Natural Health Products in a Global Marketplace: Scientific and Regulatory Perspectives

Joseph M. Betz, Ph.D.

Office of Dietary Supplements

U.S. National Institutes of Healthhttp://dietary-supplements.info.nih.gov

Overview

Dietary Supplement OverviewIntroduction to RegulationsIntroduction to National Institutes of HealthOverview of ODS Programs

Dietary Supplements in 2001: $17.7 Billion

$4.1

$1.5

$1.2 $5.8

$3.8

Source: NBJ, derived from a variety of sources

Vitamins Minerals

Herbs / Botanicals

Sports NutritionOther Supplements

Top 10 Dietary Supplementsfor 2005

Multivitamins/mineralsCalciumB vitaminsVitamin CGlucosamine/ChondroitinVitamin EFish oilsCoenzyme Q10Noni juiceProbiotics Nutrition Business Journal

• General health/good for you (16%)• Arthritis (7%)• Memory improvement (6%)• Energy (5%)• Immune booster (5%)• Joints (4%)• Supplement diet (4%)• Sleep aid (3%)• Prostate (3%)• No reason (2%)• All other reasons (45%)

JAMA, 2002

Ten Most Common Reasons for Taking Supplements

(The Slone Survey)

Traditional (Herbal) Medicine in the U.S.

Practice of medicine and the licensing of physicians are regulated by the 50 individual states

National laws deal mostly with products• U.S. Food and Drug Administration (FDA)

FD&C Act

ProductsFoods, dietary supplements, or drugs

based on “intended use”• e.g Psillyium husk can be a food, dietary

supplement or drug• Applicable regulations for the category apply

Intended use is ascertained by accompanying labeling claims, advertising materials, or oral or written statements

Botanical Drugs

Intended use to cure, treat, mitigate, etc.Subject to current drug regulations

– Pre-market approval for GRASE

Unique qualities recognized by the FDA– inherently more complex than synthetics– more likely to be components in mixtures– active constituents and activity not always

well defined

DSHEA(Dietary Supplement Health and Education Act - 1994)

• Amended the FD & C Act• Defined dietary supplements• Established regulatory framework

• Food and Drug Administration (FDA)• As foods, not as drugs

• Established rules for what a label should contain• Gave FDA authority to write GMP• Called for creation of the Office of Dietary

Supplements– Placed it in the Office of the Director at the National

Institutes of Health

Dietary Supplement

• “...any product (other than tobacco) that contains a vitamin, mineral, herb, or other botanical or amino acid and is intended as a supplement to the diet.”

• A concentrate, metabolite, constituent, or combination of the above– Prior to DSHEA, most botanicals treated as

food additives or as drugs• Approved, unapproved

Dietary Supplement Foods, therefore safe by definition

• No premarket safety approval except “new dietary ingredients” (75 day notification)

Statements of Nutritional Support (“Structure/Function”) claims permitted• No premarket approval for efficacy required (30 day

notification) Disease claims prohibited Intended for ingestion NOT REPRESENTED AS CONVENTIONAL

FOODGuide to Dietary Supplements

http://vm.cfsan.fda.gov/~dms/dietsupp.html

New Dietary Ingredients

• Not marketed in U.S. prior to 10/15/94• Not a new ingredient:

– If ingredient was “in the food supply… in a form... not chemically altered”

• No list of “FDA approved” ingredients• Mfr. Determines whether “new”

– notifies FDA 75 d pre-market

• Exempt from food additive provisions

Dietary Supplements

• 21 CFR Part 111• Current Good Manufacturing Practice in

Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements; Final Rule

• Published June 25, 2007• http://www.cfsan.fda.gov/~lrd/fr07625a.html

Dietary Supplements

• 21 CFR Part 111– Requires manufacturers to set specifications– Requires manufacturers to test to see if

specifications are met using “scientifically valid” methods

General Provisions

• CGMP applies to activities associated with– manufacturing– packaging– holding– distributing

