The US Food and Drug Administration issued its guidance to industry for preparation and submission of food additive petitions. The FDA Guidance for Industry document 221 is titled, Recommendations for Preparation and Submission of Animal Food Additive Petitions.
The document urges early and regular contact with FDA's Center for Veterinary Medicine, including pre-petition consultations and consultations to address issues related to target animal safety studies. It also recommends any Food Additive Petitions include a proposed regulation with information to ensure the additive's safety under all conditions of use.
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