Today the Food and Drug Administration (FDA) announced three major regulatory initiatives designed to further implement the Dietary Supplement Health and Education Act of 1994 (DSHEA). These initiatives -- a regulatory strategy, an open public meeting, and a draft guidance document for industry -- are significant steps FDA has taken in the implementation of DSHEA.
"These initiatives refine the direction the agency is taking to regulate dietary supplements," said FDA Acting Commissioner Lester M. Crawford. "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."
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. FDA has published a Federal Register notice about the public meeting as well as two notices describing the other initiatives.
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 (i.e., dietary ingredients that were not marketed in the United States before October 15, 1994), a pre-market safety notification to FDA is required by law.
To further the effective implementation of this requirement, FDA has announced its second initiative -- a public meeting on November 15, 2004 that is designed to seek public comment on the type, quantity, and quality of evidence manufacturers should provide FDA in a new dietary ingredient notification.
The agency does not anticipate any immediate changes to its enforcement process. As the agency clarifies what constitutes a NDI for which a notification must be submitted to FDA, FDA will continue to communicate with industry. In addition, FDA will thoroughly review comments it receives from the public meeting before implementing any next steps.
The agency is committed to taking action against unsafe products. For example, a fter determining that products containing androstenedione posed significant health risks and lacked NDI notifications, FDA sent warning letters to 23 companies in March 2004 asking them to cease distributing products sold as dietary supplements that contain androstenedione and warning them that they could face further enforcement actions if they did not take appropriate measures.
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 1,600 pages of comments. Publication of a cGMP final rule is one of the agency's highest priorities.
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 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.
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.
"The guidance FDA has issued today sends a clear and strong reminder to marketers that claims about the benefits of dietary supplements, wherever they appear, must be truthful and substantiated by high quality scientific evidence," said Federal Trade Commission Chairman Deborah Platt Majoras. "Today's FDA action leaves no doubt that our two agencies are united in our efforts to combat false or unfounded claims. We look forward to continuing our close collaboration with FDA to attack deceptive and unsubstantiated claims in the dietary supplement market."
Whether consumers are purchasing dietary supplements to improve their appearance, promote general health, or help them maintain a healthier lifestyle, consumers may fall victim to products that cheat them out of their money or steer them away from products that are proven to achieve the results they are seeking.
In fact, on October 22, 2004 FDA sent eight warning letters to dietary supplement distributors making unsubstantiated claims for dietary supplement products promoted for weight loss over the Internet. Since those claims lacked adequate substantiation, they are considered false or misleading; therefore, the products are misbranded.
FDA also today sent a letter to major retailers of dietary supplements to inform them that products labeled with unsubstantiated claims are misbranded and that FDA may take enforcement action against misbranded products in their possession. FDA intends to start a program of inspections of retail establishments to identify products bearing unsubstantiated claims in their labeling.
"FDA will continue to protect consumers by pursuing products that violate the law," said Dr. Crawford.
FDA is soliciting comments from the public and industry on both the regulatory strategy and the topics to be discussed at the public meeting, which will be held on November 15, 2004. Written comments will be received until 60 days after the date of publication in the Federal Register and may be addressed to Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Submit electronic comments.
Public Meeting -- Nov. 15, 2004
- Federal Register Notice (PDF)
- Registration Form and Notice (Center for Food Safety and Applied Nutrition)