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Dietary Supplements in Complementary Medicine
- 1. Dietary Supplements Dietary Supplements Foodsor Drugs? Foods or Drugs? Complementary & Alternative Medicine Complementary & Alternative Medicine 1 1
- 2. 2 2 What is aDietary Supplement? What is a Dietary Supplement? Definition: Definition: (Sec 3.) (Sec 3.) – A A product product (other than tobacco) (other than tobacco) intended intended to to supplement supplement the diet that bears or contains the diet that bears or contains one or more of the following dietary ingredients one or more of the following dietary ingredients Vitamins Vitamins Minerals Minerals Herbs or other botanicals Herbs or other botanicals Amino acids Amino acids Concentrate, metabolite, constituent, extract or Concentrate, metabolite, constituent, extract or combination of above listed ingredients combination of above listed ingredients
- 3. Dietary Supplement Healthand Dietary Supplement Health and Education Act of 1994 (DSHEA) Education Act of 1994 (DSHEA) Reclassified botanicals as dietary supplements, Reclassified botanicals as dietary supplements, distinct from food or drugs distinct from food or drugs Plant extracts, enzymes, vitamins, minerals, Plant extracts, enzymes, vitamins, minerals, hormonal products available without prescription hormonal products available without prescription may carry “structure-function” claims may carry “structure-function” claims Cannot claim to prevent or cure specific Cannot claim to prevent or cure specific conditions conditions Must display disclaimer, “This statement has not Must display disclaimer, “This statement has not been evaluated by the Food and Drug been evaluated by the Food and Drug Administration. This product is not intended to Administration. This product is not intended to diagnose, treat, cure or prevent any disease.” diagnose, treat, cure or prevent any disease.”
- 4. 4 4 Dietary Supplements Dietary Supplements Traditionallydefined 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 diet ingestion as a supplement to the diet Must be identified on label as a D/S Must be identified on label as a D/S
- 5. 5 5 Dietary Supplements Dietary Supplements Distinguishedfrom Drugs Distinguished from Drugs: : – Drug = Drug = article intended to diagnose, cure, article intended to diagnose, cure, mitigate, treat, or prevent disease mitigate, treat, or prevent disease – Both intended to affect Both intended to affect structure structure and and function function of body of body – Drug must undergo FDA approval after clinical Drug must undergo FDA approval after clinical studies to determine effectiveness and safety studies to determine effectiveness and safety – D/S = no pre-market testing D/S = no pre-market testing
- 6. 6 6 History of Dietary Historyof Dietary Supplements Supplements 1938 Act established standards of identity 1938 Act established standards of identity for vitamins and minerals for vitamins and minerals Proxmire Amendments Proxmire Amendments extended FDA extended FDA jurisdiction to advertising of Vits and mins jurisdiction to advertising of Vits and mins – Prohibited FDA from setting max limits on Prohibited FDA from setting max limits on potency potency – Forbade FDA from classifying supplements as Forbade FDA from classifying supplements as drugs drugs
- 7. 7 7 History of Dietary Historyof Dietary Supplements Supplements 1990 Nutritional Labeling and Education 1990 Nutritional Labeling and Education Act Act – Permitted use of therapeutic claims made about Permitted use of therapeutic claims made about vits/mins vits/mins 1994 President Clinton signed 1994 President Clinton signed Dietary Dietary Supplement, Health and Education Act Supplement, Health and Education Act (DSHEA) into law (DSHEA) into law Defined D/S Defined D/S as as “ “separate regulatory separate regulatory category of food” category of food”
- 8. 8 8 DSHEA DSHEA Created Created Office ofDietary Supplements Office 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 structure structure and and function function claims claims After passage of DSHEA, sales After passage of DSHEA, sales increased to 13 billion per year increased to 13 billion per year. .
- 9. 9 9 Dietary Dietary Supplements Supplements Distinguished from Foods Distinguishedfrom Foods: : – Foods not Foods not intended intended to affect to affect structure structure and and function function – D/S intended only to D/S intended only to supplement supplement diet diet Not represented for use as conventional Not represented for use as conventional food food Not intended as Not intended as sole item of a meal sole item of a meal or or the diet” the diet”
- 10. 10 10 Dietary Dietary Supplements Supplements No premarket approval Nopremarket approval Manufacturer responsible for safety Manufacturer responsible for safety evaluation evaluation If D/S contains a If D/S contains a new ingredient new 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 illness Safe = no significant risk of illness
- 11. 11 11 Good Manufacturing Good Manufacturing Practices Practices DSHEAauthorized DSHEA authorized specific GMPs specific GMPs for D/S for D/S – Limitations Limitations 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 Act Administrative Procedure Act – subjected to public comment subjected to public comment
- 12. Required Labeling ofDietary Required Labeling of Dietary Supplements under DSHEA Supplements under DSHEA Name (echinacea, for example) Name (echinacea, for example) Ingredient information Ingredient information Disclaimer: "This statement has not been Disclaimer: "This statement has not been evaluated by the Food and Drug evaluated by the Food and Drug Administration. This product is not intended to Administration. This product is not intended to diagnose, treat, cure or prevent any disease." diagnose, treat, cure or prevent any disease." Supplement Facts panel, which includes Supplement Facts panel, which includes serving size, amount and active ingredient. serving size, amount and active ingredient. Name and address of manufacturer, packer Name and address of manufacturer, packer or distributor. or distributor.
