure or system of the body such that it does not function properly (eg cardiovascular dis ease) or a state of health
leading to such dysfunctioning (eg hypertension) except that diseases resulting from essential nutrient deficiencies (eg scurvy pellagra) are not
included in this definition
Proposals for health claims legislation being framed by Food Standards Australia and New Zealand (FSANZ) include definitions for diseaselsquo and serious
diseaselsquo which distinguish in terms both of severity of condition and of level of claim
Disease an unhealthy condition characterised by clinically significant signs or symptoms
Serious disease or condition forms of disease conditions ailments or defects which are generally accepted to be beyond the ability of the
average consumer to evaluate accurately and to treat safely without regular supervision by a suitably qualified health care professional
Where disease-risk reduction relates to one of a number of factors in the aetiology of disease the concept of preventionlsquo itse lf poses a number
of difficulties as like diseaselsquo it is not clearly defined in law
Coppens et al 2001 survey use of preventionlsquo in relation to the first EU Medicines Directive 6565 where prevention has had a history of use in terms
of vaccination and infectious diseases Prevention is a word with an absolute indication and its use is clear and distinct in nature and includes some
statistical certainty nonetheless with chronic diseases there is an overlap where reduction of disease risk pertains to one factor sufficient to prevent the
occurrence likely to be based on epidemiological evidence from studies of population cohorts Coppens et al propose that prevention has three facets
a) Prevention of disease occurrence where
the disease is not (yet) present
the therapy can prevent the occurrence of the disease with substantial statistical certainty
b) Prevention of episodes of the disease where
the disease is present
the therapy decreases the number duration or severity of disease episodes with a substantial statistical certainty
c) Prevention of progression of the patientlsquos underlying disease where
the disease is present
the therapy has been shown to delay the progression of the disease with a substantial statistical certainty
At the other end of the spectrum treatlsquo denotes a purpose of action intention therefore becomes a key determinant in claim status Intention in
consumption is important for the enforcement of health claims where (average) consumer understanding is a factor Consumption of supplemental vitamin
D3 to support bone health or with a substantiated claim reduce the risk of osteoporosis comes under the food domain However consumption of
supplemental vitamin D3 for the purposes of immune-modulation would be medicinal
The principle of disease risk reduction (DRR) as distinct from prevention was incorporated into EU law in EC 19242006 on nutrition and health claims
on food (NHCR) which requires that all structurefunction and DRR claims on food including supplements must be preapproved by the EU Commission
and meet a standard of substantial scientific agreement While the DRR paradigm recognises that chronic disease conditions are the product of multiple
gene-environment influences it nonetheless still must be predicated on what diseaselsquo is in biological terms The EU-funded PASSCLAIM projec t was
tasked with establishing how health claims would be substantiated and to identify functional biomarkers or surrogate end-point markers for use in the
assessment process PASSCLAIM working groups produced reports on diet -related cardiovascular disease bone health and osteoporosis physical
performance and fitness mental state and performance body weight insulin sensitivity and diabetes diet -related cancer and gut health and
immunity At January 2011 the European Food Safety Authority (EFSA) charged with the process of assessing claims is yet to fully clarify its
assessment criteria
24 Functional foods food bioactives and nutraceuticals
While the EU regulates foods containing plant sterolsstanols there is no formal definition of functional foodlsquo The EU FUFOSE project used a working
definition of functional foods that ―affect beneficially one or more target functions in the body beyond adequate nutriti onal effects in a way that is
relevant to either an improved state of health and well -being andor reduction of risk of disease FUFOSE noted that a functional food can be a natural
food one to which a component has been added or removed where a component has been modified or its bioavailability modifie d or any combination or
multiples of all the possibilities Therefore functional foods in the EU must be foods with health claims as defined by the NHCR
BANT sponsors a 2 day seminar on cPNI on 8-9 of Sep 2011
organised by Bonusan under the auspices of the Natura Foundation
wwwbantorgukbantjspmemberpdfseminarsBONUSAN_CPNIpdf
Page 12 of
Although in 2006 the US FDA proposed that the term functional foodlsquo be regulated (21 Code of Federal Regulations Part 101 and Part 170)it still has no
formal definition of that or of nutraceuticallsquo Earlier in 2004 the US Department of Health and Human Services (DHHS) launch ed a consultation on a
proposed definition of bioactive food componentslsquo In its supplementary information to the proposal the DHHS stated that bioactives may have multiple
sites of action may interact with one or more dietary constituents and may act directly or indirectly to produce a functional outcome citing as examples
lycopene long-chain omega-3 fatty acids isoflavones sulphorophane and resveratrol Establishing a definition of a food bioactive was a first step
towards evaluating their significance in promoting health and disease prevention then guiding research priorities and science-based information to help
guide public health policylsquo The definition proposed was
―Bioactive food components are constituents in foods or dietary supplements other than those needed to meet basic human nutr itional needs that are
responsible for changes in health status
As of early 2011 the work on defining food bioactives has not progressed Respondents to the 2004 consultation made strong representations about a
definition of bioactivity which excluded nutrients arguably the most important bioactive category of food components Seventeen written responses were
received in response to the consultation a number of which proposed alternate definitions Common themes in those alternate definitions include use of
the term physiologically activelsquo or physiological benefitlsquo reference to structure functionlsquo and disease -risk reductionlsquo and (ILSI North America) ―as
measured through utilizing appropriate methodology and biomarkers
In January 2011 the US National Academies of Science publishedPerspectives on Biomarker and Surrogate Endpoint Evaluation with recommendations
for establishing a framework for harmonising biomarker use across all areas including drugs and foods
3 Dosage and the homeostasis model what is lsquonormalrsquo
The ECJ Judgement C-8807 of 5 March 2009 determined that substances ―which while having an effect on the human body do not significantly
affect the metabolism and thus do not strictly modify the way in which it functions should not be classified as medicinal products by function
(see Commission v Germany paragraph 60 and Hecht-Pharma paragraph 41) Dosage therefore is a key criterion in determining food from medicine
of botanicals and from May 2011 is likely to be used by national authorities in enforcement This complements the homeostasis model produced by
the European Council in 2008 to distinguish foods and medicinal products The model incorporates the notion of intended use of the product and the
nature of the induced effect food induces the physiological effects characterised by maintainsupportoptimiselsquo and medicine induces the physiological
functions characterised by restorecorrectmodifylsquo It is a self-contained integrated approach but is predicated on the definition of homeostasis being
defined as ldquothe status of a person whose physiological parameters function within the limits considered as normal But while normal
physiological parameters may be defined by (sometimes quite large) reference ranges nutritional prerequisites or dietary ref erence intakes are not fully
harmonised throughout the EU nor do they take account of ancestral or inter-individual variation which characterise different sub-populations The lack
of harmonisation means some EU Member States regard supra -RDA vitamin and mineral supplements as medicines where others including the UK
have taken a more liberal approach The EU-funded EurRECA network of excellence is tasked with developing methodologies and recommendations to
standardise the process of setting pan-EU micronutrient recommendations This will inform progress in setting maximum permitted levels of vitamins and
minerals in food supplements However the extent of inter-individuality may prove problematic in 2007 the UK Committee on Toxicity in its working
group report on variability and uncertainty stated that for vitamins and minerals ―variability in the response of individuals has the potential to result in a
situation which a given level of exposure could be essential for some but toxic for others
What is normallsquo in dietary requirements underpins the basis on which both medicinal and health claims are evaluated namely that a healthy balanced
diet is generally able to provide all micronutrient requirements by normal healthy individuals for health maintenance Two signi ficant sub-populations
however threaten to undermine that approach In the UK the Healthy Start programme administered by statutory instrument by the Department
of Health and National Health Service provides two bespoke Healthy Start-branded vitamin supplements for low income beneficiaries for women free
during pregnancy and up until their baby is one year old and for children from 6 months of age until their fourth birthday Non-beneficiaries can
purchase Healthy Start-branded supplements at low cost from health clinics Health professionals are encouraged to make sure that mothers and
children ―get two important vitamins that they may not be getting in adequate quantities ndash even from a healthy balanced diet These are vitamins A and D
for children and vitamin D and folic acid for women While it is prohibited under the NHCR to claim that a healthy balanced diet cannot in general
provide all nutrients needed there is no such prohibition under medicinal law and the Healthy Startvitamins are marketed under a UK medicines
licence [PL015110003] This conflict adds to the problems of robust implementation of the NHCR which is already stymied by the lack of
A credible transparent system of scientific assessment
An agreed nutrient profiling system
A harmonised pan-EU characterisation of a healthy balanced diet
4 Going forward
Added to the woes of the NHCR looms a new era of personal genomicmetabolomic profiling and personalised nutrition in the for m of P4
medicinelsquo (personalised predictive preventive participatory) In its essence nutrigenomicslsquo incorporates two aspects
The effect of food components on the genome and epigenome
The extent of ancestral and individual variation
If disease can be classified at the molecular level what effect does this have on the meaning of homeostasislsquo and medicine lsquo These key terms need full
and comprehensive definition both in biology and law so that the food -medicine continuum is fully resolved and the foundation is laid for the successful
application of both personalised medicine and personalised nutrition Innovation and continued investment in wellness products by the food industry
depend on a clear consistent and transparent system of claims assessment
From Pharm to Fork in the Nutrigenomic Era Is It Food or Medicine- Cont
Page 13 of 13 Topic of the Month - Cardiovascular Health
Nutri Link Clinical Education - wwwnleducationcouk
They believe in supporting the health care professionals who count on them for
effective nutritional solutions Their team of CAM-leading experts are committed to
providing you with the latest unbiased scientific research and clinical support plus a
vast array of continuing education opportunitieshellipbecause as practitioners they
understand that knowledge is the key to positive patient results
FM Town - wwwfmtowncom
Its all about relevancy Being in a 100 Functional Medicine environment will give
you an opportunity to get direct and immediate access to all the information that is
most relevant to you FMTown is private and highly relevant in its scope of focus
Get connected to an amazing online resource which can grow with you and support
your Functional Medicine Journey
Institute for Functional Medicine - wwwfunctionalmedicineorg
IFM Membership is your gateway to a community of like-minded clinicians and
researchers It is primarily aimed at clinicians and scientists whose interest in
functional medicine is deeply connected to examining the emerging research
attending CME courses discussing issues and patients with colleagues and so
forth Membership helps to build a network of practitioners from many disciplines
who are using and studying functional medicine every day
Food Science Central - wwwfoodsciencecentralcom
Food Science Central is the home of IFIS Publishing on the web Here you can
learn about products and services and access FREE articles on many topics in food
science food technology and nutrition
Monthly ArticlesPapers
ANXIETY AND CARDIOVASCULAR RISK REVIEW OF
EPIDEMIOLOGICAL AND CLINICAL EVIDENCE
O Olafiranye G Jean-Louis F Zizi J Nunes and MT Vincent
wwwncbinlmnihgovpmcarticlesPMC3150179pdfnihms-
301210pdf
POST-TRAUMATIC STRESS DISORDER AND
CARDIOVASCULAR DISEASE
Steven S Coughlin
wwwncbinlmnihgovpmcarticlesPMC3141329pdfTOCMJ-5-
164pdf
STUDIES OF GENE VARIANTS RELATED TO INFLAMMATION
OXIDATIVE STRESS DYSLIPIDEMIA AND OBESITY
IMPLICATIONS FOR A NUTRIGENETIC APPROACH
Maira Ladeia R Curti Patrıcia Jacob Maria Carolina Borges
Marcelo Macedo Rogero and Sandra Roberta G Ferreir
wwwncbinlmnihgovpmcarticlesPMC3136190pdfJOBES2011-
497401pdf
EFFECT OF AN OFFICE WORKSITE-BASED YOGA
PROGRAM ON HEART RATE VARIABILITY A RANDOMIZED
CONTROLLED TRIAL
Birinder S Cheema Paul W Marshall Dennis Chang Ben
Colagiuri and Bianca Machliss
wwwncbinlmnihgovpmcarticlesPMC3154869pdf1471-2458-
11-578pdf
CARDIOVASCULAR COMPLICATIONS IN CKD PATIENTS
ROLE OF OXIDATIVE STRESS
Elvira O Gosmanova and Ngoc-Anh Le
wwwncbinlmnihgovpmcarticlesPMC3022166pdfCRP2011-
156326pdf
TARGETING STEM CELL NICHES AND TRAFFICKING FOR
CARDIOVASCULAR THERAPY
Nicolle Kraumlnkel Gaia Spinetti Silvia Amadesi and Paolo Madeddu
wwwncbinlmnihgovpmcarticlesPMC3017934pdfukmss-
33677pdf
INTERACTION OF SLEEP QUALITY AND PSYCHOS OCIAL
STRESS ON OBESITY IN AFRICAN AMERICANS THE
CARDIOVASCULAR HEALTH EPIDEMIOLOGY STUDY (CHES)
Aurelian Bidulescu Rebecca Din-Dzietham Dorothy L Coverson
Zhimin Chen Yuan-Xiang Meng Sarah G Buxbaum Gary H Gib-
bons Verna L Welch
wwwbiomedcentralcomcontentpdf1471-2458-10-581pdf
PATHOPHYSIOLOGIC MECHANISMS LINKING IMPAIRED
CARDIOVASCULAR HEALTH AND NEUROLOGIC
DYSFUNCTION THE YEAR IN REVIEW
Ki E Park Carl J Pepine
wwwccjmorgcontent77Suppl_3S40fullpdf+html
BERRIES EMERGING IMPACT ON CARDIOVASCULAR
HEALTH
Arpita Basu Michael Rhone and Timothy J Lyons
wwwncbinlmnihgovpmcarticlesPMC3068482pdf
nihms171310pdf
THE PLACENTA IS A PROGRAMMING AGENT FOR
CARDIOVASCULAR DISEASE
KL Thornburg PF OlsquoTierney and S Louey
wwwncbinlmnihgovpmcarticlesPMC2846089pdf
nihms177889pdf
Useful Websites
BANT - the seal of excellence for nutrition health professionals
Page 8 of 13
6 Gotto AM Brinton EA Assessing low levels of high-density lipoprotein cholesterol as a risk factor in coronary heart disease J Am Coll Cardiol
2004 Mar 343(5)717-24
7 van Lennep JE Westerveld HT Van Lennep HW Zwinderman AH Erkelens DW van der Wall EE Apolipoprotein concentrations durin g treat
ment and recurrent coronary artery disease events Arterioscler Thromb Vasc Biol 2000 Nov20(11)2408 -13
8 Ford ES Giles WH Dietz WH Prevalence of the metabolic syndrome among US adults findings from the third National Health an d Nutrition
Examination Survey JAMA 2002 Jan 16287(3)356-9
9 Taylor AJ Merz CN Udelson JE 34th Bethesda Conference ―Can atherosclerosis imaging techniques improve the detection of pa tients at risk
