The U.S. Food and Drug Administration (FDA) has released a set of documents regarding the transition phase after the FDA’s longstanding Memorandum of Understanding (MOU) with the Association of American Feed Control Officials (AAFCO) expires on October 1, 2024.

To be legally marketed, an ingredient used in animal food (including pet food) must be the subject of an FDA-approved animal food additive petition (FAP) or be generally recognized as safe (GRAS) for the intended use in animal food. Under the MOU, the FDA has been providing scientific and technical assistance to AAFCO as they decide whether to include ingredients in the AAFCO Official Publication.

Although the MOU is expiring, the FDA said it will continue to work closely with AAFCO and state regulatory partners to help ensure the safety of the animal food supply.

To solicit public input, the FDA has issued a Request for Comments (RFC) asking stakeholders to address specific questions and requests for information about the FDA’s Food Additive Petition (FAP) and GRAS Notification programs, to help the agency determine what changes, if any, may be needed to better serve public health and improve the path to market for new animal food ingredients.

Draft Guidance for Industry (GFI) #293, “FDA Enforcement Policy for AAFCO-Defined Animal Feed Ingredients,” explains that, despite the expiration of the MOU with AAFCO, the FDA generally does not intend to initiate enforcement action in response to:

Related:AAFCO, FDA ending longstanding animal feed ingredient review MOU

Draft GFI #294, “Animal Food Ingredient Consultation (AFIC),” describes an interim Animal Food Ingredient Consultation (AFIC) process for firms to engage with the FDA regarding ingredients for which firms may have otherwise used the AAFCO ingredient definition process. While the FDA evaluates its current Food Additive Petition and GRAS Notification programs for animal food, the AFIC process would provide an additional way for firms to consult with the FDA regarding new animal food ingredients and for the FDA to review information from developers and the public regarding the ingredients and any relevant safety concerns. The AFIC process would also include opportunities for public awareness of and input on the ingredients for which the FDA is providing consultation.

The draft guidance explains that the FDA generally would not intend to take enforcement action against an ingredient for being an unapproved animal food additive if the FDA has sent an AFIC “consultation complete” letter, provided the ingredient is used in accordance with the terms described in the letter and there continues to be no questions or concerns about the safety of the ingredient.

The FDA intends to consider comments and information submitted to docket FDA-2024-N-2979. The most helpful submissions would pertain to one or more of the questions posed in the Federal Register Notice of Availability. The comment period for this RFC opens on August 9, 2024, and will be open for 120 days, ending on December 9, 2024.

In addition to establishing the RFC docket to accept electronic/written comments, the FDA also intends to hold multiple virtual stakeholder listening sessions focused on the FDA’s pre-market animal food review programs and the questions laid out in the RFC. Interested attendees will be grouped based on the sectors they represent. Those interested in participating in a listening session should email [email protected] by no later than September 1, 2024, with their first and last name, email address, phone number, and organization/affiliation.