Supplement Quality, Stage Right . . .
two: Reference materials - testing accuracy in the spotlight
materials are like a fingerprint in a "whodunit" -- they allow chemists
to determine whether or not a substance being tested matches that
of a specific bioactive chemical. Reference materials have long
been used in the pharmaceutical industry to assess product quality,
but until recently the complexities of plant chemistry made it difficult
to make accurate reference materials for botanical supplements.
starring actor in developing botanical references is the Institute
for Nutraceutical Advancement (INA) -- a consortium of supplement
manufacturers formed in 1998 that already has 6 reference standards
available, is preparing 5 more, and continues to develop additional
standards on an ongoing basis.
actor entering the drama is the U. S. Pharmacopoeia (USP). With
more than 1200 reference materials available, USP is the ultimate
standards diva. In addition to prescription and over-the-counter
drugs, USP reference samples include: caffeine, sugar and other
sweeteners, amino acids, many vitamins and a few minerals. USP is
joining the cast of reference material players in order to help
the National Institutes of Health (NIH) conduct accurate clinical
trials of botanical supplements.
it will be some time before the USP has any botanical reference
materials available. According to Mark Blumenthal, Executive Director
of the American Botanical Council (ABC), "It will take several years
before they get underway, but the ultimate result will be reduced
cost for industry in conducting quality control testing."
three: You can't find the scientific evidence for health claims
without a program
newcomer to the quality standards drama is the Research-based Dietary
Ingredient Association (RDIA), also formed in 1998, which held a
conference in Washington DC in November 2000 focusing on a different
quality issue: scientific evidence about health claims. The conference
was designed to begin a process for granting a "seal of approval"
for health claims based on third party reviews.
judging a health claim, participants agreed the review should examine
the totality of the evidence rather than just one or a few studies,"
said John Hathcock, of the Council for Responsible Nutrition (CRN)
and moderator for the conference session on "Issues Involved in
Science-Based Reviews." Hathcock added, "Participants also concluded
that reviews should focus on the relationship between the food or
supplement and the bodily function or disease being impacted. This
would determine whether a specific claim described that relationship
the Washington conference, the FDA and FTC indicated they would
support a third-party process for reviewing and validating health
claims -- if that third party was authoritative and neutral. The
proposed third party reviewer is the Life Sciences Research Office
(LSRO), which has conducted impartial research studies in the fields
of biomedicine, health care, nutrition, and food safety since 1962
and is now a member of the American Society for Nutritional Sciences
twists in the health-claim scenario
RDIA membership is in large part defined by large, multinational
food manufacturers -- who want to make health claims about functional
foods . . .
Enter Supplement Quality, Stage Right
In the ongoing drama of controversy surrounding nutritional
supplements . . .