US FDA opens public portal for reporting cosmetic adverse events

The US Food and Drug Administration (FDA) has launched a public dashboard for consumers to access and report cosmetics that they believe to have exhibited adverse effects. The interactive tool aims to increase government–constituent transparency.

The FDA Adverse Event Reporting System (FAERS) Public Dashboard for Cosmetic Products is designed to facilitate the public’s access to “real-time” event data on cosmetic products. 

The move is part of the FDA’s modernization strategy under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). 

“Adverse event reporting should be fast, seamless, and transparent,” says FDA Commissioner Martin Makary. “People who navigate the government’s clunky adverse event reporting websites should not have to wait months for that information to become public. We’re closing that waiting period and will continue to streamline the process from start to finish.”

The FDA has issued a disclaimer that it does not verify reports in the dashboard and that their publication does not indicate that it has concluded that the product caused the adverse event. Additionally, the FAERS data is not an indicator of the cosmetic product’s overall safety profile.

Information transparency

Described as “user-friendly,” the platform allows users to download report listings or data sets. Reports are updated daily to include the most recent submissions. FAERS for cosmetics contains reports for moisturizers, shampoos, conditioners, hair dyes, and tattoos.

“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,” says Makary.

The US FDA has released a public dashboard in an effort to improve transparency in cosmetic adverse event reporting. The dashboard includes “serious” adverse event reports submitted by “responsible persons” for cosmetic products under requirements established by MoCRA. It also features voluntary adverse event reports submitted to the FDA by health care professionals, consumers, salon professionals, and cosmetologists. 

Users can search and view reports using various search terms, including the product name and adverse event term. Additionally, users can filter and sort results by different criteria, such as the severity level of the adverse event, date, or report type. 

This data was previously only available through the Human Foods Complaint System (HFCS), formerly known as the CFSAN Adverse Event Reporting System (CAERS). The new dashboard centralizes the reporting and query process.

Earlier this year, we spoke to compliance firm Registrar Corp after finding that half (48%) of the companies selling imported cosmetics at America’s top 25 retailers were non-compliant with the US FDA’s cosmetics regulations. 

At the time, the personal care industry was anticipating how incoming US health department appointees under the new Trump presidency, such as Makary, might address the potential threat to consumer safety.

US regulatory moves

In US cosmetic safety news, California recently became the first US state to ban plastic microbeads in leave-on personal care and cleaning products. Assembly Bill 823 passed the Senate Floor, taking effect on January 1, 2029. Another year will allow the selling out of stocks before additionally banning the sales of cosmetics containing plastic glitter in 2030.  

In May, Personal Care Insights attended an expert panel hosted by the FDA to discuss the dangers of talc in cosmetics. The international panel unanimously favored a ban. 

The EU will ban the powder in 2027 due to its health risks when applied to the skin or ingested. FDA Commissioner Makary stressed that the US should follow the EU’s lead on the ban.