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FDA Releases Two Draft Guidances, Seeks Public Comment on Pre-market Animal Food Ingredient Review Programs

UPDATE: On October 23, 2024, the FDA finalized Guidance for Industry #293: FDA Enforcement Policy for AAFCO-Defined Animal Feed Ingredients. 

Draft GFI #294: Animal Food Ingredient Consultation (AFIC) has not yet been finalized. The agency will notify the public when final guidance is issued.

Through December 9, 2024, the agency will continue to accept comments and information submitted to docket FDA-2024-N-2979 in response to the Request for Comments on the FDA’s pre-market animal food review processes.

August 8, 2024

The U.S. Food and Drug Administration today 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, AAFCO remains an important partner to the FDA. The FDA will continue to work closely with AAFCO and state regulatory partners to help ensure the safety of the animal food supply. 

Documents Released

Request for Comments (RFC) on FDA’s pre-market animal food review processes

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Draft Guidance for Industry (GFI) #293, “FDA Enforcement Policy for AAFCO-Defined Animal Feed Ingredients”

Draft GFI #293 explains that, despite the expiration of the MOU with AAFCO, the FDA generally does not intend to initiate enforcement action in response to:

  • Interstate marketing of animal food ingredients that are not approved animal food additives or GRAS for the intended use, but are listed in the ingredient definition chapter of the 2024 AAFCO OP, and for which FDA has no safety questions or concerns, and
  • Use of animal food ingredient names that are not common or usual names but are defined in the AAFCO OP, unless use of the name causes the label to be false or misleading.

Draft GFI #294, “Animal Food Ingredient Consultation (AFIC)”

Draft GFI #294 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. 

Public Comment Opportunities

Request for Comments (RFC) on FDA’s pre-market animal food review programs

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. To submit an electronic comment, visit docket FDA-2024-N-2979. Instructions for submitting comments can be found in the Federal Register NOA.

Stakeholder Listening Sessions

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 AnimalFoodIngredientRFC@fda.hhs.gov by no later than September 1, 2024, with their first and last name, email address, phone number, and organization/affiliation.

Comments on Draft GFI #293

Starting on August 9, 2024, the FDA is accepting public comments on draft GFI #293, “FDA Enforcement Policy for AAFCO-Defined Animal Feed Ingredients,” until September 9, 2024. Due to the time-sensitive nature of the guidance, the FDA does not intend to extend the 30-day comment period before it begins work on the final version of the guidance. To submit an electronic comment, visit docket FDA-2024-D-2977. For instructions on commenting, please refer to the Federal Register Notice of Availability for draft GFI #293.

Comments on Draft GFI #294

Starting on August 9, 2024, the FDA is accepting public comments on draft GFI #294, “Animal Food Ingredient Consultation (AFIC),” until September 9, 2024. Due to the time-sensitive nature of the guidance, the FDA does not intend to extend the 30-day comment period before it begins work on the final version of the guidance. To submit an electronic comment, visit docket FDA-2024-D-2978. For instructions on commenting, please refer to the Federal Register Notice of Availability for draft GFI #294.

Additional Information

Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.

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