The Food Safety Modernization Act (FSMA) requires all food facilities (including most breweries) to register with the Food and Drug Administration (FDA) and complete a biennial renewal. The latest biennial registration renewal period ended on December 31, 2020. However, the FDA had previously allowed facilities more time to obtain and submit a unique facility identifier (UFI) with their registration submission, a requirement that began during the 2020 biennial registration renewal period. Now the FDA is further extending the time period to obtain and submit a UFI until December 31, 2022.
To determine if your brewery is required to register, consult the Brewers Association FDA Registration & Food Safety Modernization Act (FSMA) Compliance Flow Chart.
There is no fee for renewal, but failure to register is a prohibited act under the Food, Drug, and Cosmetic Act (FD&C Act). The FDA has developed a renewal overview and a step by step guide to facilitate compliance. New in 2020, breweries are required to provide a Unique Facility Identifier (UFI) during registration and renewals. This additional piece of information are required for submissions beginning in October 2020. FDA guidance documents published to date state that the only UFI format currently accepted by the FDA is the Data Universal Numbering System (DUNS©). This is a service administered by a private firm, Dun and Bradstreet, and is provided free of charge. If the FDA decides to accept other UFI formats, it will update its guidance accordingly.
The FDA understands that for some, a DUNS number has remained difficult to obtain. The FDA will allow registrants to enter “PENDING” in the UFI field of their registration if they have not obtained a DUNS number. The FDA also does not intend to cancel any registrations for facilities with UFIs that cannot be verified at this time. Food facilities that would like FDA to consider the use of an alternative identifier other than DUNS or that have questions about registration can contact the FDA Unified Registration and Listing System (FURLS) Helpdesk: by phone 1-800-216-7331 or 240-247-8804; or by email at FURLS@fda.gov.