FDA Issues Updated Instructions for Serious Adverse Event Reporting for Cosmetic Products

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which will go into effect on December 29, 2023, requires the reporting of serious adverse events in cosmetics. The U.S. Food and Drug Administration (FDA) gave an update on December 14, 2023.

Within 15 business days after a serious adverse event related to the use of cosmetic items in the US, a responsible party has a responsibility to report it to the FDA. A copy of the label must be placed on or inside the retail package of the previously mentioned cosmetic product by the person in charge. Within a year of the first report to the FDA, if the responsible person learns of any medical or other information regarding the adverse event, they must notify the FDA of any new information within 15 business days.

As defined by section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act, a responsible person is the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product.

A serious adverse event:

a. Results in:

• Cause deaths
• a life-threatening experience;
• inpatient hospitalization;
• a persistent or significant disability or incapacity;
• a congenital anomaly or birth defect;
• an infection; or significant disfigurement (including serious and persistent rashes, second- or third-degree burns, significant hair loss, or persistent or significant alteration of appearance), other than as intended under conditions of use that are customary or usual; or

b. Required, based on reasonable medical judgment.

The MoCRA recommends that the responsible person submit serious adverse event reports using the current MedWatch Form 3500A to submit. The FDA updated the instructions for the MedWatch Form 3500A.