The U.S. Food and Drug Administration (FDA) posted a July 19, 2016, safety report warning of adverse event complaints concerning WEN by Chaz Dean Cleansing Conditioner products.

According to an FDA statement, the agency has received 127 adverse event reports from consumers, the largest number of adverse events reports ever received about a cosmetic hair cleansing product. Consumers have reported hair loss, balding, hair breakage, itching and rashes.

During inspections of manufacturing and distribution facilities, FDA also discovered that there have been more than 21,000 complaints reported  to Chaz Dean, Inc. and Guthy Renker, LLC. According to the safety report warning, FDA has asked the company to “provide any data that might help us to better understand the reports of hair loss associated with the use of Wen by Chaz Dean Cleansing Conditioner Products.”

FDA also posted a concurrent Dear Health Care Provider Letter asking physicians with patients who have used the products and experienced adverse events to submit a report to the agency. It also asks health care providers to share with those patients FDA’s statement and FDA’s Information for Consumers.