By David Fairfield, Senior Vice President, Feed
The U.S. Food and Drug Administration (FDA) on Dec. 10 finalized guidance to facilitate consultations between FDA and ingredient sponsors before 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 is submitted to the agency.
Guidance #262, Pre-Submission Consultation Process for Animal Food Additive Petitions or Generally Recognized as Safe (GRAS) Notices, provides information about the animal FAP and GRAS notification processes and pre-submission consultations. The guidance also contains recommendations associated with establishing investigational food additive (IFA) files – a voluntary process initiated by ingredient sponsors whereby confidential data, ideas, and information associated with an FAP or a GRAS notice may be exchanged with FDA.
The guidance strongly encourages ingredient sponsors to contact FDA’s Center for Veterinary Medicine (CVM) early in the FAP or GRAS notice development process by emailing Animalfoodfirstname.lastname@example.org. FDA states engaging with the agency while submissions still are in progress allows ingredient sponsors to discuss questions and concerns as they arise, and has the potential to improve the quality of FAP or GRAS notice submissions.
In fiscal year 2020, CVM received new appropriation funding supported by NGFA that has allowed its Division of Animal Feeds to expand its animal food ingredient review capabilities by hiring new personnel. In addition, CVM has reorganized the Division of Animal Feeds with the goal of enhancing the timeliness, predictability, quality and consistency of the review process.
The following is additional information related to FDA’s approval of ingredients for use in animal food.
- Food Additive Petitions for Animal Food
- Generally Recognized as Safe (GRAS) Notification Program
- Current Animal Food GRAS Notices Inventory