The US Food and Drug Administration (FDA) has proposed a ban on formaldehyde and formaldehyde-releasing chemicals, leaving chemicals in smooth and straightening products unpublished, with no definitive timeline for release. I have CosmeticsDesign Previously reported With the ongoing delay, industry experts predicted the ban would be made public next month, but could face further setbacks.
“The proposed ban now remains as an unpublished proposal by the FDA,” Hill Ward Henderson’s lawyer, Allison Stevenson, told CosmeticsDesign. “The FDA is currently forecasting a release date for March 2025, but as we’ve seen over the past few years, this proposed release date is not a guarantee and could be delayed even further.”
Regulatory challenges and delays
The FDA does not provide specific reasons for delays in the final decision to the ban. However, Stevenson suggested that industry pushbacks and management transitions could be factors.
“It is reasonable to assume that the ban will suspend production of the product and that there will be concerns or pushbacks from market benefits that may be concerned about the survival rate of the product in the future,” she said. I said.
She further explained: “The FDA wants to ensure that the new administration is in place in this regulation and is delaying publication to allow FDA officials to consider and consider the proposal.”
When implemented, the ban will result in regulations in line with international standards, including those of the European Union. This already limits the formaldehyde in cosmetics.
Several US states are also taking action independently. For example, California implemented a ban in effect on January 1, 2025 via the Toxic Cosmetics Act, Stevenson noted.
Legal and Compliance Considerations
The ultimate ban imposes new legal obligations on manufacturers and suppliers and requires that the product continue to be distributed in order to continue FDA regulations. A violation of compliance can lead to regulatory enforcement actions, including injunctions and corrective actions.
“If a manufacturer ignores the rules, it could be liable for any regulatory violations in actions raised by the Department of Justice,” explained Stephenson. “Reliefs include interstate commerce and injunctions for products that fall into requirements for corrective action.”
Beyond regulations enforcement, businesses can face lawsuits from consumers claiming harm. “Simply because the rules are not yet in force, but if consumers believe that the use of the product is causing harm and the manufacturer is obligated to prevent that harm and violation, then consumers claim injuries to the manufacturer. “We can take action to do that,” she added.
Stevenson also advised manufacturers to actively evaluate product formulations to prepare for potential enforcement. “Companies need to carry out continuous and consistent internal and external ‘audits’ of their current product lines,” she said.
“Do they put products in the market space that violate a potential ban?” she asked. “If so, can they conduct their own internal testing and research to determine whether the ingredient-free reformulation can produce an effective product that meets consumer demands? ” She also recommended third-party audits to ensure compliance with scientific and regulatory standards.
Impact of the Trump Administration’s regulatory approach
The cosmetics regulatory landscape could change under the current administration, indicating that it prefers a decline in agency surveillance. “We’ve already seen, for example, that the Trump administration proposed a ban on tobacco menthol that was on the table (but not yet confirmed) during the Biden administration,” Stevenson noted.
Given this stance, she suggested that formaldehyde bans could face additional obstacles. “In light of the current administration’s autonomy statements regarding the autonomy of the institutions, I assume that this ban is unlikely to be implemented under the Trump administration, compared to under the Biden administration, and that it is possible to use the consumer and other governments. I don’t think the manufacturer is unreasonable.”
Industry impact and future outlook
Industry lobbying could play a role in shaping the outcome of the proposed ban. Modernising the Cosmetics Regulation Act of 2022 (MOCRA) has granted the FDA greater authority over beauty product safety, but Stephenson believes that changing regulatory priorities could impact enforcement I pointed out that there is.
“We may be in an age where the FDA is not very interested in surveillance and enforcing regulators,” she said. “This is the case for rules that open the doors for industry lobbyists to have a major impact on agency and council authority, perhaps not completely blocking proposals or completely prohibiting ingredients and enforcing restrictions on their use. You may get a fix.”
Consumer safety advocates have long sought stricter regulations on formaldehyde in hair products, primarily due to concerns about disproportionate exposure among communities of color. “There’s frustration among the groups in light of the ongoing delays, and that’s understandable,” Stevenson said.
“What’s particularly noteworthy here is that this is an ingredient that is primarily used by the community of colour,” she continued. “If this administration and institutions abandon the rules entirely,” she revealed.
Impact on future bans of ingredients
The formaldehyde ban could set a precedent for future ingredient restrictions in the cosmetic and personal care industry. “This is an industry that has not been extensively underwent federal oversight in the last 80 years,” explained Stephenson.
“If this ban is made public, the FDA should focus on cosmetic safety and could set a precedent that it could easily push away potential future bans on other materials. There is,” she added.
Manufacturers and suppliers are encouraged to continue to provide information and prepare for potential change as they navigate regulatory uncertainties. It remains to be seen whether the FDA’s proposed ban or regulatory momentum will stall under the current administration.
