FDA unveils FAERS tool for Cosmetic Product Adverse Event

On 12 September 2025, The U.S. Food and Drug Administration (FDA) has launched the FDA Adverse Event Reporting System (FAERS) Public Dashboard for Cosmetic Products, an interactive platform designed to provide real-time access to adverse event reports associated with cosmetic products. FDA has released the update as a press announcement on the portal. This initiative enhances transparency, empowers stakeholders with accessible safety information, and supports the FDA’s broader modernization strategy. The system covers a broad range of cosmetic categories, such as moisturizers, shampoos, conditioners, hair dyes, and tattoos.

FDA Adverse Event Reporting System (FAERS)

The launch of this dashboard aligns with the FDA’s push toward radical transparency, complementing earlier initiatives such as real-time reporting of adverse events and medication errors for drugs and therapeutic biologics. The platform centralizes reports exclusively related to cosmetic products, including those required under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) and voluntary submissions from healthcare professionals, consumers, and cosmetic industry professionals.

Insights from the FAERS Dashboard

• Real-time Access: Daily updated reports, downloadable datasets.
• Comprehensive Search: Filter by product, event, severity, date, or type.
• Public Transparency: Addresses demand for safety visibility.
• Limitations: Reports unverified; do not confirm causation or safety profile.



Obligations for Stakeholders

Under MoCRA, companies are required to submit serious adverse event reports for cosmetic products to the FDA, while healthcare professionals, salon professionals, cosmetologists, and consumers are encouraged to voluntarily report incidents to strengthen safety surveillance. Although the dashboard enhances transparency, the data serves only as a monitoring tool and not a definitive safety assessment, requiring businesses to analyze signals proactively and take mitigation measures when risks are identified.