By A plan for the US Food and Drug Administration to propose banning formaldehyde and certain formaldehyde-releasing chemicals from being used in hair-straightening products remains in limbo under President Donald Trump.
Due to concerns about these chemicals’ links to cancer risks, the FDA under the Biden administration considered proposing a ban on these ingredients in certain cosmetic products such as chemical hair relaxers and pressing products, which are disproportionately advertised to Black women.
But official action was never taken, which now leaves the rule for the Trump administration to consider.
“Even though it would have really important public health impacts across the country, I’m not confident that this is something that is going to become an FDA priority or something that we’re going to see the FDA push through,” said Melanie Benesh, vice president of government affairs at the nonprofit Environmental Working Group, which has petitioned for more than a decade for regulations around the use of certain chemicals in cosmetics.
“Formaldehyde is a known carcinogen, so it is associated with cancer. It increases cancer risks for the salon workers, in particular, who are doing these treatments, but also dangerous levels of exposures for consumers who might be receiving these treatments,” she said. “There are associations with reproductive harms, there are associations with asthma and other immune effects, and then also acute, short-term effects, like stinging eyes, headaches, that customers and salon workers have reported.”
A ‘high hazard’ ingredient
Scientists have long identified an association between the use of hair-straightening chemical products with an increased risk of certain hormone-related cancers, including ovarian and breast cancers, and uterine cancer, particularly among Black and Latina women. Research suggests that about 50% of products advertised to Black women contain these types of chemicals, compared with about 7% that are advertised to White women, according to the Harvard T.H. Chan School of Public Health. These include both types of products that can be used at home or in salons.
A report released Tuesday by the Environmental Working Group said that among 4,011 personal care products marketed to Black women, less than a quarter – 21% – are considered “low hazard” in the group’s own cosmetics database, which rates the safety of products based on their chemical ingredients. Being of low hazard means the product’s ingredients are considered to be of low risk to human health.
But about 1 in 20 products in the group’s analysis ranked as “high hazard” based on the scoring methodology, meaning the product’s ingredients are linked with a high risk of concerning health impacts.
“One of the high-hazard ingredients that we identify is formaldehyde,” Benesh said. “There definitely is a formaldehyde connection, along with other chemicals of concern, like some parabens and phthalates and other hair-relaxing chemicals that are in those products that are marketed to Black women.”
Another cosmetic company, L’Oréal, does not sell products on EWG’s list of hair straighteners that contain or release formaldehyde but said it supports the FDA’s plans to propose a rule.
“Our highest priority is the health and wellbeing of all our consumers. Our products are subject to a rigorous scientific evaluation of their safety by experts who also ensure that we strictly follow all regulations in every market in which we operate,” L’Oréal spokesperson Jason Kaplan said in an email. “L’Oréal does not add formaldehyde as an ingredient in any of its products in any market in the world. We welcome and support the U.S. Food and Drug Administration’s (FDA) proposal across the entire beauty industry.”
US Reps. Shontel Brown of Ohio, Nydia Velázquez of New York and Ayanna Pressley of Massachusetts have long supported the proposed rule, encouraging the FDA to propose a ban.
But now, “I’m honestly very worried. When was the last time Donald Trump sided with Black women over Big Business? President Trump’s track record gives me no reason to believe that his Administration would take action on this issue,” Brown said in an email.
“The frustrating thing is that this shouldn’t be controversial. We’re talking about basic consumer protection here,” she said. “It’s heartbreaking to think that all this time these products could have been harmful and it’s enraging that now we have so much evidence that we need to take action and it’s not happening. You wonder why we’re not being listened to.”
Trump’s nominee to lead the FDA, Dr. Marty Makary, is awaiting confirmation, but agency spokesperson Courtney Rhodes said the proposed rule continues to be a “high priority” for the agency.
“The FDA’s Fall 2024 Unified Agenda of Regulatory and Deregulatory Actions (the Unified Agenda) noted that the agency is planning to propose a rule would ban formaldehyde and other formaldehyde-releasing chemicals hair smoothing or hair straightening products and help protect public health by reducing the risk of exposure to this harmful substance,” Rhodes said in a statement Monday.
“This proposal is based on the science and data, including an FDA risk assessment, focus groups, and evaluation of the current literature that includes more recent data showing a link between formaldehyde and hair smoothing products and an increased cancer risk. The proposed rule continues to be a high priority and is still in the rulemaking process.”
