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Dietary Dietary SupplementsSupplementsFoods or Drugs?Foods or Drugs?

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Dietary Dietary SupplementsSupplements

Alternative therapies and Alternative therapies and natural remedies natural remedies – (Wholistic Medicine(Wholistic Medicine

Dietary supplements = 6.5 Dietary supplements = 6.5 billion / Prescription Drug billion / Prescription Drug sales = 85 billionsales = 85 billion

Increased consumer Increased consumer dissatisfaction with dissatisfaction with conventional health careconventional health care

½ of US population use ½ of US population use Dietary SupplementsDietary Supplements

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History of Dietary History of Dietary SupplementsSupplements

1938 Act established standards of identity 1938 Act established standards of identity for vitamins and mineralsfor vitamins and minerals

Proxmire AmendmentsProxmire Amendments extended FDA extended FDA jurisdiction to advertising of Vits and minsjurisdiction to advertising of Vits and mins– Prohibited FDA from setting max limits on Prohibited FDA from setting max limits on

potencypotency– Forbade FDA from classifying supplements as Forbade FDA from classifying supplements as

drugsdrugs

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History of Dietary History of Dietary SupplementsSupplements

1990 Nutritional Labeling and Education 1990 Nutritional Labeling and Education ActAct– Permitted use of therapeutic claims made about Permitted use of therapeutic claims made about

vits/minsvits/mins

1994 President Clinton signed 1994 President Clinton signed Dietary Dietary Supplement, Health and Education ActSupplement, Health and Education Act (DSHEA) into law(DSHEA) into law

Defined D/SDefined D/S as as ““separate regulatory separate regulatory category of food”category of food”

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DSHEADSHEA

Created Created Office of Dietary SupplementsOffice of Dietary Supplements within National Institute of Health (NIH)within National Institute of Health (NIH)

Permits statements of nutritional Permits statements of nutritional support including support including structurestructure and and functionfunction claims claims

After passage of DSHEA, sales After passage of DSHEA, sales increased to 13 billion per yearincreased to 13 billion per year..

CFSAN oversees regulation of D/SCFSAN oversees regulation of D/S

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What is a Dietary Supplement?What is a Dietary Supplement?

Definition: Definition: (Sec 3.)(Sec 3.)

– A A productproduct (other than tobacco) (other than tobacco) intendedintended to to supplementsupplement the diet that bears or contains the diet that bears or contains one or more of the following dietary one or more of the following dietary ingredientsingredients

VitaminsVitaminsMineralsMineralsHerbs or other botanicalsHerbs or other botanicalsAmino acidsAmino acidsConcentrate, metabolite, constituent, extract or Concentrate, metabolite, constituent, extract or combination of above listed ingredientscombination of above listed ingredients

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Dietary SupplementsDietary Supplements

Traditionally defined as products made of Traditionally defined as products made of one or more essential nutrients such as one or more essential nutrients such as vitamins, minerals, and proteins, but…vitamins, minerals, and proteins, but…

DSHEA broadened definition to include DSHEA broadened definition to include almost any product intended for almost any product intended for ingestion as a supplement to the dietingestion as a supplement to the diet

Must be identified on label as a D/SMust be identified on label as a D/S

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Dietary SupplementsDietary Supplements

Distinguished from DrugsDistinguished from Drugs::– Drug = Drug = article intended to diagnose, cure, article intended to diagnose, cure,

mitigate, treat, or prevent diseasemitigate, treat, or prevent disease– Both intended to affect Both intended to affect structurestructure and and

functionfunction of body of body– Drug must undergo FDA approval after Drug must undergo FDA approval after

clinical studies to determine effectiveness clinical studies to determine effectiveness and safetyand safety

– D/S = no pre-market testingD/S = no pre-market testing

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Dietary Dietary SupplementsSupplements

Distinguished from FoodsDistinguished from Foods::– Foods not Foods not intendedintended to affect to affect structurestructure

and and functionfunction– D/S intended only to D/S intended only to supplementsupplement diet diet

