The US Food and Drug Administration’s (FDA) proposed ban on formaldehyde and formaldehyde-releasing chemicals in hair smoothing and straightening products remains unpublished, with no definitive timeline for release. CosmeticsDesign has previously reported on the continued delays, and while the ban was projected to be published next month, according to industry experts, it may face further setbacks.
“Right now, the proposed ban remains as an unpublished proposal by the FDA,” said Allison Stevenson, an attorney at Hill Ward Henderson told CosmeticsDesign. “The FDA has currently projected a release date of March 2025, but as we have seen over the past couple of years, this proposed release date is not a guarantee and could be delayed even further.”
Regulatory challenges and delays
The FDA has not provided specific reasons for the delay in finalizing the ban. However, Stevenson suggested that industry pushback and administrative transitions could be contributing factors.
“It would be reasonable to assume that there has been either concern or pushback from marketplace interests that may be concerned that a ban would interrupt their production of their product(s), and their product(s) viability in the marketplace going forward,” she said.
Additionally, she explained, “It could be that the FDA wants to ensure that the new administration is on board with this regulation, and is delaying publication in order to permit incoming FDA officials to review and consider the proposal.”
If implemented, the ban would bring US regulations in line with international standards, including those in the European Union, which already restricts formaldehyde in cosmetic products.
Several US states are also taking action independently. California, for example, implemented a ban effective on January 1, 2025, via its Toxic-Free Cosmetics Act, Stevenson noted.
Legal and compliance considerations
A finalized ban would impose new legal obligations on manufacturers and suppliers, requiring compliance with the FDA’s rule to continue product distribution. Noncompliance could lead to regulatory enforcement actions, including injunctions or corrective measures.
“If a manufacturer disregards the rule, they could be liable for regulatory violations in actions brought by the Department of Justice,” Stevenson explained. “Remedies could include an injunction on the product entering interstate commerce and requirements to take corrective action.”
Beyond regulatory enforcement, companies could also face litigation from consumers alleging harm. “Simply because the rule has not gone into effect yet, a consumer could still bring an action alleging injuries against a manufacturer if the consumer believes that their use of the product caused harm, and that the manufacturer had a duty to prevent that harm and breached that duty,” she added.
Stevenson also advised manufacturers to proactively assess their product formulations to prepare for potential enforcement. “Companies should be continuously and consistently performing internal and external ‘audits’ of their current product lines,” she said.
“Are they putting products into the market space that would violate a potential ban?” she asked. “If so, are they able to conduct their own internal tests and studies to determine if a reformulation without that ingredient can produce an effective product that will meet the consumers’ demands?” She also recommended third-party audits to ensure compliance with scientific and regulatory standards.
Impact of the Trump Administration’s regulatory approach
The regulatory landscape for cosmetic products may shift under the current administration, which has signaled a preference for reduced agency oversight. “We have already seen, for example, the Trump administration withdraw a proposed ban on menthol in cigarettes that was on the table (but not finalized) during the Biden administration,” Stevenson noted.
Given this stance, she suggested that the formaldehyde ban may face additional obstacles. “In light of the current administration’s vocalization on agency autonomy, I do not think consumers or manufacturers would be unreasonable in assuming that there is less likelihood of this ban ever going into effect under the Trump administration, as compared to under the Biden administration.”
Industry influence and future outlook
Industry lobbying efforts could also play a role in shaping the outcome of the proposed ban. While the Modernization of Cosmetics Regulation Act (MoCRA) of 2022 granted the FDA greater authority over cosmetic product safety, Stevenson pointed out that shifting regulatory priorities could impact enforcement.
“We may be entering an era where the FDA is less concerned with exercising its oversight and regulatory authority,” she said. “This may open up doors for industry lobbyists to exercise greater influence over agency and congressional authority, and presumably impede the proposal altogether, or obtain a modification of the rule which would not outright ban the ingredient but implement limitations on its use.”
Consumer safety advocates have long called for stricter regulation of formaldehyde in hair products, mainly due to concerns over disproportionate exposure among communities of color. “There has been frustration amongst the groups in light of the continued delay, and that is understandable,” Stevenson said.
“What is particularly noteworthy here is that this is an ingredient that is used primarily by communities of color,” she continued. “If this administration and the agency abandons the rule altogether,” she clarified, “it could (and I believe very likely would) create the perception that the administration is not prioritizing the health and safety of this consumer base in particular.”
Implications for future ingredient bans
The formaldehyde ban could set a precedent for future ingredient restrictions in the cosmetics and personal care industry. “This is an industry that has not undergone extensive federal oversight in the last 80 years,” Stevenson explained.
“If this ban is published,” she added, “it could set the precedent that the FDA should and could be focusing on cosmetics safety, and make potential future bans on other ingredients easier to push through.”
As manufacturers and suppliers navigate regulatory uncertainty, they are encouraged to stay informed and prepare for potential changes. Whether the FDA moves forward with its proposed ban or regulatory momentum stalls under the current administration remains to be seen.
