The article focuses on the impact of the Modernization of Cosmetics Regulation Act (MoCRA) on the cosmetics industry, emphasizing the shift toward improved adverse event reporting and our new AEM Software. The new regulation, which came into effect at the end of 2023, requires cosmetic companies to enhance transparency by listing contact information on packaging for consumers to report any adverse effects. This significant change requires companies to track, evaluate, and report these events to the FDA, adding a layer of accountability.

Jaclyn Bellomo, Senior Director of Cosmetic Science and Regulatory Affairs at Registrar Corp, highlights the difficulties brands face in adapting to MoCRA’s new standards. She notes that the process of reporting adverse events is not straightforward. It involves careful assessment by trained staff to determine the severity of the issue and compliance with FDA requirements for detailed information gathering.

To address these challenges, Registrar Corp has developed Adverse Event Management (AEM) software. This software provides companies with an electronic contact method, typically in the form of a QR code or URL on product packaging, allowing consumers to directly report incidents. The AEM platform automatically notifies brands in real-time when an event is reported, ensuring swift action. It also organizes and tracks data, formatting serious reports for FDA submission, easing the compliance burden.

Bellomo underscores that AEM not only streamlines the process but also helps brands comply with MoCRA’s regulations effectively. As companies navigate these new requirements, tools like AEM become essential for managing consumer safety data, enhancing industry accountability, and ensuring compliance with FDA standards.

Read the full article on Cosmetics Design.