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Monday, September 15, 2025International

The US FDA launches a public database on undesirable effects

La US FDA lance une base de données publique sur les effets indésirables

On 12 September 2025, the US Food and Drug Administration announced the launch of a public database of its Adverse Event Reporting System (FAERS) for cosmetic products, intended for consultation by consumers.

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“This launch marks another step in the FDA’s modernization strategy, which includes radical transparency”, the Agency says in it press release.
And transparency is complete, since this database, linked to a search engine, gives consumers access to all available data on undesirable effects reported to the FDA since 2001, with the promise of daily updates.
The public has free access to all this data and can apply various selection filters, such as product name, brand, type of adverse reaction, date of occurrence, etc.

All reports of undesirable effects are published, whether they are mandatory reports submitted to the MoCRA, voluntary reports from manufacturers and distributors, or reports made by healthcare professionals or consumers themselves.
Hence this warning from the Agency: “Reports in this dashboard have not been verified by the FDA, and their publication does not indicate that the FDA has concluded the product caused the adverse event. Additionally, the FAERS data is not an indicator of the safety profile of the cosmetic product.”

Sources
FDA Launches Real-Time Adverse Event Reporting Dashboard for Cosmetic Products, Press announcement, FDA, 12 September 2025

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