FDA Update

FDA Launches Real-Time Adverse Event Reporting Dashboard for Cosmetic Products

The FDA just announced the launch of the FDA Adverse Event Reporting System (FAERS) Public Dashboard for Cosmetic Products, an interactive tool designed to facilitate the public’s ability to query real-time adverse event data on cosmetic products. The user-friendly platform allows users to download report listings or data sets, with reports that are updated daily to include the most recent submissions.

Last week’s launch marks another step in the FDA’s modernization strategy, which includes radical transparency. It follows the agency’s recent announcement on real-time reporting of adverse event and medication errors data for drugs and therapeutic biologics.

The dashboard is dedicated exclusively to reports of cosmetic product adverse events, making the data easier to search. It includes serious adverse event reports submitted by responsible persons for cosmetic products under requirements established by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), as well as voluntary adverse event reports submitted to the FDA by healthcare professionals, consumers, salon professionals, cosmetologists, and others. The FAERS dashboard contains adverse event reports for cosmetic products, such as moisturizers, shampoos, conditioners, hair dyes and tattoos.

FAERS cosmetic product adverse event data will no longer be available in the Human Foods Complaint System (HFCS) | FDA, formerly known as the CFSAN Adverse Event Reporting System (CAERS).

Questions?

For more information on the FDA Adverse Event Reporting System (FAERS) Public Dashboard for Cosmetic Products, please email us at: info@mdiconsultants.com and ref: FAERS.