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FDA finalizes guidance to expedite animal food additive petition, GRAS review processes

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Guidance to facilitate consultations between FDA and stakeholders.

The U.S. Food & Drug Administration has 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, said FDA.

Guidance #262, Pre-Submission Consultation Process for Animal Food Additive Petitions or Generally Recognized as Safe (GRAS) Notices, 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.

In fiscal year 2020, FDA’s Center for Veterinary Medicine (CVM) received new appropriation funding that has allowed the Division of Animal Feeds to ramp up its animal food ingredient review capabilities by expanding the team by hiring talented new reviewers from a variety of scientific disciplines, including biology, animal science, chemistry, toxicology and food technology. In addition, CVM has reorganized the Division of Animal Feeds to improve the timeliness, predictability, quality and consistency of the review process. With these improvements, CVM will be able to facilitate bringing safe new ingredients to market that improve the safety, quality, and nutritional value of animal food.

The guidance strongly encourages stakeholders to contact FDA’s Center for Veterinary Medicine early in the FAP or GRAS notice development process by emailing [email protected] Engaging with the agency while these submissions are still in progress allows stakeholders to discuss questions and concerns as they arise, and has the potential to improve the quality of FAP or GRAS notice submissions.

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