FDA Issues Updated Guidance on Compliance and Date for Providing an Acceptable Unique Facility Identifier (DUNS number) for the Foreign Supplier Verification Programs
April 27, 2022
Today, the FDA issued an updated guidance for industry, Compliance with Providing an Acceptable Unique Facility Identifier for the Foreign Supplier Verification Programs for Food Importers Regulation. The updated guidance replaces the temporary policy put in place with the March 2018 guidance of the same name, by stating that beginning on July 24, 2022 the use of the entity identification code “UNK” will no longer be an option when filing an entry with U.S. Customs and Border Protection (CBP).
The guidance provides information to human and animal food importers on requirements under the Foreign Supplier Verification Programs for Food Importers (FSVP) regulation. The FSVP regulation requires that each entry line of food imported to the U.S. is accompanied by identification information about the FSVP importer. This information is provided electronically when filing entry with CBP and includes the unique facility identifier (UFI) recognized as acceptable by the FDA. The UFI currently recognized as acceptable by FDA for importer identification is a Dun & Bradstreet (D&B) Data Universal Numbering System (DUNS) number.
The March 2018 version of the guidance for industry provided for the temporary use of the identity code UNK (unknown), in lieu of a DUNS number. Beginning July 24, 2022, the temporary policy will no longer be in place – meaning that FSVP importers will be required to ensure that they are in compliance with the FSVP regulation by providing their valid 9-digit DUNS number in the Entity Number field. The new guidance also provides information to FSVP importers who may have multiple DUNS numbers.
The FSVP regulation requires that for each line of food offered for entry into the U.S., FSVP importers must ensure that their name, email address, and a UFI recognized as acceptable by the FDA (currently, the DUNS number), are provided electronically when filing entry with CBP. When the change is in effect, electronic entry submissions containing “UNK” in the Entity Number field will be rejected by CBP’s electronic import system.
An FSVP importer may obtain a DUNS number from D&B free of charge. It may take approximately 30 business days or longer to receive a DUNS number from D&B after submitting a request. D&B also provides for expedited delivery of a DUNS number for a one-time charge. To obtain a DUNS number, please contact D&B directly by phone at 866-705-5711 or at https://www.dnb.com/duns-number/get-a-duns.html. An FSVP importer with an existing DUNS number does not need to obtain a new DUNS number.
The FDA will provide notification to FSVP importers through updated guidance if there are changes, including if the agency recognizes additional UFIs as acceptable in the future.
For questions about import entry data requirements, please contact FDA’s Division of Import Operations via email at FDAImportsInquiry@fda.hhs.gov.
For technical questions related to the FSVP regulation, please contact the FSMA Technical Assistance Network (TAN) at FSMA TAN to submit your questions electronically.
For More Information
- Guidance for Industry: Compliance with Providing an Acceptable Unique Facility Identifier for the Foreign Supplier Verification Programs for Food Importers Regulation
- FSMA Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals