The FDA requires all domestic and foreign facilities that manufacture, process, pack, or hold dietary supplements, for importation or distribution in the United States to register with the FDA. The Food Safety Modernization Act (FSMA) now requires biennial registration renewal to be done every even-numbered year.
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.
Foreign food facilities must provide their Food Facility Registration Number to the FDA and U.S. Customs and Border Protection through an FDA Prior Notice filing when importing dietary supplements. Any products not in compliance may be refused by the FDA or Customs and Border Protection, causing significant delays.