MoCRA Facility Registration & Product Listing: 2025 Compliance Guide

What MoCRA Changed for the Cosmetics Industry

Signed into law in December 2022, the Modernization of Cosmetics Regulation Act (MoCRA) fundamentally transformed how the FDA oversees cosmetic products sold in the United States. For the first time, cosmetic manufacturers and distributors are required to register their facilities and list their products with the FDA — obligations that were previously voluntary.

If your company manufactures, processes, packs, or holds cosmetic products for distribution in the U.S., MoCRA applies to you — including foreign facilities that export cosmetics to the American market.

Facility Registration Requirements

Who Must Register

Any facility that manufactures or processes cosmetic products for U.S. distribution must register with the FDA. This includes:

Domestic manufacturers and contract manufacturers
Foreign manufacturers exporting to the U.S.
Facilities that repack or relabel finished cosmetics

Small businesses (average annual gross sales under $1 million, not involving certain high-risk products) may qualify for an exemption.

What Information Is Required

When registering your facility, you must submit:

Facility name, address, and contact information
Name of the responsible person or U.S. agent (for foreign facilities)
Product categories manufactured at the facility
A unique Facility Establishment Identifier (FEI) number

Registration Deadlines and Renewal

Initial registration was due December 29, 2023 for most facilities
Registrations must be renewed biennially (every two years)
Any changes to registration information must be updated within 60 days

Product Listing Requirements

What Must Be Listed

Every cosmetic product marketed in the U.S. must be listed with the FDA. A listing covers:

Product name and category
Applicable cosmetic product categories (FDA's defined list)
List of ingredients (using INCI nomenclature)
Name and address of the responsible person
The facility where the product is manufactured or processed

Annual Updates

Product listings must be updated annually, and any new products must be listed within 120 days of first marketing in the U.S.

Safety Substantiation

MoCRA codified the requirement that cosmetic products must be adequately substantiated for safety before marketing. This means:

Maintaining safety data for each product and its ingredients
Having documented evidence that the product is safe under intended or reasonably foreseeable conditions of use
The responsible person (typically the brand owner) bears this responsibility

While FDA does not require pre-market approval for cosmetics, companies must be prepared to provide safety information upon request.

Adverse Event Reporting

Under MoCRA, responsible persons must:

Report serious adverse events (those involving hospitalization, significant disfigurement, or medical intervention) to FDA within 15 business days
Maintain records of all adverse event reports for 6 years
Include contact information on product labels for consumers to report adverse events

Labeling Requirements Under MoCRA

MoCRA introduced a new labeling requirement: cosmetic product labels must include a domestic address, domestic phone number, or electronic contact that consumers can use to report adverse events and obtain product information.

Common Compliance Mistakes to Avoid

Assuming you're exempt without verifying your annual revenue and product categories
Missing renewal deadlines — FDA has indicated it will enforce registration requirements
Incomplete ingredient listings — all ingredients must be listed using proper INCI names
No documented safety substantiation — this is now a legal requirement, not just a best practice
Forgetting foreign facility requirements — if you manufacture outside the U.S. and sell in the U.S., you must register

How United Regulatory Can Help

Navigating MoCRA compliance requires expertise across regulatory submissions, safety documentation, and labeling review. Our team provides:

Facility registration and product listing submissions through FDA's Cosmetics Direct portal
Safety substantiation packages tailored to your product formulations
Adverse event reporting systems and SOP development
Label review and update to ensure full MoCRA compliance
Ongoing monitoring of FDA guidance as MoCRA regulations continue to evolve