Dietary Supplements

Dietary Supplements Confusing Nomenclature

Dietary SupplementsComplementary and Alternative Medicine (CAM)HerbalsBotanicalsAlternative medicine"Homeopathic" medicine not a synonym

Complementary and Alternative Medicine (CAM)

a group of diverse medical & health care systems, practices, & products that are not presently considered to be part of conventional medicine

Conventional medicine

(a.k.a. Western medicine) "is practiced by medical doctors and doctors of osteopathic medicine (DO) and by allied health professionals (e.g. physical therapists, psychologists, nurses).

Complementary Medicine

in conjunction with conventional medicine & therapies

Alternative medicine

in place of traditional conventional & therapies

Types of CAM

Natural productsMind and Body MedicineManipulative and Body-Based PracticesOther Practices

Natural products

Dietary SupplementsMegavitaminsProbiotics

Dietary Supplements

Herbal medicine (Botanicals)Things derived from plant baseA natural product


very high doses of vitaminsA natural product


Live micro-organisms which, when administered in adequate amounts, confer a health benefit on the hostPrebiotics - refer to chemicals that induce the growth and/or activity of microorganisms (e.g., bacteria and fungi) that contribute to the well-being of their hostA natural product

Mind and Body Medicine

MeditationYogaAcupunctureDeep-breathing exerciseRelaxationTai Chi (Chinese martial arts)HypnosisImagery

Manipulative and Body-Based Practices

ChiropractorsPhysical Therapy Massage therapy

Other Practices

Spiritual healingEnergy (magnet or light therapy)Folk remediesPilatesAromatherapy

Dietary Supplements

2007 National Health Interview Survey (NHIS) survey of US citizens showed 38% of adults (≥18 y/o) use CAM18% of adults and 4% of children used a non-vitamin/mineral dietary supplementTop Non-Vitamin SellersFish Oil/Omega-3-Fatty AcidsGlucosamineEchinaceaFlaxseedGinseng

Who uses Dietary Supplements

Gender: Female > MenAge: 50-69 y/oCollege education or higherLiving in the WestPhysically ActiveHigher socioeconomic statusPrivate health insurance holders


Dietary Supplement Health and Education Act (DSHEA Act of 1994)The Dietary Supplement & Nonprescription Drug Consumer Protection Act (effective December 2007)

Dietary Supplement Health and Education Act (DSHEA Act of 1994)

Approved by CongressNot strict regulation for purity and potency standards Lack of strict manufacturing practicesDo not have to follow good manufacturing processes (GMP)Supplements are considered foods not drugsEvidence of safety and efficacy not required (No clinical trials necessary)

The Dietary Supplement & Nonprescription Drug Consumer Protection Act (effective December 2007)

Requires manufacturers to report serious AEs (adverse effects) to FDA, within 15 business days after company learns of AEIn theory, helps FDA identify safety issuesNo clinical trials needed still - however, if someone reports an adverse effect, they need to report it to the FDA

FDA Regulation

Not approved by FDA before marketingMust notify FDA if marketing "new dietary ingredients" (i.e. after 10/1994)If they are adding a new ingredient that has not been used before, they need to notify the FDAMust be labeled as a dietary supplement; must have a supplement facts labelAll ingredients must be listed

FDA Regulation

FDA monitors for false and misleading claimsMust not claim to treat or cure a specific disease or condition, e.g. "cures cancer"FDA must prove a dietary supplement is unsafe before it can remove from marketFederal Trade Commission (FTC) monitors advertising

Appropriate Claims

Health ClaimNutrient content claimStructure-function claim

Health claim

Require FDA approvalIngestion of certain substance may reduce risk of a certain condition (specifically stated)E.g. Calcium reduces risk of osteoporosis The dietary supplements can claim these

Nutrient content claim

Require FDA approvalAmount of substance in productE.g. "Excellent Source of..."(20% Daily Value)Ex.) excellent source of vitamin D

Structure-function claim

Overall health maintenanceE.g. Calcium supports bone health or supports healthy cholesterol levels

