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Dietary Supplements: Kava: a case study. NUTR 547 - Nutrition Update David L. Gee, PhD Summer 2006. What is a Dietary Supplement?. Dietary Supplement Health and Education Act (1994) contains one or more dietary ingredients

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dietary supplements kava a case study

Dietary Supplements:Kava: a case study

NUTR 547 - Nutrition Update

David L. Gee, PhD

Summer 2006

what is a dietary supplement
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
what types of claims can be made on the labels of dietary supplements
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.
how does the fda regulate dietary supplements
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.
does the fda regulate the quality of dietary supplements
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).
what about usp verified dietary supplements
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
is there a need for standardization or required usp verification
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
is there a need for standardization or required usp verification8
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.
what are botanical dietary supplements
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
many drugs originated from herbs
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