Action date set for next month
In 2021, the FDA received a citizen petition from salon workers, the Environmental Working Group and the nonprofit Women’s Voices for the Earth requesting that the agency take regulatory action to prohibit formaldehyde and formaldehyde-releasing chemicals, like methylene or glycol, in hair-smoothing products and hair-straightening products.
“The FDA has indicated that they’re going to grant our petition that we filed in 2021 and propose a rule to ban formaldehyde in hair-straightening treatments, but the target date keeps getting pushed further and further back,” Benesh said.
The proposed rule that was under consideration by the Biden administration had a possible action date of April 2024, which was pushed back to July 2024 and then September 2024.
“What we have seen is the FDA kicking the can down the road on this rule,” Benesh said.
Now, in the Trump administration, the proposed rule has an action date of March 2025, but it remains unclear whether it will be published next month, said Allison Stevenson, a Florida-based attorney at Hill Ward Henderson law firm who specializes in cosmetics-related litigation issues.
“When you have a new administration come in who is a different political party than the prior administration, that creates this world of unknowns, not just in whether this rule will ever be published and, if so, when it is going to be published – but is this new administration on board with this anticipated rule? And a couple of things have to fall in place for that,” Stevenson said.
“Right now, we have someone who is serving as the acting FDA commissioner while we wait on this administration’s nominee for FDA commissioner to go through the Senate confirmation process,” she said. “It would be fair to assume that whoever comes in and takes the helm of the FDA … I would expect them to take some time to have the opportunity to review not just this pending proposal but anything that is in the hopper on the FDA’s end and work with the administration to make sure that their next steps are in line with the goals and the directives of the administration.”
‘There’s a lot of uncertainty’
The FDA plan could face one of several fates: It could be immediately withdrawn, could remain under review and in limbo for even longer, or could be immediately published.
Benesh said she’d be surprised if the proposed rule gets published in March.
“The new Trump administration, which is now in place, has issued a freeze on all rules that have not been sent to the Federal Register. That would include this rule on formaldehyde,” she said. “And the Trump administration has pretty publicly committed to a deregulatory agenda.”
As part of the regulatory process, if the proposed rule is issued, the FDA is expected to receive public comments on it, and after reviewing those comments, the agency could decide whether further action is needed before a final rule could be put into place. Manufacturers would not be required to make any changes until that happens.
If it’s published, the FDA is expected to propose language noting that “these chemicals are used in certain cosmetic products that are applied to human hair as part of a combination of chemical and heating tool treatment intended to smooth or straighten the hair” and that these types of hair-straightening chemical products are “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.”
But another possibility is that the proposed rule could be published with some changes.
“They could issue a version of the rule that says ‘we’re not banning it outright, but we are capping the acceptable limits per unit and provide a figure of volume per unit,’ ” Stevenson said. “We really don’t know what manufacturers are going to be required to do until we actually see its publication.”
Some jurisdictions – including Maryland, California and Washington – have issued their own rules on the use of formaldehyde and formaldehyde-releasing chemicals in hair-straightening products at the state level, and other states have expressed interest.
“So you’re going to have manufacturers in a situation where they are trying to comply not just with newly enacted or anticipated state regulations but also this unknown quotient in what the FDA ban will be, assuming it ever comes to fruition at all,” Stevenson said.
Uncertainty also remains around whether the FDA’s office will have appropriate staffing to enforce any rules around hair products and cosmetics. The Trump administration is seeking to overhaul and shrink the federal workforce, and Trump has issued multiple executive actions that affect federal workers, including requiring them to return to the office full-time and making it easier to lay off certain career civil servants.
Sign up here to get The Results Are In with Dr. Sanjay Gupta every Friday from the CNN Health team.
The administration also has offered federal employees a deferred resignation package and is planning widespread layoffs among those who don’t accept the incentive.
“There’s a lot of uncertainty, I think, as to what is going to happen to rules when there is this overarching push by the Trump administration to gut agencies,” Benesh said.
“We don’t know if the FDA is going to lose staff,” she said. “The part of the FDA that is responsible for this regulation – the Office of Cosmetics and Colors – was already one of the smallest, most under-resourced offices at the FDA. We don’t know if staff are going to leave and exacerbate the resource issues. We don’t know if the FDA is going to be hesitant to issue new regulations if it means they have to withdraw other regulations.”