AAFCO, FDA Fail to Renew MOU for New Animal Food Ingredient Definitions

Ending a longstanding partnership between them, the US Food and Drug Administration (FDA) and Association of American Feed Control Officials (AAFCO) will not seek to renew a Memorandum of Understanding (MOU 225-07-7001), through which the two organizations collaborated on new animal feed ingredient definitions for the last 17 years.

A statement from Austin Therrell, executive director of AAFCO, suggests the association was reluctant to let the MOU expire, but will continue to seek ways in which it can support the FDA through federal- and state-level regulatory activities in the animal food industry.

“AAFCO believes that its ingredient definition process has been a shining example of successful collaboration and partnership between states and the federal government,” Therrell said. “Although we are disappointed that the MOU is not being renewed, we are committed to being a conduit between the FDA and state regulatory programs, and to our work to provide standardization to the animal food industry.”

This disappointment was echoed by the American Feed Industry Association (AFIA) and the National Grain and Feed Association (NGFA).

So, What Does This Mean for the Animal Food Industry?

Starting Sept. 1, 2024, AAFCO will no longer accept Feed Ingredient Definition requests to give the organization time to submit remaining requests to the FDA until the MOU expires on Oct. 1, 2024. At this point, these two organizations will go their separate ways and explore independent avenues for a “seamless transition,” as stated by AAFCO.

On Aug. 8, 2024, the FDA issued two draft guidance documents regarding its interim processes for new feed ingredients. The first details the agency’s enforcement policy for AAFCO-defined animal feed ingredients, in which the FDA shared that it does not intend to enforce interstate marketing of non-approved animal food ingredients that are not listed in the 2024 AAFCO Official Publication (OP). The agency also does not plan to enforce the use of common or usual ingredients listed in the AAFCO OP unless the name of the ingredient is misleading or false.

The second draft guidance introduces an interim Animal Food Ingredient Consultation (AFIC) process, offering animal feed companies an alternative way to consult with the FDA on new ingredients, as well as review relevant information and safety concerns. This process would also inform the public and allow them to provide input on new ingredients under FDA consultation. The agency reiterated it would not enforce penalties for non-approved animal food additives as long as the FDA has issued an AFIC “consultation complete” letter for the ingredient, and in the absence of questions or concerns regarding the ingredient’s safety. 

On the AAFCO side of the equation, members voted during the organization’s Annual Meeting Aug. 7-9, 2024, to approve the AFIC Ingredients draft guidance posed by the FDA, as well as a motion for AAFCO to pursue the establishment of a new ingredient definition process involving an expert panel for the scientific review of proposed ingredients. The details of this new AAFCO process remain vague for now.

Until new processes are in place, feed ingredient manufacturers will need to seek alternative pathways for new ingredient approvals. This could be done through the food additive petition process, the Generally Recognized As Safe (GRAS) notification program, or through the FDA’s interim AFIC process, the last of which was published in a draft guidance on Aug. 8, 2024.

A Challenge and An Opportunity

The AFIA estimates it takes an average of three to five years to gain regulatory approval for new animal food ingredients — for domestic livestock as well as companion animals — through the current process. This process costs companies an average of $600,000 per ingredient, according to the AFIA, making it both tedious and expensive in a realm of rapid innovation and dog-eat-dog competition.

For several years, animal food industry advocates have sought to streamline this arduous process in favor of a more efficient way to approve new feed ingredients for livestock and pets. These efforts have included additional funding for the FDA Center for Veterinary Medicine (CVM) to speed up the ingredient approval process, but opportunities for improvement remain.

It has yet to be seen whether the expiration of this MOU between AAFCO and the FDA will create more questions than answers. However, while uncertainty looms large, regulators and officials seem hopeful that a new-and-improved process is within reach that would benefit both regulators and animal feed innovators. 

“This decision opens the doors for AAFCO to look at new and innovative solutions in the ingredient space, and to seek out additional partners that can provide strong, science-based guidance to our state officials,” Therrell noted.

BSM Partners is staying close to this issue and will share more through its podcast, Barking Mad, as the situation develops. Stay tuned for this upcoming episode.

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About the Authors

Jordan Tyler is the Director of Media at BSM Partners. She has more than five years of experience reporting on trends, best practices and developments in the North American pet nutrition industry. Tyler resides in Bentonville, Arkansas, with her husband and their four furry family members.

Neeley Bowden is a Manager of Special Services on the BSM Partners Product Innovation team. She earned her bachelor's degree in pet food production and is pursuing her master's in food science. In her early career, she worked in product innovation of pet food ingredients, focusing on the development of palatability enhancers. Bowden calls her horse farm in South Carolina home, along with her faithful canine, Allie.