2 Dietary Supplements Alternative therapies and natural remedies (Wholistic MedicineDietary supplements = 6.5 billion / Prescription Drug sales = 85 billionIncreased consumer dissatisfaction with conventional health care½ of US population use Dietary Supplements
3 History of Dietary Supplements 1938 Act established standards of identity for vitamins and mineralsProxmire Amendments extended FDA jurisdiction to advertising of Vits and minsProhibited FDA from setting max limits on potencyForbade FDA from classifying supplements as drugs
4 History of Dietary Supplements 1990 Nutritional Labeling and Education ActPermitted use of therapeutic claims made about vits/mins1994 President Clinton signed Dietary Supplement, Health and Education Act (DSHEA) into lawDefined D/S as “separate regulatory category of food”
5 DSHEACreated Office of Dietary Supplements within National Institute of Health (NIH)Permits statements of nutritional support including structure and function claimsAfter passage of DSHEA, sales increased to 13 billion per year.CFSAN oversees regulation of D/S
6 What is a Dietary Supplement? Definition: (Sec 3.)A product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredientsVitaminsMineralsHerbs or other botanicalsAmino acidsConcentrate, metabolite, constituent, extract or combination of above listed ingredients
7 Dietary SupplementsTraditionally defined as products made of one or more essential nutrients such as vitamins, minerals, and proteins, but…DSHEA broadened definition to include almost any product intended for ingestion as a supplement to the dietMust be identified on label as a D/S
8 Dietary Supplements Distinguished from Drugs: Drug = article intended to diagnose, cure, mitigate, treat, or prevent diseaseBoth intended to affect structure and function of bodyDrug must undergo FDA approval after clinical studies to determine effectiveness and safetyD/S = no pre-market testing
9 Dietary Supplements Distinguished from Foods: Foods not intended to affect structure and functionD/S intended only to supplement dietNot represented for use as conventional foodNot intended as sole item of a meal or the diet”
10 Dietary Supplements No premarket approval Manufacturer responsible for safety evaluationIf D/S contains a new ingredient:Manufacturer must submit information that ingredient “can reasonably be expected to be safe” within 75 days of marketingSafe = no significant risk of illness
11 Adulteration under DSHEA D/S is adulterated if it or an ingredient presents “significant or unreasonable risk of illness or injury” when used as directedIf contains a new ingredient standard is “insufficient information to provide assurance that ingredient does not present….”FDA has burden of proving D/S is unsafe once product is marketed
12 Adulteration under DSHEA Prior to DSHEA, FDA tactic was to declare “dubious” supplements as “unapproved food additives”DSHEA prohibits FDA from doing thisSince DSHEA, no FDA enforcement jurisdiction unless can prove supplement is “unsafe”(significant or unreasonable risk of injury)
13 FDA Enforcement Authority: FDA bears “Burden of Proof”Must prove that product is “unsafe”DSHEA requires “de novo” (fresh look) determination for each caseNo longer presumes FDA is correct on scienceFDA must provide 10 days notice before initiating civil proceedingOnly required in criminal case before DSHEAWhose idea was this!!!!!!!!!!!
14 Good Manufacturing Practices DSHEA authorized specific GMPs for D/SLimitationsCannot impose standard if no “available analytical methodology”“that exist only in the minds of the inspector”Cannot impose standard not promulgated under Administrative Procedure Actsubjected to public comment
15 Labeling of Dietary Supplements DSHEA authorized to provide accurate information to consumersLabel must include:Name of each ingredientQuantity of each ingredientTotal weight of all ingredient if a blendIdentity of part of plant derived fromTerm “Dietary Supplement”Must contain nutritional labeling information alsoCalories, fat, sodium
16 Health ClaimsDSHEA authorized use of FDA approved “Health claims” on labelDescribe the connection between a nutrient or food substance and a disease or health-related condition(diet/disease relationship)Statements may be included on the label that give the manufacturers description of the role of the D/SNot authorized by FDAManufacturer resp. for accuracy and truth of statement
17 FDA Approved Health Claims Folic acid and neural tube pregnanciesCalcium and osteoporosisSodium and hypertensionFruits and vegetables and cancerDietary lipids and cancerSaturated fat and cholesterol and coronary artery disease
18 Structure and Function Claims Manufacturers may use S/F claimsNot authorized by FDAMust be true and not misleadingMust be accompanied by disclaimer“This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent any disease”Examples:“Calcium builds strong bones”“Antioxidants maintain cell integrity”
19 Other Claims: Health-maintenance claims: Non-disease claims: “Maintains healthy circular system”Non-disease claims:“helps you relax”“for muscle enhancement”Cannot make maintenance claims about osteoporosis and other “serious diseases”Can make health claim about relationship between a product or substance and the disease if approved
20 Nutraceuticals / Functional Foods Nutraceuticals / Designer foods / Phytochemicals / Functional Foods“any food or food ingredient considered to provide medical or health benefits, including prevention and treatment of diseaseNo legal status in US!!
21 Terminology Nutraceuticals Functional Foods Phytochemicals Nutrient rich products with limited health claimsFunctional FoodsAny modified food or ingredient that may provide a benefit beyond the traditional nutrients it containsPhytochemicalsSuch foods that are derived from naturally occurring ingredients
22 Some Examples: Benecol Glucosamine New Approved Health Claims “Plant stanol esters”GlucosamineNew Approved Health ClaimsFlavonoids (Teas) and heart disease
23 Summary Not food, not drug, broadly definition under DSHEA (1994) Regulated by FDA/CFSAN since DSHEANo premarket approval even if contains new ingredientMust be labeled as “Dietary Supplements”Nutraceuticals not regulated by FDA
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