MoCRA Cosmetic Facility Registration & Listing

The Modernization of Cosmetics Regulation Act (MoCRA) requires cosmetic facilities that manufacture or process products for U.S. distribution to register with FDA, list all products, and comply with new safety and labeling requirements. LMG handles the complete process.

MoCRA Compliance Facility Registration Product Listing Foreign Facilities Welcome Since 2009

Regulatory Reference

MoCRA — Cosmetic Registration at a Glance

Legal Authority

Modernization of Cosmetics Regulation Act of 2022 (MoCRA); FD&C Act §607

Who Must Register

Any facility that manufactures or processes cosmetic products for U.S. distribution

Facility Renewal

Biennially — every two years from initial registration

Product Listing Update

Annually — all marketed products must be listed and updated each year from the date of initial listing.

Amendment Deadline

Within 60 days of any change to registration information

Foreign Facilities

Must designate a U.S. Agent physically located in the United States

Responsible Person

Manufacturer, packer, or distributor named on product label — responsible for safety & compliance

FDA Government Fee

$0 — no FDA fee for MoCRA facility registration or product listing

60 daysTo Report Changes

120 daysNew Product Listing

BiennialFacility Renewal

AnnualProduct Listing Update

Who Must Register Under MoCRA?

MoCRA requires any facility that manufactures or processes cosmetic products for distribution in the United States to register with FDA and list all marketed products — whether the facility is domestic or foreign.

Registration Required

Domestic cosmetic manufacturers and processors
Foreign facilities manufacturing cosmetics for U.S. distribution
Contract manufacturers producing cosmetics for U.S. brands
Private label manufacturers formulating cosmetics for U.S. sale
Facilities that repackage cosmetic products (filling product containers)
Facilities producing cosmetics sold via TikTok Shop, Amazon, or direct-to-consumer into the U.S.

Exempt from Registration

Beauty salons and spas that don't manufacture products on-site
Cosmetic retailers, pharmacies, and distribution facilities
Hospitals, physicians' offices, and health care clinics
Facilities that only label, relabel, package, repackage, hold, or distribute
Small businesses with avg. gross U.S. sales under $1M/year — with exceptions (see below)

MoCRA Registration Requirements & Timeline

MoCRA introduced firm deadlines for initial registration, product listing, amendments, and renewal. Missing these windows can expose your facility to FDA enforcement action and import refusals.

Initial Facility Registration

Facilities manufacturing or processing cosmetics as of December 29, 2022 must have registered by July 1, 2024. Facilities that begin operations after December 29, 2022 must register within 60 days of first engaging in manufacturing or processing, or by July 1, 2024 — whichever is later. Foreign facilities must designate a U.S. Agent as part of registration.

Initial Cosmetic Product Listing

The Responsible Person for a cosmetic product marketed as of December 29, 2022 must have submitted a product listing by July 1, 2024. For products first marketed after that date, the listing must be submitted within 120 days of first marketing the product, or by July 1, 2024 — whichever is later.

Annual Product Listing Update

Cosmetic product listings must be updated annually to reflect any discontinued products, or changes to the label design. This is separate from the facility renewal cycle. LMG manages all annual listing updates for clients to ensure continuous compliance.

Biennial Facility Renewal

Cosmetic facility registrations must be renewed every two years. Failure to renew results in a lapsed registration. Unlike drug and device registrations, there is no fixed October–December renewal window — the renewal is tied to the anniversary of the facility's initial registration date.

Amendments — Within 60 Days of Any Change

Any changes to registration information — facility address, ownership, Responsible Person, or U.S. Agent — must be reported to FDA within 60 days of the change, including changes that result in cancellation of the registration. LMG files all amendments promptly on behalf of clients.

