After Record Number of Complaints, FDA Issues Safety Alert for Hair Conditioner
The FDA has not yet determined a possible cause for the adverse reactions
The U.S. Food and Drug Administration is investigating reports of hair loss, balding, rashes and other issues stemming from the use of WEN by Chaz Dean Cleansing Conditioners, a line of products by a Los Angeles stylist.
In a post on its website on July 19, the FDA said consumers who experienced a reaction after using WEN conditioner products should stop using the product and consult with their dermatologist or other health care provider.
Consumers should also report to the FDA any reactions they may have experienced while using the products. The conditioners come in three varieties: Sweet Almond Mint, Lavender and Pomegranate
According to the WEN website, the conditioners cleanse "hair thoroughly without lather or harsh sulfates found in some ordinary shampoos."
The FDA said that as of July 7, 2016, the agency had received 127 adverse event reports directly from consumers about WEN conditioner products, the largest number of reports ever associated with any cosmetic hair cleansing product, including cleansing conditioners.
The FDA also said that when it inspected the manufacturing and distribution facilities for these products, it learned that consumers had reported reactions to the products in more than 21,000 complaints submitted to Chaz Dean, Inc. and Guthy Renker LLC, the companies that market and manufacture the products.
The FDA has not yet determined a possible cause for the adverse reactions. The agency said it 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.
Infomercial giant Guthy-Renker, told NBC in a statement on July 20, 2016: “We have confidence in WEN® by Chaz Dean. We have no evidence that WEN, or any of the individual ingredients in WEN, causes hair loss. WEN is used by hundreds of thousands of satisfied customers, and all formulations of the product comply with applicable regulations wherever it is sold. We have consistently cooperated with the FDA with respect to any inquiries regarding WEN and we intend to continue to do so.”
Last year, more than 200 people in 40 different states filed a class-action lawsuit against Wen Hair Care and Guthy-Renker. The lawsuit, filed by the law firm of Christiansen Davis, alleged that using the company's cleansing conditioner resulted in baldness, rashes, scalp irritation, hair breakage and hair discoloration, NBC News reported.
The lawsuit also alleged that the manufacturer knew about these complaints but refused to do anything about them, including removing the products from stores.
In a statement provided to NBC News in December 2015, Wen, Guthy-Renker and Chaz Dean rebutted the lawsuit's claims, saying, "There is no scientific evidence to support any claim that our hair care products caused anyone to lose their hair. There are many reasons why individuals may lose their hair, all unrelated to Wen hair products."
"We intend to vigorously contest the allegations made against our products. And we encourage any customer with any questions to contact us," the statement added.
The FDA said it will provide additional updates on its investigation as new information becomes available.