The Food and Drug Administration has announced three major regulatory initiatives designed to further implement the Dietary Supplement Health and Education Act of 1994 (DSHEA). The actions include a regulatory strategy, an open public meeting, and a draft guidance document for industry.

"These initiatives refine the direction the agency is taking to regulate dietary supplements," Acting FDA Commissioner Dr. Lester M. Crawford said in announcing the initiatives in November 2004. "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."

The agency plans to improve the transparency, predictability, and consistency of its scientific evaluations and regulatory actions to protect consumers against unsafe dietary supplements and dietary supplements being promoted with unauthorized, false, or misleading claims. The FDA 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, the FDA will work collaboratively with partners in federal agencies and other organizations to improve the factual basis for the agency's safety and enforcement decisions about dietary supplements. Those partners include the National Institutes of Health's 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, and the PDA's National Center forToxicological Research.

The FDA will also implement a transparent, systematic, and predictable process to evaluate safety concerns about dietary ingredients and dietary supplements. The process begins with identifying an issue of concern, called "signal detection" by the agency. Signals of a possible safety concern can come from federal, state, and local health agencies; 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, the FDA may then seek input from an independent third-party review.

The agency's regulatory actions will be based on the total scientific evidence available, including the pharmacology of the substance, scientific literature, adverse event reports, and evidencebased reviews. The FDA has a variety of options for protecting the public from unsafe supplements, 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 the FDA before they are marketed. However, in the case of some new dietary supplements, such as dietary ingredients that were not marketed in the United States before Oct. 15, 1994, a premarket safety notification to the FDA is required by law.

The second initiative-a public meeting held in November 2004-was designed to seek public comment on the type, quantity, and quality of evidence manufacturers should provide the agency in a new dietary ingredient notification.

Another aspect of the regulatory strategy is to establish industry-wide standards to help ensure that dietary supplements are manufactured consistently as to identity, purity, quality, strength, and composition. The FDA is currently reviewing and evaluating more than 1,600 pages of comments on a proposed rule to establish current good manufacturing practice (CGMP) requirements for dietary supplements. Publication of a final CGMP rule is one of the agency's highest priorities.

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 on packaging to determine whether the substances listed as dietary ingredients can be lawfully marketed in dietary supplements.

The third initiative reflects the PDA'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 claimsuch as a structure claim-made under the Federal Food, Drug, and Cosmetic Act. The draft guidance document provides manufacturers flexibility in the precise amount and type of evidence that constitutes adequate substantiation. Providing a standard for substantiation may also help to preserve consumer confidence in these products.

"FDA will continue to protect consumers by pursuing products that violate the law," Crawford says.

　　From Healthy.net