Navigating the Waters of MoCRA: A Guide for Cosmetic Industry Stakeholders

The cosmetic industry is undergoing a significant transformation with the introduction of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).

This landmark legislation represents the most substantial overhaul of the United States' cosmetics regulation since 1938, aiming to elevate product safety, transparency, and consumer trust. Here, we explore the expanded FDA authority under MoCRA, the key requirements and changes, and provide guidance for navigating these new regulatory waters.

Expanded FDA Authority

MoCRA marks a pivotal shift in the regulatory framework, granting the Food and Drug Administration (FDA) unprecedented authority over the cosmetics sector. This expansion enables the FDA to more effectively ensure the safety of cosmetic products, a crucial development given the widespread daily use of these products by consumers. The FDA's enhanced role under MoCRA involves overseeing various aspects of the cosmetics industry, from ingredient safety to product labeling and manufacturing practices.

Key Requirements and Changes

Adverse Event Reporting: MoCRA mandates that cosmetic companies report serious adverse events, such as severe allergic reactions or chemical burns, within 15 business days. These events are significant health-related incidents directly linked to the use of a cosmetic product. The act also requires companies to maintain these records for six years (three years for small businesses), underscoring the importance of robust record-keeping and monitoring systems.

Facility Registration and Renewal: Under MoCRA, manufacturers and processors must register their facilities with the FDA and renew this registration every two years. This critical step ensures the FDA can monitor entities involved in cosmetic production, enhancing the overall oversight of the industry.

Cosmetic Product Listing: Companies are required to list each cosmetic product with the FDA, detailing ingredients and other relevant information. This comprehensive product listing aids the FDA in tracking and ensuring the safety of cosmetic products on the market.

Navigating MoCRA Compliance

Navigating the new MoCRA landscape involves understanding and implementing several key steps to ensure compliance:

Understand the Scope of MoCRA: Stakeholders must first comprehend the breadth and depth of MoCRA's impact on their operations. This includes familiarizing themselves with the expanded FDA authority and the specific requirements introduced by the act.

Implement Robust Reporting Systems: Establishing effective systems for adverse event reporting is crucial. Companies must ensure that they can promptly report adverse events to the FDA and maintain detailed records as required.

Register and Renew Facilities: Organizations should methodically approach the process of facility registration, ensuring that all necessary information is accurately provided to the FDA. Regular renewal of this registration is also essential to maintain compliance.

List Cosmetic Products Diligently: Meticulous attention to the product listing process is vital. Companies must ensure that all products are listed with the FDA, with accurate and comprehensive information provided.

Conclusion

The enactment of MoCRA signifies a new era in cosmetic regulation, emphasizing safety, transparency, and accountability. For manufacturers, brand owners, and other stakeholders in the cosmetic industry, understanding and adhering to these new regulations is paramount. By proactively navigating the complexities of MoCRA, companies can ensure compliance, safeguard consumer trust, and uphold the integrity of their products in the marketplace. With the right approach and resources, navigating the waters of MoCRA can become a manageable and rewarding journey towards enhanced product safety and industry excellence.