Key Points
- Rule Challenge: Altria subsidiaries Helix Innovations and NJOY are asking a federal court to vacate FDA’s 2021 PMTA rule, arguing that the current review framework conflicts with statutory requirements.
- 180-Day Dispute: The case centers on when the Tobacco Control Act’s 180-day review period begins and whether FDA’s Acceptance and Filing Reviews lawfully affect that timeline.
- Documented Delays: A federal government audit previously found substantial PMTA delays, while the new complaint cites Helix and NJOY applications that have remained pending well beyond 180 days.
- Faster FDA Reviews: FDA has reduced its application backlog, streamlined review stages and issued more marketing orders, but Altria argues that faster reviews do not resolve problems in the underlying regulatory framework.
- Broader Legal Impact: The case could affect how FDA calculates review timelines and structures the PMTA process, although the court has not yet ruled on the plaintiffs’ claims.
2Firsts
Shenzhen, September 3, 2026
Two Altria Group subsidiaries on Sept. 2, U.S. Eastern Time, filed a federal lawsuit seeking to invalidate the U.S. Food and Drug Administration's 2021 rule governing premarket tobacco product applications.
Helix Innovations LLC, which makes on! nicotine pouches, and e-cigarette company NJOY LLC brought the case together with the Texas Food & Fuel Association and two Texas retailers, GWT Distributing LLC, doing business as Brady's Package Store, and Hometown Liquor LLC. The defendants are the FDA, the U.S. Department of Health and Human Services and Acting Commissioner of Food and Drugs Kyle Diamantas.
The lawsuit was filed in the U.S. District Court for the Northern District of Texas, Lubbock Division, as Case No. 5:26-cv-00199-H.
2Firsts obtained and reviewed the 49-page complaint filed with the court. The plaintiffs are asking the court to declare the 2021 PMTA rule unlawful, vacate it, require FDA to establish a new review process consistent with statutory deadlines, and prevent the agency from enforcing premarket-review requirements against certain Helix and NJOY products whose applications have been pending for more than 180 days.
Reuters separately reported the lawsuit on Sept. 2 under the headline “Altria sues FDA over tobacco product review system.” According to Reuters, an FDA official said the agency was committed to facilitating access to less harmful alternatives for adult smokers while protecting young people, and that FDA would carefully review the issues raised in the lawsuit.
The case comes as FDA is already moving to accelerate PMTA reviews. The agency says it sharply reduced its application backlog in 2025, eliminated a longstanding queue at the first stage of PMTA review and is applying lessons from a nicotine-pouch pilot to a broader range of applications. On Aug. 28, days before the lawsuit, FDA authorized the JUUL2 device and tobacco- and menthol-flavored pods.
Unlike a challenge to an individual marketing decision, however, the new lawsuit targets the rule that structures the PMTA process itself.
Altria Targets the Structure of PMTA Review
The lawsuit centers on FDA's Premarket Tobacco Product Applications and Recordkeeping Requirements final rule, published in October 2021.
The rule sets detailed content and format requirements for PMTAs and formalizes several stages of FDA review. Under 21 CFR § 1114.27, FDA conducts an Acceptance Review, followed by a Filing Review to determine whether an application contains sufficient information for substantive review. The regulation provides that FDA will complete review and act within 180 days of receiving an application that meets the applicable filing requirements.
Helix and NJOY argue that this framework conflicts with the Tobacco Control Act.
21 U.S.C. § 387j says FDA must act on a PMTA “as promptly as possible,” and “in no event later than 180 days after the receipt of an application” under subsection (b).
Subsection (b), however, also specifies what an application must contain. Those requirements include reports on health-risk investigations, product and manufacturing information, labeling, samples FDA may reasonably require, and other relevant information the agency may require.
The dispute is therefore not simply over the meaning of “receipt.” It also turns on when a submission becomes an “application” within the meaning of subsection (b), and whether FDA's 2021 rule lawfully defines that point.
The plaintiffs contend that FDA improperly delays the statutory clock through Acceptance and Filing Reviews and by requiring additional information or product samples before treating an application as ready for the 180-day review period. They also argue that the rule imposes unnecessarily burdensome information requirements and that FDA failed to adequately consider more streamlined pathways, particularly for non-combustible products.
