special thank you to diabetes care and education workgroup...

No, Low and Reduced Calorie Sweeteners:Hot Topics from A - Z

2/8/2013

1DCE Webinarwww.dce.org

Diabetes Care and EducationPractice Group presents:

“No, Low and Reduced Calorie Sweeteners:Hot Topics From A to Z”

Robyn Flipse, MS, RD

Alan Rulis, PhD

Thank you for joining us. Our program will begin shortly.

You can download the handouts by logging in at thewww.DCE.org – Member Features tab – My Media

Special Thank You toDCE Leaders Andrea Dunn, RD, LD, CDE

DCE Chair

Lisa Brown, RD, LD, CDE

Chair Elect

Amy Hess Fischl,MS, RD,LDN,BC-ADM ,CDE

Industry Relations Chair

Susan Rizzo, RD, LD, CDE

Professional Development

Workgroup Members Suzanne Pecoraro, RD, MPH, CDE

Paula Ackerman, MS, RD, CDE

Kim Hadley, RD, CDE

Andrea Hebert, RD, CDE

Niharika Jaiswal, RD, CDE

Michelle Nabatian Routhenstein, MSRD CDN

Mary Lou Perry, RD, CDE

Donna Plyler, RD, CDE

Adam Reppert, RD, CDE

Sarah Williams, RD, LD, CDE

Contact us: [email protected]

Participation Information• Handouts: www.dce.org; log in, go to MemberFeatures tab – My Media

• Attendee control panel – upper right

• Polling questions – vote using keyboard

• Question and Answer session

• Submit at any time using Questions Pane

• Speaker will answer at end of program

SpeakersRobyn Flipse, MS, RDRegistered Dietitian specializing in food, nutrition and healthcommunications. She has been on the professional staffs atThe Estee Corporation, Raritan Bay Health ServicesCorporation, the College of Medicine and Dentistry and JerseyShore University Medical Center Hospital. [email protected]

Alan Rulis, PhDRetired from the federal government in 2006 after 30 years atthe U.S. Food and Drug Administration, including nine asDirector of the FDA’s Office of Food Additive Safety (1995–2004). He was Senior Advisor for Special Projects in the FDA’sCenter for Food Safety and Applied Nutrition from 2004 untilhis retirement. [email protected]

www.caloriecontrol.org

Presenter Disclosure

Robyn Flipse, MS, RDDiscloses that she is a consultant for The Coca-Cola Company and for McNeil Nutritionals, LLC,makers of Splenda. Academy of Nutrition &

DieteticsD C E Practice Group

-- Webinar --February 12, 2013

Alan Rulis, Ph.D.Exponent, Inc.

FDA Regulatory Approval Process forFood Ingredients

Safety Decisions on Low- and Reduced- CalorieSweeteners


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Resource Paper

“FDA’s Food Ingredient ApprovalProcess – Safety assurance based onscientific assessment”

A.M. Rulis & J.A. Levitt, Regulatory Toxicology &Pharmacology 53 (2009) 20-31.

Some questions about additives:(including non-nutritive sweeteners)

• How does FDA reach decisions on the safety of foodingredients ?

• What constitutes adequate safety data ?

• Who performs the studies for premarket safety review of newfood additives ? Who reviews the safety data ?

• How does FDA reach decisions in the face of uncertainty inthe scientific data and information?

• How is “precaution” built into the FDA process ?

• Should safety decisions, once made, ever be reviewed ?How, and by whom? What is the standard foroverturning a previous decision? How does FDAadapt to and consider new scientific knowledge ?

• How does the GRAS process work ? What are the criteria forGRAS status ?

To Cover:

1. Brief Historical Context 150 years of Saccharin: “Some things

never change…”

2. FDA’s Modern Context: Law, science and policy: “Regulatory

decision making”

3. A Few Examples Aspartame, Acesulfame-K, Sucralose, and

GRAS uses of stevia and SGFE

To Cover:


never change…”


decision making”



Chemical Structure of Discoverers of Saccharin, 1879

Two photos of Professor IraRemsen (1846-1927)

Second President of JohnsHopkins University

Fahlberg, an Ira Remsenresearch fellow

Ira Remsen Constantine Fahlberg


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Smithsonian Museum of American HistoryReconstruction of Remsen’s Lab

at Johns Hopkins University

At the turn of the 20th Century: Saccharinbegins its controversial regulatory history

• Harvey Wiley (FDA’s “founding father”) thought saccharinwas unsafe

• President Theodore Roosevelt was in favor of it (he used ithimself on the advice of his physician)

• “Disagreements” ensued at a remarkable 1908 White Housemeeting between Dr. Wiley and President Roosevelt

Harvey Wiley’s 1929 Memoir From Dr. Wiley’s 1929 Memoir

Roosevelt: “You tell me that saccharin isinjurious to health ?”

