Altria Sues FDA: U.S. PMTA Review System Faces Judicial Challenge (Condensed)-henonicotine.com

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Altria Sues FDA: U.S. PMTA Review System Faces Judicial Challenge (Condensed) September 07, 2026

Altria Sues FDA: U.S. PMTA Review System Faces Judicial Challenge (Condensed)

On September 2 (U.S. Eastern Time), Helix Innovations and NJOY, both subsidiaries of Altria Group, together with the Texas Food & Fuel Association and two retailers, sued the FDA and HHS, asking the federal court to vacate the 2021 PMTA rule (filed in the U.S. District Court for the Northern District of Texas, Lubbock Division, Case No. 5:26-cv-00199-H).

Core Dispute: When Does the 180-Day Review Clock Start?

The Tobacco Control Act requires the FDA to act on a PMTA "as soon as practicable" and no later than 180 days after receipt of the application.
Altria argues that the FDA keeps pushing back the starting point of the 180-day clock through acceptance review, filing review, and supplemental information requests; the 2021 rule also demands extensive data submissions without establishing a streamlined review pathway for non-combustible products.
The FDA responded that it is accelerating its reviews and will carefully examine the issues raised by the lawsuit.

Documented Review Delays

A 2023 HHS-OIG audit found significant delays across the 15 authorized ENDS products it sampled; as of October 2022, more than 53,000 products still lacked a final FDA decision.
Altria says its 45 PMTAs for the original on! nicotine pouches, filed in May 2020, have now been pending for over 2,270 days without a final determination.
On on! PLUS: Altria counts 361 days from the date of resubmission, while the FDA says it issued a decision about three months after the scientific review began — the two different calculations being exactly the crux of the case.

Prior Cases

In March 2026, Imperial Brands' Fontem US also sued the FDA over the 180-day requirement, but did not directly challenge the 2021 rule.
In February 2026, the Fifth Circuit rejected another challenge to the 2021 rule in Kealani Distribution v. FDA; in August 2026, however, the same court ruled against the FDA in the NicQuid case on procedural grounds (neither case directly ruled on the 180-day theory).

What's Next

The lawsuit is just beginning; it does not automatically invalidate the 2021 rule or pause pending reviews. The plaintiffs have already sought preliminary and permanent injunctions.
This is an APA-based challenge to agency rulemaking, with no jury trial; the focus will be on statutory interpretation and the FDA's administrative record.
If the court only addresses case-specific relief, the impact may be limited; if it sides with vacating the rule, the FDA may need to redesign how the 180-day clock is calculated and how acceptance and filing reviews are structured.

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