FDA Drafts Product Health Claims Guidance

(July 10, 2007) — The Food and Drug Administration (FDA) has proposed a system to evaluate evidence submitted to justify health claims in a draft guidance, “Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims.” This document “updates the agency’s approach to the review of the publicly available scientific evidence for significant scientific agreement (SSA) and qualified health claims.”

The draft guidance is on FDA’s website at: http://www.cfsan.fda.gov/~dms/hclmgui5.html.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Comments on the draft guidance document must be received by September 7, 2007. The announcement of this draft guidance in Monday’s Federal Register includes instructions on submitting comments: http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-13274.pdf.

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.

In evaluating health claim petitions, FDA considers whether the evidence supporting the relationship that is the subject of the claim meets the SSA standard, which provides that FDA shall authorize a health claim to be used on conventional foods if the agency “determines, based on the totality of the 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.”

AHPA members with any concerns about FDA’s draft guidance should file comments with FDA and notify AHPA’s Government Relations Committee of their concerns so that AHPA may consider filing comments as well.


The American Herbal Products Association (AHPA) is the only national trade association devoted to herbal issues. Representing the core of the botanical trade—comprised of the finest growers, processors, manufacturers and marketers of herbal products—our mission is to promote the responsible commerce of herbal products. AHPA committees generate self-regulations to ensure the highest level of quality with respect to the way herbal products are manufactured, labeled, and sold. Website: www.ahpa.org.

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