When Regulation Fails, Litigation Steps In: FDA Stalls on Formaldehyde Ban While Hair Relaxer Lawsuits Push Forward
The FDA has again missed its deadline to ban formaldehyde, a known carcinogen, from hair-straightening products.
The agency has debated regulation since at least 2016. Although a proposed rule emerged in 2023, multiple missed deadlines have stalled consumer protection efforts. Meanwhile, those most exposed — salon workers and Black and Hispanic women who frequently use hair relaxers — remain at risk.
At the same time, over 10,000 women are suing major hair relaxer companies, claiming that long-term use led to uterine and ovarian cancers. Most of these lawsuits have been grouped into a federal multidistrict litigation (MDL) overseen by Judge Mary M. Rowland in the Northern District of Illinois.
In mass tort cases involving hundreds or thousands of plaintiffs who have been injured by the same product, consolidating them in a single court makes litigation more efficient.
This week, the parties in the hair relaxer MDL presented expert testimony during “Science Day,” a hearing where experts explain the medical and toxicological issues. Science Day is an informal, off-the-record hearing meant to help judges grasp the science before making difficult evidentiary rulings as the litigation progresses.
Much of the discussion centered on chemicals in hair relaxers that disrupt the endocrine system, like phthalates and parabens. The dangers of cancer-causing substances, including formaldehyde and chemicals that release formaldehyde, were also a main focus.
Plaintiffs’ expert, Dr. Thomas Zoeller, explained that when hormone disruptors are mixed with cancer-causing chemicals like formaldehyde, it is a “perfect storm” for creating a permissive environment that allows cancer cells to form and grow.
When Courts Act Faster Than Regulators: Lessons From Talc and Asbestos
The hair relaxer lawsuits are still in the early stages. While legal cases can move slowly, courts often bring about accountability and change long before government agencies do. We have seen this happen before, especially with talc and asbestos.
For decades, regulators were aware of asbestos contamination in talcum powder products, but the FDA did not take action to protect consumers from this hazard. In fact, there is still no federal ban on cosmetic talc in the U.S., and the agency recently withdrew proposed uniform testing rules for asbestos in cosmetics.
Despite the lack of regulation, billions of dollars have been awarded to cosmetic talc users by juries across the country who agreed the products were dangerous and that companies like Johnson & Johnson should have taken action to protect consumers.
J&J ultimately removed talc from its baby powder worldwide in 2023, but not due to government regulations. It happened because of lawsuits, because women spoke out, and because juries listened when regulators did not.
The situation with hair relaxer products is starting to look very similar. Instead of waiting years or for huge jury verdicts, the FDA could take action now. The agency could set real rules, require safer products and stop future harm.
Every month of delay means more people are exposed, more uncertainty and more risk for the communities that are least protected and most affected.
Right now, there is a race to see whether government action or the courts will bring real, lasting change first. If the past is any guide, it will not be the FDA that protects women first. It will be the courts.