- 13. Supplement Facts Panel SupplementFacts Panel
- 14. Dietary Supplement Claims DietarySupplement Claims Health claim: describes the relationship Health claim: describes the relationship between a substance and a disease between a substance and a disease condition; FDA does not approve, but must condition; FDA does not approve, but must be notified be notified Qualified health claim: based on emerging Qualified health claim: based on emerging scientific evidence; must be approved by scientific evidence; must be approved by FDA FDA Structure-function claim: most common; does Structure-function claim: most common; does not claim to prevent disease, but a not claim to prevent disease, but a physiological effect is noted, e.g. “increases physiological effect is noted, e.g. “increases blood flow to the heart.” blood flow to the heart.”
- 15. 15 15 Health Claims Health Claims DSHEAauthorized use of DSHEA authorized use of FDA approved FDA approved “Health claims” on label “Health claims” on label Describe 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 condition or 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/S of the D/S – Not authorized by FDA Not authorized by FDA – Manufacturer resp. for accuracy and truth of statement Manufacturer resp. for accuracy and truth of statement
- 16. Labeling Under DSHEA LabelingUnder DSHEA Allowed Allowed This product helps to This product helps to increase blood flow to the increase blood flow to the heart. heart. This product promotes This product promotes urinary tract health urinary tract health This product improves This product improves absent-mindedness. absent-mindedness. This product reduces This product reduces stress and frustration stress and frustration Not Allowed Not Allowed This product prevents This product prevents heart disease heart disease This product prevents This product prevents urinary tract infections. urinary tract infections. This product reduces risk This product reduces risk of Alzheimer’s Disease. of Alzheimer’s Disease. This product improves This product improves depression. depression.
- 17. 17 17 FDA Approved Health FDAApproved Health Claims Claims Folic acid Folic acid and neural tube pregnancies and neural tube pregnancies Calcium Calcium and osteoporosis and osteoporosis Sodium Sodium and hypertension and hypertension Fruits and vegetables Fruits and vegetables and cancer and cancer Dietary lipids Dietary lipids and cancer and cancer Saturated fat Saturated fat and and cholesterol cholesterol and and coronary artery disease coronary artery disease
- 18. 18 18 Structure and Function Structureand Function Claims Claims Manufacturers may use S/F claims Manufacturers may use S/F claims – Not authorized by FDA Not authorized by FDA Must be true and not misleading Must be true and not misleading Must be accompanied by disclaimer Must be accompanied by disclaimer – “ “This statement has not been evaluated by This statement has not been evaluated by the FDA. This product is not intended to the FDA. This product is not intended to diagnose, treat, cure or prevent any diagnose, treat, cure or prevent any disease” disease” Examples: Examples: – “ “Calcium builds strong bones” Calcium builds strong bones” – “ “Antioxidants maintain cell integrity Antioxidants maintain cell integrity” ”
- 19. 19 19 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” Cannot Cannot make maintenance claims about make maintenance claims about osteoporosis and other osteoporosis and other “serious diseases” “serious diseases” Can Can 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 approved approved
- 20. 20 20 Nutraceuticals / FunctionalFoods Nutraceuticals / Functional Foods Nutraceuticals / Designer foods / Nutraceuticals / Designer foods / Phytochemicals / Functional Foods Phytochemicals / 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 disease and treatment of disease No legal status in US!! No legal status in US!!
