FDA’s New Reporting Standards for Cosmetic Adverse Events

The FDA has announced significant updates for reporting severe adverse events in cosmetics, as required by the 2022 Modernization of Cosmetics Regulation Act (MoCRA). These important changes, affecting manufacturers, packers, and distributors, will become enforceable on December 29, 2023.

Key points of the FDA’s update include:

  1. Reporting Requirements: The designated “responsible person” – often the manufacturer, packer, or distributor listed on the label of a cosmetic product – must report any serious adverse events to the FDA within 15 business days. This report should include a copy of the product label or retail packaging. Furthermore, should new medical or pertinent information about the event arise within one year of the original report, it must also be submitted within a 15-day timeframe.
  1. Definition of Serious Adverse Events: The FDA characterizes adverse severe events as those leading to outcomes such as death, life-threatening experiences, inpatient hospitalization, significant disability or incapacity, congenital anomalies or congenital disabilities, serious infections, or significant disfigurement. This also encompasses events requiring medical or surgical intervention to prevent such outcomes​​.
  1. Reporting Process: To report serious adverse events, the FDA recommends using MedWatch Form 3500A, which is available for download and can be filled out. This form, along with necessary documentation like label images and photos of the event, should be submitted via email or mail. Additionally, the FDA is developing an electronic submission system to streamline and improve the management of these reports.
  1. Future Developments: The FDA has updated the instructions for completing the MedWatch Form 3500A (https://www.fda.gov/media/69876/download) to simplify the reporting process. Additionally, the agency plans to provide further information on the electronic submission process for serious adverse event reports shortly. It encourages this method of submission when it becomes available​​.

This update signifies a significant step in ensuring consumer safety and maintaining stringent regulatory oversight in the cosmetics industry. The FDA’s focus on improving the reporting process and moving towards electronic submissions demonstrates a commitment to keeping pace with technological advancements while prioritizing public health.