The Modernization of Cosmetics Regulation Act (MoCRA), signed into law in December 2022, represents the most significant update to U.S. cosmetics regulation in over 80 years. For beauty brand founders, understanding MoCRA is no longer optional — it is a fundamental part of running a compliant business. Whether you are launching your first product or managing an established line, these regulations affect how you formulate, manufacture, label, and sell your products.

What Is MoCRA?

MoCRA gives the FDA greater authority to regulate the cosmetics industry. Before MoCRA, cosmetics were one of the least regulated product categories under FDA oversight. The new law introduces requirements that bring cosmetics regulation closer in line with other consumer products, including mandatory facility registration, product listing, adverse event reporting, and safety substantiation.

The goal of MoCRA is to improve consumer safety while creating a more transparent cosmetics marketplace. For brands that have always prioritized quality and safety, many of these requirements simply formalize existing best practices. For others, compliance will require meaningful changes to their operations.

Key Requirements for Cosmetics Brands

MoCRA introduces several core requirements that every cosmetics brand must understand and comply with. These requirements are being phased in over time, but brands should be working toward full compliance now.

Facility Registration: All manufacturing and processing facilities must register with the FDA and renew their registration every two years.
Product Listing: Brands must submit a listing for each cosmetic product, including ingredients and labeling information.
Good Manufacturing Practices: Facilities must follow GMP guidelines to ensure product safety and consistency.
Safety Substantiation: Brands must have adequate evidence that their products are safe under normal use conditions.
Adverse Event Reporting: Serious adverse events must be reported to the FDA within 15 business days.
Labeling Requirements: Products must include proper ingredient labeling, allergen declarations for certain fragrances, and contact information for adverse event reporting.

Facility Registration and Product Listing

Facility registration is one of the most straightforward MoCRA requirements, but it is also one of the most important. Every facility that manufactures or processes cosmetics for distribution in the United States must register with the FDA. This includes contract manufacturers, private label facilities, and any brand that manufactures its own products. Registration must be renewed every two years.

Product listing requires brands to submit detailed information about each product they sell, including the product name, category, ingredient list, and labeling. This creates a centralized database that helps the FDA monitor the cosmetics market and respond to safety concerns more effectively. If you are working with a contract manufacturer, coordinate with them to ensure all products manufactured on your behalf are properly listed.

Safety Substantiation and Adverse Event Reporting

Under MoCRA, brands must be able to demonstrate that their products are safe. This does not necessarily mean conducting clinical trials for every product, but it does mean having adequate data — from ingredient safety assessments, stability testing, microbiological testing, and other relevant studies — to support the safety of your formulations.

Adverse event reporting is a critical compliance area. If a consumer experiences a serious adverse event related to your product, you are required to report it to the FDA within 15 business days. You must also maintain records of all adverse event reports for at least six years. Having a clear process for receiving, documenting, and reporting adverse events is essential.

How Working with an FDA-Registered Manufacturer Helps

One of the most effective ways to ensure MoCRA compliance is to partner with a manufacturer that is already FDA-registered and follows GMP protocols. An experienced manufacturer will have facility registration in place, follow documented GMP procedures, conduct stability and safety testing as part of their standard process, maintain proper batch documentation for traceability, and provide the documentation you need for product listing and compliance audits.

Working with the right manufacturing partner does not eliminate your compliance responsibilities as a brand, but it significantly reduces the complexity and risk. At Romano Group, our FDA-registered facility and GMP-compliant processes are designed to help brands meet MoCRA requirements with confidence, so you can focus on growing your business while knowing your products meet the highest regulatory standards.

Romano Group Team

Expert insights on beauty manufacturing, formulation, and regulatory compliance.