Continuing with our coverage of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), today’s focus centers on the FDA’s guidance on cosmetic product listings. MoCRA signifies the most noteworthy expansion of FDA’s authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic (FD&C) Act was passed in 1938.
Under MoCRA, cosmetics manufacturers and brand owners have new obligations to adhere to. For the first time, these include mandatory facility registration with FDA, mandatory product listing with FDA, and compliance with requirements regarding safety substantiation and good manufacturing practices. Additionally, manufacturers and brand owners are obliged to report any adverse events.
As previously reported, a deep dive into these significant updates reveals their far-reaching impacts within the industry and multiple levels of the supply chain, not least towards enhancing the safety and integrity of cosmetic products.
It’s crucial for legal professionals working in this sector to have deep comprehension of these new guidelines. Their adept understanding should inform effective strategies, and ensure the companies they work for are on the right side of regulatory compliance. The new requirements also provide an opportunity to engage with the FDA on defining best practices within the industry.
To this effect, Bryan Cave Leighton Paisner offers an insightful exploration into the implications and implementation strategies of MoCRA’s requirements. Through the series, legal professionals and other stakeholders can gain an enriched understanding of the latest regulatory updates in cosmetics production, manufacturing, and distribution. Stay tuned for further reports as we dissect these changes, keeping you abreast with the evolving legal landscape.