Food Establishment Registration
The Bioterrorism Act of 2002 requires domestic and foreign facilities that manufacture, process, pack, or hold food for human consumption (including dietary supplements and dietary ingredients) in the United States to register with FDA. This registration requirement enables FDA to quickly identify and locate affected food processors and other establishments in the event of deliberate or accidental contamination of food.
The regulation requires the owner, operator, or agent in charge the food facility to register with FDA, provide information about the name and address at which, and all trade names under which, the registrant conducts business, and information about certain categories of food the facility produces. For a foreign facility, the registration must also include the name of the U.S. agent for the facility.
Registration is required for domestic facilities whether or not food from the facility enters interstate commerce. Domestic facilities are also required to provide emergency contact information. All changes to such information must be reported within 60 days.
Have questions about the registration requirements? We can help you file or we can do it for you.
When Must Your Facility Register
Facilities that go into business after December 12, 2003, must register before they begin
manufacturing/processing, packing, or holding operations.
How Often Your Facility Must Register
Registration is required only once for each food facility. However, if required registration information about your facility changes, you must update the registration.
Who May Register
The owner, operator, or agent in charge of a facility, or an individual authorized by one of them, may register that facility.
Foreign facilities must designate a U.S. agent, who lives or maintains a place of business in the U.S. and is physically present in the U.S., for purposes of registration. The U.S. agent may be authorized to register the facility.
What If Your Facility Fails to Register
Failure to register your facility, update required elements, or cancel registration in accordance with this regulation is a prohibited act under the Federal Food, Drug, and Cosmetic Act. The Federal government can bring a civil action against persons who commit a prohibited act, or it can bring a criminal action in Federal court to prosecute persons who are responsible for the commission of a prohibited act, or both.
If a foreign facility is required to register but fails to do so, food from that facility that is offered for import into the U.S. is subject to refusal. The food may be held within the port of entry, unless directed elsewhere by FDA or the Customs and Border Protection Service (CBP).