Those are allegations and legal arguments by the plaintiffs. No court has ruled in this case that FDA's interpretation of the 180-day requirement, or the 2021 PMTA rule itself, is unlawful.
Government Audit Documented Lengthy PMTA Reviews
An independent government audit has documented substantial delays in FDA's PMTA process, although it did not resolve the statutory question now raised by Helix and NJOY.
In 2023, the HHS Office of Inspector General examined FDA's review of electronic nicotine delivery system applications. For all 15 authorized ENDS products in its sample, the watchdog found that FDA did not issue marketing orders within the 180-day timeline.
As of October 2022, the audit also found that FDA had yet to decide applications covering 53,128 of nearly 6.7 million ENDS products submitted by the September 2020 deadline.
The same audit, however, found that FDA generally followed applicable federal statutes, regulations, policies and procedures when granting or denying marketing orders for the applications it reviewed.
The new complaint goes further, asserting that FDA has never complied with the 180-day deadline. That statement is the plaintiffs' allegation. The inspector general's findings independently establish that significant delays occurred in the applications it examined, but they do not establish that every PMTA FDA has ever decided exceeded the statutory timeline.
The complaint also argues that the current system disadvantages manufacturers that comply with premarket requirements while competitors continue selling unauthorized products. FDA has separately made enforcement against certain unauthorized ENDS and nicotine-pouch products a regulatory priority. Whether the design of the 2021 PMTA rule caused or materially expanded the unauthorized market, as the complaint contends, has not been established by a court.
Altria Points to Years of Waiting
Helix and NJOY use their own applications to illustrate the practical consequences of the system they are challenging.
According to the complaint reviewed by 2Firsts, Helix submitted 45 PMTAs for its original on! nicotine pouch products on May 15, 2020. The plaintiffs say those applications had remained pending for more than 2,270 days when the lawsuit was filed.
Newer on! PLUS applications provide a more recent example.
FDA records show that six on! PLUS products were resubmitted in December 2024. An FDA scientific review document records a Dec. 23, 2024 submission date and Dec. 24 receipt date. FDA completed Acceptance Review on May 2, 2025, and Filing Review on Sept. 11.
The six products — 6-mg and 9-mg pouches in mint, tobacco and wintergreen — were authorized in December 2025 after participating in FDA's nicotine-pouch pilot.
FDA described those decisions as being completed in “record time”. The agency later said the products were authorized about three months after scientific review began. The complaint, using a different starting point, says the marketing orders came 361 days after Helix resubmitted the applications.
The figures use different starting points: the complaint counts from resubmission, while FDA's “record time” refers to the scientific-review stage. That difference is directly relevant to the lawsuit's central dispute over when the statutory review period begins.
The complaint says related 12-mg on! PLUS applications remain pending despite their inclusion in the pilot. It also cites additional on! applications submitted in September 2024.
FDA records show that four Helix products were authorized on Aug. 4. FDA subsequently recorded additional Helix marketing granted orders on Aug. 19. Its current authorized nicotine-pouch list contains six on! products across the Rich Berry, Cappuccino and Autumn Spice varieties in 2-mg and 4-mg strengths.
The lawsuit also covers e-cigarettes. According to the complaint, NJOY submitted supplemental PMTAs for its ACE device and pods in November 2025, and FDA had not issued final orders within 180 days under the plaintiffs' interpretation of the statute.
FDA Is Already Trying to Speed Up Review
FDA's recent actions show that the agency is attempting to reduce review times without replacing the 2021 rule.
FDA launched its nicotine-pouch pilot in September 2025, introducing more frequent real-time communication between reviewers and applicants to identify scientific and technical issues earlier.
In May, Center for Tobacco Products Acting Director Bret Koplow said FDA had reduced its backlog of premarket applications by approximately 70% during 2025.
For the first time in years, Koplow said, applications were no longer waiting in a queue to enter Acceptance Review. FDA also said it was accelerating Filing Review, allowing products ready for decisions to be separated from others in the same submission that still required additional information, and developing expedited procedures for certain supplemental PMTAs.
