How to Register Your Foreign Cosmetics Facility with FDA Under MoCRA

Published by US Compliance Agent LLC

If you operate a cosmetics manufacturing facility outside the United States and your products are sold in the U.S. market, MoCRA requires you to register that facility with the FDA. This is not optional — it is a legal requirement that directly affects your ability to export cosmetics to the United States.

This guide walks through the entire process step by step: what you need before you start, how to navigate FDA's electronic system, and how to avoid common mistakes that delay or block registrations.

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Before You Begin: What You Need

Gather the following information before starting the registration process. Having everything ready will allow you to complete the registration in one session rather than starting and stopping.

Facility information:

- Legal name of your facility

- Physical address of the manufacturing or processing facility (this must be the actual location where cosmetics are made, not a corporate headquarters if they are different)

- Phone number and email address for the facility

- DUNS number (Dun & Bradstreet), if available — this is optional but helpful

U.S. Agent information:

- Full legal name of your U.S. Agent (person or company)

- Physical U.S. address (must be a street address, not a P.O. Box)

- U.S. phone number

- Email address

- Your U.S. Agent must have agreed to serve in this role before you enter their information

Owner/operator information:

- Name of the facility owner or parent company

- Contact information for the person responsible for the registration submission

Product information (for product listing):

- Product names and brand names

- Product categories (FDA uses specific cosmetic product categories)

- Ingredient lists for each product

- Responsible Person information for each product

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Step 1: Create an FDA Account

All MoCRA facility registrations and product listings are submitted through FDA's electronic system. You will need an FDA account to access the system.

Go to FDA's Industry Systems page and create an account if you do not already have one. You will need a valid email address. FDA will send a verification email, and you will set up a password and security questions.

If your company already has an FDA account from previous interactions with the agency — for example, from food facility registration or drug establishment registration — you may be able to use that same account. However, cosmetic facility registration is a separate module within FDA's systems.

Step 2: Access the Cosmetic Registration Portal (FURLS)

Once your FDA account is active, navigate to the Facility Registration and Product Listing System (FURLS) for cosmetics. This is the specific module within FDA's systems dedicated to MoCRA compliance.

Within FURLS, you will see options for facility registration and product listing. Start with facility registration — you must register your facility before you can list products.

Step 3: Register Your Facility

The facility registration form will ask for several pieces of information:

Facility name and address. Enter the legal name of your manufacturing or processing facility and its physical address. For foreign facilities, make sure you select the correct country and provide the address in a format that FDA's system can accept. Some international address formats may require adjustment.

Facility type. You will be asked to identify the type of activities performed at your facility — manufacturing, processing, packing, or holding cosmetic products. Select all that apply to your operation.

Owner/operator information. Provide the name and contact details of the entity that owns or operates the facility.

U.S. Agent designation. This is the critical field for foreign facilities. Enter your U.S. Agent's name, physical U.S. address, phone number, and email address.

The system will not allow you to complete the registration without a valid U.S. Agent. If you do not have one yet, you will need to stop and arrange for a U.S. Agent before proceeding.

If you need a U.S. Agent, US Compliance Agent provides immediate onboarding — you can receive your U.S. Agent designation letter and contact details within minutes, allowing you to return to the FURLS system and complete your registration without delay. Visit our [MoCRA U.S. Agent service page] for details.

Review and submit. Once all fields are completed, review your information carefully. Errors in facility registration — particularly incorrect U.S. Agent information — can cause problems later when FDA attempts to contact your facility.

After submission, FDA will assign your facility an FDA Establishment Identifier (FEI) number if you do not already have one. This number is your facility's unique identifier in FDA's system and will be used for all future regulatory interactions.

Step 4: List Your Products

After your facility is registered, the next step is product listing. MoCRA requires that all cosmetic products sold in the United States be listed with FDA.

For each product, you will need to provide:

Product name and brand name. The name as it appears on the product label, along with the brand name under which it is sold.

Product category. FDA uses a standardized set of cosmetic product categories. Select the category that best describes your product. If your product falls into multiple categories (for example, a tinted moisturizer that functions as both a skincare product and a makeup product), select all applicable categories.

Ingredient list. Provide the complete list of ingredients for the product, including fragrance and flavor components to the extent required by MoCRA.

