The Modernization of Cosmetics Regulation Act of 2022

The world of cosmetics is about to undergo a profound transformation. The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents the most significant expansion of the FDA's authority to regulate cosmetics since the passage of the Federal Food, Drug, and Cosmetic Act in 1938. Designed to enhance the safety of cosmetic products that millions of consumers use daily, MoCRA is set to reshape the industry landscape. This comprehensive guide will provide you with an in-depth understanding of MoCRA, its key provisions, and the critical deadlines that the cosmetics industry must meet by December 29, 2023.

Unveiling MoCRA: A New Era for Cosmetic Regulation

MoCRA's foundations can be found in the Consolidated Appropriations Act of 2023, specifically in Division FF, Title III, Subtitle E, starting with section 3501. This groundbreaking law introduces several pivotal requirements for the cosmetics industry, all of which must be addressed by the looming deadline.

Key Provisions of MoCRA

Facility Registration: Manufacturers and processors within the cosmetics industry are mandated to register their facilities with the FDA. These registrations must be renewed biennially. A notable aspect of MoCRA is that it grants the FDA the authority to suspend the registration of a facility under certain circumstances. If the FDA determines that a cosmetic product, manufactured or processed by a registered facility and distributed in the United States, poses a reasonable probability of causing severe adverse health consequences or death to humans, it may suspend the facility's registration. This suspension equates to a prohibition on distributing or selling any cosmetic products from the facility within the United States.

Product Listing: Another crucial requirement under MoCRA is product listing. Responsible persons—defined as the manufacturers, packers, or distributors of cosmetic products whose names appear on the product label—must provide a comprehensive listing of each cosmetic product they market. This listing must include detailed information about product ingredients, and updates must be submitted annually.

Safety Substantiation: Companies and individuals who manufacture or market cosmetics bear the responsibility of ensuring the safety of their products. While the law and FDA regulations do not mandate specific tests to demonstrate the safety of individual products or ingredients, a responsible person must ensure and maintain records supporting adequate safety substantiation for their cosmetic products. Manufacturers can rely on relevant safety data already available to support product safety. Notably, MoCRA does not require animal testing for cosmetic products. It is essential, however, that all safety data be derived from scientifically robust methods.

For additional resources on cosmetics safety substantiation, visit "Product Testing of Cosmetics."

Further Regulatory Developments Under MoCRA

 In addition to the key provisions mentioned above, MoCRA requires industry compliance with forthcoming FDA regulations, including:

Good Manufacturing Practice (GMP) Requirements: The FDA will establish GMP requirements for facilities involved in the manufacture of cosmetic products. These requirements aim to ensure that cosmetics are produced under controlled and consistent quality standards. For more information on GMP requirements, explore resources like "Public Meeting: Good Manufacturing Practices for Cosmetic Products Listening Session" and "Draft Guidance for Industry: Cosmetic Good Manufacturing Practices."

Fragrance Allergen Labeling: MoCRA introduces fragrance allergen labeling requirements. These requirements will enhance transparency for consumers with fragrance sensitivities. Stay informed about the development of these regulations.

 Asbestos Detection in Talc-Containing Cosmetic Products: The FDA will establish standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products. This measure aims to safeguard consumers from exposure to potentially harmful substances.

Navigating the Transition with EWC

MoCRA is ushering in a new era of cosmetic regulation, driven by a commitment to consumer safety. As the December 29, 2023, deadline approaches, the cosmetics industry faces an imperative to adapt and comply. At EWC, we are dedicated to guiding you through this transformative journey, ensuring that your business not only meets the requirements of MoCRA but thrives in a safer and more accountable cosmetic landscape. Together, we're shaping the future of cosmetics regulation for the well-being of all.

For further insights, personalized guidance, and support with MoCRA compliance, email us at info@equitywellness.org.