The makers of the popular Brazilian Blowout line of hair-straightening products — which can cost up to $500 per salon treatment — have agreed to change their labeling to warn consumers that the treatments can release formaldehyde gas, which is considered a carcinogen and can cause irritation of the eyes and skin, according to a report from USA Today.
The move by GIB LLC comes following a lawsuit from the California state attorney general's office. The products are labeled as formaldehyde-free, but last September the FDA warned that Brazilian Blowout contains "dangerously high levels" of the gas. According to a report from WebMD, the FDA found that Brazilian Blowout products contained between 8.7 percent and 10.4 percent formaldehyde. Levels about 0.1 percent required an occupational hazard alert under guidelines from the U.S. Occupational Safety and Health Administration (OSHA).
At the time, GIB CEO Mike Brady denied that his company's products contained formaldehyde.
The FDA and OSHA issued their first health hazard about Brazilian Blowout in April 2011 to let salon workers and owners know about the potential for formaldehyde exposure from these products.
The FDA issued a warning letter to GIB on Aug. 22, 2011, saying "Brazilian Blowout contains methylene glycol, the liquid form of formaldehyde, which, under the conditions of use prescribed in the labeling, releases formaldehyde when hair treated with the product is heated with a blow dryer and then with a hot flat iron." The agency reported a wide range of health problems that had been reported by users of the products: "Adverse events have reported the following injuries associated with Brazilian Blowout: eye disorders (irritation, increased lacrimation, blurred vision, hyperaemia); nervous system disorders (headache, burning sensation, dizziness, syncope), and respiratory tract (dyspnea, cough, nasal discomfort, epistaxis, wheezing, rhinorrhea, throat irritation, nasopharyngitis). Other reported symptoms included nausea hypotrichosis, chest pain, chest discomfort, vomiting, and rash."
The FDA has authority over product packaging, but has none over the operation of salons. OSHA, on the other hand, governs workplace safety, including air conditions.
The FDA's warning letter presented CEO Brady with an ultimatum: "You should take prompt action to correct the violations cited in this letter. Failure to do so may result in enforcement action without further notice, including, but not limited to, seizure and/or injunction."
The state of California, where GIB is located, followed the FDA's letter with its lawsuit, charging deceptive practices.
Health concerns over Brazilian Blowout had been voiced for some time before the FDA letter was sent. Oregon Health & Science University issued a report (PDF) about the products in September 2010 after complaints from stylists at one of that state's salons.
According to a March 2011 report from Fox News, Brazilian Blowout treatments can cost between $200 and $500 and last several months. Despite the growing health concerns, the products have been popular in Hollywood, where celebrities such as Nicole Kidman and Halle Berry have used the treatment.
GIB has agreed to pay $600,000 in penalties and fines and provide salons with a product safety brochure. The company has already changed the labeling of its products.