Understanding GFI #293: Have Certain Pet Food Ingredients Been at Risk of Non-Compliance?

Anyone who has been following the recent events in pet food ingredient approval processes knows there has been a fair amount of unrest. One big change was a recent announcement by the US Food and Drug Administration Center for Veterinary Medicine (FDA-CVM) that a Memorandum of Understanding (MOU) it had with AAFCO for the last 17 years was not going to be renewed. The MOU was part of the AAFCO New Ingredient Definition process, which was one of the three pathways for companies to get new ingredients approved for pet food use. Now that the MOU was not renewed, only two other pathways for new ingredient approvals exist—through a Generally Recognized As Safe (GRAS) Notice, or a Food Additive Petition, both of which are administered by the FDA—and both the FDA and AAFCO have announced alternatives to these two remaining pathways.

In lieu of the MOU not being renewed, the FDA rolled out its draft Guidance For Industry (GFI) #294, the Animal Food Ingredient Consultation, which was described as an interim process for companies to utilize without the further existence of the AAFCO Ingredient Definition Process. AAFCO has also made known that it has been working on its own alternative proposal for new pet food ingredient approvals in partnership with Kansas State University. However, the description of this new proposed process mentions nothing about having the FDA-CVM play a role or even providing input into this process. Because the FDA-CVM ultimately holds the authority to regulate all pet food via the Food, Drug and Cosmetic Act of 1938, the feasibility of this proposal from AAFCO and K-State is currently unclear.

What some people may not realize is that by not renewing the MOU with AAFCO, the FDA-CVM in a way indicated that ingredients listed in the AAFCO Official Publication (OP) that have not gone through a Food Additive Petition Process, earned GRAS status, or been reviewed by the FDA as part of the previous AAFCO Ingredient Definition Process could be subject to regulatory discretion by the FDA. In other words, hundreds of ingredients we use every day in pet food production would have been declared by the FDA as unsafe to use in pet food. However, the reality is that, as expected, the FDA-CVM has stated in its more recent GFI #293, “…FDA generally does not intend to initiate enforcement action with respect to the food additive approval requirements of the FD&C Act for ingredients listed in the 2024 AAFCO OP that are not approved food additives or GRAS.” 

What most experts thought would happen with the finalization of the FDA GFI #293 did happen, in that the FDA did not take enforcement action in regard to the previously mentioned ingredients that were not GRAS, part of a Food Additive Petition, or reviewed by FDA under the discontinued MOU. But there would have been serious ramifications to the industry—and eventually to consumers—if FDA would have taken the stance that if a pet food ingredient listed in the AAFCO OP was not GRAS, part of a Food Additive Petition, or reviewed by FDA as part of the former MOU. Any ingredient that didn’t fit one of these pathways would be unlawful to use in pet food. That list would be very long and devastating to the pet food industry.

The bottom line of all of this is that the FDA took a commonsense approach in regard to these other ingredients in the AAFCO OP. However, in the ever-changing landscape of pet food ingredient approval processes, it is anybody’s guess what will happen next. One message the experts at BSM Partners picked up on is that the FDA seems willing to work with the industry and AAFCO on new pet food ingredient approvals going forward, but the industry and AAFCO better be willing to have a robust way of reviewing safety and toxicology for new pet food ingredients if they want to continue to be a part of this process.

In short, the recent shifts in pet food ingredient approval processes highlight the complexities and uncertainties that the industry faces. These new developments raise questions about how new and existing ingredients will be evaluated and approved moving forward. By implementing GFI #293, the FDA has offered a temporary reprieve, yet it signals a need for the pet food industry and AAFCO to pull the weight of this new system. As the regulatory landscape continues to evolve, collaboration between the FDA, AAFCO, and industry stakeholders will be essential to navigate these changes and ensure that pet food products remain safe, compliant, and accessible for all consumers.

BSM Partners has the experience and expertise to help companies navigate this ever-changing ingredient approval landscape in support of pet health. Learn more about the FDA-AAFCO split and what comes next for the industry and pet owners in our podcast episode, "Are AAFCO and FDA Ever Getting Back Together? How Their Split Will Reshape Pet Nutrition."

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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.