The purpose of this document is to provide guidance for industry on the requirements for a foreign supplier verification program (FSVP) in 21 CFR part 1, subpart L, that importers of human or animal food must establish and follow to ensure that each food they import into the United States meets applicable U.S. requirements and is not adulterated or (for human food) misbranded with respect to allergen labeling.

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities.  Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  

The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

This guidance provides questions and answers to facilitate importers’ understanding of the FSVP requirements.

Download the Draft Guidance

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Related Information

• FSMA Rule on FSVP for Importers of Food for Humans and Animals
• Additional FSMA Guidances

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Questions?

For questions regarding this draft document, contact the Office of Compliance, Center for Food Safety and Applied Nutrition (CFSAN), at 240-701-5986 (regarding human food), or the Office of Surveillance and Compliance, Center for Veterinary Medicine (CVM), at 240-402-6246 (regarding animal food).