U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
February 29, 2000

"Dear Colleague" Letter
Clarifying FDA Contacts for Structure/Function
Claims of Dietary Supplements

Dear Colleague, Dietary Supplements Community:

As you know, on January 6, 2000 the Food and Drug Administration (FDA) issued a final rule concerning statements made for dietary supplements relative to the effect of the product on the structure or function of the body. The topic of structure/function claims, by its nature, crosses a number of boundaries within FDA. As a consequence, several units within FDA were involved in the development of the rule, including the Center for Food Safety and Applied Nutrition (CFSAN), the Center for Drug Evaluation and Research (CDER), the agency's Office of Policy (OP), and the agency's Office of Chief Counsel (OCC). Moreover, because of the cross-cutting nature of the principles inherent in the rule, staff from the Office of Policy were responsible for integrating the issues and drafting the rule itself.

We recognize that this situation has led to some confusion as to whom to contact with specific questions concerning the final rule. We are sending this letter to help clarify the responsible person and contact points within FDA.

As the preamble to the rule makes clear, an important component of structure/function claim considerations is the nature of the distinction between a "disease" and a "non-disease" state or condition. This issue and related issues within the context of the rule have been designated as the lead responsibility of CDER, consistent with the statutory responsibility over claims to diagnose, treat, cure or mitigate disease. As such, CDER has made staff available to respond to inquiries focused on this aspect of the final rule. In addition, because discussions and decisions related to disease/non-disease states and other related components of the rule are likely to be overarching, CDER is leading an agency-wide working group (including CFSAN, OP and OCC) to focus on these topics. The objectives will be to develop the necessary guidance on the appropriate scope and boundaries for structure/function vs. disease claims (as promised in the preamble to the final rule), and to provide an arena where specific and important issues related to disease/non-disease topics can be addressed systematically and consistently. FDA's recent announcement with respect to claims related to pregnancy would fall under this category for CDER lead responsibility.

CFSAN will be responsible for overseeing the implementation of the rule relative to dietary supplements, particularly as it relates to enforcement. FDA will be streamlining its internal enforcement process so that CFSAN, which reviews the 30-day notifications of structure function claims, will also be able to follow through on any necessary enforcement action. CFSAN will also take the lead for responding to petitions concerning effective date and similar implementation issues. The Center's recent re-organization creates a dedicated Enforcement division within the new Office of Nutritional Products, Labeling and Dietary Supplements and will enhance the Center's effectiveness in this regard. The Center will, of course, ensure that all of its activities are consistent with the provisions of the rule.

We wish to emphasize very clearly at this time that the implementation of the rule will be fully consistent with the provisions of the Dietary Supplement Health and Education Act (DSHEA) and derived from the principles outlined in the legislation. The "division of labor" related to the development and, as needed, further specification for the rule is intended to enhance the Agency’s effectiveness in achieving that goal.

We hope this information is helpful to you. We encourage you to contact us to discuss any questions you may have.

Hypertext updated by cjm/dms/kwg 2000-NOV-27