How to Choose a U.S. FDA Agent: Criteria for Foreign Manufacturers (2026)
Updated: Oct 6
When FDA or U.S. customs needs to reach a foreign facility, they contact the U.S. Agent named on that facility's registration — and under 21 CFR 1.227, FDA treats information given to the U.S. Agent as the equivalent of giving it to the facility itself. That single sentence is why the choice matters: a notice delivered to an Agent who does not read it, route it, or escalate it has still, as far as the regulation is concerned, been delivered to you.
Most foreign manufacturers choose an Agent once, at registration, on price alone, and never revisit it until something goes wrong. This article sets out what to actually evaluate — what the role is, who is allowed to hold it, the criteria that separate an active Agent from a passive listing, and what changing Agents involves.
What a U.S. Agent actually does
A U.S. Agent is the domestic point of contact a foreign facility designates so FDA can communicate efficiently about that facility's registration and related regulatory matters.
For food facilities, 21 CFR 1.227 describes the U.S. Agent as a communications link between FDA and the foreign facility for both emergency and routine communications, and states that FDA will treat representations by the U.S. Agent as those of the foreign facility. The Agent is who FDA contacts when an emergency arises, unless the registration specifies otherwise.
For foreign drug establishments the duties are spelled out more explicitly. Under 21 CFR 207.69, the designated U.S. agent is responsible for reviewing, disseminating, routing and responding to all communications from FDA including emergency communications; for responding to questions concerning drugs that are imported or offered for import into the United States; and for assisting FDA in scheduling inspections.
Two things follow. First, this is an active job description, not a name on a form — "routing," "responding" and "assisting" all assume someone is reading the mail. Second, the same label covers different programs: a food facility Agent under Part 1 Subpart H and a drug establishment Agent under Part 207 are governed by different rules and different portals. One Agent relationship does not automatically cover every product class a company sells. If your company registers in more than one program, confirm in writing which registrations your Agent is actually named on.
Who can serve as a U.S. Agent
For FDA food facility registration, the U.S. Agent must be a person residing or maintaining a place of business in the United States whom the foreign facility designates as its agent — and 21 CFR 1.227 states that a U.S. Agent may not be in the form of a mailbox, answering machine or service, or other place where an individual acting as the foreign facility's agent is not physically present.
The drug framework sets the same floor in nearly identical words: 21 CFR 207.69 requires that the United States agent reside or maintain a place of business in the United States and may not be a mailbox, answering machine or service, or other place where a person acting as the United States agent is not physically present.
The requirement is therefore not a formality that a forwarding address satisfies. FDA's 2018 Small Entity Compliance Guide puts the eligibility plainly — the U.S. agent lives or maintains a place of business in the United States and is physically present in the United States — and adds a second control: FDA will not confirm a registration or registration renewal, or provide a registration number, until the person identified as the U.S. agent confirms that the person agreed to serve. An Agent who cannot be reached to give that confirmation can hold up the registration itself.
Beyond the legal floor, the practical question is whether the address on the record is a place where regulatory work happens. Axentra's is: a real place of business in Albuquerque, New Mexico, staffed by the people who handle the client's FDA correspondence.
Criteria for choosing a U.S. Agent
Foreign manufacturers should choose a U.S. Agent on documented U.S. presence, proven ability to receive and act on FDA communications, regulatory literacy for their product class, clearly defined scope, and transparent fees — not on the lowest quote.
Five things to ask before you sign:
Reachability. Who answers during U.S. business hours, and is it a named person or a shared queue? Ask for the name and direct contact of the individual who will handle FDA correspondence for your facility, and test it before you appoint them.
A real U.S. place of business. Not a mail drop. The regulations rule out a mailbox or answering service outright, so ask what the address actually is and who works there.
Verifiable identity as an Agent. FDA operates a U.S. Agent Voluntary Identification System for food facilities, which lets U.S. agents independently identify the facilities they represent; when a facility supplies a valid agent identification number matching the name and address on file, FDA considers the agent verified without taking additional steps. Participation is voluntary, so ask whether your prospective Agent holds an identification number under it.
Regulatory literacy for your class. A food facility Agent's duties under Part 1 and a drug establishment Agent's duties under Part 207 are not interchangeable. Ask which programs the provider actually works in, and who on their side reads a warning letter or an import notice and knows what it means.
Scope and fee transparency. Get in writing which registrations the Agent is named on, what is included when FDA makes contact, and what is billed separately. Axentra's U.S. Agent services are $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. Pricing in depth is set out in our 2026 U.S. FDA Agent cost guide.
Red flags in a passive or mailbox arrangement
A mailbox or passive listing that cannot reliably receive and escalate FDA communications is not a substitute for an active U.S. Agent.
None of the following is about any particular provider — they are patterns worth checking for in whatever arrangement you currently have. No one answers the phone during U.S. business hours. There is no named individual, only a ticket queue or a generic inbox. The listed address turns out to be a forwarding service. The scope of what you are paying for is never written down. The service is described as registration only, with no stated plan for what happens when FDA actually makes contact. Correspondence has arrived late, or you have learned about it from a customer rather than from your Agent.
If any of these describe your situation, the question is not whether your provider is dishonest — it is whether the arrangement can do the job the regulation assumes. We covered that distinction in detail in Mailbox vs Active U.S. FDA Agent: what to require in 2026.
Appointing an Agent is not registering the facility
Appointing a U.S. Agent is not the same as registering the facility: registration creates the facility's record with FDA, while the Agent is the U.S. contact named on that record, under rules specific to each program.
