Popular Hair Care Product Under FDA Investigation After Thousands of Consumer Complaints

The U. S. Food and Drug Administration (FDA) has opened an investigation into WEN by Chaz Dean Cleansing Conditioner following thousands of consumer complaints of “hair loss, breakage, balding, itching and rash” after using the hair care product. WEN by Chaz Dean Cleansing Conditioner is a combination of shampoo and conditioner manufactured and marketed by Guthy-Renker, LLC.

Cosmetics, including hair care products, do not undergo rigorous FDA testing and do not have to be FDA-approved before being manufactured and sold to consumers. Adverse Event reports are formal consumer complaints filed with the FDA documenting problems with pharmaceuticals, food, and other products including cosmetics. The FDA monitors Adverse Event reports filed with it and may open an investigation into a cosmetic product if the number or severity of complaints warrants evaluation of the safety of a product.

As of July 7, 2016, the FDA had received 127 Adverse Event reports from consumers about WEN by Chaz Dean Cleansing Conditioner, the greatest number of complaints ever received by the FDA for a hair care product. While inspecting the facilities in which WEN is manufactured, the FDA also discovered more than 21,000 additional consumer complaints made directly to Chaz Dean, Inc. and Guthy-Renker, LLC about WEN by Chaz Dean Cleansing Conditioner.

The FDA has not determined a cause for the complaints, but at this point does not believe the product is contaminated with microbes. The FDA has requested additional data from Chaz Dean, Inc. and Guthy-Renker, LLC, and is searching for any changes in manufacturing, and evaluating quality controls for the cleansing conditioner.

The FDA recommends if you are using the cleansing conditioner and begin to suffer from any scalp problems, to discontinue use and contact your healthcare provider.

Healthcare providers and consumers are encouraged to file Adverse Event reports if side effects occur. Adverse Event reports can be filed through www.fda.gov/MedWatch/report or www.fda.gov/Cosmetics/ComplianceEnforcement/AdverseEventReporting/default.htm.

The FDA will update consumers on its findings once its investigation is complete.