WASHINGTON, DC (November 15, 2004) – The Food & Drug Administration (FDA) recently announced three regulatory initiatives designed to further implement the Dietary Supplement Health and Education Act of 1994. The FDA described the initiatives – a regulatory strategy, an open public meeting and a draft guidance document for industry – as “significant steps” in the implementation of the act. “These initiatives refine the direction the agency is taking to regulate dietary supplements,” according to Lester M. Crawford, FDA acting commissioner. “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 said it 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 plans to continue its efforts of monitoring and evaluating product safety, ingredient safety and product labeling. In the first initiative – a regulatory strategy – FDA will seek to improve the evidentiary base the agency uses to make safety and enforcement decisions about dietary ingredients and supplements. FDA also will implement “a transparent, systematic, and predictable process” to evaluate safety concerns about dietary ingredients and supplements.
The process begins with a “signal detection” (identifying an issue of concern), the FDA said. Signals may 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 signals indicates that there may be a public health problem, the FDA may then seek input from an independent third party review. The FDA said its 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.
Under the Dietary Supplement Health and Education Act, dietary supplements do not need approval from the 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 the FDA is required by law.
FDA’s second initiative – a public meeting scheduled to be held today – was designed to seek public comment on the type, quantity, and quality of evidence manufacturers should provide FDA in a new dietary ingredient notification.The third FDA initiative seeks comment on a draft guidance document concerning the amount, type and quality of evidence a manufacturer should have to substantiate a claim made under the Federal Food, Drug, and Cosmetic Act. The document provides manufacturers flexibility in the precise amount and type of evidence that constitutes adequate substantiation.
On October 22, the FDA sent eight warning letters to distributors making unsubstantiated claims for dietary supplement products promoted for weight loss over the Internet. Since the claims lacked adequate substantiation, according to the FDA, they are considered false or misleading and, therefore, the products are “misbranded.”
The FDA recently sent letters to major retailers of dietary supplements warning 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.