Wiley: “Yes, Mr. President, I do tell you that.”

Roosevelt: “Dr. Rixey gives it to me everyday.”

Wiley: “Mr. President, he probably thinks youmay be threatened with diabetes.”

Roosevelt: “Anybody who says saccharin isinjurious to health is an idiot.”

Saccharin – not without controversy

• Court cases from 1908 to 1925: While FDA eventually gaveup the struggle, the agency still believed it to be “harmful tohealth”

• 1958 saccharin appears on the first “GRAS*” lists

• 1977 FDA proposed to ban it again (bladder cancer in rats)

• 1977 Congress overrode the ban, asked NAS to study;warning label placed on products containing it

Use of this product may be hazardousto your health. This product contains

saccharin which has been determined tocause cancer in laboratory animals.

* More about GRAS later…

Saccharin – not without controversy

• 1977 – 1992 Congress places a moratorium on FDA’sproposed ban.

• 2000: New studies show the mechanism of action forcancer in rodent studies not to be relevant to humanexposure. The National Toxicology Program, in the 9th

edition of its Report on Carcinogens, removessaccharin from the list of substances reasonablyanticipated to be a human carcinogen.

• 2000: President Clinton signs into law a bill to removethe warning label from saccharin containing products.


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Aspartame

Saccharin

Acesulfame-K

Sucralose

Neotame

Alitame

Alitame

Cyclamate

Sugar Alcohols

“Trehalose”

Tagatose

NHDC

Stevia (Reb-A)

Thaumatin

Today…an assortment ofalternative sweeteners…and growing

Monk fruit(Siraitia grosvenorii)or SG fruit extract

(SGFE)

Aspartame

Saccharin

Acesulfame-K

Sucralose

Neotame

Alitame

Alitame

Cyclamate

Sugar Alcohols

“Trehalose”

Tagatose

NHDC

Stevia (Reb-A)

Thaumatin

Today…an assortment ofalternative sweeteners…and growing

Monk fruit(Siraitia grosvenorii)or SG fruit extract

(SGFE)

To Cover:


never change…”


decision making”



Polling Question # 1

1. Do you feel you have a goodunderstanding of the FDA’s foodadditive approval process andGenerally Recognized as Safe(GRAS) process?

a) Yes

b) No

The Modern FDA Context, 2013

The Harvey W. Wiley BuildingCollege Park, MD

Answers come at the Intersection ofScience, Law and Regulatory Policy

The Federal Food, Drug,& Cosmetic Act

Risk Management,Risk Communi-cation; Threshold ofRegulation,Priority Setting,The “Principle ofCommensurateEffort,” Labeling,“Precaution,” etc.

Chemistry,Toxicology(Paracelsus),Risk Assess-ment,SafetyAssess-ment


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The FD&C ActThe FD&C Act

Defines “food additive” (w/ “GRASexemption”)

Requires premarket approval of new uses offood additives, if not “GRAS”

Establishes the standard of data review

Establishes the standard of safety

Establishes formal rulemaking proceduresfor petition review

------------since FDAMA of 1997:------------------

Defines “food contact substance” (FCS)

Establishes a premarket notificationprogram for food contact substances

For both food additives and“GRAS”* ingredients….

The standard of safety -

“…reasonable certainty of no harm…”

The standard of review -

“Fair evaluation of the data . . .”

* GRAS to be defined and discussed more later in this presentation.

The concept of safety used in this legislationinvolves the question of whether a substance ishazardous to the health of man or animal. Safetyrequires proof of a reasonable certainty that noharm will result from the proposed use of anadditive.

It does not -- and cannot -- require proofbeyond any possible doubt that no harm willresult under any conceivable circumstance.

H.R. Report No. 2284, 85th Congress 1958

“REASONABLE CERTAINTY OF NO HARM”Legislative History of the FD&C Act

The Standard of Safety:“Reasonable Certainty of No Harm”

It is not intended to ensure, nor is itpossible to ensure, safety with absolutecertainty: ….i.e., “Reasonable Certainty of No Harm”

is not :“Certainty of no conceivable (theoretical)possibility of harm.”

