"Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act;" Availability

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The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act." The guidance describes the amount, type, and quality of evidence that FDA recommends a manufacturer have to substantiate a claim under this section of the Federal Food, Drug, and Cosmetic Act (the act).