Industry-sponsored supplement cmte. could facilitate labeling, safety reviews.

DIETARY SUPPLEMENT EXPERT ADVISORY COMMITTEE ESTABLISHMENT by the supplement industry is endorsed by the President's Commission on Dietary Supplement Labels in its June 24 draft report. The advisory committee could "provide scientific review of label statements and claims and...guidance to the industry regarding the safety, benefit and appropriate labeling of specific products," the report suggests.

"The commission believes the dietary supplement industry and consumers alike would benefit from an increased level of scientific input into decisions regarding label statements for dietary supplements," the draft explains. An advisory committee additionally could help make product safety determinations.

The American Herbal Products Association, National Nutritional Foods Association and Utah Natural Products Alliance have proposed a botanical ingredient review to FDA that would establish standards for safety, uses, labeling and dosages for botanical supplements ("The Tan Sheet" March 3, In Brief). The groups told the commission at a March meeting that industry would like to proceed with the creation of such a review with or without the "blessing" of FDA ("The Tan Sheet" March 10, p. 12).

"Such a committee might be supported by one or more industry trade associations or might be established as an independent entity funded by grants and/or fees for services," the draft report suggests. The Council for Responsible Nutrition, in a same-day release, noted that it will recommend the establishment of a permanent entity such as a foundation to support an advisory panel.

An advisory committee should be composed of scientific experts with appropriate backgrounds in nutrition, pharmacognosy, pharmacology, health promotion and disease prevention, medicine and toxicology, the seven-member commission urges. Several commission members have said participation by the U.S. Pharmacopeial Convention, FDA, the National Academy of Sciences and international bodies such as the World Health Organization also would be valuable.

The report cites the Cosmetic, Toiletry & Fragrance Association Cosmetic Ingredient Review expert panel and the Flavor & Extract Manufacturers Association review of flavor compounds as two examples of successful industry-organized and funded reviews. "The commission recognizes that the support of an expert advisory committee in the pursuit of a comprehensive review of dietary supplement ingredients would be a major and costly undertaking," the report notes. "However, the success of the CTFA and FEMA reviews indicates that the value of the undertaking may be well worth the investment."

The commission states that the public generally would be better served by more research into the relationships between dietary supplements and maintaining health and/or avoiding disease, noting that incentives should be developed to encourage supplement makers to invest in research. Because of the small size of many dietary supplement companies, there has been limited investment in research on product efficacy, the report observes.

"Conducting clinical research to assess the validity of statements of nutritional support could be difficult," the commission points out. "A claim that a product provides a feeling of well-being may be confounded with the placebo effect, thus double-blind studies using placebo would be essential to assessing such statements," it continues. "A statement that a product enhances immune function requires an appropriate challenge with acceptable clinical and biochemical methodology to determine whether the product actually improves resistance to common conditions such as colds and flu," the commission says, adding "such research is resource intensive."

"FDA might consider a mechanism for review of research conducted to validate a statement of nutritional support such that the label disclaimer mandated by [the Dietary Supplement Health & Education Act] could be modified or removed," the report suggests. "More consideration is needed of the ways to provide sufficient resources to FDA to make it possible for the agency to take on such an additional responsibility."

The label commission also recommends that federal agencies continue to support studies on the health effects of supplements. "Research should be expanded beyond the traditionally supported areas associated with vitamin and mineral supplements and include research on some of the more promising botanical products used as dietary supplements," the report notes.

The commission points out a need for the National Institutes of Health Office of Dietary Supplements "to take a major proactive role in fulfilling its purposes, including exploring more fully the potential role of dietary supplements and promoting scientific study of their benefits." The office should be funded at the level set in DSHEA, which provides for an annual budget of $5 mil., the draft notes. ODS has a budget of about $1 mil.