Last month, the US Food and Drug Administration (FDA) announced that it would begin daily publication of adverse event data for drugs and biologics via the FDA Adverse Event Reporting System (FAERS).
Three weeks later, the FDA has now announced that — for the first time — it would also begin publishing adverse event data for cosmetic products via FAERS.
Per the FDA, the launch of the FAERS Public Dashboard for Cosmetic Products is another step in the agency’s modernization strategy, including efforts to promote “radical transparency.” The public facing, easily searchable dashboard includes serious adverse event reports submitted to the FDA pursuant to new reporting requirements under the Modernization of Cosmetics Regulation Act of 2022, as well as voluntary submissions by any number of parties, including health care professionals and consumers. Notably, users can search for adverse events data using a variety of search terms, including product name and reaction term (e.g., rash, eye injury, etc.).
While the FDA requires visitors to acknowledge a robust disclaimer stating that, among other things, the FDA has not verified adverse event reports in the dashboard, publication in the dashboard does not mean that the FDA has concluded that a product caused an adverse event, and the FAERS data is not an indicator of the safety profile of the cosmetic product, this is unlikely to deter anxious consumers, competitors, or class action attorneys from drawing their own conclusions.
Companies marketing cosmetic products in the United States must be cognizant of the FDA’s adverse event reporting requirements and ensure they have adequate systems in place to determine whether consumer complaints constitute reportable adverse events. Companies may also want to monitor adverse event data reported in FAERS, as it could serve as a basis for competitor or class action challenges and could potentially inform consumer decision-making, despite the FDA’s clear disclaimers.
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