The US Bioterrorism Act demands all firms dealing with food for human or non-human consumption in the US, to have FDA registration. Irrespective of the facilities being domestic or foreign, they are required by law to register the facility with FDA for manufacturing, processing, holding, or packing nourishment for consumption. FDA registration includes dietary supplements and food contact substances.
FDA food facility registration is necessary for all domestic facilities. Foreign facilities are also required to register with the FDA, unless food products from the facility undergo subsequent processing by another foreign firm, before being exported to the US. However, if the processing done by the second foreign firm is of a minimal nature, such as labeling, both firms require FDA registration.
FDA registration provides FDA with data on the origination and distribution of food products within the US. This aids in the detection of and quick response to real or possible threats to the food supply. Information from FDA registration also allows FDA to notify the firm that may be the cause of the real or possible threat.
Every foreign food firm is required to have an agent who interacts with the FDA, and serves as the representative for domestic communications for the firm. Although FDA does not issue certificates of registration, the registered firm does get an FDA Registration number.
FDA food registration must be renewed every even-numbered year. Therefore, if a food facility registers for the first time in an even-numbered year, the renewal will not occur until two years later. However, if the food facility registers for the first time in an odd-numbered year, the first renewal will take place the following year, which will be an even-numbered year, with each subsequent renewal occurring every two years, always on even-numbered years.
Our firm provides assistance towards enrollment with FDA Registration and compliance with FDA Bioterrorism act requirements. We also offer FDA Agent service for FDA registration purposes.