Dietary Supplements & Herbs:

1. Dietary Supplements & Herbs: Just because they’re natural doesn’t mean they’re safe!

2. The next big miracle!

3. Supplements: a booming industry! spent on natural products (excluding vitamins and minerals) of people using complementary therapy of people do not tell their doctors of use $15 BILLION 52% 70+%

4. Objectives What you need to know: • Definitions • Supplements in the marketplace • Are supplements safe? • How to select supplements • Resources

5. Definitions The following definitions are provided by the Office of Dietary Supplements (National Institutes of Health)

6. Dietary ingredients • Vitamins (“chemicals necessary for life”) • Minerals • Herbs or other botanicals • Amino acids • Other substances or their parts • Enzymes, organ tissues, extracts, concentrates, metabolites, etc

7. New dietary ingredients • A dietary ingredient not sold in the US in a dietary supplement before October 15, 1994 • Example • SAM-e (2001)

8. What is a dietary supplement? • A product that: • Is intended to add to the diet • Contains 1 or more dietary ingredients • Is intended to be taken by mouth • Capsule • Gelcaps • Tablet • Liquid • Teas, Extracts, Tinctures, Powders, etc • Is labeled on the front panel as a dietary supplement

9. Herbs

10. What are herbs? • Subsets of botanicals • Plant, or plant part valued for its medicinal or therapeutic properties, flavor and/or scent • Other names: • Botanical products • Herbal products • Phytomedicines • Herbs are “Dietary supplements” Office of Dietary Supplements, National Institutes of Health

11. Forms of herbs Turmeric • Fresh or dried products • Liquid or solid extracts • Tablets • Capsules • Powders • Tea Chamomile tea

12. Common preparation: Tea • Also called an infusion • Made by • Adding boiling water • To fresh or dried botanicals • Steeping them • Use hot or cold

13. Common preparation: Decoction • Roots, bark and berries • Require more forceful extraction • Simmered in boiling water longer than tea • Use hot or cold

14. Common preparation: Extract • Made by: • Soaking botanical in a liquid that removes specific types of chemicals • Liquid used • As is • Or evaporated to make dry extract • Used in capsules and tablets

15. Common preparation: Tincture • Made by: • Soaking a botanical in a solution of • Alcohol and water • Sold as liquids • Used for concentrating and preserving botanicals • Made in different strengths • Expressed as botanical-to-extract ratio

16. Dietary supplements in the marketplace Regulations

18. Regulations, or lack there ofDSHEA (1994 Dietary Supplement Health and Education Act) • Regulated by FDA (US Food and Drug and Administration) • As foods • But differently FROM foods and drugs • “Regulations” determined by intent of usage 1994 The year that the FDA “lets their hair down”! Herbal Supplement Industry becomes deregulated

19. Approval process: Drugs • Needpremarket approval • Safety and effectiveness must be proven BEFORE market • Monitored for safety • Can be recalled

20. Approval process: food products/additives • Need premarket approval

21. Approval process: supplements • Do not need premarket approval • Safety and effectiveness evaluated AFTER marketing • Manufacturers submit “proof” before marketing to FDA • Not required, however • Unsafe products not allowed to be marketed • Takes years to recall

22. Labeling must be • Truthful • Not Misleading • FDA can remove product otherwise • Deceptive? CSPIE is suing Coca-Cola for deceptive health claims: • Reduce risk for chronic disease • Promote healthy joints • Support immune function

23. Claims on supplements • CANNOT claim • Diagnose, cure, lessen, treat or prevent a disease • CAN claim • Health claim • Nutrient content claim • Structure/function claim

24. Health claims • Describes a relationship between food, food component, dietary supplement ingredient and reducing RISK of a disease or health related condition

25. Nutrient content claims • Describes the relative amount of a nutrient or dietary substance in a product

26. Structure/function claims • Describes how a product may affect the organs or system of the body • Cannot mention any specific disease • NO FDA approval required BUT • FDA must receive text within 30 days of claim • MUST have a disclaimer

27. Disclaimer All claims must include this statement: “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent any disease”

29. Are supplements effective and safe?

30. Research shows…. • YES! Some supplements are effective! • Folic acid (birth defects) • Calcium (bone) • Vitamin D (bone, immune system, cancer, etc), etc • Promising • St Johns Wort (mild to moderate depression) • Omega-3 (heart), etc

31. BUT (and there’s always a but!) • Not enough research conducted on many others • Issues at stake: Public TRUST • Integrity • Effectiveness • Purity • Safety • Natural=safe • $$$$$ = OK! You get what you pay for….RIGHT? “A deregulated industry is like allowing a fox in the hen house” -Global Industry Analysts

32. Not enough research • New field…need more time • “Fence-sitters” • Downright dangerous (and widely available) • Aristolochic acid • Kava • Yohimbe • Bitter orange • Glandular extracts, etc

33. Safety • Most important • Difficult to assess • Not enough studiesNO studies in some populations • Interactions: • Food-herb • Drug-herb • Multiple herb

34. Purity, integrity • Labels not always accurate with ingredients • Contamination (lead, arsenic, etc) • Unidentified ingredients • The strength not always accurate

35. Unsubstantiated Claims • False advertising • This is why we have a disclaimers on supplements!

36. Overdosing issues • Vitamins and minerals well studied • Most water-soluble OK • Fat soluble and minerals can be dangerous • Other supplements not studied well • What is too high? • No %DV • Combinations increase risks

37. Supplements NOT the same as food! • Food contains active and unknown ingredients that may synergistically interact for health benefits • Also contain fiber • Flavor • Supplements many times contain active ingredients only of functional foods • But what about the ones not discovered yet?

38. How to select supplements

39. New FDA rules • GMP: Good Management Practices • Manufacturers will be required to evaluate identity, purity, strength and composition of products • What will this do? • That supplements contain what the labels claim • Free of contaminants • However…. • Risks still remain • FDA pre-market approval not required

40. Look for standardized herbal supplements • The U.S. Pharmacopeia's "USP Dietary Supplement Verified" seal • indicates the supplement has met certain manufacturing standards. • Others • Consumerlab.com • Good Housekeeping • NSF International • GMP Helps you ensure you are getting a PURE product as opposed to a contaminated product (free of lead, mercury, or drugs)

41. Buy single herb products This product has 16 herbs • Need to show quantity of each herb • Beware of numerous and unknown amounts of mixtures This product has one

42. Multivitamins • Are a better choice than single vitamin or minerals • Vitamins and minerals work TOGETHER for better absorption • Stick with major brands • Talk to doctor or nutritionist before taking individual

43. Beware of outrageous claims • If it’s too good to be true, then it probably is • Such as • Can treat or cure disease • A “cure-all” • “Totally Safe” • “No side effects” • “Natural” doesn’t mean “safe”

44. Beware of foreign supplements • European and Canadian supplements are highly regulated and standardized but • Not other countries

45. Discuss with doctor/pharmacist • ALWAYS tell health care professional all supplements you are taking • ASK before you take supplements • DISCUSS name brands

46. Be Careful if • You are: • Younger than 18 • Older than 65 • Pregnant or breast-feeding • Taking OTC or Rx medications • Having surgery soon

47. Spend your money wisely • Just because they’re expensive doesn’t mean they’re better! • Sometimes cheaper to get medicine than supplement • Is it really helping?

48. NEVER substitute supplements for Rx medications

49. Report adverse side effects • FDA MedWatch • 1-800-FDA-1088(toll-free phone number)

50. Resources