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.
In a letter sent to Mike Brady, CEO GIB, the FDA gave its first official warning, giving the company until yesterday to comply with the FDA's directives, otherwise the products could be taken off US shelves and further injunctions could be filed against the company.
In tests, conducted by both the FDA and the Occupational Safety and Health Administration dangerous levels of the liquid form of formaldehyde, ranging from 8.7 percent to 10.4 percent, were found.
Industry debate
Formaldehyde is commonly found in a number of "Brazilian style" keratin-based hair straighteners, and has been listed as a carcinogen by the FDA, although Brazilian Blowout denies unsafe levels in its products.
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."
In a string of controversy lasting over a year, the FDA has been urged to 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 regulations are under scrutiny, and are being rectified in the Safe Cosmetics Act of 2011, which is currently being debated in Congress.
Brazilian Blowout’s plant-derived cousin
Meanwhile Brazilian Blowout has launched its latest hair straightening product, the Zero smoothing treatment which it states is a plant-derived kerasafe bonding system which contains no formaldehyde.
It is applied in the same way as the original Brazilian Blowout treatment and the company claims the result is exactly the same.
When questioned on whether this launch means the original treatment will be discontinued or whether it questions the safety or integrity of this treatment, the company states it is 100 percent confident of the original treatment and is backed by its worldwide popularity, and will remain on shelves.
However, according to the FDA letter, GIB will only be able to keep selling the product if the ingredients list is specifically modified to exclude any form of formaldehyde. Failure to do so could result in the seizure of Brazilian Blowout products, and legal proceedings against the company.