Appropriate claims

All dietary supplements must have following statement:"This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease."CANNOT claim to cure, mitigate, treat or prevent disease

Label Requirements

Name of Product & the word "supplement"Quantity of contentsManufacturer's, packager's or distributor's nameDirections for useMust contain "Supplemental Facts" panelList of all the ingredients that are in the supplement

Good Manufacturing Practices (GMPs)

June 22, 2007: Final rule issued by FDA establishing regulations to require current good manufacturing practices (CGMPs) for dietary supplements. (effective August 2007)Quality controls for consistent processing of dietary supplementsManufactured consistently as to identity, purity, strength, and compositionDoes not address the safety of their ingredients, or their effects on health when proper manufacturing techniques are used

Good Manufacturing Practices (GMPs)

Prevents: Dietary supplements that contain ingredients in amounts that are greater or less than those listed on the label wrong ingredient, other contaminants (e.g., bacteria, pesticide, glass, lead), foreign material in container, improper packaging, and mislabeled

U.S. Pharmacopeia (USP) Dietary Supplement Verification Program

(Voluntary Program for manufacturers)Tests dietary supplements for purity, integrity, safe manufacturing, dissolutionAll listed ingredients are in bottle in the declared amountDoes not contain harmful levels of contaminantsWill break down & release ingredients in bodyMade under good manufacturing practicesLook for this seal on the bottle to verify finished product

U.S. Pharmacopeia (USP) Dietary Supplement Verification Program

Look at USP website for list of verified products verified Dietary Supplement Ingredient (useful for manufacturers)

NSF Dietary Supplement Verification Program

NSF certifies products against NSF/ANSI 173, the only American National Standard that establishes requirements for the ingredients in dietary and nutritional supplements. There are three main components:Label claim reviewToxicology reviewContaminant review

Label claim review

certify that what's on the label is in the bottle

Toxicology review

certify product formulation (we don't test for efficacy)

Contaminant review

ensure the product contains no undeclared ingredients or unacceptable levels of contaminants

Dietary supplement safety

Presence of Banned Drugs in Dietary Supplements Following FDA RecallsPresence of Banned Drugs in Dietary Supplements Following FDA RecallsDo not Contain the Products listed on the Label

Do not Contain the Products listed on the Label

~50% of all class I drug recalls since 2004 have involved dietary supplementsResearchers purchased, directly from supplement manufacturer or distributed websites:Supplements available at least 6 months after they were recalled for adulteration with pharmaceutical ingredientsSupplement name, manufacturer, and distributer listed on the purchased supplement was identical to the FDA recallSamples analyzed using gas or liquid chromatography-mass spectrometry

Presence of Banned Drugs in Dietary Supplements Following FDA Recalls

Results: 27 supplements were analyzedSupplements were purchased mean of 34.3 months after the FDA recall (range 8-52 months)2/3 contained a pharmaceutical adulterantFor 63% of those, it was the same adulterant identified by the FDA22% contained an additional banned ingredientLimitations:Unsure of date of manufactureWas it before or after the recall?

Previously Recognized Safety Issues

Androstenedione ("Andro"), 2004FDA pulled from market; may be unsafe b/c converted to steroid testosteroneEphedrine Alkaloids (Ma huang, ephedra), 2004FDA prohibited sale due to risk of high blood pressure, stroke, myocardial infarction, etc.Kava, 2002FDA warned public about rare hepatic failure

FDA MedWatch

Use the FDA Medwatch System to identify a recent safety issue about a dietary supplementStart at and navigate to Medwatch

Key Points about Dietary Supplements

Dietary supplements are considered foods NOT drugsDietary supplements are not FDA approved and FDA must prove a dietary supplement is unsafe before it can be removed from marketDSHEA Act of 1994, excluded dietary supplements from strict purity and potency standards that are applied to Rx and OTC meds

Key Points about Dietary Supplements

Dietary supplements can make 3 types of claims: health claims, nutrient content claim, and structure/function claimsGMPs are quality controls for consistent processing of dietary supplements, not safety and efficacy measures