Confusing the two is common and costly, because a company that believes it has "registered" by hiring an Agent may have no valid registration at all — and a company that registers without naming a reachable Agent may find the registration unconfirmed. The two obligations run together but they are not the same obligation. The distinction is unpacked in FDA Agent vs facility registration: what's the difference in 2026, and the registration side is covered on our FDA facility registration and FDA food facility registration pages.
What changing your U.S. Agent involves
Changing the U.S. Agent named on an FDA registration is an ordinary administrative update to the registration record, not a re-registration — the new Agent has to be identified on the record and, for foreign food facilities, confirm that they agreed to serve before FDA confirms the registration.
At a practical level that means three things: the facility keeps ownership of its own FDA account and registration number, the change is made against the existing record rather than by starting over, and the new Agent has to be in place and responsive for the confirmation step under 21 CFR 1.231 to complete. For food facilities the natural moment to do it is during the biennial renewal window, when the record is being reconfirmed anyway.
We do not publish click-by-click portal instructions here, because FDA's systems change and a stale screenshot helps no one. Axentra handles the appointment or switch on the facility's behalf.
Working with Axentra as your U.S. Agent
Axentra Global Pharma Compliance LLC acts as an active U.S. Agent for foreign food, cosmetics and dietary supplement facilities from a real place of business in the United States, with a named senior regulatory contact rather than a shared queue.
U.S. Agent services are $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. What the engagement includes is a named contact who confirms the appointment with FDA, receives and routes FDA communications, and is reachable when an inspection or import question arrives. The facility keeps ownership of its FDA account throughout.
One line worth keeping straight: registering a facility, listing a product, or appointing a U.S. Agent does not mean FDA has approved the facility or its products, or verified the information submitted. FDA states this directly for cosmetics — the assignment of a facility registration number or product listing number does not indicate FDA approval of the facility or its cosmetic products. Registration is a listing obligation, not an approval.
Axentra Global Pharma Compliance LLC · 1209 Mountain Road Pl NE, Suite N, Albuquerque, NM 87110 · 505-358-4858 · info@axentracompliance.com
Frequently asked questions
How should a foreign manufacturer choose a U.S. FDA Agent?
Choose on documented U.S. presence, proven ability to receive and act on FDA communications, regulatory literacy for your product class, clearly defined scope, and transparent fees — not on the lowest quote. The reason presence and reachability rank first is regulatory, not stylistic: under 21 CFR 1.227 FDA treats information provided to the U.S. Agent as the equivalent of providing it to the foreign facility, so an unread notice is still a delivered notice. Ask for the named individual who will handle your FDA correspondence, confirm the address is a place of business rather than a mail drop, and get the scope in writing. Axentra's U.S. Agent services are $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.
Is a mailbox enough to serve as an FDA U.S. Agent?
A mailbox or answering service is not enough under 21 CFR 1.227 — the U.S. Agent must be a person who resides or maintains a place of business in the United States and can act as FDA's communications link. For the full physical-presence rule, red flags, and how to verify an Agent, see Mailbox vs Active U.S. FDA Agent.
Who can be a U.S. Agent for FDA food facility registration, and what does the Agent do?
For food facility registration, the U.S. Agent must be a person residing or maintaining a place of business in the United States whom the foreign facility designates, and may not be a mailbox, answering machine or service, or a place where the individual acting as agent is not physically present (21 CFR 1.227). The Agent serves as the communications link between FDA and the facility for emergency and routine communications, and FDA will not confirm a registration or renewal until the person named confirms they agreed to serve (21 CFR 1.231; FDA Small Entity Compliance Guide, 2018). Other programs set their own rules — foreign drug establishments designate a single U.S. agent under 21 CFR 207.69 — so confirm which registrations your Agent is named on. Axentra serves as U.S. Agent for food, cosmetics and dietary supplement facilities: U.S. Agent services. Pricing detail is in our 2026 cost guide.
Sources (opened 22 September 2026)
21 CFR 1.227 (definition of U.S. agent; mailbox exclusion; communications link; FDA treats information to the agent as provided to the facility) — eCFR, current as of 9/17/2026 — https://www.ecfr.gov/current/title-21/section-1.227
21 CFR 1.231 (FDA will not confirm a foreign facility's registration until the U.S. agent confirms agreement to serve) — eCFR, current as of 9/17/2026 — https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-1/subpart-H
21 CFR 207.69 (foreign drug establishments designate a single U.S. agent; residence/place of business; reviewing, disseminating, routing and responding to FDA communications; assisting with inspections) — eCFR, current as of 9/17/2026 — https://www.ecfr.gov/current/title-21/section-207.69
FDA, Registration of Food Facilities: What You Need to Know About the FDA Regulation — Small Entity Compliance Guide (May 2018) — https://www.fda.gov/media/85098/download
FDA, U.S. Agent Voluntary Identification System for food facilities — content current as of 10/16/2020 — https://www.fda.gov/food/hfp-constituent-updates/fda-establishes-us-agent-voluntary-identification-system-food-facilities
FDA, Registration and Listing of Cosmetic Product Facilities and Products ("the assignment of a facility registration number or product listing number does not indicate FDA approval") — content current as of 09/09/2026 — https://www.fda.gov/cosmetics/registration-listing-cosmetic-product-facilities-and-products
Axentra Global Pharma Compliance LLC provides regulatory consulting and U.S. Agent services. This article is general information, not legal advice. FDA registration, listing, or appointment of a U.S. Agent does not indicate FDA approval of any facility or product.
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