Food and Drug Administration officials issued a warning letter to the makers of a popular hair straightening product, Brazilian Blowout, on Wednesday, saying the company's smoothing solutions contain levels of formaldehyde linked to illness in salon workers and customers.
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FDA officials said the popular product used to flatten wiry hair is "adulterated" and "misbranded." Although labels on the products distributed by the North Hollywood, Calif., firm say they contain no formaldehyde, or are "formaldehyde free," the FDA's own tests found high levels of methylene glycol, which releases formaldehyde when treated hair is subjected to heat from a blow dryer or hot flat iron.
FDA analysis found levels of methylene glycol ranged from 8.7 percent to 10.4 percent in tested samples. Levels higher than 0.1 percent require an occupational hazard alert according to Occupational Safety and Health Administration regulations. Formaldehyde is a known carcinogen.
"Brazilian Blowout is misbranded because its label and labeling (including instructions for use) makes misleading statements regarding the product's ingredients and fails to reveal material facts with respect to consequences that may result from the use of the product," wrote Michael W. Roosevelt, acting director of the Office of Compliance at the FDA's Center for Food Safety and Applied Nutrition.
'Misunderstanding,' company chief says
Mike Brady, the chief executive for Brazilian Blowout, said the FDA's warning letter was based on a "misunderstanding" and added the company's products have never exceeded OSHA guidelines for airborne exposure to formaldehyde.
"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," Brady said, referring to a statement posted on the company's website.
Salon owners and customers who've used Brazilian Blowout are most likely exposed to formaldehyde through inhalation. They've reported injuries ranging from eye irritation and blurred vision to headaches, fainting, wheezing and chest pain.
Brazilian Blowout officials have until Sept. 12 to respond or face possible seizure of the product and court action.
Beauty industry leaders, including the National Health Nail and Beauty Salon Alliance, have been pressing the FDA to take stronger action against Brazilian Blowout. In a press release, the group welcomed the agency's action, but said it was slow to occur and not stringent enough.
“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,” said 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.”
Women resist giving up straight hair
One problem surrounding Brazilian Blowout has been the popularity of the company's products, despite serious questions about potential harm. The two-hour hair treatments, which cost about $250, transform coarse, kinky hair into soft, smooth hair for two or three months. Some women devoted to straight hair have resisted giving up the treatment.
Brazilian Blowout officials have maintained that their products contain no formaldehyde, despite tests in Oregon and Canada that found evidence to the contrary.
OSHA guidelines state that no employee should be exposed to an airborne concentration of formaldehyde that exceeds 0.75 parts per million part of air within eight hours, or 2 parts per million in a 15-minute period.
Brady, the CEO, said the firm's products, even when combined with heat and dispersed into the air, fall well within those guidelines.
"We're going to work with the FDA," Brady added.
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