FDA Sued Over Allegedly Dangerous Hair Straightening TreatmentsDec 20, 2016
Non-profit Groups Allege FDA Failed to Protect Public from Formaldehyde in Brazilian Blowout
The U.S. Food and Drug Administration (FDA) is being sued by the Environmental Working Group (EWG) and the Women's Voices for the Earth, two non-profit environmental advocacy groups who allege that the agency failed to protect the public from formaldehyde exposure associated with hair straightening treatments. The lawsuit, filed in the U.S. District Court for the District of Columbia, alleges that the FDA failed to adequately regulate hair products containing formaldehyde. According to the National Cancer Institute, formaldehyde has been linked nasal cancer in rats; the chemical may also be carcinogenic in humans.
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"For years stylists have reported that the application of these hair treatments caused difficulty breathing, eye irritation and nosebleeds," Tina Sigurdson, EWG assistant general counsel, said in a Dec. 14, 2016 press release. "The FDA has been aware of the health hazards associated with the products since at least 2008. Despite these dangers, the FDA has yet to take action to remove them from the market."
According to the release, EWG filed a citizen's petition in 2011 asking the FDA to investigate the formaldehyde risks with hair straightening products. The agency has not addressed the formal request, or taken regulatory action, the group says.
"The health risks posed by these products deserved immediate action from the FDA when it was brought to their attention in 2008," said Alexandra Scranton, director of science and research for Women's Voices for the Earth, according to the release. "Allowing salon workers and their customers to continue to be harmed by these products for over six years is unconscionable."
The lawsuit focuses on keratin hair straightening treatments, known by the popular brand name Brazilian Blowout. The product contains a liquid, which is applied to the hair and then heated using blow dryers and straightening irons. According to EWG, these products can release formaldehyde into the air with high temperatures. "High levels of formaldehyde, a potent allergen and human carcinogen, make many keratin hair straightening treatments a serious health threat to both clients and salon workers." the group states in the release.
FDA Warning Letters, OSHA Hazard Alert
The group states that, in response to the known dangers of formaldehyde in hair straightening products, the FDA has only created an informational website and issued warning letters to two manufacturers. The agency states on its websites, that "The warning letters issued by FDA address products that contain methylene glycol, which, when heated, releases formaldehyde into the air. Because these products must be applied with heat, formaldehyde is released when people use them following directions on the label." A warning letter was issued to the importer and distributor of Brazilian Blowout Acai Professional Smoothing Solution GIB LLC dba Brazilian Blowout).
The FDA also cites a Hazard Alert issued by the Occupational Safety and Health Administration (OSHA). Federal investigations showed that products labeled as "formaldehyde free" released formaldehyde levels exceeding OSHA safety standards.
Complaints have been submitted over hair straightening products such as Brazilian Blowout (Acai Professional Smoothing Solution, Professional Brazilian Blowout Solution), Brasil Cacau Cadiveu, Keratin Complex Smoothing Therapy (Natural Keratin Smoothing Treatment, Express Blow Out, Natural Keratin Smoothing Treatment Blonde), and Marcia Teixeira (Advanced Brazilian Keratin Treatment, Extreme De-Frizzing Treatment).
Brazilian Blowout Acai Professional Smoothing Solution and Brasil Cacau Cadiveu, both labeled "formaldehyde free" were found to release levels of formaldehyde above OSHA limits. Regulators identified the issue via air tests.
The risk of formaldehyde exposure with hair straightening products came under OSHA scrutiny when a hair stylist complained of nosebleeds, eye irritation and difficulty breathing after using a Brazilian Blowout product labeled "formaldehyde-free". The complaint was investigated by Oregon OSHA.
The FDA told ATTN it does not comment on pending litigation, and reiterated its authority regarding cosmetic products. "Under the Federal Food, Drug, and Cosmetic Act, cosmetic products and ingredients do not need FDA premarket approval, with the exception of color additives," an FDA spokesperson said, according to ATTN. "Companies and individuals who manufacture or market cosmetics have a legal responsibility to ensure the safety of their products, but the agency does not have the authority to require companies to present data demonstrating the safety of their products before they are marketed."
Formaldehyde Health Risks
Formaldehyde is a colorless, strong-smelling vapor that can cause serious health problems. Formaldehyde is hazardous when it is inhaled, exposed to the skin, eyes or ingested. You may also be exposed if you touch a product containing formaldehyde and then touch your face or food without washing your hands first. Exposure to formaldehyde can cause eye and nose irritation, coughing and wheezing. OSHA states that formaldehyde is a "sensitizer" that can result allergic reactions of the skin, eyes and lungs. This may lead to subsequent asthma, skin rashes and itching. Formaldehyde can cause blindness if sprayed in the eyes.
Some products may not directly claim that they contain formaldehyde. "Because of the way the formaldehyde reacts in these products, some manufacturers, importers, or distributors might list other names for formaldehyde on product information or might claim that the product is ‘formaldehyde-free.'" OSHA states. "Formaldehyde might be listed as methylene glycol, formalin, methylene oxide, paraform, formic aldehyde, methanal, oxomethane, oxymethylene, or CAS Number 50-00-0." All of these are different names for formaldehyde by OSHA standards.
Formaldehyde may also be produced by other chemicals under certain conditions. For example, timonacic acid may release the chemical during the hair straightening process. "The bottom line is that formaldehyde can be released from hair smoothing products that list any of these names on the label and workers can breathe it in or absorb it through their skin. Workers can be exposed to formaldehyde during the entire hair straightening process, especially when heat is applied (e.g. blow-drying, flat ironing)." OSHA warns.
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