FDA Launches Dashboard to Provide Access to Real-Time Adverse Event Data for Cosmetics

At a Glance

• The launch of this dashboard follows the agency’s recent announcement of real-time reporting capabilities for adverse event and medication error data concerning drugs and therapeutic biologics.
• Although we acknowledge the technical challenges for dashboard users and significant limitations of the data (limited in number, and not evidence of a product’s overall safety, etc.), the tool still provides access to reports that may contain valuable safety and efficacy feedback for companies.

The U.S. Food and Drug Administration (FDA) has announced the launch of the FDA Adverse Event Reporting System (FAERS) Public Dashboard for Cosmetic Products. This interactive tool enables the public to access and query real-time adverse event (AE) data related to cosmetic products. The dashboard features a user-friendly interface, allowing users to download both report listings and data sets. Notably, the reports are updated daily to reflect the most recent submissions.

This initiative represents a continued effort in FDA’s broader modernization strategy, which emphasizes radical transparency. The launch of this dashboard follows the agency’s recent announcement of real-time reporting capabilities for adverse event and medication error data concerning drugs and therapeutic biologics.

FDA Commissioner Marty Makary, M.D., M.P.H., emphasized the importance of this initiative, stating: “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.” It also serves as a good example of how FDA is leveraging technology in the new leadership’s effort to improve public health outcomes and regulatory processes.

Advanced Search Capabilities

FDA’s announcement says the dashboard includes advanced search functionalities that allow users to filter data by various parameters, such as product type, date range and specific adverse event, which would certainly make it easier for consumer and professional users to locate relevant information for analysis of patterns, etc.

The dashboard begins with a healthy disclaimer where users must acknowledge and accept that FDA has made no assessment as to causation or correlation associated with the cosmetics-related AE reports, among other things.

Guidance for Cosmetic Companies’ Use

Although there are technical challenges for dashboard users and significant limitations of the data (limited in number, and not evidence of a product’s overall safety, etc.), the tool still provides access to reports that may contain valuable safety and efficacy feedback for companies. AI-supported analysis of such real-world data could generate insights and otherwise meaningfully inform decision-making related to the scope and extent of safety substantiation to maintain.