What Is a MoCRA U.S. Agent? Requirements for Foreign Cosmetics Companies

Published by US Compliance Agent LLC

If you manufacture cosmetics outside the United States and sell them into the U.S. market, there is a regulatory requirement you cannot afford to overlook: designating a MoCRA U.S. Agent.

The Modernization of Cosmetics Regulation Act — known as MoCRA — was signed into law on December 29, 2022. It represents the most sweeping overhaul of U.S. cosmetics regulation since the Federal Food, Drug, and Cosmetic Act of 1938. Among its many provisions, MoCRA requires every foreign cosmetic facility to designate a U.S.-based agent as part of its FDA facility registration.

This article explains what a MoCRA U.S. Agent is, who needs one, what the agent does, and how to get one in place — so your company can stay compliant and keep selling into the largest cosmetics market in the world.

What Changed Under MoCRA?

Before MoCRA, the U.S. cosmetics industry operated under a largely voluntary regulatory framework. FDA had limited authority over cosmetic products, and foreign facilities had minimal registration or reporting obligations.

MoCRA changed that. The law grants FDA new authority over cosmetics, including mandatory facility registration, product listing, adverse event reporting, Good Manufacturing Practice (GMP) standards, and safety substantiation requirements.

For foreign manufacturers, one of the most immediate and practical requirements is the U.S. Agent designation. Without it, your facility registration in FDA's electronic system — the Facility Registration and Product Listing System, known as FURLS — cannot be completed.

In short: no U.S. Agent, no registration. No registration, no legal access to the U.S. cosmetics market.

What Is a MoCRA U.S. Agent?

A MoCRA U.S. Agent is a person or company physically located in the United States that serves as the official point of contact between your foreign cosmetic facility and the U.S. Food and Drug Administration (FDA).

The U.S. Agent is not your importer, your distributor, or your regulatory consultant. The agent's role is specifically defined: to receive communications from FDA on your behalf, forward those communications to you, and assist in facilitating correspondence between your company and the agency.

Think of the U.S. Agent as your official mailbox and phone line for FDA matters — someone who ensures that when FDA reaches out, there is a responsive, U.S.-based contact ready to receive and relay that information.

Who Needs a MoCRA U.S. Agent?

Any foreign establishment that manufactures, processes, packs, or holds cosmetic products for distribution in the United States is required to register with FDA under MoCRA — and as part of that registration, must designate a U.S. Agent.

This includes:

• Foreign cosmetics manufacturers producing finished products for the U.S. market

• Contract manufacturers (OEM/ODM) producing cosmetics on behalf of U.S. brands

• Private-label cosmetic producers located outside the United States

• Foreign repackers and relabelers of cosmetic products destined for U.S. sale

• Foreign cosmetic ingredient suppliers that also operate finished-product facilities

If your facility is located anywhere outside the United States and your cosmetic products end up on U.S. shelves — whether through direct export, through a U.S. importer, or through an e-commerce platform like Amazon — you need a U.S. Agent.

Domestic U.S. facilities do not need a U.S. Agent. The requirement applies exclusively to foreign establishments.

What Does a MoCRA U.S. Agent Do?

The responsibilities of a MoCRA U.S. Agent are clearly defined under the law. Your U.S. Agent must:

Receive FDA communications. This includes inspection notices, compliance letters, adverse event inquiries, verification requests, and any other correspondence from FDA related to your cosmetic facility or products.

Forward communications promptly. When FDA contacts your U.S. Agent, the agent must relay that communication to your designated company contact without delay. Timely forwarding is critical — particularly for inspection scheduling and adverse event follow-ups, which operate on tight regulatory timelines.

Be available during U.S. business hours. Your U.S. Agent must be reachable by FDA during normal business hours in the United States. This means having an active U.S. phone number and the ability to respond to FDA inquiries in a timely manner.

Assist with adverse event reporting. Under MoCRA Section 605, cosmetic companies are required to report serious adverse events to FDA within 15 business days. Your U.S. Agent serves as a relay point for any adverse event inquiries that FDA directs to your facility.

Provide a U.S. mailing address. Your agent must have a physical address in the United States — not a P.O. Box — where FDA can send official correspondence related to your facility.

It is important to understand what a U.S. Agent does not do. The agent does not submit your facility registration for you, does not prepare your product listings, does not conduct GMP audits, does not review your product labels, and does not provide legal or regulatory consulting. Those responsibilities remain with your company or with the regulatory consultants you choose to hire.

What Happens If You Do Not Have a U.S. Agent?

The consequences of operating without a designated U.S. Agent are straightforward and severe:

Your facility registration will not be accepted. The FDA's FURLS system requires a valid U.S. Agent designation as part of the registration process. If you leave this field blank or provide invalid information, your registration cannot be completed.

Your products may be refused entry. Without a valid registration, your cosmetic products may be detained or refused at U.S. ports of entry. U.S. Customs and Border Protection works with FDA to screen imports, and unregistered facilities are flagged.

Product listing delays. MoCRA requires product listing in addition to facility registration. If your facility registration is incomplete due to a missing U.S. Agent, your product listings will also be delayed.

Adverse event reporting complications. If a serious adverse event occurs involving one of your products and FDA cannot reach your facility through a U.S.-based contact, this creates a compliance gap that could lead to enforcement action.

