Today, let me introduce you to MoCRA, the Modernization of Cosmetics Regulation Act, which is essential for exporting cosmetics to the United States.
The United States remains a key export market for K-beauty. As of 2023, the U.S. accounted for 18.7% of total cosmetics exports, ranking second, with a significant growth rate of 57.2% compared to the previous year.
From the increased interest in skincare among Gen Z to premium men’s cosmetics, the U.S. beauty market continues to grow steadily while diversifying.
However, entering the U.S. market now requires not only excellent product quality but also a solid ability to comply with local regulations. Especially with the implementation of the Modernization of Cosmetics Regulation Act (MoCRA), both brands and manufacturers must adhere to new obligations.
1. What is MoCRA? A Major Overhaul of U.S. Cosmetics Regulations
MoCRA represents the largest change to cosmetics regulations since the FD&C Act (Federal Food, Drug, and Cosmetic Act) of 1938, passed during the Biden administration. It grants the FDA (Food and Drug Administration) the following authority over cosmetics:
1) Mandatory registration of manufacturing facilities and product listings
2) Access to safety data
3) Obligations to report adverse events
4) Authority to enforce product recalls
Additionally, the existing Fair Packaging and Labeling Act (FPLA) remains in effect, requiring essential details such as product name, full ingredient list, manufacturer information, and volume to be displayed.
Below are the key points of MoCRA that must be followed going forward.
2. Key Features of MoCRA
1) Registration of Manufacturing Facilities and Submission of Product Listings
All cosmetics manufacturing and processing facilities (including overseas manufacturers) producing products distributed in the U.S. must register with the FDA and submit Product Listings. This applies to facilities “manufacturing or processing (including importers) cosmetics distributed in the U.S.”
a. FEI numbers and DUNS numbers must be obtained
b. Updates are required every two years, with amendments submitted within 60 days of changes
c. All brand names manufactured at the facility must be reported to prevent manufacturer misrepresentation
⚠️ Previously, products could be sold without registration, but now explicit registration procedures are mandatory.
2) Safety Data and Adverse Event Reporting
While brands do not need to submit safety reports in advance, they must prepare and retain Safety Substantiation for each product, similar to Europe’s CPNP PIF.
[Safety Data Requirements]
a. Must be supported by tests, research, or analysis conducted by scientifically trained professionals
b. These records must be maintained by the Responsible Person (RP, usually the brand or importer)
c. There are no specific standards approved or provided by the FDA, which could lead to disputes or lawsuits if problems arise.
[Adverse Event Reporting Requirements]
a. The Responsible Person must retain records of adverse events for six years (three years for small businesses)
b. Severe adverse events must be reported to the FDA within 15 business days.
: Reporting methods: Submit the MedWatch Form 3500A, email (CAERSCosmetics@fda.hhs.gov), or mail (FDA CDER Mail Center).
📈 Recently, there has been an increase in cases where consumers report adverse effects to the FDA after purchasing products through Amazon, emphasizing the importance of risk management for brands.
3) Labeling Requirements
Under MoCRA, labeling requirements similar to the FPLA continue to apply, requiring the inclusion of: Product name, volume, manufacturer information, and full ingredient list.
[Label Components]
a. Principal Display Panel: Front panel
b. Information Panel: Side or rear panels
c. While expiration dates are not mandatory, they are recommended for quality control purposes.
4) Upcoming GMP Standards
Until now, the U.S. lacked specific national GMP standards for cosmetics and generally followed ISO 22716.
However, by the end of 2025, the FDA plans to release a draft of its own GMP standards for cosmetics. Upon implementation, the FDA will gain authority to inspect manufacturing facilities and review records, and even general cosmetic manufacturers (not just OTC sunscreen products) must comply with these standards.
Manufacturers without GMP certification could face increased risks in exporting to the U.S.
5) Color Additive Regulations
The FDA has strict standards for color additives, making them a frequent cause of import rejections.
[Batch Certification/Exemption for Color Additives]
a. Color additives are one of the most regulated areas by the FDA and a common reason for import rejection.
b. According to FDA regulations, all color additives must be approved for their intended use.
c. Petroleum-based color additives require batch certification from the FDA. d. Some color additives are exempt from batch certification (e.g., MICA and minerals or plant-based additives).
[Points to Note for Products Containing Color Additives]
a. Confirm whether the color additive is FDA-approved for its intended use.
b. If pre-approved, verify whether the color additive requires batch certification.
c. Ensure the name of the color additive is correctly listed in compliance with FDA regulations on the finished product label.
As of December 16, 2023, the FDA has introduced the new system, FDA Cosmetics Direct, based on the existing OTC registration system (CDER). All MoCRA-related registrations will now be processed via this platform.
Looking at the key points of MoCRA, you can see how challenging the FDA procedures have become, even for general cosmetics beyond OTC registration. However, on the flip side, MoCRA regulations are expected to enhance brand credibility and transparency.