Under the FDA Foreign Supplier Verification Program (FSVP) rule, most U.S. importers must develop FSVP plans to provide adequate assurances that their foreign suppliers are producing food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 418 (Hazard Analysis and Risk-based Preventive Controls) or section 419 (Standards for Produce Safety) of the U.S. Food, Drug, and Cosmetic Act.
The FDA this week issued the final guidance for the “Foreign Supplier Verification Programs for Importers of Food for Humans and Animals.” The FSVP is a regulation under the foundational FDA Food Safety Modernization Act, that makes importers accountable for verifying that foreign suppliers are producing food in a manner that meets U.S. safety standards.
The purpose of the final guidance is to provide direction to the 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.[1] The pronouns “I,” “me,” and “you” are used in this guide 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.
Because FDA’s FSVP regulations pertain to the importation of human and animal food, they contain several terms that are similar or similar-sounding to those also used by U.S. Customs and Border Protection (CBP) relating to the importation of all merchandise. However, because of the different authorities implemented by FDA and CBP, these terms may have different meanings. Where relevant, this guidance clarifies these differences in certain Questions and Answers. For guidance from CBP on basic importing and exporting, see Basic Importing and Exporting | U.S. Customs and Border Protection (cbp.gov).
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