As of October 1, 2024, the Association of American Feed Control Official's (AAFCO) Annual Official Publication is no longer definitive as to which feed additives are FDA-approved or, otherwise, have been determined to be "generally recognized as safe" (GRAS). (See the November 26, 2024, article for more information on Final Guidance for Industry #293.) This change in policy is consistent with the Agenda issued by the Center for Veterinary Medicine (CVM) in September 2023, which emphasized the CVM's commitment to reassessing and modifying its programs and processes. (See the November 8, 2024, article for more information on the Agenda for Animal and Veterinary Innovation.)
October 1st has come and gone, with no final, established process that animal feed manufacturers and developers can rely on to determine whether a new additive is FDA-approved or, otherwise, GRAS. CVM has, however, proposed an interim process by which animal feed additives may be assessed for safety while it continues to assess its Animal Food Additive Petition and GRAS Notification programs: the Animal Food Ingredient Consultation Process Draft Guidance for Industry (access here: CVM GFI #294 - Animal Food Ingredient Consultation (AFIC) | FDA).
If and when the Draft Guidance becomes final (comments close December 9, 2024), CVM will provide this interim Consultation process (AFIC process) to any firm developing animal food additives for which they would have previously relied on the AAFCO ingredient definition process. CVM has also included a safe harbor provision in this proposed process, which might come as good news for those worried about the sunset of the AAFCO process.
If CVM does not have questions or concerns about the safety of the ingredient upon conclusion of the AFIC process, a "consultation complete" letter will be posted to the AFIC completed inventory webpage. The letter provides a type of safe harbor, as CVM does not intend, generally, to initiate enforcement actions on such ingredients being used in accord with the letter. This safe harbor would presumably be in effect until CVM has finished its assessment of the Animal Food Additive Petition and GRAS Notification programs and has issued new guidance for them.
More information about the process can be found here: Evaluation of FDA Pre-market Animal Food Programs and Plan for Consultations | FDA.
