Regulatory Alert: FDA AAFCO MOU Transition Plan

APPA joins the National Animal Supplement Council (NASC) in sending this letter to its membership.  As you may already know, it was announced earlier this month that FDA will end its long-standing Memorandum of Understanding (MOU) with AAFCO on October 1, 2024, which means FDA will no longer use the AAFCO Ingredient Definition Request Process as a means for vetting and approving ingredients for animal feed and pet food.

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.

In anticipation of its partnership with AAFCO concluding, on August 8, FDA released a set of documents regarding the agency’s transition plan for responsibly implementing a new ingredient approval process. We encourage you to familiarize yourself with these Draft Guidance for Industry (GFI) documents and, as an industry stakeholder, participate in the public comment opportunity if you have comments or questions to share

Documents Released

Docket FDA-2024-N-2979 “Request for Comments (RFC) Pre-Market Animal Food Ingredient Review Program)” solicits stakeholder input in addressing specific questions and requests for information about FDA’s Food Additive Petition (FAP) and Generally Recognized as Safe (GRAS) notification programs, to help the agency determine changes that may be needed to better serve public health and improve the path to market for new animal food ingredients.

Draft GFI #293 “FDA Enforcement Policy for AAFCO-Defined Animal Feed Ingredients” explains that FDA will use enforcement discretion for the ingredients listed in the 2024 AAFCO Official Publication (OP) and does not intend to initiate enforcement action in response to 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)” describes an interim AFIC process for engaging with FDA regarding ingredients for which firms may have otherwise used the AAFCO ingredient definition process. While FDA evaluates its current FAP and GRAS Notification programs for animal food, the AFIC process would provide an additional means for consulting with FDA about new animal food ingredients.

Action Item: Stakeholder Comment Opportunities

FDA is seeking stakeholder comment on draft GFI #293 and #294 from August 9 – September 9.  Along with NASC, APPA will submit comments on behalf of the membership. Member companies must send their comments for inclusion in the APPA and NASC submissions to Bill Bookout (b.bookout@nasc.cc) by end of business on Thursday, August 29. This collaborative approach will ensure our collective voice is heard, and that final guidance reflects the needs and perspectives of our industry.

You are also free to submit comments on your own using the information below for instructions:

Docket FDA-2024-N-2979: Starting August 9 and ending December 9, stakeholders are invited to submit input via Request for Comments: Pre-Market Animal Food Ingredient Review Programs on specific questions and requests for information about FDA’s Food Additive Petition (FAP) and Generally Recognized as Safe (GRAS) notification programs, to help the agency determine changes that may be needed to better serve public health and improve the path to market for new animal food ingredients. Submission instructions can be found in the Federal Register NOA.

Draft GFI #293 & #294: Starting August 9 and ending September 9, FDA is accepting public comments on draft GFI #293 and draft GFI #294. Due to the time-sensitive nature of the documents, the FDA does not intend to extend the 30-day comment period before it begins work on the final version of the guidance. Submission instructions can be found in the Federal Register NOA.