Pet food innovation is moving quickly across the United States. From novel proteins and functional ingredients to fermentation-derived compounds and upcycled materials, manufacturers are continuing to develop increasingly sophisticated products for companion animals.
But innovation in pet food comes with regulatory considerations.
In the U.S., ingredients intended for use in animal food — including pet food — must fit within FDA’s regulatory framework. One of the most important concepts in that framework is GRAS, or Generally Recognized as Safe.
As innovation in animal nutrition accelerates, understanding how GRAS applies to pet food ingredients is becoming increasingly important for manufacturers entering the U.S. market.
Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), substances intentionally added to food for humans or animals are generally considered food additives unless an exemption applies. One of the primary exemptions is GRAS status.
In simple terms, a substance may be considered GRAS when qualified experts generally recognize it as safe under its intended conditions of use.
For pet food ingredients, this is an important distinction because GRAS status is not universal. It applies to:
An ingredient considered acceptable in one application is not automatically acceptable across all animal food uses. The regulatory assessment often depends heavily on the ingredient’s composition, intended use, manufacturing process, and target species.
The modern pet food market extends far beyond traditional feed ingredients.
Today’s products increasingly incorporate:
As these ingredients become more specialized, companies often require stronger scientific and regulatory substantiation to support commercialization in the U.S. market.
Many ingredients originally developed for dietary supplements, food and beverage applications, or biotechnology platforms for humans, may require additional evaluation before they can be used in pet food.
In many cases, GRAS becomes one of the clearest pathways for supporting the lawful use of an ingredient in animal food.
For animal food ingredients in the United States, there are generally two primary FDA-recognized regulatory pathways:
The GRAS pathway is commonly used when sufficient scientific evidence exists to support safety under the intended conditions of use.
Food Additive Petitions are more formal FDA approval processes generally used when an ingredient does not meet GRAS criteria or when additional regulatory authorization is needed.
The appropriate pathway often depends on the ingredient itself, the intended species, available safety data, and the proposed conditions of use.
Historically, many animal food ingredients entered the U.S. market through the Association of American Feed Control Officials (AAFCO) Ingredient Definition process. These ingredients would then be listed in chapter 6 of AAFCO’s Official Publication, following which they were generally considered acceptable by states for use in pet food.
However, the regulatory landscape changed significantly following the expiration of the Memorandum of Understanding (MOU) between AAFCO and FDA in October 2024.
As a result:
FDA has stated that ingredients intended for animal food generally must either:
This shift has created a more structured regulatory environment for companies developing innovative pet food ingredients.
Establishing GRAS status for a pet food ingredient typically involves a detailed scientific and regulatory review.
This may include evaluation of:
FDA’s GRAS framework also emphasizes that the safety conclusion should be generally recognized among qualified experts and supported by publicly available scientific information.
For novel ingredients, this can require significant scientific and regulatory substantiation before commercialization.
Companies pursuing a GRAS pathway for pet food ingredients may choose between:
With a self-affirmed GRAS conclusion, the company independently determines that the ingredient is GRAS based on the available evidence and commissions review of this conclusion by an independent and qualified expert panel.
Alternatively, companies may voluntarily submit a GRAS notice to FDA’s Center for Veterinary Medicine (CVM). FDA may then respond with a “no questions” letter if it does not object to the notifier’s conclusion.
While FDA notification is currently voluntary, many manufacturers pursue it to provide additional transparency and commercial confidence.
One of the biggest challenges in pet food innovation is that regulatory considerations are often addressed late in development.
Since an ingredient’s regulatory pathway may depend on:
Evaluating regulatory positioning early can help identify potential data gaps/concerns, reduce delays, and support long-term commercialization planning.
dicentra supports companies developing pet food ingredients, feed additives, and novel animal nutrition products for the U.S. market.
Our services include:
Whether your ingredient is a novel protein, functional additive, fermentation-derived ingredient, or upcycled material, our team can help assess the appropriate regulatory pathway and support your commercialization goals.
If your company is developing a pet food ingredient or animal feed additive for the U.S. market, reach out to us to discuss your GRAS strategy, regulatory considerations, and animal food compliance requirements.