for ischemic heart disease J Amer Coll Cardiol 2003 Jun 4(11)411860 -2
10 Rifai N Ridker PM Inflammatory markers and coronary heart disease Curr Opin Lipidol 2002 Aug13(4)383-9
11 Albert CM et al Prospective study of C-reactive protein homocysteine and plasma lipid levels as predictors of sudden cardiac death
Circulation 2002 Jun 4105 (22)2595-9
12 Bermudez EA Ridker PM C-reactive protein statins and the primary prevention of atherosclerotic cardiovascular disease Prev Cardiol 2002
Winter5(1)42-6
13 Schroecksnadel K Frick B Winkler C Fuchs D Crucial role of interferon-gamma and stimulated macrophages in cardiovascular disease Curr
Vasc Pharmacol 2006 Jul4(3)205-13
14 Rifai N Ridker PM Inflammatory markers and coronary heart disease Curr Opin Lipidol 2002 Aug13(4)383-9
15 Albert CM et al Prospective study of C-reactive protein homocysteine and plasma lipid levels as predictors of sudden cardiac death
Circulation 2002 Jun 4105 (22)2595-9
16 Bermudez EA Ridker PM C-reactive protein statins and the primary prevention of atherosclerotic cardiovascular disease Prev Cardiol 2002
Winter5(1)42-6
17 Blake GJ Ridker PM Inflammatory mechanisms in atherosclerosis from laboratory evidence to clinical application Ital Heart J 2001 Nov2
(11)796-800
18 Osiecki HE The role of chronic inflammation in cardiovascular disease and its regulation by nutrients Altern Med Rev 2004 Mar9(1)32-53
Conversion Table This will help you to convert the markers in this article from US units into units used on UK blood tests
Reference ranges given are typical but may vary depending on lab used Eg Biolab given reference range for cholesterol is that target should be below
4 to 5 depending on clinical factors
Featured Article by Dicken Weatherby on Cardiovascular Health
Studies
CHIA SEEDS MAY OFFER OMEGA-3 HEART AND LIVER BENEFITS STUDY
wwwnutraingredients-usacomHealth-condition-categoriesCardiovascular-
healthChia-seeds-may-offer-omega-3-heart-and-liver-benefits-Study
c=TRR9CYYlHK48nEzv7WRu8CTrplNtVNvfamputm_source=Newsletter_Productampu
tm_medium=emailamputm_campaign=Newsletter2BProduct
DORMANT ANTIOXIDANT HAS lsquoUNPARALLELEDrsquo BENEFITS
wwwnutraingredients-usacomHealth-condition-categoriesCardiovascular-
healthDormant -antioxidant-has-unparalleled-benefits
WHOLE MANGOSTEEN FRUIT AND ITS BENEFITS
wwwthewholefruitcomstructure_functionphp
The early research on the whole mangosteen fruit and its numerous
nutritional components is both promising and precise Feel like digging in
Herelsquos a snapshotmdashjust a small samplemdashof the studies that back the
impressive edge of whole mangosteen formulation and supplementation
Neutralizes Free Radicals
Supports a Healthy Cardiovascular System
Supports Cartilage and Joint Function
Strengthens the Immune System
Promotes a Healthy Seasonal Respiratory System
Maintains Intestinal Health
Other Supportive Papers
Monthly ReportsStudiesWebinarsVideocasts
Publications
Destination 2020 - A Plan for Cardiac and Vascular Health
wwwbhforgukpublicationsview-publicationaspxps=1000855
Webinars
You need to register your details before you can access these webi-
nars FREE OF CHARGE
2010 State-of-the-Art Webinar Series in Cardiovascular Disease
Webinar I
Webinar II
Webinar III
Videocasts
Vitamin D cardiovascular disease and cancer emerging evi-
dence [electronic resource] JoAnn E Manson
httpvideocastnihgovlaunchasp15689
Heart failure in women
httpvideocastnihgovlaunchasp15838
Demystifying Medicine - Cardiovascular disease in the eras of
imaging and stem cells
httpvideocastnihgovlaunchasp16573
Demystifying Medicine - Arteriosclerotic cardiovascular disease
Number one killer and the Framingham experience
httpvideocastnihgovlaunchasp14936
US reference range To convert from US to UK UK units
Cholesterol 150-220 mgdL Multiple by 002586 336-52 mmoll
HDL 40-90 mgdL Multiple by 002586 103-232 mmol
LDL 60-130 mgdL Multiple by 002586 155 ndash 336 mmoll
BANT sponsors a 2 day seminar on cPNI on 8-9 of Sep 2011
organised by Bonusan under the auspices of the Natura Foundation
wwwbantorgukbantjspmemberpdfseminarsBONUSAN_CPNIpdf
Page 9 of 13
On Saturday 21st May the Alliance for Natural Health International supported by the GNC and BANT held its first
training and education day for practitioners helping them through the minefield of legislative requirements facing the
natural health sector The conference was well attended by over 240 practitioners whose feedback confirms that the
information was critical to their ability to manage their practices compliantly in the future and was summed up succinctly
by one of the delegates
I think the conference today really hits the mark in terms of tak ing a very complex set of regulations and putting it into a
digestible form for practitioners laying out not only the regulations but also the practical side of how we live within thi s
new regulatory environment
Kathleen Devereaux
We understand that many were not able to attend the conference in person but as promised we have now produced a full download of the daylsquos
sessions in video format which includes the pre-reading pack sent to delegates a comprehensive delegate volume of notes covering the days event and
an extensive reference list of supporting documentation We know its been a few weeks since the event but it takes time to p rofessionally edit the raw
footage so we hope that youll now feel part of it as if you had actually been there with us
Having attended the ANH conference I was able to get a real picture about the Rules and Regulations NTs are up against Understanding this legislation
and how it affects NT practice is an important part of being a responsible NT We need to learn the language of these new rul es and in doing so feel
empowered and in control of our work environment This conference DVD and info should be an essential part of your NT toolk it
Melanie de Grooth BANT AdministratorGeneral Manager
This comprehensive package costs pound40 with proceeds going to the ANH campaign fund and is available to practitioners and student practitioners only
Those practitioners who are going to be successful in this new environment will need to uniquely express themselves according to their qualifications and
experience A me too approach where everyone says the same things is not going to allow you to stand out from the crowd At the heart of this is an
understanding of the principles behind the rules and regulations as well as solutions allowing you to not fall foul of it Provided in the printed and video
outputs from our seminar are all the basics youll need to move confidently forward in this difficult and confusing regulatory climate and we will be
following up with more support in due course
As NT practitioners we are facing a maze of rules and regulations that will affect how we work in the future I therefore urge you all to purchase the must
have DVD from the recent excellent ANH training conference entitled Rules and Regulations in Clinical Practice Developing your Practice in Spite of the
EU Regulatory Juggernaut This is an extremely useful toolk it for your practice and will assist you in understanding these l egislative changes
Catherine Honeywell - Chair BANT Council
PURCHASE DOWNLOAD - wwwanh-europeorgrules-and-regulations-training-buy-download We also invite you to sign up for our regular
eAlerts wwwanh-europeorguserregister and to check out our practitioner pages - wwwanh-europeorgpractitioners
Thank you ANH-Intl
ANH-Intl Rules and Regulations DVD Now on Sale
BANT Page on Rules and Regulations If you have not already done so please make sure you access the presentations we have
provided on Rule and Regulations Affecting NT Practice and Understanding the Scope and
Definition for Medicinal Claims
An incredible amount of time and effort has gone into this project and we are sure that you will
now easily be able to navigate your way through the complicated array of rules and regulations
that impact on our practise of Nutritional Therapy
We would like to thank ANH-Intl and give credit to them for auditing and contributing the source
materials which BANT has interpreted and presented in this unique format The format and
presentation are the copyright of BANT and should not be reproduced without prior permission
We would also like to give a special thank you to Louise Carder who tirelessly gave of her time
and expertise to help BANT produce these slides ndash thank you Louise
You can access these slides at the following link wwwbantorgukbantjspmemberrulesRegulation faces
They have been designed for best use online You can of course print them out but you will then not be able to benefit from using the hyperlinks for
navigation Please take some time out of your busy schedules to carefully work and read through these slides This informati on is an essential part of
you Nutritional Therapy toolkit and will help you to be a better and more responsible practitioner
Understanding these Rules and Regulations will not only empower you as a practitioner but will
also demonstrate your level of commitment to your clients and the profession
From time to time we will update the content of the slides but will always let you know when this
has been done
IMPORTANT
After the renewals in October all full members will be emailed a copy of what you currently state
on you BANT profile under Special Interests and Further Information It will be your responsi-
bility to check the information is correct in relation to the ASA Rules and the Rules and
Regulations affecting NT practice Use this link to access the ARC Toolkit and FAQs on the
ASA rules wwwbantorgukbantjspmemberASARulesfaces
Page 10 of
FoodInfo Online Features 1 April 2011
httpwwwfoodsciencecentralcomfscixid16088
copy IFIS Publishing 2011 - All Rights Reserved
From pharm to fork in the nutrigenomic era is it food or medicine
Susan A McGinty and Dominic Man
London South Bank University 103 Borough Road London SE1 0AA
1 Introduction
The foodmedicine boundary has long been opaque with responsibility for medicines and food regulation coming under different European Commission
directorates This has led to a lack of integration at the EU level between food and medicine which has been further exacerbat ed by a lack of
harmonisation of implementation at Member State level of EU food law From 1 May the EU Traditional and Herbal Medicines Products Directive
(THMPD) comes fully into force and the elements of a perfect stormlsquo may be moving into place Manufacturers will no longer be able to supply
unlicensed herbal medicines to the public The European Medicines Agencylsquos (EMEA) has a database of medicinal herbs which includes inter
alia sage thyme garlic onion cinnamon pumpkin seed linseed juniper berry peppermint leaf and aniseed The UKlsquos Medicines and Healthcare
Products Regulatory Agency (MHRA) has published its own list of herbs and classifies them as medicinefoodcosmetic - also reflecting the problem of
the regulation of products and claims for cosmeceuticals From May 2011 ―it is the competence and responsibility of national authorities to decide on a
case by case basis whether a herbal product fulfils the definition of medicinal product A survey of the fundamental definitions clarifications by the
European Court of Justice (ECJ) and an examination of the European Councillsquos homeostasis model spotlights areas which may nee d to be reconciled if
the overall regulatory framework is capable of adapting to the era of systems biology and personalised medicinenutrition i ncluding dermagenetics
2 The devil in the detail the definitions
21 Food
Article 2 of EC 1782002 defines food including supplements as ―any substance or product whether processed partially processed or unprocessed
intended to be or reasonably expected to be ingested by humans This definition is straightforward but allows interpretation of reasonably expectedlsquo to
determine a medicinal product where dosagelsquo may be seen as a critical element ndash see later
22 Medicine bdquoform‟ and bdquofunction‟
Directive 200183EC of 6 November 2001 defined a medicine as either ―any substance or combination of substances presented for treating or
preventing disease in human beings or ―any substance or combination of substances which may be administered to human beings with a view to making
a diagnosis or to restoring correcting or modifying physiological balance in human beings This linked marketing activities and intention of consumption
to medicinal functionality In 2004 Directive 200427EC amended the definition of a medicine to ―any substance or combination of substances
presented as having properties for treating or preventing disease in human beings or any substance or combination of substances which may be used
in or administered to human beings either with a view to restoring correcting or modifying physiological functions by exerting a pharmacological
immunological or metabolic action or to making a medical diagnosis Article 22 of the 2004 Directive goes on to state ―In cases of doubt where
taking into account all its characteristics a product may fall within the definition of a medicinal productlsquo and within the definition of a product covered by
other Community legislation the provisions of this Directive shall apply
This definition had the technical effect of making all bioactive food components meet the medicinal standard by function if not by presentation and has
left Member State medicines regulators the EMEA and the European Commissionlsquos Directorate General Enterprise and Industry (DGEI) in the driving
seat as to determining product status and enforcement Nonetheless the ECJ ruled in C-31905 Commission of the European Communities v Federal
Republic of Germany of 15 November 2007 that the definition of a medicinal product by function should be interpreted restrictively since it was des igned
to cover only products whose pharmacological properties have been scientifically observed and not substances which while ha ving an effect on the
human body do not significantly affect the metabolism and thus do not strictly modify the way in which it functions
The formlsquo of a medicine versus a food supplement was also tested in C-31905 in which the Commission accused the Federal Republic of Germany of
breach of its obligations under Articles 28 and 30 of the EC Treaty (free movement of goods) by classifying a garlic preparat ion in capsule form as a
medicinal product The ECJ held that a capsule form was not of itself sufficient to decide whether a product was medicinal that the capsule form is not
exclusive to medicinal products and the product in question only contained natural garlic and could not have any additional e ffects (positive or negative)
compared to garlic in its natural state A medicinal product must have the function of preventing or treating disease beneficial effects for health in general
are not sufficient
The ECJ clarifications pose a fundamental problem for Member State medicines regulators consistently using formlsquo and functi onlsquo as theirbenchmark
standards Pillcapsuletincture forms regularity of consumption defined posology and ADME (absorption distribution metabolism and excretion) and
the accompanying claims have long been the determinants in borderline product adjudications
23 Prevention or disease-risk reduction
The EU has no definition of diseaselsquo in any of its regulatory instruments except for medically diagnosed conditions or using w ider public health
frameworks for measuring disease prevention in terms ofQuality of Life Years (QALYs) and Disability Adjusted Life Years (DALY s) for example It has not
From Pharm to Fork in the Nutrigenomic Era Is It Food or Medicine
BANT - the seal of excellence for nutrition health professionals
Page 11 of From Pharm to Fork in the Nutrigenomic Era Is It Food or Medicine- Cont
adopted a fully transparent and credible suite of biomarkers surrogate or end-markers to establish healthdisease status and bi ofunctionality In the UK
The Medicines Act 1968 (as amended) defines disease as something which ―includes any injury ailment or adverse condition whether of body or
mind The lack of a clear legal definition has been recognised by the ECJ where disease has been intrinsically linked to the definition of a medicinal
product The Court determined in C-36988 on whether eye lotion was a medicinal product or cosmetic (a cosmetic being external but being able to
protectlsquo or keep in good conditionlsquo) that on the basis of scientific knowledge ―it is for the national authorities to dete rmine whether products presented as
