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FDA to fully implement & enforce DSHEA.

At the recent Council for Responsible Nutrition (CRN) annual meeting, keynoter Lester Crawford, acting FDA commissioner, promised the audience a barrage of information to come from FDA in the coming weeks regarding the implementation and enforcement of the Dietary Supplement Health & Education Act (DSHEA). Well, it seems Dr. Crawford kept his promise because nearly two weeks later FDA announced several initiatives it would undertake to more fully implement and enforce the 1994 law.

These initiatives include a regulatory strategy, an open public meeting, which was held November 15th, and a draft guidance document for industry. These initiatives, according to the acting FDA commissioner, refine the direction FDA is taking to regulate dietary supplements. "We now have a clear roadmap to share with the dietary supplement industry, while at the same time giving consumers a higher level of assurance about the safety of dietary supplement products and the reliability of their labeling," he said.

With these initiatives FDA intends to improve the transparency, predictability and consistency of its scientific evaluations and regulatory actions to protect consumers against unsafe dietary supplements and dietary supplements making unauthorized, false or misleading claims. The agency will continue its ongoing efforts of monitoring and evaluating product safety, ingredient safety and product labeling, as well as ensuring product quality.

In the first initiative--a regulatory strategy--FDA will work collaboratively with its Federal and other partners to improve the evidentiary base FDA uses to make safety and enforcement decisions about dietary ingredients and dietary supplements. Those partners include the National Institutes of Health Office of Dietary Supplements and National Center for Complementary and Alternative Medicine, the National Toxicology Program in the Department of Health and Human Services, the University of Mississippi's National Center for Natural Products Research, FDA's National Center for Toxicological Research, and others.

FDA will also implement a transparent, systematic and predictable process to evaluate safety concerns about dietary ingredients and dietary supplements. The process begins with a "signal detection" (identifying an issue of concern). Signals of a possible safety concern can come from federal, state and local counterparts; adverse event reports; foreign regulatory actions; media reports; information from consumer groups and consultation with experts. When the quality or quantity of these signals indicates that there may be a public health problem, FDA may then seek input from an independent third party review. FDA's regulatory actions will be based on the totality of the scientific evidence available, including the pharmacology of the substance, scientific literature, adverse event reports and evidence-based reviews. FDA has a variety of options for pursuing its public health mission, including making a determination of unreasonable risk, issuing public health advisories, educating consumers, conducting research and requiring labeling changes.

Under DSHEA, dietary supplements do not need approval from FDA before they are marketed; however, in the case of some new dietary ingredients (NDIs)--i.e., dietary ingredients that were not marketed in the U.S. before October 15, 1994--a premarket safety notification to FDA is required by law. To further the effective implementation of this requirement, FDA announced its second initiative--a public meeting. This public meeting was held on November 15, 2004 to discuss the type, quantity and quality of evidence manufacturers should provide FDA in a NDI notification (For more information on what happened at this meeting see page 22). As the agency clarifies what constitutes a NDI for which a notification must be submitted to FDA, it will continue to communicate with industry. In addition, FDA will thoroughly review comments it receives from the public meeting before implementing any next steps.

Another aspect to the strategy is ensuring product quality. This initiative addresses the need to establish industry-wide standards to help ensure that dietary supplements are manufactured consistently as to identity, purity, quality, strength and composition. On March 13, 2003, FDA published a proposed rule on current good manufacturing practice requirements (cGMP) for dietary supplements. FDA is currently reviewing and evaluating more than 1600 pages of comments. However, Dr. Crawford said at the CRN conference that the final rule can be expected in a matter of months. In addition, he offered a positive outlook regarding the impending GMPs for dietary supplements, saying that the final rule should come close to industry expectations.

Because FDA is committed to protecting consumers against dietary supplements that make false or misleading claims, including unsubstantiated claims, the agency will also continue to monitor and evaluate dietary supplement labeling and take enforcement action, as appropriate. This measure will include the monitoring of labeling claims, including claims in accompanying literature such as flyers, brochures and catalogs, and in Internet labeling.

Other measures include identifying and taking enforcement action against products whose labeling fails to reveal material facts, targeting those products that pose the greatest risk to consumers; obtaining and analyzing samples of dietary supplements in the marketplace to verify that the contents are consistent with the labeling; and reviewing Supplement Facts panels to determine whether the substances listed as dietary ingredients can be lawfully marketed in dietary supplements.

The third initiative reflects FDA's commitment to fully implement DSHEA by asking for comments on a draft guidance document on the amount, type and quality of evidence a manufacturer should have to substantiate a claim made under 403 (r)(6) of the Federal Food, Drug, and Cosmetic Act (the Act), e.g., a structure/function claim. While the Act, as amended by DSHEA, requires substantiation for such claims, it does not define the term. The draft guidance document provides manufacturers flexibility in the precise amount and type of evidence that constitutes adequate substantiation.

FDA feels providing a standard for substantiation may also help to preserve consumer confidence in these products. In preparing this draft guidance, FDA reviewed regulations, case law, the Federal Trade Commission (FTC) guidance on substantiating claims made for dietary supplements in advertising, as well as recommendations from the Commission on Dietary Supplement Labels.

FTC has typically applied a substantiation standard of "competent and reliable scientific evidence" to claims made for dietary supplements in advertising. FDA intends to apply a standard consistent with FTC's approach when it reviews label and other claims. FDA also intends to start a program of inspections of retail establishments to identify products bearing unsubstantiated claims in their labeling.
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Title Annotation:TOP OF THE NEWS
Publication:Nutraceuticals World
Geographic Code:1USA
Date:Dec 1, 2004
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