The notorious hair straightening products company, Brazilian Blowout, has received its first official warning from the Food and Drug Administration (FDA), which has stated that the products are 'adulterated' and misbranded.
The company has until Sept. 12 to comply with the FDA's directives, otherwise the products could be taken off U.S. shelves and further injunctions could be filed against the company, the agency said today (Sept. 7).
The FDA is asking Brazilian Blowout to reduce the level of formaldehyde from its products and change its misleading labels and advertising, which state that the products are formaldehyde-free.
The FDA conducted their own sample analysis of the product, and found dangerously high levels of the liquid form of formaldehyde, ranging from 8.7 percent to 10.4 percent. The Occupational Safety and Health Administration (OSHA) requires an occupational hazard alert at levels higher than 0.1 percent.
Formaldehyde, commonly found in a number of "Brazilian style" keratin-based hair straighteners, is extremely dangerous and a known carcinogen, the FDA said.
The FDA reported that salon workers and consumers have already reported a number of injuries to the FDA, including eye disorders, nervous system disorders, respiratory tract problems, chest pain, vomiting and rash.
Michael Roosevelt, acting director in the FDA's Office of Compliance states in the letter to the company: "Brazilian Blowout is an adulterated cosmetic because it bears or contains a deleterious substance that may render it injurious to users under the conditions of use prescribed in your labeling."
He continued: "Brazilian Blowout contains the liquid form of formaldehyde, methylene glycol; however, the product label declares that the product contains 'No Formaldehyde' or is 'Formaldehyde Free.' This declaration renders your product misbranded because it is a false and misleading statement."
Since the beginning of the controversy almost one year ago, the National Healthy Nail and Beauty Salon Alliance (Alliance) has called on the FDA to take swift action with a national recall, the agency said.
"We thank the FDA for issuing this highly anticipated warning. Stylists need to know about the dangers of using this toxic product on a day to day basis," said Women's Voices for the Earth's executive director Erin Switalski, on behalf of the Alliance.
"Brazilian Blowout can no longer lie to the public about their contents and continue to claim their product to be safe," said Miriam Yeung, executive director of the National Asian Pacific American Women's Forum.
Brazilian Blowout and similar products have been banned in Australia, Canada, Ireland, France and Germany. OSHA has issued a national hazard alert, and the cosmetics industry's own safety review board came out with an opinion critiquing the safety of hair straighteners using formaldehyde, the FDA said. This year the National Academy of Sciences (NAS) released its long-awaited report on formaldehyde, confirming the EPA's determination that formaldehyde causes cancer in humans. Yet, manufacturers have done little to address these concerns.
"If consumers have been wondering why they've still been able to get Brazilian Blowouts despite so much troubling news, the answer is because our regulatory system is broken," says Anuja Mendiratta, a representative of the California Healthy Nail Salon Collaborative. "Laws that are supposed to protect consumers and workers simply aren't enough. Even when a product has clearly been shown to poison people, the FDA has little authority to take immediate meaningful action in the case of cosmetics."
The National Healthy Nail and Beauty Salon Alliance has demanded that the FDA immediately recall Brazilian Blowout and similar products. However, the FDA can only issue a "voluntary recall," meaning that the government cannot mandate the removal of dangerous products from the market. These lax regulations are under scrutiny, and are being rectified in the Safe Cosmetics Act of 2011, which is currently being debated in Congress. The new law would set safety standards for chemicals used in personal care and salon products before they reach the marketplace, and phase out toxic ingredients such as formaldehyde found in the Brazilian Blowout.