• Manufacturer needs to comply with requirements applicable to operations performed– contractor needs to comply with applicable

requirements and– contracting firm responsible for contractor’s

performance

Proposed Requirement Highlights

• Personnel

• Physical plant internal environment

• Equipment and utensils

• Production and process controls– quality control unit– master manufacturing & batch production records

Public Law 109–462

• Dietary Supplement and Nonprescription Drug Consumer Protection Act– http://www.fda.gov/opacom/laws/pl109462.html– 22 Dec 2006, took effect Dec 2007

• Mandatory Serious Adverse Event Reporting for OTC drugs and Dietary Supplements– Manufacturer must provide a mechanism for

reporting (reports to manufacturer)– Manufacturer must report serious events to FDA

Public Health Security and Bioterrorism Preparedness and Response Act of

2002

• Signed into law June 12, 2002

• Relevant Provision is Title 3: Protecting Safety and Security of Food and Drug Supply.

• Title 3 contains 15 sections with relevant provisions to the DS industry.

Homeland Security

• SECTION 303: Administrative Detention– FDA may order the detention of foods when credible

evidence exists that they present a threat of serious adverse health consequences or death to humans or animals

• SECTION 305: Registration of Facilities– Requires that any facility engaged in manufacturing,

processing, packaging or holding food for consumption in the U.S. register with the Secretary

Homeland Security• SECTION 414: Maintenance/Inspection of Records

– Companies and individuals involved in any aspect of food production must make and keep records

– If FDA suspects dangerous adulteration, records must be made available

• SECTION 307: Prior Notice of Imported Food Shipments– Require submission of prior notice of arrival providing

each of the following:• Identity of: article, manufacturer and shipper, grower,

country of origin, country from which article is shipped, port of entry

– Articles failing to meet these requirements shall be refused admission to the U.S

The National Institutes of HealthThe National Institutes of Health

DSHEA and the NIH

• DSHEA called for creation of the Office of Dietary Supplements

• Placed at the National Institutes of Health in the Office of the Director

• Formally established in 1995

• Strategic planning process guided the first few years of its activities

NIH is the Nation’s Medical Research AgencyNIH is the Nation’s Medical Research Agency

• 27 Institutes and Centers• Total NIH Budget for 2006: $28 billion • Grants, Contracts, Cooperative Agreements • Department of Health & Human Services

www.nih.gov

Research

• Intramural- “in-house” at Institutes

• Extramural– Grants, Cooperative Agreements, Contracts

• http://grants.nih.gov/grants/funding/funding.htm

– More than 80% of the NIH budget– Subject to competitive review

• Investigator-initiated • Request for Application (RFA)

The Primary Function of NIH is to The Primary Function of NIH is to Conduct and Support Medical ResearchConduct and Support Medical Research

• 65% Basic Research

• 25% Translational• 15% Clinical

NIH Funding for Dietary Supplement NIH Funding for Dietary Supplement Research Has Increased SignificantlyResearch Has Increased Significantly

0

50

100

150

200

250

300

1999 2000 2001 2002 2003 2004 2005

$ Million$ Million

THE OFFICE OF DIETARY

SUPPLEMENTS

ODS Mission is to Strengthen ODS Mission is to Strengthen Knowledge and Understanding of Knowledge and Understanding of

Dietary SupplementsDietary Supplements

– Evaluate Scientific Information

– Stimulate and Support Research

– Disseminate Research Results

– Educate the Public to Foster an Enhanced Quality of Life and Health for U.S. Population

EchinaceaEchinaceaEchinacea purpureaEchinacea purpurea

Office of Dietary SupplementsFY 2003 $23.0 M

29%

22%4%

12%

5%

5%

15%

2%6%

Centers ProgramGrantsDatabasesAdministrativeNHANESEvidence ProgramAnalytical MethodsConferencesTraining

• Co-funding with NIH Institutes

• Evidence-Based Reviews

• Botanical Research Centers

• Training

• Analytical Methods and Reference Materials

• Communications and Information

ODS Has a Broad Array of ProgramsODS Has a Broad Array of Programs

St. John’s WortSt. John’s WortHypericum perforatumHypericum perforatum

ODS Activities are Comprehensive and ODS Activities are Comprehensive and GlobalGlobal

• Dietary Supplement Databases

• Surveys of Supplement Use

• International Collaborations

• Workshops, Conferences, Seminars

GinkgoGinkgoGinkgo bilobaGinkgo biloba

RESEARCH AGENDA:Grants

Co-funded with NIH

ICs

ODS Grant “Portfolio”

Growth of ODS co-funded grant portfolio:• 1996: 6 grants initiated, $300,000• 2002: 39 grants initiated, total of 59 (new and

continuing), $9.3 million• 2003: total of 72 grants, $13.5 million

Broad portfolio: basic, clinical, training Details available on the ODS website

RESEARCH AGENDA:Evidence-

Based Review

Evidence-Based Review Program

• Systematic review of the literature, with meta-analysis as appropriate, on DS efficacy and safety

• In collaboration with the Agency for Healthcare Research and Quality (AHRQ) Evidence-Based Practice Center Network

• Major reason for conducting these reviews is to assist NIH in the development of research agendas

ODS Evidence-Based Review ProgramODS Evidence-Based Review Program

• Chromium and insulin sensitivity*

• Ephedra for weight management and athletic performance enhancement* (with NCCAM)

• Omega-3 fatty acids for cardiovascular disease prevention* (with NHLBI) and other health indications

• Health effects of soy (with NCCAM)

• Antioxidant phytochemicals/B vitamins and neurodegenerative diseases*(with NCCAM)

• Multivitamins/multiminerals and chronic disease prevention (with OMAR)

• Coagulation, diet, and dietary supplements

• Health effects of vitamin D (with multiple partners)*Congressional mandate

Evidence

• Pre-Clinical• Ecologic• Observational• Cohort• Intervention• RCT

Ephedra Efficacy and Safety• Systematic review: weight management and

athletic performance enhancement• All languages, both published and unpublished• Conclusions:

– Modest effect on weight in short term and no evidence of effect on athletic performance

– Some side effects seen in trials, some serious adverse events filed with FDA and to a major ephedra manufacturer

• Released by Secretary of DHHS, Feb 2003– Shekelle P et al, JAMA 289:1537-1545, 2003

• ODS and NCCAM convened expert panel to recommend research agenda based on review

Evidence-Based Review of Vitamin D Evidence-Based Review of Vitamin D in Relation to Bone Healthin Relation to Bone Health

Conducted byUniversity of Ottawa

Evidence-Based Practice Centre

Funded by NIH Office of Dietary Supplements &

Agency for Health Care Research and Quality

Available at

http://www.ahrq.gov/clinic/tp/vitadtp.htm&

the ODS website

Conference ObjectivesConference Objectives

Evaluate available evidence on the efficacy and safety of vitamin D, using the AHRQ evidence-based review titled, Effectiveness and Safety of Vitamin D in Relation to Effectiveness and Safety of Vitamin D in Relation to Bone HealthBone Health as the framework.

Identify gaps in knowledge on the efficacy and safety of vitamin D in general and across the life cycle.

.

