FDA Proposes Mandatory GRAS Notification Requirement

The U.S. Food and Drug Administration (FDA) has issued a proposed rule that would require the submission of a Generally Recognized as Safe (GRAS) notice for the use of a human or animal food substance that is the subject of a GRAS conclusion under 21 U.S.C. § 321(s).¹ Specifically, the “Substances Generally Recognized as Safe” proposed rule (GRAS proposed rule) would convert the current voluntary GRAS notification program into a mandatory program. The GRAS proposed rule also would establish several exceptions to the mandatory notification requirement, including a time-limited opportunity to submit streamlined information regarding substances already in interstate commerce that have been marketed on the basis of a self-determination of GRAS status. If finalized as proposed, the rule would significantly change how food substances are brought to market and would require companies to review and assess which substances in their portfolios must be notified to FDA. Comments on the proposed