FDA Adverse Event Reporting System (FAERS)

United Safety Agents
Sep 25
2 min read

United Safety Agents - FDA Adverse Event System (FAERS)

FDA Launches Real-Time Adverse Event Dashboard

In an effort to strengthen trasparency within the cosmetics industry, the U.S. Food and Drug Administration (FDA) has introduced a Real-Time Adverse Event Dashboard for Cosmetic Products, known as FDA Adverse Event Reporting System (FAERS).

This development stems from the Modernization of Cosmetics Regulation Act (MoCRA), passed in 2022, which established new safety requirements for the U.S. cosmetics market. Among these requirements is the mandatory reporting of serious adverse events linked to cosmetic products in the United States, a responsibility that falls on the designated Responsible Person for each brand.

Serious adverse event reports must be submitted to the FDA by the Responsible Person within 15 business days of the reported incident, along with a copy of the product's cosmetic label. Maintenance of these reports has also been mandated under MoCRA for up to 6 years and up to 3 years if the Responsible Person is considered a small business.

With the launch of this dashboard, the FDA is providing the public direct access to real-time data on adverse events. The tool is designed to increase visibility, accountability, and consumer trust by allowing individuals to track safety-related reports more openly than ever before. For consumers, this empowers more informed purchasing decisions, and for businesses, it underscores the need to stay vigilant in monitoring product safety and compliance.

While the FDA acknowledges that reports in the FAERS database, may have limitations, as reports received may be incomplete, inaccurate, untimely, or unverified, they still serve as a valuable resource and represent an important step toward increasing public awareness. For more detailed information on a specific product, the FDA recommends submitting a Freedom of Information Act (FOIA) request.

You can access the FAERS database here.