At Compliance Insight, Inc., we understand the critical importance of staying ahead in the rapidly evolving regulatory landscape of the cosmetics industry. The Modernization of Cosmetics Regulations Act (MoCRA) represents a significant shift in the way cosmetic products are regulated in the United States, emphasizing safety, transparency, and consumer protection. As a leading quality assurance and regulatory affairs consulting firm, we are here to guide you through every step of complying with these new requirements.

Background on MoCRA

For decades, the regulatory framework governing cosmetics in the U.S. remained relatively unchanged, lagging behind the innovations and advancements within the industry. Recognizing the need for an update to protect consumers and ensure product safety, the U.S. government introduced the Modernization of Cosmetics Regulations Act (MoCRA). This act is a comprehensive overhaul designed to align the cosmetics industry with contemporary standards of safety, testing, and accountability.

The Importance of MoCRA

MoCRA introduces a range of new requirements for cosmetic manufacturers and distributors, including but not limited to:

• Enhanced Product Safety Standards: MoCRA mandates stricter safety assessments and reporting for cosmetic products, ensuring that all items on the market have been rigorously evaluated for consumer safety.
• Mandatory Adverse Event Reporting: Companies are required to report adverse reactions to their products, providing the FDA with essential data to protect public health.
• Registration and Product Listing: MoCRA requires all cosmetic facilities and their product formulations to be registered with the FDA, promoting transparency and traceability within the industry.

New Regulations to be in Effect

The implementation of MoCRA signifies a pivotal moment for the cosmetics industry, setting new benchmarks for product safety and consumer trust. Compliance Insight, Inc. is at the forefront of interpreting these regulations, ready to assist your business in adapting to these changes efficiently and effectively. We offer comprehensive services tailored to ensure your products not only meet but exceed the new regulatory standards set forth by MoCRA.

How we can help you:

• Regulatory Strategy and Compliance Planning: Developing a customized plan to navigate MoCRA regulations as they are rolled out, tailored to your business needs.
• Labeling and Packaging Review: Ensuring your product labels are fully compliant with MoCRA labeling requirements.
• Adverse Event Reporting Systems: Implementing robust systems for monitoring and reporting adverse events in compliance with MoCRA.
• Registration and Listing: Generating and submitting the facility registration as required and listing the cosmetic products on a timely basis.  Renewing registration and listing biennually.