In a significant move towards increased transparency under the Modernization of Cosmetics Regulation Act (MoCRA), the U.S. Food and Drug Administration (FDA) has launched the FDA Adverse Event Reporting System (FAERS) Public Dashboard for Cosmetic Products.

This new, user-friendly dashboard is an interactive tool that allows the public, industry, and researchers to query and download real-time data on adverse events related to cosmetic products. According to the FDA, the reports are updated daily to include the most recent submissions.

The dashboard contains data from two key sources:

  • Mandatory Reports: Serious adverse event reports submitted by cosmetic companies (“responsible persons”) as required by MoCRA.
  • Voluntary Reports: Reports submitted to the FDA by consumers, healthcare professionals, and others.

Impact on the Industry:

This public-facing tool marks a new era of transparency for cosmetic product safety. It provides a direct view into the safety data being collected by the agency and will be a critical resource for post-market surveillance. Companies can monitor trends related to their own products, ingredients, and entire product categories.

We encourage all industry professionals, particularly those in regulatory, quality, and safety roles, to explore this new dashboard to understand its capabilities and implications for your business.

Please contact us if you require assistance with your adverse event reporting procedures or overall MoCRA compliance strategy.