MoCRA Registration Exemptions — Who Qualifies

MoCRA exempts certain businesses from facility registration and product listing requirements, including:

Beauty Shops & SalonsUnless the establishment manufactures or processes cosmetic products at that location

Retailers & DistributorsIncluding individual sales reps, direct sellers, retail distribution facilities, and pharmacies — unless manufacturing on-site

Hospitals & Health ClinicsPhysicians' offices, hospitals, and healthcare clinics providing cosmetics directly to patients

Hotels & Service ProvidersEntities that provide complimentary cosmetics to customers incidental to other services (hotels, airlines)

R&D Only EstablishmentsFacilities that manufacture or process cosmetics solely for research, evaluation, or production testing — not offered for retail sale

Labeling & Distribution OnlyEstablishments that solely label, relabel, package, repackage, hold, or distribute — but do not fill product containers

Small Business Exemption Threshold: Facilities with average gross annual U.S. cosmetic sales under $1,000,000 (adjusted for inflation) for the previous 3-year period are generally exempt. However, this exemption does not apply if the facility manufactures any of the following product types: (1) products that regularly contact the mucous membrane of the eye, (2) injectable products, (3) products intended for internal use, or (4) products that alter appearance for more than 24 hours where removal by the consumer is not customary. If your products fall into these categories, registration is required regardless of revenue.

MoCRA Cosmetic Registration Services — How LMG Can Help

LMG handles every step of your MoCRA compliance — from initial facility registration and product listing through biennial renewals, amendments, and U.S. Agent designation.

MoCRA Facility Registration

Complete preparation and submission of your FDA MoCRA cosmetic facility registration — domestic and foreign facilities.

Cosmetic Product Listing

Full product listing submission for all marketed cosmetic products, including annual updates and new product additions.

U.S. Agent Service

LMG serves as your designated U.S. Agent — mandatory for all foreign cosmetic establishments registering under MoCRA.

Biennial Renewal Management

LMG tracks your renewal cycle and manages the biennial registration renewal so your facility never lapses.

Cosmetic Label Review

Label compliance review for FDA MoCRA requirements including ingredient listing, Responsible Person details, and warning statements.

Export Certificate & TikTok FDA Registration

FDA export certificates and TikTok Shop FDA registration certificates — verifiable by customers and platform partners at fdahelp.us.

Frequently Asked Questions

Common questions about MoCRA facility registration, product listing, the small business exemption, and LMG's service.

What is MoCRA and who must comply?

MoCRA (Modernization of Cosmetics Regulation Act of 2022) is the most significant update to U.S. cosmetic regulation in over 80 years. It requires cosmetic facilities that manufacture or process products for U.S. distribution to register with FDA, list all products, designate a Responsible Person, and comply with new safety substantiation and labeling requirements. Both domestic and foreign facilities are covered.

When must facilities register and list products?

Facilities operating as of December 29, 2022 must have registered by July 1, 2024. New facilities must register within 60 days of beginning manufacturing. Product listings must be submitted within 120 days of first marketing a product. Listings must be updated annually, and facility registrations must be renewed biennially.

Does the small business exemption apply to my business?

The small business exemption covers facilities with average annual U.S. cosmetic sales under $1,000,000 for the previous 3 years. However, this exemption does not apply if your products contact the eye’s mucous membrane, are injectable, are for internal use, or alter appearance for more than 24 hours without consumer removal. If any product falls into these categories, registration is required regardless of revenue.

Is a U.S. Agent required for foreign cosmetic facilities?

Yes. Foreign cosmetic establishments must designate a U.S. Agent as part of their MoCRA facility registration. The agent must be physically located in the United States and available to receive FDA communications. LMG provides U.S. Agent services specifically for foreign cosmetic manufacturers importing into the U.S.

What is a Responsible Person under MoCRA?

The Responsible Person is the manufacturer, packer, or distributor whose name and address appears on the cosmetic product label. They are legally responsible for ensuring the product is safe, properly labeled, and compliant with all FDA MoCRA requirements — including maintaining safety substantiation records and submitting product listings.

Does my cosmetic product need FDA approval before selling in the U.S.?

No. Unlike drugs and medical devices, cosmetic products do not require FDA pre-market approval. MoCRA registration and product listing confirm your facility and products are in FDA’s database, but this is not an approval or endorsement of your product’s safety. The Responsible Person is solely responsible for ensuring product safety before marketing.