Earlier this year, the Federal Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) concluded a two-year evaluation of its animal food ingredient approval processes. This evaluation was first launched in August 2024 and it assessed both the Food Additive Petition (FAP) and Generally Recognized as Safe (GRAS) Notification review programs. After concluding in September 2026, FDA released a summary of its findings. The summary can be found here.

FDA authority

The Food Drug and Cosmetics Act (FDCA) gives FDA regulatory authority over “articles used for food or drink for man or other animals . . . and articles used for components of any such article.” 21 USC § 321(f). While the FDA shares its responsibility for human food with the US Department of Agriculture, regulation of animal food rests solely with the FDA and its sub-agency the CVM. CVM regulates several aspects of the animal food regulatory scheme including the pre-market approval of food ingredients, reviews of certain animal food labels, and food facility inspections.

Food Ingredient Review Processes

Until 2024, CVM historically utilized three pathways for ingredient entry into the marketplace – 1) Food Additive Petitions, 2) “generally recognized as safe,” and 3) AAFCO’s approval process. Under the FDCA, substances directly or indirectly added to animal food must be “used in accordance with a food additive regulation, unless it is generally recognized as safe (GRAS) for an intended use.” 21 USC § 321(s). To be approved as a food additive, an ingredient must submit a Food Additive Petition. This is typically a long process and will involve publication by the agency in the Federal Register. Click here for a more detailed breakdown on this process.

On the other hand, an ingredient can also be introduced to the marketplace through the GRAS pathway. Food ingredients that utilize this pathway are those deemed safe by qualified experts at the specified levels and for the certain uses intended by the manufacturer. Under GRAS, if an ingredient meets this safety standard, manufacturers can introduce it into the marketplace without receiving FDA approval and without notifying the agency. FDA does currently operate a voluntary notification process; however, earlier this year, the agency proposed new rulemaking to make notification mandatory for both human and animal food ingredients. To learn more about this proposed rule, click here to read NALC article “HHS Proposes Reforms to the ‘Generally Recognized As Safe’ Pathway.”

AAFCO Ingredient Definition Process  

The third pathway that FDA historically utilized was through a collaboration with non-governmental actor the Association of American Feed Control Officials (AAFCO). This membership organization, made up of state, federal, and foreign feed officials, develops standards, definitions, and enforcement policies for animal food. In particular, AFFCO creates model laws and regulations for animal food that most US states have adopted.

Prior to October 2024, AAFCO had a Memorandum of Understanding (MOU) with FDA to operate a pathway for ingredient approval, called the ingredient definition request process. In this process, a requester would draft a proposed ingredient definition and submit it to an AAFCO Investigator for approval. A proposed definition included information like a proposed name, safety assessment, the ingredients intended use, and any use limitations. Definitions that were approved through this process would be included in AAFCO’s annual publication titled the “AAFCO Official Publication.” Historically, FDA would provide scientific and technical expertise to the process – though these definitions did not carry the weight of law. However, in October 2024, the FDA-AAFCO MOU expired. This means that the AAFCO Ingredient Definition Process is no longer a viable pathway for ingredient modification or introduction. The FDA has clarified though that it will use enforcement discretion towards products that contain ingredients already introduced to the marketplace through this process. Thus, at the moment, manufacturers are free to continue using them without the risk of action by the agency.

FDA’s 2024 Announcement

Along with the expiration of the MOU, in 2024, FDA also announced that it would begin a period of evaluation for its other ingredient approval processes. Further, the agency also announced an interim program for ingredient introduction, Animal Food Ingredient Consultation (AFIC). This process required the submission of certain ingredient information and required the agency to publish an inventory of pending and completed AFICs. For more information, click here to read “Animal Food Ingredient Consolation (AFIC): Guidance for Industry.”

