FDA’s New Cosmetic Adverse Event Dashboard Presents Challenges and Opportunities

Late last week, FDA launched its real-time adverse event reporting dashboard for cosmetic products, the FDA Adverse Event Reporting System (FAERS) Public Dashboard for Cosmetic Products. This marks another step in Commissioner Makary’s “radical transparency” initiative. FDA promotes the digital site as an “interactive tool designed to facilitate the public’s ability to query real-time adverse event data on cosmetic products,” as the dashboard allows anyone to search, filter, and download adverse event data for cosmetics and beauty merchandise. Reports update daily rather than quarterly, giving the public immediate access to safety information that was previously buried in government databases.

Aside from the timeliness of the updates, this is a shift from the old world of cosmetic safety reporting. Previously, adverse event data lived in the CFSAN Adverse Event Reporting System (CAERS), was updated quarterly, and was accessible mainly through Freedom of Information Act (FOIA) requests or specialized industry databases. Now, a quick search can reveal a product name and every reported reaction in real-time. The dashboard consolidates both mandatory serious adverse event reports under 21 U.S.C. § 364a and voluntary reports from consumers, healthcare professionals, and salon workers.

The dashboard also reveals the scope of industry compliance after the passage of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), with nearly 46,000 adverse event reports submitted since the law’s mandatory reporting took effect in December 2023. There has been some hand-wringing about whether MoCRA enforcement might weaken under potential budget cuts and staffing reductions at FDA, but this activity suggests that at least the reporting requirements remain a priority for both industry and the agency.

The new system creates both challenges and opportunities for cosmetic companies of all sizes, though. The good news here is that the FDA clearly states these reports aren’t verified, and they don’t indicate the agency has concluded a product caused any adverse event. There’s a disclaimer users have to affirmatively click through that reads that submission of an adverse event report “does not constitute an admission that the facility, importer, distributor, packer, manufacturer or product caused or contributed to the event.” The dashboard also includes appropriate disclaimers about data limitations and the difference between correlation and causation.

However, competitors can now monitor products’ safety profiles as easily as checking stock prices, while consumers may make purchasing decisions based on what they read in the dashboard, including what may be raw, unverified reports. And the public nature of this unvetted data creates real litigation risks for companies, as trial attorneys may use raw adverse event reports in product liability cases without regard for the FDA’s disclaimers about causation.

Companies still need robust systems to collect, investigate, and classify adverse events within the required 15-day reporting window. Determining whether a consumer complaint rises to the level of a serious adverse event requiring FDA notification is often a complex judgment call that requires legal and regulatory expertise. Most companies have already set up monitoring systems to track both their own products and competitors’ safety profiles post-MoCRA, but here “radical transparency” means internal adverse event processes had better be rock-solid, to include training staff on proper classification protocols and ensuring robust documentation.

The dashboard doesn’t change what constitutes a serious adverse event under MoCRA, but it certainly raises the stakes for getting it right. We’ll report back on the effects the new system will have on the industry.