Not represented for use as conventional Not represented for use as conventional foodfood

Not intended as Not intended as sole item of a mealsole item of a meal or or the diet”the diet”

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Dietary Dietary SupplementsSupplements

No premarket approvalNo premarket approval

Manufacturer responsible for safety Manufacturer responsible for safety evaluationevaluation

If D/S contains a If D/S contains a new ingredientnew ingredient::– Manufacturer must submit information that Manufacturer must submit information that

ingredient “ingredient “can reasonably be expected can reasonably be expected to be safe”to be safe” within 75 days of marketing within 75 days of marketing

– Safe = no significant risk of illnessSafe = no significant risk of illness

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Adulteration under DSHEAAdulteration under DSHEA

D/S is adulterated if it or an ingredient D/S is adulterated if it or an ingredient presents presents “significant or unreasonable “significant or unreasonable risk of illness or injuryrisk of illness or injury”” when used as when used as directed directed If contains a If contains a new ingredientnew ingredient standard is standard is “insufficient information to provide “insufficient information to provide assurance that ingredient does not assurance that ingredient does not present….”present….”FDA has burden of proving D/S is unsafe FDA has burden of proving D/S is unsafe once product is once product is marketedmarketed

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Adulteration under DSHEAAdulteration under DSHEA

Prior to DSHEA, FDA tactic was to Prior to DSHEA, FDA tactic was to declare “dubious” supplements as declare “dubious” supplements as ““unapproved food additives”unapproved food additives”DSHEA prohibits FDA from doing thisDSHEA prohibits FDA from doing thisSince DSHEA, no FDA enforcement Since DSHEA, no FDA enforcement jurisdiction unless can prove jurisdiction unless can prove supplement is “supplement is “unsafeunsafe” ” – (significant or unreasonable risk of injury)(significant or unreasonable risk of injury)

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FDA Enforcement Authority:FDA Enforcement Authority:

FDA bears FDA bears “Burden of Proof”“Burden of Proof”– Must prove that product is “unsafe”Must prove that product is “unsafe”

DSHEA requires DSHEA requires “de novo”“de novo” (fresh look) (fresh look) determination for each casedetermination for each case– No longer presumes FDA is correct on scienceNo longer presumes FDA is correct on science

FDA must provide FDA must provide 10 days notice10 days notice before before initiating civil proceedinginitiating civil proceeding– Only required in criminal case before DSHEAOnly required in criminal case before DSHEA– Whose idea was this!!!!!!!!!!!Whose idea was this!!!!!!!!!!!

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Good Manufacturing Good Manufacturing PracticesPractices

DSHEA authorized DSHEA authorized specific GMPsspecific GMPs for D/S for D/S– LimitationsLimitations

Cannot impose standard if Cannot impose standard if no “available no “available analytical methodology”analytical methodology”

– ““that exist only in the minds of the inspector”that exist only in the minds of the inspector”

Cannot impose standard not promulgated Cannot impose standard not promulgated under under Administrative Procedure ActAdministrative Procedure Act

– subjected to public commentsubjected to public comment

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Labeling of Dietary SupplementsLabeling of Dietary Supplements

DSHEA authorized to provide DSHEA authorized to provide accurate accurate informationinformation to consumers to consumersLabel must include:Label must include:– NameName of each ingredient of each ingredient– QuantityQuantity of each ingredient of each ingredient– Total weightTotal weight of all ingredient if a blend of all ingredient if a blend– Identity of Identity of part of plantpart of plant derived from derived from– Term “Term “Dietary SupplementDietary Supplement””

Must contain nutritional labeling information alsoMust contain nutritional labeling information also– Calories, fat, sodiumCalories, fat, sodium

