FDA’s FSVP regulations require certain information regarding the FSVP importer to be declared at entry to the U.S. Specifically, the FSVP importer’s name, email address, and “unique facility identifier [(UFI)] recognized as acceptable by FDA” (i.e., DUNS number) must be declared.1 FDA uses this information to identify who has responsibility for FSVP for the line entry. After FSVP first went into effect, FDA issued guidance instituting a temporary policy that allowed importers to input “UNK” (unknown) as their UFI, in lieu of providing a DUNS number.2 FDA provided this temporary flexibility for importers that may have been unable to obtain a DUNS number or that needed additional time to identify who the importer would be for purposes of FSVP compliance.
FDA recently issued updated guidance that rescinds the temporary policy that permits the declaration of “UNK” in lieu of identifying the FSVP importer.3 The agency explains that it is changing its policy because importers have now had time to familiarize themselves with the FSVP requirements.
Starting on July 24, 2022, food importers must provide a valid, 9-digit DUNS number in the Entity Number field for each line entry of food. CBP will reject entry of food subject to FSVP if the line entry does not list the importer’s DUNS number. The updated guidance does not affect importers that are exempt from FSVP regulation and use an appropriate Affirmation of Compliance code to signal this in lieu of providing a DUNS number.
Next steps
Companies will want to conduct a review of their food imports to evaluate whether any action needs to be taken for entries that use the “UNK” code. Please do not hesitate to contact us if you have any questions related to FSVP compliance.
Authored by Elizabeth Fawell, Maile Gradison, and Connie Potter.
References
1 21 CFR § 1.509(a). FDA accepts Dun & Bradstreet Data Universal Numbering System (DUNS) numbers as the UFI.
2 See Action Required: FSVP Implementation Triggers New Data Entry Requirements for All Imported FDA-Regulated Foods on May 30, 2017, Hogan Lovells (May 11, 2017), available here.
3 Compliance with Providing an Acceptable Unique Facility Identifier for the Foreign Supplier Verification Programs for Food Importers Regulation: Guidance for Industry, FDA (April 2022), available here.