Findings from the Evidence Based Findings from the Evidence Based ReviewReview

• Strong evidence that Vitamin D supplementation reduces falls, fractures and bone loss in men and women 60+ y

• Not possible to separate the impact of vitamin D from Ca supplementation— typical amounts used were 700-800 IU Vitamin D/d and 500-1,200 mg Ca/d

• Sparse data on other subgroups

• Difficult to identify a specific blood level of 25(OH) D indicative of optimal bone health in all population subgroups

2003 Conference: Vitamin D and Health2003 Conference: Vitamin D and Health in the 21in the 21stst Century; Bone and Beyond Century; Bone and Beyond

(NICHD & ODS)

Evidence-based Evidence-based ReviewReview

(AHRQ & ODS)

Standard Standard Reference Reference MaterialsMaterials

25-OH D2 and D3

(NIST & ODS)

Vitamin D StatusVitamin D Status

Serum 25-OH D Measures in

NHANES

(NCHS, FDA, ODS)

AnalyticalAnalytical MethodsMethods

DevelopmentDevelopment

D2 & D3 in Foods &Dietary Supplements

(USDA & ODS)

Health Effects of Omega-3 Fatty Acids

• Asthma

• Cancer• Cardiovascular Disease • Cardiovascular Disease Risk Factors• Arrhythmogenic Mechanisms• Child and Maternal Health• Cognitive Function• Eye Health• Type II Diabetes, Rheumatoid Arthritis, and Other

Diseases• Mental Health• Organ Transplantation

Omega-3 Fatty Acids

• 11 reports; 3 EPCs– 9 focused on human studies– 2 focused on animal and in vitro

models– Collaborated on methodological

elements

• Multiple NIH Institutes and Centers• Multiple diseases and risk factors

Omega-3 Fatty Acids

Photo of Menhaden - Courtesy of National Oceanic and Atmospheric Administration (NOAA)

Or

Omega-3 and Cancer

• RAND EPC (MacLean CH, JAMA 295:403, 2006)– Tumor incidence: prospective

cohort studies– Clinical outcomes: RCTs– Tumor behavior: animal, cell culture

studies

Omega-3 and Tumor Incidence

• 19 prospective cohorts, 11 cancers– Breast: 2 significant (1 positive, 1

negative), 5 not significant– Lung: 2 significant (1 positive, 1 negative),

4 not significant

• Supported by another systematic review (Hooper L, BMJ 332:752, 2006)

Health Effects of Omega-3 Fatty Acids

• Secondary CVD Prevention– Reduces all cause mortality and

other CVD outcomes (sudden death, cardiac death, MI)

• Primary CVD Prevention– Large, consistent beneficial effect

found for serum triglyceride levels– Little or no effect found for other

CV risk factors and markers of CVD

Omega-3 Reports

•Heterogeneous data; challenging to evaluate– Methods of estimating fish or

omega-3 fatty acid intake– Background diets– Methods of reporting results

•Adverse events from clinical studies appear to be minor– However, AERs not reported

in a systematic way

From Concept to Research: Chromium

Conference (1999)

Evidence-based Review (2000)

Initiative (2001)

Funding (2001-2004)

• Chromium and Insulin Action • Chromium Enhancement of

Insulin Signaling• Chromium Effects in Impaired

Glucose Tolerance• Chromium Picolinate in the

Metabolic Syndrome• Elucidating the Biochemistry of

Chromium III• Novel Method for Chromium

Analysis in Biological Fluids• Adjuvant Therapy for Vascular

Inflammation in Diabetes

Systematic Reviews for Nutrition Topics

• Applications– Research Agenda (NIH)– Clinical Practice (ADA)– Nutrient Recommendations

(IOM)– Public Health (Gov’ts)

• Challenges– Heterogeneity– Background Diet– Misgivings

Systematic Reviews for Nutrition Topics

•Questions Paramount•Why Do an EBR?

– Vitamin E and Mortality– Antioxidants and Mortality

•EBRs Inform, but Do Not Dictate

•Keep Them Current

RESEARCH

AGENDA:Analytical

Methods and Reference Materials

Saldahna, LG, Betz, JM, Coates, PM (2004) JAOAC INT 87:162-165

Quality Correct plant Slifman et al., NEJM 339, 806-811, 1998

Correct plant part Plant collected at proper time of year Pathogen free Not filthy or decomposed, not moldy Aflatoxin, pesticide, toxic elements within

acceptable range No extraneous material-prescription drugs, etc. “High quality” raw materials/finished product

• Standardization? Marker Compounds? • Basic research into bioactive compounds needed

Product consistency

LA Times August 31, 1998

“Remedy's U.S. Sales Zoom, but Quality Control Lags St. John's wort: Regulatory vacuum leaves doubt about potency, effects of herb used for depression.”

