FDA UFI food facility registration requirement
The Federal Food, Drug, and Cosmetic Act (FFDCA) requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with the FDA.1 The statute requires registration renewal to take place during the period of 1 October – 31 December of each even-numbered year.2 The FDA regulations promulgated under the FDA Food Safety Modernization Act (FSMA) require that starting 1 October 2020 facilities must provide a UFI when registering or renewing a registration,3 and that the FDA will not confirm a registration or renewal until the agency verifies the accuracy of the UFI.4
Extended enforcement discretion
The FDA recently announced that it would be extending enforcement discretion for the UFI requirement, giving facilities until 31 December 2022 to obtain and submit an UFI.5 This flexibility comes after the FDA received feedback from stakeholders expressing concern about obtaining a UFI before the conclusion of the 2020 renewal period. The extended enforcement discretion applies until the next biennial registration period which takes place 1 October – 31 December 2022.
Details on what FDA considers an acceptable UFI, how to obtain one, and how to register are available in the Constituent Update and Guidance for Industry.
If you have questions related to this or other matters, please do not hesitate to contact us.
1 21 U.S.C. 350d
2 21 U.S.C. 350d(a)(3)
3 21 CFR 1.232(a)(2)
4 21 CFR 1.231(a)(3), (b)(5)
5 Constituent Update: FDA Extends Flexibility for Unique Facility Identifier Requirement for Food Facility Registration through December 2022 (30 Mar. 2021), https://www.fda.gov/food/cfsan-constituent-updates/fda-extends-flexibility-unique-facility-identifier-requirement-food-facility-registration-through; Guidance for Industry: Enforcement Policy for Providing an Acceptable Unique Facility Identifier (UFI) for the 2020 Food Facility Registration Biennial Renewal Period (Mar. 2021), https://www.fda.gov/media/143997/download.
Authored by Joseph Levitt and Mary Lancaster.