Hair Relaxer Formaldehyde and the FDA’s Failure to Warn

Santa Clara, CAThe FDA has known since at least 2011 that hair straighteners containing formaldehyde and other toxic chemicals have made hair salon workers and their clients sick, yet it is just now considering banning hair relaxers that contain or emit the chemical by April 2024, due to a link with long-term health effects. The agency said it has been communicating with the public since 2010 about formaldehyde’s potential health concerns, and for more than a decade it has received numerous warnings, including the cosmetic industry’s own experts stating the products unsafe.

Before an FDA proposal can become an official rule, it takes comments from the public and then may "decide to end the rulemaking process, to issue a new proposed rule, or to issue a final rule," the agency's site says. The FDA has always had the authority to ban a specific ingredient like formaldehyde, and it has removed about a dozen ingredients, including mercury compounds, from cosmetics. But numerous hair relaxer products containing formaldehyde are still sold in the U.S., including Amazon and Walmart.

The agency stated in February 2022 the following:

As hair smoothing products increased in popularity in the late 2000’s, the FDA began receiving inquiries from consumers and salon professionals about the safety of products containing formaldehyde or related ingredients. In response to these concerns, in 2010, the agency began communicating with the public to provide information about the potential health effects of these products and how to recognize products containing formaldehyde or its liquid forms, formalin and methylene glycol.

“The F.D.A. has known for decades now that these products are dangerous,’’ said Melanie Benesh, vice president for government affairs at the Environmental Working Group (EWG, an advocacy organization). “There is no reason for them not to have acted sooner.”

Formaldehyde

On its website the FDA states that breathing in formaldehyde gas can be harmful and cause immediate reactions ranging from irritation of the eyes and throat to coughing, wheezing, or chest pain to chronic or long-term problems such as more frequent headaches, asthma, skin irritation, and possibly cancer. It is also a sensitizing agent that can cause allergic reactions upon repeated exposure. Of note, the International Agency for Research on Cancer has classified formaldehyde as a human carcinogen.

Hair Relaxer Warnings Timeline

2011: The EWG petitioned the agency (and again in 2021) to ban hair products with formaldehyde.

2011: Health Canada warned that certain hair products contain more formaldehyde than the allowable limit of 0.2 per cent for the preservative in cosmetics (see product list below).

2016: The FDA’s scientists deemed formaldehyde to be a human carcinogen, and its lawyers started drafting a proposed ban. But the process halted abruptly a few months later, with no explanation.

2019: A study published in the International Journal of Cancer linked hair dye and chemical straightener use to a risk of breast cancer in women in the U.S.

2022: The National Institutes of Health published a study that found women who used hair-straightening chemicals more than four times a year more than double their risk of developing uterine cancer, and that Black women may be more affected because of higher use.

February 2022: the FDA warns that hair smoothing products release formaldehyde when heated.

December 2023: Research published by Boston University indicates that postmenopausal women who use chemical hair straighteners face an increased risk of uterine cancer. 

Spring 2023: The Office of Information and Regulatory Affairs issued a proposed rule that would ban formaldehyde (FA) and other FA-releasing chemicals (e.g., methylene glycol) as an ingredient in hair smoothing or hair straightening products marketed in the U.S.

April 2024: The FDA proposes to ban on formaldehyde and other formaldehyde-releasing chemicals like methylene glycol in straightening products.

Products listed in Health Canada’s 2011 advisory (indicating formaldehyde levels) are:

• Brazilian Blowout Smoothing Solution by Brazilian Blowout — 8.4 per cent.
• Brazilian Keratin Treatment by Marcia Teixeira — 1.8 per cent.
• Advanced Brazilian Keratin Treatment by Marcia Teixeira —1.7 per cent.
• Chocolate Extreme De-Frizzing Treatment by Marcia Teixeira —1.6 per cent.
• Keratin Complex Smoothing Therapy Treatment by Copomon (Coppola) — 1.8 per cent.
• Global Keratin Taming System Strawberry by Global Keratin — 3.0 per cent.
• Global Keratin Taming System with Juvexin Strawberry Resistant by Global Keratin — 4.4 per cent.
• Global Keratin Taming System with Juvexin Strawberry Light Wave by Global Keratin — 1.4 per cent.
• Pro-Collagen RX Keratin Treatment — 2.8 per cent.
• IStraight Keratin (Advanced Keratin Treatment) by IBS Beauty — 2.3 per cent.
• Brazilian Thermal Reconstruction by Cadiveu — 7.0 per cent.