FDA Announces Process Improvements Impacting Animal Food Producers

The U.S. Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) has concluded its two-year evaluation of the animal Food Additive Petition (FAP) and Generally Recognized as Safe (GRAS) Notification review programs and announced a series of process reforms designed to “deliver faster, more predictable outcomes for submitters.” FDA has characterized these changes as “targeted process improvements,” which include implementing earlier review timelines, allowing submitters to provide a second amendment in GRAS submissions if questions remain after FDA reviews the first amendment, and increasing flexibility regarding the scientific and manufacturing information that may be submitted, among other measures. FDA also published CVM Program Policy and Procedures Manual (PPM) 1244.3425: Animal Food Generally Recognized as Safe (GRAS) Notice Evaluation Timeline in an effort to provide greater transparency into the GRAS review process and timeline. These changes signal FDA’s intent to make the GRAS notification process more predictable and user-friendly by providing earlier feedback and additional opportunities to address agency concerns during review.

Why Did FDA Conduct an Evaluation?

FDA launched a review of its animal FAP and GRAS programs in August 2024, seeking stakeholder input on how the agency could improve the path to market for new animal food ingredients. The evaluation included a public request for comments, multiple stakeholder listening sessions, and internal staff assessments to give FDA better insight into how the FAP and GRAS programs were functioning. FDA published a summary of the results of its evaluation. This evaluation occurred against the backdrop of broader changes to the animal food ingredient regulatory landscape, including 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 the recent publication of a proposed rule requiring mandatory GRAS notice submission for human and animal food ingredients self-determined to be GRAS. While CVM’s planned improvements aim to provide faster review timelines for submitters, 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.

How Will the GRAS Notification Process Change?

FDA’s targeted improvements are designed to address industry concerns without changing the scientific standards applicable to ingredient reviews. These improvements include:

• Increased transparency regarding review timelines;
• Earlier communication with submitters;
• Availability of a second amendment during GRAS notice review;
• Expanded flexibility regarding acceptable scientific support;
• Streamlined approaches for certain manufacturing information;
• Efforts to increase international alignment in feed ingredient review and evaluation processes through collaboration with the International Cooperation for the Convergence of Technical Requirements for the Assessment of Feed Ingredients (ICCF); and
• Internal process changes intended to improve consistency and reduce reviewer burden as to each submission, potentially resulting in faster review times.

New Transparency and Communication Measures

FDA issued a new policy document, PPM 1244.3425: Animal Food GRAS Notice Evaluation Timeline, which outlines key stages of the GRAS review process and provides the agency’s timeline goals for anticipated communications with submitters throughout the review. FDA also announced that it plans to engage with submitters earlier during the review process and is seeking to notify submitters whether an amendment would be necessary within 90 days of the GRAS notice being filed, almost 40 days earlier than in the past. In addition, FDA will now allow submitters to submit a second amendment if questions remain after the agency’s review of the first amendment. In a webinar announcing the process improvements, FDA stated that, by establishing clearer review milestones and earlier engagement with submitters, the agency hopes to speed up issuance of no-questions letters, reduce unnecessary submission withdrawals by having more time to review amendments, and allow submitters to prepare for resubmissions months earlier than in the past.

Enhanced Flexibility in Data and Manufacturing Information Requirements

FDA announced its willingness to consider more flexible approaches for data submissions by expanding the use of extrapolation approaches and limiting utility data requirements. The agency will allow more streamlined manufacturing information to be submitted for common or well-understood production methods as well as other data simplifications for Chemistry, Manufacturing, and Controls (CMC) documentation. For example, FDA has stated that for well-understood manufacturing processes, a flow chart with a brief description of each step may be sufficient. However, more novel manufacturing methods may require additional data.

Significantly, FDA has committed to reducing the expectation to submit utility data with every GRAS submission. FDA acknowledged that while it prefers utility data with every submission to ensure that product claims are truthful and not misleading, it has now implemented a process that will only require utility data if it is necessary to support the safety of the ingredient.

What Does this Mean for Animal Food Producers?

FDA’s announced improvements to the animal food review process reflect an effort to address long-standing industry concerns regarding predictability, communication, confidentiality, and transparency. If implemented as described, the changes aim to improve the path to market for animal food ingredients while ensuring these programs remain grounded in science. The more flexible data submission requirements for GRAS notices may, among other things, decrease the historical need to submit confidential information as part of the submission, particularly with respect to manufacturing processes. This would be a significant improvement given that GRAS notices should generally be limited to publicly available information. Further, FDA’s timeline goals as outlined in PPM 1244.3425 may assist companies in better predicting future commercialization activities.

Companies planning future FAPs or GRAS notices should begin evaluating their submission strategies in light of these announced changes. Pre-submission consultations with FDA may be particularly helpful in seeking alignment on data expectations for your animal food ingredient in light of FDA’s process improvements.

FDA has committed to continuous improvement, emphasizing that this “is not a one-time activity.” The agency plans to monitor outcomes, refine its approach in line with the evolving animal food ingredient landscape, and engage with stakeholders to continue to enhance its FAP and GRAS programs. Companies should look for opportunities to provide FDA with feedback on these new improvements as well as recommendations for further improvements.

Wiley’s Food & Drug Practice is closely monitoring FDA’s implementation of these animal food ingredient review process improvements and can assist companies in:

• Evaluating their impact;
• Preparing submissions;
• Engaging with FDA throughout the review process; and
• Providing feedback on future program enhancements.