The cosmetics industry has always been one of the most dynamic and competitive sectors worldwide. However, entering the U.S. market comes with unique regulatory responsibilities. With the introduction of the Modernization of Cosmetics Regulation Act (MOCRA), brands must now adapt to a new, stricter compliance framework that prioritizes product safety, consumer protection, and transparency. For companies that want to thrive in the U.S., understanding MOCRA is no longer optional—it is essential.
What is MOCRA and Why is It Important?
Enacted in 2022, the Modernization of Cosmetics Regulation Act represents the most significant update to U.S. cosmetics regulation since 1938. The law establishes a comprehensive set of requirements enforced by the U.S. Food and Drug Administration (FDA). Its purpose is to ensure that cosmetics available in the U.S. market meet strict safety standards and provide consumers with clear, accurate information.
MOCRA introduces several key obligations for manufacturers, distributors, and brand owners. These include:
- Facility registration with the FDA, updated every two years.
- Product listing of each cosmetic product marketed in the U.S.
- Mandatory safety substantiation to prove that products are safe for consumer use.
- Labelling compliance, including allergen disclosures and standardized warnings.
- Appointment of a Responsible Person in the United States to oversee compliance.
Non-compliance with these regulations can result in warning letters, financial penalties, recalls, or removal from the U.S. market altogether.
CE.way’s End-to-End MOCRA Services
CE.way has extensive experience guiding companies through complex global regulatory frameworks. Our dedicated MOCRA services are tailored to help cosmetics businesses enter and remain compliant in the U.S. market.
1. Formula Review
We carefully evaluate product formulations to ensure they meet U.S. safety standards and comply with both federal and state requirements.
2. Labelling Review
Our team examines product labels for accuracy, claim substantiation, ingredient declarations, and FDA-compliant formatting, reducing the risk of costly relabeling or market withdrawal.
3. U.S. Cosmetics State Legislations
Beyond federal law, some states enforce additional cosmetic rules, such as California’s Proposition 65. We help brands stay ahead by monitoring these local requirements.
4. U.S. Responsible Person Support
Under MOCRA, each cosmetic company must designate a Responsible Person within the United States. CE.way provides full support, acting as your compliance partner and ensuring timely responses to FDA inquiries.
5. U.S. Agent Service
Our U.S. agent service ensures clear communication with the FDA and helps manage regulatory notifications effectively.
6. Product Listing
We register your products in the FDA system and keep listings up to date, as required under MOCRA.
7. Product Safety Substantiation
CE.way assists in collecting, preparing, and reviewing documentation that confirms product safety, an essential part of compliance.
8. Facility Registration
Manufacturing and processing facilities must be registered with the FDA. We manage the registration process, renewals, and updates every two years.
Why Partner With CE.way?
Expanding into the U.S. is an exciting opportunity for cosmetic brands, but regulatory mistakes can be costly. With our expertise, businesses can avoid unnecessary delays and penalties, focusing instead on growth and innovation.
CE.way offers personalized solutions, combining global regulatory knowledge with practical experience in the U.S. cosmetics market. By partnering with us, you gain peace of mind knowing that every step of your compliance journey is handled professionally and efficiently.
Start Your MOCRA Compliance Journey Today
The U.S. cosmetics market holds enormous potential, but only for those who meet the requirements of the Modernization of Cosmetics Regulation Act. CE.way is here to help you navigate the process from start to finish, making compliance straightforward and accessible.
👉 Discover more about our MOCRA services and let CE.way guide your brand toward full compliance and success in the U.S. market.
