FDA details new animal food ingredient definition process and enforcement policy after former AAFCO MOU expired.
January 6, 2025
The Food & Drug Administration announced the availability of a final Guidance for Industry (GFI) #294 – “Animal Food Ingredient Consultation (AFIC),” which is scheduled for publication in the Jan. 7, 2025, Federal Register.
This guidance describes FDA’s interim AFIC process and explains one way FDA will work with firms that are developing animal food ingredients now that its memorandum of understanding (MOU) with the Association of American Feed Control Officials (AAFCO) expired on Oct. 1, 2024, and while FDA evaluates the animal Food Additive Petition and Generally Recognized as Safe (GRAS) Notification programs.
In the notice, the agency said the AFIC process provides an additional way for engagement with FDA regarding ingredients for which firms may otherwise have used the AAFCO ingredient definition process and will help FDA identify any potential safety concerns associated with the ingredients. The process allows for public awareness of and input on such ingredients. In addition, the guidance describes FDA’s enforcement policy for certain ingredients assessed using the AFIC process.
FDA published its notice of availability for draft GFI #294 in the Aug. 9, 2024, Federal Register (89 FR 65368) and gave interested parties until Sept. 9, 2024, to comment on the draft guidance.
FDA said it received numerous comments on the draft guidance, including from the animal food and drug industries, AAFCO, a veterinary association, a state food and agriculture department and private citizens, and those comments were considered as the guidance was finalized and revised.
First, according to the new notice of availability, the agency clarified the scope of the AFIC process as including any animal food ingredient for which firms may have otherwise utilized the AAFCO ingredient definition process and also clarified that a proposed ingredient name and definition should be included in the consultation for FDA’s consideration. The recommendation to submit a statement of environmental risk was removed.
A clarification was added that firms participating in the AFIC process should not resubmit information they have already provided to FDA. Another clarification pertained to what information interested parties should include when providing comments on pending AFICs through the docket. Finally, editorial changes were made to improve clarity.This guidance represents the agency’s current thinking on AFIC and will be available at https://federalregister.gov/d/2024-31525.
The American Feed Industry Association (AFIA) issued a statement saying it is pleased to see FDA establish a new framework for the review of animal food ingredients under the AFIC program through the issuance of GFI #294, as the action marks a major shift for the regulation of animal food, providing animal food innovators an alternative pathway to the recently ended process facilitated in coordination with AAFCO.
AFIA president and chief executive officer Constance Cullman issued a statement saying: “The AFIA strongly advocated for a clear, modern FDA process that balances regulatory oversight with industry flexibility, and we are pleased to see that several of our recommendations are reflected in this new FDA guidance. Moving forward, we will work closely with the FDA to ensure that this program is efficient, inclusive and capable of accommodating the diversity of ingredients essential to animal nutrition. With our members' input, we will continue to advocate for a streamlined and adaptable approach, allowing the industry to innovate and bring safe, high-quality ingredients to the market faster. This guidance is a step forward, and we look forward to supporting its effective implementation.”
This regulatory change will replace the decades-long FDA-AAFCO pathway, which ended Oct. 1, 2024, removing one of the industry’s three primary regulatory pathways – and the one most used by ingredient innovators – for bringing safe ingredients to market, AFIA said. FDA’s purported goal for the AFIC program is to minimize delays in bringing safe ingredients to market, reduce potential gaps in ingredient reviews and establish consistent standards to prevent market disruptions.
The final GFI #294 offers a structured pathway for ingredient innovators to consult with FDA, ensuring that ingredient safety standards are met prior to market entry, the association added. Through the AFIC program, animal food innovators will have the opportunity to engage with FDA to provide data demonstrating ingredient safety. This guidance also clearly specifies submission requirements, including the type of data needed for FDA evaluation, and details FDA’s role in assessing this information, thus addressing industry’s concerns.
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