Quick Answer
MoCRA facility registration requires cosmetics manufacturers to register through FDA's Cosmetics Direct portal. You need your facility details, product category information, a Responsible Person, and (for foreign facilities) a U.S. Agent. Registration is free from FDA and must be renewed biennially.
Who Must Register Under MoCRA?
The Modernization of Cosmetics Regulation Act (MoCRA), codified in FD&C Act Section 607, requires facility registration for every establishment that manufactures or processes cosmetic products for distribution in the United States. This includes:
- Domestic manufacturers: Any U.S.-based facility that manufactures, packages, or labels cosmetic products
- Contract manufacturers: Third-party facilities that produce cosmetics on behalf of brand owners
- Foreign facilities: Any facility outside the United States that manufactures cosmetics for export to the U.S. market
Facilities that only store, distribute, or sell finished cosmetic products without manufacturing or processing them are generally exempt. The small business exemption (for companies with average gross annual sales under $1 million in cosmetic products over the previous three years) expired on December 29, 2025, under FD&C Act Section 607(b)(5). All covered facilities must now be registered regardless of size.
Before You Begin: What You Need
Gather the following information before starting your registration:
- Facility name and physical address: The actual location where cosmetics are manufactured or processed
- DUNS number: While not strictly required for cosmetics registration, having your Data Universal Numbering System number can expedite the process
- Contact person: Name, email, and phone number of the individual managing the registration
- Product categories: The types of cosmetics produced at the facility (e.g., skin care, hair care, color cosmetics, fragrances)
- Responsible Person: The manufacturer, packer, or distributor whose name appears on the product label (required under FD&C Act Section 604)
- U.S. Agent (foreign facilities only): A U.S.-based individual or entity designated to communicate with FDA on your behalf
Step-by-Step Registration Process
Step 1: Create an FDA Account
Visit access.fda.gov and create an FDA Industry Systems account if you don't already have one. You will need to verify your email and set up multi-factor authentication.
Step 2: Access Cosmetics Direct
Once logged in, navigate to the Cosmetics Direct module. This is FDA's dedicated system for MoCRA facility registration and product listing. Select "Facility Registration" to begin.
Step 3: Enter Facility Information
Provide the facility name, physical address, and type (domestic or foreign). If you operate multiple manufacturing sites, each facility must be registered separately. Enter your contact person's details and verify that all information is accurate.
Step 4: Designate a U.S. Agent (Foreign Facilities)
Foreign facilities must provide U.S. Agent information, including name, U.S. address, phone number, and email. Your U.S. Agent must confirm their willingness to serve before you can complete registration. Assurentry provides same-day U.S. Agent designation for MoCRA registrations.
Step 5: Select Product Categories
Choose the cosmetic product categories manufactured at this facility. FDA uses a standardized category system. Select all categories that apply — you can update these later if your product portfolio changes.
Step 6: Review and Submit
Review all entered information for accuracy, then submit. FDA does not charge a fee for cosmetics facility registration. You should receive a confirmation with your facility registration number within a few business days.
Important Reminder
Facility registration is only the first step. MoCRA also requires product listing for every cosmetic product you market in the U.S. Product listing is a separate submission in Cosmetics Direct and must be completed within 120 days of marketing a new product.
Biennial Renewal Requirements
MoCRA facility registrations must be renewed biennially (every two years). Facilities that initially registered in 2024 will need to renew in 2026. The renewal process requires you to verify and update your facility information, U.S. Agent details (if applicable), and product categories.
Failing to renew on time results in your registration being marked as inactive. An inactive registration means your products may be detained at U.S. ports and your facility may be flagged for enforcement action.
Common Registration Mistakes
- Incorrect facility address: Using a mailing address instead of the physical manufacturing address
- Missing U.S. Agent: Attempting to submit a foreign facility registration without designating a U.S. Agent
- Wrong product categories: Selecting categories that don't match the products actually manufactured at the facility
- Confusing registration with listing: Completing facility registration but failing to list individual products
- Forgetting contract manufacturers: Brand owners must ensure their contract manufacturers are also registered
Need help with MoCRA facility registration?
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