Dietary Supplements: Kava: a case study

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Dietary SupplementsKava a case study

• NUTR 547 - Nutrition Update
• David L. Gee, PhD
• Summer 2006

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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

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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.

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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.

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Does the FDA regulate the quality of dietary
supplements?

• Dietary supplements must comply with food Good
  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).

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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

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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

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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.

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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

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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