Transcript Dietary Supplements: Kava

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
 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?
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?
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?
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).
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?
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 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?
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
 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