FDA Warning Letter Issued for Brazilian Blowout over Formaldehyde

The U.S. Food and Drug Administration (FDA) issued a warning letter last month to Brazilian Blowout stating that its hair straightening products contain “dangerously high levels” of formaldehyde. The agency ordered Brazilian Blowout to reduce the levels of the liquid formaldehyde or face a product ban, said WebMD.

In a news release, the FDA stated that Brazilian Blowout products are adulterated and misbranded; they contain misleading labels and advertising that falsely claim Brazilian Blowout products are formaldehyde-free, said WebMD. Brazilian Blowout has until September 12th to adhere to the FDA’s directive. The FDA also stated that it received a number of injury complaints from salon workers and consumers about eye and nervous system disorders, chest pain, vomiting, rashes, and respiratory problems.

The agency called Brazilian Blowout a “notorious hair straightening products company” and said its tests detected liquid formaldehyde levels of 8.7-10.4%. The U.S. Occupational Safety and Health Administration (OSHA) mandates an occupational hazard alert for levels over 0.1%, the FDA said.

Mike Brady, Brazilian Blowout’s chief executive officer, told WebMD its products are safe and contain “a separate substance from formaldehyde” and that “the hair smoothing category is extremely popular” nationwide and its products meet OSHA standards and can be used. The FDA disagrees. “Formaldehyde, commonly found in a number of ‘Brazilian style’ keratin-based hair straighteners, is extremely dangerous and a known carcinogen,” the agency said, wrote WebMD.

In May, we wrote that Congress was urging the FDA to issue a voluntary recall of two salon hair-straightening treatments over concerns about significant formaldehyde levels. The Environmental Protection Agency (EPA) recently deemed formaldehyde a probable human carcinogen. Also, a number of House members asked the FDA to look into the treatments, including Brazilian Blowout, over health concerns. “It came to my attention that people were getting very sick, that there was hair fall, there were respiratory issues, there were all kinds of problems with Brazilian Blowout,” said Representative Jan Schakowsky (Democrat-Illinois), quoted The Associated Press (AP) previously. Schakowsky, Representative Ed Markey (Democrat-Massachusetts), and eight others wrote to the FDA this May seeking increased regulation and labeling of the formaldehyde-containing products.

Hair strengtheners are considered cosmetics and are not subject to pre-market approval. “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 of the California Healthy Nail Salon Collaborative in the FDA statement.

In October, Oregon health officials issued an alert to hair salons after workers at one Oregon salon complained of eye irritation, nose bleeds, and difficulty breathing after using the Brazilian Blowout. At the time, Oregon OSHA said it found significant formaldehyde levels Brazilian Blowout, later broadening the alert salons to take necessary precautions outlined in its formaldehyde rule when using hair-smoothing treatments, particularly those labeled “Keratin-based.”

Meanwhile, a Brazilian Blowout class action lawsuit was recently filed, seeking millions for the users of the popular hair straightening treatments and claiming the treatments contain no harsh chemicals, when in fact, they expose users to formaldehyde. The Brazilian Blowout lawsuit, one of many such claims filed in the wake of the Oregon health alert, seeks more than $5 million in class damages for fraud by omission, unjust enrichment, breach of warranty, intentional misrepresentation, false advertising, and violation of business laws.

Brazilian Blowout and similar products have been banned in Australia, Canada, Ireland, France, and Germany, said WebMD.