FDA launches public dashboard for cosmetic product adverse events
This interactive platform is designed to provide the public with easy access to real-time data on adverse events related to cosmetic products.
USA – The U.S. Food and Drug Administration (FDA) has introduced the FDA Adverse Event Reporting System (FAERS) Public Dashboard for Cosmetic Products specifically for cosmetic products.
This user-friendly tool enables users to search, filter, and download adverse event reports, which are updated daily to reflect the most recent data submissions.
The launch is part of the FDA’s broader modernization efforts, emphasizing radical transparency, and follows similar real-time reporting tools recently introduced for drugs and therapeutic biologics.
FDA Commissioner Marty Makary highlighted the public’s growing demand for transparency around cosmetic product safety, stating, “Americans are rightfully demanding greater insight into the safety and regulation of the cosmetic products they use every day.”
“This real-time dashboard is a great step in our efforts to deliver greater transparency and allow the public to help identify potential data signals.”
The dashboard focuses solely on adverse event reports related to cosmetic products such as moisturizers, shampoos, conditioners, hair dyes, and tattoos.
It includes serious adverse event reports submitted by responsible persons under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), as well as voluntary reports from healthcare professionals, consumers, cosmetologists, and salon professionals.
According to the FDA, users can perform detailed searches by product name, adverse event type, severity, report date, and other criteria to quickly locate specific information.
However, the FDA cautions that the reports in this database have not been verified, and their publication does not imply the FDA has confirmed the product caused the reported event or reflects the product’s overall safety profile.
For those wishing to report adverse events, the FDA directs users to MedWatch, its medical product safety reporting program, which is available to both health professionals and consumers.
In 2023, the FDA updated its instructions for reporting serious adverse events related to cosmetics as mandated by the Modernization of Cosmetics Regulation Act (MoCRA).
Starting December 29, 2023, manufacturers, packers, and distributors were required to report any serious adverse events within 15 business days of becoming aware of them.
Serious adverse events were defined to include death, life-threatening experiences, hospitalization, significant disability, birth defects, infections, or disfigurement beyond intended use.
The FDA also revised the MedWatch Form 3500A to make reporting easier for cosmetic companies.
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