Enforcement exposure. FDA's enforcement authority under MoCRA is still being implemented, but the agency has made clear that compliance with registration requirements — including U.S. Agent designation — is a foundational expectation.

How Is a MoCRA U.S. Agent Different from a Responsible Person?

This is one of the most common areas of confusion under MoCRA, and it is important to understand the distinction.

A U.S. Agent is the FDA's official point of contact for a foreign facility. The agent receives and forwards FDA communications. This role exists because FDA needs a way to reach foreign companies through a U.S.-based contact.

A Responsible Person is the individual or company whose name appears on the cosmetic product label. Under MoCRA, the Responsible Person is accountable for adverse event reporting, product labeling compliance, and safety substantiation. The Responsible Person is typically the U.S. brand owner, importer, or the manufacturer if the product is manufactured and branded domestically.

These are two separate roles. A single entity can serve as both in some situations, but for most foreign manufacturers, the U.S. Agent and the Responsible Person will be different parties. Your U.S. Agent handles FDA communications for your facility. Your Responsible Person handles product-level compliance obligations.

If you are a foreign contract manufacturer producing cosmetics for a U.S. brand, the U.S. brand is almost certainly the Responsible Person. You still need your own U.S. Agent for your facility registration.

How to Designate a MoCRA U.S. Agent

The process is straightforward:

Step 1: Choose your U.S. Agent. Select a U.S.-based service or individual to serve as your agent. Your agent must have a physical U.S. address and be available during U.S. business hours.

Step 2: Obtain your U.S. Agent's information. You will need the agent's name, physical address, phone number, and email address for your FDA registration.

Step 3: Enter the information in FURLS. When you complete your FDA cosmetic facility registration through the FURLS system, you will be prompted to enter your U.S. Agent's details. This is a required field — the system will not allow you to complete registration without it.

Step 4: Notify your U.S. Agent. Your agent should be aware of and have agreed to serve in this capacity before you submit the registration.

That is the entire process. There is no separate application, no fee paid to FDA for the agent designation itself, and no approval waiting period for the agent. You choose your agent, enter their information in FURLS, and your registration moves forward.

How Much Does a MoCRA U.S. Agent Cost?

Pricing for MoCRA U.S. Agent services varies significantly across the market.

Large regulatory consulting firms like Registrar Corp and Biorius typically charge $500 to $1,500 or more — but these prices usually include bundled services like registration assistance, label review, and regulatory consulting that many companies do not need.

Dedicated U.S. Agent services that focus specifically on the agent designation — providing the address, phone number, communication forwarding, and availability requirement — typically range from $199 to $400 per year.

At US Compliance Agent, our MoCRA U.S. Agent service is $249 per year. This includes your official U.S. Agent designation, a verified U.S. mailing address, a U.S. phone number, same-day forwarding of all FDA correspondence, adverse event relay, and 12-month continuous coverage.

We do not bundle unnecessary consulting services. If you only need the U.S. Agent requirement fulfilled, that is exactly what we provide.

Choosing the Right MoCRA U.S. Agent Service

When evaluating U.S. Agent providers, there are several factors worth considering:

Response time. When FDA sends a communication, how quickly does the agent forward it to you? Same-day forwarding should be the standard. Delays can create compliance issues, especially for inspection notices and adverse event inquiries.

Availability. Your agent must be reachable during U.S. business hours. Make sure the service you choose has a real phone number staffed by a real person — not just a voicemail box.

Transparency. Are there hidden fees? Charges for forwarding individual documents? Setup fees? Look for a service with straightforward annual pricing and no surprises.

Experience with regulatory agencies. While the U.S. Agent role is defined and limited, it helps to work with a service that understands how federal regulatory agencies operate. Familiarity with FDA processes, correspondence types, and timing expectations makes for more reliable service.

Separation of services. Be wary of providers that require you to purchase consulting packages you do not need in order to get a U.S. Agent designation. If you already handle your own compliance, you should not have to pay for services you will not use.

Key MoCRA Deadlines to Know

MoCRA's requirements are being implemented on a rolling basis. Key dates that affect your U.S. Agent designation:

• Facility registration and product listing requirements are already in effect. If you have not yet registered your facility in FURLS and designated your U.S. Agent, you should do so as soon as possible.

• Adverse event reporting requirements are active. Your U.S. Agent should be prepared to receive and relay adverse event inquiries from FDA.

• Good Manufacturing Practice (GMP) standards are being finalized and will require ongoing compliance.

The regulatory landscape under MoCRA continues to develop. Having your U.S. Agent in place ensures you have a reliable communication channel with FDA as new requirements are announced and enforced.

Getting Started

If your foreign cosmetic facility needs a U.S. Agent to comply with MoCRA, we can help. US Compliance Agent LLC provides affordable, focused U.S. Agent services for foreign manufacturers — without the bundled consulting fees.

Visit our MoCRA U.S. Agent service page to get started, or view our pricing page for a complete overview of our services.

US Compliance Agent LLC is a private company. We are not affiliated with, endorsed by, or connected to the FDA or any U.S. government agency. We do not provide legal advice, regulatory consulting, product testing, or certification services.