FDA Issues Draft Guidance on Evaluating Health Claims

FDA has issued a draft guidance document, Evidence-Based Review System for the Scientific Evaluation of Health Claims, to represent the agency's current thinking on:

The process for evaluating the scientific evidence for a health claim;
The meaning of the significant scientific agreement (SSA) standard in section 403(r)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 343(r)(3)) and 21 CFR 101.14(c);
Credible scientific evidence to support a qualified health claim.

This guidance document describes the evidence-based review system that FDA intends to use to evaluate the publicly available scientific evidence for SSA health claims or qualified health claims on the relationship between a substance and a disease or health-related condition. This guidance document explains the agency's current thinking on the scientific review approach FDA should use and is intended to provide guidance to health claim petitioners.

The specific topics addressed in this guidance document are:

Identifying studies that evaluate the substance/disease relationship;
Identifying surrogate endpoints for disease risk;
Evaluating the human studies to determine whether scientific conclusions can be drawn from them about the substance/disease relationship;
Assessing the methodological quality of each human study from which scientific conclusions about the substance/disease relationship can be drawn;
Evaluating the totality of scientific evidence.

Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit comments to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.

For questions regarding this draft document, contact the Center for Food Safety and Applied Nutrition at 301/436-2367.

For complete details, see the release online.