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FDA MoCRA Cosmetic Facility Registration

MoCRA requires facilities that manufacture or process cosmetics for the U.S. market to register with FDA and renew every two years. Foreign facilities must also designate a U.S. agent. We prepare the filing, submit it, and track renewals.

RegulatorU.S. FDA

PrerequisiteU.S. agent (foreign facilities)

Submission~1-2 weeks

RenewalEvery two years

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What this service is

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) added section 604 to the Federal Food, Drug, and Cosmetic Act, requiring facilities that manufacture or process cosmetics for U.S. distribution to register with FDA and renew the registration every two years.

Facility registration is the first MoCRA step: product listings must reference a valid facility registration number. FDA does not charge an official fee for cosmetic facility registration.

MoCRA (2022)FD&C Act §604

Who needs it

Own-brand factories manufacturing or processing finished cosmetics for the U.S. market

Contract manufacturers serving multiple brands (one registration per facility)

Exporters already selling cosmetics in the U.S. whose facilities are not yet registered under MoCRA

Prerequisites and sequence

Designate a U.S. agent (foreign facilities)→MoCRA Facility Registration

Foreign facilities must designate a U.S. agent as FDA's point of contact before starting the registration.
Facility name and address must match the actual production site and stay consistent with the facility information referenced in product listings.
Certain small businesses are exempt from facility registration, but the exemption never applies to facilities making products that contact the eye mucosa, are injected, are intended for internal use, or alter appearance for extended periods — assess your exemption status first.

Who holds regulatory responsibility

The facility owner or operator is responsible for registration. We prepare the filing, arrange the U.S. agent, and submit; you are responsible for the accuracy of facility and production information.

Materials we need from you

Facility name in Chinese and English and the actual production address

Facility owner/operator details and contact information

Authorized contact details of the U.S. agent (for foreign facilities)

List of cosmetic brands and product categories manufactured or processed at the facility

Business entity documentation

Process

01
Assess whether the facility must register and whether the small-business exemption applies
02
Verify company and facility details and fix the filing basis
03
Designate the U.S. agent (foreign facilities) and confirm authorization
04
Submit the facility registration through FDA's electronic submission channel
05
Obtain and archive the facility registration number for product listings
06
Set up reminders for the two-year renewal and the 60-day update window for changes

Deliverables

FDA facility registration number

Record of the submitted filing and confirmation

Renewal and change-update guidance

Timeline

With complete documents, submission is typically completed in about 1-2 weeks, depending on information verification and FDA system processing.

Scope

What we provide

Registration obligation and exemption assessment
Filing preparation and verification
U.S. agent arrangement (foreign facilities)
Submission and confirmation
Two-year renewal and change reminders

What is not included

Cosmetic GMP system building and inspection preparation (assessed separately)
Re-filing after major facility information changes (available as a separate engagement)
FDA on-site inspection support

What usually follows

MoCRA Product Listing Cosmetic Label Review Cosmetic Ingredient Review

Common pitfalls

Misjudging the small-business exemptionThe exemption never applies to facilities making products that contact the eye mucosa, are injected, are intended for internal use, or alter appearance for extended periods. Assess your exemption status by product category before deciding to skip registration.

Facility details not matching the product listingsListings must reference a valid facility registration number, and mismatched facility names or addresses will stall the listing filing. Keep registration data aligned with the actual site and update it when changes occur.

Missing the renewal and update windowsRegistration renews every two years, and key changes such as facility name or address must be updated within the required window. Set up reminders so a lapsed registration does not block your product listings.

Pricing

Pricing depends on your product, quantity, and target market. Submit your product details and we will come back with a defined scope and quote.

Request a quote

FAQ

Is MoCRA facility registration mandatory?

Yes. MoCRA entered mandatory enforcement from July 2024. Existing facilities had to register within the statutory deadline; new facilities must register within 60 days of starting to manufacture or process cosmetics for the U.S. market.

Does a contract manufacturer register separately for each brand?

No. A contract manufacturing facility registers only once; a single registration covers all cosmetic manufacturing and processing at that facility, whether for multiple brands or for itself.

Does FDA charge a fee for facility registration?

No. FDA charges no official fee for cosmetic facility registration. Service fees come from registration assistance and U.S. agent services.

What happens after registration?

Registration must be renewed every two years, and key changes such as facility name or address must be updated within the required window. In addition, the responsible person must list every marketed product.

Related services

MoCRA Product ListingMoCRA requires the responsible person named on the label to list every cosmetic marketed in the U.S. with FDA, including ingredient information, and update the listing annually. We file each product on your behalf.Cosmetic Label ReviewA clause-by-clause review of your existing label against FDA cosmetic labeling rules: claims wording, ingredient declaration, mandatory statements, type size and layout. You receive an action-point list and a suggested corrected draft, reducing misbranding risk.Cosmetic Ingredient ReviewA clause-by-clause check of your formula under the FDA framework: prohibited and restricted ingredients, color additive rules, and standardized nomenclature (INCI). Risk ingredients are flagged, laying the groundwork for label finalization and product listing.

Disclaimer

This is a filing assistance service; FDA decides whether to accept the registration. This page is general information, not legal advice.