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Dietary Supplements Foods or Drugs?

Dietary Supplements Foods or Drugs?. 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

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Dietary Supplements Foods or Drugs?

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  1. Dietary SupplementsFoods or Drugs?

  2. 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

  3. 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

  4. 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/Sas “separate regulatory category of food”

  5. 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

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

  7. 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

  8. 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

  9. 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”

  10. 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

  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 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

  12. 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)

  13. 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!!!!!!!!!!!

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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”

  19. 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

  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 disease • No legal status in US!!

  21. Terminology • Nutraceuticals • Nutrient rich productswith 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

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

  23. 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

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