FDA Releases New Guidance on Foreign Supplier Verification Programs

SILVER SPRING, Md. —  FDA released new guidance for industry on Foreign Supplier Verification Programs for Importers of Food for Humans and Animals. 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.

In general, FDA’s guidance documents 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. The pronouns “I,” “me,” and “you” are used in this guidance to refer to the importer. “Agency” and the pronouns “we” and “our” are used to refer to FDA. The term “food” includes food for humans and animals and has the meaning given in section 201(f) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321(f)), except that, for the purposes of FSVP, “food” does not include pesticides as defined in 7 U.S.C. 136(u) (21 CFR 1.500). “Food” includes:

• Articles used for food or drink for man or other animals,
• Chewing gum, and
• Articles used for components of any such article.

Read the guidance here.