By TERENCE MONMANEY, Times Medical Writer

ConsumerLab.com December 20, 2002

“1500% Variation Found in Strength of Garlic Supplements: Many labels not helpful, misleading”

Can J Clin Pharmacol (2003) 10(3):114-118“Only two products (of 54) were observed to have a total naphthodianthrone concentrations within 10% of their label claim”

Draves AH, Walker SE

“The Marketplace”

Analytical Methods and Reference Materials

• Part of original ODS Strategic Plan• U.S. Senate language for FY

2002, 03Called for ODS to allocate sufficient funds to speed up an ongoing collaborative effort to develop and disseminate validated analytical methods and reference materials for the most commonly used botanicals and other dietary supplements.

Program Goals• Designed to provide opportunities for

public/private partnership– Establish priorities (botanicals and others)– Identify potential research partners

• Develop, validate, share analytical methods

• Produce, share reference materials• Applications

– Research: characterization of test substances– Industry: implementation of GMPs/product

formulation

Recommendations• Pay attention to basic quality issues

– Identity, contaminants• Accept role of existing frameworks

for methods validation• Accept recommendations of AOAC

DS task group for prioritization of ingredients

Recommendations

• Consensus process: experts, stakeholders

• Proposed a steering committee• Timely output• Program should reward innovation• Define appropriate phytochemical

markers (basic research)• Emphasis on methods for raw

materials

Needs• New methods• Validation of methods for reliability,

accuracy, precision• Calibration standards (reference

chemicals) for methods• Matrix reference materials for

evaluation of method performance• All must be publicly available

Strategic Overview1. Short-term: build the infrastructure to

support development of validated methods and reference materials;

2. Medium-term: fund development of validated methods and reference materials using standard NIH mechanisms;

3. Long-term: make methods and reference materials readily accessible to the user community.

Saldahna, Betz, Coates (2004) JOURNAL OF AOAC INTERNATIONAL 87:162-165

Tactical Approach

• Program with 4 major components– Methods development– Methods validation– Reference materials development– Outreach/dissemination

• Includes education and training

Accomplishments• 8 supplement methods have been approved as

first action Official Methods-7 more expected by March 2008

• Published collaborative studies: – Ephedrine alkaloids in botanicals/dietary

supplements– Ephedrine alkaloids in plasma/urine– Glucosamine in raw materials and finished products– β-carotene in raw materials and finished products2

– Flavonol glycosides in Ginkgo biloba raw materials and finished products

– Campesterol, stigmasterol, and beta-sitosterol in Saw Palmetto raw materials and finished products

Accomplishments

• 9 Published Single Laboratory Validation Studies

• 7 single-laboratory validation studies in progress

• 38 additional ingredients in various stages of study

Reference Materials• Reference Materials being developed by

the ODS program: – Calibration Standards-Single chemical entities

• For construction of calibration curves for quantitative analysis

• For confirming analyte identity

– Matrix Reference Materials-Systematically characterized supplement raw materials & finished products

• Evaluation of analytical methods performance in individual laboratory settings

– No identity reference materials (for now)

Calibration Standards• Mix of research and procurement

– National Research Council (NRC)-Panax ginsenoside RM

– Calibration standard production for methods development

• Echimidine, lycopsamine, n-methyltyramine

– Calibration standards for AOACI validation work• Hypericin, hyperforin, ginkgolides, etc.

