FDA has issued a draft guidance to help companies evaluate evidence to justify health claims. Titled “Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims,” this document describes the evidence-based review system that FDA intends to use to evaluate the publicly available scientific evidence for significant scientific agreement (SSA) health claims or qualified health claims on the relationship between a substance and a disease or health-related condition. This guidance document reflects the agency’s current thinking on the scientific review approach it should use and is intended to provide guidance to health claim petitioners.

The specific topics addressed in this guidance document include: (1) identifying studies that evaluate the substance/disease relationship, (2) identifying surrogate endpoints for disease risk, (3) evaluating the human studies to determine whether scientific conclusions can be drawn from them about the substance/disease relationship, (4) assessing the methodological quality of each human study from which scientific conclusions about the substance/disease relationship can be drawn, and (5) evaluating the totality of scientific evidence.

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.

The draft guidance is available on FDA’s website at: http://www.cfsan.fda.gov/~dms/hclmgui5.html. A .pdf version is also available: http://www.fda.gov/OHRMS/DOCKETS/98fr/07d-0125-gdl0001.pdf

Comments on the draft guidance document must be received by September 7, 2007. The announcement of this draft guidance in Monday’s Federal Register includes instructions on submitting comments: http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-13274.pdf.

According to the American Herbal Products Association (AHPA), Silver Spring, MD, this new guidance document, if finalized, will replace FDA’s guidance titled “Interim Evidence-based Ranking System for Scientific Data” (http://www.cfsan.fda.gov/~dms/hclmgui4.html) published July 2003, which addresses the review of the science supporting qualified health claims, and “Guidance for Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements” (http://www.cfsan.fda.gov/~dms/ssaguide.html), published December 1999.