The United States remains one of the largest cosmetics markets in the world. However, the regulatory landscape has changed significantly since the Modernization of Cosmetics Regulation Act, known as MoCRA, was enacted in December 2022.
With key requirements such as Facility Registration and Product Listing taking effect in July 2024, regulatory compliance has become increasingly important for cosmetics brands planning to enter the U.S. market.
For indie beauty brands in particular, reviewing MoCRA requirements during the product development stage can help reduce regulatory risks and support a smoother market entry process.
In this article, we will review the key MoCRA requirements and practical considerations that brands should understand before entering the U.S. market.
Changes in the Regulatory Environment Under MoCRA
MoCRA was enacted to modernize U.S. cosmetics regulations and strengthen consumer safety oversight.
One of the most important changes is that cosmetics brands are now expected to manage regulatory information on an ongoing basis, even after a product has launched. With new requirements covering facility registration, product listing, safety documentation, and adverse event reporting, brands preparing to enter the U.S. market need a more structured approach to compliance.
For this reason, MoCRA should not be viewed simply as a registration requirement. It should be understood as a broader operational and quality management framework for selling cosmetics in the United States.
Key Requirements for Facility Registration
Facility Registration is the process of registering cosmetic manufacturing or processing facilities with the FDA for products sold in the U.S. market.
Many brands work with OEM or ODM partners and may assume that facility registration is solely the manufacturer’s responsibility. In practice, brands should also confirm that their manufacturing facilities meet the applicable requirements and clearly define responsibilities with their manufacturing partners before entering the U.S. market.
Facilities located outside the United States may also be subject to registration requirements. For this reason, it is important to verify the registration status of manufacturing partners and maintain the relevant documentation. Facility information also plays an important role in product traceability and quality management if any issues arise after launch.
In addition, facility registrations must be renewed every two years through Biennial Renewal, and new facilities are generally required to register within 60 days of beginning manufacturing or processing activities. Brands should therefore monitor both the registration status of their manufacturing partners and upcoming renewal schedules.
Product Listing Management
Product Listing refers to the submission of cosmetic product information to the FDA for products sold in the U.S. market.
This information may include product names, brand names, ingredient details, and manufacturing facility information. It must also be properly managed whenever changes occur.
For brands with multiple SKUs, the amount of information that needs to be managed increases as the product portfolio grows. Changes to product names, formulations, or packaging can create compliance challenges if product information is not organized and updated systematically.
Brands preparing to enter the U.S. market should establish a product data management system early and put clear processes in place to maintain accurate and current information.
Product Listing is not a one time submission. Brands are expected to update product information annually, including changes to existing products and discontinued products. For this reason, a strong SKU management system is highly recommended.
The Role and Responsibilities of the Responsible Person
The Responsible Person, or RP, serves as the central compliance contact under MoCRA.
The RP is not simply a contact person. This role is directly connected to key regulatory obligations, including product listing, adverse event intake and reporting, and the maintenance of safety related records. In most cases, the manufacturer, packer, or distributor identified on the product label serves as the Responsible Person.
Many brands assume that manufacturers handle all regulatory responsibilities. However, brands should also understand the role and responsibilities of the RP. Before entering the U.S. market, it is important to determine who will serve as the Responsible Person and to establish consumer inquiry channels and internal compliance procedures.
MoCRA also requires product labels to include a mailing address, phone number, or electronic contact method that allows consumers to reach the Responsible Person. As a result, designating an RP is closely connected to consumer communication and adverse event intake systems.
Scope of Safety Substantiation
MoCRA requires brands to maintain adequate substantiation demonstrating the safety of their cosmetic products.
This requirement goes beyond a single test report. It includes a broader body of supporting evidence, such as ingredient safety information, stability assessments, and quality related documentation that can show product safety under intended conditions of use.
In the U.S. market, well organized product safety documentation can also support brand credibility. For this reason, brands should establish systems for collecting, organizing, and retaining safety related information from the product development stage onward.
Serious Adverse Event Reporting Preparedness
MoCRA places strong emphasis on having systems in place to manage adverse events related to consumer safety.
Serious Adverse Events are different from routine consumer complaints, and the Responsible Person may be required to receive reports and complete the applicable reporting procedures.
Many brands focus heavily on marketing and launch preparation while leaving adverse event preparedness until later. However, in the U.S. market, records related to consumer inquiries, adverse event reports, and corrective actions may become important compliance documentation.
Brands should establish internal procedures and record management systems before product launch to ensure timely responses if any issues arise after commercialization.
Small Business Exemption Criteria
MoCRA includes exemption provisions that may relieve certain small businesses from specific regulatory obligations.
However, many brands mistakenly assume that small businesses are entirely exempt from MoCRA requirements. In reality, while certain facility registration and product listing obligations may be exempted, consumer safety obligations such as product safety substantiation and adverse event management generally remain applicable.
Certain product categories may also be excluded from exemption eligibility. For this reason, brands should evaluate both product type and regulatory scope rather than relying only on company size.
Generally, businesses with average annual sales below USD 1 million over the previous three years may qualify for certain exemptions related to facility registration and product listing. However, products intended for use in the eye area, injectable products, internally used products, or products intended to alter appearance for more than 24 hours may be excluded from exemption eligibility regardless of sales volume.
Even when the Small Business Exemption applies, obligations related to Safety Substantiation and Serious Adverse Event Reporting may still apply.
Key Practical Considerations for Indie Brands
One of the most common mistakes indie brands make is treating regulatory compliance as something to address only after product launch.
In reality, facility registration, product listing, Responsible Person designation, and safety documentation should all be considered during product development. Delaying these steps until just before launch can lead to unnecessary delays, additional costs, and avoidable regulatory risks.
Brands should also avoid assuming that OEM or ODM partners will handle all regulatory responsibilities. Understanding compliance requirements and clearly defining responsibilities between the brand owner and manufacturing partners is essential before entering the U.S. market.
In addition, the FDA is expected to continue developing cosmetic Good Manufacturing Practice regulations, making manufacturing quality systems increasingly important. Brands preparing for U.S. market entry should therefore evaluate not only current MoCRA requirements, but also the quality management and documentation capabilities of their manufacturing partners.
Final Checklist
□ Confirm Facility Registration requirements
□ Prepare Product Listing information
□ Designate a Responsible Person
□ Establish consumer inquiry channels
□ Secure product safety documentation
□ Develop adverse event response procedures
□ Define responsibilities with OEM or ODM partners
□ Review Small Business Exemption eligibility
□ Establish document and record retention systems
□ Implement procedures for updating product information
□ Monitor Facility Registration renewal schedules
□ Establish annual Product Listing update procedures
Preparing for MoCRA Compliance Early
Addressing MoCRA requirements during product development is far more efficient than trying to meet compliance requirements after entering the market.
Facility registration, product listing, Responsible Person designation, and safety documentation should all be prepared before product launch, rather than treated as follow up tasks after commercialization.
Neo Mirae provides OEM and ODM solutions from product development to manufacturing, supported by extensive experience in creating skincare and personal care products for global markets.
