MoCRA
On December 29, 2022, the U.S. enacted the most significant update to cosmetics regulation since 1938 with the Modernization of Cosmetics Regulation Act (MoCRA). This landmark legislation introduces a series of new requirements for the cosmetics industry and is poised to have a major impact on cosmetic brands distributing in the United States.
​
MoCRA represents a fundamental shift in how cosmetic products are regulated, increasing the oversight and authority of the FDA. The Act grants the FDA enhanced powers, including the ability to suspend facility registrations and mandate product recalls, ensuring greater protection for public health. With its more rigorous surveillance and inspection protocols, MoCRA brings U.S. regulations more in line with the approach taken by the European Union, focusing on consumer safety and product accountability.
1. MOCRA Regulatory Consultation & Strategy
We offer in-depth consultations to assess your current practices and develop a strategic roadmap for full MOCRA compliance. From ingredient safety evaluations to product registration, we ensure your brand meets all regulatory requirements.
​
2. Product Ingredient Safety & Compliance
We help assess the safety of your cosmetic ingredients by partnering with trusted testing and service labs to ensure they meet FDA standards and are appropriately documented. Our team will guide you through ingredient safety assessments, preparation of ingredient safety reports, and maintaining accurate, up-to-date formulations.
​
3. FDA Facility & Product Registration
We assist with the FDA registration process for both your facility and cosmetic products, ensuring that all required information is submitted accurately and on time. Our team will guide you through the entire registration process, making sure your products are fully compliant with MOCRA’s requirements and keeping your business up to date with FDA regulations.
​
4. Labeling Compliance & Review
We ensure your product labels are fully compliant with MOCRA and FDA regulations. Our team will carefully review all labeling elements, including ingredient listings, product claims, warnings, and any other required information, to ensure accuracy and adherence to the latest guidelines. We help you navigate the complex labeling requirements, reducing the risk of costly mistakes or delays.
​
5. Ongoing Compliance Monitoring
Stay proactive in compliance with continuous monitoring and audits. We offer ongoing support to ensure your products remain aligned with any future updates to MOCRA and other regulatory changes in the cosmetic industry.