CFSAN/Office of Food Additive Safety
A substance that will be added to food is subject to premarket approval by FDA unless its use is generally recognized as safe (GRAS) by qualified experts.(1) On April 17, 1997, FDA issued a proposed rule (the GRAS proposal; 62 FR 18938) that would establish a notification procedure whereby any person may notify FDA of a determination by that person that a particular use of a substance is GRAS. Although the proposed notification procedure is not yet final, FDA started accepting GRAS notices in 1998. As described in the GRAS proposal, the agency is evaluating whether each submitted notice provides a sufficient basis for a GRAS determination and whether information in the notice or otherwise available to FDA raises issues that lead the agency to question whether use of the substance is GRAS. Following this evaluation, FDA responds to the notifier by letter.
FDA's Responses to GRAS Notices
In general, FDA's response has been in one of three categories:
The agency does not question the basis for the notifier's GRAS determination;
The agency concludes that the notice does not provide a sufficient basis for a GRAS determination (e.g., because the notice does not include appropriate data and information or because the available data and information raise questions about the safety of the notified substance); or
The response letter states that the agency has, at the notifier's request, ceased to evaluate the GRAS notice.
The Inventory of GRAS Notices
In the GRAS proposal, FDA announced its intention to maintain an Inventory of GRAS Notices and the agency's response to those notices. The GRAS Inventory page is the entry point to this information. Importantly, the inventory includes all GRAS notices, regardless of whether the notice is pending at FDA or has come to closure, and regardless of the nature of FDA's response.
(1)In addition, a substance that is used in accordance with a sanction granted prior to September 6, 1958 is not subject to premarket approval.