- 21. Nutraceuticals as perChemical Nutraceuticals as per Chemical Groupings Groupings 21 21
- 22. Uses of Nutraceuticals Usesof Nutraceuticals 22 22
- 23. 23 23 Terminology Terminology Nutraceuticals Nutraceuticals – Nutrient richproducts Nutrient rich products with limited health claims with limited health claims Functional Foods Functional 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 nutrients nutrients it contains it contains Phytochemicals Phytochemicals – Such foods that are derived from Such foods that are derived from naturally naturally occurring ingredients occurring ingredients
- 24. Commonly Used Commonly Used DietarySupplements Dietary Supplements (Botanicals) (Botanicals) Echinacea Echinacea Garlic Garlic Ginger Ginger Gingko biloba Gingko biloba Ginseng Ginseng Hawthorn Hawthorn Milk thistle Milk thistle Saw palmetto Saw palmetto St. John’s wort St. John’s wort Valerian Valerian
- 25. Echinacea Echinacea Source: Source: Purple cornflower Purplecornflower Indication: Indication: Stop or moderate colds Stop or moderate colds or flu or flu Action: Action: Macrophages and their Macrophages and their secretions secretions Cautions: Cautions: Avoid if immune system Avoid if immune system is is hampered and do not hampered and do not use use continually continually
- 26. Garlic Garlic Source: Source: Garlic plant Garlicplant Indication: Indication: Lower serum cholesterol Lower serum cholesterol and and triglycerides triglycerides Action: Action: Chewing or crushing Chewing or crushing activates several sulfur- activates several sulfur- containing containing compounds compounds Cautions: Cautions: Allergies, GI symptoms, Allergies, GI symptoms, interaction with interaction with anticoagulant anticoagulant drugs drugs
- 27. Ginger Ginger Source: Source: Root ofginger plant Root of ginger plant Indication: Indication: For nausea and vomiting of For nausea and vomiting of pregnancy and motion pregnancy and motion sickness; anti-inflammatory sickness; anti-inflammatory Action: Action: Volatile oils in the rhizome, Volatile oils in the rhizome, called gingerols; may act on called gingerols; may act on serotonin serotonin receptors in the receptors in the ileum ileum Cautions: Cautions: Interaction with anti- Interaction with anti- coagulant, antihypertensive, coagulant, antihypertensive, glucose- glucose- lowering lowering drugs drugs
- 28. Gingko Biloba Gingko Biloba Source: Source:Gingko tree Gingko tree Indication: Indication: Improved blood circulation; Improved blood circulation; used to treat age-related used to treat age-related mental function mental function decline r/t decline r/t cerebrovascular insufficiency cerebrovascular insufficiency Action: Action: Flavone glycosides have Flavone glycosides have antioxidant effect, inhibit antioxidant effect, inhibit platelet platelet aggregation aggregation Cautions: Cautions: Class 2d botanical; may Class 2d botanical; may potentiate MAO inhibitors; GI potentiate MAO inhibitors; GI complaints, complaints, headache, allergy headache, allergy
- 29. Ginseng Ginseng Source: Source: Ginseng plant(radish-like Ginseng plant (radish-like herb) root herb) root Indication: Indication: General improvement from General improvement from the steroidlike components the steroidlike components Action: Action: Ginsenosides, enhanced Ginsenosides, enhanced immune function; studies immune function; studies mixed mixed Cautions: Cautions: Class 2d botanicals; Class 2d botanicals; contraindicated in persons contraindicated in persons with with hypertension; hypertension; overstimulation, GI distress overstimulation, GI distress
- 30. Hawthorn Hawthorn Source: Source: Native Europeantree; Native European tree; leaves, blossoms, fruit leaves, blossoms, fruit Indication: Indication: Improve blood flow in Improve blood flow in circulatory disorders circulatory disorders Action: Action: Dilates coronary vessels; Dilates coronary vessels; strengthens heart strengthens heart contractions and rate contractions and rate Cautions: Cautions: Class 1 botanical Class 1 botanical
- 31. Saw Palmetto Saw Palmetto Source: Source:Palm tree Palm tree Indication: Indication: Reduce incidence of BPH Reduce incidence of BPH Action: Action: Action unclear; research Action unclear; research results mixed results mixed Cautions: Cautions: Contains phytoestrogens, Contains phytoestrogens, could interfere with estrogen could interfere with estrogen therapy, therapy, oral contraceptives, oral contraceptives, other phytohormone- other phytohormone- containing herbs containing herbs
- 32. St. John’s Wort St.John’s Wort Source: Source: Perennial herb Perennial herb Indication: Indication: Mild to moderate depression Mild to moderate depression Action: Action: Hypericin and hyperforin in Hypericin and hyperforin in flowering tops; reuptake of flowering tops; reuptake of neurotransmitters neurotransmitters Cautions: Cautions: Rated as 2d botanical; may Rated as 2d botanical; may potentiate pharmaceutical potentiate pharmaceutical MAOIs; interact MAOIs; interact with other with other antidepressives; antidepressives; photosensitivity photosensitivity
- 33. Valerian Valerian Source: Source: Perennial herb;active Perennial herb; active element element in roots and rhizomes in roots and rhizomes Indication: Indication: Minor tranquilizer and sleep Minor tranquilizer and sleep aid; fewer side effects than aid; fewer side effects than medications medications Action: Action: Volatile oils (bornyl acetate Volatile oils (bornyl acetate and valerenic acid) mode of and valerenic acid) mode of action action GABA binding GABA binding Cautions: Cautions: Class 1 botanical; abrupt Class 1 botanical; abrupt withdrawal may precipitate withdrawal may precipitate symptoms symptoms
- 34. Milk Thistle Milk Thistle Source: Source:Herb in daisy family; seeds Herb in daisy family; seeds are are highest in silymarin highest in silymarin Indication: Indication: Hepatoprotective; used to Hepatoprotective; used to treat treat liver damage in cirrhosis, liver damage in cirrhosis, hepatitis, fatty hepatitis, fatty infiltration infiltration Action: Action: Silymarin stimulates protein Silymarin stimulates protein synthesis, antioxidant; shown synthesis, antioxidant; shown to be moderately effective to be moderately effective Cautions: Cautions: Class 1 botanical; mild Class 1 botanical; mild laxative effect; allergies laxative effect; allergies