Dietary Supplements Foods or Drugs 1 Dietary Supplements

Dietary Supplements Foods or Drugs? 1

Dietary Supplements Alternative therapies and natural remedies – (Wholistic Medicine Dietary supplements = 6. 5 billion / Prescription Drug sales = 85 billion Increased consumer dissatisfaction with conventional health care ½ of US population use Dietary Supplements 2

History of Dietary Supplements 1938 Act established standards of identity for vitamins and minerals Proxmire Amendments extended FDA jurisdiction to advertising of Vits and mins – Prohibited FDA from setting max limits on potency – Forbade FDA from classifying supplements as drugs 3

History of Dietary Supplements 1990 Nutritional Labeling and Education Act – Permitted use of therapeutic claims made about vits/mins 1994 President Clinton signed Dietary Supplement, Health and Education Act (DSHEA) into law Defined D/S as “separate regulatory category of food” 4

DSHEA Created Office of Dietary Supplements within National Institute of Health (NIH) Permits statements of nutritional support including structure and function claims After passage of DSHEA, sales increased to 13 billion per year. CFSAN oversees regulation of D/S 5

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 ingredients Vitamins Minerals Herbs or other botanicals Amino acids Concentrate, metabolite, constituent, extract or combination of above listed ingredients 6

Dietary Supplements Traditionally 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 diet Must be identified on label as a D/S 7

Dietary Supplements Distinguished from Drugs: – Drug = article intended to diagnose, cure, mitigate, treat, or prevent disease – Both intended to affect structure and function of body – Drug must undergo FDA approval after clinical studies to determine effectiveness and safety – D/S = no pre-market testing 8

Dietary Supplements Distinguished from Foods: – Foods not intended to affect structure and function – D/S intended only to supplement diet Not represented for use as conventional food Not intended as sole item of a meal or the diet” 9

Dietary Supplements No premarket approval Manufacturer responsible for safety evaluation If D/S contains a new ingredient: – Manufacturer must submit information that ingredient “can reasonably be expected to be safe” within 75 days of marketing – Safe = no significant risk of illness 10

Adulteration under DSHEA D/S is adulterated if it or an ingredient presents “significant or unreasonable risk of illness or injury” when used as directed If 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 11

Adulteration under DSHEA Prior to DSHEA, FDA tactic was to declare “dubious” supplements as “unapproved food additives” DSHEA prohibits FDA from doing this Since DSHEA, no FDA enforcement jurisdiction unless can prove supplement is “unsafe” – (significant or unreasonable risk of injury) 12

FDA Enforcement Authority: FDA bears “Burden of Proof” – Must prove that product is “unsafe” DSHEA requires “de novo” (fresh look) determination for each case – No longer presumes FDA is correct on science FDA must provide 10 days notice before initiating civil proceeding – Only required in criminal case before DSHEA – Whose idea was this!!!!!! 13

Good Manufacturing Practices DSHEA authorized specific GMPs for D/S – Limitations Cannot impose standard if no “available analytical methodology” – “that exist only in the minds of the inspector” Cannot impose standard not promulgated under Administrative Procedure Act – subjected to public comment 14

Labeling of Dietary Supplements DSHEA authorized to provide accurate information to consumers Label must include: – Name of each ingredient – Quantity of each ingredient – Total weight of all ingredient if a blend – Identity of part of plant derived from – Term “Dietary Supplement” Must contain nutritional labeling information also – Calories, fat, sodium 15

Health Claims DSHEA authorized use of FDA approved “Health claims” on label Describe 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/S – Not authorized by FDA – Manufacturer resp. for accuracy and truth of statement 16

FDA Approved Health Claims Folic acid and neural tube pregnancies Calcium and osteoporosis Sodium and hypertension Fruits and vegetables and cancer Dietary lipids and cancer Saturated fat and cholesterol and coronary artery disease 17

Structure and Function Claims Manufacturers may use S/F claims – Not authorized by FDA Must be true and not misleading Must 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” 18

Other Claims: Health-maintenance 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 19

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 disease No legal status in US!! 20

Terminology Nutraceuticals – Nutrient rich products with limited health claims Functional Foods – Any modified food or ingredient that may provide a benefit beyond the traditional nutrients it contains Phytochemicals – Such foods that are derived from naturally occurring ingredients 21

Some Examples: Benecol – “Plant stanol esters” Glucosamine New Approved Health Claims – Flavonoids (Teas) and heart disease 22

Summary Not food, not drug, broadly definition under DSHEA (1994) Regulated by FDA/CFSAN since DSHEA No premarket approval even if contains new ingredient Must be labeled as “Dietary Supplements” Nutraceuticals not regulated by FDA 23