The lawsuit challenges an application system Altria says has never met its statutory deadline, while ZYN is shipping at 3.9 times on!’s scale on the companies’ reported Q2 figures.
Federal law gives the FDA 180 days to act on a PMTA. Altria alleges the agency has never met that deadline; Reuters reported that some tobacco applications have remained under review for more than six years.
Now Altria subsidiaries Helix Innovations and NJOY, the Texas Food and Fuel Association and two Texas retailers are asking a federal court to set aside the FDA’s current premarket tobacco product application framework and require a replacement that complies with federal law. They sued on September 2 in the U.S. District Court for the Northern District of Texas, Lubbock Division.
The commercial stakes are already measurable. Philip Morris International reported U.S. ZYN shipments of 2.9 billion pouches in Q2 2026. At PMI’s stated U.S. conversion of 15 pouches per can, that equals about 193.3 million can-equivalents. Altria reported 49.9 million on! cans shipped in the same quarter. On that basis, ZYN’s shipment scale was about 3.9 times on!’s. It is a shipment-volume proxy, not a market-share measure.
Analysis: Put those numbers beside the alleged regulatory delay and the lawsuit becomes more than a fight over administrative timing. Altria is challenging the process while one of its main nicotine-pouch rivals is already shipping at substantially greater scale.
180 days, more than six years
For a PMTA, 21 U.S.C. § 387j says the FDA must act “as promptly as possible” and no later than 180 days after receiving the application. Altria argues that companies using the PMTA process are left waiting while unauthorized competitors gain share.
The enforcement problem has its own scale. In September 2025, the FDA and U.S. Customs and Border Protection said they had seized 4.7 million unauthorized e-cigarettes with an estimated retail value of US$86.5 million; almost all of the shipments originated in China.
Meanwhile, nicotine pouches represented 59.9% of the measured U.S. oral-tobacco category in Altria’s Q2 2026 data, up 8.1 percentage points from a year earlier. Its on! brand held 14.4% of the nicotine-pouch category, down 1.7 points year over year. Altria says those figures are based on Circana store-sample data and should not be treated as a precise measure of total market share.
The FDA is also defending its policy from plaintiffs pressing in the opposite direction. On July 14, the Campaign for Tobacco-Free Kids, the American Academy of Pediatrics, the American Heart Association, the American Lung Association and other plaintiffs sued the agency in Maryland over May 2026 enforcement guidance. They allege the policy unlawfully allows some unauthorized e-cigarettes and nicotine pouches to remain on the market while applications are pending.
Analysis: That puts the agency between two challenges built around the same system. Altria’s side attacks the pace and structure of review; the Maryland plaintiffs attack an enforcement policy they say permits unauthorized products to remain available while review continues.
August 18, August 19
The Fifth Circuit supplied two more pieces of legal context in consecutive days.
On August 19, the court vacated FDA marketing-denial orders in consolidated vaping cases because the agency had used a substantive comparative-efficacy rule without the notice-and-comment procedure required by the Administrative Procedure Act.
A day earlier, the Fifth Circuit affirmed interim relief against the FDA’s cigarette-warning rule. At that stage, it concluded that the challengers had shown a substantial likelihood that the agency exceeded its statutory authority by requiring 11 warnings rather than the nine specified by Congress.
There is an important limit. On April 2, 2025, a unanimous Supreme Court in FDA v. Wages and White Lion Investments rejected the Fifth Circuit’s change-in-position analysis and vacated its judgment. But the Court expressly declined to decide whether the FDA had improperly developed substantive standards without notice-and-comment rulemaking. The 2009 Tobacco Control Act’s premarket-authorization requirement remains the baseline.
If Altria wins, the lawsuit could change how quickly or by what procedures the FDA handles applications. It would not, by itself, eliminate the statutory requirement for premarket authorization.
Analysis: The likely significance of the case therefore lies in process rather than the disappearance of the gate itself. For companies already spending on products, manufacturing and distribution, the question is how that gate operates and how long it takes to pass through it.
US$1.2 billion, 120,000 stores
Those companies are already committing capital and shelf presence.
PMI’s Aurora, Colorado, ZYN campus represents US$1.2 billion of planned capital spending from 2024 through 2028 and began commercial production in July 2026, the company says. Helix had expanded on! PLUS to 120,000 U.S. stores and planned additional line extensions later in the year, Altria said.
Winning the lawsuit does not mean Altria wins the market. It could, however, reduce one regulatory constraint while ZYN is shipping substantially more product on the comparison above.
And another competitor is moving: British American Tobacco planned a national U.S. rollout of Velo Max in the second half of 2026.
This is not investment advice.