counter-acting certain conditions of sensations such as hunger heaviness in the legs tiredness or itching constitute a medic al product
The United States Food and Drug Administration (FDA) in its health claims legislation defines disease as
―Damage to an organ part or structure or system of the body such that it does not function properly (eg cardiovascular dis ease) or a state of health
leading to such dysfunctioning (eg hypertension) except that diseases resulting from essential nutrient deficiencies (eg scurvy pellagra) are not
included in this definition
Proposals for health claims legislation being framed by Food Standards Australia and New Zealand (FSANZ) include definitions for diseaselsquo and serious
diseaselsquo which distinguish in terms both of severity of condition and of level of claim
Disease an unhealthy condition characterised by clinically significant signs or symptoms
Serious disease or condition forms of disease conditions ailments or defects which are generally accepted to be beyond the ability of the
average consumer to evaluate accurately and to treat safely without regular supervision by a suitably qualified health care professional
Where disease-risk reduction relates to one of a number of factors in the aetiology of disease the concept of preventionlsquo itse lf poses a number
of difficulties as like diseaselsquo it is not clearly defined in law
Coppens et al 2001 survey use of preventionlsquo in relation to the first EU Medicines Directive 6565 where prevention has had a history of use in terms
of vaccination and infectious diseases Prevention is a word with an absolute indication and its use is clear and distinct in nature and includes some
statistical certainty nonetheless with chronic diseases there is an overlap where reduction of disease risk pertains to one factor sufficient to prevent the
occurrence likely to be based on epidemiological evidence from studies of population cohorts Coppens et al propose that prevention has three facets
a) Prevention of disease occurrence where
the disease is not (yet) present
the therapy can prevent the occurrence of the disease with substantial statistical certainty
b) Prevention of episodes of the disease where
the disease is present
the therapy decreases the number duration or severity of disease episodes with a substantial statistical certainty
c) Prevention of progression of the patientlsquos underlying disease where
the disease is present
the therapy has been shown to delay the progression of the disease with a substantial statistical certainty
At the other end of the spectrum treatlsquo denotes a purpose of action intention therefore becomes a key determinant in claim status Intention in
consumption is important for the enforcement of health claims where (average) consumer understanding is a factor Consumption of supplemental vitamin
D3 to support bone health or with a substantiated claim reduce the risk of osteoporosis comes under the food domain However consumption of
supplemental vitamin D3 for the purposes of immune-modulation would be medicinal
The principle of disease risk reduction (DRR) as distinct from prevention was incorporated into EU law in EC 19242006 on nutrition and health claims
on food (NHCR) which requires that all structurefunction and DRR claims on food including supplements must be preapproved by the EU Commission
and meet a standard of substantial scientific agreement While the DRR paradigm recognises that chronic disease conditions are the product of multiple
gene-environment influences it nonetheless still must be predicated on what diseaselsquo is in biological terms The EU-funded PASSCLAIM projec t was
tasked with establishing how health claims would be substantiated and to identify functional biomarkers or surrogate end-point markers for use in the
assessment process PASSCLAIM working groups produced reports on diet -related cardiovascular disease bone health and osteoporosis physical
performance and fitness mental state and performance body weight insulin sensitivity and diabetes diet -related cancer and gut health and
immunity At January 2011 the European Food Safety Authority (EFSA) charged with the process of assessing claims is yet to fully clarify its
assessment criteria
24 Functional foods food bioactives and nutraceuticals
While the EU regulates foods containing plant sterolsstanols there is no formal definition of functional foodlsquo The EU FUFOSE project used a working
definition of functional foods that ―affect beneficially one or more target functions in the body beyond adequate nutriti onal effects in a way that is
relevant to either an improved state of health and well -being andor reduction of risk of disease FUFOSE noted that a functional food can be a natural
food one to which a component has been added or removed where a component has been modified or its bioavailability modifie d or any combination or
multiples of all the possibilities Therefore functional foods in the EU must be foods with health claims as defined by the NHCR
BANT sponsors a 2 day seminar on cPNI on 8-9 of Sep 2011
organised by Bonusan under the auspices of the Natura Foundation
wwwbantorgukbantjspmemberpdfseminarsBONUSAN_CPNIpdf
Page 12 of
Although in 2006 the US FDA proposed that the term functional foodlsquo be regulated (21 Code of Federal Regulations Part 101 and Part 170)it still has no
formal definition of that or of nutraceuticallsquo Earlier in 2004 the US Department of Health and Human Services (DHHS) launch ed a consultation on a
proposed definition of bioactive food componentslsquo In its supplementary information to the proposal the DHHS stated that bioactives may have multiple
sites of action may interact with one or more dietary constituents and may act directly or indirectly to produce a functional outcome citing as examples
lycopene long-chain omega-3 fatty acids isoflavones sulphorophane and resveratrol Establishing a definition of a food bioactive was a first step
towards evaluating their significance in promoting health and disease prevention then guiding research priorities and science-based information to help
guide public health policylsquo The definition proposed was
―Bioactive food components are constituents in foods or dietary supplements other than those needed to meet basic human nutr itional needs that are
responsible for changes in health status
As of early 2011 the work on defining food bioactives has not progressed Respondents to the 2004 consultation made strong representations about a
definition of bioactivity which excluded nutrients arguably the most important bioactive category of food components Seventeen written responses were
received in response to the consultation a number of which proposed alternate definitions Common themes in those alternate definitions include use of
the term physiologically activelsquo or physiological benefitlsquo reference to structure functionlsquo and disease -risk reductionlsquo and (ILSI North America) ―as
measured through utilizing appropriate methodology and biomarkers
In January 2011 the US National Academies of Science publishedPerspectives on Biomarker and Surrogate Endpoint Evaluation with recommendations
for establishing a framework for harmonising biomarker use across all areas including drugs and foods
3 Dosage and the homeostasis model what is lsquonormalrsquo
The ECJ Judgement C-8807 of 5 March 2009 determined that substances ―which while having an effect on the human body do not significantly
affect the metabolism and thus do not strictly modify the way in which it functions should not be classified as medicinal products by function
(see Commission v Germany paragraph 60 and Hecht-Pharma paragraph 41) Dosage therefore is a key criterion in determining food from medicine
of botanicals and from May 2011 is likely to be used by national authorities in enforcement This complements the homeostasis model produced by
the European Council in 2008 to distinguish foods and medicinal products The model incorporates the notion of intended use of the product and the
nature of the induced effect food induces the physiological effects characterised by maintainsupportoptimiselsquo and medicine induces the physiological
functions characterised by restorecorrectmodifylsquo It is a self-contained integrated approach but is predicated on the definition of homeostasis being
defined as ldquothe status of a person whose physiological parameters function within the limits considered as normal But while normal
physiological parameters may be defined by (sometimes quite large) reference ranges nutritional prerequisites or dietary ref erence intakes are not fully
harmonised throughout the EU nor do they take account of ancestral or inter-individual variation which characterise different sub-populations The lack
of harmonisation means some EU Member States regard supra -RDA vitamin and mineral supplements as medicines where others including the UK
have taken a more liberal approach The EU-funded EurRECA network of excellence is tasked with developing methodologies and recommendations to
standardise the process of setting pan-EU micronutrient recommendations This will inform progress in setting maximum permitted levels of vitamins and
minerals in food supplements However the extent of inter-individuality may prove problematic in 2007 the UK Committee on Toxicity in its working
group report on variability and uncertainty stated that for vitamins and minerals ―variability in the response of individuals has the potential to result in a
situation which a given level of exposure could be essential for some but toxic for others
What is normallsquo in dietary requirements underpins the basis on which both medicinal and health claims are evaluated namely that a healthy balanced
diet is generally able to provide all micronutrient requirements by normal healthy individuals for health maintenance Two signi ficant sub-populations
however threaten to undermine that approach In the UK the Healthy Start programme administered by statutory instrument by the Department
of Health and National Health Service provides two bespoke Healthy Start-branded vitamin supplements for low income beneficiaries for women free
during pregnancy and up until their baby is one year old and for children from 6 months of age until their fourth birthday Non-beneficiaries can
purchase Healthy Start-branded supplements at low cost from health clinics Health professionals are encouraged to make sure that mothers and
children ―get two important vitamins that they may not be getting in adequate quantities ndash even from a healthy balanced diet These are vitamins A and D
for children and vitamin D and folic acid for women While it is prohibited under the NHCR to claim that a healthy balanced diet cannot in general
provide all nutrients needed there is no such prohibition under medicinal law and the Healthy Startvitamins are marketed under a UK medicines
licence [PL015110003] This conflict adds to the problems of robust implementation of the NHCR which is already stymied by the lack of
A credible transparent system of scientific assessment
An agreed nutrient profiling system
A harmonised pan-EU characterisation of a healthy balanced diet
4 Going forward
Added to the woes of the NHCR looms a new era of personal genomicmetabolomic profiling and personalised nutrition in the for m of P4
medicinelsquo (personalised predictive preventive participatory) In its essence nutrigenomicslsquo incorporates two aspects
The effect of food components on the genome and epigenome
The extent of ancestral and individual variation
If disease can be classified at the molecular level what effect does this have on the meaning of homeostasislsquo and medicine lsquo These key terms need full
and comprehensive definition both in biology and law so that the food -medicine continuum is fully resolved and the foundation is laid for the successful
application of both personalised medicine and personalised nutrition Innovation and continued investment in wellness products by the food industry
depend on a clear consistent and transparent system of claims assessment
From Pharm to Fork in the Nutrigenomic Era Is It Food or Medicine- Cont
Page 13 of 13 Topic of the Month - Cardiovascular Health
Nutri Link Clinical Education - wwwnleducationcouk
They believe in supporting the health care professionals who count on them for
effective nutritional solutions Their team of CAM-leading experts are committed to
providing you with the latest unbiased scientific research and clinical support plus a
vast array of continuing education opportunitieshellipbecause as practitioners they
understand that knowledge is the key to positive patient results
FM Town - wwwfmtowncom
Its all about relevancy Being in a 100 Functional Medicine environment will give
you an opportunity to get direct and immediate access to all the information that is
most relevant to you FMTown is private and highly relevant in its scope of focus
Get connected to an amazing online resource which can grow with you and support
your Functional Medicine Journey
Institute for Functional Medicine - wwwfunctionalmedicineorg
IFM Membership is your gateway to a community of like-minded clinicians and
researchers It is primarily aimed at clinicians and scientists whose interest in
functional medicine is deeply connected to examining the emerging research
attending CME courses discussing issues and patients with colleagues and so
forth Membership helps to build a network of practitioners from many disciplines
who are using and studying functional medicine every day
Food Science Central - wwwfoodsciencecentralcom
Food Science Central is the home of IFIS Publishing on the web Here you can
learn about products and services and access FREE articles on many topics in food
science food technology and nutrition
Monthly ArticlesPapers
ANXIETY AND CARDIOVASCULAR RISK REVIEW OF
EPIDEMIOLOGICAL AND CLINICAL EVIDENCE
O Olafiranye G Jean-Louis F Zizi J Nunes and MT Vincent
wwwncbinlmnihgovpmcarticlesPMC3150179pdfnihms-
301210pdf
POST-TRAUMATIC STRESS DISORDER AND
CARDIOVASCULAR DISEASE
Steven S Coughlin
wwwncbinlmnihgovpmcarticlesPMC3141329pdfTOCMJ-5-
164pdf
STUDIES OF GENE VARIANTS RELATED TO INFLAMMATION
OXIDATIVE STRESS DYSLIPIDEMIA AND OBESITY
IMPLICATIONS FOR A NUTRIGENETIC APPROACH
Maira Ladeia R Curti Patrıcia Jacob Maria Carolina Borges
Marcelo Macedo Rogero and Sandra Roberta G Ferreir
wwwncbinlmnihgovpmcarticlesPMC3136190pdfJOBES2011-
497401pdf
EFFECT OF AN OFFICE WORKSITE-BASED YOGA
PROGRAM ON HEART RATE VARIABILITY A RANDOMIZED
CONTROLLED TRIAL
Birinder S Cheema Paul W Marshall Dennis Chang Ben
Colagiuri and Bianca Machliss
wwwncbinlmnihgovpmcarticlesPMC3154869pdf1471-2458-
11-578pdf
CARDIOVASCULAR COMPLICATIONS IN CKD PATIENTS
ROLE OF OXIDATIVE STRESS
Elvira O Gosmanova and Ngoc-Anh Le
wwwncbinlmnihgovpmcarticlesPMC3022166pdfCRP2011-
156326pdf
TARGETING STEM CELL NICHES AND TRAFFICKING FOR
CARDIOVASCULAR THERAPY
Nicolle Kraumlnkel Gaia Spinetti Silvia Amadesi and Paolo Madeddu
wwwncbinlmnihgovpmcarticlesPMC3017934pdfukmss-
33677pdf
INTERACTION OF SLEEP QUALITY AND PSYCHOS OCIAL
STRESS ON OBESITY IN AFRICAN AMERICANS THE
CARDIOVASCULAR HEALTH EPIDEMIOLOGY STUDY (CHES)
Aurelian Bidulescu Rebecca Din-Dzietham Dorothy L Coverson
Zhimin Chen Yuan-Xiang Meng Sarah G Buxbaum Gary H Gib-
bons Verna L Welch
wwwbiomedcentralcomcontentpdf1471-2458-10-581pdf
PATHOPHYSIOLOGIC MECHANISMS LINKING IMPAIRED
CARDIOVASCULAR HEALTH AND NEUROLOGIC
DYSFUNCTION THE YEAR IN REVIEW
Ki E Park Carl J Pepine
wwwccjmorgcontent77Suppl_3S40fullpdf+html
BERRIES EMERGING IMPACT ON CARDIOVASCULAR
HEALTH
Arpita Basu Michael Rhone and Timothy J Lyons
wwwncbinlmnihgovpmcarticlesPMC3068482pdf
nihms171310pdf
THE PLACENTA IS A PROGRAMMING AGENT FOR
CARDIOVASCULAR DISEASE
KL Thornburg PF OlsquoTierney and S Louey
wwwncbinlmnihgovpmcarticlesPMC2846089pdf
nihms177889pdf
Useful Websites
BANT - the seal of excellence for nutrition health professionals
Page 9 of 13
On Saturday 21st May the Alliance for Natural Health International supported by the GNC and BANT held its first
training and education day for practitioners helping them through the minefield of legislative requirements facing the
natural health sector The conference was well attended by over 240 practitioners whose feedback confirms that the
information was critical to their ability to manage their practices compliantly in the future and was summed up succinctly
