Background

The Food and Drug Administration has made available a final guidance on how importers of food for humans and animals can comply with the requirements of the Foreign Supplier Verification Program. These include analyzing food hazards, evaluating a potential foreign supplier’s performance and the risk posed by a food, and determining and conducting appropriate foreign supplier verification activities. The guidance also addresses how importers can meet the modified FSVP requirements for importers of 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.

Changes to the draft guidance the FDA issued in January 2018 include clarification regarding the following.

- which foods are subject to the FSVP regulation

- what information must be included in the FSVP

- who may develop and perform FSVP activities

- what hazard analysis must be conducted

- what foreign supplier approval and verification activities must be conducted

- what requirements apply for importing a food for which the hazards will be controlled after importation

- how FSVP records must be maintained

- what FSVP requirements apply for imported dietary supplement components

- what FSVP requirements apply to very small importers or when importing food for certain small foreign suppliers

The FDA notes that because its 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 relating to the importation of all merchandise. However, these terms may have different meanings due to the different authorities implemented by the FDA and CBP, and the new guidance therefore clarifies these differences when relevant.

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