Evaluation

On August 8, 2024, the FDA started its evaluation of the animal Food Additive Petition and GRAS Notification programs. Specifically, the agency stated the intention of this evaluation to be “determ[ing] whether these programs were working as well as they could for industry, consumers, and public health, and identify[ing] solutions to address areas where there was room for improvement.” The evaluation was conducted through public comments, external engagement sessions, internal CVM staff interviews, and feedback from program areas. In its evaluation summary, FDA listed what it considered to be four themes in stakeholder’s concerns:

  • Confidentiality and disclosure – this theme relates to stakeholder concern for protecting their confidential business information during the review process.
  • Consistency – stakeholders expressed confusion about expectations stemming from inconsistency among FDA and CVM programs.
  • Predictability – stakeholders expressed frustration with the length and unpredictability of the agency’s review timelines.
  • Data Requirements – inconsistency about required data and information submissions.

FDA Targeted Actions

In response to these themes, FDA examined what it determined to be the root causes of concern and announced several “targeted process improvements” that it will work to implement. These actions include:

  • Provide clarity on disclosure and confidentiality requirements through plain-language communications in submitter meetings.
  • Update internal best practices to improve consistency and reduce reviewer burden.
  • Implement earlier internal review timelines, allowing faster engagement with submitters.
  • Create a second amendment opportunity within the GRAS Notice evaluation process.
  • Publish the GRAS Notice Evaluation Timeline as a formal Program Policy and Procedures Manual (PPM).
  • Expand data flexibility to reduce submitter burden without compromising safety.
  • Advance international harmonization through collaboration with ICCF.

GRAS specific actions

Two specific actions that the agency has already taken are related to its evaluation of GRAS notice submissions. First, FDA is establishing a second opportunity for submitters of a GRAS notice to amend their submissions during FDA’s evaluation process. This change comes with the agency’s publication of a timeline (discussed below) that details the deadlines and steps it will take in the review process. Along with introducing a second opportunity for submitters to make necessary changes, the published timeline shifts when FDA will be expected to notify submitters of their first opportunity to amend.

Second, FDA published a Program Policy and Procedures Manual that describes its GRAS Notice Evaluation Timeline. Formerly, there was no document that clarified the agency’s timeline for evaluating GRAS Notice submissions. This document provides a day-by-day breakdown of FDA’s actions from Day 1 to Day 270 in this process. For example, the document’s appendix includes “post-filing target milestones” like “Day 90: administrative reviewer sends first round of questions to the firm via email.” The document does clarify that these are target dates and may be adjusted due to emergency situations or operational factors.

Effect of Evaluation

Other than the publication of the GRAS timeline document, FDA has not yet taken any affirmative steps to achieve these listed priorities. Additionally, though it was first announced as an interim process while the agency conducted this evaluation, FDA has not clarified whether it will sunset the AFIC pathway. Technically, ingredients that are introduced into the market through this pathway are out of compliance under the FDCA. This is because federal law considers ingredients that were not introduced through either the FAP or GRAS pathways as “unapproved food additives.” However, FDA has chosen to practice enforcement discretion and not go after manufacturers who sell products with those ingredients. This action is similar to how the agency has stated it will treat products that contain ingredients introduced through the AAFCO pathway.

Additionally, it is important to note that the agency is currently walking through the rulemaking process for its 2026 proposed GRAS reforms. If that rule becomes final and makes GRAS notification mandatory for all animal food products, then the timeline guidance will become an important document for manufacturers seeking to utilize the GRAS pathway. Further, those reforms introduce notice requirements for animal foods already in the marketplace that contain GRAS ingredients. The agency has not specified yet if this timeline will be applicable to that notification process, but it might be an indicator of the process FDA will use to evaluate those ingredients.

 

For further information on FDA’s evaluation, click here to watch the agency’s previously recorded webinar, “Webinar: Evaluation of Pre-Market Animal Food Ingredient Review Programs.”

For more information on the federal regulation of animal feed, click here to read NALC factsheet.

For more information on state feed laws, click here to view NALC’s Commercial Feed Law Compilation.

 

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