Zdrowie i gospodarka · 09/11/2004

Draft Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled "Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act." This draft guidance describes the amount, type, and quality of evidence that FDA recommends a manufacturer have to substantiate a claim under section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act (act). FDA is also announcing its decision not to publish additional guidance on applying the structure/function rule at this time.