Responsible Person. Identify the Responsible Person for the product — the entity whose name appears on the product label and who is accountable for adverse event reporting and labeling compliance. For imported products, this is typically the U.S. importer or brand owner.

Facility association. Link the product to the registered facility where it is manufactured or processed.

You can list multiple products under the same facility registration. Each product gets its own listing entry.

Step 5: Verify and Maintain Your Registration

Registration is not a one-time event. You need to keep your information current.

Verify your U.S. Agent information. If your U.S. Agent's contact details change — or if you switch to a different U.S. Agent — update FURLS immediately. An unreachable U.S. Agent is effectively the same as having no U.S. Agent at all.

Update product listings. If you launch new products, discontinue existing products, or change product formulations, update your listings in FURLS accordingly.

Respond to registration renewals. MoCRA establishes a registration renewal requirement. Monitor FDA communications for renewal deadlines and ensure your registration remains active.

Keep records. Maintain copies of your registration confirmations, FEI number, U.S. Agent designation letter, and product listing submissions. These records may be requested during an FDA inspection or audit.

Common Mistakes to Avoid

Using a P.O. Box for your U.S. Agent address. FDA requires a physical U.S. address for the U.S. Agent, not a P.O. Box. If your agent provides only a P.O. Box, your registration may be flagged or rejected.

Entering incorrect U.S. Agent contact information. If FDA cannot reach your U.S. Agent at the phone number or email address on file, this creates an immediate compliance issue. Double-check all contact details before submitting.

Registering a corporate headquarters instead of the manufacturing facility. The registration is for the facility where cosmetics are actually manufactured, processed, packed, or held — not for a corporate office or sales office that does not handle products.

Failing to designate a U.S. Agent before starting registration. The FURLS system requires U.S. Agent information as part of the registration process. If you begin the registration without having an agent in place, you will hit a wall. Arrange your U.S. Agent first.

Assuming your U.S. importer automatically serves as your U.S. Agent. Your importer can serve as your U.S. Agent, but this does not happen automatically. Someone must be specifically designated and their information entered into FURLS. Unless your importer has explicitly agreed to serve as your U.S. Agent and you have entered their information accordingly, you do not have a U.S. Agent on file.

Not listing all products. Some manufacturers register their facility but forget — or choose not — to list all their products. Product listing is a separate requirement, and FDA expects complete listings for all cosmetic products sold in the U.S.

Ignoring renewal requirements. Registration is not permanent. If you miss a renewal deadline or fail to maintain your registration, your facility's status may lapse, potentially affecting your ability to export products to the U.S.

How Long Does the Registration Process Take?

The registration itself can be completed in a single session if you have all your information ready — typically 30 to 60 minutes for the facility registration, plus additional time for product listings depending on how many products you have.

The main variable is preparation time. If you need to set up a U.S. Agent, gather ingredient lists, confirm Responsible Person information, and organize your facility details, the preparation can take a few days to a week.

Once submitted, FDA processes registrations electronically. Your FEI number is typically assigned promptly, and your facility appears in FDA's database shortly after submission.

What Happens After Registration?

Once your facility is registered and your products are listed, you are in FDA's system as a known cosmetic establishment. This means:

FDA can contact you through your U.S. Agent. Expect that FDA may send verification communications, inspection notices, or general correspondence through your U.S. Agent. Make sure your agent is prepared and responsive.

Your facility is eligible for FDA inspection. MoCRA grants FDA authority to inspect cosmetic facilities. While routine inspections of foreign facilities are less common than domestic inspections, they do occur — and FDA may also conduct inspections at the time of import through its field offices.

You must maintain compliance. Registration is the starting point, not the finish line. Ongoing obligations include adverse event reporting, GMP compliance (once final rules are issued), maintaining accurate product listings, and responding to FDA communications through your U.S. Agent.

Getting Help with Registration

If you need assistance with the U.S. Agent component of your registration, US Compliance Agent can have you set up in minutes. Our MoCRA U.S. Agent service is $249 per year and includes everything you need for the U.S. Agent portion of your FURLS registration: a verified U.S. mailing address, a U.S. phone number, same-day forwarding of FDA correspondence, and your official designation letter.

We do not provide registration submission services, product listing assistance, or regulatory consulting. We provide the U.S. Agent designation — and we do it fast, affordably, and reliably.

Visit our MoCRA service page or pricing page to get started.

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.