“No Harm to Health”

The “Reasonable Certainty of NoHarm” standard is, in fact,

a “no harm” standard, where“harm” is harm to health.

Traditional Safety Evaluation

• Estimation of probable consumer exposureto the additive

• Review of toxicological studies in animals

• Safety decision using “formal rulemaking”(i.e., publication in the Federal Register withrights of review)


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Toxicological Testing…the FDA/CFSAN “Redbook”

Minimum Toxicity Tests

ordinarily required

“Concern Levels”

I II IIIShort-term tests for genetic toxicity X X X

Metabolism & pharmacokineticstudies

X X

Short-term tox tests with rodents X

Subchronic tox tests with rodents X X

Subchronic tox tests with non-rodents

X

Reproduction study w/ teratologyphase

X X

One-Yr tox tests with non-rodents X

Carcinogenicity study with rodents X

Chronic tox/ carcinogenicity studywith rodents

X

FDA Safety Evaluation(the “Cliff’s Notes” Version)

• Conservative estimation of probable consumerexposure to the additive (EDI based on lifetimeaverage “eaters only” estimates using serving sizes,freq. of eating, and concentration in the food)

• FDA review of toxicological studies in animals (HNELfrom chronic studies and “thresholds” for toxiceffects)

• Application of appropriate “Safety Factors” or“uncertainty factors” (10X [species extrapolation],10X [human variation] to get the ADI)

• Safety decision by comparing ADI to EDI (noanticipated adverse effects at human consumptionlevels)

EDI: Estimated daily intake mg/kg bw/d in humans;HNEL: Highest no-effect level mg/kg bw/d in animals;ADI: Acceptable daily intake mg/kg bw/d in humans

The fundamental “Safety Criterion”

• The “EDI” must not exceed the “ADI.”

EDI and ADI are “decision benchmarks”

Both are very conservative estimates.

In reality, people’s actual exposures areoften far below the EDI.

To Cover:


never change…”


decision making”


GRAS uses of Stevia and SGFE

Examples

The food additives :

Aspartame

Acesulfame-K

Sucralose

GRAS Ingredients:

Stevia; SGFE


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Examples


Aspartame

Acesulfame-K

Sucralose

GRAS Ingredients:

Stevia; SGFE

Aspartame

• Discovered in 1965 by G. D. Searle’schemist James Schlatter

• Initial FDA approval in 1974 for dry food use

• OK’d for soft drink use in 1983

• ADI in the U.S.: 50 mg/kg bw/day

Controversy from Day 1

• Objections filed upon first FDA approval in1974

• FDA convenes a Public Board of Inquiry 1980

• 1983 Aspartame OK’d by FDA for soft drinkuse

• 1985 Consumer complaints; CDC analyzes

• 1987 GAO report: “FDA followed properprocedures in approving aspartame and inmonitoring aspartame safety.”

Recent Challenges toAspartame Safety

• Studies by Dr. Morando Soffritti of theCesare Maltoni Cancer Research Center, of theEuropean Ramazzini Foundation of Oncologyand Environmental Sciences in Bologna, Italy

• Published in 2005, 2006, and 2010

• Not all the data were made available, including,at times, some histopathology slides

Nevertheless, after reviewing thenew data:

• Both FDA and the European Food SafetyAuthority concluded that there is no reason torevise the previously established ADI forAspartame.

• In response to updated Ramazzini data of2009, EFSA stated that there is no indicationof carcinogenic or genotoxic potential, and noreason to change the ADI.

• After 2010 studies of Saffritti and Halldorsson,EFSA again reaches the same conclusion.


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Recent review paper:

• Berna Magnuson et al, Critical Reviews ofToxicology, 2007 37(8) pp 629-727:“Aspartame: a safety evaluation based oncurrent use levels, regulations, andtoxicology and epidemiology studies.”

FDA’s 2006 statement onAspartame

• “To date….the agency has not beenpresented with scientific information thatwould support a change in our conclusionsabout the safety of aspartame. Thoseconclusions are based on a detailed reviewof a large body of information, includingmore than 100 toxicological and clinicalstudies regarding the sweetener's safety.”

Examples


Aspartame

Acesulfame-K

Sucralose

GRAS Ingredients:

Stevia; SGFE

1988

Acesulfame-Potassium,Acesulfame-K (or simply, “ACK”)

• ACK discovered accidentally in 1967 by KarlClauss of Hoechst.

