Anyone who works with animal feed ingredients and follows how they are approved for use in animal feed in the United States is likely aware of the long-standing Memorandum of Understanding (MOU) that established a working partnership between the Food and Drug Administration (FDA) and the Association of American Feed Control Officials (AAFCO) Ingredient Definition Request Process to review and approve ingredients. Essentially, FDA’s responsibility to regulate and ensure the safety of animal feed and pet food, at least as it relates to the ingredients they contain, has been based on the AAFCO process for 17 years under this mutual agreement.
And now everyone is probably aware of the announcement late last week (August 2, 2024) that FDA and AAFCO will not renew the MOU before it expires on October 1, 2024. This is significant and promises to shake up, even disrupt, the ingredient approval process. The question is: is this for good or for bad?
“Disappointment” is the prevailing reaction
According to statements from several industry associations, including AAFCO, this development is not a positive one. “AAFCO believes its ingredient definition process has been a shining example of successful collaboration and partnership between the states and the federal government,” said Austin Therrell, executive director, in a press release announcing the termination of the MOU. “While we are disappointed that the MOU will not be renewed, we are committed to serving as a mediator between FDA and state regulatory programs and advocating for standardization in the pet food industry.”
Other organizations, such as the American Feed Industry Association (AFIA) and the National Grain and Feed Association also expressed their disappointment at the announcement.
Interestingly, a very committed organization has so far taken a neutral stance. A brief explanation of the Institute of Animal Nutrition (PFI), issued on August 2, read: “PFI will not take a position on this until we hear FDA’s transition plan and proposed process. PFI looks forward to participating in the public comment period outlined by FDA in its letter to stakeholders today and to reviewing the guidance documents describing the transition period.”
Why is this interesting? Because PFI proposed a major change to the review and approval of animal feed ingredients in 2023. It recommended that FDA have sole decision-making authority over animal feed ingredients and eliminate review and approval by state feed control officials. (The members of AAFCO are those officials.)
Then, in February 2024, members of the U.S. House of Representatives introduced a new bill, the Pet Food Uniform Regulatory Reform (PURR) Act of 2024 (HR7380), which, according to a PFI press release, “would eliminate the state review process for pet food labels and favor federal regulation to ensure consistency and efficiency, similar to human food standards. It would also codify AAFCO pet food ingredient definitions and marketing claims to eliminate state-level discrepancies that hinder innovation, cause delays, and lead to litigation.” (Not surprisingly, PFI fully supported the bill.)
Of course, PFI may not have known that FDA would not renew the MOU with AAFCO. I wonder if the introduction of the Purr Act influenced FDA’s decision.
Did the MOU’s turbulent history lead to this?
The MOU has had a checkered history. As early as 2016, there were fears that it would not be renewed after its next expiration on October 1, 2017. Concerns raised by industry regulatory experts at the time focused on FDA’s discretion in enforcing AAFCO’s ingredient reviews and what might happen to the more than 500 approved ingredients on the market if the MOU expired.
“The problem with this collaborative effort is that the AAFCO process, while scientifically rigorous, is one that FDA views as being based on discretion in enforcement—that is, it is not a formally approved process for approving new food ingredients,” David Dzanis, DVM, PhD, DACVN, wrote in a Petfood Insights column in late 2012, after the MOU was renewed for the second time. Or, as George Burdock, PhD, president of the Burdock Group, explained, the MOU had no legal force at the FDA or at the national level, but was only valid in the states that adopted it.
It is currently unknown if this is FDA’s primary reason for not renewing the MOU. It is also unclear what, if anything, will happen to the hundreds of ingredients currently used in pet food and animal feed under the MOU/AAFCO process.
“AAFCO and FDA are working independently on plans that will enable a seamless transition and continue to support the U.S. pet food industry,” AAFCO’s press release said. “FDA is also evaluating its pet food ingredient review authorities and processes to determine if changes are needed to better serve the public health and ensure that new ingredients have a predictable path to market. Both organizations will provide additional details on the transition in the coming weeks.”
These details can’t come soon enough for a key part of the pet food and animal feed industry that is currently undergoing change. “AFIA expressed concern that the dissolution of the MOU will make the U.S. market less attractive to innovators by increasing uncertainty in the regulatory review processes and potentially increasing the time and cost of getting new pet food ingredients approved,” wrote my colleague Elise Schafer.
Indeed. No market likes uncertainty and rarely succeeds in times of chaos.
