F.D.A. issues draft guidance on health claim evaluation

by Eric Schroeder
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WASHINGTON — The Food and Drug Administration has proposed an evidence-based review system for evaluating significant scientific agreement (S.S.A.) and qualified health claims. As it pertains to health claims, an evidence-based review system is a systematic science-based evaluation of the strength of the scientific evidence to support a proposed claim about a substance/disease relationship.

The draft guidance, entitled "Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims," is open for comment until Sept. 7. If finalized, the guidance would replace earlier F.D.A. guidance put in place in July 2003 ("Interim Evidence-Based Ranking System for Scientific Data") and December 1999 ("Guidance for Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements").

According to the F.D.A., the draft guidance represents the administration’s current thinking on the scientific review process for S.S.A. and qualified health claims and their relationship between a substance and a disease or health-related condition. It does not, however, create or confer any rights for or on any person and does not bind the agency or the public, the F.D.A. said.

In evaluating a petition for an authorized health claim, the F.D.A. said it considers whether the evidence supporting the relationship that is the subject of the claim meets the S.S.A. standard. This standard provides that the F.D.A. shall authorize a health claim to be used on conventional foods if the agency "determines based on the totality of the publicly available evidence (including evidence from well-designed studies conducted in a manner that is consisted 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."

Under the approach set out in the draft guidance, the F.D.A. said it intends to evaluate the results of the studies from which scientific conclusions may be drawn and rate the strength of the total body of publicly available evidence.

"The agency plans to conduct this evaluation by considering the study type (e.g., intervention, prospective cohort, case-control, cross-sectional), methodological quality rating previously assigned, quantity of evidence (number of the various types of studies and sample sizes), relevance of the body of scientific evidence to the U.S. population or target subgroup, whether study results supporting the proposed claim have been replicated, and the overall consistency of the total body of evidence," the F.D.A. stated.

Regarding the specificity of the health claim language, the F.D.A. in its draft guidance said language "should reflect the level of scientific evidence with specificity and accuracy. However, gaps in the scientific evidence may sometimes limit the information that can be included in the claims."

The full guidance is available here.

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