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Tuesday, April 28, 2009

FDA: Teaching Science Concepts and Inquiry with Food

Dietary Supplements

Dr. Kenneth Taylor

Broad Responsibilities

Varied ProductsCommon food and food ingredientsComplex medical & surgical devicesTherapeutic pharmaceuticalsRadiation-emitting consumer and medical products

Varied Regulatory ApproachesReview of safety and efficacy for new drugs and

medical devicesPerformance standards for x-ray machines &

microwave ovensNo prior approval for cosmetics and dietary

supplements

Broad Responsibilities

Where do you think FDA offices are located?

Use clip art to show the location.

Pause Two Minutes for Pause Two Minutes for QuestionsQuestions

Dietary Supplement Health and Education Act of 1994

(DSHEA)

Public Law 103-417

Signed into law October 25, 1994

Congressional Record at 108 Stat. 4325

Intent of CongressIntent of Congress

Limit impediments to marketing Limit impediments to marketing and promotion of dietary and promotion of dietary supplementssupplements

Promote availability of Promote availability of supplements to consumers to supplements to consumers to improve healthimprove health

Promote disseminating Promote disseminating informationinformation

DSHEA Poll QuestionDSHEA Poll Question

Under DSHEA were Under DSHEA were supplements exempted from supplements exempted from regulation?regulation?

Yes Yes NoNo

What DSHEA Didn’t DoWhat DSHEA Didn’t Do

Changed way we regulate Changed way we regulate supplementssupplements

Did not exempt supplements Did not exempt supplements from regulationfrom regulation

Did not limit FDA’s ability for Did not limit FDA’s ability for enforcementenforcement

Did not undermine integrity of Did not undermine integrity of drug development incentivesdrug development incentives

Dietary Supplements Overview

General regulatory framework

Claims

General safety

Interpreting DSHEAInterpreting DSHEA

No legislative historyNo legislative history

Plain language of the statutePlain language of the statute

Statement of AgreementStatement of Agreement

Congressional FindingsCongressional Findings

Balance Congressional intent and Balance Congressional intent and consumer protectionconsumer protection

What is a dietary What is a dietary supplement?supplement?

1)

2)

Please Raise your hand to volunteer

What is a dietary What is a dietary supplement?supplement?

“…“…a product (other than tobacco) a product (other than tobacco) intended to supplement the dietintended to supplement the diet that that bears or contains one or more” bears or contains one or more” designated ingredientsdesignated ingredients

21 U.S.C. 321(ff)(1)21 U.S.C. 321(ff)(1)

““Intended to supplement the diet”Intended to supplement the diet”

DietDiet: “usual food or drink of man”: “usual food or drink of man”

SupplementSupplement: “augment diet to : “augment diet to promote health and reduce risk of promote health and reduce risk of disease”disease”

Dietary IngredientsDietary Ingredients

Vitamin, Mineral, Amino acidVitamin, Mineral, Amino acid

Not limited to “nutritionally recognized”Not limited to “nutritionally recognized”

Herb or other botanicalHerb or other botanical

Any part of a plantAny part of a plant

Dietary substanceDietary substance for for use by manuse by man to to supplement the diet by increasing the total supplement the diet by increasing the total dietary intakedietary intake

Concentrate, metabolite, constituent, extract, Concentrate, metabolite, constituent, extract, or combination of any ingredient aboveor combination of any ingredient above

321(ff)(1)21 U.S.C.321(ff)(1)21 U.S.C.

““Dietary substance for Dietary substance for use by man”use by man”

““of or pertaining to the diet” and of or pertaining to the diet” and “usual food or drink of man”“usual food or drink of man”

Mere presence in the diet does Mere presence in the diet does not confer status as “dietary not confer status as “dietary substance”substance”

Not include harmful substancesNot include harmful substancesFor use in diet of For use in diet of manman

Other RequirementsOther Requirements

A product that is intended for ingestionA product that is intended for ingestion

Pill, capsule, liquid, powder, “other”Pill, capsule, liquid, powder, “other”

Not Not represented for use as represented for use as conventional foodconventional food

Delivery system may resemble Delivery system may resemble conventional food formsconventional food forms

Not a sole item of a meal or dietNot a sole item of a meal or diet

Labeled a “dietary supplement”Labeled a “dietary supplement”21 U.S.C. 321(ff)(2)21 U.S.C. 321(ff)(2)

In the previous slide, the In the previous slide, the word “ingestion” refers to word “ingestion” refers to any route taken into the any route taken into the body.body.

