Must Dietary Supplement Register with FDA?
The US Bio-terrorism Act demands all firms dealing with food for human or non-human consumption in the US, to have FDA registration. Dietary supplements are regulated as food products and therefore must comply with the registration requirements under the Bioterrorism Act.
Domestic and Foreign companies are required by law to register the facility with FDA for manufacturing, processing, holding or packing dietary supplements. Foreign facilities are also required to register with the FDA, unless food products from the facility undergoes 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 origin and distribution of dietary supplement products within the US.
Every foreign dietary supplement firm is required to have a US 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 a FDA Registration number.
FDA dietary supplement registration must be renewed every even numbered year. Therefore, if a dietary supplement facility registers for the first time in an even numbered year, the renewal will not occur until two years later. However, if the dietary supplement 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.