1616

Health ClaimsHealth Claims

DSHEA authorized use of DSHEA authorized use of FDA approvedFDA approved “Health claims” on label“Health claims” on labelDescribe the connection between a Describe the connection between a nutrient or food substance and a disease nutrient or food substance and a disease or health-related conditionor health-related condition – ((diet/disease relationship)diet/disease relationship)

Statements may be included on the label that Statements may be included on the label that give the manufacturers description of the role give the manufacturers description of the role of the D/Sof the D/S– Not authorized by FDANot authorized by FDA– Manufacturer resp. for accuracy and truth of statementManufacturer resp. for accuracy and truth of statement

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FDA Approved Health FDA Approved Health ClaimsClaims

Folic acidFolic acid and neural tube pregnancies and neural tube pregnancies

CalciumCalcium and osteoporosis and osteoporosis

SodiumSodium and hypertension and hypertension

Fruits and vegetablesFruits and vegetables and cancer and cancer

Dietary lipidsDietary lipids and cancer and cancer

Saturated fatSaturated fat and and cholesterolcholesterol and and coronary artery diseasecoronary artery disease

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Structure and Function Structure and Function ClaimsClaims

Manufacturers may use S/F claimsManufacturers may use S/F claims– Not authorized by FDANot authorized by FDA

Must be true and not misleadingMust be true and not misleadingMust be accompanied by disclaimerMust be accompanied by disclaimer– ““This statement has not been evaluated This statement has not been evaluated

by the FDA. This product is not intended by the FDA. This product is not intended to diagnose, treat, cure or prevent any to diagnose, treat, cure or prevent any disease”disease”

Examples:Examples:– ““Calcium builds strong bones”Calcium builds strong bones”– ““Antioxidants maintain cell integrityAntioxidants maintain cell integrity””

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Other Other Claims:Claims:

Health-maintenance claims:Health-maintenance claims:– ““Maintains healthy circular system”Maintains healthy circular system”

Non-disease claims:Non-disease claims:– ““helps you relax”helps you relax”– ““for muscle enhancement”for muscle enhancement”

CannotCannot make maintenance claims about make maintenance claims about osteoporosis and other osteoporosis and other “serious diseases”“serious diseases”CanCan make health claim about relationship make health claim about relationship between a product or substance and the between a product or substance and the disease if disease if approvedapproved

2020

Nutraceuticals / Functional FoodsNutraceuticals / Functional Foods

Nutraceuticals / Designer foods / Nutraceuticals / Designer foods / Phytochemicals / Functional FoodsPhytochemicals / Functional Foods

““any food or food ingredient any food or food ingredient considered to provide medical or considered to provide medical or health benefits, including prevention health benefits, including prevention and treatment of diseaseand treatment of disease

No legal status in US!!No legal status in US!!

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TerminologyTerminology

NutraceuticalsNutraceuticals– Nutrient rich productsNutrient rich products with limited health claimswith limited health claims

Functional FoodsFunctional Foods– Any modified food or ingredient that may Any modified food or ingredient that may

provide a provide a benefit beyond the traditional benefit beyond the traditional nutrientsnutrients it contains it contains

PhytochemicalsPhytochemicals– Such foods that are derived from Such foods that are derived from naturally naturally

occurring ingredientsoccurring ingredients

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Some Examples:Some Examples:

BenecolBenecol– ““Plant stanol esters”Plant stanol esters”

GlucosamineGlucosamine

New Approved Health ClaimsNew Approved Health Claims– Flavonoids (Teas) and heart Flavonoids (Teas) and heart

diseasedisease

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SummarySummary

Not food, not drugNot food, not drug, broadly definition , broadly definition under DSHEA (1994)under DSHEA (1994)

Regulated by FDA/Regulated by FDA/CFSANCFSAN since DSHEA since DSHEA

No premarket approvalNo premarket approval even if contains even if contains new ingredientnew ingredient

Must be Must be labeled as “Dietary labeled as “Dietary SupplementsSupplements””

Nutraceuticals Nutraceuticals not regulatednot regulated by FDA by FDA