These initiatives -- a regulatory strategy, an open public meeting, and a draft guidance document for industry -- are significant steps FDA has taken in the implementation of DSHEA.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."
The 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.
FDA will continue to protect consumers by pursuing products that violate the law
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.
FDA will also implement a transparent, systematic, and predictable process to evaluate safety concerns about dietary ingredients and dietary supplements.
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 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.
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.
Another aspect to the strategy is ensuring product quality.
The third initiative reflects FDA's commitment to fully implement DSHEA by asking for comments on a draft guidance document on the amount, type and quality of evidence a manufacturer should have to substantiate a claim made under 403 (r)(6) of the Federal Food, Drug, and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.
"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.
Dr Crawford commented, "FDA will continue to protect consumers by pursuing products that violate the law".