FDA Updates Instructions for Reporting Severe Adverse Events for Cosmetic Products under MoCRA

On December 14, 2023, the U.S. Food and Drug Administration (FDA) has updated the instructions for reporting severe adverse events for cosmetic products as mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). MoCRA requires reporting of serious adverse events from December 29, 2023. 

A responsible person  must notify the FDA within 15 working days of significant adverse events involving cosmetic goods in the U.S., including a copy of the labeling on the retail packaging of the product. Additional medical or other information received by the responsible person within one year of the initial report, must be submitted to the FDA within 15 business days. 

The responsible person is the manufacturer, packer, or distributor of a cosmetic product whose name appears on the product's label in accordance with section 4(a) of the Fair Packaging and Labeling Act or section 609(a) of the FD&C Act is considered. 

A serious adverse event is defined as an event that:  

(A)  Results in: 

• death  

• a life-threatening experience 

• inpatient hospitalization 

• a persistent or significant disability or incapacity 

• a congenital anomaly or birth defect 

• an infection 

• significant disfigurement (including serious and persistent rashes, second- or third-degree burns, significant hair loss, or persistent or significant change of appearance), other than as intended under customary or usual conditions of use. 

B) Necessitates a medical or surgical intervention based on reasonable medical judgment in order to  prevent an outcome mentioned in (A) above.

The FDA updated the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) web page in November 2023, recommending that industry responsible persons use the current MedWatch Form 3500A, which can be downloaded and completed at MedWatch: The FDA Safety Information and Adverse Event Reporting Program - Mandatory (PDF), to submit serious adverse event reports for cosmetics.