Dietary Supplements: Kava: a case study

1. Dietary Supplements:Kava: a case study NUTR 547 - Nutrition Update David L. Gee, PhD Summer 2006

2. What is a Dietary Supplement? • Dietary Supplement Health and Education Act (1994) • contains one or more dietary ingredients • vitamins; minerals; herbs or other botanicals; amino acids; and other substances • intended to supplement the diet • intended to be taken by mouth as a pill, capsule, tablet, or liquid • labeled on the front panel as being a dietary supplement. • Prior to DSHEA there were ~4000 dietary supplements • 2005 there were ~29,000 with ~1000 added per year

3. What types of claims can be made on the labels of dietary supplements? • DSHEA regulates dietary supplements as foods • Health claims • Nutrient content claims • Structure-Function claims • "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.” • Unlike drugs, dietary supplements cannot have claims to diagnose, treat, cure, or prevent any disease.

4. How does the FDA regulate dietary supplements? • If available prior to 1994, FDA review of safety not required; assumed to be safe. • “New” dietary supplement ingredients • manufacturer must provide “reasonable evidence” that the ingredient is safe. • Once marketed, the FDA must prove a supplement to be unsafe to remove it from the market.

5. Does the FDA regulate the quality of dietary supplements? • Dietary supplements must comply with foodGood Manufacturing Practices (GMP) • safety and sanitation • not dietary supplement quality • FDA proposing to rules to ensure supplements are unadulterated and that supplements are accurately labeled • Dietary supplements are not required to be “standardized” (manufactured and tested in a way to ensure standard amount of active ingredient).

6. What about USP verified dietary supplements? • US Pharmacopeia (USP) • non-government, non-profit organization • recognized by Federal law as official body that sets the standards for drugs and dietary supplements • dietary supplements are not required to comply with USP standards • Insures • integrity, purity • dissolution, safe manufacturing

7. Is there a need for “Standardization” or required USP verification? • ConsumerLab testing • tested 27 multi-vit-min supplements • 9 failed to comply with one or more USP requirements • children's product contained more than 150% of the labeled content, exceeding upper limit for an adult • failed the USP disintegration test • prenatal product, contained only 75% of the amount of folic acid claimed on the label • had only 50% of the claimed amount of this important vitamin

8. Is there a need for “Standardization” or required USP verification? • In a separate ConsumerLab.com study of 32 coenzyme Q10 (CoQ10) • the content ranged from no detectable quantity in one product to 175% of the claimed amount in another. • Canadian Journal of Clinical Pharmacology • 54 commercial St. John's Wort products tested for the marker compound hypericin • Only two products tested within 10% of the stated label amount, and on average, most products contained only half of the labeled amount of hypericin.

9. What are Botanical Dietary Supplements? • Botanicals are plants or parts of plants valued for its medicinal or therapeutic properties, flavor, and/or scent. • Herbs are botanicals that are used to maintain or improve health

10. Many drugs originated from herbs • Willow bark (Hippocrates) • Fever of malaria • Salicin • Active ingredient • Pro-drug • Salicylic acid • More potent • GI irritant • Acetyl salicylic Acid • Better tolerated • Ibuprofen • Further reduction of side effects