By Vincent Cruz

If your cosmetic products are made outside the United States and sold to American customers, MoCRA requires your foreign facility to name a U.S. agent when it registers with FDA. The agent is FDA’s official point of contact for your facility.

Plenty of companies now sell this service, and their offers look similar at first glance. They are not. This guide gives you a practical framework for comparing them: what the agent actually does day to day, the criteria that matter, the red flags that should make you walk away, and the exact questions to ask before you sign anything.

For the legal requirements of who qualifies as an agent, see Who Can Be a MoCRA U.S. Agent? Requirements Explained. This article is about choosing between providers once you know you need one. For the full compliance picture, start with the MoCRA Compliance Guide for Cosmetic Brands.

What the U.S. agent actually does

The role is narrower than most sales pages suggest, and wider than “a name on a form.” A U.S. agent:

Is listed on your facility registration (Form FDA 5066) as FDA’s contact for the facility
Receives FDA correspondence directed at your facility and relays it to you promptly
Answers FDA’s questions about the facility when the agency reaches out
Receives FDA’s automated renewal reminders (Cosmetics Direct emails the agent, the facility contact, and the account contact)
In some cases, assists with or files registration amendments on your behalf

What the agent does not do: approve your products, certify your facility, or give you any special standing with FDA. Anyone selling the service as a shortcut to FDA favor is misrepresenting it. For what happens when filings go wrong, see What Happens If You Don’t Register Under MoCRA?.

7 criteria to compare

1. Real physical presence in the United States

FDA requires the agent to reside in the U.S. or maintain a U.S. place of business and be physically present in the country. A mailbox or answering service alone does not satisfy this. Ask where the provider actually operates from and who on their team handles FDA correspondence. A legitimate provider will answer this plainly.

2. A named human who handles your account

You are trusting this company with time-sensitive FDA mail. Find out who specifically receives it, what their process is for forwarding it to you, and what their response-time commitment is. “Our team monitors everything” is not an answer. A named contact with a stated turnaround time is.

3. FDA correspondence handling, spelled out

The core of the service is simple: FDA contacts your agent, your agent tells you fast. Ask exactly how that works. Email forwarding within one business day? A client portal? Phone call for urgent items? Get the SLA in writing, in the contract, not just on a sales call.

4. Transparent, published pricing

You should be able to see the full price before you talk to anyone. That means the one-time setup or onboarding fee and the recurring monthly or annual fee, stated as numbers. Be wary of “contact us for a quote” pricing for what is essentially a standardized administrative service. As a reference point, our own pricing is published on our pricing page: $450 one-time onboarding plus $34.99 per month, per facility. Whatever provider you choose, insist on seeing the numbers up front. For a deeper breakdown of how agent services are priced, see MoCRA U.S. Agent Pricing: What Foreign Brands Really Pay.

5. A written service agreement

A professional provider gives you a contract that covers scope of services, fees and billing terms, how correspondence is handled, confidentiality of your business information, term and termination, and what happens on cancellation. If a provider wants you to pay before showing you the agreement, that is a red flag.

6. A formal resignation process on cancellation

This one is easy to overlook and expensive to get wrong. Your facility must always have a designated U.S. agent on file with FDA. When you cancel, the outgoing agent should formally resign through the proper channel and coordinate so there is no gap in coverage. Ask how they handle this. A provider with no clear answer may simply stop responding, leaving your registration pointing at a dead contact. See MoCRA U.S. Agent Resignation: How to Cancel Safely for why the exit matters as much as the signup.

7. Responsiveness before you are a customer

Send a pre-sales email with a real question and time the reply. If a company takes a week to answer a prospect asking about a service whose entire value is prompt communication, believe what you just learned.

Red flags: when to walk away

Mailbox-only or virtual address with no staff. If the “U.S. presence” is a mail drop and nobody can tell you who opens the mail, keep looking.
No written contract. Handshake deals have no place in regulatory representation.
Vague pricing. “Custom quotes,” setup fees that appear at checkout, or monthly fees buried in fine print.
Promises of FDA approval, certification, or special access. FDA does not approve cosmetics, does not certify facilities, and does not issue registration certificates (see FDA’s September 2026 clarification). Any provider implying otherwise is either confused or dishonest.
Claims of FDA affiliation or endorsement. No private agent service is affiliated with or endorsed by FDA. This site is not either.
No resignation process. If they cannot explain what happens when you leave, assume the exit will be messy.
Pressure tactics. Limited-time discounts on a compliance service are a sales gimmick, not a reason to hurry a regulatory decision.

Questions to ask before you sign

Copy these into your email to any provider you are evaluating:

Who specifically will handle FDA correspondence for my facility, and what is the guaranteed relay time?
What is your full fee schedule, one-time and recurring, and where is it published?
Can I review the service agreement before paying?
What is your process when I cancel, and how do you handle formal resignation with FDA?
How do you handle an urgent FDA contact, such as records requests or inspection-related mail?
Will you file my facility registration and product listings, or only serve as the listed agent? (These are different services. Know which you are buying. See Facility Registration vs Product Listing.)
How do you handle the biennial registration renewal, and is it included in the fee? (Renewal is every two years based on your initial registration date. See MoCRA Biennial Renewal Explained.)

A good provider answers all seven directly and in writing. Evasive answers are themselves an answer.

How this fits into your overall timeline

Choosing an agent is one step in getting compliant. The typical sequence is: confirm you need to register (the small-business exemption worksheet can help), request your FEI number, choose your agent, file the facility registration, then file product listings. For realistic timing on each step, see How Long Does MoCRA Facility Registration Take?. If you already have an agent and want to switch, the process is an amended registration, covered in How to Change Your MoCRA U.S. Agent.

FAQ

Do I legally need a U.S. agent, or is it optional?
If your facility is outside the U.S. and manufactures or processes cosmetics for the American market, naming a U.S. agent is required as part of facility registration. It is not optional.

Can my U.S. distributor or importer be my agent?
They can, if they meet FDA’s requirements: U.S. residence or place of business and physical presence in the country, plus willingness to take on the correspondence duties. Many brands prefer an independent agent so the role does not depend on a commercial relationship that could end.

What is a fair price for a U.S. agent service?
Pricing varies, but the service is fundamentally administrative: a listed contact plus correspondence handling. Be skeptical of very high fees and of very low teaser rates that jump after the first year. Our published pricing is $450 one-time plus $34.99 per month per facility.

Can one agent represent multiple facilities?
Yes. A provider can serve as agent for any number of facilities, and multi-facility brands typically use the same agent for all of them. Confirm volume terms in writing if you have several facilities.

What happens if my agent stops responding?
Your registration still lists them as FDA’s contact, which means FDA mail goes nowhere. You would need to amend your registration to name a new agent. This is why the resignation and transfer process matters; see How to Change Your MoCRA U.S. Agent.

Does the agent file my product listings too?
Not automatically. Serving as the listed U.S. agent and preparing filings are separate services. Some providers bundle them, some do not. Ask which you are buying before you assume.

Next step: Not sure where your facility stands? Run the free FEI check to see whether you already have an FDA Establishment Identifier, or contact us with questions about appointing a U.S. agent. No obligation either way.

See also: how much a MoCRA U.S. agent costs — a provider-by-provider price comparison.

How to Choose a MoCRA U.S. Agent: What to Compare and Red Flags