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FDA's Draft Guidance on Animal Food Additive Petitions Includes Section on Packaging

The U.S. Food and Drug Administration's (FDA) Center for Veterinary Medicine (CVM) has released a draft guidance document on the preparation and submission of animal food additive petitions (FAPs). The Guidance for Industry Recommendations for Preparation and Submission of Animal Food Additive Petitions, while not binding, provides recommendations on the type of information that should be included in FAPs for food additives intended for use in animal food. Specific recommendations related to packaging are provided in Section C.2(a) ("Manufacturing methods and controls") of the draft guidance document. The document is intended to facilitate submission of data in accordance with Section 409 of the Federal Food, Drug, and Cosmetic Act and 21 C.F.R. Part 571.

The draft document was posted on FDA's website on September 10, 2013, and is available for comment until November 9, 2013. Comments made after the November 9 deadline will continue to be accepted, but may not be reflected in a revised guidance document. Comments may be submitted online at or mailed to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.