WEN Attorneys Meet With Top FDA Officials In ‘Continued Cooperation’
This article was originally published in The Rose Sheet
CFSAN Director Susan Mayne and other high-level FDA officials met with Guthy-Renker and WEN leadership and outside attorneys in September. The substance of the meeting is being kept under wraps, but it shows FDA’s continued involvement in the WEN issue, which drove discussion at the recent Senate HELP Committee hearing on cosmetics.
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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.
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.
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.