The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) has introduced requirements for cosmetic companies to report serious adverse events associated with their products.

Definition of Serious Adverse Event:

A serious adverse event is defined as any health-related event associated with the use of a cosmetic product that results in: death, life-threatening experience, inpatient hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect, infection, significant disfigurement (including serious and persistent rashes, second- or third-degree burns, significant hair loss, or persistent or significant alteration of appearance), or requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described above.