This guidance document is intended to provide our recommendations on best practices for convening a “GRAS panel.” By “GRAS,” we mean “generally recognized as safe.” See section II.A for a discussion of the GRAS provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act). By “GRAS panel,” we mean a panel of qualified experts who independently evaluate whether the available scientific data, information, and methods establish that a substance is safe under the conditions of its intended use in human food or animal food as part of an evaluation of whether adding that substance to food is lawful under the GRAS provision of the FD&C Act. In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required.
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