FDA said no additional products would be added to the original nicotine-pouch pilot. Instead, it intends to apply lessons from the program to all nicotine-pouch PMTAs and use some of its real-time communication practices more broadly.
The changes have coincided with a series of marketing decisions. FDA authorized additional Helix products in August, followed by 11 ZYN ULTRA nicotine pouches on Aug. 21 and three JUUL2 products on Aug. 28.
FDA currently lists 43 authorized nicotine-pouch products and 48 authorized e-cigarette products.
For Helix and NJOY, however, faster review does not resolve their underlying legal argument: whether the process used to conduct those reviews complies with the timetable Congress established.
Other PMTA Disputes Have Reached the Courts
Altria's subsidiaries are not the first tobacco companies to take FDA to court over the PMTA system, although previous cases have raised different legal questions.
In March, Fontem US, an Imperial Brands subsidiary, challenged FDA's handling of PMTAs for Zone nicotine pouches and also invoked the Tobacco Control Act's 180-day language. A federal judge considering the case said the dispute concerned FDA's treatment of a specific application rather than a generally applicable rule. That differs from the Helix and NJOY case, which expressly seeks vacatur of the 2021 PMTA rule.
The judicial record on FDA's PMTA framework has not moved in only one direction.
In February, the U.S. Court of Appeals for the Fifth Circuit rejected a separate challenge in Kealani Distribution v. FDA, holding that FDA had made a reasonable, good-faith effort to comply with the Regulatory Flexibility Act when it promulgated the final PMTA rule. The court also noted that some information requirements come directly from Congress and cannot simply be eliminated by regulation. Kealani did not decide when the 180-day PMTA clock begins.
In August, the same appeals court ruled against FDA in separate litigation involving NicQuid and other e-cigarette companies. The court found that FDA had used a comparative-efficacy standard for flavored e-cigarettes that amounted to a substantive rule without going through the notice-and-comment process required by the Administrative Procedure Act. It vacated the marketing denial orders at issue and remanded the cases to FDA. That decision concerned FDA's review methodology, not the 180-day deadline or the validity of the entire 2021 PMTA rule.
Previous litigation therefore provides context for the new case, but it does not establish that courts have accepted the legal theory Helix and NJOY are now advancing.
What Comes Next
The Sept. 2 complaint starts the district-court case. It does not itself invalidate the 2021 PMTA rule, suspend FDA's premarket requirements or authorize Helix or NJOY products that remain under review.
The plaintiffs have requested preliminary and permanent injunctive relief, including an order preventing FDA from enforcing premarket-review requirements against their products with PMTAs pending for more than 180 days. The request in the complaint does not itself provide that protection.
If the plaintiffs separately seek preliminary relief, the court could address that request before reaching the merits. Under the Federal Rules of Civil Procedure, federal agencies and federal officials sued in their official capacities generally have 60 days after service on the U.S. attorney to respond, although motions, service timing and court orders can affect the actual schedule.
The merits of the case are likely to center on statutory interpretation and the administrative record because the lawsuit challenges federal agency rulemaking under the Administrative Procedure Act.
The scope of any eventual decision could vary significantly. A narrow ruling could resolve procedural issues or relief specific to the plaintiffs without substantially changing FDA's national PMTA system. If the court ultimately accepts the challenge to the 2021 rule and grants broader relief, FDA could be required to reconsider aspects of its review framework, including how the 180-day period is calculated and how Acceptance and Filing Reviews operate.
A final judgment — and certain rulings involving injunctive relief — could be appealed to the U.S. Court of Appeals for the Fifth Circuit.
FDA says it is speeding PMTA review. Helix and NJOY are asking the court to decide whether the framework governing those reviews complies with the timetable Congress established.
For continuing coverage of developments in the U.S. FDA's PMTA process, follow 2Firsts.
Cover image generated by AI.
References
- Helix Innovations LLC et al. v. U.S. Food and Drug Administration et al., Case No. 5:26-cv-00199-H, Complaint, U.S. District Court for the Northern District of Texas, filed Sept. 2, 2026. Original 49-page court filing obtained and reviewed by 2Firsts via CourtListener.
- Premarket Tobacco Product Applications and Recordkeeping Requirements, 86 Fed. Reg. 55,300 (Oct. 5, 2021).
