Key Takeaways:
Like many federal systems touched since President Trump began his second term, the U.S. Food and Drug Administration’s Adverse Event Reporting System (FAERS) dashboard has been replaced—but this overhaul may prove to be one of the rare upgrades.
In March, the agency announced a new all-in-one adverse event reporting platform that collapses multiple adverse event reporting systems across cosmetics, vaccines, and animal foods and drugs into one system called the FDA Adverse Event Monitoring System (AEMS).
“The [AEMS] serves as a unified platform to consolidate multiple reporting systems previously used across all FDA-regulated product categories, including cosmetics,” an FDA representative told BeautyMatter. “It advances FDA's cosmetics safety surveillance capabilities under the Federal Food, Drug, and Cosmetic Act, as amended by the Modernization of Cosmetics Regulation Act [MoCRA].”
According to the representative, the dashboard will allow users to search by the original suspect reported product name and adverse event terms, offering the public “transparency and analytical capability that was not previously available for cosmetics.”
The FDA anticipates that this increased transparency will help spur the submission of more detailed and complete reports from consumers, healthcare providers, and other members of the public. With more reports now appearing in real time, regulators caution that the data could be misinterpreted by consumers who assume reports indicate confirmed safety issues.
“Users should interpret adverse event data with appropriate scientific rigor, recognizing that reports represent associations rather than confirmed causation and require careful evaluation in context,” the FDA representative stated. “FDA notes that adverse event reports submitted to FDA do not undergo validation or verification of accuracy, completeness, or consistency, and that the existence of a report does not establish that a product caused or contributed to an adverse event.”
The launch of AEMS is part of a broader modernization effort inside the agency aimed at replacing outdated internal systems and improving public access to regulatory data. Previously, adverse event reports were scattered across seven separate databases, including FAERS, the Vaccine Adverse Event Reporting System (VAERS), and several systems tracking animal drugs and food complaints.
The FDA launched FAERS just six months ago; the agency had an unusually short lifespan, even by the standards of President Trump’s second-term rapid regulatory shakeups.
Together, these systems processed roughly 6 million adverse event reports per year but were widely criticized for their fragmented architecture and difficult user interface. According to the FDA, the legacy systems cost the agency approximately $37 million annually to operate.
By consolidating those databases into AEMS, the agency expects to generate $120 million in savings over the next five years while also improving its ability to detect safety signals across product categories.
“The FDA’s previous adverse event reporting systems were outdated and fragmented and made important data difficult to access,” said FDA Commissioner Marty Makary, MD, MPH, in a statement announcing the launch. “These clunky systems also wasted millions of taxpayer dollars and created blind spots in our postmarket surveillance of products ranging from drugs and vaccines to cosmetics.”
Makary added that the new platform marks a significant step forward in the agency’s push to modernize its data infrastructure. “Starting today, the FDA will have a single, intuitive adverse event platform that will better serve agency scientists, researchers, and the public.”
Over the coming months, additional legacy reporting systems—including those tracking medical devices, tobacco products, and dietary supplements—will be migrated into AEMS. By May 2026, the agency expects the platform to contain real-time adverse event reports across all FDA-regulated products, while maintaining safeguards to ensure that individually identifiable patient or consumer information is not disclosed.
The agency also expects the real-time publication of reports to reduce the volume of Freedom of Information Act (FOIA) requests for adverse event data, which historically had to be released on a quarterly basis.
“The platform's advanced data management, unified architecture, and search capabilities are expected to enable more effective monitoring, facilitate trend identification across diverse product categories, and support timely regulatory decision-making to protect public health through improved data integration and analysis capabilities,” the FDA representative concluded.
For the beauty industry, the new system arrives as regulators begin implementing MoCRA, the most significant overhaul of US cosmetics regulation in decades. The law expanded requirements around adverse event reporting, giving the FDA new authority to monitor post-market safety data and mandate recalls when necessary.