The FDA Center for Veterinary Medicine released the Final Guidance for Industry today for its enforcement policy for AAFCO-defined animal feed ingredients (access here). The big news is that FDA will no longer be reviewing the annual list of feed ingredient definitions, but it will be releasing another Guidance for Industry that will provide animal feed developers and manufacturers other methods to consult with the Center for Veterinary Medicine regarding the safety of their feed additives. These updates were announced as part of the continuing changes to the Center for Veterinary Medicine, which will also be evaluating the animal Food Additive Petition and the process by which a substance can be identified as "generally recognized as safe" (GRAS).
The Association of American Feed Control Officials (AAFCO) is a voluntary membership organization that provides model laws and regulations for feed-control programs that nearly all of states in the U.S. have adopted. FDA is a member of the organization and, prior to October 1, 2024, had served as the scientific and technical reviewer for the organization's animal food ingredient definitions listed in the AAFCO annual publication. These definitions are relied upon by industry to identify feed additives that are FDA-approved or otherwise have been determined to be GRAS.
Even though FDA is parting ways with the AAFCO review process for animal food definitions, animal feed developers and manufacturers can, for the time being, continue to rely on the 2024 AAFCO Official Publication definitions of animal food additives and GRAS substances. As a part of the Final Guidance, FDA announced that it has no plans to initiate enforcement actions under the FD & C Act for additives or substances identified as GRAS in the 2024 Official Publication and used according to the intended use, specifications, and limits listed in that publication. FDA similarly does not plan to initiate labeling enforcement actions for substances labeled according to the 2024 AAFCO Official Publication definitions.
It will be important, however, for feed developers and manufacturers to keep an eye out for the final Guidance for Industry #294, "Animal Food Ingredient Consultation (AFIC)," and for the announcement of new processes by which an additive may be approved or a substance may be identified as GRAS through the Center for Veterinary Medicine.
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