Yes Yes NoNo

““Intended for ingestion”Intended for ingestion”

Ordinary and plain meaning of Ordinary and plain meaning of “ingestion”“ingestion”

Take into the stomach and Take into the stomach and gastrointestinal tract gastrointestinal tract

US v. Ten Cartons, Ener-B Nasal GelUS v. Ten Cartons, Ener-B Nasal Gel, , 888 F. Supp. 381, 393-94 888 F. Supp. 381, 393-94 (E.D.N.Y.), aff’d, 72 F.3d 285 (2d (E.D.N.Y.), aff’d, 72 F.3d 285 (2d Cir. 1995)Cir. 1995)

““Represented as conventional food”Represented as conventional food”

Think “how is it to be used” or Think “how is it to be used” or “what is it a substitute for”“what is it a substitute for”

named a snack or uses another named a snack or uses another common or usual food namecommon or usual food name

uses a standardized food nameuses a standardized food name

uses label uses label representations/pictures that representations/pictures that suggest conventional food usessuggest conventional food uses

““Represented as conventional food” Represented as conventional food” - Examples- Examples

““Supplement soups”Supplement soups”

(Jun. 21, 1999 ltr., Hain Food Group)(Jun. 21, 1999 ltr., Hain Food Group)

““Cereals”Cereals”

(Jun. 5, 2001 WL, US Mills, Inc.)(Jun. 5, 2001 WL, US Mills, Inc.)

Chewing gumChewing gum

Bottled waterBottled water

(Jun. 7, 2001 ltr., Better Health Labs)(Jun. 7, 2001 ltr., Better Health Labs)

Beverages/Drinks?Beverages/Drinks?

Drug Exclusion ClauseDrug Exclusion Clause

Does not include Does not include an articlean article that is an: that is an:approved new drug, antibiotic, or biologicapproved new drug, antibiotic, or biologicauthorized investigational new drug, antibiotic, or authorized investigational new drug, antibiotic, or biologicbiologic

UNLESS “UNLESS “MarketedMarketed as a dietary supplement or as a dietary supplement or as a food before such approval or authorization”as a food before such approval or authorization”

Relevant to OTCs with an approved NDA or IND Relevant to OTCs with an approved NDA or IND under 21 U.S.C 351under 21 U.S.C 35121 U.S.C. 321(ff)(3)21 U.S.C. 321(ff)(3)

Pharmanex, Inc. v. Shalala, No. 2:97CV262K, 2001 WL Pharmanex, Inc. v. Shalala, No. 2:97CV262K, 2001 WL 741419 (D. Utah, Mar. 30, 2001)741419 (D. Utah, Mar. 30, 2001)

Pause Two Minutes for Pause Two Minutes for QuestionsQuestions

New Dietary Ingredients (NDIs)New Dietary Ingredients (NDIs)

Those that were not marketed as a dietary Those that were not marketed as a dietary supplement or a food prior to Oct. 15, 1994supplement or a food prior to Oct. 15, 1994

FDA notification required before introducing FDA notification required before introducing a product with an NDIa product with an NDI

21 C.F.R § 190.621 C.F.R § 190.6

No authoritative list of “old” dietary No authoritative list of “old” dietary ingredients ingredients

21 U.S.C. 350(b)21 U.S.C. 350(b)

New Dietary Ingredients New Dietary Ingredients (NDIs)(NDIs)

The dietary supplement contains only dietary The dietary supplement contains only dietary ingredients that have been present in the ingredients that have been present in the food supply as an “article used for food” in a food supply as an “article used for food” in a form in which the food has not been form in which the food has not been chemically alteredchemically altered

““food" means (1) articles used for food or food" means (1) articles used for food or drink for man or other animals, (2) chewing drink for man or other animals, (2) chewing gum, and (3) articles used for components gum, and (3) articles used for components of any such article. [21 U.S.C. 321 (f)]of any such article. [21 U.S.C. 321 (f)]““chemically altered” – look to chemically altered” – look to Congressional RecordCongressional Record

21 U.S.C. 350b (a)(1)21 U.S.C. 350b (a)(1)

New Dietary Ingredients New Dietary Ingredients (NDIs)(NDIs)

The manufacturer or distributor The manufacturer or distributor submits asubmits a premarket notificationpremarket notification to to FDA that contains history of use or FDA that contains history of use or other evidence of safety other evidence of safety establishing that the NDIestablishing that the NDI “will “will reasonably be expected to be reasonably be expected to be safe”safe” when used as when used as recommended/ suggested in the recommended/ suggested in the product’s labelingproduct’s labeling

