For our Corporate Organizational Members, the FDA is sending out a reminder to ensure that required facilities were properly registered and listed under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
The July 1, 2024 deadline for facility registration and product listing under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). Businesses that have averaged less than $1 million in gross annual sales of cosmetics over the past three years, and which do not manufacture or process certain cosmetic products, may be exempt from these requirements. However, the exemptions do not extend to other requirements, some of which are already in effect, such as those involving maintenance of FDA-standard safety substantiation files for all cosmetic products and implementation of systems to capture, manage, and ensure timely reporting of adverse events.
Failure to comply with the new MoCRA regulations significantly increases risk of exposure to consumer lawsuits and mandatory recalls. Non-compliance may also affect a company's ability to obtain or renew insurance coverage and to collaborate with U.S.-based contract manufacturers, distributors, and shippers. Additionally, e-commerce platforms like Amazon will soon implement procedures to verify compliance of listed cosmetic products, making readiness essential.
If you need additional information, click here for more information regarding the upcoming MoCRA deadline.
Information above authored by Susan G. Etheridge, Esq., Alternative Health Law Firm, P.O. Box 82243, Tampa, FL 33682, (813) 444-3033, susan@alternativehealthlaw.com, www.alternativehealthlaw.com