The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the first major change to FDA’s cosmetics authorities since the passage of the Food, Drug, and Cosmetic Act in 1938. Among other changes in requirements, MoCRA establishes the first ever requirement for cosmetic companies to monitor and document all consumer allegations of adverse health effects and report to the FDA those adverse events that meet FDA’s new and revised definition of a “serious” adverse event specific to cosmetics.
Enactment of the Mandatory Adverse Event reporting section of the legislation is December 29th, 2023, less than 2 months away!
Now is a good time for manufacturers to review their capabilities and ability to comply with the new requirements. With 19+ years of experience providing FDA compliance reporting services, SafetyCall is well equipped to provide cosmetic manufacturers assistance with their adverse event reporting
Contact us today to explore how SafetyCall can help your organization!