Letter from the Center Director
Letter to Stakeholders
FDA Task Force on Consumer Health Information for Better Nutrition
Dear Colleague, FDA Foods Community:
The Food and Drug Administration (FDA) has formed a Task Force that will address qualified health claims in foods.
I am pleased to provide you with a copy of the letter announcing the formation of the Task Force and a list of the Task Force members.
To associations, please forward copies of this letter to your members. We will also send copies to the trade press and post on our website at www.cfsan.fda.gov. Thank you.
| Joseph A. Levitt |
Dear Stakeholders:
On December 18, 2002, Commissioner Mark B. McClellan announced a major new initiative to make available to consumers more and better information about the health benefits of foods and dietary supplements. The ultimate goal of the initiative is to help American consumers make sound dietary decisions, thereby reducing the risk of certain diseases and improving the public health. FDA is pursuing this objective in two ways: by encouraging marketers of conventional foods and dietary supplements to make accurate, science-based claims about the health benefits of their products, and by creating strong disincentives through enforcement action for dietary supplement marketers to make false or misleading claims. This letter focuses on the former of these activities and describes the process FDA intends to use to implement those aspects of the initiative relating to qualified health claims for conventional foods.
FDA is committed to an orderly process for the review and authorization of health claims in the labeling of conventional foods, and we are working to develop procedures to implement those aspects of the initiative relating to qualified health claims. The agency is also committed to assuring that stakeholders remain fully informed of our progress as we implement the initiative.
As announced, an internal FDA Task Force is developing new procedures for the review of qualified health claims. Known as the FDA Task Force on Consumer Health Information for Better Nutrition, the group will be chaired by Deputy Commissioner Lester Crawford, and I will serve as Vice-Chair. A list of Task Force members is enclosed. FDA will also be consulting with other Government experts in the fields of health information and nutrition, as appropriate.
The Task Force is expected to take approximately 6 months to complete its mission, and our efforts will be focused in several key areas. First, the Task Force will develop additional scientific guidance on how FDA will apply the "weight of the evidence" standard for qualified health claims. The guidance will help food marketers develop health claim petitions by explaining the type of substantiating scientific evidence needed for a claim. Second, the Task Force will identify both internal and external procedures for implementing the initiative. This aspect of the work of the Task Force will include an analysis of staffing needs with a view to assuring timely review of health claim petitions. Finally, the Task Force will address the framework for future rulemaking to give FDA's new policy on qualified health claims the force and effect of law. Currently, FDA's policy for qualified health claims in the labeling of conventional foods is set forth only in a guidance document, which is non-binding.
As announced, all qualified health claims are still subject to the statutory requirement of FDA authorization. The basic process remains an agency review of a petition requesting authorization of a specific health claim. Under existing procedures, FDA has 100 days following submission of the petition to "file" the petition. If a petition is "filed," then in the next 90 days, FDA must provide the petitioner with one of the following three responses: (a) An administrative proceeding to promulgate a regulation authorizing an unqualified health claim; (b) a letter informing the petitioner that FDA will use its enforcement discretion and allow use of a properly qualified health claim as described in the letter; or (c) a letter informing the petitioner that FDA is denying the petition.
FDA is committed to timely, orderly implementation of the initiative. We, therefore, request that parties interested in submitting health claim petitions, to the extent practicable, identify priorities for such claims and consider submitting consolidated or joint petitions to the agency. This will help FDA use its finite resources for the review of health claim petitions more effectively. While FDA recognizes economic considerations will contribute to decisions concerning the selection of proposed claims for agency review, we encourage the food industry to be mindful of the public health goal of the initiative and consider selecting health claims that will, if authorized, achieve the greatest benefits to public health. Until the Task Force has developed procedures and guidance governing the submission and review of health claim petitions, prospective petitioners should consult with CFSAN's Office of Nutritional Products, Labeling and Dietary Supplements regarding appropriate substantiating documentation and other issues relating to health claim petitions.
We hope this information is useful to you. As discussed above, FDA is committed to dialogue with health professionals, the food industry, consumers, and other stakeholders on this topic. We will provide more information about our efforts relating to health claims and other aspects of the initiative as appropriate. In the meantime, we welcome your comments and suggestions.
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Sincerely,
Joseph A. Levitt Director Center for Food Safety and Applied Nutrition |
Enclosure
Chair - Lester Crawford, D.V.M., Ph.D.
Deputy Commissioner, Food and Drug Administration (FDA)
Vice Chair - Joseph A. Levitt
Director, Center for Food Safety and Applied Nutrition (CFSAN)
Executive Secretariat - Peter A. Salsbury
Science Policy Analyst, Office of the Center Director, CFSAN
Members
Norris Alderson, Ph.D.
Associate Commissioner for Science, FDA
William Allaban, Ph.D.
Deputy Director, National Center for Toxicological Research, FDA
Van Hubbard, Ph.D.
Director, Division of Nutrition Research Coordination, National Institutes of Health
William K. Hubbard
Associate Commissioner for Policy and Planning, FDA
L. Robert Lake, Esq.
Director of Regulations and Policy, CFSAN
Michael Landa, Esq.
Deputy Chief Counsel, FDA
Joanne R. Lupton, Ph.D.
Visiting Scientist, Office of Nutritional Products, Labeling and Dietary Supplements, CFSAN
(Regents Professor and William W. Allen Endowed Chair in Human Nutrition, Texas A&M.)
Alan M. Rulis, Ph.D.
Director, Office of Food Additive Safety, CFSAN
Christine L. Taylor, Ph.D.
Director, Office of Nutritional Products, Labeling and Dietary Supplements, CFSAN
Kathleen Ellwood, Ph.D., Associate Director for Nutrition Science and Policy, CFSAN (alternate)
Elizabeth A. Yetley, Ph.D.
Lead Scientist for Nutrition, CFSAN
FDA Task Force on Consumer Health Information for Better Nutrition Established January 16, 2003
FDA Announces Initiative to Provide Better Health Information for Consumers December 18, 2002
Guidance for Industry: Qualified Health Claims in the Labeling of Conventional Foods and Dietary Supplements December 18, 2002