FDA Food Facility Registration

To carry out the provisions of the Bioterrorism Act (BTA), the US Food and Drug Administration (FDA) published two interim final regulations on October 10, 2003. The first provision requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to be registered with the FDA. The second provision requires that any shipment coming into the US must be sent with a prior notice to FDA.  

Importations from unregistered facilities will be held at the port of entry or denied entry into the US. Additionally, foreign facilities need to appoint a US agent as part of their FDA facility registration. Deringer provides US agency services to foreign food facilities and has represented clients before FDA since the inception of the Bioterrorism reporting requirements.

Benefits of Deringer's FDA Agency Program:

  • FDA registration support
  • Updates regarding FDA regulations provided regularly on Deringer’s website or available by email
  • Electronic submissions of your pre-arrival information to FDA
  • Support services in building your FDA product code
  • Help with questions regarding the FDA import process
  • All food importations require FDA prior-notice; Deringer works with importers to facilitate submission of the required information to FDA prior to shipment arrival

To designate Deringer as your US Agent, please review and complete the Bioterrorism-US Agency Agreement and Annex I and then return it to Deringer’s FDA Administrator via email or fax (518-298-7592). After receipt of the Agreement and Annex document, Deringer's FDA Administrator will provide information and instructions on how to complete the registration process.