– USP Reference Materials• Berberine, hydrastine, β-sitosterol, 6-gingerol, shoagol,

eleutherosides B and E, actein, 23-epi-26-deoxyactein, secoisolariciresinol diglucoside

Matrix Reference MaterialsNational Institute of Standards & Technology

(NIST)

• 5-year project to produce SRMs for 6-8 botanicals-Interagency Agreement (IAG)– NIST, CFSAN, CDER, ODS collaboration– Obtain authentic Botanical Reference Materials

(BRM)– Develop and validate analytical methods for actives

and/or markers– Assign values using the NIST certification approach-

Measure with 2 or more methods/labs– Assign values for heavy metals/pesticides– Issue NIST Certificate of Analysis

National Institute of Standards & Technology (NIST)

• Completed• Ephedra• Ω-3’s in cod liver oil

RM– Ginkgo biloba• β-carotene (carrot oil)• Bitter orange• Multivitamin/mineral

• 2007• Saw palmetto• α-tocopherols• Green tea• Various Vaccinium

berries• Ω-3’s in seed oils• Vitamin D in serum• Vitamins B6, B12 in serum

• Acquisitions in progress (no date available)• St. John’s wort• Black cohosh

Future Directions• Based in part on reviewer

recommendations:– Accelerate methods

development/validation by:• Supporting mechanism for selection,

prioritization, review of methods• Devoting more resources to direct funding of

laboratory work• De-emphasizing Official Methods of Analysis• Concentrating on optimization/Single Laboratory

Validation studies• Engaging ODS Botanical Centers Program with

AMRM

Future Directions• Provide more resources for

development, optimization, and validation of methods and materials for nutrient determination in DS– Systematic review of the state of nutrient

methods

Future Directions• Provide increased resources for tools

that allow laboratories to demonstrate proficiency– Emphasis on evaluation tools for SLV

methods– Expand NIST SRM program– NIST pilot laboratory proficiency program

has begun and is recruiting participants• Provide increased resources for tools

that allow stakeholders to use methods– Calibration standards

Conclusions• Past 5 years have been a time to identify

stakeholders and build an analytical community– Researchers, QA personnel, Contract

Laboratories– Progress is accelerating

• Supplement Methods published in J AOAC Int:– 2000-2001-Zero– 2002-2006-approximately 100

– Challenges remain• Estimated number of unique products projected by

2010 = 40,000

RESEARCH

AGENDA:Dietary

Supplement Ingredient Database

Database of DS Ingredients• ODS held workshops with Federal and academic

researchers, and the private sector to explore the feasibility of developing databases for dietary supplements

• Considerable research funded by NIH and other agencies on dietary supplement use– Depends on accurate measures of intake

• Emerging opportunities for public-private partnership in meeting research needs

• Published in J Nutrition 133: 573S – 634S, 2003• Congressional language (’04)

Progress Toward Analytically Supported Dietary Supplement Database

DSID Dietary Supplement

ingredient Database at ARS

Goal: Analytically Supported Goal: Analytically Supported Dietary Supplement DatabaseDietary Supplement Database

NHANES Label-Based

Dietary Supplement Database

RESEARCH AGENDA:Botanical

Research Centers

Congressional MandateCongressional Mandate Botanicals Initiative 1999Botanicals Initiative 1999

“Establish a botanical research initiativeEstablish a botanical research initiative

with major research institutions in thewith major research institutions in the

United States.United States.”

National Center for Complementary and Alternative MedicineNational Institutes of Health

Office of Dietary SupplementsNational Institutes of Health

What is a Botanical?What is a Botanical?• Whole plants or plant parts (e.g.,

bark, leaves, stems, roots, flowers, fruits, seeds, berries, extracts)

• Medicinal Plants and Foods

• Algae and macroscopic fungiGingerGinger

Zingiber officinaleZingiber officinale

St. John’s WortSt. John’s WortHypericum Hypericum perforatumperforatum

Green TeaGreen TeaCamellia sinensisCamellia sinensis

CranberryCranberryVaccinium Vaccinium

macrocarponmacrocarpon

FlaxseedFlaxseedLinum Linum

usitatissimumusitatissimum

BRC Program ObjectivesBRC Program Objectives

• Build Collaborative Research Teams to Advance Basic Science to Inform Clinical Studies– Characterize Chemical Composition and

