FDA Overhauls Animal Food Ingredient Review Process After Two-Year Evaluation

The U.S. Food and Drug Administration's Center for Veterinary Medicine (CVM) has concluded a two-year evaluation of its animal Food Additive Petition (FAP) and Generally Recognized as Safe (GRAS) Notification review programs and announced a series of process reforms designed to, in the agency's words, "deliver faster, more predictable outcomes for submitters," according to a legal analysis published by law firm Wiley Rein on 30 September 2026.

FDA launched the review in August 2024, soliciting stakeholder input through a public request for comments, multiple listening sessions, and internal staff assessments. The agency subsequently published a summary of its evaluation findings.

Key Process Changes

FDA has characterised the reforms as "targeted process improvements" rather than changes to underlying scientific standards. Among the most significant changes, the agency will now allow submitters to provide a second amendment in GRAS submissions if questions remain after FDA reviews the first amendment — a step not previously available. FDA also plans to notify submitters whether an amendment would be necessary within 90 days of a GRAS notice being filed, which the Wiley Rein analysis describes as "almost 40 days earlier than in the past."

To support transparency, FDA published CVM Program Policy and Procedures Manual (PPM) 1244.3425: Animal Food Generally Recognized as Safe (GRAS) Notice Evaluation Timeline, which outlines key review stages and the agency's timeline goals for communications with submitters throughout the process.

In a webinar announcing the changes, FDA stated that by establishing clearer review milestones and earlier engagement, the agency hopes to speed up the issuance of no-questions letters, reduce unnecessary submission withdrawals, and allow submitters to prepare for resubmissions earlier.

Flexible Data and Manufacturing Requirements

The reforms also expand the flexibility of data submissions. For well-understood manufacturing processes, the Wiley Rein analysis notes that FDA has stated "a flow chart with a brief description of each step may be sufficient," while more novel manufacturing methods may still require additional data. The agency will also streamline Chemistry, Manufacturing, and Controls (CMC) documentation requirements for common or well-understood production methods.

On utility data — information submitted to support product claims — FDA has committed to reducing its standing expectation. According to the analysis, the agency has "implemented a process that will only require utility data if it is necessary to support the safety of the ingredient," a departure from its previous preference to receive such data with every submission.

International Alignment and Continuous Improvement

The reforms also include efforts to align feed ingredient review internationally through collaboration with the International Cooperation for the Convergence of Technical Requirements for the Assessment of Feed Ingredients (ICCF).

FDA has characterised the initiative as ongoing, emphasising that this "is not a one-time activity," and plans to monitor outcomes and engage with stakeholders to continue refining both the FAP and GRAS programs.

Broader Regulatory Context and Uncertainty

The Wiley Rein analysis places the reforms within a shifting regulatory landscape that includes the expiration of FDA's Memorandum of Understanding with the Association of American Feed Control Officials (AAFCO) for the feed ingredient definition request process, the creation of the transitional Animal Food Ingredient Consultation (AFIC) program, and a proposed rule that would make GRAS notice submission mandatory for human and animal food ingredients self-determined to be GRAS.

The analysis flags a potential resource constraint, noting that "it remains uncertain whether the agency will be able to keep pace with the expected surge in submissions if the proposed mandatory notification rule is finalized without a corresponding increase in resources, including additional review staff." This uncertainty is the authors' interpretation based on the regulatory context.