SILVER SPRING, MD. — Following news that the US Food and Drug Administration’s (FDA) Memorandum of Understanding (MOU) with the Association of American Feed Control Officials (AAFCO) would not renew upon its expiration this October, the FDA released a set of documents on Aug. 8 regarding its plans for transition.
Under the MOU, the FDA has been providing its scientific and technical assistance to AAFCO for the ingredient review process for animal feed and pet food, helping AAFCO decide whether specific ingredients should be included in the AAFCO Official Publication. Though the FDA has chosen not to renew the MOU, the agency plans to continue to work closely with AAFCO and state regulators to help ensure the food safety of animal food, according to the agency.
With the MOU set to expire, and the ingredient review process now up in the air, the FDA has drafted guidance and is seeking public comment on its pre-market animal food review processes.
Currently, to be legally marketed, an ingredient used in animal nutrition must be subject to an FDA-approved animal food additive petition (FAP) or be generally recognized as safe (GRAS). The agency is now requesting input from industry stakeholders on the FAP and GRAS programs to enable it to determine if changes are necessary in order to ensure food safety and improve the path to market for ingredients. Stakeholders can submit their comments until Dec. 9.
Additionally, the agency has released two Guidance for Industry (GFIs) drafts on animal food ingredients. GFI #293, called “FDA Enforcement Policy for AAFCO-Defined Animal Feed Ingredients,” and GFI #294, called “Animal Food Ingredient Consultation (AFIC)”.
GFI #293 details that the FDA does not intend to initiate enforcement action on the interstate marketing of animal food ingredients that are not approved as additives or under GRAS, but are listed in the ingredient definition chapter of the 2024 AAFCO Official Publication. The agency also does not intend to enforce the use of ingredient names that are not common or usual, but are defined in the AAFCO Official Publication, unless the name is false or misleading.
GFI #294 details an interim AFIC process, allowing firms to engage with the FDA regarding an ingredient review process that otherwise might have been used with AAFCO. In addition to its FAP and GRAS programs, this AFIC process would provide an additional way for firms to consult with the FDA regarding new ingredients, and would enable the FDA to review information from developers and the public regarding any safety concerns on the ingredients. The AFIC would also offer opportunities for the public to provide input on the consulted ingredients.
The FDA is currently accepting stakeholder comments on these GFIs until Sept. 9.
Learn more about the FDA’s guidance on animal food ingredient review programs.
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