On September 22, 2026, FDA’s Center for Veterinary Medicine announced several changes intended to make the review of animal-food ingredient submissions faster, more transparent, and more predictable.

The agency released CVM Program Policy and Procedures Manual 1244.3425, which establishes target milestones for reviewing animal-food GRAS notices. FDA also published a summary of its evaluation of the animal Food Additive Petition and GRAS Notification programs.

These actions do not change the legal standard for determining whether an animal-food ingredient is generally recognized as safe. They do, however, provide important new information for planning submissions and responding to FDA questions.

New Animal-Food GRAS Review Milestones

FDA’s target review process now includes:

• Within 30 days after receipt: Administrative pre-filing review;
• Day 1: Notice is formally filed and scientific review begins;
• Day 75: Internal reviewer meeting;
• Approximately day 90: First round of FDA questions sent to the notifier;
• Approximately day 104: Target date for the notifier’s first amendment;
• Approximately day 134: Second round of questions, if needed;
• Approximately day 148: Target date for a second amendment, with no extension contemplated;
• Day 180: FDA may issue a 90-day extension letter;
• Approximately day 215: Target response when no second amendment is required; and
• Day 270: Target response when a second amendment is submitted.

Most of these milestones are internal FDA process goals rather than legally binding deadlines. The underlying regulation continues to provide for a 180-day review period, which FDA may extend by 90 days.

A Second Amendment Opportunity

One of the most meaningful changes is the addition of a second amendment opportunity during the review.

Previously, animal-food GRAS notifiers had limited opportunities to resolve substantive questions within the review period. If significant issues remained, the notifier could face a “cease to evaluate” letter and need to revise and resubmit the notice.

The additional amendment cycle should allow FDA and the notifier to address remaining scientific or technical questions without immediately ending the review. However, the timeline is compressed. A notifier may have only about two weeks to prepare each amendment, and FDA states that no extension will be granted for the targeted second-amendment deadline.

Companies should therefore anticipate likely questions before filing and keep scientific experts, laboratories, manufacturers, and regulatory personnel available during the critical review period.

Greater Flexibility in Supporting Data

FDA also described several changes intended to reduce unnecessary submission burdens where scientifically appropriate. These include:

• Greater use of safety-data extrapolation across animal species;
• Limiting utility or efficacy data to circumstances in which those data are genuinely needed;
• Accepting simplified Chemistry, Manufacturing, and Controls presentations, including flowcharts, narrative summaries, and reference tables; and
• Identifying potential deficiencies earlier so that submitters have more time to respond.

These statements should not be interpreted as eliminating the need for a complete dossier. Ingredient identity, manufacturing controls, specifications, batch analyses, stability, intended use, exposure, target-animal safety, and supporting scientific evidence must still be adequate to establish safety under the proposed conditions of use.

The level of support will continue to depend on the ingredient, animal species, life stage, use level, duration of exposure, and available safety information.

Practical Implications for Filing Strategy

Companies preparing animal-food GRAS notices should consider the following:

1. Use a pre-submission meeting to clarify FDA expectations for safety studies, species extrapolation, utility data, CMC documentation, and confidential information.
2. Conduct a mock FDA review before filing to identify likely questions.
3. Prepare potential amendment materials before the first FDA information request arrives.
4. Reserve scientific and management resources during approximately days 85 through 150.
5. Ensure laboratories and manufacturers can respond quickly to requests for methods, raw data, batch records, or revised specifications.
6. Treat the published milestones as planning targets, not guaranteed FDA response dates.

The new process should improve predictability and may reduce unsuccessful reviews for well-prepared notices. Its practical benefit, however, will depend on the notifier’s ability to respond rapidly and completely.

EZFDA Consulting supports animal-food ingredient developers with regulatory-pathway assessments, GRAS notices, food-additive petitions, exposure calculations, safety-data strategies, pre-submission meetings, and responses to FDA questions.