The F.D.A. Wanted to Ban Some Hair Products. It Never Happened.

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In 2016, agency scientists deemed hair straighteners containing formaldehyde to be unsafe, according to newly obtained emails.

Credit...Preston Gannaway for The New York Times

Roni Caryn Rabin

Oct. 21, 2020, 11:15 a.m. ET

It’s been more than a decade since a popular hair treatment called Brazilian Blowout appeared in salons, promising months of straight hair after a single application. But soon users were complaining that the product emitted noxious fumes that stung their eyes, brought on headaches, nosebleeds and nausea, and made it hard to breathe.

Government health inspectors said the culprit was formaldehyde, a chemical that has been linked to cancer. Although the labels on the bottles claimed the product was “formaldehyde-free,” it contained a solution called methylene glycol, which converts to formaldehyde gas after coming in contact with air.

The Food and Drug Administration has allowed Brazilian Blowout and similar products, called keratin treatments, to remain on the market despite the recommendations of its own scientists, according to internal agency emails obtained under the Freedom of Information Act by the advocacy group Environmental Working Group and shared with The New York Times.

F.D.A. scientists deemed hair straighteners with formaldehyde unsafe in 2016, and agency lawyers started drafting rules for a proposed ban, the emails show.

“This is a very big deal for us, and for the public,” an agency scientist wrote to her colleagues on July 26, 2016.

But a ban never happened. Internal emails about the drafting of new rules continued for a few months before the process appears to have abruptly halted. F.D.A. officials have not yet provided the Environmental Working Group with any internal documents or communications on the topic written after December 2016, despite the group’s request.

An F.D.A. spokeswoman did not directly respond to questions about why the agency’s move to ban hair straightening products with formaldehyde stalled, saying only that the agency’s Center for Food Safety and Nutrition considered a rule “as one of several potential actions.” She said the cosmetics division had shifted its attention to tattoo inks, talc and allergens in makeup.

The revelations of the intended ban come at a time when public trust in the F.D.A., the agency responsible for reviewing the safety of coronavirus therapies and vaccines, has been shaken. Critics have questioned the agency’s emergency approval of Covid-19 treatments, and many Americans fear the agency is being pressured to prematurely authorize a coronavirus vaccine.

Susan Mayne, who heads the center that oversees cosmetics, was one of several senior F.D.A. officials who recently wrote an article in USA Today pledging to make decisions about the safety and effectiveness of Covid-19 treatments and vaccines based on the available science. She declined a request for an interview about the agency’s handling of the hair straighteners.

The National Cancer Institute, part of the National Institutes of Health, has noted links between formaldehyde and cancer. Studies of workers exposed to high levels of formaldehyde, like embalmers, have found an increased risk of myeloid leukemia and rare cancers of the nose and pharynx.

Even the cosmetics industry’s own expert panel, asked in 2011 by the F.D.A. to evaluate the safety of the hair straighteners, concluded it is unsafe to use formaldehyde in products designed to be used with heat, such as blow dryers or flat irons.

To use the products safely, “you’d have to do the treatments in a wind tunnel,” said Bart Heldreth, executive director of the group, called the Cosmetic Ingredient Review, which was created and funded by the cosmetics industry’s trade association, the Personal Care Products Council.

The F.D.A. has limited authority over cosmetics products, which unlike drugs do not require approval before being brought to market. But the agency can ban ingredients from cosmetics and has done so for about a dozen ingredients, including mercury compounds and some cattle products.

In April 2011, the Environmental Working Group — which ranks the safety of personal care products on its Skin Deep Cosmetics database — filed a petition asking the F.D.A. to ban formaldehyde in hair straighteners, and to require warning labels about the risks.

The agency did not respond to the group’s petition until 2017, but its Office of Cosmetics and Colors started testing hair straightening products for formaldehyde in 2011, the emails show.

In August 2011, the agency sent a warning letter to Brazilian Blowout’s manufacturer, GIB LLC, based in Agoura Hills, Calif., saying that testing had found that up to 10 percent of the product was methylene glycol, which scientists consider formaldehyde in solution, and that corrective action was required. The company disputed the findings, saying that methylene glycol and formaldehyde are distinct substances and that the straighteners release only trace amounts of formaldehyde. The products, whose own data safety sheet lists the ingredient as “methylene glycol (formaldehyde),” continued to be sold.

By 2014, scientists at the F.D.A.’s cosmetics division had begun working on a scientific risk assessment — a formal analysis that influences regulatory policies — of formaldehyde, according to a Dec. 19, 2014, email from Nakissa Sadrieh, the director of the division, to her boss, Dr. Linda Katz, the director of the Office of Cosmetics and Colors.

