Guidance for Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements; Availability

The Nutrition Labeling and Education Act of 1990 (NLEA), which amended the Federal Food, Drug, and Cosmetic Act (the act), authorized FDA to allow food labels to carry statements that describe the relationship between a food substance and a disease or health-related condition (``health claims'') (section 403(r)(1)(B) of the act (21 U.S.C. 343(r)(1)(B))). To ensure the scientific validity of health claims, NLEA required that FDA authorize a health claim in the labeling of conventional foods only if the agency ``determines, based on the totality of publicly available scientific evidence (including evidence from well-designed studies conducted in a manner which is consistent with generally recognized scientific procedures and principles), that there is significant scientific agreement, among experts qualified by scientific training and experience to evaluate such claims, that the claim is supported by such evidence'' (section 403(r)(3)(B)(i) of the act (21 U.S.C. 343(r)(3)(B)(i))). By regulation, FDA adopted the same standard for health claims in the labeling of dietary supplements (Sec. 101.14(c)(21 CFR 101.14(c)). In 1996, FDA asked its FAC to convene a working group to develop a guide for preparing petitions for health claims. In response to the recent decision of the Court of Appeals for the District of Columbia Circuit in Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999), which required FDA to clarify the meaning of ``significant scientific agreement,'' the focus of the FAC Working Group shifted to the scientific review of data for health claims and the interpretation of the significant scientific agreement standard. The working group's final report entitled ``Interpretation of Significant Scientific Agreement in the Review of Health Claims'' was made public during the FAC meeting of June 24 and 25, 1999. FDA concurs with the conclusions of the working group and is issuing a guidance based on the working group's final report. This guidance represents the agency's current thinking on the meaning of the significant scientific agreement standard in section 403(r)(3) of the act (21 U.S.C. 343(r)(3)) and Sec. 101.14(c). It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. This guidance is a Level 1 guidance under FDA's good guidance practices (GGP's) (62 FR 8961, February 27, 1997). Consistent with GGP's, the agency is soliciting public comment, but is implementing the guidance immediately to promptly comply with the decision in Pearson v. Shalala.

II. Comments

Interested persons should submit written comments on the guidance to the Dockets Management Branch (address above), by February 22, 2000, to ensure adequate consideration in the preparation of a revised guidance, if warranted. However, written comments may be submitted at anytime. Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. The guidance and received comments may be seen in the office above between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

An electronic version of the guidance also is available on the Internet at www.cfsan.fda.gov/dms/guidance.html#lab.

Dated: December 17, 1999. Margaret M. Dotzel, Acting Associate Commissioner for Policy. [FR Doc. 99-33279 Filed 12-20-99; 1:04 pm] BILLING CODE 4160-01-F