FDA Misses Deadline to Ban Formaldehyde in Hair Relaxers

Santa Clara, CAThe FDA has missed its own April deadline to ban formaldehyde in hair-relaxers, despite mounting pressure to remove the hazardous chemical from all hair-straightener products, and despite no opposition to its removal. Critics say the agency’s failure to deal with the proposed new regulation would do far too little, in addition to being far too late. After all, the FDA's role is to prevent harm from happening in the first place. Many Black women with serious health issues linked to these products have filed over 6,000 hair relaxer lawsuits against manufacturers and the longer the FDA stalls, more complaints are inevitable.

The FDA’s proposal in Spring 2023 to ban formaldehyde and other formaldehyde-releasing chemicals like methylene glycol in straightening products is due to a link with long-term adverse health effects. “Use of hair smoothing products containing FA and FA-releasing chemicals is linked to short-term adverse health effects, such as sensitization reactions and breathing problems, and long-term adverse health effects, including an increased risk of certain cancers.” One study by the National Institute of Environmental Health Sciences discovered that hair-straightening chemicals increase uterine cancer risk. Another study published in the International Journal of Cancer found that women who used chemical straighteners had up to a 30 percent increased risk of developing breast cancer than those who didn’t.

The Agency told NBC News that “the Unified Agenda estimates the action date for the NPRM [Notice of Proposed Rulemaking] as April 2024. We are still developing the proposed rule and cannot comment further about questions of timing or content at this time.” At the time of writing, It is still unclear why the FDA has not released its proposed ban.

FDA’s Critics

The Environmental Working Group (EWG) petitioned the FDA to ban formaldehyde in hair straighteners back in 2011 and again in 2021 to protect “professional stylists and their clients.” It sued over the issue in 2016. The FDA promised in 2017 only to review whether to ban formaldehyde while denying EWG’s request to require a warning label. In 2018, the case was dismissed due to procedural issues.

By March 2021, the FDA sent a special women’s health alert urging caution for anyone using formaldehyde in hair-smoothing treatments. David Andrews, senior scientist at EWG, says the agency’s stalling reflects broader problems. “It’s a clear example of failure in public health protection,” he told by KFF Health News.

Linda Birnbaum, former director of the National Institute of Environmental Health Sciences and the National Toxicology Program went a step further and said, “The fact that formaldehyde is still allowed in hair care products is mind-blowing to me …I don’t know what we’re waiting for.”

FDA Cosmetics Authority

One main reason for the  delay is the FDA’s  limited powers when it comes to cosmetics and personal-care products, according to Lynn Goldman, a former assistant administrator for toxic substances at the U.S. Environmental Protection Agency. She explained that, under the law, the FDA must consider all chemical ingredients "innocent until proven guilty." And Melanie Benesh, EWG’s vice president of government affairs, described to NBC NEWS that the field of cosmetics is the “Wild, Wild West of regulation” since the FDA has historically had more limited authority over them, “compared to other items under their jurisdiction, like food and drugs.”

The FDA states that the law does not require cosmetic products and ingredients, other than color additives, to have FDA approval before they go on the market. A former director of the FDA's Office of Cosmetics and Colors said the federal agency often waits for the industry to voluntarily remove hazardous ingredients. It is up to the manufacturer to ensure their product is properly labeled and they are responsible for the safety and labeling of their products and ingredients. However, the FDA can take action against cosmetics on the market that do not comply with the law, usually with a warning letter outlining what violations need to be corrected. But that action is clearly not timely.

Formaldehyde

This chemical is mostly known for its use as embalming fluid. The National Toxicology Program listed it back in 2011 as a known human carcinogen, or substance that causes cancer. According to the American Cancer Society, exposure to formaldehyde has been linked to cancer in both lab studies in animals and people. Yet formaldehyde is still a common ingredient in relaxers.

Meanwhile, "It's important to understand what we are putting in our mouths, on our skin, in our hair, so it's important to read the labels," said Dr. Deborah Scott, director of the hair loss clinic at Brigham & Women's Hospital. "I think it's important if you're having your hair straightened to have them share the label with you. We know there are lists of compounds like formaldehyde or formaldehyde releasers, or formaldehyde substitutes like methylene glycol, which turns into formaldehyde with heat. It's important to look for these ingredients and avoid them."

On a positive note, reports to the California Department of Public Health's Safe Cosmetics Program show a tenfold drop in products containing formaldehyde between 2009 and 2022.