Navigating the complex world of cosmetic regulations in the United States can be challenging, especially with the introduction of the Modernization of Cosmetics Regulation Act (MoCRA). At CE.way, we specialize in US MoCRA FDA cosmetics regulatory assistance, helping brands and manufacturers ensure their cosmetic products are compliant, safe, and ready for the U.S. market.
Our team combines deep regulatory expertise with a fully equipped in-house laboratory, offering all necessary testing and compliance services under one roof. Whether you’re a start-up entering the market for the first time or an established international company expanding to the U.S., CE.way provides a smooth, transparent, and efficient route to compliance.
Understanding MoCRA – The New Era of Cosmetic Regulation in the U.S.
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents the most significant change to U.S. cosmetic laws in decades. Its primary goal is to enhance product safety, increase transparency, and ensure accountability within the cosmetic industry.
From December 29, 2023, all cosmetic products placed on the U.S. market must comply with MoCRA’s requirements, which include:
- Mandatory facility registration and product listing with the FDA
- Appointment of a Responsible Person for each product
- Implementation of Good Manufacturing Practices (GMP)
- Safety substantiation for all cosmetic ingredients and finished products
- Adverse event reporting
- Updated labelling requirements effective by the end of 2024
At CE.way, we guide clients through each step of this process, ensuring that every submission, report, and document is properly prepared and submitted according to FDA standards.
MoCRA Exemptions for Small Businesses
MoCRA recognizes the unique position of small cosmetic businesses and provides certain regulatory exemptions to support innovation and market entry.
Small businesses (those with less than $1,000,000 in annual U.S. sales over the last three years) are exempt from specific requirements such as facility registration, GMP, and product listing, unless they produce higher-risk products, such as:
- Eye-area products
- Injectables
- Internally used cosmetics
- Long-lasting or altering products
However, these companies must still meet essential safety obligations, including product labelling, safety substantiation, and adverse event reporting. CE.way helps ensure that even small businesses maintain compliance without unnecessary complexity.
Comprehensive CE.way MoCRA Services
To help cosmetic brands comply with MoCRA, we provide an all-in-one solution tailored to your needs:
- US Responsible Person support
- US Agent service
- Formula and labelling review
- Product safety substantiation
- Product listing and facility registration
- Efficacy and safety testing in our in-house laboratory
Our clients trust CE.way because we combine scientific precision with regulatory expertise. With over 1,000 companies served, 7,000+ products notified, and clients from 38+ countries, we are one of the most experienced partners in global cosmetics compliance.
Why Choose CE.way?
Working with CE.way means working with a team that understands both the science and the legislation behind cosmetics. We don’t just handle paperwork — we ensure your formulations are compliant, your documentation is accurate, and your entry to the U.S. market is seamless.
Whether you need a Responsible Person in the U.S. or comprehensive US MoCRA FDA cosmetics regulatory assistance, we are your trusted partner from concept to compliance.
👉 Learn more and get started today at https://ceway.us/