Study Their Biological Effects

– Develop and Improve Preclinical Model Systems

• Cultivate the Use of Contemporary Technologies and Innovative Approaches

• Conduct Clinical Studies (optional)

EchinaceaEchinaceaEchinacea purpureaEchinacea purpurea

Botanical Research CentersBotanical Research Centers2005 - 20102005 - 2010

• Multidisciplinary Teams

• Emphasis on Quality Assurance/Quality Control

• Studies of Basic Mechanisms

• Identify Active Constituent(s) and Explore Mechanism(s) of Action

• Clinical Evaluation (optional)

• Thematic Focus With High Public Health Impact

AdministrativeAdministrativeCoreCoreResearch ProjectsResearch Projects

P1P1 P2P2 P3P3

BotanyBotanyPlant SciencesPlant Sciences

““Chemistry”Chemistry” Clinical StudiesClinical StudiesBiostatisticsBiostatistics

Resource CoresResource CoresResource CoresResource Cores

EACEAC

Pilot StudiesPilot Studies

TrainingTraining

Each NIH Botanical Research Center has Each NIH Botanical Research Center has its Own Individual Focusits Own Individual Focus

• University of Illinois at ChicagoUniversity of Illinois at Chicago– Botanicals for Women’s Health Botanicals for Women’s Health

• Purdue University/University of Alabama Birmingham/ Purdue University/University of Alabama Birmingham/ RutgersRutgers– Botanicals for Age-Related Diseases Botanicals for Age-Related Diseases

• Iowa State University/University of IowaIowa State University/University of Iowa– Botanicals and Immune FunctionBotanicals and Immune Function

Each NIH Botanical Research Center has Each NIH Botanical Research Center has its Own Individual Focusits Own Individual Focus

• Pennington Biomedical Research Center/RutgersPennington Biomedical Research Center/Rutgers– Botanicals and Metabolic SyndromeBotanicals and Metabolic Syndrome

• Memorial Sloan Kettering/Cornell/Chinese University Memorial Sloan Kettering/Cornell/Chinese University Hong Kong Hong Kong – Botanical Immunomodulators and CancerBotanical Immunomodulators and Cancer

• Wake Forest/Brigham and Women’s HospitalWake Forest/Brigham and Women’s Hospital– Botanical Lipids and Inflammatory DiseasesBotanical Lipids and Inflammatory Diseases

• Do Soy Isoflavones Have Beneficial Skeletal Effects in Postmenopausal Women?

• Can Black Cohosh Alleviate Menopausal Hot Flashes?

• Do Anthocyanins Improve Insulin Sensitivity?

• Does Echinacea have antiviral activity?

Sample Research QuestionsSample Research Questions

Two EB Articles

• Botanicals for age-related diseases: from field to practice. CM Weaver, S Barnes, JM Wyss, H Kim, DM Morre, DJ Morre, JE Simon, M Lila, EM Janie, and MG Ferruzzi

• Technologies and experimental approaches at the National Institutes of Health Botanical Research Centers. S. Barnes, DF Birt, BR Cassileth, WT Cefalu, FH Chilton, NR Farnsworth, I Raskin, RB van Breemen, and CM Weaver

Multidisciplinary ResearchMultidisciplinary Research

• Collaborative Effort • Make Use of Unique Areas of Expertise• Integrate Activities• Develop Collegial Environment• Recognize Individual Contributions

www.nih.gov

RESEARCH TRANSLATION:

Information Resources

Information Resources

• Conferences/Workshops

• Research Findings

• Fact Sheets– Vitamins, minerals, botanicals

• Bibliographic Database– World literature– Consumer version

"The secret of being tiresome is to tell

everything."-Voltaire