• ACK first permitted for use as a nonnutritivesweetener in food in July 1988 for “dry fooduses.” (53 FR 28379, 28380 and 28381)

• Hoechst Celanese Corp. (currently Nutrinova, Inc.)petitioned FDA for use of ACK in nonalcoholicbeverages in 1990

Expansion of ACK use to nonalcoholicbeverages raised new issues

• A particular breakdown product of ACK inacidic beverages, i.e., acetoacetamide,presented potential toxicological safetyconcerns to FDA

• Even though this chemical is NOT theprimary additive….

• The FD&C Act Sec. 409(c)(5)(a) addresses“…any substance formed in or on foodbecause of the use of the additive”


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FDA’s conclusions:

• These concerns were ultimately resolved,however, by FDA conducting an in depth riskassessment on the compound

• FDA approved ACK for use in non-alcoholicbeverages in 1988. Final Rule published July6, 1998, (83 FR 36344-36365)

Examples


Aspartame

Acesulfame-K

Sucralose

GRAS Ingredients:

Stevia; SGFE

1998 Sucralose timeline

• Original petition filed by McNeil SpecialtyProducts Co. in May 1987.

• Final rule permitting use published byFDA in April 1998.

• Almost 11 years under FDA review….

Principal Factors in theSucralose Safety Review

• Identity

• Intake estimates

• Toxicology testing

• The ADI -- EDI comparison

• Special Studies (diabetics)

• Final Safety Judgment

During the Safety Review FDArequired additional studies

• Six new studies to resolve an issue with thegrowth rate and body weight gain of the testanimals; and

• Five new studies to resolve an issueconcerning blood glucose homeostasis as apotential issue for glucose control indiabetics.


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Sucralose Final Rules

• Regulation permitting sucralose to beused as a sweetener in a wide variety offoods, including beverages, waspublished in Fed. Reg. of April 3, 1998.

• Subsequently this was expanded toinclude general use in food, limited onlyby cGMP, in 64 FR 43909, Aug. 12, 1999.

Examples


Aspartame

Acesulfame-K

Sucralose

GRAS Ingredients:

Stevia; SGFE

What is the GRAS concept ?

How is it similar to, and how does it differfrom, FDA’s traditional pre-market safetyevaluation process for food and coloradditives ?

“G R A S”generally recognized as safe

“GRAS” and Fed. Food, Drug, andCosmetic Act definition of “food additive”

201(s): “…any substance, the intendeduse of which results or may reasonablybe expected to result, directly orindirectly, in its becoming a componentor otherwise affecting the characteristicsof any food…

if such substance is not generallyrecognized, among experts qualified byscientific training and experience…to besafe under the conditions of its intendeduse”

What is different about theGRAS process?

• While the safety standard is the same as forfood additives (RCNH)….

• Information must be widely publicly disseminated,and

• there also must be a basis to conclude that thereis a consensus among qualified experts that theproposed use is safe.

• As noted, this approach is permitted by the FD&CAct, and represents an exemption to the FDA pre-market review and approval procedures.

FDA’s “GRAS Notice”* Procedures

• Submitter sends a GRAS “Notice” to FDA assertingGRAS status for a use of a food ingredient

• Notice Includes all relevant safety data

• Notice shows that these data are in the publicdomain and are not only “known” by, but alsoaccepted by, a consensus among qualifiedscientists

• Notice may contain a report by an Expert Panel thathas vetted and supports the submitter’s conclusions

* GRAS notices are submitted to FDA under its proposed rule of April 17,1997, published in the Federal Register at 62 FR 18938-18964. Comment Periodre-opened on December 28, 2010; comments were due by March 28, 2011.


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Safety Evaluation(applicable to many GRAS situations)

• Conservative estimation of probable consumerexposure to the additive (EDI based on lifetimeaverage “high eaters only” estimates using servingsizes, freq. of eating, and concentration in the food)

• FDA review of toxicological studies in animals (HNELfrom chronic studies and “thresholds” for toxiceffects)

• Application of appropriate “Safety Factors” or“uncertainty factors” (10X [species extrapolation],10X [human variation] to get the ADI)

• Safety decision by comparing ADI to EDI (noanticipated adverse effects at human consumptionlevels)

EDI: Estimated daily intake mg/kg bw/d in humans;HNEL: Highest no-effect level mg/kg bw/d in animals;ADI: Acceptable daily intake mg/kg bw/d in humans

FDA’s response to a GRAS Noticeand Expert Panel Opinion

• No final rule in the Federal Register orregulation in the Code of Federal Regulations

• FDA does not necessarily make its own agencydecision about the safety of the use of theingredient

• Rather, by letter FDA acknowledges theconclusion of the independent Panel andcommunity of experts, and may indicate that it“has no further questions at this time….”