A year later, Dr. Sadrieh told her toxicologist colleagues that the formaldehyde review was a “priority,” and that time was of the essence. “I am trying to follow up and make sure that this project is completed within expected timeline,” she wrote on June 18, 2015.

By then, the agency had received dozens of complaints about the products, particularly from hair dressers.

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Credit...Preston Gannaway for The New York Times

One hair stylist complained of migraines, nausea, blurred vision, sore throat and a loss of her sense of smell after treatments in her salon. “When is the FDA going to step in?” she asked in a June 22, 2014, complaint.

By July 2016, the cosmetics division’s risk assessment had been completed, finding that formaldehyde was a human carcinogen, and a date was set for an internal F.D.A. briefing on formaldehyde. On July 15, Dr. Sadrieh said in an email that, based on the safety research, she would make the case for restricting its use.

On July 26, she emailed everyone at the agency’s Center for Food Safety and Applied Nutrition, which oversaw her cosmetics division, with some big news: The center was “proposing to develop regulations to ban the use of formaldehyde in hair smoothing products.”

A few weeks later, regulatory action seemed imminent. An F.D.A. lawyer, Allison Bonnenburg, was assigned to the task, and emailed Dr. Sadrieh on Aug. 18. “Finally, someone who cares about the public,” Dr. Sadrieh wrote to Dr. Katz.

On Oct. 5, Dr. Sadrieh sent a draft of the safety review to Dr. Katz. “It is time to celebrate,” she wrote. She also sent a draft to Ms. Bonnenburg to help her in writing the ban.

Then, in mid-December, just before Donald J. Trump was to be sworn in, Ms. Bonnenburg was abruptly pulled off the project. Given the lawyer's commitment and the amount of time she had already spent working on the regulation, Dr. Sadrieh was crestfallen. “I doubt that anything will now happen, at least in my lifetime,” she wrote Dec. 16. (Dr. Sadrieh, who still works at the F.D.A., declined to comment about the content of her emails.)

The lawyers assigned in Ms. Bonnenburg’s place were unfamiliar with the issues and did not seem to have read the reports carefully, she said. “Don’t these people talk to each other, or read documents that we send them?” Dr. Sadrieh wrote on Dec. 22 to a toxicologist, Tyna Dao.

“Man, this is so frustrating,” Ms. Dao responded. ”Because you’ve already considered and addressed all these issues YEARS AGO.”

What happened next is not clear, as the agency has not released any emails from 2017 or later. But the ban was never enacted.

Brazilian Blowout and other conditioners with formaldehyde are still on the market. Complaints have led some salons, which charge hundreds of dollars for the treatment, to provide them only in well-ventilated areas or offer them only on certain days. Some products are also available for purchase by consumers to use in their homes.

Heat is crucial to the process: Directions call for applying the product to the hair, blow drying the hair with a hair dryer, and then using a flat iron heated to at least 380 degrees to straighten the hair. The concern is that heat converts the liquid formaldehyde into a gas and releases it into the air.

Reached by phone in early October, Monte Devin Semler, who is listed in California business records as the trustee of an entity that manages GIB LLC and who says on his LinkedIn profile that he is the owner and founder of Brazilian Blowout, hung up after being asked to comment. He did not respond to emails.

Another manufacturer, Van Tibolli Beauty PR, was told by the F.D.A. on Sept. 2, 2015, that its GK Hair Taming System products contained formaldehyde, and that labels warning consumers of possible health effects, including cancer, were required. F.D.A. officials said last week that the case had been resolved, but refused to provide further details. The company’s president, Van Tibolli, said in a phone interview that some of his company’s hair straightening products still contain methylene glycol, the liquid form of formaldehyde.

Products containing formaldehyde may soon be taken off the market in at least one state: Last month, Gov. Gavin Newsom of California signed the Toxic-Free Cosmetics Act into law. The law prohibits the use of a dozen chemicals in cosmetics, including formaldehyde, mercury, phthalates and parabens.

Salon workers experience the most exposure to the hair straightening products, according to the nonprofit group Women’s Voices for the Earth. Many hair dressers say they always assumed products that were on the market were safe.

“When I would try to speak up about this, my co-workers always said, ‘If it was that bad for you, it wouldn’t be legal,’” said Emily Baedeker, a hair dresser in Alameda, Calif., who got migraines when Brazilian Blowout was used around her. “The assumption is that there is an invisible safety net that protects us.”

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