Seeing the Forest for the Trees: Are There Any New Insights in Regulatory Pathways for New Pet Food Ingredients?

Written by Dr. Bradley Quest , DVM?

For those keeping score, let’s review what has changed in the past few months for the new pet food ingredient world.?In October, the US Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) elected not to renew the Memorandum of Understanding (MOU) that had been in place between AAFCO and the FDA for the past 17 years.?We have discussed the details of the MOU in previous articles, but in brief, one of the ways for new pet food ingredients to gain approval for use was via the AAFCO New Ingredient Definition Process. The FDA provided safety and utility oversight regarding new ingredients using this process, which was the basis for the MOU.? When the FDA did not renew the MOU, the AAFCO New Ingredient Approval Process had no basis for safety review and, therefore, is no longer recognized as a valid pathway for new pet food ingredient approvals.?

Since all of this has hit the fan, both AAFCO and the FDA have announced new wrinkles for the ingredient approval process. The FDA has come out with the now final Guidance For Industry (GFI) #293, which states the FDA will not challenge the use of currently approved ingredients in AAFCO’s Official Publication.? This applies to ingredients that underwent the AAFCO New Ingredient Approval Process, the FDA Food Additive Petition process, or the Generally Recognized as Safe (GRAS) Notice process. The FDA has also issued the draft GFI #294, which details the Animal Food Ingredient Consultation (AFIC).?This is the FDA’s answer to an interim ingredient approval process in place of the MOU, but doesn’t look much different from the Food Additive Petition Process we discussed in a previous podcast episode.?

On the AAFCO side, they have developed a draft proposal process that would utilize AAFCO investigators and committees, similar to the previous MOU with the FDA. The difference is that instead of the FDA providing safety review oversight, Kansas State University would assemble an expert panel. We have commented on this proposal before and still wonder how such a process could proceed without the approval of the FDA-CVM, as they have full regulatory oversight of pet food per the Food Drug and Cosmetic Act of 1938.?

Well, that wasn’t as brief of a review as one would like, but there’s a lot there to unpack.? AAFCO is collecting industry comments and feedback on its newly proposed process. Pet Food Institute (PFI), a pet food industry trade association, has made public its comments on the proposed AAFCO-KSU new ingredient approval process, stating that there may be conflicts of interest within AAFCO’s proposal, as universities are often funded by industry, which might introduce bias on the part of subject matter experts hired by Kansas State to review data on new ingredient approvals.?For instance, if a subject matter expert takes funding from a private company with a vested interest in getting a certain ingredient approved, there may be a potential problem.??

Other potential drawbacks PFI listed include doubt in the public’s mind about a process that does not involve FDA review.?Also, as stated earlier, any new AAFCO process would have to be recognized by the FDA before new ingredients can be used in pet food.?PFI also indicated that such an AAFCO-Kansas State pathway may not be acceptable to international pet food ingredient usage, as are the currently accepted processes.?PFI also voiced their opinion on how the university and subject matter experts should be selected and pointed to the FDA to help guide that expert reviewer selection process.?Finally, PFI stated that regulatory and academic review standards may be different and, therefore, might jeopardize the validity of such a safety review.?

While we at BSM Partners agree with some of the points that PFI makes, such as requesting AAFCO and Kansas State further elaborate on how the subject matter expert reviewers will be chosen, vetted for potential conflicts of interest, and what their credentials will be, we also feel that PFI has aligned themselves with complete federal oversight of pet food.?Indications of PFI’s preference for complete federal control are evidenced in their statement: “…We do not feel the food safety review proposed by KSU nor the outcome of publishing in the AAFCO Official Publication will accomplish this aim.”? The “aim” here is a “streamlined regulatory structure,” according to PFI. However, we believe completely centralizing all regulatory oversight would make it much easier for the largest players in the pet food industry to lobby federal agencies and lawmakers for regulations that could benefit them—and potentially hurt others.?

Another example of PFI’s position is its firm support of H.R. 7380, the Pet Food Uniform Regulatory Reform (PURR) Act of 2024, introduced in the U.S. House of Representatives earlier this year.?H.R. 7380 proposes to give full regulatory oversight of all pet food and labeling to the FDA-CVM and would remove local shared state control of such regulations.? BSM Partners has publicly made it clear that we, along with many others in the pet food industry, are against the PURR Act because we feel it takes away local state regulatory control of pet food and puts it 100% in the hands of an understaffed and underfunded federal agency.??

Without the breadth and experience of state regulatory officials, industry experts, and FDA experts who make up AAFCO, the current regulatory state of pet food would likely become even more difficult and slower. Eliminating state, industry, and academic expertise is not the answer to any of the pet food regulatory processes and questions currently facing the industry.?

About the author?

Dr. Bradley Quest , DVM is the Principal Veterinarian at BSM Partners. He has practiced veterinary medicine, developed and tested hundreds of pet health products and helps navigate pet food ingredient approval for clients.?