FDA Issues Final Guidance for Animal Food Additive GRAS Petitions
The U.S. Food and Drug Administration (FDA) has announced the availability of a final guidance for industry entitled “Pre-Submission Consultation Process for Animal Food Additive Petitions or Generally Recognized as Safe (GRAS) Notices.” The guidance provides uniform, consistent process information to industry to facilitate effective and efficient review of pre-consultation submissions for animal food additives or GRAS notices for intended use in animal food.
This level 1 guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115) and represents the current thinking of FDA on the pre-submission consultation process for animal food additive petitions or GRAS notices for intended use in animal food.
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