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FDA – Food and Dietary Supplements

Facility Registration + US Agent (Foreign Facility)

Fee: $399 / year ($599 for 2 years)

Foreign facilities that manufacture, process, pack or hold food for consumption in the United States must register with FDA, with limited exceptions. The registration is renewed between October 1 and December 31 of each even-numbered year. FDA charges no fee for registration and issues no certificate; it assigns the facility a registration number.

Who Is Obligated?

The foreign facility that manufactures, packs or holds the food. If the food is further processed at another foreign facility beyond minor activities such as labeling, the registration obligation passes to that facility. A foreign facility must designate a US Agent who resides or maintains a place of business in the United States and must provide an FDA-accepted facility identifier (DUNS) in the registration.

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 serve as your designated US Agent and handle communication between FDA and your facility.
  • We check the DUNS number to be used in the registration.
  • We track the renewal period in even-numbered years.

What You Receive

  • FDA facility registration number
  • Summary of the information used in the registration
  • Renewal period reminder
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Foreign Food Facility FDA Registration and US Agent Application

Information requested on the FDA registration form for the registration, biennial renewal, or update of your food facility located outside the United States. US Agent service is included in this package.

  1. 1 Preliminary Information
  2. 2 Facility
  3. 3 Activities and Products
  4. 4 US Agent
  5. 5 Responsible Person and Billing
  6. 6 Submit
1. Preliminary Information

The person completing the form and whether the facility is required to register.

Does the facility manufacture, process, pack, or hold food? *
Are you a broker, distributor, or importer? *
Has the facility been registered with the FDA before? *

Your details are used only to prepare your application. An unfinished application is kept in this tab.

Frequently Asked Questions

What document do I receive at the end of registration?
FDA does not issue a certificate for registration; it assigns your facility an FDA facility registration number. We send you this number and a summary of the information used in the registration.
When is the registration renewed?
The registration is renewed between October 1 and December 31 of each even-numbered year. We track the renewal period and notify you before it is due.
Do I also need to find a US Agent?
No. A foreign facility must designate a US Agent in the United States, and in this package we are designated as your US Agent; FDA reaches your facility through us.
Does FDA charge a fee for this registration?
No, FDA does not charge a fee for food facility registration. The fee you pay is for our US Agent service.
What does my fee cover, and when is it renewed?
Our fee is for the US Agent service and is renewed annually. The FDA registration is renewed every two years, between October 1 and December 31 of even-numbered years; we handle this renewal and any information updates during the year as part of our US Agent service.

Sources: 21 CFR 1.225; 21 CFR 1.226; 21 CFR 1.227; 21 CFR 1.230; 21 CFR 1.232; FDA: Food facility registration fees.