21 U.S.C. 350b (a)(2)21 U.S.C. 350b (a)(2)

Dietary Supplement ClaimsDietary Supplement Claims

Structure/Function ClaimsStructure/Function Claims

Health ClaimsHealth Claims

Significant Scientific AgreementSignificant Scientific Agreement

Qualified Health ClaimsQualified Health Claims

DiseaseDiseaseDrug: article intended to treat, cure, Drug: article intended to treat, cure, prevent, mitigate or diagnose a diseaseprevent, mitigate or diagnose a diseaseDisease or Health-Related ConditionDisease or Health-Related Condition““Damage to an organ, part, structure, or Damage to an organ, part, structure, or system of the body such that it does not system of the body such that it does not function properly (e.g. Coronary heart function properly (e.g. Coronary heart disease, or a state of health leading to disease, or a state of health leading to such dysfunctioning (e.g. hypertension)” such dysfunctioning (e.g. hypertension)”

(21 CFR 101.14(a)(5))/21 CFR 101.93(g)(1)(21 CFR 101.14(a)(5))/21 CFR 101.93(g)(1)

““Dietary Supplement Dietary Supplement Claims”Claims”

DSHEA (1994) DSHEA (1994)

Classical nutrient deficiency diseaseClassical nutrient deficiency disease

Effect on Structure or function of the Effect on Structure or function of the bodybody

Mechanism of effect on Mechanism of effect on structure/functionstructure/function

General well-beingGeneral well-being[21 U.S.C. 343 (r)(6)][21 U.S.C. 343 (r)(6)]

STRUCTURE/FUNCTION STRUCTURE/FUNCTION REGULATIONREGULATION

January 6, 2000 Federal Register January 6, 2000 Federal Register (65 FR 1000) [21 CFR §101.93](65 FR 1000) [21 CFR §101.93]

Not limited to serious diseasesNot limited to serious diseasesAct doesn’t distinguish minor vs. Act doesn’t distinguish minor vs. serious conditionsserious conditions

Congress was silent on this Congress was silent on this mattermatter

Caveat for Use of the Rule to Caveat for Use of the Rule to Define Disease ClaimsDefine Disease Claims

Context is Context is CRITICALCRITICAL

A disease claim may be explicit or implicitA disease claim may be explicit or implicit

Not always possible to have absolute Not always possible to have absolute distinctions between disease and non-distinctions between disease and non-disease claimsdisease claims

Need to consider all information in labeling Need to consider all information in labeling and elsewhereand elsewhere

Few claims are likely to be always or never Few claims are likely to be always or never appropriateappropriate

Please Match the Expressed Disease with the Implicit Claim by using clip art.

Arthritis Arthritis Cancer Cancer BPH BPH Fibromyalgia Fibromyalgia

For individuals experiencing constant muscle ache and stiffness, fatigue, and sleeping problems

Alleviates frequent urinating in older men

Alleviates degeneration of discs and joints; Reduces joint pain and inflammation

Prevent spread of neoplastic cells

Disease Claims Define the Disease Claims Define the ProductProduct

ExpressedExpressed ImplicitImplicitArthritis inflammationArthritis inflammation Alleviates degeneration of Alleviates degeneration of

discs and joints; Reduces discs and joints; Reduces joint pain joint pain

Cancer Cancer Prevent spread of Prevent spread of neoplastic neoplastic cellscells

BPHBPH Alleviates frequent urinating Alleviates frequent urinating in in older menolder men

FibromyalgiaFibromyalgia For individuals experiencing For individuals experiencing constant muscle ache and constant muscle ache and stiffness, fatigue, and stiffness, fatigue, and

sleeping sleeping problemsproblems

Disease Claims Define the Disease Claims Define the ProductProduct

DiseaseDisease Structure/FunctionStructure/FunctionAlternative to prozacAlternative to prozac Alternative to anabolic steroidsAlternative to anabolic steroidsHelp insulin maintain blood sugarHelp insulin maintain blood sugar Replace potassium losses Replace potassium losses

associated with diuretic drugsassociated with diuretic drugsHelps statin drugs lower cholesterolHelps statin drugs lower cholesterol Maintains normal blood Maintains normal blood

cholesterolcholesterolReduces pain and inflammationReduces pain and inflammation Maintains joint health and Maintains joint health and

comfortcomfortToxemia in pregnancyToxemia in pregnancy Alleviates ordinary morning Alleviates ordinary morning

sickness associated with sickness associated with pregnancy pregnancy

Supports antiviral responseSupports antiviral response Supports the immune systemSupports the immune system

Antibiotic; AnalgesicAntibiotic; Analgesic Energizer, adaptogenEnergizer, adaptogen

Alleviates colon ulcers for individualsAlleviates colon ulcers for individuals SSupports healthy colon functionupports healthy colon functiontaking doxorubicintaking doxorubicin

Pause Two Minutes for Pause Two Minutes for QuestionsQuestions

Dietary Supplement ClaimsDietary Supplement ClaimsNLEA Health Claims (1990)NLEA Health Claims (1990)

