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Enter Supplement Quality, Stage Right . . .

Act two: Reference materials - testing accuracy in the spotlight

Reference 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.

Today's 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.

Another 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.

However, 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."

Act three: You can't find the scientific evidence for health claims without a program

Another 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.

"In 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 accurately."

At 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 (ASNS).

next page Plot 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 . . .

previous page Enter Supplement Quality, Stage Right
In the ongoing drama of controversy surrounding nutritional supplements . . .



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