ANIMAL FOOD GRAS REGULATORY UPDATE
FDA Publishes Animal Food GRAS Review Timeline: Key Milestones for Ingredient Firms
On September 22, 2026, FDA’s Center for Veterinary Medicine (CVM) published its first timeline for reviewing animal food Generally Recognized as Safe (GRAS) notices in PPM 1244.3425. The timeline sets target milestones for FDA questions, company amendments, and response letters. It gives ingredient firms a clearer basis for planning, but does not create new binding deadlines or guarantee a shorter review; the statutory review period remains 180 days and may be extended by 90 days.
Issued: September 22, 2026 180 days, with a possible 90-day extension Animal food GRAS notices
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How FDA’s animal food GRAS review timeline works
FDA’s new schedule, set out in PPM 1244.3425, describes target milestones for the agency’s review of animal food GRAS notices. FDA aims to complete its administrative pre-filing evaluation within 30 days of receiving a notice. If FDA accepts the notice for filing, the filing letter date is Day 1. The schedule counts days as calendar days.
Day 75: FDA targets an internal reviewer meeting.
Day 90: FDA targets sending its first questions to the notifier.
Day 104: The target date for the notifier’s first amendment. FDA may allow an occasional extension of about one week.
Day 134: FDA targets a second round of questions, if needed.
Day 148: The target date for a second amendment, if requested; FDA does not plan to grant extensions for this amendment.
Day 215 or Day 270: FDA targets issuing its response letter, depending on whether a second amendment is submitted.
These are program targets, not a guarantee that FDA will meet every milestone or issue a favorable response. The statutory review period is 180 days from filing and may be extended by 90 days under 21 CFR 570.265(b). Companies should distinguish that statutory period from the internal target dates in the PPM.
Other changes to animal food ingredient reviews
CVM’s review also describes a more interactive process, including earlier engagement with notifiers and a second opportunity to amend a notice when needed. FDA also indicated that it may accept different types of information where scientifically appropriate. Depending on the notice, this may include cross-species safety arguments, utility data when needed to address safety, or simplified chemistry, manufacturing, and controls (CMC) documentation. The scientific basis for a GRAS conclusion remains essential.
The PPM is distinct from FDA’s August 2026 proposed rule on GRAS oversight for human and animal food. That rule remains a proposal; it should not be treated as a final requirement.
Impact and actionable advice for global companies
For international ingredient manufacturers and suppliers seeking access to the U.S. animal food market, the timeline makes the expected review stages more visible. It also puts a premium on having technical teams ready to respond promptly to FDA questions and prepare amendments within the target windows.
Companies preparing a notice should consider the following steps:
Confirm the appropriate regulatory pathway. Assess whether a GRAS notice is appropriate for the ingredient and intended conditions of use. FDA’s Guidance for Industry #262 describes CVM’s pre-submission consultation process.
Plan backward from the filing date. Build internal review and decision deadlines around the Day 90, Day 104, Day 134, and Day 148 targets, allowing time to coordinate scientific, regulatory, and legal input.
Organize the supporting evidence. Prepare information on ingredient identity, manufacturing, specifications, impurities, intended use, exposure, and animal safety. For ingredients used in food-producing animals, assess whether human food safety data are also relevant.
Set response owners and escalation routes. Assign responsibility for monitoring FDA correspondence, evaluating questions, and approving amendments so the company can respond within the applicable target window.
Review disclosure considerations. Understand confidentiality limits and how submitted information may be treated in FDA’s animal food GRAS notice inventory.
Companies assessing whether a substance is used in animal food or human food should also review the differences between the relevant pathways. REACH24H’s overview of FDA GRAS requirements for feed and food provides further context.
How REACH24H Can Help
REACH24H supports companies evaluating U.S. market-entry pathways for animal food ingredients, including FDA GRAS, Animal Food Ingredient Consultation (AFIC), and AAFCO Scientific Review of Ingredient Submissions (SRIS). Our team can help assess pathway options, organize technical evidence, and plan regulatory submissions across markets while accounting for each pathway’s distinct requirements.
Contact REACH24H’s regulatory specialists to discuss your animal food ingredient’s U.S. market-entry strategy.
