Owners, operators, or agents in charge of a domestic or foreign facility engaged in manufacturing/processing, packing, or holding food for consumption by humans or animals in the U.S., are required to register the facility with the FDA. The registration and renewal period is open between October 1 and December 31, 2024.
The FDA will consider the registration of a food facility to be expired if a facility’s registration is not renewed by December 31, 2024. There is no fee associated with registration or renewal. Owners, operators, or agents in charge of food facilities must submit their renewal information electronically through their FDA Industry Systems (FIS) account, unless they have received a waiver that allows for paper submission.
All facilities must include a unique facility identifier (UFI) recognized as acceptable to the FDA with the food facility registration (FFR) submission. The UFI is used to verify that the facility-specific address associated with the UFI is the same address associated with the facility’s registration. Currently, the FDA recognizes the Data Universal Numbering System (DUNS) number as an acceptable UFI. The DUNS number is assigned and managed by Dun & Bradstreet (D&B) and can be obtained or verified by visiting D&B’s website.
Food facility registration is critical to helping the FDA identify the location and possible source of a foodborne illness outbreak or potential bioterrorism incident. Food facility registration requirements were initiated with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and amended by the FDA Food Safety Modernization Act (FSMA) in 2011. FSMA requires facilities to submit additional information to the FDA and to renew their registrations every other year.
The following resources are available to assist in the registration and renewal process:
FFR Renewal:
- Food Facility Registration User Guide: Biennial Registration Renewal
- D&B + FDA Joint Web Presentation on Biennial Food Facility Registration Renewal (youtube.com)
FFR Guidance:
- Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Seventh Edition)
- Draft Guidance for Industry: Supplemental Questions and Answers Regarding Food Facility Registration
FFR User Guides:
- Food Facility Registration User Guide: Step-by-Step Instructions for Registration
- Food Facility Registration User Guide: Update Facility Registration
- Food Facility Registration User Guide: Summary of Fields
FIS User Guides:
- FDA Industry Systems: Create New Account Quick Start Guide
- FDA Industry Systems User Guide: Summary of Fields in Account Management
Food facilities with questions can contact the Data Management Support Services: by phone 1- 240-247-8804; or by email at FURLS@fda.gov on U.S. Government business days (Monday to Friday, excluding U.S. government holidays) from 9:00 a.m. to 6:00 p.m. Eastern Time (see Federal Holidays (opm.gov) and Current Status (opm.gov).
Posted in Dietary Supplements, FDA and USDA Regulatory Update, Foods.