The FDA's Center for Veterinary Medicine finalized changes to its animal food ingredient review programs, implementing targeted improvements to deliver faster, more predictable outcomes while maintaining scientific rigor. Key changes include clearer communication about confidentiality requirements, streamlined documentation, earlier internal timelines, expanded data flexibility, and a second amendment opportunity within the GRAS Notice evaluation process.
- FDA issued updated CVM Program Policy and Procedures Manual 1244.3425 establishing documented benchmarks for GRAS Notice evaluation timelines and submitter expectations
- Four main stakeholder concerns addressed: confidentiality clarity, consistency across FDA programs, predictable review timelines, and clearer data requirements
- Plain-language communication of disclosure and confidentiality requirements developed with disclosure experts for pre-submission conferences
- Expanded data flexibility includes safety arguments across species, simplified chemistry documentation, and limited utility data requirements where scientifically appropriate
- FDA continues collaboration with ICCF (International Cooperation for Convergence of Technical Requirements) to align animal food ingredient standards internationally
The U.S. Food and Drug Administration's Center for Veterinary Medicine (CVM) released the results of its evaluation of the animal Food Additive Petition (FAP) and Generally Recognized as Safe (GRAS) Notification review programs, the two pathways that govern how most new animal food ingredients reach the market.
The evaluation, launched in August 2024, included soliciting public comments, conducting 14 external engagement sessions, holding internal CVM staff interviews and analyzing feedback across program areas. Participants in the listening sessions included animal food industry associations, state regulatory partners, industry consultants, consumers and animal food ingredient manufacturers. The evaluation sought input on how to better serve public health and improve the review process for new animal food ingredients.
According to the FDA summary, commenters valued the regulatory certainty and intellectual property protections of the FAP process, while the GRAS notification process was cited for offering a faster path to market and greater marketing flexibility. Stakeholders also highlighted pre-submission consultations with FDA as a valuable resource across both programs.
Four areas of concern
Stakeholder concerns centered on four areas:
- Confidentiality and disclosure: Uncertainty was expressed about what information would be disclosed, and when. Some stakeholders emphasized the importance of protecting confidential business information throughout the review process.
- Consistency: Apparent inconsistences between CVM and other FDA program areas created confusion about expectations.
- Predictability: Long and unpredictable review timelines were among the most frequently cited frustrations.
- Data requirements: Unclear or shifting expectations about what data and information are needed added to submitter burden and uncertainty.
Stakeholders also expressed interest in more structured, iterative engagement during GRAS Notice reviews and greater international harmonization, and raised questions about market exclusivity, risk-based review and recognition of foreign regulatory reviews.
Targeted process impovements
In response, FDA said it is implementing several targeted process improvements intended to deliver faster, more predictable outcomes for submitters while preserving the scientific rigor of its animal food reviews.
As part of these improvements, FDA issued CVM Program Policy and Procedures Manual (PPM) 1244.3425: Animal Food Generally Recognized as Safe (GRAS) Notice Evaluation Timeline.
The PPM describes the GRAS Notice evaluation process, outlines updates made to increase engagement with submitters and is intended to improve successful outcomes within the evaluation window. It also establishes a documented benchmark for when firms can expect requests and responses from FDA.
Other changes outlined in the summary include:
- Plain-language communication of disclosure and confidentiality requirements, developed with disclosure experts, for use in pre-submission conferences and other submitter meetings.
- Updated internal best practices and streamlined review documentation to improve consistency across reviewers and submissions.
- Earlier internal review timelines, so FDA can identify potential deficiencies and contact submitters sooner.
- A second amendment opportunity within the GRAS Notice evaluation process.
- Expanded data flexibility where scientifically appropriate, including extrapolation approaches such as building safety arguments across species, limiting utility data requirements to situations where they are needed and continuing to accept simplified chemistry, manufacturing and controls documentation, such as flow charts, narrative summaries and reference tables.
- Continued collaboration with the International Cooperation for the Convergence of Technical Requirements for the Assessment of Feed Ingredients (ICCF) to align standards internationally.
FDA said it will continue to monitor outcomes, seek feedback and refine its approach.
The FDA added that animal food stakeholders are encouraged to review the Summary: Evaluation of Pre-market Animal Food Ingredient Review Programs and Webinar: Evaluation of Pre-market Animal Food Ingredient Review Programs for a full account of public feedback, FDA's conclusions and details on how the process changes will affect animal food submissions.
