Per the notice below, the United States Food and Drug Administration (FDA) has launched an adverse event reporting dashboard for cosmetic products.

FDA Launches Real-Time Adverse Event Reporting Dashboard for Cosmetic Products

The U.S. Food and Drug Administration today announced the launch of the FDA Adverse Event Reporting System (FAERS) Public Dashboard for Cosmetic Products, an interactive tool designed to facilitate the public’s ability to query real-time adverse event data on cosmetic products.  The user-friendly platform allows users to download report listings or data sets, with reports being updated daily to include the most recent submissions.  Today’s launch marks another step in the FDA’s modernization strategy, which includes radical transparency.  It follows the agency’s recent announcement on real-time reporting of adverse event and medication errors data for drugs and therapeutic biologics.

“Americans are rightfully demanding greater insight into the safety and regulation of the cosmetic products they use every day.  This real-time dashboard is a great step in our efforts to deliver greater transparency and allow the public to help identify potential data signals,” said FDA Commissioner Marty Makary, M.D., M.P.H.

The dashboard is dedicated exclusively to reports of cosmetic product adverse events, making the data easier to search.  It includes serious adverse event reports submitted by responsible persons for cosmetic products under requirements established by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), as well as voluntary adverse event reports submitted to the FDA by healthcare professionals, consumers, salon professionals, cosmetologists, and others.  The FAERS dashboard contains adverse event reports for cosmetic products, such as moisturizers, shampoos, conditioners, hair dyes, and tattoos.  Users can search and view reports using various search terms including the product name and adverse event term.  Additionally, users can filter and sort results by different criteria, such as severity level of the adverse event, date, or report type.  This comprehensive search capability ensures that users can efficiently locate the specific information they need from the database.  Reports in this dashboard have not been verified by the FDA, and their publication does not indicate that the FDA has concluded the product caused the adverse event.  Additionally, the FAERS data is not an indicator of the safety profile of the cosmetic product.  To learn more, read the frequently asked questions.  For information about reporting adverse events, visit MedWatch, the FDA’s medical product safety reporting program for health professionals, patients, and consumers.

Related Information:

• FDA Adverse Event Reporting System (FAERS) Public Dashboard for Cosmetic Products
• Modernization of Cosmetics Regulation Act of 2022 (MoCRA) | FDA
• How to Report a Cosmetic Product Related Complaint | FDA
• OpenFDA: An application program interface (API) alternative providing public FDA data including cosmetic product adverse event data