Rigorous and predictable ingredient review processes enable America's pet food companies to deliver safe and innovative foods to animal companions. For decades, the industry has had the food-additive petition, the Generally Recognized as Safe (GRAS) framework and the Association of American Feed Control Officials' (AAFCO) ingredient definition processes for the review of safe and effective ingredients.
These pathways were rarely perfect, but they were available and consistent. However, changes over the last two years have led to the additions of the Animal Food Ingredient Consultation (AFIC) and AAFCO's Scientific Review of Animal Food Ingredients, which the industry is having to navigate and utilize.
Now, the industry is facing another possible shakeup with the Food and Drug Administration's proposal to revise the GRAS notification process for human and animal food substances.
How the GRAS process works
Under federal law, a substance intentionally added to food is considered a food additive that requires FDA premarket review and approval unless it is generally recognized as safe by qualified experts or through scientific procedures under conditions of its intended use.
The GRAS process has been in place since the 1958 amendment to the Federal Food, Drug and Cosmetic Act created this exemption. Regulations finalized in 2016 established a voluntary procedure through which a manufacturer may choose to notify the FDA of a conclusion that a substance is GRAS under the conditions of its intended use in food.
Despite misinformation online, the FDA does not "approve" a GRAS notice submission. Instead, the agency may state that it has no questions about the company's conclusion, determine that the notice does not provide a sufficient basis for that conclusion or stop its evaluation at the company's request. An FDA no-questions letter applies to the submitted basis for a specific use; it is not a universal safety ruling for the ingredient. This process has worked to safely bring dozens of innovative products to the market that support animal health and wellbeing.
What the proposed rule would change
Led by Health and Human Services Secretary Robert F. Kennedy Jr., the FDA's proposed rule would require manufacturers who are introducing a substance into interstate commerce under the GRAS provision to notify the agency of that conclusion unless a specific exemption applies. The rule proposes to exempt animal food ingredients that have received a no-questions letter from FDA; are affirmed as GRAS in Title 21 of the Code of Federal Regulations, parts 582 or 584; were in use prior to 1958; are currently defined in Chapter 6, "Official Feed Terms, Common or Usual Ingredient Names and Ingredient Definitions" of the 2024 edition of the Official Publication of AAFCO; or have completed review through the AFIC process. The proposal also includes a time-limited, streamlined submission option for substances already in commerce by the time the rule becomes effective.
The American Feed Industry Association (AFIA) supports strong, science-based regulatory systems and recognizes the Trump administration's efforts to strengthen the safety and transparency of food systems. Ingredient oversight is the foundation of a safe animal food supply.
It also shapes whether companies choose to invest resources in ingredients that can improve nutrition, support animal health or make pet food production more efficient. As the FDA considers changes, the agency must build a system that is also clear, timely and practical for animal food manufacturers, and that incentivizes continued innovation.
The AFIA is reviewing the proposal and will provide comments to the FDA. The final rule and resulting regulatory changes should protect animal and public health, improve transparency and preserve rigorous scientific decision-making. The rule should also include realistic implementation periods, efficient procedures and the agency resources needed to keep reviews timely and predictable.
Pet owners expect safe products, honest information and continued progress in nutrition. Manufacturers need understandable rules and a process they can plan around. Modern ingredient review processes can meet those expectations, but only if sound policy and effective implementation move forward together.
Leah Wilkinson is the vice president of public policy and education for the American Feed Industry Association (AFIA).
