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

What is a Dietary Supplement? zDietary 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

What types of claims can be made on the labels of dietary supplements? zDSHEA regulates dietary supplements as foods yHealth claims yNutrient content claims yStructure-Function claims y"This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.” zUnlike drugs, dietary supplements cannot have claims to diagnose, treat, cure, or prevent any disease.

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

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

What about USP verified dietary supplements? zUS Pharmacopeia (USP) ynon-government, non-profit organization yrecognized by Federal law as official body that sets the standards for drugs and dietary supplements ydietary supplements are not required to comply with USP standards yInsures xintegrity, purity xdissolution, safe manufacturing

Is there a need for “Standardization” or required USP verification? zConsumerLab testing ytested 27 multi-vit-min supplements x9 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

Is there a need for “Standardization” or required USP verification? zIn a separate ConsumerLab.com study of 32 coenzyme Q10 (CoQ10) ythe content ranged from no detectable quantity in one product to 175% of the claimed amount in another. zCanadian Journal of Clinical Pharmacology y54 commercial St. John's Wort products tested for the marker compound hypericin yOnly two products tested within 10% of the stated label amount, and on average, most products contained only half of the labeled amount of hypericin.

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

Many drugs originated from herbs zWillow bark (Hippocrates) yFever of malaria zSalicin yActive ingredient yPro-drug zSalicylic acid yMore potent yGI irritant zAcetyl salicylic Acid yBetter tolerated zIbuprofen yFurther reduction of side effects