July 2007

FDA drafts product health claims guidance

The Food and Drug Administration (FDA) has drafted a guidance that includes a proposed a system to evaluate evidence submitted to justify health claims.

According to the federal agency, the purpose of the document, titled “Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims,” is to update FDA’s current approach on the process for evaluating scientific evidence for a health claim and credible scientific evidence to support a qualified health claim.

“Because of the similarity between the scientific reviews for SSA [significant scientific agreement] and qualified health claims, FDA intends to generally use the approach set out in this draft guidance for evaluating  the scientific evidence in petitions that are submitted for an SSA health claim or qualified health claim,” the draft guidance states.

The draft guidance is available for comment until Sept. 7. The announcement of this draft guidance in the Federal Register includes instructions on submitting comments: www.fda.gov/OHRMS/DOCKETS/98fr/E7-13274.pdf.

American Herbal Products Association (AHPA) may consider filing comments on the document.

This new guidance document, if finalized, will replace FDA’s guidance titled “Interim Evidence-based Ranking System for Scientific Data,” published in July 2003, and “Guidance for Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements” published December 1999.

The draft guidance is available on FDA’s Web site at www.cfsan.fda.gov/~dms/hclmgui5.html.

Sources: American Herbal Products Association, www.ahpa.org; NutraIngredients-USA.com, http://nutraingredients-usa.com

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