Brazilian Blowout Gets Blowback From the FDA

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It’s official: Brazilian Blowout is dangerous, according to the U.S. Food and Drug Administration (FDA).

Five months ago, the U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA) issued a hazard alert about 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.

Now the FDA has 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.

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.”

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The company has until mid-Sept. 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 the FDA’s Center for Food Safety and Applied Nutrition, in the 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% that the Cosmetics Ingredient Review Expert Panel considers safe. (Why is formaldehyde in hair products, you ask? Because it helps bind keratin to hair, straightening it.)

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For its part, the makers of Brazilian Blowout say the product is safe. “We have been tested countless times by OSHA,” Brady told NPR’s Shots blog. “And we have never exceeded a safety standard ever.”

“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,” a brief statement on the product website says, encouraging hair salons to “continue to confidently offer the Brazilian Blowout treatment to your customers.”

Many salons across the U.S. may be currently using Brazilian Blowout or similar frizz-taming products. In April, Healthland contributor Bryan Walsh spoke with Jane Houlihan, vice president for research at the Environmental Working Group. She said: “We surveyed 41 top salons and found that almost all of them are using hair-straightening treatments. We look across the industry, and the fact is if you’re using a Brazilian-style keratin treatment, it’s almost certainly releasing formaldehyde.”

Given the FDA’s warning, Brazilian Blowout may not be around much longer, at least not in its current formulation. It’s already been banned in Canada. But the fact that a hair product containing potentially dangerous levels of formaldehyde was able to end up in salons in the first place shows just how lacking regulation of the cosmetics industry is.

MORE: OSHA’s Brazilian Blowout Hazard Alert

Sora Song is the editor of TIME Healthland. Find her on Twitter at @sora_song. You can also continue the discussion on Healthland’s Facebook page and on Twitter at @TIMEHealthland.