AAFCO Has Proposed a Solution to Federal Pet Food Ingredient Oversight. But Could It Actually Work?

The pet food industry has come to a regulatory crossroads following the US Food and Drug Administration’s (FDA) decision to end its long-standing partnership with the Association of American Feed Control Officials (AAFCO) on new pet food ingredient approvals. With the ending of the Memorandum of Understanding (MOU) on Oct. 1, 2024, AAFCO has introduced a new proposal, developed in partnership with Kansas State University, to fill the gap left by the FDA’s withdrawal. But can this new process realistically succeed without the FDA’s blessing?

As companies grapple with this shifting landscape, the future of pet food innovation and ingredient approval hangs precariously in the balance. Let’s first explore the context behind this shift, then take a deeper look into AAFCO and Kansas State’s recent proposal.

Breaking It Down

Pet food in the US is regulated at both the federal and state levels. The Federal Food Drug and Cosmetic Act of 1938 gives regulatory oversight of both human food and pet food to the FDA, among other responsibilities. In 2011, the Food Safety Modernization Act (FSMA) brought pet food production under the same regulatory standards as human food production in terms of facility and regulation standardization. Historically, the FDA’s Center for Veterinary Medicine (CVM) has worked very closely with the American Association of Feed Control Officials (AAFCO). AAFCO is made up of state regulatory officials, officials from the FDA-CVM, as well as industry experts. AAFCO is a voluntary organization but sets guidelines for nutrient requirements, labeling standards, claims substantiation, and other regulatory guidelines, and has served in whole or as the general regulatory guidelines for all states’ pet food regulatory standards for decades.

However, in 2024, the pet food regulatory landscape entered a state of flux. The year started with the introduction of H.R. 7380, the Pet Food Uniform Regulatory Reform Act (PURR Act), in February 2024 into the US House of Representatives. The goal of this piece of proposed legislation is to remove all local and state regulatory oversight of pet food and centralize it solely within the authority of the FDA-CVM. There are many problems with this legislation that are beyond the scope of this writing.  One big problem is the current resource constraints among FDA personnel, not to mention the associated federal funding that would be needed to facilitate this legislation. Remember, just because legislation becomes law does not mean it gets funded.

The next big regulatory shockwave happened on Aug. 2, 2024, when the FDA-CVM announced that starting on Oct. 1, 2024, it would cease to recognize the Memorandum of Understanding (MOU) that had been in place for the past 17 years between FDA-CVM and AAFCO. The purpose of the MOU was to serve as a regulatory pathway for ingredient companies to seek new AAFCO Ingredient Definitions for novel pet food ingredients. The MOU was utilized by many companies over the years to bring new pet food ingredients to market. The cessation of the MOU has left a large void in the pathways available for companies seeking new pet food ingredient approvals. Many companies who were already in the MOU process when it was discontinued without warning are wondering what to do now.

With the MOU gone, there are only two ways for companies to seek new ingredient approvals, both of which are through the FDA-CVM: A Food Additive Petition (FAP) or a Generally Recognized as Safe (GRAS) Notice. There is currently no new ingredient process that involves regulatory experts except those within the FDA. This significantly limits the resources from state regulatory agencies as well as industry experts that would have been available to review safety, utility, process, and quality control data for novel pet food ingredients.

To make matters more confusing, in response the FDA’s non-renewal of the MOU in August, the agency has issued the Animal Food Ingredient Consultation (AFIC) Draft Guidance for Industry (GFI) #294. This draft GFI proposes the AFIC as an interim process that companies can use in lieu of the previous MOU with AAFCO. The FDA-CVM has stated it will review its current Food Additive Petition and GRAS Notice processes.

When the AFIC is examined in detail, there seems to be very little difference between it and the current Food Additive Petition process to the extent of information required by the FDA and time it would take to go through this approval route. The processes, timelines, and FDA oversight all seem very much the same. The only real difference is that the FAP allows for non-public disclosure of manufacturing methods, processes and quality procedures, while any information submitted through the AFIC process would be made available to the public. Other than that discrepancy, there seems to be no real advantages to companies.

AAFCO Answers

More recently, another notable proposal become public on Oct. 2. AAFCO and Kansas State University released the draft AAFCO and Kansas State University Olathe-led Scientific Panel for Ingredient Approval. 

This proposed alternative ingredient approval pathway is outlined in detail in the public release. It states that, “In the past, AAFCO has relied on FDA to provide the scientific review panel for animal feed ingredient definitions. This partnership is ending Oct.1, 2024, and AAFCO is pursuing new partnerships to provide the scientific review panels for ingredient submissions.” The proposed process outline for this new ingredient approval process is similar to the former FDA/AAFCO MOU process, except it will eliminate a preliminary “tentative” review, which is supposed to decrease the total timeline from 18 months for the old AAFCO-FDA MOU process to 9 months for this new proposal.

When one reads this public release, it appears that AAFCO believes it has the authority to draft a new ingredient approval process and employ Subject Matter Experts (SMEs), rather than rescinding the review of scientific data provided by companies seeking new ingredient definitions solely to the FDA-CVM. The release also states that Kansas State will provide a proposal for the management of this Expert Review Process.

Having one entity that is led by a few individuals could be problematic when it comes to the Expert Review Process.  It could potentially remove the involvement of existing SMEs, such as those who exist in the current AAFCO organization. Also, the more centralized a process becomes, the easier it is for special interest groups to exert their influence, which could be corruptive. This must be examined and debated extensively.

There seems, however, to be some key things missing from this proposal. Currently, pet food is regulated under the Food Drug and Cosmetic Act, which gives the FDA-CVM full authority over regulatory oversight. Nowhere in this proposal is there any mention of an FDA review and agreement for involvement with this process. It also mentions a tentative timeline for “process for start-up completed” of May 1, 2025 which can be interpreted as the targeted implementation date.  The only other way that regulatory change could happen is by legislation, and we do not see that happening before May of 2025 either. Unless we are missing some key components of how the FDA-CVM fits into this new process proposed by AAFCO, we can’t imagine how it can be implemented.

So, What Now?

2024 has been an eventful year when it comes to pet food regulation. The FDA’s non-renewal of its MOU with AAFCO was a big change for the industry, and many believe it may be linked to other events, such as the introduction of the PURR Act. In the absence of doing nothing, AAFCO has released a new ingredient proposal process in partnership with Kansas State University, but it makes us wonder how they would actually have the regulatory authority to do so without the FDA’s buy-in and agreement. 

Stay tuned, as this will probably get even more interesting as time goes along. Our expert team at BSM Partners will continue to interpret the facts and details as we see them come in.

To learn more about the cessation of the AAFCO-FDA MOU and BSM Partners’ insights about the future of new pet food ingredient approvals, tune in to our podcast episode here, or check out our other resources as we closely follow this regulatory development.

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About the Author

Dr. Bradley Quest is the Principal Veterinarian at BSM Partners. He has practiced clinical veterinary medicine and has developed, studied, and clinically tested pet health products (including dental products for pets) for the past two decades.