FDA Releases Updated Guidance for Foreign Suppliers Importing Food Goods into the United States

Beginning July 24 the Food and Drug Administration (FDA) will end its policy of allowing the entity identification code (or UNK) number to be used in place of the Data Universal Numbering System (or DUNS) on entry forms for foreign supplier verification program importers. 

This guidance provides information on the requirement under the Foreign Supplier Verification Programs for Food Importers (FSVP) regulation for the importer of a food to ensure that for each entry line of food offered for importation into the United States the unique facility identifier (UFI) recognized as acceptable by FDA for importer identification is provided electronically when filing entry with U.S. Customs and Border Protection (CBP). The UFI initially recognized as acceptable by FDA for importer identification is a Dun & Bradstreet (D&B) Data Universal Numbering System (DUNS) number. The pronoun “you” is used in this guidance to refer to the FSVP importer as defined in the FSVP regulation (21 CFR 1.500).

This guidance replaces FDA’s “Compliance with Providing an Acceptable Unique Facility Identifier for the Foreign Supplier Verification Programs Regulation: Guidance for Industry” issued March 2018.  

The March 2018 guidance provided for the temporary use of the entity role code “UNK” (to represent “unknown”) in lieu of a DUNS number, to be provided in the Entity Number field for importer identification when filing entry with CBP for a food subject to FSVP.  FDA explained that while the agency expected all importers to provide their UFI in accordance with 21 CFR 1.509(a), the agency recognized that this was a new requirement and some factors may have prevented importers from doing so.  Therefore, FDA provided that for FSVP importers temporarily unable to obtain a DUNS number, FDA intended to allow filers to transmit the value “UNK” in the UFI field for the FSVP importers.   

Needs and circumstances have changed since FDA announced its temporary policy, as FSVP importers have now had ample time to familiarize themselves with the requirements in 21 CFR 1.509(a).  Accordingly, beginning on July 24, 2022, FSVP importers must comply with the requirement in 21 CFR 1.509(a) of providing a unique facility identifier recognized as acceptable by FDA when filing entry with CBP.  This guidance also provides additional information for what importers should do when they have multiple DUNS numbers.

Consistent with 21 CFR 1.509(a), the FSVP importer will be required to ensure that their valid, 9-digit DUNS number is provided in the Entity Number field.  CBP will reject an entry line of a food subject to the FSVP regulation when the importer’s DUNS number is not provided in the Entity Number field.

For more information, visit the FDA website at https://www.fda.gov/