Modernization of Cosmetics Regulation Act Overview

This document is a guide detailing the Modernization of Cosmetics Regulation Act (MoCRA) of 2022 and its implications for cosmetic regulation in the United States. It outlines the responsibilities of manufacturers, packers, and distributors, referred to as Responsible Persons, and the requirements for facility registration and product listing. The guide specifies that all cosmetic products marketed by December 29, 2022, must be listed by December 2023, and those introduced afterward must be listed within 120 days. It also emphasizes the need for adequate safety substantiation for cosmetic products and mandates reporting of serious adverse events to the FDA. Additionally, the document discusses upcoming changes in labeling requirements and the enforcement powers of the FDA under MoCRA. It concludes with a checklist of actions that stakeholders should take to comply with the new regulations, including designating a Responsible Person and reviewing records for safety substantiation.