Companies using formaldehyde in their manufacturing processes, and those that sell products incorporating formaldehyde-containing components from upstream suppliers, should be aware of a potential shift in the evolving regulatory landscape of formaldehyde, including a potential divergence between the federal- and state-level regulators. Against this backdrop are additional and emerging litigation risks, with disputed science on formaldehyde hazards being tested in courtrooms with mixed results for the plaintiff and defense bar. 

As to the regulatory developments, the Environmental Protection Agency (EPA) periodically reviews chemicals such as formaldehyde under the Toxic Substances Control Act (TSCA) to determine appropriate risk management strategies. On 3 December 2025, the EPA released for public comment an Updated Draft Risk Calculation Memorandum for Formaldehyde (Draft Risk Calculation), conducted under TSCA. The period for public comment closed on 2 February 2026, and the Draft Risk Calculation remains under consideration with the EPA. Once finalized, the Draft Risk Calculation may lead to a revised TSCA risk evaluation less scrutinizing of formaldehyde exposures. 

Changes in New EPA Draft Risk Calculation

This Draft Risk Calculation marks a shift from the last final formaldehyde risk evaluation by the EPA in December 2024. The 2024 final risk evaluation noted that “formaldehyde presents an unreasonable risk of injury to human health” under certain conditions.¹ After risk assessments of formaldehyde in 2022 and 2024, the anticipated trend was toward greater regulation of formaldehyde. We previously discussed this potential for increased regulatory scrutiny. However, the new Draft Risk Calculation suggests a significant shift in regulatory priorities and a potential reduction in federal regulatory scrutiny of formaldehyde.

Notably, the recent Draft Risk Calculation shifts away from the 2024 evaluation’s reliance on two components developed by the Integrated Risk Information System (IRIS) program: (1) the chronic noncancer reference concentration, and (2) the cancer inhalation unit risk. Instead, the EPA Draft Risk Calculation proposes that primary emphasis be placed on protection against acute sensory irritation—immediate, short-term effects like eye, nose, and throat irritation—rather than chronic exposures, which refer to low-dose exposure over extended periods. This change suggests that EPA is prioritizing the mitigation of more immediately noticeable health effects, with less emphasis on potential long-term risks of chronic exposures, such as cancer or chronic noncancer conditions where the science is less settled.

The Draft Risk Calculation removes conditions of use that no longer indicate unreasonable risk for workers and consumers due to long-term inhalation. Historically, concerns often focused on indoor environments due to the perceived potential for prolonged formaldehyde exposure from products such as manufactured wood, although the science behind those concerns remains unsettled. But because the Draft Risk Calculation now omits consideration of cancer and chronic noncancer risks for some lower-dose indoor uses, it effectively reduces the overall risk profile for these settings. This change may influence both regulatory enforcement and public perception of formaldehyde risks in homes, offices, and schools. The Draft Risk Calculation does however still acknowledge unreasonable risk to consumers and workers from acute inhalation and dermal exposures. As a result, formaldehyde-containing products such as glues, sealants, automotive care products, and leather products may still receive increased regulatory attention.²

Practically speaking, if the Draft Risk Calculation becomes final, it would raise the levels of formaldehyde that workers are permitted to be exposed to—moving the levels from the proposed lower chronic noncancer and cancer exposure levels identified by IRIS to higher levels causing sensory irritation. If the EPA ultimately deemphasizes risks associated with chronic exposure, manufacturers of products containing formaldehyde may face a reduced regulatory burden. The revised framework could result in fewer restrictions and compliance requirements for manufacturers, especially in relation to products used or stored indoors.

State Regulation of Formaldehyde

While the federal regulatory burden concerning formaldehyde may potentially be less restrictive, at the state level there has nonetheless been an increase in both proposed and enacted legislation focused on prohibiting the use of formaldehyde and other chemicals in cosmetic, personal care, and consumer products. California, Maryland, and Washington prohibit the manufacture, sale, or distribution of cosmetic products that contain certain chemicals, including formaldehyde.³ Similar legislation went into effect recently in Vermont on 1 January 2026, with Oregon to soon follow in January 2027.⁴ And some states, such as Minnesota, restrict the use of formaldehyde in children’s products, including personal care products.⁵

State legislative action focused on formaldehyde shows no signs of slowing. Moreover, given the apparent new federal position on formaldehyde, it is possible that state regulation increases in an effort to fill any perceived voids in the regulation of formaldehyde use. In addition to the regulatory compliance challenges that may result from a patchwork of different regulations, companies should also be cognizant of how this increased regulatory focus may also lead to an uptick in litigation. 

Recent Formaldehyde Litigation

Increased attention from regulators along with a significant jury verdict this past year are likely to continue to draw attention from enterprising plaintiff lawyers and potential claimants. For example, an Alameda County, California jury last year awarded US$18.7 million to employees who alleged the synthetic materials present in their uniforms, including formaldehyde, caused them to experience adverse health conditions.⁶

Litigation results were, however, mixed in 2025. In a similar suit to the Alameda County case,⁷ defendants were granted summary judgment, in part, because plaintiffs’ symptoms “present[ed] incomplete and unreliable information from which no reasonable lay jury could deduce a causal connection.”⁸ The judge also found the testimony from the plaintiffs’ experts to be inadmissible.⁹ Specifically, both experts were found to have failed to present a theory for how “exposure might have caused the plaintiffs’ symptoms,” and the judge critiqued the experts for failing to “provide any support—test results, studies, peer-reviewed literature, or otherwise[.]”¹⁰

The EPA’s recent shift regarding the risks of formaldehyde may further underscore the scientific challenges plaintiffs face in pursuing tort claims related to the alleged health risks of exposure to formaldehyde. Claimants alleging injuries related to chronic formaldehyde exposure, such as long-term respiratory issues or cancer, for example, may find it more challenging to support their arguments against the backdrop of regulatory developments at the federal level. On the other hand, increased state regulations could have the opposite effect. Accordingly, companies must be mindful of how regulatory developments may impact the effectiveness of their litigation defense strategies and work with counsel to adapt those strategies as appropriate.

Any company that uses formaldehyde in its operations or that manufactures products containing formaldehyde should be mindful of these developments and the evolving regulatory and litigation risks. Our lawyers have significant experience managing risks associated with chemicals not fully assessed from a health or risk perspective, as well as chemicals like formaldehyde that have been widely used for many years and are facing additional scrutiny as a result of modern developments. We have also developed an Emerging Contaminants Task Force that is prepared to provide strategic counseling and representation at every turn, whether it be regulatory monitoring and compliance, managing the use of chemicals in operations, defending personal injury and class action litigation, or pursuing insurance recovery.