Consumers, Health Practitioners Heeded FDA’s Call For WEN-Related AEs
This article was originally published in The Rose Sheet
FDA’s safety alert in July, asking WEN users and their doctors to share information regarding hair loss-related adverse events, yielded approximately 1,000 reports in just over two months, contributing to a massive increase in cosmetic AE reports for FY 2016.
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In a Q&A posting, FDA Office of Cosmetics and Colors Director Linda Katz offered perspective on how the division handles adverse event reports and makes a case for mandatory AE reporting. She also explains how FDA reacted when WEN-related AERs began rolling in.
FDA’s release of AER data removes some secrecy surrounding cosmetic product adverse events but could create a false alarm about the industry. The data dump comes as Congress is considering legislation that would mandate that cosmetics firms provide FDA with reports of serious adverse events they receive.
WEN is “new” spelled backwards, but the safety scrutiny facing the hair-care brand is anything but. FDA continues to investigate related adverse-event reports, but 2017 could be the year that Guthy-Renker and Chaz Dean dispense with the lion’s share of consumer complaints and associated payouts.