On 12 September 2025, the US Food and Drug Administration (FDA) announced the launch of the FDA Adverse Event Reporting System (FAERS) Public Dashboard for Cosmetic Products. FAERS is an interactive tool that provides the public with real-time access to adverse events reports associated with cosmetic products.
The new dashboard includes both serious adverse event reports submitted by responsible persons for cosmetic products, as defined under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), and voluntary reports submitted to the FDA by healthcare professionals, consumers, salon professionals, cosmetologists, and others.
Through this public platform, users can search, filter, and download adverse event data. Reports are updated daily, improving transparency and accessibility.
Adverse event reporting under MoCRA
Among the key requirements established by MoCRA, cosmetic manufacturers and distributors are now required to maintain a system for recording adverse events and for reporting serious adverse events to the FDA, a framework similar to that used for medical devices.
In addition, cosmetic product labels must now include a contact point for consumers to report adverse events directly to the responsible person, their US agent, or another suitable entity authorized on their behalf. This contact information – such as an email address – must be clearly identified on the label to ensure consumers understand its purpose.
Important warning on data interpretation
The FDA warns that the reports displayed in the dashboard have not been verified by the agency. The inclusion of a report in the database does not indicate that the FDA has determined a cosmetic product caused the reported event. In this sense, the data should not be interpreted as an indicator of a product’s overall safety profile.
If you have questions on MoCRA compliance or want to appoint Obelis as your U.S. Agent and adverse event contact point, contact us.
Chiara Lai
Regulatory Intelligence and Innovation Department
13/10/2025
References:
FDA. (2025). FDA Launches Real-Time Adverse Event Reporting Dashboard for Cosmetic Products. Retrieved on 13 September 2025.
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