by one of the delegates
I think the conference today really hits the mark in terms of tak ing a very complex set of regulations and putting it into a
digestible form for practitioners laying out not only the regulations but also the practical side of how we live within thi s
new regulatory environment
Kathleen Devereaux
We understand that many were not able to attend the conference in person but as promised we have now produced a full download of the daylsquos
sessions in video format which includes the pre-reading pack sent to delegates a comprehensive delegate volume of notes covering the days event and
an extensive reference list of supporting documentation We know its been a few weeks since the event but it takes time to p rofessionally edit the raw
footage so we hope that youll now feel part of it as if you had actually been there with us
Having attended the ANH conference I was able to get a real picture about the Rules and Regulations NTs are up against Understanding this legislation
and how it affects NT practice is an important part of being a responsible NT We need to learn the language of these new rul es and in doing so feel
empowered and in control of our work environment This conference DVD and info should be an essential part of your NT toolk it
Melanie de Grooth BANT AdministratorGeneral Manager
This comprehensive package costs pound40 with proceeds going to the ANH campaign fund and is available to practitioners and student practitioners only
Those practitioners who are going to be successful in this new environment will need to uniquely express themselves according to their qualifications and
experience A me too approach where everyone says the same things is not going to allow you to stand out from the crowd At the heart of this is an
understanding of the principles behind the rules and regulations as well as solutions allowing you to not fall foul of it Provided in the printed and video
outputs from our seminar are all the basics youll need to move confidently forward in this difficult and confusing regulatory climate and we will be
following up with more support in due course
As NT practitioners we are facing a maze of rules and regulations that will affect how we work in the future I therefore urge you all to purchase the must
have DVD from the recent excellent ANH training conference entitled Rules and Regulations in Clinical Practice Developing your Practice in Spite of the
EU Regulatory Juggernaut This is an extremely useful toolk it for your practice and will assist you in understanding these l egislative changes
Catherine Honeywell - Chair BANT Council
PURCHASE DOWNLOAD - wwwanh-europeorgrules-and-regulations-training-buy-download We also invite you to sign up for our regular
eAlerts wwwanh-europeorguserregister and to check out our practitioner pages - wwwanh-europeorgpractitioners
Thank you ANH-Intl
ANH-Intl Rules and Regulations DVD Now on Sale
BANT Page on Rules and Regulations If you have not already done so please make sure you access the presentations we have
provided on Rule and Regulations Affecting NT Practice and Understanding the Scope and
Definition for Medicinal Claims
An incredible amount of time and effort has gone into this project and we are sure that you will
now easily be able to navigate your way through the complicated array of rules and regulations
that impact on our practise of Nutritional Therapy
We would like to thank ANH-Intl and give credit to them for auditing and contributing the source
materials which BANT has interpreted and presented in this unique format The format and
presentation are the copyright of BANT and should not be reproduced without prior permission
We would also like to give a special thank you to Louise Carder who tirelessly gave of her time
and expertise to help BANT produce these slides ndash thank you Louise
You can access these slides at the following link wwwbantorgukbantjspmemberrulesRegulation faces
They have been designed for best use online You can of course print them out but you will then not be able to benefit from using the hyperlinks for
navigation Please take some time out of your busy schedules to carefully work and read through these slides This informati on is an essential part of
you Nutritional Therapy toolkit and will help you to be a better and more responsible practitioner
Understanding these Rules and Regulations will not only empower you as a practitioner but will
also demonstrate your level of commitment to your clients and the profession
From time to time we will update the content of the slides but will always let you know when this
has been done
IMPORTANT
After the renewals in October all full members will be emailed a copy of what you currently state
on you BANT profile under Special Interests and Further Information It will be your responsi-
bility to check the information is correct in relation to the ASA Rules and the Rules and
Regulations affecting NT practice Use this link to access the ARC Toolkit and FAQs on the
ASA rules wwwbantorgukbantjspmemberASARulesfaces
Page 10 of
FoodInfo Online Features 1 April 2011
httpwwwfoodsciencecentralcomfscixid16088
copy IFIS Publishing 2011 - All Rights Reserved
From pharm to fork in the nutrigenomic era is it food or medicine
Susan A McGinty and Dominic Man
London South Bank University 103 Borough Road London SE1 0AA
1 Introduction
The foodmedicine boundary has long been opaque with responsibility for medicines and food regulation coming under different European Commission
directorates This has led to a lack of integration at the EU level between food and medicine which has been further exacerbat ed by a lack of
harmonisation of implementation at Member State level of EU food law From 1 May the EU Traditional and Herbal Medicines Products Directive
(THMPD) comes fully into force and the elements of a perfect stormlsquo may be moving into place Manufacturers will no longer be able to supply
unlicensed herbal medicines to the public The European Medicines Agencylsquos (EMEA) has a database of medicinal herbs which includes inter
alia sage thyme garlic onion cinnamon pumpkin seed linseed juniper berry peppermint leaf and aniseed The UKlsquos Medicines and Healthcare
Products Regulatory Agency (MHRA) has published its own list of herbs and classifies them as medicinefoodcosmetic - also reflecting the problem of
the regulation of products and claims for cosmeceuticals From May 2011 ―it is the competence and responsibility of national authorities to decide on a
case by case basis whether a herbal product fulfils the definition of medicinal product A survey of the fundamental definitions clarifications by the
European Court of Justice (ECJ) and an examination of the European Councillsquos homeostasis model spotlights areas which may nee d to be reconciled if
the overall regulatory framework is capable of adapting to the era of systems biology and personalised medicinenutrition i ncluding dermagenetics
2 The devil in the detail the definitions
21 Food
Article 2 of EC 1782002 defines food including supplements as ―any substance or product whether processed partially processed or unprocessed
intended to be or reasonably expected to be ingested by humans This definition is straightforward but allows interpretation of reasonably expectedlsquo to
determine a medicinal product where dosagelsquo may be seen as a critical element ndash see later
22 Medicine bdquoform‟ and bdquofunction‟
Directive 200183EC of 6 November 2001 defined a medicine as either ―any substance or combination of substances presented for treating or
preventing disease in human beings or ―any substance or combination of substances which may be administered to human beings with a view to making
a diagnosis or to restoring correcting or modifying physiological balance in human beings This linked marketing activities and intention of consumption
to medicinal functionality In 2004 Directive 200427EC amended the definition of a medicine to ―any substance or combination of substances
presented as having properties for treating or preventing disease in human beings or any substance or combination of substances which may be used
in or administered to human beings either with a view to restoring correcting or modifying physiological functions by exerting a pharmacological
immunological or metabolic action or to making a medical diagnosis Article 22 of the 2004 Directive goes on to state ―In cases of doubt where
taking into account all its characteristics a product may fall within the definition of a medicinal productlsquo and within the definition of a product covered by
other Community legislation the provisions of this Directive shall apply
This definition had the technical effect of making all bioactive food components meet the medicinal standard by function if not by presentation and has
left Member State medicines regulators the EMEA and the European Commissionlsquos Directorate General Enterprise and Industry (DGEI) in the driving
seat as to determining product status and enforcement Nonetheless the ECJ ruled in C-31905 Commission of the European Communities v Federal
Republic of Germany of 15 November 2007 that the definition of a medicinal product by function should be interpreted restrictively since it was des igned
to cover only products whose pharmacological properties have been scientifically observed and not substances which while ha ving an effect on the
human body do not significantly affect the metabolism and thus do not strictly modify the way in which it functions
The formlsquo of a medicine versus a food supplement was also tested in C-31905 in which the Commission accused the Federal Republic of Germany of
breach of its obligations under Articles 28 and 30 of the EC Treaty (free movement of goods) by classifying a garlic preparat ion in capsule form as a
medicinal product The ECJ held that a capsule form was not of itself sufficient to decide whether a product was medicinal that the capsule form is not
exclusive to medicinal products and the product in question only contained natural garlic and could not have any additional e ffects (positive or negative)
compared to garlic in its natural state A medicinal product must have the function of preventing or treating disease beneficial effects for health in general
are not sufficient
The ECJ clarifications pose a fundamental problem for Member State medicines regulators consistently using formlsquo and functi onlsquo as theirbenchmark
standards Pillcapsuletincture forms regularity of consumption defined posology and ADME (absorption distribution metabolism and excretion) and
the accompanying claims have long been the determinants in borderline product adjudications
23 Prevention or disease-risk reduction
The EU has no definition of diseaselsquo in any of its regulatory instruments except for medically diagnosed conditions or using w ider public health
frameworks for measuring disease prevention in terms ofQuality of Life Years (QALYs) and Disability Adjusted Life Years (DALY s) for example It has not
From Pharm to Fork in the Nutrigenomic Era Is It Food or Medicine
BANT - the seal of excellence for nutrition health professionals
Page 11 of From Pharm to Fork in the Nutrigenomic Era Is It Food or Medicine- Cont
adopted a fully transparent and credible suite of biomarkers surrogate or end-markers to establish healthdisease status and bi ofunctionality In the UK
The Medicines Act 1968 (as amended) defines disease as something which ―includes any injury ailment or adverse condition whether of body or
mind The lack of a clear legal definition has been recognised by the ECJ where disease has been intrinsically linked to the definition of a medicinal
product The Court determined in C-36988 on whether eye lotion was a medicinal product or cosmetic (a cosmetic being external but being able to
protectlsquo or keep in good conditionlsquo) that on the basis of scientific knowledge ―it is for the national authorities to dete rmine whether products presented as
counter-acting certain conditions of sensations such as hunger heaviness in the legs tiredness or itching constitute a medic al product
The United States Food and Drug Administration (FDA) in its health claims legislation defines disease as
―Damage to an organ part or structure or system of the body such that it does not function properly (eg cardiovascular dis ease) or a state of health
leading to such dysfunctioning (eg hypertension) except that diseases resulting from essential nutrient deficiencies (eg scurvy pellagra) are not
included in this definition
Proposals for health claims legislation being framed by Food Standards Australia and New Zealand (FSANZ) include definitions for diseaselsquo and serious
diseaselsquo which distinguish in terms both of severity of condition and of level of claim
Disease an unhealthy condition characterised by clinically significant signs or symptoms
Serious disease or condition forms of disease conditions ailments or defects which are generally accepted to be beyond the ability of the
average consumer to evaluate accurately and to treat safely without regular supervision by a suitably qualified health care professional
Where disease-risk reduction relates to one of a number of factors in the aetiology of disease the concept of preventionlsquo itse lf poses a number
of difficulties as like diseaselsquo it is not clearly defined in law
Coppens et al 2001 survey use of preventionlsquo in relation to the first EU Medicines Directive 6565 where prevention has had a history of use in terms
of vaccination and infectious diseases Prevention is a word with an absolute indication and its use is clear and distinct in nature and includes some
statistical certainty nonetheless with chronic diseases there is an overlap where reduction of disease risk pertains to one factor sufficient to prevent the
occurrence likely to be based on epidemiological evidence from studies of population cohorts Coppens et al propose that prevention has three facets
a) Prevention of disease occurrence where
the disease is not (yet) present
the therapy can prevent the occurrence of the disease with substantial statistical certainty
b) Prevention of episodes of the disease where
the disease is present
the therapy decreases the number duration or severity of disease episodes with a substantial statistical certainty
c) Prevention of progression of the patientlsquos underlying disease where
the disease is present
the therapy has been shown to delay the progression of the disease with a substantial statistical certainty
At the other end of the spectrum treatlsquo denotes a purpose of action intention therefore becomes a key determinant in claim status Intention in
consumption is important for the enforcement of health claims where (average) consumer understanding is a factor Consumption of supplemental vitamin
D3 to support bone health or with a substantiated claim reduce the risk of osteoporosis comes under the food domain However consumption of
supplemental vitamin D3 for the purposes of immune-modulation would be medicinal
The principle of disease risk reduction (DRR) as distinct from prevention was incorporated into EU law in EC 19242006 on nutrition and health claims
on food (NHCR) which requires that all structurefunction and DRR claims on food including supplements must be preapproved by the EU Commission
and meet a standard of substantial scientific agreement While the DRR paradigm recognises that chronic disease conditions are the product of multiple
gene-environment influences it nonetheless still must be predicated on what diseaselsquo is in biological terms The EU-funded PASSCLAIM projec t was
tasked with establishing how health claims would be substantiated and to identify functional biomarkers or surrogate end-point markers for use in the
assessment process PASSCLAIM working groups produced reports on diet -related cardiovascular disease bone health and osteoporosis physical
performance and fitness mental state and performance body weight insulin sensitivity and diabetes diet -related cancer and gut health and
immunity At January 2011 the European Food Safety Authority (EFSA) charged with the process of assessing claims is yet to fully clarify its
assessment criteria
24 Functional foods food bioactives and nutraceuticals
While the EU regulates foods containing plant sterolsstanols there is no formal definition of functional foodlsquo The EU FUFOSE project used a working
