The Food and Drug Administration has terminated its temporary enforcement discretion allowing filers to select the “pending UFI option” for food facility registrations.
Foreign and domestic facilities that manufacture, process, pack, or hold food for human or animal consumption in the U.S. must obtain and submit a unique facility identifier with their registration submissions. The requirement to include a UFI applies to both new facilities registering for the first time and those submitting a registration renewal.
The FDA currently recognizes only the DUNS number as an acceptable UFI for food facility registration. Because a DUNS number has been difficult for some to obtain, the FDA had allowed registrants to enter “PENDING” in the UFI field of their registration if they had not obtained one.
However, apparently having determined that there has been sufficient time for facilities to obtain a DUNS number, effective March 10 the FDA started notifying foreign and domestic facilities that food facility registrations without an accurate UFI will be canceled.
As a result, the FDA will no longer confirm registrations or provide facilities with a registration number until it verifies the accuracy of their facility's UFI and verifies that the facility-specific address associated with the UFI is the same address associated with the registration.
If the FDA determines that a foreign food facility is not registered, the food being imported or offered for import into the U.S. from that facility is subject to being held at the port of entry unless U.S. Customs Border Protection concurrence is obtained for the export and the food is immediately exported from the port of arrival. Food held in this circumstance must not be entered and must not be delivered to the importer, owner, or ultimate consignee until the foreign facility is registered appropriately. The FDA ordinarily will not allow the food to be transferred by any person from the port of entry into the U.S. or from the secure facility.
For more information on this and other FDA issues, please contact FDA consultant Domenic Veneziano at (202) 734-3939 or via email.
This article was originally published in the Sandler, Travis & Rosenberg Trade Report on March 29, 2023.