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

Today, the U.S. FDA has provided an update on its ongoing activities related to serious adverse event reporting mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which are enforceable starting December 29, 2023.

A responsible person is required to report serious adverse events associated with the use of cosmetic products in the United States to FDA within 15 business days. The responsible person must include a copy of the label on or within the retail packaging of such cosmetic product. If the responsible person receives medical or other information about the adverse event within 1 year of the initial report to FDA, they must submit this new information to FDA within 15 business days.

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

The FDA identifies a serious adverse event as an adverse 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; 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) requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described in (A) above.

In November 2023, FDA updated the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) Web page to recommend that industry responsible persons submit serious adverse event reports for cosmetics by using the current MedWatch Form 3500A that is downloadable and fillable at MedWatch: The FDA Safety Information and Adverse Event Reporting Program – Mandatory (PDF).

FDA is developing a process for submitting electronic mandatory adverse event reports for cosmetics. FDA will provide more information on the launch date in the coming months. Electronic format seems to be the preferred FDA way to facilitate efficiency and timeliness of data submission and management for the agency.

In today’s update, the FDA provided an address and email address as the current options to submit the completed form and the requested information.