FDA Finalizes Guidance to Help Improve and Expedite Animal Food Additive Petition and GRAS Notice Review Processes

Today the U.S. Food and Drug Administration finalized guidance to facilitate consultations between FDA and stakeholders before the submission of an animal food additive petition (FAP) or a notice concluding that a substance is generally recognized as safe (GRAS) for its intended use in animal food to the agency. Pre-submission consultations are intended to help stakeholders comply with the applicable requirements for an FAP or a GRAS notice, making the submission process more efficient and effective, and facilitating the introduction of safe new products onto the market.

Guidance #262 provides non-binding recommendations for submissions to investigational food additive (IFA) files, use of foreign data in a submission, describing circumstances under which the submission of study protocols is recommended, an explanation of FDA’s review process for IFA submissions, and best practices for communication between FDA and stakeholders regarding these regulatory submissions.

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