MO · 10-Q · 2026Q3 · Full report

FDA PMTA Review Litigation

ALTRIA GROUP, INC. · 2026-10-29 · Importance 34 · Surprise 42

In September 2026, Helix, NJOY and certain trade partners sued the FDA in the U.S. District Court for the Northern District of Texas, alleging that the agency routinely fails to issue marketing orders within the FSPTCA’s 180-day deadline for premarket tobacco product applications (PMTAs). The plaintiffs asked the court to require the FDA to adopt a new rule or process to meet those statutory deadlines. In October 2026, the court stayed the case to allow the FDA to undertake rulemaking addressing defects in the current rule identified in the lawsuit.

Key facts

• In September 2026, Helix, NJOY and certain trade partners sued the FDA in the U.S. District Court for the Northern District of Texas, alleging that the FDA routinely failed to issue PMTA marketing orders within the 180-day statutory period. source
• In October 2026, the court stayed the PMTA review litigation at the parties’ request to allow the FDA to conduct rulemaking addressing defects in its current rule. source