Substances Generally Recognized as Safe; Final Rule

The Food and Drug Administration (FDA) is issuing a final rule that amends and clarifies the criteria in FDA regulations for when the use of a substance in food for humans or animals is not subject to the premarket approval requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) because the substance is generally recognized as safe (GRAS) under the conditions of its intended use. FDA is amending its regulations to replace the voluntary GRAS affirmation petition process with a voluntary notification procedure under which any person may notify FDA of a conclusion that a substance is GRAS under the conditions of its intended use. The clarified criteria for GRAS status should help stakeholders draw more informed conclusions about whether the intended conditions of use of a substance in food for humans or animals complies with the FD&C Act, and the notification procedure will enable stakeholders to be aware of whether FDA has questioned the basis of a conclusion of GRAS status.
The notice was published in the Federal Register on 17 August 2016, 81 FR 54959 and can be found at: https://www.gpo.gov/fdsys/pkg/FR-2016-08-17/pdf/2016-19164.pdf.