definition of functional foods that ―affect beneficially one or more target functions in the body beyond adequate nutriti onal effects in a way that is
relevant to either an improved state of health and well -being andor reduction of risk of disease FUFOSE noted that a functional food can be a natural
food one to which a component has been added or removed where a component has been modified or its bioavailability modifie d or any combination or
multiples of all the possibilities Therefore functional foods in the EU must be foods with health claims as defined by the NHCR
BANT sponsors a 2 day seminar on cPNI on 8-9 of Sep 2011
organised by Bonusan under the auspices of the Natura Foundation
wwwbantorgukbantjspmemberpdfseminarsBONUSAN_CPNIpdf
Page 12 of
Although in 2006 the US FDA proposed that the term functional foodlsquo be regulated (21 Code of Federal Regulations Part 101 and Part 170)it still has no
formal definition of that or of nutraceuticallsquo Earlier in 2004 the US Department of Health and Human Services (DHHS) launch ed a consultation on a
proposed definition of bioactive food componentslsquo In its supplementary information to the proposal the DHHS stated that bioactives may have multiple
sites of action may interact with one or more dietary constituents and may act directly or indirectly to produce a functional outcome citing as examples
lycopene long-chain omega-3 fatty acids isoflavones sulphorophane and resveratrol Establishing a definition of a food bioactive was a first step
towards evaluating their significance in promoting health and disease prevention then guiding research priorities and science-based information to help
guide public health policylsquo The definition proposed was
―Bioactive food components are constituents in foods or dietary supplements other than those needed to meet basic human nutr itional needs that are
responsible for changes in health status
As of early 2011 the work on defining food bioactives has not progressed Respondents to the 2004 consultation made strong representations about a
definition of bioactivity which excluded nutrients arguably the most important bioactive category of food components Seventeen written responses were
received in response to the consultation a number of which proposed alternate definitions Common themes in those alternate definitions include use of
the term physiologically activelsquo or physiological benefitlsquo reference to structure functionlsquo and disease -risk reductionlsquo and (ILSI North America) ―as
measured through utilizing appropriate methodology and biomarkers
In January 2011 the US National Academies of Science publishedPerspectives on Biomarker and Surrogate Endpoint Evaluation with recommendations
for establishing a framework for harmonising biomarker use across all areas including drugs and foods
3 Dosage and the homeostasis model what is lsquonormalrsquo
The ECJ Judgement C-8807 of 5 March 2009 determined that substances ―which while having an effect on the human body do not significantly
affect the metabolism and thus do not strictly modify the way in which it functions should not be classified as medicinal products by function
(see Commission v Germany paragraph 60 and Hecht-Pharma paragraph 41) Dosage therefore is a key criterion in determining food from medicine
of botanicals and from May 2011 is likely to be used by national authorities in enforcement This complements the homeostasis model produced by
the European Council in 2008 to distinguish foods and medicinal products The model incorporates the notion of intended use of the product and the
nature of the induced effect food induces the physiological effects characterised by maintainsupportoptimiselsquo and medicine induces the physiological
functions characterised by restorecorrectmodifylsquo It is a self-contained integrated approach but is predicated on the definition of homeostasis being
defined as ldquothe status of a person whose physiological parameters function within the limits considered as normal But while normal
physiological parameters may be defined by (sometimes quite large) reference ranges nutritional prerequisites or dietary ref erence intakes are not fully
harmonised throughout the EU nor do they take account of ancestral or inter-individual variation which characterise different sub-populations The lack
of harmonisation means some EU Member States regard supra -RDA vitamin and mineral supplements as medicines where others including the UK
have taken a more liberal approach The EU-funded EurRECA network of excellence is tasked with developing methodologies and recommendations to
standardise the process of setting pan-EU micronutrient recommendations This will inform progress in setting maximum permitted levels of vitamins and
minerals in food supplements However the extent of inter-individuality may prove problematic in 2007 the UK Committee on Toxicity in its working
group report on variability and uncertainty stated that for vitamins and minerals ―variability in the response of individuals has the potential to result in a
situation which a given level of exposure could be essential for some but toxic for others
What is normallsquo in dietary requirements underpins the basis on which both medicinal and health claims are evaluated namely that a healthy balanced
diet is generally able to provide all micronutrient requirements by normal healthy individuals for health maintenance Two signi ficant sub-populations
however threaten to undermine that approach In the UK the Healthy Start programme administered by statutory instrument by the Department
of Health and National Health Service provides two bespoke Healthy Start-branded vitamin supplements for low income beneficiaries for women free
during pregnancy and up until their baby is one year old and for children from 6 months of age until their fourth birthday Non-beneficiaries can
purchase Healthy Start-branded supplements at low cost from health clinics Health professionals are encouraged to make sure that mothers and
children ―get two important vitamins that they may not be getting in adequate quantities ndash even from a healthy balanced diet These are vitamins A and D
for children and vitamin D and folic acid for women While it is prohibited under the NHCR to claim that a healthy balanced diet cannot in general
provide all nutrients needed there is no such prohibition under medicinal law and the Healthy Startvitamins are marketed under a UK medicines
licence [PL015110003] This conflict adds to the problems of robust implementation of the NHCR which is already stymied by the lack of
A credible transparent system of scientific assessment
An agreed nutrient profiling system
A harmonised pan-EU characterisation of a healthy balanced diet
4 Going forward
Added to the woes of the NHCR looms a new era of personal genomicmetabolomic profiling and personalised nutrition in the for m of P4
medicinelsquo (personalised predictive preventive participatory) In its essence nutrigenomicslsquo incorporates two aspects
The effect of food components on the genome and epigenome
The extent of ancestral and individual variation
If disease can be classified at the molecular level what effect does this have on the meaning of homeostasislsquo and medicine lsquo These key terms need full
and comprehensive definition both in biology and law so that the food -medicine continuum is fully resolved and the foundation is laid for the successful
application of both personalised medicine and personalised nutrition Innovation and continued investment in wellness products by the food industry
depend on a clear consistent and transparent system of claims assessment
From Pharm to Fork in the Nutrigenomic Era Is It Food or Medicine- Cont
Page 13 of 13 Topic of the Month - Cardiovascular Health
Nutri Link Clinical Education - wwwnleducationcouk
They believe in supporting the health care professionals who count on them for
effective nutritional solutions Their team of CAM-leading experts are committed to
providing you with the latest unbiased scientific research and clinical support plus a
vast array of continuing education opportunitieshellipbecause as practitioners they
understand that knowledge is the key to positive patient results
FM Town - wwwfmtowncom
Its all about relevancy Being in a 100 Functional Medicine environment will give
you an opportunity to get direct and immediate access to all the information that is
most relevant to you FMTown is private and highly relevant in its scope of focus
Get connected to an amazing online resource which can grow with you and support
your Functional Medicine Journey
Institute for Functional Medicine - wwwfunctionalmedicineorg
IFM Membership is your gateway to a community of like-minded clinicians and
researchers It is primarily aimed at clinicians and scientists whose interest in
functional medicine is deeply connected to examining the emerging research
attending CME courses discussing issues and patients with colleagues and so
forth Membership helps to build a network of practitioners from many disciplines
who are using and studying functional medicine every day
Food Science Central - wwwfoodsciencecentralcom
Food Science Central is the home of IFIS Publishing on the web Here you can
learn about products and services and access FREE articles on many topics in food
science food technology and nutrition
Monthly ArticlesPapers
ANXIETY AND CARDIOVASCULAR RISK REVIEW OF
EPIDEMIOLOGICAL AND CLINICAL EVIDENCE
O Olafiranye G Jean-Louis F Zizi J Nunes and MT Vincent
wwwncbinlmnihgovpmcarticlesPMC3150179pdfnihms-
301210pdf
POST-TRAUMATIC STRESS DISORDER AND
CARDIOVASCULAR DISEASE
Steven S Coughlin
wwwncbinlmnihgovpmcarticlesPMC3141329pdfTOCMJ-5-
164pdf
STUDIES OF GENE VARIANTS RELATED TO INFLAMMATION
OXIDATIVE STRESS DYSLIPIDEMIA AND OBESITY
IMPLICATIONS FOR A NUTRIGENETIC APPROACH
Maira Ladeia R Curti Patrıcia Jacob Maria Carolina Borges
Marcelo Macedo Rogero and Sandra Roberta G Ferreir
wwwncbinlmnihgovpmcarticlesPMC3136190pdfJOBES2011-
497401pdf
EFFECT OF AN OFFICE WORKSITE-BASED YOGA
PROGRAM ON HEART RATE VARIABILITY A RANDOMIZED
CONTROLLED TRIAL
Birinder S Cheema Paul W Marshall Dennis Chang Ben
Colagiuri and Bianca Machliss
wwwncbinlmnihgovpmcarticlesPMC3154869pdf1471-2458-
11-578pdf
CARDIOVASCULAR COMPLICATIONS IN CKD PATIENTS
ROLE OF OXIDATIVE STRESS
Elvira O Gosmanova and Ngoc-Anh Le
wwwncbinlmnihgovpmcarticlesPMC3022166pdfCRP2011-
156326pdf
TARGETING STEM CELL NICHES AND TRAFFICKING FOR
CARDIOVASCULAR THERAPY
Nicolle Kraumlnkel Gaia Spinetti Silvia Amadesi and Paolo Madeddu
wwwncbinlmnihgovpmcarticlesPMC3017934pdfukmss-
33677pdf
INTERACTION OF SLEEP QUALITY AND PSYCHOS OCIAL
STRESS ON OBESITY IN AFRICAN AMERICANS THE
CARDIOVASCULAR HEALTH EPIDEMIOLOGY STUDY (CHES)
Aurelian Bidulescu Rebecca Din-Dzietham Dorothy L Coverson
Zhimin Chen Yuan-Xiang Meng Sarah G Buxbaum Gary H Gib-
bons Verna L Welch
wwwbiomedcentralcomcontentpdf1471-2458-10-581pdf
PATHOPHYSIOLOGIC MECHANISMS LINKING IMPAIRED
CARDIOVASCULAR HEALTH AND NEUROLOGIC
DYSFUNCTION THE YEAR IN REVIEW
Ki E Park Carl J Pepine
wwwccjmorgcontent77Suppl_3S40fullpdf+html
BERRIES EMERGING IMPACT ON CARDIOVASCULAR
HEALTH
Arpita Basu Michael Rhone and Timothy J Lyons
wwwncbinlmnihgovpmcarticlesPMC3068482pdf
nihms171310pdf
THE PLACENTA IS A PROGRAMMING AGENT FOR
CARDIOVASCULAR DISEASE
KL Thornburg PF OlsquoTierney and S Louey
wwwncbinlmnihgovpmcarticlesPMC2846089pdf
nihms177889pdf
Useful Websites
BANT - the seal of excellence for nutrition health professionals
Page 10 of
FoodInfo Online Features 1 April 2011
httpwwwfoodsciencecentralcomfscixid16088
copy IFIS Publishing 2011 - All Rights Reserved
From pharm to fork in the nutrigenomic era is it food or medicine
Susan A McGinty and Dominic Man
London South Bank University 103 Borough Road London SE1 0AA
1 Introduction
The foodmedicine boundary has long been opaque with responsibility for medicines and food regulation coming under different European Commission
directorates This has led to a lack of integration at the EU level between food and medicine which has been further exacerbat ed by a lack of
harmonisation of implementation at Member State level of EU food law From 1 May the EU Traditional and Herbal Medicines Products Directive
(THMPD) comes fully into force and the elements of a perfect stormlsquo may be moving into place Manufacturers will no longer be able to supply
unlicensed herbal medicines to the public The European Medicines Agencylsquos (EMEA) has a database of medicinal herbs which includes inter
alia sage thyme garlic onion cinnamon pumpkin seed linseed juniper berry peppermint leaf and aniseed The UKlsquos Medicines and Healthcare
Products Regulatory Agency (MHRA) has published its own list of herbs and classifies them as medicinefoodcosmetic - also reflecting the problem of
the regulation of products and claims for cosmeceuticals From May 2011 ―it is the competence and responsibility of national authorities to decide on a
case by case basis whether a herbal product fulfils the definition of medicinal product A survey of the fundamental definitions clarifications by the
European Court of Justice (ECJ) and an examination of the European Councillsquos homeostasis model spotlights areas which may nee d to be reconciled if
the overall regulatory framework is capable of adapting to the era of systems biology and personalised medicinenutrition i ncluding dermagenetics
2 The devil in the detail the definitions
21 Food
Article 2 of EC 1782002 defines food including supplements as ―any substance or product whether processed partially processed or unprocessed
intended to be or reasonably expected to be ingested by humans This definition is straightforward but allows interpretation of reasonably expectedlsquo to
determine a medicinal product where dosagelsquo may be seen as a critical element ndash see later
22 Medicine bdquoform‟ and bdquofunction‟
Directive 200183EC of 6 November 2001 defined a medicine as either ―any substance or combination of substances presented for treating or
preventing disease in human beings or ―any substance or combination of substances which may be administered to human beings with a view to making
a diagnosis or to restoring correcting or modifying physiological balance in human beings This linked marketing activities and intention of consumption
to medicinal functionality In 2004 Directive 200427EC amended the definition of a medicine to ―any substance or combination of substances
presented as having properties for treating or preventing disease in human beings or any substance or combination of substances which may be used
in or administered to human beings either with a view to restoring correcting or modifying physiological functions by exerting a pharmacological
immunological or metabolic action or to making a medical diagnosis Article 22 of the 2004 Directive goes on to state ―In cases of doubt where
taking into account all its characteristics a product may fall within the definition of a medicinal productlsquo and within the definition of a product covered by
other Community legislation the provisions of this Directive shall apply
This definition had the technical effect of making all bioactive food components meet the medicinal standard by function if not by presentation and has
left Member State medicines regulators the EMEA and the European Commissionlsquos Directorate General Enterprise and Industry (DGEI) in the driving
seat as to determining product status and enforcement Nonetheless the ECJ ruled in C-31905 Commission of the European Communities v Federal
Republic of Germany of 15 November 2007 that the definition of a medicinal product by function should be interpreted restrictively since it was des igned
to cover only products whose pharmacological properties have been scientifically observed and not substances which while ha ving an effect on the
human body do not significantly affect the metabolism and thus do not strictly modify the way in which it functions
The formlsquo of a medicine versus a food supplement was also tested in C-31905 in which the Commission accused the Federal Republic of Germany of
breach of its obligations under Articles 28 and 30 of the EC Treaty (free movement of goods) by classifying a garlic preparat ion in capsule form as a
medicinal product The ECJ held that a capsule form was not of itself sufficient to decide whether a product was medicinal that the capsule form is not
