Anticipating an influx of health claims petitions now that less stringent approval standards are in the works, FDA is urging industry to consider limits on the number of submissions.

In a Jan. 15 letter to stakeholders, FDA Center for Food Safety & Applied Nutrition Director Joseph Levitt says "FDA is committed to timely, orderly implementation" of a formalized approach to approving qualified health claims.

"We therefore request," he continues, "that parties interested in submitting health claims 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 claims petitions more effectively," he points out. Levitt also notes the center's staffing needs will be analyzed "with a view to assuring timely review" of petitions.

In weighing prospective claims for agency review, "we encourage the food industry to...consider selecting health claims that will, if authorized, achieve the greatest benefit to public health," Levitt states.

The agency recognizes "economic considerations" also will contribute to decisions, he adds.

Until new procedures for substantiating qualified claims have been established, Levitt recommends prospective petitioners consult with the Office of Nutritional Products, Labeling & Dietary Supplements regarding "appropriate documentation" and other issues.

The internal FDA task force charged with developing procedures for reviewing qualified health claims will convene for the first time in February, the agency announced in a ¹ Jan. 16 release.

The group's early priorities will include identifying "mechanisms to obtain additional public input," FDA indicated. Creation of the task force was announced by FDA Commissioner Mark McClellan, MD/PhD, in mid-December (² Also see "FDA Consumer Health Information Task Force To Be Chaired By Crawford" - Pink Sheet, 23 December, 2002., p. 11).

At that time, FDA also pledged implementation of a "reasonable consumer" standard in evaluating scientific support for qualified health claims and a renewed effort to curb misleading claims.

The Task Force on Consumer Health Information For Better Nutrition will meet on a monthly basis and has six months to fulfill its mission, which includes producing recommendations on how the agency should use a "weight of evidence" standard to review qualified health claims.

The group also will develop a "framework of regulations that will give these principles the force and the effect of law," and "develop a consumer studies research agenda designed to best present scientifically based information to consumers in a truthful and nonmisleading way," according to the agency.

As previously announced, FDA Deputy Commissioner Lester Crawford, PhD, will chair the 13-member task force, with Levitt serving as vice chair. CFSAN Office of the Center Director Science Policy Analyst Peter Salsbury will serve as executive secretariat.

The majority of members are from CFSAN, including: Director of Regulations & Policy Robert Lake; Office of Food Additive Safety Director Alan Rulis, PhD; ONPLDS Director Christine Taylor, PhD; and Lead Scientist for Nutrition Elizabeth Yetley, PhD.

Also from CFSAN are Office of Nutritional Products Visiting Scientist Joanne Lupton, PhD, and Associate Director for Nutrition Science & Policy Kathleen Elwood, PhD, who will be an alternate. Lupton is Regents professor and William Allen Endowed Chair in Human Nutrition at Texas A&M.

Additional members include: FDA National Center for Toxicological Research Deputy Director William Allaban, PhD; FDA Associate Commissioner for Science Norris Alderson, PhD; FDA Associate Commissioner for Policy & Planning William Hubbard; and FDA Deputy Chief Counsel Michael Landa.

National Institutes of Health Division of Nutrition Research Coordination Director Van Hubbard, PhD, is the only member of the group recruited from outside FDA.

Prioritized, Consolidated Health Claims Petitions Requested By FDA’s Levitt

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