Characterize the Characterize the relationshiprelationship between the presence between the presence or level of a or level of a substancesubstance and a and a disease or health-disease or health-related conditionrelated condition

Claim or elements may be explicit or implicitClaim or elements may be explicit or implicit

New claims established by petition and rule making. New claims established by petition and rule making. Significant Scientific Agreement validity standard Significant Scientific Agreement validity standard appliesapplies

[21 U.S.C. 343 (r)(1) – r(5)][21 U.S.C. 343 (r)(1) – r(5)]

Dietary Supplement ClaimsDietary Supplement Claims

Health Claims (Continued)Health Claims (Continued)

Required Minimum Nutrient ContentRequired Minimum Nutrient Content

10% DV/serving of vitamins A & 10% DV/serving of vitamins A & C, calcium, iron, protein, fiberC, calcium, iron, protein, fiber

14 authorized SSA health claims14 authorized SSA health claims

[21 U.S.C. 343 (r)(1) – (5)][21 U.S.C. 343 (r)(1) – (5)]

Dietary Supplement ClaimsDietary Supplement ClaimsQUALIFIED HEALTH CLAIMSQUALIFIED HEALTH CLAIMS

Do not meet the SSA validity standardDo not meet the SSA validity standard8 authorized qualified health claims8 authorized qualified health claims

Selenium and cancerSelenium and cancerAntioxidant vitamins and cancerAntioxidant vitamins and cancerNuts and heart diseaseNuts and heart diseaseWalnuts and heart diseaseWalnuts and heart diseaseOmega-3 fatty acids and heart diseaseOmega-3 fatty acids and heart diseaseB vitamins and vascular diseaseB vitamins and vascular diseasePhosphatidylserine and dementiaPhosphatidylserine and dementia0.8 mg Folic acid and birth defects0.8 mg Folic acid and birth defects

Amendment for SafetyAmendment for Safety

A dietary supplement is adulterated if:A dietary supplement is adulterated if:Presents unreasonable risk of illness or injuryPresents unreasonable risk of illness or injury

conditions of use recommended or suggestedconditions of use recommended or suggested

Inadequate information for assurance of safety for new Inadequate information for assurance of safety for new dietary ingredientsdietary ingredients

Secretary declares to pose an imminent hazardSecretary declares to pose an imminent hazard

Contains a dietary ingredient that is poisonous or Contains a dietary ingredient that is poisonous or deleteriousdeleterious

21 U.S.C. 342(f)(1)21 U.S.C. 342(f)(1)

Amendment for SafetyAmendment for Safety

FDA shall bear the burden proof to show FDA shall bear the burden proof to show that a dietary supplement is adulteratedthat a dietary supplement is adulterated

21 U.S.C. 342(f)(1)21 U.S.C. 342(f)(1)

Amendment for SafetyAmendment for Safety

Ephedrine Alkaloids (February 11, 2004 Federal Ephedrine Alkaloids (February 11, 2004 Federal Register; 69 FR 6787) Register; 69 FR 6787)

Adulteration determination based on:Adulteration determination based on:

evidence on ephedrine pharmacologyevidence on ephedrine pharmacology

peer-reviewed scientific literature on ephedrine peer-reviewed scientific literature on ephedrine safety and effectivenesssafety and effectiveness

adverse event reportsadverse event reports

seminal report by an independent instituteseminal report by an independent institute

public comment on ephedrine-associated health public comment on ephedrine-associated health risks. risks.

SummarySummaryDSHEA remains a dynamic law subject to interpretationDSHEA remains a dynamic law subject to interpretationFDA’s implementation intended to balance Congress’ FDA’s implementation intended to balance Congress’ intent and consumer protectionintent and consumer protectionNo legislative historyNo legislative history

Plain language of the statutePlain language of the statuteStatement of AgreementStatement of AgreementCongressional FindingsCongressional FindingsInterpretation of Court Decisions and relevant case Interpretation of Court Decisions and relevant case lawlaw

November 9, 2004 Implementation and Enforcement November 9, 2004 Implementation and Enforcement Strategy (69 FR 64957) Strategy (69 FR 64957) (http://www.fda.gov/bbs/topics/news/2004/NEW01130.h(http://www.fda.gov/bbs/topics/news/2004/NEW01130.html)tml)

Office of Nutrition, Labeling, and Dietary Supplements

Center for Food Safety and Applied Nutrition

5100 Paint Branch ParkwayCollege Park, MD 20740-3835

(301)436-2375(301)436-2639 (fax)

kenneth.taylor@fda.hhs.gov

Kenneth M.P. Taylor, Ph.D.

http://www.elluminate.com

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