"This is what's called an unreasonable delay suit," said Scott Faber, the group's senior vice president of government affairs. The FDA is "legally bound to respond within a year" of a request, he said. The agency has not done so, and now, "the petitioner can make the argument of undue delay, and that's what we're doing here."
After a request, Van Tibolli made a label change to its keratin hair-straightening treatment sold under the GK Hair brand, said Meghan McHugh, the company's international business development manager. It used the exact wording provided by the FDA.
"People are aware that there's methylene glycol in the product," McHugh said, adding, "that's one of the first things they learn about the ingredients." Usually, customers communicate with the company a lot about how to use the products, but having learned this information from the start, they typically don't complain.
"We've always been very transparent with this type of information," McHugh said.
Brazilian Blowout did not respond to a request for comment.
Originally, in 2011, the Environmental Working Group filed a formal request with the FDA to investigate the marketing practices of more than a dozen companies the group accused of hiding formaldehyde ingredients within their products.
Faber said the group is ultimately asking the FDA to examine whether a warning is required. It also wants the FDA to examine whether methylene glycol (a form of formaldehyde) should be used at all in these products and, if so, what amount is permissible.
"This is a chemical that is so dangerous that even the industry's own self-regulatory program, what's called the Cosmetic Ingredient Review, has concluded that it should not be used in hair-straightening products," Faber said. As the original petition explained, some keratin hair-straightening products list "methylene glycol" as an ingredient, which is formaldehyde in a solution, he explained.
Dr. Beth Jonas, chief scientist for the Personal Care Products Council
, explained that the FDA convened an independent review panel, made up of scientific and medical experts.
They found that the safety of methylene glycol and formaldehyde in hair-straightening products depends on chemical concentration levels, the temperature used during application and ventilation, among other factors.
"They concluded that under present practices of use and concentration, formaldehyde and methylene glycol are unsafe in hair straightening products
," Jonas wrote in an email. "Personal Care Products Council fully supports the panel's findings."
However, the products are still available, and consumers and salon workers continue to use them.
Sensitivity to gas
When methylene glycol solution is applied to the hair and heated, it is inhaled as formaldehyde gas -- and this is where the health problems begin, said Alexandra Scranton, director of science and research at Women's Voices for the Earth
. The Montana-based environmental group, led by women, joined the Environmental Working Group in the complaint filed against the FDA.
"I talked to one woman who was like, 'I can't blow dry my hair. Every time I put heat to my hair, it gases off, and I can't breathe, and I'm coughing, and my eyes swell up,' " Scranton said, explaining that once someone becomes sensitive to formaldehyde, "even much, much lower exposures" to the chemical will cause their body to react.
Unfortunately, "there's no reversing sensitization," added Scranton, whose description of the body's reaction to formaldehyde is confirmed by a safety report published in the International Journal of Toxicology
Some salon workers become sensitized to it after routine exposures to this chemical at work, and then "they have trouble doing their job, because these same symptoms keep coming back," explained Scranton. Even worse, they are encountering formaldehyde not only at work but in many other environments including their homes, since it is used to manufacture some wood products, including cabinetry and flooring.
As Scranton put it, "formaldehyde is real hard to avoid in our culture, so they don't know when they're going to be exposed to it and have this terrible reaction."
Meanwhile, salon workers and the women who use these straightening products are often unaware of the contents.
Though there's more awareness today than in 2010, when she first began educating salon workers about these products, "there's still a general impression that, "Well, if it's on the shelves of the beauty supply store, it must be safe to use,' " Scranton said. "Even if it's got a formaldehyde warning somewhere buried on a safety data sheet."
Generally, there isn't a warning on the label, though occasionally a product will recommend "adequate ventilation" on the instructions, explained Scranton. These products are required by law to have a safety data sheet listing the hazardous chemicals.
Although some of the safety data sheets do list formaldehyde exposure risks -- at least among the products that have been the subject of lawsuits in various ways -- some products have outdated information, said Scranton: "It's a bit of a mix."
Faber said personal care product companies are virtually unregulated by the FDA, which "everyone admits -- including the industry -- that FDA has very, very limited authority to ban or even restrict chemicals."
Under the Federal Food, Drug, and Cosmetic Act, cosmetic products and ingredients do not need premarket approval, with the exception of color additives. But those who manufacture or market cosmetics have a legal responsibility to ensure the safety of their products.
When the FDA becomes aware of a cosmetic posing a risk, it can notify the public so that consumers can make informed decisions. All the FDA's warning letters are publicly available
Of the estimated 6,000 chemicals used in personal care products, Faber said, only nine "have ever been banned for health reasons and only because they are like truly the equivalent of poisons."
Yet the FDA notes that the US Occupational Safety and Health Administration has issued a Hazard Alert
to hair salon owners and workers about potential formaldehyde exposure from working with these products.
"Even though the Cosmetic Ingredient Review (Expert Panel) has concluded that methylene glycol and formaldehyde are the same thing and you shouldn't use methylene glycol in hair-straightening products, it's not binding, so companies are free to ignore that," Faber said.
Jonas noted that the Personal Care Products Council contracts "outline our expectations for ethical business practices. These often include provisions for labor rights, and health and safety." Violation of these provisions, said Jonas, can result in cancellation of business partnerships.
Still, Faber maintains that the FDA needs to rule on formaldehyde within hair-straightening products: "This is one of those cases. ... You know, nothing is open and shut -- but this is as close as you get!"