July 19, 2016
Dear Health Care Provider,
The U.S. Food and Drug Administration is currently investigating reports of hair loss, hair breakage, balding, itching, and rash reported to be associated with the use of WEN by Chaz Dean Cleansing Conditioners, manufactured and marketed by Chaz Dean, Inc. and Guthy Renker LLC, and we need your help to investigate these adverse events further. Because cosmetic-related adverse events often result in skin irritation, allergic reactions, and hair loss, we believe that health care providers, particularly dermatologists, play a critical role in helping the FDA receive appropriate reports, including critical medical information and descriptions of findings.
From February 18, 2011 through July 7, 2016, the FDA has received 127 reports of adverse events associated with the use of WEN by Chaz Dean Cleansing Conditioners, which is the largest number of hair-related adverse events the FDA has ever received for any hair care product. Additionally, the FDA has become aware of more than 21,000 adverse event reports received by Chaz Dean, Inc. and Guthy Renker LLC. The FDA has not yet identified a cause for the reported adverse events. The FDA depends on physicians and other medical professionals to alert us to health issues they are seeing in their patients that may be related to cosmetic products, such as cleansing conditioners. Unlike drugs, cosmetics are not reviewed or approved by FDA before marketing, and the law does not require cosmetic manufacturers to provide to the FDA safety data on their products or to share adverse event reports that they receive.
Information Needed from Health Care Providers
The FDA is asking physicians with patients who have experienced adverse events after using WEN by Chaz Dean Cleansing Conditioner products to report the event to the agency, including the following information, with informed consent from the patient, as appropriate:
- A case description of the adverse events, including the specific cleansing conditioner products the patient used, how long he or she used the cleansing conditioner products, and how long he or she kept the product in his or her hair. (Specific product labeling would be helpful.)
- The autoimmune status of the patient.
- Relevant laboratory and biopsy results.
- Concomitant medication and cosmetic use.
Communication with Patients
We are asking for your help in communicating with your patients in the following ways:
- Advise your patients about reported hair loss and other complaints reported to be associated with use of WEN by Chaz Dean Cleansing Conditioner products and share with them our FDA Statement and FDA Information for Consumers About WEN by Chaz Dean Cleansing Conditioners, and
- Encourage your patients who experience adverse events after using WEN by Chaz Dean Cleansing Conditioner products to report these events to the FDA.
We appreciate the extra time and effort it takes for health professionals to compile and submit such reports. This information is extremely valuable in helping us identify signals of potential safety issues, which can in turn help protect others from injury.
For additional information:
- FDA Statement
- FDA Information for Consumers About WEN by Chaz Dean Cleansing Conditioners
- Submit a Complaint: How to Report a Cosmetic-Related Problem