Key Points
The U.S. District Court for the Northern District of Texas stayed the Helix and NJOY challenge to FDA's 2021 PMTA rule on Oct. 8.
FDA announced Sept. 28 that it intends to reassess the PMTA regulatory framework and may initiate new rulemaking to replace the current system.
The parties said a new or amended FDA final rule could have a significant effect on the litigation.
R.J. Reynolds Vapor, Modoral Brands and American Snuff filed an unopposed motion to intervene on Sept. 8; the motion remained pending as of Oct. 9.
2Firsts
October 10, 2026
According to an Oct. 8 order from the U.S. District Court for the Northern District of Texas, U.S. District Judge James Wesley Hendrix granted a joint request by the FDA and plaintiffs including Altria subsidiaries Helix Innovations LLC and NJOY LLC to stay litigation challenging the agency's 2021 Premarket Tobacco Product Application, or PMTA, rule while FDA pursues anticipated rulemaking concerning the regulation.
Hendrix said the motion was granted for the reasons set out by the parties, citing FDA's anticipated rulemaking concerning the final rule at issue.
The court directed the parties to file a joint status report within 45 days and every 45 days thereafter.
Parties Sought Stay After FDA Announced PMTA Reassessment
The stay was jointly requested by the plaintiffs and the federal government rather than sought by one side over the other's objection.
The parties filed their joint motion on Sept. 29. Defendants include FDA, Acting FDA Commissioner Kyle Diamantas and the U.S. Department of Health and Human Services. Plaintiffs include Altria subsidiaries Helix Innovations and NJOY, the Texas Food & Fuel Association and retailers GWT Distributing LLC and Hometown Liquor LLC.
Their request followed FDA's Sept. 28 announcement that it intends to reassess its experience implementing the 2021 PMTA rule and evaluate changes to the regulatory framework, potentially including new rulemaking to replace the existing system.
FDA cited its experience under the 2021 rule, recent judicial developments, the growth of an unauthorized and unregulated market and the pace of new product introductions.
The agency also said it would continue processing PMTAs and applying the statutory appropriate-for-the-protection-of-the-public-health, or APPH, standard while evaluating the framework.
In seeking the stay, the parties said a new or amended final rule from FDA could have a significant effect on the litigation.
Helix and NJOY Seek Vacatur of 2021 PMTA Rule
Helix, NJOY and the other plaintiffs filed their complaint on Sept. 2 in the Northern District of Texas under the Administrative Procedure Act.
The challenged regulation is FDA's 2021 final rule, Premarket Tobacco Product Applications and Recordkeeping Requirements, which sets requirements for the content and format of PMTAs and establishes procedures governing the agency's review of applications.
The plaintiffs are asking the court to declare the rule unlawful, vacate and set it aside, remand it to FDA, and require the agency to adopt a new rule or review process that complies with what they say are the statutory deadlines established by the Tobacco Control Act.
They also seek preliminary and permanent injunctive relief preventing FDA from enforcing relevant premarket requirements against certain Helix and NJOY products with PMTAs that have been pending for more than 180 days.
The Oct. 8 stay does not rule on the merits of those claims and does not vacate the 2021 PMTA rule.
180-Day Review Period at Center of Challenge
A central issue in the complaint is how FDA applies the Tobacco Control Act's timeframe for acting on PMTAs.
The plaintiffs contend that the statute requires FDA to issue decisions within 180 days and that the agency's Acceptance Review, Filing Review and subsequent scientific review process has allowed applications to remain unresolved far beyond that period.
They allege FDA has “never complied” with the statutory system for reviewing new tobacco products and argue that the 2021 final rule compounded delays.
Those claims remain allegations. The court has not ruled that FDA violated the statutory 180-day requirement.
The plaintiffs also blame the regulatory system for contributing to the growth of unauthorized products in the U.S. market, arguing that prolonged reviews disadvantage companies participating in the PMTA process while unauthorized products remain available.
The court has not adopted that causal claim as a finding.
Helix Has Received Marketing Orders for Other Nicotine Pouch Products
Helix Innovations is Altria's nicotine pouch business and markets products under the on! brand, while NJOY operates Altria's e-cigarette portfolio.
FDA's public marketing-order records show that multiple Helix nicotine pouch products have received marketing authorization, including on! PLUS products in December 2025 and additional Helix decisions in August 2026.
The plaintiffs argue that the current rule has prevented the marketing of other Helix and NJOY smoke-free products whose applications remain pending.
FDA marketing authorization for one product does not extend to other products from the same manufacturer. Marketing orders apply only to the specific products covered by those decisions.
Reynolds Companies Seek to Join the Case
Six days after the original complaint was filed, R.J. Reynolds Vapor Company, Modoral Brands Inc. and American Snuff Company LLC filed an unopposed motion on Sept. 8 seeking to intervene in the Helix and NJOY litigation.
The three companies are part of Reynolds American.
They also filed a proposed intervenor complaint echoing key elements of the plaintiffs' challenge and seeking vacatur of the 2021 PMTA rule.
Reynolds has publicly argued that the existing PMTA framework has contributed to lengthy review delays and regulatory uncertainty and does not reflect Congress's intended review process.
As of Mealey's Oct. 9 report, Hendrix had not ruled on the companies' motion to intervene.
RJR therefore remains a proposed intervenor rather than a party whose intervention has already been formally granted by the court.
FDA Rulemaking Becomes Central to Next Stage of Case
When FDA announced its PMTA reassessment on Sept. 28, it specifically cited recent judicial developments, including litigation in the Northern District of Texas challenging the current regulatory framework.
The agency said it is considering a modernized framework intended to better reflect current market conditions and provide greater clarity and predictability.
FDA has not yet published the text of a proposed replacement rule, identified the specific provisions it intends to change or announced a timetable for completing new rulemaking.
The stay means the plaintiffs' effort to vacate the 2021 rule will not proceed on its previous litigation schedule while FDA's regulatory review develops. The parties must update the court every 45 days.
Any future proposed or final rule could affect which issues remain live in the case and the scope of any further judicial review.
For now, the court has made no merits determination on the legality of the 2021 PMTA rule, FDA's compliance with the 180-day review requirement or the injunctive relief sought by the plaintiffs.
Follow 2Firsts for timely updates on global tobacco and nicotine regulations, market developments and industry trends.
Cover Image generated by AI
