Hair Cleansing Products
CFSAN is aware of adverse events, such as hair loss, hair breakage, balding, itching and rash reported to occur with the use of certain hair cleansing products based on reports submitted to the CFSAN Adverse Event Reporting System (CAERS). Reported products include shampoos, conditioners, and cleansing conditioners, often referred to as “shampoo alternatives,” which are marketed as being free of detergents and foaming agents.
The FDA first became aware of adverse health effects associated with the use of cleansing conditioners in 2011 as a result of reports of hair loss submitted to the FDA. By 2016, following constituent outreach, the FDA received over 1,400 adverse event reports, including accounts of significant hair loss (alopecia), from consumers and health care providers.
In an attempt to better understand the cause of these adverse events, the FDA contracted with Columbia University’s Medical Center Department of Dermatology to conduct a study on hair loss and the connection to the use of certain cosmetic products and ingredients. 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. However, further investigation is needed in order to draw a firm connection to the use of certain hair products and/or their ingredients to alopecia.
The FDA regulates cosmetics, including cleansing conditioners, under the authority of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act. Under these laws, cosmetic products and ingredients, with the exception of color additives, are not approved by the FDA before they go on the market. However, cosmetics must be properly labeled and must not be adulterated. For example, they must be safe under the labeled or customary conditions of use. Companies and individuals who manufacture or market cosmetics are responsible for the safety and labeling of their products and ingredients. The FDA can take action against cosmetics on the market that do not comply with the law. To learn more, see FDA Authority Over Cosmetics.
The FDA continues monitoring adverse events associated with the use of hair cleansers. We encourage physicians and other health care providers to submit an adverse event report to the FDA if they have patients who have experienced such problems. Additionally, consumers who experience problems such as hair loss, balding, itching, rash or other reactions, as a result of using one of these products, should stop using the product immediately and contact their health care provider. Then, inform the FDA about the incident as soon as possible.
You can report a reaction online or by phone:
- Contact the FDA’s MedWatch reporting system, either online or by phone at 1-800-332-1088.
- Contact your nearest FDA district office consumer complaint coordinator.
When you report your problem to the FDA, please provide as much detail as possible about the specific product you used and your reaction. More information about these products and the reported problems can help us in our investigation to determine the cause and what actions we can take under the laws we enforce to protect and promote public health.