Animal Feed Regulatory Pathways

by Adam Orr, EAS Consulting Group Independent Consultant

As you know, food is regulated by the FDA under the Federal Food Drug and Cosmetic Act (FDCA). In brief, it defines food as articles used for food or drink for man or other animals and defines food additives as any substance which may result, directly or indirectly, in becoming a component of food or affecting its characteristics, unless it is generally recognized as safe (GRAS) for its intended use (21 U.S.C. section 321).

It is the FDA Center for Veterinary Medicine (CVM) and Division of Animal Food Ingredients that oversees the regulation of animal feed and pet food. There are currently four options to address the regulatory status of a new ingredient for livestock, poultry, aquaculture, or pet food.

Food Additive

Food additives require pre-market approval by FDA to establish the conditions of safe use, which is achieved by filing a petition with the FDA Commissioner. The petition process for animal use is described beginning in Title 21 Code of Federal Regulations Part 571 (21 CFR 571).^[1] Once accepted for filing, a notice is published in the Federal Register. Upon favorable review of the petition and data contained within, an official action by FDA is taken to draft and publish a regulation prescribing under what conditions the additive may be used. This regulation is then published in the Federal Register and in 21 CFR part 573.^[2]

The petition itself will contain roughly nine technical sections including Additive identity and composition, Intended use and use rate, Data supporting the intended effect, Analytical methods, Target animal Safety, Human food safety, Environmental safety, Label, and Proposed regulation. The review of these sections are conducted on an iterative basis and can proceed back-and-forth between FDA and firm as many times as needed to address any outstanding questions. Each individual review cycle should take no more than 180 days.

GRAS

If the use of an article is GRAS, then it is not subject to the pre-market approval requirements of food additives. However, a firm may notify the FDA regarding its conclusion that use of an ingredient is GRAS. The agency will then provide comments related to the firm’s conclusion, but the agency does not make a conclusion of its own regarding the ingredient or its use.

The GRAS Notification process for animals was completed in 2016 and is codified beginning in 21 CFR 570.203. A firm is not required to notify the FDA of its GRAS conclusion, but if it chooses to notify FDA, once the notice is accepted for filing, it will be published on the FDA-CVM Current Animal Food GRAS Notices Inventory (rather than the Federal Register).^[3] Note the GRAS Inventory for human foods and animal feeds are two separate lists. When FDA completes its evaluation of the Notice, it will publish a letter to the GRAS Inventory indicating that it “had no questions” or “had questions” related to the firm’s GRAS conclusion. There is one round of review for FDA to evaluate your Notice, including one opportunity to make minor revisions.

The future and the scope of the GRAS program is uncertain. As you probably heard, Health and Human Services Secretary, Robert F. Kennedy Jr will seek rulemaking to eliminate GRAS self-determination provision.^[4]

AFIC

In response to ending the Memorandum of Understanding (MOU) with Association of American Feed Control Officials (AAFCO), FDA-CVM established the Animal Food Ingredient Consultation (AFIC) program. It is stated to be an interim and temporary program but there is no indication when, or if, it would end. When drafted, it was limited to only ingredients intended as primary sources of nutrients, but that was revised in the final Guidance to include any feed ingredient. FDA will publicize on a dedicated website (as opposed to the Federal Register) a list of consultation requests which will identify the ingredient and sponsoring firms. Once accepted for filing, the general public will have an opportunity to submit comments and data to the file to support or oppose the ingredient. The FDA’s final letter of conclusion will also be publicly posted on the AFIC website.

AAFCO

Since 1920, AAFCO has printed the AAFCO Official Publication, which contained a comprehensive list of animal feed ingredients to help bring uniformity for feed among the States. Beginning in 2007, FDA-CVM entered into an MOU with AAFCO to provide scientific and technical expertise for the review of ingredients. These ingredients, though technically unapproved food additives, were accepted for use in animal feed and pet food under a policy of enforcement discretion. With the end of FDA’s MOU with AAFCO, the enforcement discretion policy will not be extended to new ingredient definitions published by AAFCO.

In January 2025, AAFCO voted to approve a proposal by Kansas State University (KState) to continue scientific review of new animal feed ingredients.^[5] It is my understanding that the KState reviewed ingredients will be based upon a GRAS self-determinations paradigm to address the legality of inter-state commerce of the ingredients. As mentioned above, the Agency is seeking rulemaking to eliminate the GRAS self-determination provision. I think the future of the AAFCO ingredient definition program remains unclear and uncertain.

Which Pathway to Choose?

When it comes to choosing a regulatory path for a new or revised feed ingredient/additive for livestock feed or pet food, the options can be confusing and overwhelming. For a lot of ingredients, any of the paths will work and it is simply an issue of personal choice. For others, it would be wise to carefully choose the path best suited to the ingredient in question and its unique characteristics or political implications.

[1] https://www.ecfr.gov/current/title-21/chapter-I/subchapter-E/part-571

[2] https://www.ecfr.gov/current/title-21/chapter-I/subchapter-E/part-573?toc=1

[3] https://www.fda.gov/animal-veterinary/generally-recognized-safe-gras-notification-program/current-animal-food-gras-notices-inventory

[4] https://www.hhs.gov/about/news/2025/03/10/hhs-secretary-kennedy-directs-fda-explore-rulemaking-eliminate-pathway-companies-self-affirm-food-ingredients-safe.html

[5] https://www.aafco.org/news/aafco-votes-yes-on-new-regulatory-pathway-for-animal-food-ingredients/