FDA issues final guidance for Foreign Supplier Verification Programs for importers of food for humans and animals, including dietary supplements

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FDA today issued final guidance for its Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals. The regulation is part of the FDA Food Safety Modernization Act (21 CFR Part 1, Subpart L), whose aim is to ensure that foreign food suppliers meet U.S. safety standards and that imported products are not adulterated (for human food) or misbranded regarding allergen labeling.

FDA’s final guidance outlines how importers should comply with FSVP requirements, including analyzing hazards in food, evaluating risks posed by the food, and how to conduct verification activities. This includes requirements for importers of dietary supplements. FDA guidance documents serve as the agency’s recommendations for actions but are not legally enforceable.

The guidance also clarifies FSVP regulations alongside regulations of the U.S. Customs and Border Protection. FDA states: “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, due to 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.”