FDA Provides Updated Instructions for Reporting Serious Adverse Events Under MoCRA

On December 14, 2023, the FDA issued an update with further instructions on  serious adverse event reporting under the Modernization of Cosmetics Regulation Act of 2022 (“MoCRA”), which is enforceable starting December 29, 2023.

Pursuant to MoCRA, a “responsible person” (i.e., “the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label”) is required to submit a report on all serious adverse events associated with the intended use of a cosmetic product within 15 business days of receiving that information. Along with the report, responsible persons must submit a copy of the label and any medical or other information they received. And for the year following any reported event, responsible persons must submit any new medical information they receive within 15 business days of receipt. Under MoCRA, responsible persons also have the option of including a statement denying that the cosmetic product caused or contributed to the event; that statement will become part of the record in the event FDA releases adverse event information to the public.

A serious adverse event includes those that result in:

• death,
• threat to life,
• inpatient hospitalization,
• persistent or significant disability or incapacity,
• congenital anomaly or birth defect,
• infection, or
• significant disfigurement.

Notably, serious adverse events do not include minor or transient reactions.

The FDA recommends that responsible persons submit these serious adverse event reports electronically by completing the updated MedWatch Form 3500A in accordance with the updated instructions. The FDA is currently developing a process for electronic submission of serious adverse event reports for cosmetic products, and it has promised to provide more information on the launch date for this electronic submission process “in the coming months.”

In the meantime, responsible persons can send the completed MedWatch Form 3500A, as well as all required information and any optional statement, by email at: CosmeticAERS@fda.hhs.gov or by mail to:

FDA CDER Mail Center
Attn: Cosmetics MedWatch reports
White Oak Campus, Building 22, G0207
10903 New Hampshire Ave.
Silver Spring, MD 20993