- 21 U.S.C. § 387j — Application for Review of Certain Tobacco Products.
- 21 CFR § 1114.27 — FDA PMTA Review Procedure.
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-K/part-1114/subpart-C/section-1114.27
- HHS Office of Inspector General — The Food and Drug Administration Needs To Improve the Premarket Tobacco Application Review Process for Electronic Nicotine Delivery Systems To Protect Public Health (2023).
- FDA — CTP Acting Director Statement: New Steps Forward in Accelerating Innovation and Efficiency in Product Review, May 7, 2026.
- FDA — FDA Authorizes 6 Nicotine Pouch Products, Completing Review in Record Time, December 2025.
- FDA — Technical Project Lead Review, Helix Innovations on! PLUS.
- FDA — Pilot Program Update: FDA Authorizes 4 New Nicotine Pouches, Aug. 4, 2026.
- FDA — Nicotine Pouch Products Authorized by the FDA.
- FDA — FDA Authorizes 11 New Nicotine Pouches, Aug. 21, 2026.
https://www.fda.gov/tobacco-products/ctp-newsroom/fda-authorizes-11-new-nicotine-pouches
- FDA — E-Cigarettes, “Vapes” and Other ENDS Authorized by the FDA.
- FDA — FDA Authorizes Marketing of JUUL2 E-Cigarette Device and Tobacco- and Menthol-Flavored Pods, Aug. 28, 2026.
- FDA — Enforcement Priorities for Certain New Tobacco Products Marketed Without Premarket Authorization.
- Fontem US LLC et al. v. FDA et al., U.S. District Court for the Northern District of Texas, March 23, 2026 order.
https://law.justia.com/cases/federal/district-courts/texas/txndce/4%3A2026cv00322/416817/31/
- Kealani Distribution LLC v. FDA, U.S. Court of Appeals for the Fifth Circuit, Feb. 26, 2026.
https://www.ca5.uscourts.gov/opinions/pub/25/25-40135-CV0.pdf
- NicQuid LLC et al. v. FDA, U.S. Court of Appeals for the Fifth Circuit, Aug. 19, 2026.
https://www.ca5.uscourts.gov/opinions/pub/25/25-60369-CV0.pdf
- Federal Rules of Civil Procedure.
https://www.uscourts.gov/sites/default/files/rules-of-civil-procedure.pdf
Disclaimer
This article is provided solely for professional research, industry discussion, and informational purposes. Any references to brands, companies, products, technologies, or policies are made for factual reporting and analytical purposes only, and do not constitute endorsement, recommendation, promotion, or advertising by 2Firsts.
Nicotine-containing products, including but not limited to cigarettes, e-cigarettes, heated tobacco products, and nicotine pouches, carry significant health risks. Readers are responsible for complying with all applicable laws and regulations in their respective jurisdictions, including age restrictions and access limitations.
The information contained in this article should not be regarded as investment, legal, medical, regulatory, or commercial advice. While 2Firsts strives to ensure the accuracy and reliability of its content, it does not assume liability for any direct or indirect loss arising from errors, omissions, inaccuracies, or reliance on the information contained herein.
This article is not intended for individuals below the legal age for accessing tobacco or nicotine-related information in their jurisdiction.
Copyright Notice
This article is either original content produced by 2Firsts or content reproduced, translated, summarized, or adapted from third-party sources with attribution where applicable. The intellectual property rights of the original content remain with 2Firsts or the respective original rights holders.
No individual or organization may copy, reproduce, distribute, republish, modify, translate, or otherwise use this content without prior authorization. Any unauthorized use may result in legal action.
For copyright-related inquiries, corrections, or removal requests, please contact: info@2firsts.com.
AI-Assisted Translation and Editing Notice
Portions of this article may have been translated, edited, or reviewed with the assistance of artificial intelligence tools to improve efficiency and readability. Due to the limitations of AI-assisted translation and editing, discrepancies, omissions, or inaccuracies may exist when compared with the original source.
Where applicable, readers are advised to refer to the original source for the most complete and accurate information. If you identify any errors or believe that any content infringes upon your rights, please contact us at info@2firsts.com, and we will review and address the matter promptly.