• Ingredient is “safe and lawful in use” based onsubmitter’s assertion of GRAS

Chemical Structure of

Rebaudioside-Aa steviol glycoside from…

…leaves of the Stevia rebaudiana,plant

Stevia was the subject of a 2008“G R A S Notice” to FDA

• Initial submitters of GRAS exemption claimsfor stevia made use of FDA’s voluntaryGRAS Notice Process

• The first GRAS exemption claims for steviawere submitted to FDA in May 2008

Principal Factors in thesubmitters’ stevia safety dossiers

• Identity, manufacture, and purity specifications



– ADME**; Animal feeding studies

– Human clinical data including BP and bloodglucose homeostasis data

• ADI -- EDI comparison

• Final Safety Judgment by GRAS notice submittersincluding Expert Panel opinions

** Absorption, Distribution, Metabolism, Excretion

Stevia has been the subject ofnumerous G R A S Notices to FDA

GRAS Notice No. Date of FDA Response Letter

GRN 252; Whole Earth Sweetener,Co.

December 17, 2008

GRN 253; Cargill, Inc. December 17, 2008

GRNs 278, 282, 303, 318, 329, 348,354, 365, 369, 380, 388, 393, and418

Between July 2009 and June 2012

Typical FDA response letters conclude that, “the agency has no questionsat this time.”

The time frame from submission to FDA response is months, not years.


2/8/2013


Chemical Structure of

Siraitia grosvenoriiprincipal

sweetening component

Mogroside V(a.k.a. “Monk Fruit” extracts)

SGFE

Principal Elements in thesubmitters’ SGFE safety dossier

• Identity, manufacture, and purityspecifications



• ADI -- EDI comparison

• Final Safety Judgment by GRAS noticesubmitters including Expert Panelopinions

SGFE has been the subject oftwo G R A S Notices to FDA

GRAS Notice No. Date of FDA Response Letter

GRN 301; J Heimbach, LLC (BioVittoria, Ltd.)

January 15, 2010

GRN 359; Cantox Health Sciences,Intl., (Guilin Layn Natural Ingreds.Corp.)

April 11, 2011

THANK YOU !

….looking forward to yourQUESTIONS…

No, Low and ReducedCalorie Sweeteners:

Hot Topics From A - Z

Tuesday, February 12, 2013

Presented by Robyn Flipse, MS, MA, RD

Sponsored by The Calorie Control Council

SUGAR

OR SUBSTITUTES?


2/8/2013


Objectives for Clinical Application● Identify distinct features of approved no, low, reduced calorie sweeteners available today and those in development

● Review intake trends for caloric sweeteners and no, low, and reduced calorie sweeteners, and the current dietary guidelinesfor them

● Recognize populations with any restrictions in their use of no, low and reduced calorie sweeteners

● Explore benefits of no, low and reduced calorie sweeteners based on available evidence

Objective #1:

Identify distinct features ofapproved no, low and reducedcalorie sweeteners availabletoday and those in development

Other Terms for “Sweeteners”

● Natural sweetener ● Sugar alcohol

● Synthesized sweetener ● Polyglycitol

● Alternative sweetener ● Polyol

● Sugar replacer ● High-intensity sweetener

● Sugar substitute ● Intense sweetener

● Artificial sweetener ● No calorie sweetener

● Low calorie sweetener ● Non-nutritive sweetener

● Reduced calorie sweetener ● Noncaloric sweetener

Approved Terms for “Added Sugars”on Ingredient Lists

● Anhydrous dextrose ● Lactose

● Brown sugar ● Malt syrup

● Confectioner’s powdered sugar ● Maltose

● Corn syrup ● Maple syrup

● Corn syrup solids ● Molasses

● Dextrose ● Nectars

● Fructose ● Pancake syrup

● High fructose corn syrup ● Raw sugar

● Honey ● Sucrose

● Invert sugar ● White granulated sugar

http://www.choosemyplate.gov/weight-management-calories/calories/added-sugars.html

