Altria is suing the FDA's approval system

On September 2, 2026, two subsidiaries of the Altria group, Helix Innovations (nicotine on!) pouches and NJOY (e-cigarettes), filed a lawsuit in federal court in Lubbock, Texas, against the Food and Drug Administration (FDA), the U.S. Department of Health and Human Services, and the agency's acting commissioner, Kyle Diamantas. The plaintiffs, joined by the Texas Food and Fuel Association, a Texas trade association for convenience store distributors, and two retailers, are asking the judges to overturn the 2021 rule governing pre-market review of tobacco and nicotine products and to order the FDA to implement a new system. They cite the 180-day legal deadline stipulated by the Tobacco Control Act, which they allege the agency has consistently failed to meet.

This legal action comes at the end of several months of regulatory relaxations obtained by manufacturers from the US administration, and extends a sequence of legal challenges brought by the industry against the main health control mechanism available to the FDA regarding tobacco and nicotine.

A lawsuit seeking to overturn the 2021 rule

The procedure targets the rule published on October 5, 2021, which sets out the requirements applicable to applications for premarket tobacco product applications (PMTA). This rule provides for several steps prior to the actual scientific review, including an admissibility phase followed by a phase to verify the completeness of the dossier.

The plaintiffs' central argument concerns these intermediate steps. The Tobacco Control Act requires the FDA to decide on an application within 180 days of receiving it. According to the complaint, the agency is delaying the start of this countdown by multiplying preliminary reviews and requests for additional information before deeming a file accepted. The plaintiffs are asking that the 2021 rule be declared illegal and overturned, that the FDA be required to implement a process that complies with the legal timeframe, and that no enforcement action be taken against their pending products beyond this deadline.

The complaint supports this argument with several examples. The initial applications filed by Helix Innovations for on! nicotine pouches, submitted on May 15, 2020, were still pending more than 2,270 days after their filing. Applications submitted for on! PLUS pouches under the FDA's expedited process were also still pending, even though the agency had set a target of processing them by December 2025. Furthermore, a report by the U.S. Department of Health and Human Services Inspector General published in 2023 noted that, as of October 2022, the FDA had not yet issued a decision on applications covering tens of thousands of vaping products filed before the September 2020 deadline.

An examination system contested by industry

The prior authorization process is mandatory for any new tobacco or nicotine product in the United States, a market estimated at $22 billion. The FDA must determine that the product will have a net benefit to public health, which includes assessing the potential for initiation and addiction among young people. This decision criterion, established by Congress, has led the agency to reject tens of millions of applications.

Manufacturers have been denouncing the system's overload and competition from unlicensed products, mostly imported, for several years. According to data cited by Reuters, this parallel market represents at least 70% of US vaping product sales, with an estimated value of $8 billion in 2024. As of early September 2026, 43 nicotine pouches and 48 vaping products had FDA approval. The agency, for its part, indicates that it reduced the backlog of applications by approximately 70% during 2025. It also specifies that it launched an accelerated pilot program for nicotine pouches in September 2025 and issued several authorizations during August 2026, including eleven ZYN ULTRA products from Philip Morris International, as well as the JUUL device and its flavored cartridges.

When asked about the complaint, the FDA stated that it remains committed to facilitating access for adult smokers to lower-risk alternatives while protecting youth from nicotine addiction. It added that it would carefully review the issues raised. An Altria spokesperson said the complaint was filed before the statute of limitations expired in order to correct a system described as having a long history of dysfunction.

This dispute is part of a pattern of deregulation and recurring attacks against the public agency.

The complaint filed on September 2, 2026, is not an isolated incident. In August 2025, NJOY had already filed a lawsuit in a Louisiana federal court, accusing the FDA of failing to issue a ruling nearly three years after being petitioned, an inaction the plaintiffs characterized as a de facto veto. That same month, Altria launched its on! PLUS pouches and RJ Reynolds its VUSE ONE line of disposable vapes, without prior authorization from the agency, arguing that the agency had exceeded the 180-day deadline.[1].

These initiatives were coupled with a sustained lobbying campaign targeting the US executive branch, documented by several press investigations: meetings with the administration, financial contributions from manufacturers to applicants, and mobilization of contacts in Washington. In May 2026, the FDA announced that it would not prioritize prosecutions against certain vaping products and nicotine pouches marketed without authorization, provided their applications met certain criteria. This announcement represented a significant shift, adopted without prior public consultation and followed, a few days later, by the resignation of the FDA commissioner.[2]. Manufacturers also obtained the first approvals for flavored vapes, an accelerated review process for nicotine pouches, and then, in June 2026, the opportunity for Philip Morris International to present ZYN pouches as less harmful than cigarettes.[3].

Legal action is a recurring tactic used by the tobacco industry to challenge measures that go against its interests.

Resorting to the courts is a long-documented tactic employed by tobacco manufacturers. The scholarly literature on industry strategies describes a recurring use of administrative and constitutional litigation to delay or even overturn the implementation of public health measures, increase their political and administrative costs, and discourage public decision-makers from taking further action.[4].

The issue goes beyond this specific case. By seeking to overturn the 2021 rule, the plaintiffs are not simply challenging the processing times; they are attacking the very structure of prior review. Brian King, former director of the FDA's Center for Tobacco Products and now with the Campaign for Tobacco-Free Kids, believes that Altria is trying to lower the scientific standards established by Congress to protect public health, continuing the industry's repeated efforts to circumvent and weaken this safeguard.

The American sequence is distinguished less by recourse to the courts than by the simultaneous activation of levers in just over a year: influence on the executive branch, marketing of products without waiting for the agency's decision, and then challenging the regulation in court. Each of these actions aims, in a coordinated and specific manner, to influence public decision-making (political power, the market, the judiciary). Their convergence significantly reduces the health authority's room for maneuver, even when it has already granted some flexibility. It is precisely to prevent this type of situation that countries introduced the provision in Article 5.3 of the WHO Framework Convention on Tobacco Control, which requires Parties to protect their public health policies from the commercial interests of the tobacco industry.[5]. The outcome of the proceedings initiated in Lubbock will thus influence the level of scientific requirements applicable to nicotine products on the American market. However, beyond this market, manufacturers frequently use favorable rulings, particularly those from the FDA, to try to impose their products in other countries.

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[1] Jim McDonald, Fed Up with the FDA, Big Tobacco Goes Nuclear, Vaping360, August 26, 2025, accessed September 3, 2026

[2] Yasmeen Abutaleb, Emma Rumney, Chris Prentice, Big Tobacco comes out on top after US FDA shake-up, Reuters, May 26, 2026, accessed September 3, 2026

[3] CNBC, FDA lets Philip Morris market Zyn nicotine pouches as less harmful than cigarettes, CNBC, June 30, 2026, accessed September 3, 2026

[4] Sarah L. Steele, Anna B. Gilmore, Martin McKee, David Stuckler, The role of public law-based litigation in tobacco companies' strategies in high-income, FCTC ratifying countries, 2004-14, Journal of Public Health, vol. 38, no. 3, pp. 516-521, September 17, 2016, accessed September 3, 2026

[5] World Health Organization, Guidelines for implementation of Article 5.3 of the WHO Framework Convention on Tobacco Control, Secretariat of the WHO Framework Convention on Tobacco Control, 2008, accessed 3 September 2026