MoCRA Cosmetic Registration Process in the USA: A Complete 2026 Compliance Guide

Axentra compliance
2 days ago
4 min read

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant expansion of FDA authority over cosmetics in over 80 years. Since December 29, 2023, both domestic and foreign cosmetic manufacturers are legally required to register their facilities and list their products with the FDA — or risk import refusals, FDA enforcement actions, and being shut out of the US market.

This guide covers everything you need to know about the MoCRA cosmetic registration process in the USA: who must comply, how to register step by step, what your product labels must include, and how to maintain ongoing compliance in 2026.

What Is MoCRA and Why Does It Matter for Cosmetic Manufacturers?

MoCRA, signed into law on December 29, 2022, amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to give the FDA significantly greater oversight of cosmetic products sold in the United States. Key new powers under MoCRA include:

Mandatory facility registration for all cosmetic manufacturers and processors
Mandatory product listing for all cosmetic product lines distributed in the USA
Safety substantiation requirements for all cosmetic products before US distribution
Serious adverse event reporting obligations for manufacturers and distributors
Good Manufacturing Practice (GMP) standards to be issued by FDA regulation
FDA authority to order mandatory recalls of unsafe cosmetic products

Who Must Register Under MoCRA?

MoCRA facility registration applies to any person or company that owns or operates a facility that manufactures or processes cosmetic products for US distribution. This includes:

Domestic US cosmetic manufacturers and processors
Foreign cosmetic manufacturers whose products are exported to and distributed in the USA
Contract manufacturers producing cosmetics on behalf of brands sold in the US
Indie beauty brands and cosmetic startups manufacturing or co-packing products for the US market

Small business exemption: Businesses with average annual gross sales of cosmetics under $1 million over the previous 3 years may qualify for an exemption from facility registration. However, these small businesses are still required to submit product listings.

Step-by-Step MoCRA Cosmetic Registration Process

Follow these steps to complete your MoCRA facility registration and product listing correctly:

Step 1 — Assess Applicability: Confirm that your facility and products are subject to MoCRA. Verify whether your business qualifies for any exemptions (small business, clinical investigations, etc.).
Step 2 — Appoint a U.S. Agent (Foreign Manufacturers Only): Foreign facilities must designate a U.S.-based FDA Agent before registration can be submitted. The U.S. Agent serves as the official FDA contact and must have a physical US address.
Step 3 — Create a Cosmetics Direct Account: Access the FDA's Cosmetics Direct electronic submission portal at cosmeticsdirect.fda.gov. Create an account using your FDA Industry Systems (FIS) credentials.
Step 4 — Submit Facility Registration: Enter your facility name, physical address, all product categories manufactured at the facility, responsible person information, and U.S. Agent details. Each physical manufacturing location requires a separate registration.
Step 5 — Complete Product Listing: For each cosmetic product line, file a product listing with: product name, cosmetic category (per FDA list), applicable FDA product listing number, full ingredient list in INCI format and descending order, responsible person name and contact details, and the facility where the product is manufactured.
Step 6 — Document Safety Substantiation: Compile and retain adequate safety information to substantiate that your cosmetic product is safe under labeled and reasonably foreseeable conditions of use. This documentation must be available to the FDA upon request.
Step 7 — Renew Regularly: Facility registrations must be renewed every two years. Product listings must be updated annually and whenever a material change occurs (new ingredient, new product name, discontinued product, etc.).

MoCRA Cosmetic Labeling Requirements: What Must Appear on Your Label?

MoCRA strengthened and expanded US cosmetic labeling requirements. Your product labels must now include:

A complete ingredient list using INCI (International Nomenclature Cosmetic Ingredient) names, in descending order of predominance
Name and domestic address or phone number of the responsible person (US importer or distributor)
Fragrance allergen disclosures — MoCRA requires disclosure of any of 26 specific fragrance allergens if present above threshold concentrations
Professional-use only warning statements where applicable
Net quantity of contents in both US customary and metric units

MoCRA Compliance Deadlines and Penalties for Non-Compliance

The initial MoCRA compliance deadlines have already passed: December 29, 2023 for large businesses and July 1, 2024 for small businesses. If you have not yet registered, you are currently out of compliance. Consequences of non-compliance include:

FDA import alerts that prevent your products from entering the United States
FDA warning letters and public enforcement disclosures that can damage brand reputation
Mandatory product recalls initiated by the FDA for safety concerns
Civil monetary penalties for failure to register or maintain required records

How Axentra Global Supports Your MoCRA Compliance

Axentra Global Pharma Compliance LLC provides end-to-end MoCRA compliance support for cosmetic manufacturers worldwide. Our MoCRA services include:

U.S. Agent designation for foreign cosmetic facilities — same-day available
Cosmetics Direct facility registration filing and annual renewal management
Product listing preparation and submission for all cosmetic product lines
Ingredient and labeling review against MoCRA, state cosmetic laws (California SB 312, NY AB 2762), and EU Cosmetics Regulation
Fragrance allergen disclosure assessment and label update guidance
Adverse event reporting program setup and ongoing compliance monitoring

If you are a cosmetic startup entering the US market, an established international brand expanding your distribution, or an existing manufacturer who missed the initial MoCRA deadline, Axentra can get you compliant quickly and cost-effectively. Contact our team today for a free consultation on your MoCRA registration requirements.