Environmental Groups Sue FDA over Hair Care Treatments
Environmental Groups Sue FDA over Hair Care Treatments

Lawsuit Alleges FDA Failed Act on Hair Products Containing Formaldehyde

Two environmental groups have filed a lawsuit against the U.S. Food and Drug Administration (FDA) for allegedly failing to protect consumers from hair straightening products containing formaldehyde. The products in question are keratin hair straightening treatments, often sold under the brand name Brazilian Blowout. Users apply a liquid to the hair, and then apply heat using blow dryers and straightening irons. The lawsuit was filed by the non-profit environmental advocacy groups Environmental Working Group (EWG) and the Women’s Voices for the Earth, in the U.S. District Court for the District of Columbia. The groups allege that the agency failed to properly regulate the hair straightening products.

Parker Waichman LLP has decades of experience representing consumers in lawsuits over allegedly defective and dangerous products. The firm continues to offer free legal consultations to individuals with questions about filing a lawsuit.

Formaldehyde may be carcinogenic, or cancer causing, in humans. Studies have linked formaldehyde exposure to nasal cancer in mice, according to the National Cancer Institute.

“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.”

In 2011, EWG filed a citizens petition calling for regulators to investigate the presence of formaldehyde in hair straightening products. According to the group’s press release, the FDA has not addressed the petition or acted on the group’s request.

“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.”

EWG alleges that keratin hair straightening treatments are dangerous because they release formaldehyde into the air at 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.

Manufacturers Receive Warning Letters, OSHA Issues Hazard Alert

EWG alleges that that FDA has failed to take regulatory action to protect consumers, stating that the agency has only issued warning letters to two manufacturers and created an informational web page. “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.” regulators state on their website.

The FDA issued a warning letter to the importer and distributor of Brazilian Blowout Acai Professional Smoothing Solution GIB LLC dba Brazilian Blowout).

The agency notes that the Occupational Safety and Health Administration (OSHA) has issued a hazard alert regarding products claiming to be “formaldehyde free”. Despite the label, these products release 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).

Upon air tests, regulators found that Brazilian Blowout Acai Professional Smoothing Solution and Brasil Cacau Cadiveu, both labeled “formaldehyde free” were found to release levels of formaldehyde above OSHA limits.

OSHA was first alerted to the issue when a hair stylist complained of nosebleeds, eye irritation and difficulty breathing after using a Brazilian Blowout product labeled “formaldehyde-free”. Oregon OSHA investigated the case.
The FDA does not comment on pending litigation, the agency said to ATTN. The agency reiterated its role regarding cosmetic products, stating “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 Exposure Can Cause Health Problems

Individuals exposed to formaldehyde can suffer from various health problems, including eye and nose and eye irritation, coughing and wheezing. The substance is a colorless, strong-smelling vapor that is toxic when exposed to the skin, eyes or ingested. If you touch a product containing formaldehyde and then touch your face or food without washing your hands first, you may experience symptoms of exposure.

According to OSHA, formaldehyde is a “sensitizer” that can cause allergic reactions of the skin, eyes and lungs. Users may subsequently suffer asthma, skin rashes and itching. If exposed in the eyes, formaldehyde can cause blindness.

In some cases, products release formaldehyde may not list this chemical on the label. “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.

Environmental Groups Sue FDA over Hair Care Treatments
Environmental Groups Sue FDA over Hair Care Treatments

“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.

Other chemicals may produce formaldehyde under certain conditions. For instance, timonacic acid may release formaldehyde 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 states.

Contact Product Liability Attorneys at Parker Waichman

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