Do Foreign Cosmetic Facilities Need a US Agent?

If you make cosmetics outside the US and want them on American shelves, the question of who represents you stateside comes up fast, usually right after someone mentions MoCRA for the first time. The short version: yes, a foreign facility registering under MoCRA needs a US agent, and that role carries more weight than a mailing address.

Why FDA cares who's local

MoCRA (the Modernization of Cosmetics Regulation Act, passed in 2022) built facility registration and product listing into federal law for the first time. Before that, cosmetic oversight in the US was thin compared to drugs. Now FDA wants a named, reachable point of contact for every registered facility, and if that facility sits in another country, FDA needs someone physically in the US who can receive communications on its behalf. That's the US agent.

Think of it from FDA's side. If there's an adverse event report, a request for records, or a facility inspection question, FDA doesn't want to be routing everything through time zones and translation. The US agent exists to close that gap.

What the US agent actually does

The role is narrower than people expect. A US agent typically:

• Serves as the official point of contact FDA can reach during US business hours
• Assists in scheduling inspections and communications between FDA and the foreign facility
• Is listed on the facility registration itself

What the US agent is not, by default, is your responsible person. Those are separate roles under MoCRA, though in smaller operations the same company or individual sometimes ends up wearing both hats. The responsible person is the one who ensures safety substantiation exists and manages adverse event recordkeeping for the product. The US agent's job is narrower and more procedural: being findable and responsive.

Who can serve as a US agent

There's no requirement that this be a law firm or a specialized compliance shop, though many foreign manufacturers choose to hire one because the role demands consistent availability and familiarity with FDA correspondence. In practice, the US agent is often:

• A US-based regulatory consultant or compliance firm
• A US-based distributor or importer with an existing relationship to the brand
• In some cases, a US subsidiary of the foreign manufacturer itself

What matters is that the person or entity is physically present in the US and genuinely reachable, not a nominal name on a form. If FDA contacts your US agent and gets no response, that reflects on the facility's registration status.

Facility registration versus product listing

It's worth separating two things that get conflated:

Requirement	What it covers	Who it applies to
Facility registration	The physical site where cosmetics are manufactured or processed	Facilities, including foreign ones shipping into the US
Product listing	Each cosmetic product and its ingredients	Responsible person, tied to a registered facility

A foreign facility needs to register regardless of whether the responsible person is domestic or foreign. The US agent requirement attaches to the facility registration specifically, because that's the piece FDA most needs a reliable US contact for.

Small business exemptions don't remove the agent requirement

MoCRA does carve out exemptions for some small businesses from registration and listing obligations, based on manufacturing volume and other factors. But if your facility doesn't qualify for that exemption and you're operating from outside the US, the US agent requirement stands. Don't assume small-batch or artisanal status gets you out of this. The exemption criteria are specific, and they're worth checking against FDA's current guidance rather than assuming.

Practical steps for a foreign manufacturer

1. Confirm whether your facility qualifies for a small business exemption before assuming you need to register at all.
2. If registration is required, identify a US-based agent before you file, since the agent's information goes on the registration itself.
3. Clarify separately who your responsible person is. It might be you, it might be your US distributor, but it needs to be a defined answer, not an assumption.
4. Keep your US agent's contact information current. A registration with a stale or unreachable agent contact can create friction exactly when you don't want it, during an FDA inquiry.

None of this is exotic paperwork, but it's easy to underestimate if you're used to a regulatory environment where facility-level registration isn't a thing. Canada's Cosmetic Notification Form works at the product level, not the facility level, so manufacturers coming from that system sometimes assume the US works the same way. It doesn't.

Cosmetic Comply is built around the notification side of this world, starting with Canada's CNF process, with US, EU, and Australian filing support coming. If you're mapping out what MoCRA compliance looks like for your specific setup, whether you're the facility, the responsible person, or both, it helps to separate the roles clearly before you file anything.