Registration and “U.S. Agent” Appointments for Foreign Food Facilities
The FDA requires all domestic and foreign facilities that manufacture, process, pack, or hold food or beverages, for importation or distribution in the United States to register with the FDA. Any imported foods or imported beverages not in compliance with FDA’s food facility registration requirements may be refused by FDA or CBP.
Foreign food facilities must also designate a U.S. Agent when registering their food facility with the FDA. The U.S. Agent is a person or entity located within, or that maintains an office, in the United States. The U.S. Agent plays the role of the domestic representative for the foreign facility through which all communication with the FDA takes place.
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 the year 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.
The registered food facility must cancel the U.S. FDA registration within 60 days, if the facility stop or ceases the operation. Previously registered food facilities that does not have U.S. FDA registration information does not require re-registration such facilities can contact U.S. FDA to obtain registration information. Every foreign food facility must have a U.S. FDA Agent who acts as the domestic communications representative for that facility. Foreign facilities must provide the U.S. FDA agent information at the time of FDA registration, and must update the FDA registration information if the facility changes the U.S. FDA agent.
The Bio-terrorism Act requires U.S. 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. JAD Regulatory Consultants were trained and certified by the FDA on the Bio-terrorism Act.
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