The U.S. FDA is requiring all non-exempt domestic and foreign food facilities to renew their registrations between 1 October 2022 and 31 December 2022.
The United States FDA, consistent with the Bioterrorism Act’s mandate to take steps to prevent terrorist attacks and/or emergencies involving the food supply of the United States, established regulations requiring the registration of food facilities, the giving of advance notice for shipments of imported food, and, in defined contexts, the appointment of a U.S. agent for the purpose of facilitating communication. The registration requirement applies, on a pre-commencement of operations basis, to non-exempt owners, operators, or agents in charge of either a domestic or foreign facility that is engaged in manufacturing/processing, packing, or holding food for human or animal consumption in the U.S. (21 CFR 1.226 exempts, in general terms, farms, retail food establishments, restaurants, non-profit food establishments, fishing vessels, and USDA-regulated facilities). There are currently 220,586 food facilities registered with the FDA. Approximately 42% of these registrations correspond to foreign food facilities (with registration concentrations in Canada, Mexico, France, Italy, Japan, and China). The Food Safety Modernization Act expanded on this regulatory foundation by requiring the biennial (i.e., in every even-numbered year) renewal of food facility registrations.
In line with the biennial timing dynamic, 2022 is a food facility registration renewal year. To this end, the FDA is requiring all non-exempt food facilities to renew their registrations between 1 October 2022 and 31 December 2022. Most food facility registrations must, per recently updated FDA requirements, be completed electronically using the Firm Establishment Identifier (FEI) and FURLS Food Facility Registration (FFR) portals. An FDA Industry System (FIS) account is required to access program resources. In completing the renewal process, food facilities will have the opportunity to edit certain elements of the information provided under 21 CFR 1.232 at the time of the original registration. Importantly, renewing food facilities are required to furnish a Unique Facility Identifier (UFI). The only facility identifier the FDA recognizes in this connection is the Data Universal Numbering System (DUNS) number assigned and managed by Dun and Bradstreet. Renewing food facilities can obtain and verify DUNS numbers here. DUNS numbers corresponding to a food facility’s actual location (as opposed to that of a food facility’s corporate headquarters) must be in place by the close of the renewal period. In what constitutes a break from prior practice, renewing food facilities will no longer be permitted to satisfy this requirement by specifying a “pending” status. Similarly, the FDA requires that information and identifiers exactly match across its systems and portals. There is no fee or cost to renew a food facility registration. Additional FDA guidance on the registration renewal process can be accessed here.
Food facility registrations that are not timely renewed will be deemed expired by the FDA (and removed from a registrant’s account pursuant to a cancelation action). The FDA can, in turn, consider expired registrations as a failure to register. The foregoing are prohibited acts under the Food, Drug, and Cosmetic Act that can, under certain circumstances, open the door to debarment and/or a judicial (civil or criminal) referral. Foreign food facilities that fail to timely renew registrations will have their imported food products denied entry and held, pending registration, either at the port or a secure facility. Domestic food facilities that fail to timely renew registrations will, on the other hand, be prohibited from exporting their food products. Parties who seek to avoid the disruptions and costs which flow from non-compliance with the requirements of the aforementioned laws and regulations should act now to ensure that the domestic and foreign food facilities in their supply chains timely renew all FDA registrations during the forthcoming renewal period.