Other Terms for “Added Sugars”Not Recognized by FDA as Ingredients

● Agave nectar ● Fruit nectar

● Beet sugar ● Glucose

● Cane juice ● Liquid fructose

● Cane sugar ● Rice sugar or syrup

● Crystal dextrose ● Sugar cane juice

● Evaporated corn sweetener ● Sorghum syrup

● Fruit juice concentrate ● Table sugar

J Acad Nutr Diet. 2012;112(5):739-758J Acad Nutr Diet. 2012;112(11):1828-1834

Features of Intense Sweeteners in UseIntense Sweetener FDA

ApprovedGRAS Sweetness

X SugarADI1

mg/kg BWEDI2

mg/kg BW

Acesulfame Potassium √ 200 15 0.2-1.7

Aspartame √ 160-220 50 0.2-4.1

Monk Fruit Extract(luo han guo)

√ 150-300 NotEstablished

6.8

Neotame √ 7000-13,000

18 0.05-0.17

Saccharin √ 300 5 0.1-2.0

Stevia(steviol glycosides)

√ 250 43 1.3-3.4

Sucralose √ 600 5 0.1-2.0

3 As established by the JECFA

2 Estimated Daily Intake is derived from the amount of the additive to be added to foods, assuming 100% replacement of sugars andother nonnutritive sweeteners, and the typical consumption of those foods by people of different ages and health status.

1 Acceptable Daily Intake is a value 100 times greater than the amount found to be the highest amount with no effect andconsistent with the FDA standard “reasonable certainty of no harm.”


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How Much Sweetener Can You Use?

Sweetener ADImg/kg BW

Tabletopmg/packet

Beveragesmg/ounce

150 lb (68 kg) person/dayTotal mg packets ounces

Acesulfame K 15 50 4 1020 20 240

Aspartame 50 34 16 3400 100 213

Neotame 18 Notavailable

Notavailable

1224 Not Notavailable available

Saccharin 5 23 3 340 15 113

Stevia (steviolglycosides)

GRAS or41

27 3 272 10 91

Sucralose 5 11 5 340 31 68

Monk FruitExtract

GRAS Notavailable

Notavailable

Not Not Notavailable available available

1 Determined by Joint Expert Committee on Food Additives of the Food and Agriculture Organization and World Health Organization

Color-coded Table-top Sweeteners

Pink =Saccharin

Green = Stevia

Blue =Aspartame

Yellow = SucraloseOrange = MonkFruit Extract

Features of Polyols in UsePolyols FDA

ApprovedGRAS Sweetness

x Sugar1

EstimatedThresholds2

Erythritol √ .60-.80 40 g

Isomalt √ .45-.65 40 g

Isomaltulose √ .50 Not available

HydrogenatedStarch Hydrolysates(HSH)

√ .25-.50 Varied dependingon mix of polyols

Lactitol √ .30-.40 30 g

Maltitol √ .90 40 g

Mannitol √ .50-.70 20g

Sorbitol √ .50-.70 30 g

Xylitol √ 1 30 g

1J Acad Nutr Diet. 2012;112(5):739-7582 Am J Clin Nutr. 1995;62(suppl):1161S-1168S

New & Novel Sweeteners in DevelopmentNameGeneric/Brand

Composition SweetnessX sugar

Status

Alitame/Aclame™ L-aspartic acid + D-alanine 2000 FDA petition declined in 1986; notcurrently under review in US

Brazzein/Cweet™ Protein from fruit of W. African Oubliplant

500-2000 Patent to genetically engineer it intomaize, then extract it

Curculin Protein from fruit of Malaysian plant 430-2070 Not legal in US; approved in Japan

D-Tagatose Naturally occurring monosaccharidefound in dairy products

.75 - .92 GRAS; ADI 15g/50 kg/d; EDI 7.5g/d

Glycyrrhizin Glycoside found in licorice root 30-50 GRAS as a flavoring agent in US, not assweetener

Mabinlin Proteins extracted from seed ofChinese plant

10 Not approved in US

Miraculin Glycoprotein from berry ofW. African plant

Not sweet, but ataste-modifier

Denied GRAS status in US, no FDAapplication

Monellin Protein from fruit of W. African shrub 800-2000 Not legal in US; approved in Japan

Neohesperidindihydrochalcone

Glycoside derived from citrus 340 Not approved in US; approved by EFSA

Pentadin Protein from fruit of W. African Oubliplant

500 Not approved in US

Thaumatin Mixture of proteins from W. Africankatemfe fruit

2000 GRAS as flavor enhancer in US; approvedby EFSA, Israel, Japan

Trehalose/Ascend™ Alpha-linked disaccharide naturallyfound in rye fungus

.45 GRAS in US; inexpensively made fromstarch in Japan

Objective #2:

Review intake trends forcaloric sweeteners and no,low, and reduced caloriesweeteners, and the currentdietary guidelines for them

Use of Caloric and Noncaloric Sweeteners in USConsumer Packaged Foods, 2005-2009

85,451 unique processedand packaged food andbeverage products wereidentified that were notraw, single ingredients, orduplicate products indifferent sizes.

