The Intersection Of MoCRA And Data Privacy

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) brought major changes to cosmetics regulation. Among other changes, it aligned cosmetics adverse-event record-keeping and reporting with over-the-counter drug requirements. Under MoCRA, cosmetics manufacturers, distributors, and packers must report consumer claims of “serious adverse events” to the U.S. Food and Drug Administration (FDA). Qualifying events include death, life-threatening conditions, inpatient hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect, infection, and significant disfigurement. MoCRA also requires cosmetics manufacturers, distributors, and packers to keep records of any “adverse event,” meaning any negative health-related event, for at least six years. As the MoCRA requirements came into effect prior to most of the state privacy laws being enacted, cosmetic companies should be mindful of compliance with the applicable state data privacy laws in