FDA Dietary Supplement Facility Registration and US Agent Requirement

In 2011, the FDA Food Safety Modernization Act (FSMA) amended U.S. food safety laws, requiring all foreign and domestic food businesses to register their facilities that manufacture, process, package or food intended for human or animal consumption. Dietary supplements are included in this requirement. This allows FDA to have access to all food and dietary supplement facilities so that they may be inspected if necessary, in order to prevent serious adverse health reactions. Under FSMA, all dietary supplement facilities must renew their registrations with FDA every even-numbered year. 

Domestic dietary supplement companies can submit a registration form for facilities online. However, foreign dietary supplement companies must designate a U.S. Agent for their facilities before they are able to register. This Agent must physically reside in the United States and be  available 24-hours a day to handle all communications with FDA regarding questions about shipments and scheduling facility inspections. Your agent must be listed on your FDA registration documents. 

Each facility is also required to provide a Unique Facility Identifier (UFI) to the FDA upon registration. Your U.S. Agent can help you with this.

Failure to register or renew registration of dietary supplement facilities may result in the detainment of shipments, shipping delays, and possible criminal actions. 

US Imports has specialists that can help you with registering your facility and can also serve as your U.S. Agent if importing to the United States. Contact us at info@usimports.us for more information.