17 distinct food and beveragecategories contained some type ofsweeteners.

77% of the caloriespurchased containedcaloric sweetener, 3%noncaloric sweetener, 23%had no sweeteners.

73% of the volume offoods purchasedcontained caloricsweetener, 15%contained noncaloric.

Most commonly used Caloric Sweeteners:o Corn syrupo Sorghumo Caneo High fructose Corn Syrupo Fruit Juice Concentrate

Most common Noncaloric Sweeteners inDiet Beverages:o Acesulfame potassiumo Aspartameo Sucraloseo Saccharin

J Acad Nutr Diet. 2012;112(11):1828-1834


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Figure 3

Copyright © 2012 Academy of Nutrition and Dietetics Terms andConditio

Containing Any Caloric Sweeteners (CS)—▪— % Total calories purchased containing any CS

—▪— % Total volume purchased containing any CS

Containing Any Noncaloric Sweeteners (NCS)—^— % Total calories purchased containing any NCS—●— % Total volume purchased containing any NCS

Trends in the proportion of total calories and total volumeof consumer packaged goods purchased during 2005-2009that contain any caloric sweetener and any noncaloricsweetener

J Acad Nutr Diet. 2012;112(11):1828-1834

Closing the Sugar Gap withNo, Low and Reduced Calorie Sweeteners

NHANES1999-2000 2007-2008

Dietary Guidelines2005 2010

AHA/ADA2009

% total energy fromadded sugars/day 18.1 14.7 8 5 - 15 5 - 7

grams of addedsugar/day 100.1 76.7 32 24 - 32 24 - 36

teaspoons of addedsugar/day 25 20 8 6 - 8 6 - 9

Small Changes Can Lead to Big Results

“A habitual energy imbalance of about 50-100kcal per day may be sufficient to cause thegradual weight gain seen in most persons.This means unintended weight gain occurseasily but also that modest, sustained changesin lifestyle could mitigate or reverse suchenergy imbalance.”

N Eng J Med 2011;364-2392-2404

Calories Saved withNo, Low and Reduced Calorie Sweeteners

Product Calories In Place of Caloriessaved

Table-top sweetener (one packet) 0 Sugar (2 tsp) 32

Fat-free, light yogurt (6 oz container) 80 Fat-free yogurt 95

Sugar-free syrup (1/4 cup) 20 Syrup 180

Sugar-free preserves (1 tbsp) 10 Preserves 40

Sugar-free pudding (1/2 cup) 60 Pudding 70

Sugar-free gelatin (1/2 cup) 10 Gelatin 70

Diet soda (12 oz) 0 Regular soda 140

Light cranberry juice cocktail (8 oz) 0 Cranberry juicecocktail

90

Objective #3:

Recognize populations withany restrictions in their use ofno, low and reduced caloriesweeteners

Children and Pregnant Women• FDA approval covers the entire population

• Toxicology testing is done on males, females and the developingfetus. Appropriate animals models are used

• Saccharin crosses the placental barrier, but “there is no evidencethat saccharin effects reproduction or the fetus in animalstudies”1

• Diabetes in pregnancy requires nutrient density without highcarbohydrate intake or excess calories

• Using ADI, children could have higher intakes due to theirrelatively smaller size and high food and fluid intake

• Polyols are naturally found in foods and in common medicines

1 Samuel M. Cohen, Ph.D., Professor and Chair, Pathology and Microbiology, Havlik-Wall Professor of Oncology,

University of Nebraska School of Medicine


2/8/2013


Phenylketonuria

• Aspartame (Equal, Nutra-sweet) is composed

of the amino acids phenylalanine and aspartic acid

• Phenylalanine is widely found in protein-rich foodsand all dietary sources must be controlled for PKU

• 6000 consumer products worldwide containaspartame

• Products in US and UK must have label statement,“Phenylketonurics: Contains Phenylalanine”

• PKU in US is 1 in 15,000 births

http://emedicine.medscape.com/article/947781-overview

Diabetes, Impaired Glucose Toleranceand Hypoglycemia

• All are managed, in part, by control of the type andamount of carbohydrate in the diet

