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Guidance Issuing OfficeOffice of Food Additive Safety
This draft guidance document is intended to provide our recommendations on best practices for convening a "GRAS panel."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 this document, we refer to a person who is responsible for a conclusion that a substance may be used in food on the basis of the GRAS provision of the FD&C Act as the "proponent" of GRAS status for that substance under the conditions of its intended use. In some cases, the process whereby the proponent evaluates whether the available data and information support a conclusion that a substance is GRAS under the conditions of its intended use includes considering the opinion of a GRAS panel. Depending on the outcome of the GRAS panel's analysis, the proponent could either reach a conclusion regarding the safety of the substance under the conditions of its intended use, or be advised of one or more issues (such as gaps in the data and information, or alternative interpretations of the available data and information) that warrant investigation before a conclusion can be drawn about whether the substance is safe under the conditions of its intended use.
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities.
Instead, guidances describe our 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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2017-D-0085.