FDA Finalizes Supplement Claims Substantiation Guidance

WASHINGTON—FDA has issued final guidance on substantiation requirements for dietary supplement claims. Initially published in November 2004, with comments accepted until January 2005, the final version of "Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act." details the amount, type, and quality of evidence FDA recommends a manufacturer have to substantiate a claim under the act.

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Comments can be submitted at any time. Click here for more information on the guidance and how to submit comments.