FDA Ban on Hair Relaxers With Formaldehyde Delayed Again: Reports

A proposal by federal regulators to ban the use of formaldehyde in hair relaxer products, which have been linked to increased cancer risks, has been pushed back to September, according to recently released documents.

The U.S. Food and Drug Administration (FDA) first proposed a ban on formaldehyde in hair relaxer products in October 2023, which would affect both formaldehyde and chemicals that release it, such as methylene glycol. Under the rule, such chemicals would no longer be allowed in hair relaxer products sold in the U.S., which have been widely used by African American and minority women for decades.

Originally, the agency indicated the rule was expected to be finalized in April 2024, but the month passed with no word on the final ban, and many products continue be sold as hair relaxers with formaldehyde, which could lead to the development of uterine cancer, ovarian cancer and other injuries.

Now, according to a new update on the proposed formaldehyde rule published by the Office of Management and Budget, finalization of the ban has been pushed back to September. No reason for the delay has been provided, but various news agencies report that FDA officials say putting such rules in place takes time, and requires approvals at various levels throughout the agency.

Formaldehyde use in hair relaxers has been associated with both short-term and long-term health effects, according to FDA warnings when the proposed rule was first announced, including skin reactions, respiratory problems, and an increased risk of certain types of cancer.

Manufacturers such as L’Oreal and Revlon already face thousands of hair relaxer lawsuits brought by women diagnosed with uterine cancer, endometrial cancer, ovarian cancer and other injuries that were allegedly caused by endocrine disrupting chemicals contained in many of the most popular products on the market in the U.S., including Dark & Lovely, Just for Me, ORS Olive Oil Motions, Optimum Care and others.

Formaldehyde Health Concerns

Formaldehyde is an industrial chemical used to make many construction and building materials, paper products and cosmetics. However, exposure to high levels of the chemical can cause serious health problems when inhaled or absorbed through the skin.

Short-term exposure to formaldehyde can cause eye irritation if inhaled or allergic reactions if it touches the skin, while longer exposure can result in lung damage, severe eye irritation, reproductive issues, asthma, allergy-related conditions, and even cancer.

Health experts have raised concerns about exposure to formaldehyde for years, especially involving workplace environments and certain consumer products. Research published by the American Academy of Neurology in 2021 found that long-term formaldehyde exposure in the course of employment was associated with a 21% higher risk of cognitive impairment, including lower IQ scores and memory loss.

In 2022, the U.S. Environmental Protection Agency found that formaldehyde exposure from the use of industrial products may be associated with rare but serious cancers. The agency indicated that long-term exposure to even low formaldehyde levels could cause nasopharyngeal cancer, sinonasal cancer and myeloid leukemia, which impacts bone marrow and blood cells.

As a result of the report, the U.S. Occupational Safety and Health Administration (OSHA) limited occupational formaldehyde exposure in the workplace to 0.75 ppm on average over an eight-hour workday, or 2 ppm not exceeding a 15-minute period.

In April, the EPA issued a draft evaluation declaring that formaldehyde exposure is an unreasonable risk to human health.

July 2024 Hair Relaxer Lawsuits Update

As a result of the failure to warn about the risk of cancer from hair relaxers, L’Oreal and other manufacturers now face thousands of product liability lawsuits filed throughout the federal court system. Given common questions of fact and law raised in the complaints, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established coordinated pretrial proceedings for all hair relaxer lawsuits in January 2023, centralizing the claims before U.S. District Judge Mary Rowland in the Northern District of Illinois.

To help gauge the strengths and weaknesses of this evidence, the parties proposed competing draft hair relaxer lawsuit bellwether trial plans in November 2023, which outlined a process for selecting a small group of bellwether cases, which will go through case-specific discovery in preparation for early trial dates. However, the parties have been unable to agree on several key points regarding the bellwether selections, as well as when the first trials should begin, and how big a factor general causation should play in the early phases of the litigation.

While the stated intention of bellwether trials is to identify the most representative lawsuits, parties in complex litigation often jockey to make selections that are most beneficial to their side, as the average hair relaxer lawsuit payouts will have a substantial impact on the amount of money the manufacturers may be required to pay to avoid the need for thousands of individual cases to go before separate juries nationwide.

Following coordinated discovery in the MDL and any early bellwether trials, if the parties fail to negotiate hair relaxer settlements for individuals diagnosed with uterine cancer, endometrial cancer, ovarian cancer, uterine fibroids and other complications, Judge Rowland may later remand each individual lawsuit directly filed in the MDL back to the U.S. District Court where it would have originated for a separate trial.