July 5, 2022

Volume XII, Number 186

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FDA Updates FSVP Guidance on UFI

  • On April 27, 2022, FDA issued updated guidance on the requirement, under the Foreign Supplier Verification Programs for Food Importers (FSVP) regulation, for food importers to ensure that each entry line of food offered for importation to the U.S. has an acceptable unique facility identifier (UFI) that is provided electronically when filing entry with the U.S. Customers and Border Protection. FDA has recognized the Dun & Bradstreet (D&B) Data Universal Numbering System (DUNS) number as acceptable for this purpose.

  • Previously, FDA issued a guidance that provided for the temporary use of the entity role code “UNK” (unknown) in place of a DUNS number. The policy was intended to be temporary, as FDA acknowledged that it was a new requirement and that some factors may have prevented importers from providing their UFI. This new guidance intends to update the previous one by removing the temporary policy that allowed for the use of the “UNK” code.

  • FDA now provides that importers have had “ample time” to familiarize themselves with the UFI requirements. As such, beginning on July 24, 2022, FSVP importers will no longer be permitted to use the code “UNK” and must instead ensure that a valid DUNS number is provided.

© 2022 Keller and Heckman LLPNational Law Review, Volume XII, Number 118
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About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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