The U.S. Food and Drug Administration sent a warning letter to the makers of Brazilian Blowout confirming that the product is “adulterated” with the liquid form of formaldehyde, “which, under the conditions of use prescribed in the labeling,” releases dangerous levels of the chemical — a known carcinogen — into the air to be inhaled.
<FDA’s conclusion comes a year after Oregon’s Occupational Health and Safety Administration (OSHA) reached a similar conclusion after testing 105 samples of keratin-based hair straightening solutions.
Five months ago, the U.S. Department of Labor’s Occupational Safety and Health Administration (US/OSHA) issued a hazard alert about “http://www.brazilianblowout.com/”>Brazilian Blowout and similar hair smoothing and straightening products, warning that hair salon workers and clients could potentially be exposed to formaldehyde by using them.
The FDA letter also said that Brazilian Blowout is “misbranded” because the product’s label falsely declares it to contain “No Formaldehyde” or that it is “Formaldehyde Free.”
GIB LLC, which manufactures the Brazilian Blowout solution, has until mid-September to address the violations cited by the FDA or risk having its product seized. “It is your responsibility as a manufacturer to ensure that the products your firm markets are safe,” wrote Michael W. Roosevelt, acting director of the Office of Compliance at FDA’s Center for Food Safety and Applied Nutrition, in the GIB LLC, which manufactures the Brazilian Blowout solution, has until mid-September to address the violations cited by the FDA or risk having its product seized. “It is your responsibility as a manufacturer to ensure that the products your firm markets are safe,” wrote Michael W. Roosevelt, acting director of the Office of Compliance at FDA’s Center for Food Safety and Applied Nutrition, in the .”http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm270809.htm”
warning letter to Brazilian Blowout CEO Mike Brady..Salon workers and customers using the hair-straightening solutions have suffered side effects like eye and throat irritation, headache, dizziness, burning sensations, breathing problems, nosebleeds, chest pain, vomiting, and rash, according to the FDA.
Formaldehyde is released when hair treated with Brazilian Blowout is heated with a blow dryer and then with a hot flat iron, as the product’s labeling recommends. The FDA’s analysis found that Brazilian Blowout contains 8.7% to 10.4% formaldehyde, which puts it in the range of embalming fluid used by funeral homes — and is far higher than the 0.2 percent concentration that the FDA’s Cosmetics Ingredient Review Expert Panel considers safe. “We have been tested countless times by OSHA, and we have never exceeded a safety standard ever,” Brady told National Public Radio. However, Brady’s statement conflicts with test results released by Oregon OSHA last year. Last October, Oregon OSHA investigators said that of 56 samples of Brazilian Blowout had elevated levels of formaldehyde — even though 37 of those samples were labeled “formaldehyde free.”.The company went as far as to sue Oregon OSHA last year to prevent the agency from releasing its testing data, but later dropped the suit. Despite the FDA’s demand for GIB to cure the violations cited in its letter, a brief statement. on the company’s product website says.“In our continued effort to clear up misinformation about the Brazilian Blowout, we are delighted to be working with the FDA in demonstrating that the Brazilian Blowout complies with both state and federal guidelines.”