FDA Seeks Info From Injured WEN Users, Docs As Investigation Continues
This article was originally published in The Rose Sheet
Executive Summary
As recently reported by The Rose Sheet, FDA continues to investigate more than 21,000 adverse-event reports from users of WEN Cleansing Conditioners, marketed by Chaz Dean and Guthy-Renker, LLC. The agency published an alert July 19, noting that the cause of the AEs is still not known, and issued a call to consumers and health care providers for information that could help to fill in the blanks.
You may also be interested in...
US FDA Convinced: Cosmetic Adverse Event Reports Aren’t Telling Whole Story
Linda Katz, director of the FDA’s cosmetics office, says to “stay tuned” for federal legislative developments in 2022, maintaining her position that voluntary adverse-event reporting paints an incomplete picture of consumers’ experience with cosmetic products across the US.
FDA Eyeing Study On Cosmetic Hair-Care/Hair-Loss Link
Interested parties capable of conducting in vivo and in vitro tests "to study alopecia that may be associated with the use of commercially available cosmetic hair products and individual ingredients in these products" must respond to FDA's Sources Sought Notice by Feb. 26.
2017 In Review: FDA's Cosmetics Slowdown Could Bolster Case For Legislative Jumpstart
FDA's cosmetics activities fell off noticeably compared with 2016, and the change in the White House spurred the agency to begin looking for regulatory burdens to eliminate while shuffling priorities away from cosmetics to make do with proposed cuts in federal funding. In this climate, robust cosmetics oversight may depend on a legislative update, with multiple draft bills on the table.