In 2011, the U.S. Food and Drug Administration (FDA) started receiving voluntary Adverse Event Reports (AERs) of hair loss (alopecia), as well as hair breakage, and thinning hair associated with the use of certain hair cleansing products.
Alopecia is a health disorder that occurs when the hair production cycle is disrupted; it can be temporary or permanent with varying degrees of severity. Hair loss can be caused by various external and internal factors, including physiological and psychological stress, certain medical conditions, childbirth, major surgery, hormonal changes, physical trauma as well as exposure to allergens and ingredients present in cosmetic hair products.
In July 2016, the FDA announced that the agency was conducting an investigation of AERs, including reports of hair loss, hair breakage, balding, itching and rash, from certain hair cleansing products. In the course of the investigation, the FDA looked at information available to the agency, in order to better understand the voluntary AERs.
Columbia University Study
As part of the FDA’s investigation, the agency contracted Columbia University’s Medical Center Department of Dermatology to assess the effects of select cosmetic hair products and select ingredients in those products and a possible connection to alopecia in consumers who used those products.
The products were selected by the FDA based on the number of AERs and the seriousness of the adverse events in the reports the FDA received. The choice of ingredients to study was based on various factors, including frequency of use of the cosmetic hair product, the presence of the ingredient in cosmetic hair products reported to have an associated adverse event of hair loss, and published scientific literature.
The goal of the study was to understand the mechanisms of hair loss associated with the use of select cosmetic hair products and ingredients used in these products. The study was completed by Columbia University and a report provided to the FDA in 2023.
The study found that mice treated with either DevaCurl Low-Poo Delight Cleanser or WEN Sweet Almond Mint Cleansing Conditioner, over a prolonged period of time, displayed abnormal hair growth cycles. Also, five ingredients found in both the DevaCurl and WEN products: Rosemary extract, Calendula extract, Methylchloroisothiazolinone, Methylisothiazolinone, and Polysorbate 60, were assessed.
While this study was insightful, it was unable to draw a firm connection between the use of certain hair cleansing products and ingredients, and alopecia.
At this time, the FDA is continuing to follow this issue by assessing the adverse event reports related to hair cleansers submitted to the agency. If additional information is obtained that may shed light as to the causality of hair loss, we will inform the public.
If you experience hair loss, you should contact your healthcare provider. As with any cosmetic product, if you experience an adverse event that you think may be related to the use of that product, you should also cease to use the product and report the event to the FDA.
For more information, visit How to Report a Cosmetic Related Complaint.