The Modernization of Cosmetics Regulation Act (MoCRA), enacted in December 2022, marks the most significant update to U.S. cosmetics legislation in over 80 years. For the first time, the U.S. Food and Drug Administration (FDA) has expanded authority to oversee cosmetics with stricter requirements for safety, labeling, and compliance. For international and domestic brands alike, understanding and adapting to MoCRA is now essential to succeed in the U.S. cosmetics market.
What MoCRA Means for Cosmetics Companies
Under MoCRA, cosmetic manufacturers, packers, and distributors face new obligations that bring the U.S. market closer to international regulatory standards. These include:
- Facility Registration – Domestic and foreign manufacturing facilities must register with the FDA and renew every two years.
- Product Listing – Each cosmetic sold in the U.S. must be listed with the FDA, including its ingredients and Responsible Person.
- Safety Substantiation – Companies must maintain scientific evidence proving the safety of their products.
- Labeling Requirements – Labels must include full ingredient lists, safety warnings, and comply with both federal and state-level rules.
- U.S. Responsible Person & Agent – Foreign brands must appoint a U.S.-based representative to communicate directly with the FDA.
Failure to comply can lead to FDA enforcement actions, import refusals, and product recalls—making compliance more critical than ever.
CE.way: Your Partner in MoCRA Compliance
At CE.way, we specialize in guiding cosmetic companies through every stage of MoCRA compliance. Our services include:
- Formula Review to ensure products contain only permitted ingredients.
- Labeling Review to verify FDA-compliant packaging and claims.
- Product Safety Substantiation with toxicological assessments and documentation.
- Product Listing & Facility Registration to handle FDA submissions on your behalf.
- Acting as your U.S. Responsible Person or Agent, providing seamless communication with regulators.
By combining expert regulatory knowledge with hands-on support, CE.way simplifies complex compliance tasks, allowing brands to focus on growth while we handle the legal framework.
Why Brands Trust CE.way
Our global clients, from emerging indie brands to large-scale manufacturers, rely on us for peace of mind. By partnering with CE.way, companies can enter the U.S. market confidently, knowing their products are safe, compliant, and ready for distribution.
As one international partner shared:
“CE.way is our cosmetics consultant who looks after compilation of PIF, safety assessments and notifications. Their professionalism and expertise make compliance simple and reliable.”
Secure Your Place in the U.S. Market
The new MoCRA legislation has changed the cosmetics landscape in the United States. But with CE.way by your side, compliance does not have to be complicated. From formula reviews and labeling to acting as your U.S. Responsible Person, we make sure your brand meets every requirement.
👉 Ready to expand into the U.S.? Contact CE.way today and let us help you bring your cosmetics to one of the world’s most competitive markets with full regulatory confidence.
