CSMS # 55593773 - FDA Food Facility Registration Update: Temporary Enforcement Discretion for Pending Unique Facility Identifiers (UFI) No Longer Available

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CSMS # 55593773 - FDA Food Facility Registration Update: Temporary Enforcement Discretion for Pending Unique Facility Identifiers (UFI) No Longer Available

FDA’s temporary enforcement discretion that provided the option to select the “Pending UFI Option” for Food Facility Registrations has been terminated.

In accordance with the requirements under 21 Code of Federal Regulations (CFR) §1.231(a)(3), FDA will not confirm your registration or provide you with a registration number until FDA verifies the accuracy of your facility's UFI and verifies that the facility-specific address associated with the UFI is the same address associated with your registration.

If FDA determines that a foreign food facility is not registered in accordance with title 21 CFR §1.231(a)(3), the food being imported or offered for import into the United States from the foreign facility is subject to being held at the port of entry in accordance with section 801(l) of the FD&C Act, unless U.S. Customs Border Protection (CBP) concurrence is obtained for the export of the food 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. 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.

Background

Title 21 CFR 1.231(a)(3) requires facilities to provide a UFI recognized as acceptable by FDA. Currently, FDA recognizes the Data Universal Numbering System D-U-N-S (DUNS) as an acceptable UFI.

October 2020, guidance was issued, and firms were provided enforcement discretion on this requirement to allow sufficient time to obtain DUNS numbers.

March 10, 2023, FDA started notifying foreign and domestic facilities that Food Facility Registrations (FFR) without an accurate Unique Facility Identifier (UFI) will be canceled.

For questions, contact FDA Industry Systems/ FDA Unified Registration and Listing Systems (FURLS)/ Technical Help at 1-800-216-7331 or 1-240-247-8804 between email 9 AM-6PM Eastern Time. Alternatively, you can email FURLS@fda.gov.

For information on obtaining a DUNS number, see the Import Safety Lookup Portal User Guide.

For questions regarding Prior Notice, or with perishable shipments, please contact the FDA's Division of Food Defense Targeting (DFDT). The DFDT can be reached 24/7/365 at (866) 521-2297 or prior.notice@fda.hhs.gov

For ACE inquiries, FDA ACE Support can be reached from 8 a.m. to 8 p.m. ET, Monday-Friday (excluding federal holidays) at ACE_Support@fda.hhs.gov.

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