Question 1

Do foreign manufacturers need an FDA U.S. Agent?

Accepted Answer

If your foreign facility manufactures, processes, packs, or holds food (including dietary supplements) for U.S. consumption, you should designate a U.S. Agent as part of FDA food facility registration. The agent is FDA’s communications link in the United States and must reside in or maintain a place of business in the U.S.—not a mailbox or answering service alone. Separate programs (devices, drugs, cosmetics) have their own agent rules; confirm the category that applies to your products. Axentra provides U.S. Agent services at $249 per facility per year for food, dietary supplements and cosmetics, with a 2-year price lock; API, OTC, pharma and device work is quoted by class.

Question 2

What is the difference between an FDA U.S. Agent and FDA facility registration?

Accepted Answer

Facility registration is the facility’s filing with FDA (identity, activities, product categories, and required contacts). A U.S. Agent is the U.S.-based person or entity named in that registration so FDA can reach the foreign facility for routine and emergency communications. You should complete registration with accurate agent details; FDA does not confirm a foreign food facility registration until the designated agent confirms they agreed to serve. Registration assignment is not product approval.

Question 3

Who can serve as an FDA U.S. Agent for a foreign food facility?

Accepted Answer

Under 21 CFR 1.227, a U.S. Agent is a person who resides in or maintains a place of business in the United States and is designated by the foreign facility for registration purposes. The agent may not be only a mailbox, answering machine, or service where no individual is physically present. One person is designated as the U.S. Agent for food facility registration; that does not prevent other commercial agents (e.g., brokers) for other business purposes.

Question 4

What does an FDA U.S. Agent actually do?

Accepted Answer

For foreign food facilities, the U.S. Agent acts as the communications link between FDA and the facility for routine and emergency contacts. FDA treats information or documents provided to the agent as provided to the facility, and may treat agent representations as those of the facility. The agent is not automatically your importer of record, customs broker, or FSVP importer unless you separately arrange that role.

Question 5

Can I change my FDA U.S. Agent?

Accepted Answer

Yes. Food facility registration information—including U.S. Agent name, address, phone, and email—should be updated within 60 calendar days of a change (21 CFR 1.234). After you update agent information, FDA verifies that the newly named person agreed to serve before confirming the update. Plan the handoff so confirmation is not left hanging during busy renewal windows.

Question 6

Why hasn’t FDA confirmed my foreign facility registration after I submitted it?

Accepted Answer

For foreign food facilities, FDA will not confirm registration or issue a registration number until the person named as U.S. Agent confirms they agreed to serve (21 CFR 1.231). FDA also verifies the facility’s unique facility identifier (UFI; currently DUNS). If agent confirmation or UFI verification fails, fix those fields and resubmit rather than assuming the portal “lost” the filing.

What a Canada Responsible Person does

Canada Cosmetics · Responsible Person & CNF

Canada Responsible Person & Cosmetic Notification for Foreign Beauty Brands

CNF timeline & what goes on the form

What Axentra handles

Who this is for