exclusive to medicinal products and the product in question only contained natural garlic and could not have any additional e ffects (positive or negative)
compared to garlic in its natural state A medicinal product must have the function of preventing or treating disease beneficial effects for health in general
are not sufficient
The ECJ clarifications pose a fundamental problem for Member State medicines regulators consistently using formlsquo and functi onlsquo as theirbenchmark
standards Pillcapsuletincture forms regularity of consumption defined posology and ADME (absorption distribution metabolism and excretion) and
the accompanying claims have long been the determinants in borderline product adjudications
23 Prevention or disease-risk reduction
The EU has no definition of diseaselsquo in any of its regulatory instruments except for medically diagnosed conditions or using w ider public health
frameworks for measuring disease prevention in terms ofQuality of Life Years (QALYs) and Disability Adjusted Life Years (DALY s) for example It has not
From Pharm to Fork in the Nutrigenomic Era Is It Food or Medicine
BANT - the seal of excellence for nutrition health professionals
Page 11 of From Pharm to Fork in the Nutrigenomic Era Is It Food or Medicine- Cont
adopted a fully transparent and credible suite of biomarkers surrogate or end-markers to establish healthdisease status and bi ofunctionality In the UK
The Medicines Act 1968 (as amended) defines disease as something which ―includes any injury ailment or adverse condition whether of body or
mind The lack of a clear legal definition has been recognised by the ECJ where disease has been intrinsically linked to the definition of a medicinal
product The Court determined in C-36988 on whether eye lotion was a medicinal product or cosmetic (a cosmetic being external but being able to
protectlsquo or keep in good conditionlsquo) that on the basis of scientific knowledge ―it is for the national authorities to dete rmine whether products presented as
counter-acting certain conditions of sensations such as hunger heaviness in the legs tiredness or itching constitute a medic al product
The United States Food and Drug Administration (FDA) in its health claims legislation defines disease as
―Damage to an organ part or structure or system of the body such that it does not function properly (eg cardiovascular dis ease) or a state of health
leading to such dysfunctioning (eg hypertension) except that diseases resulting from essential nutrient deficiencies (eg scurvy pellagra) are not
included in this definition
Proposals for health claims legislation being framed by Food Standards Australia and New Zealand (FSANZ) include definitions for diseaselsquo and serious
diseaselsquo which distinguish in terms both of severity of condition and of level of claim
Disease an unhealthy condition characterised by clinically significant signs or symptoms
Serious disease or condition forms of disease conditions ailments or defects which are generally accepted to be beyond the ability of the
average consumer to evaluate accurately and to treat safely without regular supervision by a suitably qualified health care professional
Where disease-risk reduction relates to one of a number of factors in the aetiology of disease the concept of preventionlsquo itse lf poses a number
of difficulties as like diseaselsquo it is not clearly defined in law
Coppens et al 2001 survey use of preventionlsquo in relation to the first EU Medicines Directive 6565 where prevention has had a history of use in terms
of vaccination and infectious diseases Prevention is a word with an absolute indication and its use is clear and distinct in nature and includes some
statistical certainty nonetheless with chronic diseases there is an overlap where reduction of disease risk pertains to one factor sufficient to prevent the
occurrence likely to be based on epidemiological evidence from studies of population cohorts Coppens et al propose that prevention has three facets
a) Prevention of disease occurrence where
the disease is not (yet) present
the therapy can prevent the occurrence of the disease with substantial statistical certainty
b) Prevention of episodes of the disease where
the disease is present
the therapy decreases the number duration or severity of disease episodes with a substantial statistical certainty
c) Prevention of progression of the patientlsquos underlying disease where
the disease is present
the therapy has been shown to delay the progression of the disease with a substantial statistical certainty
At the other end of the spectrum treatlsquo denotes a purpose of action intention therefore becomes a key determinant in claim status Intention in
consumption is important for the enforcement of health claims where (average) consumer understanding is a factor Consumption of supplemental vitamin
D3 to support bone health or with a substantiated claim reduce the risk of osteoporosis comes under the food domain However consumption of
supplemental vitamin D3 for the purposes of immune-modulation would be medicinal
The principle of disease risk reduction (DRR) as distinct from prevention was incorporated into EU law in EC 19242006 on nutrition and health claims
on food (NHCR) which requires that all structurefunction and DRR claims on food including supplements must be preapproved by the EU Commission
and meet a standard of substantial scientific agreement While the DRR paradigm recognises that chronic disease conditions are the product of multiple
gene-environment influences it nonetheless still must be predicated on what diseaselsquo is in biological terms The EU-funded PASSCLAIM projec t was
tasked with establishing how health claims would be substantiated and to identify functional biomarkers or surrogate end-point markers for use in the
assessment process PASSCLAIM working groups produced reports on diet -related cardiovascular disease bone health and osteoporosis physical
performance and fitness mental state and performance body weight insulin sensitivity and diabetes diet -related cancer and gut health and
immunity At January 2011 the European Food Safety Authority (EFSA) charged with the process of assessing claims is yet to fully clarify its
assessment criteria
24 Functional foods food bioactives and nutraceuticals
While the EU regulates foods containing plant sterolsstanols there is no formal definition of functional foodlsquo The EU FUFOSE project used a working
definition of functional foods that ―affect beneficially one or more target functions in the body beyond adequate nutriti onal effects in a way that is
relevant to either an improved state of health and well -being andor reduction of risk of disease FUFOSE noted that a functional food can be a natural
food one to which a component has been added or removed where a component has been modified or its bioavailability modifie d or any combination or
multiples of all the possibilities Therefore functional foods in the EU must be foods with health claims as defined by the NHCR
BANT sponsors a 2 day seminar on cPNI on 8-9 of Sep 2011
organised by Bonusan under the auspices of the Natura Foundation
wwwbantorgukbantjspmemberpdfseminarsBONUSAN_CPNIpdf
Page 12 of
Although in 2006 the US FDA proposed that the term functional foodlsquo be regulated (21 Code of Federal Regulations Part 101 and Part 170)it still has no
formal definition of that or of nutraceuticallsquo Earlier in 2004 the US Department of Health and Human Services (DHHS) launch ed a consultation on a
proposed definition of bioactive food componentslsquo In its supplementary information to the proposal the DHHS stated that bioactives may have multiple
sites of action may interact with one or more dietary constituents and may act directly or indirectly to produce a functional outcome citing as examples
lycopene long-chain omega-3 fatty acids isoflavones sulphorophane and resveratrol Establishing a definition of a food bioactive was a first step
towards evaluating their significance in promoting health and disease prevention then guiding research priorities and science-based information to help
guide public health policylsquo The definition proposed was
―Bioactive food components are constituents in foods or dietary supplements other than those needed to meet basic human nutr itional needs that are
responsible for changes in health status
As of early 2011 the work on defining food bioactives has not progressed Respondents to the 2004 consultation made strong representations about a
definition of bioactivity which excluded nutrients arguably the most important bioactive category of food components Seventeen written responses were
received in response to the consultation a number of which proposed alternate definitions Common themes in those alternate definitions include use of
the term physiologically activelsquo or physiological benefitlsquo reference to structure functionlsquo and disease -risk reductionlsquo and (ILSI North America) ―as
measured through utilizing appropriate methodology and biomarkers
In January 2011 the US National Academies of Science publishedPerspectives on Biomarker and Surrogate Endpoint Evaluation with recommendations
for establishing a framework for harmonising biomarker use across all areas including drugs and foods
3 Dosage and the homeostasis model what is lsquonormalrsquo
The ECJ Judgement C-8807 of 5 March 2009 determined that substances ―which while having an effect on the human body do not significantly
affect the metabolism and thus do not strictly modify the way in which it functions should not be classified as medicinal products by function
(see Commission v Germany paragraph 60 and Hecht-Pharma paragraph 41) Dosage therefore is a key criterion in determining food from medicine
of botanicals and from May 2011 is likely to be used by national authorities in enforcement This complements the homeostasis model produced by
the European Council in 2008 to distinguish foods and medicinal products The model incorporates the notion of intended use of the product and the
nature of the induced effect food induces the physiological effects characterised by maintainsupportoptimiselsquo and medicine induces the physiological
functions characterised by restorecorrectmodifylsquo It is a self-contained integrated approach but is predicated on the definition of homeostasis being
defined as ldquothe status of a person whose physiological parameters function within the limits considered as normal But while normal
physiological parameters may be defined by (sometimes quite large) reference ranges nutritional prerequisites or dietary ref erence intakes are not fully
harmonised throughout the EU nor do they take account of ancestral or inter-individual variation which characterise different sub-populations The lack
of harmonisation means some EU Member States regard supra -RDA vitamin and mineral supplements as medicines where others including the UK
have taken a more liberal approach The EU-funded EurRECA network of excellence is tasked with developing methodologies and recommendations to
standardise the process of setting pan-EU micronutrient recommendations This will inform progress in setting maximum permitted levels of vitamins and
minerals in food supplements However the extent of inter-individuality may prove problematic in 2007 the UK Committee on Toxicity in its working
group report on variability and uncertainty stated that for vitamins and minerals ―variability in the response of individuals has the potential to result in a
situation which a given level of exposure could be essential for some but toxic for others
What is normallsquo in dietary requirements underpins the basis on which both medicinal and health claims are evaluated namely that a healthy balanced
diet is generally able to provide all micronutrient requirements by normal healthy individuals for health maintenance Two signi ficant sub-populations
however threaten to undermine that approach In the UK the Healthy Start programme administered by statutory instrument by the Department
of Health and National Health Service provides two bespoke Healthy Start-branded vitamin supplements for low income beneficiaries for women free
during pregnancy and up until their baby is one year old and for children from 6 months of age until their fourth birthday Non-beneficiaries can
purchase Healthy Start-branded supplements at low cost from health clinics Health professionals are encouraged to make sure that mothers and
children ―get two important vitamins that they may not be getting in adequate quantities ndash even from a healthy balanced diet These are vitamins A and D
for children and vitamin D and folic acid for women While it is prohibited under the NHCR to claim that a healthy balanced diet cannot in general
provide all nutrients needed there is no such prohibition under medicinal law and the Healthy Startvitamins are marketed under a UK medicines
licence [PL015110003] This conflict adds to the problems of robust implementation of the NHCR which is already stymied by the lack of
A credible transparent system of scientific assessment
An agreed nutrient profiling system
A harmonised pan-EU characterisation of a healthy balanced diet
4 Going forward
Added to the woes of the NHCR looms a new era of personal genomicmetabolomic profiling and personalised nutrition in the for m of P4
medicinelsquo (personalised predictive preventive participatory) In its essence nutrigenomicslsquo incorporates two aspects
The effect of food components on the genome and epigenome
The extent of ancestral and individual variation
If disease can be classified at the molecular level what effect does this have on the meaning of homeostasislsquo and medicine lsquo These key terms need full
and comprehensive definition both in biology and law so that the food -medicine continuum is fully resolved and the foundation is laid for the successful
application of both personalised medicine and personalised nutrition Innovation and continued investment in wellness products by the food industry
depend on a clear consistent and transparent system of claims assessment
From Pharm to Fork in the Nutrigenomic Era Is It Food or Medicine- Cont
Page 13 of 13 Topic of the Month - Cardiovascular Health
Nutri Link Clinical Education - wwwnleducationcouk
They believe in supporting the health care professionals who count on them for
effective nutritional solutions Their team of CAM-leading experts are committed to
providing you with the latest unbiased scientific research and clinical support plus a
vast array of continuing education opportunitieshellipbecause as practitioners they
understand that knowledge is the key to positive patient results
FM Town - wwwfmtowncom
Its all about relevancy Being in a 100 Functional Medicine environment will give
you an opportunity to get direct and immediate access to all the information that is
most relevant to you FMTown is private and highly relevant in its scope of focus
Get connected to an amazing online resource which can grow with you and support
your Functional Medicine Journey
Institute for Functional Medicine - wwwfunctionalmedicineorg
IFM Membership is your gateway to a community of like-minded clinicians and
researchers It is primarily aimed at clinicians and scientists whose interest in
functional medicine is deeply connected to examining the emerging research
attending CME courses discussing issues and patients with colleagues and so
forth Membership helps to build a network of practitioners from many disciplines
who are using and studying functional medicine every day
Food Science Central - wwwfoodsciencecentralcom
Food Science Central is the home of IFIS Publishing on the web Here you can
learn about products and services and access FREE articles on many topics in food
science food technology and nutrition
Monthly ArticlesPapers
ANXIETY AND CARDIOVASCULAR RISK REVIEW OF
EPIDEMIOLOGICAL AND CLINICAL EVIDENCE
O Olafiranye G Jean-Louis F Zizi J Nunes and MT Vincent
wwwncbinlmnihgovpmcarticlesPMC3150179pdfnihms-
301210pdf
POST-TRAUMATIC STRESS DISORDER AND
CARDIOVASCULAR DISEASE
Steven S Coughlin
wwwncbinlmnihgovpmcarticlesPMC3141329pdfTOCMJ-5-
164pdf
STUDIES OF GENE VARIANTS RELATED TO INFLAMMATION
OXIDATIVE STRESS DYSLIPIDEMIA AND OBESITY
IMPLICATIONS FOR A NUTRIGENETIC APPROACH
Maira Ladeia R Curti Patrıcia Jacob Maria Carolina Borges
Marcelo Macedo Rogero and Sandra Roberta G Ferreir
