In a bold step toward greater public transparency, the U.S. Food and Drug Administration (FDA) has officially launched the FAERS Public Dashboard for Cosmetic Products. This new online tool provides real-time access to adverse event reports tied to cosmetic and personal care products, making it easier than ever for the public, regulators, and industry stakeholders to peek behind the curtain of product safety.
Launched under FDA Commissioner Makary’s “radical transparency” initiative, the dashboard represents a clear departure from the slower, less accessible systems of the past, and creates both opportunities and challenges for regulated industry. In this Insight, we break down what the new system does, how it fits into the evolving regulatory landscape under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), and what companies should be doing now to manage both compliance and reputational risk.
Key Features of the New Dashboard (Spoiler: It’s Not Just Face Cream)
The FDA Adverse Event Reporting System (FAERS) Public Dashboard for Cosmetic Products provides a searchable, interactive, and downloadable interface that consolidates:
- Mandatory serious adverse event reports submitted by manufacturers, packers, and distributors under MoCRA.
- Voluntary reports submitted by consumers, healthcare professionals, and salon professionals.
Unlike the previous CFSAN Adverse Event Reporting System (CAERS), which was updated quarterly and was largely inaccessible to the public without Freedom of Information Act (FOIA) requests, the new FAERS dashboard:
- Updates daily, providing nearly real-time visibility into new adverse event reports.
- Is publicly accessible, requiring no credentials or regulatory background.
- Allows users to filter by product name, type of adverse event, demographic information, and more.
As of the dashboard’s launch, FDA reports that nearly 46,000 adverse event reports have been submitted since MoCRA’s mandatory reporting provisions took effect in December 2023.
Regulatory Context: MoCRA in Action
This launch represents one of the most visible outcomes to date of the Modernization of Cosmetics Regulation Act of 2022, which significantly expanded FDA’s authority over the cosmetics industry. Among other changes, MoCRA introduced:
- Mandatory serious adverse event reporting within 15 business days of receiving the information.
- Expanded recordkeeping and safety substantiation requirements.
- FDA authority to access records, issue recalls, and suspend product registration for non-compliance.
The new dashboard reinforces the public-facing side of MoCRA by bringing transparency to the volume and nature of adverse events associated with cosmetics, in a way that is immediate, open-access, and broadly visible.
Why It Matters for Industry
If you manufacture, distribute, or sell cosmetics under U.S. jurisdiction, the dashboard introduces a new level of scrutiny. And not just from FDA—everyone’s watching now.
Heightened Public and Legal Exposure
Real-time, unfiltered reports mean increased exposure to consumer perception and legal risk. While the FDA has clearly stated that these reports are not verified and do not imply causation, that distinction may be lost on the average consumer—or ignored entirely by an eager plaintiff’s attorney.
Trial lawyers may mine the dashboard for “evidence” of unsafe products, regardless of whether those claims are substantiated. Companies should be ready to respond with context, documentation, and legal strategy.
Competitive Intelligence—Now With Daily Updates
The dashboard offers industry players a window into their competitors’ adverse event trends. Curious how that trendy serum your competitor just launched is performing? Now you can check. But remember—it works both ways. Your data is just as visible, so consistency and clarity in reporting matter more than ever.
A cluster of consumer-reported issues—even if minor—could prompt inquiries from competitors, consumers, or regulators.
Increased Need for Internal Systems and Training
The dashboard doesn’t just raise the stakes—it raises the bar. Companies must have solid internal systems to:
- Identify and triage consumer complaints.
- Determine whether an event meets the MoCRA definition of “serious.”
- Submit reports within 15 business days.
- Document everything in compliance with FDA inspection expectations.
What Companies Should Be Doing Now
With the dashboard live and public interest growing, regulated companies should take proactive steps to mitigate risk and ensure compliance:
- Audit Your Adverse Event Processes: Review how your team receives, investigates, and reports incidents across all customer touchpoints—social media, reviews, call centers.
- Clarify “Serious” Event Criteria: Make sure your team understands the thresholds and knows when to escalate.
- Train Teams Across Departments: Regulatory, legal, customer service, and marketing must be aligned.
- Monitor the Dashboard: Watch for trends in your data and competitors’ data.
- Have a Communications Strategy: Prepare messaging for internal teams, consumers, and media in advance.
Looking Ahead: Real-Time Transparency Is the New Normal
The FDA’s cosmetic dashboard is more than a technical update—it’s a shift in how cosmetic safety is managed, perceived, and litigated. It invites public scrutiny, encourages consumer activism, and raises the bar for what regulators (and the public) expect from the industry.
For companies, this means there’s no room for regulatory shortcuts. Adverse event management is no longer a back-office process—it’s a front-page issue with implications for legal risk, brand reputation, and consumer trust.
The companies that thrive in this new era will be the ones who treat compliance as a competitive advantage. So dust off your SOPs, train your teams, and get familiar with the dashboard—because in today’s regulatory environment, the only thing worse than a product recall is a compliance gap on display for everyone to see.
About Garg Law
Garg Law advises companies across the life sciences, personal care, and consumer product sectors on FDA compliance, regulatory strategy, and litigation risk. We help clients build robust systems to meet evolving obligations under MoCRA and other federal and state regulatory frameworks. If your team needs support navigating the new dashboard or strengthening adverse event processes, contact us at info@garg-law.com.
