FDA – Food and Dietary Supplements
Facility Registration (US Facility)
Fee: $299 / year
Food facilities in the United States also register with FDA, even if the food does not enter interstate commerce. The registration rules and the biennial renewal are the same as for foreign facilities; FDA charges no registration fee.
Who Is Obligated?
A facility that manufactures, processes, packs or holds food in the United States. A domestic facility does not designate a US Agent; the registration lists the email address of the facility’s contact person and an emergency contact.
What We Do
- We assess your facility’s registration obligation and any exemption.
- We file the registration in FDA’s system on your behalf.
- We check the facility identifier (DUNS).
- We track the renewal period and information updates.
What You Receive
- FDA facility registration number
- Summary of the information used in the registration
- Renewal period reminder
US Food Facility FDA Registration Application
Information requested on the FDA registration form for the registration, biennial renewal, or update of your food facility in the United States.
Frequently Asked Questions
- I only sell my products in my own state. Do I still need to register?
- Yes. Food facilities in the United States register with FDA even if the food does not enter interstate commerce; we evaluate any exemption based on your facility’s activities.
- Does a domestic facility need a US Agent?
- No. A domestic facility does not designate a US Agent; the registration lists the email address of the facility’s contact person and an emergency contact.
- Is registration a one-time step?
- No, the registration is renewed every two years and updated when the information changes. Updates within the calendar year are included in the service.
Sources: 21 CFR 1.225; 21 CFR 1.230; 21 CFR 1.231; 21 CFR 1.232.
