Last month the Food and Drug Administration (FDA or the Agency) announced the launch of the FDA Adverse Event Reporting System (FAERS) Public Dashboard for Cosmetic Products. This interactive dashboard provides access to real-time adverse event data on cosmetic products and will be updated daily to include the latest submissions. According to FDA, the dashboard supports the Agency’s modernization strategy and follows the start of real-time reporting of adverse events related to drugs and therapeutic biologics. Below we provide an overview of the dashboard and discuss the implications for industry.
Overview of the FAERS Public Dashboard for Cosmetic Products
The dashboard is intended to be user-friendly, allowing the public to search reports, for example, by product name or adverse event term. Reports can be filtered and sorted by severity, date, or report type, and the data is downloadable. Additionally, the dashboard:
- Contains serious adverse event reports submitted by responsible persons, as required by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
- Includes voluntary adverse event reports from consumers, healthcare professionals, cosmetologists, and others
- Covers a wide range of cosmetic products (e.g., shampoos, conditioners, hair dyes, moisturizers, tattoos)
Implications for Industry Stakeholders
FDA has clarified that (1) adverse event data in FAERS is not a definitive indicator of a cosmetic product’s safety profile, and (2) reports are unverified and do not mean the Agency has determined that the product caused the event. However, because consumers, advocacy groups, and litigators now have real-time access to this data, cosmetic manufacturers should anticipate potential reputational and legal implications. To prepare, companies may want to::
- Develop a proactive communications plan: Create messaging so that you are ready to respond to questions from consumers and supply chain partners about adverse event reports appearing in the FDA dashboard
- Improve internal reporting systems: Ensure that your adverse event reporting procedures fully comply with MoCRA’s requirements. Train staff so that reports are captured and escalated appropriately
- Monitor FDA updates: Regularly track the FDA dashboard for mentions of your products and industry-wide trends
- Engage with counsel: Work with counsel to assess litigation risk and update legal strategies when needed
