FDA's Real-Time Adverse Event Reporting

The U.S. Food and Drug Administration (FDA) has launched a public dashboard for cosmetic products. This interactive platform enables users to download reports or data sets, with reports being updated daily to include the latest submissions. Users can search for and view reports using various search terms including the product name and adverse event term. They can also filter and sort results by different criteria, such as the severity level of the adverse event, the date or the report type. 

FDA Adverse Event Reporting System (FAERS)

The FAERS is the FDA's primary database for collecting and analyzing adverse event reports, serious medication errors, and product quality complaints relating to prescription drugs and therapeutic biologics. It contains reports submitted by healthcare professionals, consumers, and manufacturers. However, the current dashboard is dedicated exclusively to reports of adverse events involving cosmetic products. These include serious adverse event reports submitted by responsible persons for cosmetic products under the requirements of the Modernization of Cosmetics Regulation (MoCRA), as well as voluntary adverse event reports submitted to the FDA by healthcare professionals, consumers, salon professionals, cosmetologists and others. 

The FDA has not verified reports published on this dashboard, and their publication does not indicate that the FDA has concluded the product caused the adverse event. Additionally, FAERS data does not indicate the safety profile of the cosmetic product. Read the FDA News Release on the Dashboard for Cosmetic Products to learn more.