US Food and Drug Administration Expands FAERS Dashboard to Include Cosmetic Products

Shoshana Golden and Emily Cowley Leongini of Arent Fox Schiff report that the US Food and Drug Administration (FDA) has broadened its transparency efforts by expanding access to adverse event data. Following last month’s decision to publish daily reports for drugs and biologics through the FDA Adverse Event Reporting System (FAERS), the agency has now launched a public dashboard specifically for cosmetic products.

This marks the first time cosmetic adverse events are made available through FAERS. According to the FDA, the initiative is part of its modernization strategy to enhance “radical transparency.” The dashboard compiles serious adverse event reports submitted under the Modernization of Cosmetics Regulation Act of 2022, as well as voluntary reports from healthcare professionals, consumers, and other parties. Users can search data by product name, reaction type, and other criteria, making the system broadly accessible.

While the FDA requires visitors to acknowledge a disclaimer clarifying that publication does not indicate a confirmed causal link between products and reported reactions, Golden and Leongini note that the information could still influence consumer perceptions, spark competitor actions, or serve as the basis for class litigation. The Food and Drug Administration emphasizes that adverse event reports are not an authoritative measure of product safety, but that distinction may be overlooked by external audiences.

For compliance officers, the expansion highlights the importance of maintaining systems to identify, assess, and report adverse events. Beyond reporting obligations, monitoring FAERS data can help companies anticipate reputational or legal risks. Golden and Leongini stress that organizations should treat this shift as both a compliance requirement and a strategic consideration in managing consumer and regulatory expectations.