wwwncbinlmnihgovpmcarticlesPMC3136190pdfJOBES2011-
497401pdf
EFFECT OF AN OFFICE WORKSITE-BASED YOGA
PROGRAM ON HEART RATE VARIABILITY A RANDOMIZED
CONTROLLED TRIAL
Birinder S Cheema Paul W Marshall Dennis Chang Ben
Colagiuri and Bianca Machliss
wwwncbinlmnihgovpmcarticlesPMC3154869pdf1471-2458-
11-578pdf
CARDIOVASCULAR COMPLICATIONS IN CKD PATIENTS
ROLE OF OXIDATIVE STRESS
Elvira O Gosmanova and Ngoc-Anh Le
wwwncbinlmnihgovpmcarticlesPMC3022166pdfCRP2011-
156326pdf
TARGETING STEM CELL NICHES AND TRAFFICKING FOR
CARDIOVASCULAR THERAPY
Nicolle Kraumlnkel Gaia Spinetti Silvia Amadesi and Paolo Madeddu
wwwncbinlmnihgovpmcarticlesPMC3017934pdfukmss-
33677pdf
INTERACTION OF SLEEP QUALITY AND PSYCHOS OCIAL
STRESS ON OBESITY IN AFRICAN AMERICANS THE
CARDIOVASCULAR HEALTH EPIDEMIOLOGY STUDY (CHES)
Aurelian Bidulescu Rebecca Din-Dzietham Dorothy L Coverson
Zhimin Chen Yuan-Xiang Meng Sarah G Buxbaum Gary H Gib-
bons Verna L Welch
wwwbiomedcentralcomcontentpdf1471-2458-10-581pdf
PATHOPHYSIOLOGIC MECHANISMS LINKING IMPAIRED
CARDIOVASCULAR HEALTH AND NEUROLOGIC
DYSFUNCTION THE YEAR IN REVIEW
Ki E Park Carl J Pepine
wwwccjmorgcontent77Suppl_3S40fullpdf+html
BERRIES EMERGING IMPACT ON CARDIOVASCULAR
HEALTH
Arpita Basu Michael Rhone and Timothy J Lyons
wwwncbinlmnihgovpmcarticlesPMC3068482pdf
nihms171310pdf
THE PLACENTA IS A PROGRAMMING AGENT FOR
CARDIOVASCULAR DISEASE
KL Thornburg PF OlsquoTierney and S Louey
wwwncbinlmnihgovpmcarticlesPMC2846089pdf
nihms177889pdf
Useful Websites
BANT - the seal of excellence for nutrition health professionals
Page 11 of From Pharm to Fork in the Nutrigenomic Era Is It Food or Medicine- Cont
adopted a fully transparent and credible suite of biomarkers surrogate or end-markers to establish healthdisease status and bi ofunctionality In the UK
The Medicines Act 1968 (as amended) defines disease as something which ―includes any injury ailment or adverse condition whether of body or
mind The lack of a clear legal definition has been recognised by the ECJ where disease has been intrinsically linked to the definition of a medicinal
product The Court determined in C-36988 on whether eye lotion was a medicinal product or cosmetic (a cosmetic being external but being able to
protectlsquo or keep in good conditionlsquo) that on the basis of scientific knowledge ―it is for the national authorities to dete rmine whether products presented as
counter-acting certain conditions of sensations such as hunger heaviness in the legs tiredness or itching constitute a medic al product
The United States Food and Drug Administration (FDA) in its health claims legislation defines disease as
―Damage to an organ part or structure or system of the body such that it does not function properly (eg cardiovascular dis ease) or a state of health
leading to such dysfunctioning (eg hypertension) except that diseases resulting from essential nutrient deficiencies (eg scurvy pellagra) are not
included in this definition
Proposals for health claims legislation being framed by Food Standards Australia and New Zealand (FSANZ) include definitions for diseaselsquo and serious
diseaselsquo which distinguish in terms both of severity of condition and of level of claim
Disease an unhealthy condition characterised by clinically significant signs or symptoms
Serious disease or condition forms of disease conditions ailments or defects which are generally accepted to be beyond the ability of the
average consumer to evaluate accurately and to treat safely without regular supervision by a suitably qualified health care professional
Where disease-risk reduction relates to one of a number of factors in the aetiology of disease the concept of preventionlsquo itse lf poses a number
of difficulties as like diseaselsquo it is not clearly defined in law
Coppens et al 2001 survey use of preventionlsquo in relation to the first EU Medicines Directive 6565 where prevention has had a history of use in terms
of vaccination and infectious diseases Prevention is a word with an absolute indication and its use is clear and distinct in nature and includes some
statistical certainty nonetheless with chronic diseases there is an overlap where reduction of disease risk pertains to one factor sufficient to prevent the
occurrence likely to be based on epidemiological evidence from studies of population cohorts Coppens et al propose that prevention has three facets
a) Prevention of disease occurrence where
the disease is not (yet) present
the therapy can prevent the occurrence of the disease with substantial statistical certainty
b) Prevention of episodes of the disease where
the disease is present
the therapy decreases the number duration or severity of disease episodes with a substantial statistical certainty
c) Prevention of progression of the patientlsquos underlying disease where
the disease is present
the therapy has been shown to delay the progression of the disease with a substantial statistical certainty
At the other end of the spectrum treatlsquo denotes a purpose of action intention therefore becomes a key determinant in claim status Intention in
consumption is important for the enforcement of health claims where (average) consumer understanding is a factor Consumption of supplemental vitamin
D3 to support bone health or with a substantiated claim reduce the risk of osteoporosis comes under the food domain However consumption of
supplemental vitamin D3 for the purposes of immune-modulation would be medicinal
The principle of disease risk reduction (DRR) as distinct from prevention was incorporated into EU law in EC 19242006 on nutrition and health claims
on food (NHCR) which requires that all structurefunction and DRR claims on food including supplements must be preapproved by the EU Commission
and meet a standard of substantial scientific agreement While the DRR paradigm recognises that chronic disease conditions are the product of multiple
gene-environment influences it nonetheless still must be predicated on what diseaselsquo is in biological terms The EU-funded PASSCLAIM projec t was
tasked with establishing how health claims would be substantiated and to identify functional biomarkers or surrogate end-point markers for use in the
assessment process PASSCLAIM working groups produced reports on diet -related cardiovascular disease bone health and osteoporosis physical
performance and fitness mental state and performance body weight insulin sensitivity and diabetes diet -related cancer and gut health and
immunity At January 2011 the European Food Safety Authority (EFSA) charged with the process of assessing claims is yet to fully clarify its
assessment criteria
24 Functional foods food bioactives and nutraceuticals
While the EU regulates foods containing plant sterolsstanols there is no formal definition of functional foodlsquo The EU FUFOSE project used a working
definition of functional foods that ―affect beneficially one or more target functions in the body beyond adequate nutriti onal effects in a way that is
relevant to either an improved state of health and well -being andor reduction of risk of disease FUFOSE noted that a functional food can be a natural
food one to which a component has been added or removed where a component has been modified or its bioavailability modifie d or any combination or
multiples of all the possibilities Therefore functional foods in the EU must be foods with health claims as defined by the NHCR
BANT sponsors a 2 day seminar on cPNI on 8-9 of Sep 2011
organised by Bonusan under the auspices of the Natura Foundation
wwwbantorgukbantjspmemberpdfseminarsBONUSAN_CPNIpdf
Page 12 of
Although in 2006 the US FDA proposed that the term functional foodlsquo be regulated (21 Code of Federal Regulations Part 101 and Part 170)it still has no
formal definition of that or of nutraceuticallsquo Earlier in 2004 the US Department of Health and Human Services (DHHS) launch ed a consultation on a
proposed definition of bioactive food componentslsquo In its supplementary information to the proposal the DHHS stated that bioactives may have multiple
sites of action may interact with one or more dietary constituents and may act directly or indirectly to produce a functional outcome citing as examples
lycopene long-chain omega-3 fatty acids isoflavones sulphorophane and resveratrol Establishing a definition of a food bioactive was a first step
towards evaluating their significance in promoting health and disease prevention then guiding research priorities and science-based information to help
guide public health policylsquo The definition proposed was
―Bioactive food components are constituents in foods or dietary supplements other than those needed to meet basic human nutr itional needs that are
responsible for changes in health status
As of early 2011 the work on defining food bioactives has not progressed Respondents to the 2004 consultation made strong representations about a
definition of bioactivity which excluded nutrients arguably the most important bioactive category of food components Seventeen written responses were
received in response to the consultation a number of which proposed alternate definitions Common themes in those alternate definitions include use of
the term physiologically activelsquo or physiological benefitlsquo reference to structure functionlsquo and disease -risk reductionlsquo and (ILSI North America) ―as
measured through utilizing appropriate methodology and biomarkers
In January 2011 the US National Academies of Science publishedPerspectives on Biomarker and Surrogate Endpoint Evaluation with recommendations
for establishing a framework for harmonising biomarker use across all areas including drugs and foods
3 Dosage and the homeostasis model what is lsquonormalrsquo
The ECJ Judgement C-8807 of 5 March 2009 determined that substances ―which while having an effect on the human body do not significantly
affect the metabolism and thus do not strictly modify the way in which it functions should not be classified as medicinal products by function
(see Commission v Germany paragraph 60 and Hecht-Pharma paragraph 41) Dosage therefore is a key criterion in determining food from medicine
of botanicals and from May 2011 is likely to be used by national authorities in enforcement This complements the homeostasis model produced by
the European Council in 2008 to distinguish foods and medicinal products The model incorporates the notion of intended use of the product and the
nature of the induced effect food induces the physiological effects characterised by maintainsupportoptimiselsquo and medicine induces the physiological
functions characterised by restorecorrectmodifylsquo It is a self-contained integrated approach but is predicated on the definition of homeostasis being
defined as ldquothe status of a person whose physiological parameters function within the limits considered as normal But while normal
physiological parameters may be defined by (sometimes quite large) reference ranges nutritional prerequisites or dietary ref erence intakes are not fully
harmonised throughout the EU nor do they take account of ancestral or inter-individual variation which characterise different sub-populations The lack
of harmonisation means some EU Member States regard supra -RDA vitamin and mineral supplements as medicines where others including the UK
have taken a more liberal approach The EU-funded EurRECA network of excellence is tasked with developing methodologies and recommendations to
standardise the process of setting pan-EU micronutrient recommendations This will inform progress in setting maximum permitted levels of vitamins and
minerals in food supplements However the extent of inter-individuality may prove problematic in 2007 the UK Committee on Toxicity in its working
group report on variability and uncertainty stated that for vitamins and minerals ―variability in the response of individuals has the potential to result in a
situation which a given level of exposure could be essential for some but toxic for others
What is normallsquo in dietary requirements underpins the basis on which both medicinal and health claims are evaluated namely that a healthy balanced
diet is generally able to provide all micronutrient requirements by normal healthy individuals for health maintenance Two signi ficant sub-populations
however threaten to undermine that approach In the UK the Healthy Start programme administered by statutory instrument by the Department
of Health and National Health Service provides two bespoke Healthy Start-branded vitamin supplements for low income beneficiaries for women free
during pregnancy and up until their baby is one year old and for children from 6 months of age until their fourth birthday Non-beneficiaries can
purchase Healthy Start-branded supplements at low cost from health clinics Health professionals are encouraged to make sure that mothers and
children ―get two important vitamins that they may not be getting in adequate quantities ndash even from a healthy balanced diet These are vitamins A and D
for children and vitamin D and folic acid for women While it is prohibited under the NHCR to claim that a healthy balanced diet cannot in general
provide all nutrients needed there is no such prohibition under medicinal law and the Healthy Startvitamins are marketed under a UK medicines
licence [PL015110003] This conflict adds to the problems of robust implementation of the NHCR which is already stymied by the lack of
A credible transparent system of scientific assessment
An agreed nutrient profiling system
A harmonised pan-EU characterisation of a healthy balanced diet
4 Going forward
Added to the woes of the NHCR looms a new era of personal genomicmetabolomic profiling and personalised nutrition in the for m of P4
medicinelsquo (personalised predictive preventive participatory) In its essence nutrigenomicslsquo incorporates two aspects
The effect of food components on the genome and epigenome
The extent of ancestral and individual variation
If disease can be classified at the molecular level what effect does this have on the meaning of homeostasislsquo and medicine lsquo These key terms need full
and comprehensive definition both in biology and law so that the food -medicine continuum is fully resolved and the foundation is laid for the successful
application of both personalised medicine and personalised nutrition Innovation and continued investment in wellness products by the food industry
depend on a clear consistent and transparent system of claims assessment
From Pharm to Fork in the Nutrigenomic Era Is It Food or Medicine- Cont
Page 13 of 13 Topic of the Month - Cardiovascular Health
Nutri Link Clinical Education - wwwnleducationcouk
They believe in supporting the health care professionals who count on them for
effective nutritional solutions Their team of CAM-leading experts are committed to
providing you with the latest unbiased scientific research and clinical support plus a
vast array of continuing education opportunitieshellipbecause as practitioners they
understand that knowledge is the key to positive patient results
FM Town - wwwfmtowncom
Its all about relevancy Being in a 100 Functional Medicine environment will give
you an opportunity to get direct and immediate access to all the information that is
most relevant to you FMTown is private and highly relevant in its scope of focus
Get connected to an amazing online resource which can grow with you and support
your Functional Medicine Journey
Institute for Functional Medicine - wwwfunctionalmedicineorg
IFM Membership is your gateway to a community of like-minded clinicians and
researchers It is primarily aimed at clinicians and scientists whose interest in
functional medicine is deeply connected to examining the emerging research
attending CME courses discussing issues and patients with colleagues and so
forth Membership helps to build a network of practitioners from many disciplines
who are using and studying functional medicine every day
Food Science Central - wwwfoodsciencecentralcom
Food Science Central is the home of IFIS Publishing on the web Here you can
learn about products and services and access FREE articles on many topics in food
science food technology and nutrition
Monthly ArticlesPapers
ANXIETY AND CARDIOVASCULAR RISK REVIEW OF
EPIDEMIOLOGICAL AND CLINICAL EVIDENCE
O Olafiranye G Jean-Louis F Zizi J Nunes and MT Vincent
wwwncbinlmnihgovpmcarticlesPMC3150179pdfnihms-
301210pdf
