FDA Food Registration Regulations
The U.S. Food and Drug Administration (US FDA) ensures that food sold in the United States is safe, wholesome, and properly labeled. This applies to food produced domestically and food from foreign countries. The Federal Food, Drug, and Cosmetic Act (FD and C Act) and the Fair Packaging and Labeling Act are the Federal laws governing food products under US FDA jurisdiction.
FDA Food Registration - US FDA Food Facility Registration Requirements
The Bioterrorism Act requires US FDA registration for domestic and foreign food facilities that manufacture, process, pack, or hold food for human or animal consumption in the U.S. Owner, operator, or agent in charge of domestic or foreign food facility is required to register their facility with the US FDA. Domestic facilities require FDA registration whether or not food from the facility enters interstate commerce. Foreign food facilities that manufacture/process, pack, or hold food also require US FDA registration unless food from that facility undergoes further processing (including packaging) by another foreign food facility before the food is exported to the U.S. However, if the subsequent foreign food facility performs an only minimal activity, such as putting on a label, both food facilities require US FDA registration. Acidified and law-acid food manufacturers also require FDA food canning establishment (FCE) registration. The dietary supplement manufacturers also require US FDA registration.
The new FDA Food Safety Modernization Act (FSMA)
The US FDA food facility registration was a one-time registration process till FY 2012. The new FDA Food Safety Modernization Act (FSMA) requires Biennial Registration Renewal for domestic and foreign Food Facilities. Previously registered facilities should renew the registration between October 1 and December 31 of each even-numbered year starting from 2012. If any of the mandatory information in the registration changes, the registered food facility must update the registration within 60 days with US FDA. If the facility stops or ceases its operation, the registered food facility must cancel the US FDA registration within 60 days. Previously registered food facilities that do not have US FDA registration information do not require re-registration. Such facilities can contact US FDA to obtain registration information. Every foreign food facility must have a US FDA Agent who acts as the domestic communications representative. Foreign facilities must provide the US FDA agent information at the time of FDA registration and update the FDA registration information if the facility changes the US FDA agent.
The food facility registration and prior notice help the US FDA with information on the origin and distribution of food products, thereby detecting and quick response to actual or potential threats to the U.S. food supply. Registration information also helps US FDA to notify the food establishment that may be affected by the actual or potential threat. The US FDA registration statistics show a total of 208,034 food facility registrations, out of which 87,729 are domestic registrations and 120,305 are foreign registrations, as of March 2, 2023.
Liberty Management Group assists in US FDA food facility registration and helps to comply with FDA bioterrorism act requirements. LMG also provides US FDA Agent service for foreign food facilities. Please note US FDA does not issue a certificate of registration, nor does the US FDA recognize a registration certificate issued by a third party, but the US FDA issue a registration number for each registered food facility; the FDA registration number does not denote the US FDA approval of the facility.
DUNS Number Requirements - FAQ
- FDA food facility registration assistance
- Food Labeling Review
- US FDA Agent service for foreign food facilities
- FCE registration assistance
FDA Registration & U.S. Agent
USD 349 (Annually)
FCE Registration Assistance
Food / Supplement Label Review
USD 649 / Product