Is Self-Affirmed GRAS Going Away? 

The pet food ingredient approval landscape has had a lot of changes in the past year. Following the discontinuation of the Memorandum of Understanding (MOU) between the US Food and Drug Administration (FDA) and the Association of American Feed Control Officials (AAFCO) in October 2024, the FDA introduced the Animal Food Ingredient Consultation (AFIC) process earlier this year. Additionally, it was announced that AAFCO and Kansas State University’s Scientific Review of Ingredient Submissions (SRIS) will be launched in 2025.  

The historical pet food ingredient approval pathways involving the FDA's Center for Veterinary Medicine (CVM) that have remained constant amid these changes are the Food Additive Petition (FAP) and Generally Recognized as Safe (GRAS) routes, which pet food ingredient companies can still utilize.  

Since the GRAS process was outlined in 2016, two methods have been established for ingredient companies to reach a GRAS determination. The first is to submit a dossier to the FDA CVM proving that an ingredient is GRAS for the intended species and use. If the FDA concurs with the company’s conclusion, it issues a letter of no objection, which means that the pet food ingredient is not subject to pre-market approval. In other words, the FDA is not objecting to the use of the ingredient in pet food as defined in the GRAS submission.  

The alternative method that ingredient companies currently use to navigate the GRAS ingredient process is to convene their own subject matter experts to review the ingredient’s safety data. Based on their findings, the experts render the decision on whether the ingredient is indeed GRAS. This is the self-affirmed GRAS process for new ingredients, as it is reviewed by experts convened by the sponsor or pet food company and not by the FDA.  

Criticism of self-affirmed GRAS are that the public has potentially no visibility into what safety data is constructed and whom the reviewers of this information are, as there is no requirement for public disclosure. Unless the ingredient company decides to make this information publicly available, its non-transparency could potentially put consumers and their pets at risk.  

When a pet food ingredient GRAS submission is reviewed by the FDA and given a letter of no objection, it is published in the FDA’s Animal Food GRAS Notice Inventory. This makes the GRAS notice available to the public. It is also listed in the AAFCO Official Publication (OP), which lists all other ingredients historically approved for pet food use. An ingredient that uses the self-affirmed GRAS route does not get published in the AAFCO OP, nor is the GRAS determination made public unless the sponsoring company elects to do so. A self-affirmed GRAS determination is also not published in the FDA Animal Food GRAS Notice Inventory.  

In March of 2025, the US Department of Health and Human Services (HHS), of which the FDA is a part, announced that it would be examining the GRAS notice pathway, including evaluating whether self-affirmed GRAS should be discontinued. More recently, on Sept. 4, the FDA published its Unified Regulatory Agenda, a list of current regulations that the FDA is developing or has completed and are ready for comments or implementation. The purpose of the Unified Regulatory Agenda is to provide the public and interested industries visibility into new regulations or deregulations of ingredients, pharmaceuticals, medical devices, and anything else in which the FDA has regulatory oversight. Of interest in the most recent agenda is the new proposed rule 0910-AJ02.  

This proposed new addition would, if implemented, “…amend the Generally Recognized as Safe (GRAS) regulations in 21 CFR parts 170 and 570 to require the mandatory submission [to FDA] of GRAS notices for the use of human and animal food substances that are purported to be GRAS.” If implemented, this would effectively make the self-affirmed GRAS route of using new ingredients for both human and pet food in violation of this new FDA rule. According to HHS and the FDA CVM, this would increase public and industry transparency of food ingredients, because no matter if an ingredient were approved via a FAP, through the new FDA AFIC route, or with this new language through the GRAS route, all information would now be publicly available for any new food ingredients used in both pet and human food.  

From a consumer transparency standpoint, the end of the self-affirmed GRAS pathway is a positive thing for the consumer. The public deserves to know what information was used to review the safety and utility of new food ingredients.   

Of course, it is expected that companies whose ingredients have previously undergone self-affirmed GRAS determination will object and have the chance to comment on this new proposed rule. If implemented, this new rule will likely not take complete effect for at least a year or more. Companies that are currently marketing food ingredients that have utilized the self-affirmed GRAS pathway should be evaluating the completeness and rigor of their scientific dossier that determined their self-affirmed GRAS status. It may become necessary for them to submit a dossier for FDA review of their GRAS determination in the format required by the FDA. Ingredient companies should be preparing for the likely implementation of the new rule and be seeking guidance from expert regulatory and scientific consultants who can help them navigate this process.  

One other unknown component at this time is how the proposed FDA rule 0910-AJ02 would affect the new AAFCO-Kansas State SRIS ingredient pathway. Currently, this pathway utilizes subject matter experts assembled by the SRIS team to review nutritional, safety, and other necessary data about an ingredient. If deemed safe by the subject matter expert panel, the new ingredient is taken to AAFCO for a vote to determine if the ingredient will be included in the AAFCO OP. Since the SRIS process does not directly involve review by FDA-CVM and has been described as “…essentially AAFCO self-affirmed GRAS…" by SRIS officials, this may become problematic if the FDA actually implements proposed rule 0910-AJ02, which will eliminate the self-affirmed GRAS route for new ingredient use.  

Significant work and resources have been put into the SRIS process by both AAFCO and Kansas State University. Their goal of expediting safety reviews of new ingredients compared to other currently available pathways, along with the proposed decrease in the time it takes for companies to bring new ingredients to market, should be applauded. However, it is unclear how the proposed (and likely to be implemented) changes to eliminate self-affirmed GRAS will affect this new SRIS route of pet food ingredient approval.   

One thing is for sure: the regulatory landscape for pet food ingredient approvals and usage will not be any quieter in the next year than it has been in the last. The experts at BSM Partners will stay up to date on changes made and new changes ahead for pet food ingredients, and we are poised to help ingredient companies and innovators navigate which route is best for them. And if the self-affirmed GRAS pathway is no longer allowed, it will be a positive step for transparency for the consumer. 

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About the Author

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