POST-TRAUMATIC STRESS DISORDER AND
CARDIOVASCULAR DISEASE
Steven S Coughlin
wwwncbinlmnihgovpmcarticlesPMC3141329pdfTOCMJ-5-
164pdf
STUDIES OF GENE VARIANTS RELATED TO INFLAMMATION
OXIDATIVE STRESS DYSLIPIDEMIA AND OBESITY
IMPLICATIONS FOR A NUTRIGENETIC APPROACH
Maira Ladeia R Curti Patrıcia Jacob Maria Carolina Borges
Marcelo Macedo Rogero and Sandra Roberta G Ferreir
wwwncbinlmnihgovpmcarticlesPMC3136190pdfJOBES2011-
497401pdf
EFFECT OF AN OFFICE WORKSITE-BASED YOGA
PROGRAM ON HEART RATE VARIABILITY A RANDOMIZED
CONTROLLED TRIAL
Birinder S Cheema Paul W Marshall Dennis Chang Ben
Colagiuri and Bianca Machliss
wwwncbinlmnihgovpmcarticlesPMC3154869pdf1471-2458-
11-578pdf
CARDIOVASCULAR COMPLICATIONS IN CKD PATIENTS
ROLE OF OXIDATIVE STRESS
Elvira O Gosmanova and Ngoc-Anh Le
wwwncbinlmnihgovpmcarticlesPMC3022166pdfCRP2011-
156326pdf
TARGETING STEM CELL NICHES AND TRAFFICKING FOR
CARDIOVASCULAR THERAPY
Nicolle Kraumlnkel Gaia Spinetti Silvia Amadesi and Paolo Madeddu
wwwncbinlmnihgovpmcarticlesPMC3017934pdfukmss-
33677pdf
INTERACTION OF SLEEP QUALITY AND PSYCHOS OCIAL
STRESS ON OBESITY IN AFRICAN AMERICANS THE
CARDIOVASCULAR HEALTH EPIDEMIOLOGY STUDY (CHES)
Aurelian Bidulescu Rebecca Din-Dzietham Dorothy L Coverson
Zhimin Chen Yuan-Xiang Meng Sarah G Buxbaum Gary H Gib-
bons Verna L Welch
wwwbiomedcentralcomcontentpdf1471-2458-10-581pdf
PATHOPHYSIOLOGIC MECHANISMS LINKING IMPAIRED
CARDIOVASCULAR HEALTH AND NEUROLOGIC
DYSFUNCTION THE YEAR IN REVIEW
Ki E Park Carl J Pepine
wwwccjmorgcontent77Suppl_3S40fullpdf+html
BERRIES EMERGING IMPACT ON CARDIOVASCULAR
HEALTH
Arpita Basu Michael Rhone and Timothy J Lyons
wwwncbinlmnihgovpmcarticlesPMC3068482pdf
nihms171310pdf
THE PLACENTA IS A PROGRAMMING AGENT FOR
CARDIOVASCULAR DISEASE
KL Thornburg PF OlsquoTierney and S Louey
wwwncbinlmnihgovpmcarticlesPMC2846089pdf
nihms177889pdf
Useful Websites
BANT - the seal of excellence for nutrition health professionals
Page 12 of
Although in 2006 the US FDA proposed that the term functional foodlsquo be regulated (21 Code of Federal Regulations Part 101 and Part 170)it still has no
formal definition of that or of nutraceuticallsquo Earlier in 2004 the US Department of Health and Human Services (DHHS) launch ed a consultation on a
proposed definition of bioactive food componentslsquo In its supplementary information to the proposal the DHHS stated that bioactives may have multiple
sites of action may interact with one or more dietary constituents and may act directly or indirectly to produce a functional outcome citing as examples
lycopene long-chain omega-3 fatty acids isoflavones sulphorophane and resveratrol Establishing a definition of a food bioactive was a first step
towards evaluating their significance in promoting health and disease prevention then guiding research priorities and science-based information to help
guide public health policylsquo The definition proposed was
―Bioactive food components are constituents in foods or dietary supplements other than those needed to meet basic human nutr itional needs that are
responsible for changes in health status
As of early 2011 the work on defining food bioactives has not progressed Respondents to the 2004 consultation made strong representations about a
definition of bioactivity which excluded nutrients arguably the most important bioactive category of food components Seventeen written responses were
received in response to the consultation a number of which proposed alternate definitions Common themes in those alternate definitions include use of
the term physiologically activelsquo or physiological benefitlsquo reference to structure functionlsquo and disease -risk reductionlsquo and (ILSI North America) ―as
measured through utilizing appropriate methodology and biomarkers
In January 2011 the US National Academies of Science publishedPerspectives on Biomarker and Surrogate Endpoint Evaluation with recommendations
for establishing a framework for harmonising biomarker use across all areas including drugs and foods
3 Dosage and the homeostasis model what is lsquonormalrsquo
The ECJ Judgement C-8807 of 5 March 2009 determined that substances ―which while having an effect on the human body do not significantly
affect the metabolism and thus do not strictly modify the way in which it functions should not be classified as medicinal products by function
(see Commission v Germany paragraph 60 and Hecht-Pharma paragraph 41) Dosage therefore is a key criterion in determining food from medicine
of botanicals and from May 2011 is likely to be used by national authorities in enforcement This complements the homeostasis model produced by
the European Council in 2008 to distinguish foods and medicinal products The model incorporates the notion of intended use of the product and the
nature of the induced effect food induces the physiological effects characterised by maintainsupportoptimiselsquo and medicine induces the physiological
functions characterised by restorecorrectmodifylsquo It is a self-contained integrated approach but is predicated on the definition of homeostasis being
defined as ldquothe status of a person whose physiological parameters function within the limits considered as normal But while normal
physiological parameters may be defined by (sometimes quite large) reference ranges nutritional prerequisites or dietary ref erence intakes are not fully
harmonised throughout the EU nor do they take account of ancestral or inter-individual variation which characterise different sub-populations The lack
of harmonisation means some EU Member States regard supra -RDA vitamin and mineral supplements as medicines where others including the UK
have taken a more liberal approach The EU-funded EurRECA network of excellence is tasked with developing methodologies and recommendations to
standardise the process of setting pan-EU micronutrient recommendations This will inform progress in setting maximum permitted levels of vitamins and
minerals in food supplements However the extent of inter-individuality may prove problematic in 2007 the UK Committee on Toxicity in its working
group report on variability and uncertainty stated that for vitamins and minerals ―variability in the response of individuals has the potential to result in a
situation which a given level of exposure could be essential for some but toxic for others
What is normallsquo in dietary requirements underpins the basis on which both medicinal and health claims are evaluated namely that a healthy balanced
diet is generally able to provide all micronutrient requirements by normal healthy individuals for health maintenance Two signi ficant sub-populations
however threaten to undermine that approach In the UK the Healthy Start programme administered by statutory instrument by the Department
of Health and National Health Service provides two bespoke Healthy Start-branded vitamin supplements for low income beneficiaries for women free
during pregnancy and up until their baby is one year old and for children from 6 months of age until their fourth birthday Non-beneficiaries can
purchase Healthy Start-branded supplements at low cost from health clinics Health professionals are encouraged to make sure that mothers and
children ―get two important vitamins that they may not be getting in adequate quantities ndash even from a healthy balanced diet These are vitamins A and D
for children and vitamin D and folic acid for women While it is prohibited under the NHCR to claim that a healthy balanced diet cannot in general
provide all nutrients needed there is no such prohibition under medicinal law and the Healthy Startvitamins are marketed under a UK medicines
licence [PL015110003] This conflict adds to the problems of robust implementation of the NHCR which is already stymied by the lack of
A credible transparent system of scientific assessment
An agreed nutrient profiling system
A harmonised pan-EU characterisation of a healthy balanced diet
4 Going forward
Added to the woes of the NHCR looms a new era of personal genomicmetabolomic profiling and personalised nutrition in the for m of P4
medicinelsquo (personalised predictive preventive participatory) In its essence nutrigenomicslsquo incorporates two aspects
The effect of food components on the genome and epigenome
The extent of ancestral and individual variation
If disease can be classified at the molecular level what effect does this have on the meaning of homeostasislsquo and medicine lsquo These key terms need full
and comprehensive definition both in biology and law so that the food -medicine continuum is fully resolved and the foundation is laid for the successful
application of both personalised medicine and personalised nutrition Innovation and continued investment in wellness products by the food industry
depend on a clear consistent and transparent system of claims assessment
From Pharm to Fork in the Nutrigenomic Era Is It Food or Medicine- Cont
Page 13 of 13 Topic of the Month - Cardiovascular Health
Nutri Link Clinical Education - wwwnleducationcouk
They believe in supporting the health care professionals who count on them for
effective nutritional solutions Their team of CAM-leading experts are committed to
providing you with the latest unbiased scientific research and clinical support plus a
vast array of continuing education opportunitieshellipbecause as practitioners they
understand that knowledge is the key to positive patient results
FM Town - wwwfmtowncom
Its all about relevancy Being in a 100 Functional Medicine environment will give
you an opportunity to get direct and immediate access to all the information that is
most relevant to you FMTown is private and highly relevant in its scope of focus
Get connected to an amazing online resource which can grow with you and support
your Functional Medicine Journey
Institute for Functional Medicine - wwwfunctionalmedicineorg
IFM Membership is your gateway to a community of like-minded clinicians and
researchers It is primarily aimed at clinicians and scientists whose interest in
functional medicine is deeply connected to examining the emerging research
attending CME courses discussing issues and patients with colleagues and so
forth Membership helps to build a network of practitioners from many disciplines
who are using and studying functional medicine every day
Food Science Central - wwwfoodsciencecentralcom
Food Science Central is the home of IFIS Publishing on the web Here you can
learn about products and services and access FREE articles on many topics in food
science food technology and nutrition
Monthly ArticlesPapers
ANXIETY AND CARDIOVASCULAR RISK REVIEW OF
EPIDEMIOLOGICAL AND CLINICAL EVIDENCE
O Olafiranye G Jean-Louis F Zizi J Nunes and MT Vincent
wwwncbinlmnihgovpmcarticlesPMC3150179pdfnihms-
301210pdf
POST-TRAUMATIC STRESS DISORDER AND
CARDIOVASCULAR DISEASE
Steven S Coughlin
wwwncbinlmnihgovpmcarticlesPMC3141329pdfTOCMJ-5-
164pdf
STUDIES OF GENE VARIANTS RELATED TO INFLAMMATION
OXIDATIVE STRESS DYSLIPIDEMIA AND OBESITY
IMPLICATIONS FOR A NUTRIGENETIC APPROACH
Maira Ladeia R Curti Patrıcia Jacob Maria Carolina Borges
Marcelo Macedo Rogero and Sandra Roberta G Ferreir
wwwncbinlmnihgovpmcarticlesPMC3136190pdfJOBES2011-
497401pdf
EFFECT OF AN OFFICE WORKSITE-BASED YOGA
PROGRAM ON HEART RATE VARIABILITY A RANDOMIZED
CONTROLLED TRIAL
Birinder S Cheema Paul W Marshall Dennis Chang Ben
Colagiuri and Bianca Machliss
wwwncbinlmnihgovpmcarticlesPMC3154869pdf1471-2458-
11-578pdf
CARDIOVASCULAR COMPLICATIONS IN CKD PATIENTS
ROLE OF OXIDATIVE STRESS
Elvira O Gosmanova and Ngoc-Anh Le
wwwncbinlmnihgovpmcarticlesPMC3022166pdfCRP2011-
156326pdf
TARGETING STEM CELL NICHES AND TRAFFICKING FOR
CARDIOVASCULAR THERAPY
Nicolle Kraumlnkel Gaia Spinetti Silvia Amadesi and Paolo Madeddu
wwwncbinlmnihgovpmcarticlesPMC3017934pdfukmss-
33677pdf
INTERACTION OF SLEEP QUALITY AND PSYCHOS OCIAL
STRESS ON OBESITY IN AFRICAN AMERICANS THE
CARDIOVASCULAR HEALTH EPIDEMIOLOGY STUDY (CHES)
Aurelian Bidulescu Rebecca Din-Dzietham Dorothy L Coverson
Zhimin Chen Yuan-Xiang Meng Sarah G Buxbaum Gary H Gib-
bons Verna L Welch
wwwbiomedcentralcomcontentpdf1471-2458-10-581pdf
PATHOPHYSIOLOGIC MECHANISMS LINKING IMPAIRED
CARDIOVASCULAR HEALTH AND NEUROLOGIC
DYSFUNCTION THE YEAR IN REVIEW
Ki E Park Carl J Pepine
wwwccjmorgcontent77Suppl_3S40fullpdf+html
BERRIES EMERGING IMPACT ON CARDIOVASCULAR
HEALTH
Arpita Basu Michael Rhone and Timothy J Lyons
wwwncbinlmnihgovpmcarticlesPMC3068482pdf
nihms171310pdf
THE PLACENTA IS A PROGRAMMING AGENT FOR
CARDIOVASCULAR DISEASE
KL Thornburg PF OlsquoTierney and S Louey
wwwncbinlmnihgovpmcarticlesPMC2846089pdf
nihms177889pdf
Useful Websites
BANT - the seal of excellence for nutrition health professionals
Page 13 of 13 Topic of the Month - Cardiovascular Health
Nutri Link Clinical Education - wwwnleducationcouk
They believe in supporting the health care professionals who count on them for
effective nutritional solutions Their team of CAM-leading experts are committed to
providing you with the latest unbiased scientific research and clinical support plus a
vast array of continuing education opportunitieshellipbecause as practitioners they
understand that knowledge is the key to positive patient results
FM Town - wwwfmtowncom
Its all about relevancy Being in a 100 Functional Medicine environment will give
you an opportunity to get direct and immediate access to all the information that is
most relevant to you FMTown is private and highly relevant in its scope of focus
Get connected to an amazing online resource which can grow with you and support
your Functional Medicine Journey
Institute for Functional Medicine - wwwfunctionalmedicineorg
IFM Membership is your gateway to a community of like-minded clinicians and
researchers It is primarily aimed at clinicians and scientists whose interest in
functional medicine is deeply connected to examining the emerging research
attending CME courses discussing issues and patients with colleagues and so
forth Membership helps to build a network of practitioners from many disciplines
who are using and studying functional medicine every day
Food Science Central - wwwfoodsciencecentralcom
Food Science Central is the home of IFIS Publishing on the web Here you can
learn about products and services and access FREE articles on many topics in food
science food technology and nutrition
Monthly ArticlesPapers
ANXIETY AND CARDIOVASCULAR RISK REVIEW OF
EPIDEMIOLOGICAL AND CLINICAL EVIDENCE
O Olafiranye G Jean-Louis F Zizi J Nunes and MT Vincent
wwwncbinlmnihgovpmcarticlesPMC3150179pdfnihms-
301210pdf
POST-TRAUMATIC STRESS DISORDER AND
CARDIOVASCULAR DISEASE
Steven S Coughlin
wwwncbinlmnihgovpmcarticlesPMC3141329pdfTOCMJ-5-
164pdf
STUDIES OF GENE VARIANTS RELATED TO INFLAMMATION
OXIDATIVE STRESS DYSLIPIDEMIA AND OBESITY
IMPLICATIONS FOR A NUTRIGENETIC APPROACH
Maira Ladeia R Curti Patrıcia Jacob Maria Carolina Borges
Marcelo Macedo Rogero and Sandra Roberta G Ferreir
wwwncbinlmnihgovpmcarticlesPMC3136190pdfJOBES2011-
497401pdf
EFFECT OF AN OFFICE WORKSITE-BASED YOGA
PROGRAM ON HEART RATE VARIABILITY A RANDOMIZED
CONTROLLED TRIAL
Birinder S Cheema Paul W Marshall Dennis Chang Ben
Colagiuri and Bianca Machliss
wwwncbinlmnihgovpmcarticlesPMC3154869pdf1471-2458-
11-578pdf
CARDIOVASCULAR COMPLICATIONS IN CKD PATIENTS
ROLE OF OXIDATIVE STRESS
Elvira O Gosmanova and Ngoc-Anh Le
wwwncbinlmnihgovpmcarticlesPMC3022166pdfCRP2011-
156326pdf
TARGETING STEM CELL NICHES AND TRAFFICKING FOR
CARDIOVASCULAR THERAPY
Nicolle Kraumlnkel Gaia Spinetti Silvia Amadesi and Paolo Madeddu
wwwncbinlmnihgovpmcarticlesPMC3017934pdfukmss-
33677pdf
INTERACTION OF SLEEP QUALITY AND PSYCHOS OCIAL
STRESS ON OBESITY IN AFRICAN AMERICANS THE
CARDIOVASCULAR HEALTH EPIDEMIOLOGY STUDY (CHES)
Aurelian Bidulescu Rebecca Din-Dzietham Dorothy L Coverson
Zhimin Chen Yuan-Xiang Meng Sarah G Buxbaum Gary H Gib-
bons Verna L Welch
wwwbiomedcentralcomcontentpdf1471-2458-10-581pdf
PATHOPHYSIOLOGIC MECHANISMS LINKING IMPAIRED
CARDIOVASCULAR HEALTH AND NEUROLOGIC
DYSFUNCTION THE YEAR IN REVIEW
Ki E Park Carl J Pepine
wwwccjmorgcontent77Suppl_3S40fullpdf+html
BERRIES EMERGING IMPACT ON CARDIOVASCULAR
HEALTH
Arpita Basu Michael Rhone and Timothy J Lyons
wwwncbinlmnihgovpmcarticlesPMC3068482pdf
nihms171310pdf
THE PLACENTA IS A PROGRAMMING AGENT FOR
CARDIOVASCULAR DISEASE
KL Thornburg PF OlsquoTierney and S Louey
wwwncbinlmnihgovpmcarticlesPMC2846089pdf
nihms177889pdf
Useful Websites
BANT - the seal of excellence for nutrition health professionals