The FDA has announced the availability of its final guidance, “Foreign Supplier Verification Programs for Importers of Food for Humans and Animals: Guidance for Industry.” The purpose of the document is to provide guidance for industry on the requirements for a foreign supplier verification program in 21 CFR part 1, subpart L, that importers of human or animal food must establish and follow to ensure each food they import into the U.S. meets applicable U.S. requirements and is not adulterated or (for human food) misbranded with respect to allergen labeling.
The guidance explains how to comply with the FSVP regulation, including, but not limited to, requirements to analyze the hazards in food, evaluate a potential foreign supplier’s performance and the risk posed by a food, and determine and conduct appropriate foreign supplier verification activities.
It also addresses how importers can meet the modified FSVP requirements for importing dietary supplements, very small importers, importers of food from certain small foreign suppliers, and importers of food from countries whose food safety systems the FDA has officially recognized as comparable or determined to be equivalent to that of the U.S.
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The guidance provides questions and answers to facilitate importers’ understanding of the FSVP requirements. The term “food” includes articles used for food or drink for people or animals, chewing gum, and articles used for components of any such item.
The document has been issued consistent with the FDA’s good guidance practices regulation. Companies can use an alternative approach, if it satisfies the requirements of the applicable statutes and regulations.
To obtain the guidance, go to https://www.fda.gov/FoodGuidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.
