WEN by Chaz Dean Cleansing Conditioners: FDA Statement - Investigation of Adverse Event Reports

[Posted 07/19/2016]

AUDIENCE: Consumer, Family Practice, Dermatology

ISSUE: The FDA is investigating reports of hair loss, hair breakage, balding, itching, and rash associated with the use of WEN by Chaz Dean Cleansing Conditioner products.

While the FDA continues its investigation, consumers should be aware of reactions reported in association with the use of WEN by Chaz Dean Cleansing Conditioner products.  Consumers who experience a reaction after using WEN by Chaz Dean Cleansing Conditioner products should stop using the product and consult with their dermatologist or other health care provider. The agency also urges consumers to report to FDA any reactions they may have experienced when using these products.

The FDA has not yet determined a possible cause for the adverse events that have been reported, and will provide additional updates as new information becomes available.

BACKGROUND: As of July 7, 2016, the FDA had received 127 adverse event reports directly from consumers about WEN by Chaz Dean Cleansing Conditioner products, the largest number of reports ever associated with any cosmetic hair cleansing product, including cleansing conditioners. FDA is also investigating more than 21,000 complaints reported directly to Chaz Dean, Inc. and Guthy Renker, LLC that FDA learned of during inspections of manufacturing and distribution facilities.

The FDA has not yet determined a possible cause for the adverse events that have been reported, and today has called on 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.” The FDA also has reached out to physicians and other health care providers asking them to notify their patients of hair loss and other complaints associated with the use of these products and to report adverse events to the agency. 

RECOMMENDATION: While the FDA continues its investigation, consumers should be aware of reactions reported in association with the use of WEN by Chaz Dean Cleansing Conditioner products. Consumers who experience a reaction after using WEN by Chaz Dean Cleansing Conditioner products should stop using the product and consult with their dermatologist or other health care provider.

See the “Dear Healthcare Provider letter” and “FDA Information for Consumers” for additional information.

Healthcare professionals and consumers are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[07/19/2016 - Statement - FDA]
[07/19/2016 - Dear Health Care Provider Letter - FDA]
[07/19/2016 - FDA Information for Consumers About WEN by Chaz Dean Cleansing Conditioners - FDA]
[07/19/2016 - FDA Authority Over Cosmetics – FDA]