A U.S. Agent is a person or company physically located in the United States that a foreign manufacturer designates as its official point of contact with the FDA. The Agent receives FDA communications, helps coordinate inspections, and is reachable in an emergency but does not take on the manufacturer’s legal responsibility for the product itself.
Any foreign facility that manufactures, processes, packs, or holds food, drugs, dietary supplements, cosmetics, or medical devices for the U.S. market generally must designate a U.S. Agent before, or as part of, registering with the FDA. Domestic (U.S.-based) facilities don’t need one.
Four things, consistently defined across FDA’s regulations for food, drugs, devices, and cosmetics: (1) serves as FDA’s point of contact for questions and correspondence about the registration, (2) assists in scheduling and facilitating FDA inspections of the foreign facility, (3) receives and relays urgent notices, including recalls, import alerts, and public health communications, without delay, and (4) keeps its own contact information current with FDA (changes to the Agent’s name, address, or phone generally must be reported within about 10 business days). One legal detail worth knowing: for drug establishments specifically, FDA regulations state that delivering a communication to the U.S. Agent is treated as legally equivalent to delivering it to the foreign manufacturer directly: the Agent isn’t just a convenience, it’s where the clock can start on your obligation to respond.
Technically yes, if they’re willing and physically based in the U.S., but it’s not usually a good idea. The Agent must be reliably reachable during U.S. business hours and respond quickly to FDA, which is a real operational commitment most distributors and forwarders aren’t set up for (or interested in). Most manufacturers use a dedicated registered-agent service instead.
Yes. There’s no limit on how many companies a single U.S. Agent can represent, which is why dedicated agent services exist.
No. The U.S. Agent is a communications and liaison role, not a guarantor of product compliance. Legal responsibility for the product (labeling, safety, manufacturing standards) stays with the manufacturer, and for cosmetics under MoCRA, with the designated “Responsible Person,” which is a separate role. The reverse isn’t true either: designating someone as your FDA U.S. Agent doesn’t automatically make them your agent for receiving a lawsuit. A 2025 federal court ruling (Aguila v. RQM+LLC) confirmed that an FDA-registered U.S. Agent is not the same as an agent authorized to accept service of process under the Federal Rules of Civil Procedure: the two roles are legally distinct.
They’re not the same thing. The Responsible Person is the entity legally accountable for a cosmetic product’s safety and labeling compliance and can be the manufacturer, packer, or distributor; it does not need to be based in the U.S. The U.S. Agent is specifically the FDA’s point of contact inside the U.S. A foreign cosmetics company typically needs both roles filled, and one company can sometimes serve both functions if structured correctly.
The FDA will refuse to complete your facility registration or product listing. Without a valid registration, your products can be refused entry at the U.S. border, held, or placed under an import alert, and in some cases treated as misbranded or adulterated under the FD&C Act, which carries its own consequences. In short: no Agent generally means no legal access to the U.S. market.
The Agent’s full legal name, U.S. physical street address (no P.O. boxes or virtual mailboxes), phone number, and email, submitted as part of your facility/establishment registration through FDA’s electronic system.
After you submit the registration, FDA sends the designated Agent a confirmation request through its system. The Agent has to formally accept (typically within about 10 business days, depending on the product category). If the Agent doesn’t respond or declines, the registration isn’t considered complete until a new Agent is designated and confirmed.
They’re two separate requirements. A DUNS number is the unique facility identifier (UFI) FDA uses to verify and track facilities, and it’s required for food, drug, and device establishment registrations (this has not been replaced by the federal UEI system, which applies to grants/contracts, not FDA registration). After your registration is processed, FDA also issues its own tracking number called an FEI (FDA Establishment Identifier), separate from, and issued later than, your DUNS number. You need an active DUNS number and a confirmed U.S. Agent regardless; one doesn’t substitute for the other.
No, and this is a common point of confusion. Appointing a U.S. Agent and completing facility registration are compliance steps, not an FDA endorsement or approval of the product. Many product categories (most foods, cosmetics, and lower-risk devices) are never “FDA approved” in that sense. Registration is a different concept from premarket approval or clearance, which only applies to specific categories like new drugs and certain medical devices.
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