• No and low calorie sweeteners have no impact onglucose and insulin levels, though bulking agents may

• Polyols are absorbed more slowly than glucose orsucrose so have a lower postprandial glucose response

• Polyols have a low glycemic index

• Polyols provide an average of 2 calories per gram

• Half the polyols (and fiber) are counted as “Net Carbs”

J Am Diet Asso.2008;108(4):S34-S39Nutr Res Rev. 2003;16:163-191

Adaptation to Polyols

• Best if consumed in a solid form with a meal

• Introduce slowly, like adding more fiber to the diet

• Easier to tolerate if eaten in small amountsthroughout the day

• Allow for differences in gastrointestinal motility,transit time, enzymatic activity, gut microflora

• Consider pre-existing GI conditions (celiac disease,irritable bowel syndrome, lactose intolerance)

Objective #4:

Explore benefits of no, lowand reduced caloriesweeteners based onavailable evidence

Hunger, Appetite, and Weight Control:

• Available evidence indicates nonnutritive sweeteners do notaffect appetite in adults, while there are insufficient studies inchildren to draw a conclusion

• Nonnutritive sweeteners do not increase food intake in adultsor children and can create a modest energy savings if used inplace of sugar-sweetened products

• When used in place of more energy dense foods, nonnutritivesweeteners can improve diet quality and weight management

www.andevidencelibrary.comJ Acad Nutr Diet 2012;112(5):739-757

Diabetes Management andGlycemic Response• Nonnutritive sweeteners were not found to raise plasma

glucose, insulin, HbA1c or C-peptide in subjects with diabetesmellitus or non-diabetic subjects

• Most low and no calorie tabletop sweetener packets containbulking agents that are a source of carbohydrates so they mayraise plasma glucose levels if consumed in large enoughquantities

• The substitution of nonnutritive sweeteners for nutritivesweeteners in foods, beverages or recipes that contain otherglycemic ingredients does not modify the effect of thoseingredients

Diab Care. 2012;35(8):1798-1808Position of the Academy of Nutrition and Dietetics: Use of Nutritive and Nonnutritive Sweeteners J Acad Nutr Diet2012;112(5):739-757


2/8/2013


Diet Quality and Dental Health• Regular users of diet soda had several markers of healthier diets,

including higher intakes of fruits, vegetables, whole grains, low fat dairyproducts and less saturated fat and sodium 1

• The biggest consumers of diet beverages were white males and femalesbetween 20-59 years of age with higher education and higher income,who were more physically active and either trying to lose weight or notgain weight2

• A meta-analysis conducted by the American Dental Association foundxylitol effective in preventing and reducing the occurrence of dentalcaries3

• A health claim that sweeteners do not promote dental caries has beenapproved for sugar alcohols, erythritol, D-tagatose, sucralose, andisomaltulose4

1 Diab Care. 2009;32:688-694.2 Drewnowski & Rehm 2012, unpublished3 J Food Sci. 2005;70(1), S42-S46.4 J Am Diet Asso. 2006;106(12):1992-2000

ConclusionHuman beings have an innate preference for

sweet tasting foods and beverages

Excess calories from all sources contribute toweight gain and obesity

Added sugars are widely available, making iteasier to consume more of them

Alternative sweeteners are available that can givefoods and beverages a sweet taste with fewercalories

No, low and reduced calorie sweeteners can beused to replace some caloric sweeteners in orderto reduce total caloric intake

Thank you

Robyn Flipse, MS, MA, RD

Nutrition Communication Services

www.Robyn Flipse.com

Question & Answer• We will begin the Q & A with the questions

submitted during the program

• You can continue to submit using theQuestions Pane

• We will post the answers to unansweredquestions on the DCE website(www.dce.org)

Post-Webinar Survey & CPEU• You will be receiving an email within the

next 24 hours that contains a link to thepost-webinar survey

• Upon completion of the survey, you will bere-directed to another link to obtain yourCertificate of Completion

• Deadline to complete the survey :February 19, 2013

One week after the webinar!

Our next DCE Webinar“Diabetes and Depression:

Using an integrated care approach to helpimprove diabetes outcomes”

Date/Time

Tuesday, March 19th

12 noon Central Time

Presenters

Chris Beamish, MSW, LICSW

Laura Nielsen, Psy.D., LP

Watch for details in DCE Updates & www.dce.org

special thank you to diabetes care and education workgroup...

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