By Timothy S. Donahue
Top Takeaways:
- 180-day fight: Altria says FDA has repeatedly violated the statutory deadline for deciding new tobacco product applications.
- Market imbalance: The company argues compliant manufacturers are stuck waiting while unauthorized competitors gain U.S. market share.
- System challenge: Altria and its fellow plaintiffs want a federal court to set aside FDA’s current approach and force the agency to develop a lawful review system.
Altria is done waiting on the FDA.
Altria Group and two of its subsidiaries sued the U.S. Food and Drug Administration on Wednesday, seeking to compel an overhaul of the agency’s tobacco product review system after years of delays the company says have left lawful manufacturers waiting while unauthorized competitors capture market share.
The lawsuit, filed in the U.S. District Court for the Northern District of Texas in Lubbock, challenges the FDA’s administration of the premarket tobacco product application (PMTA) process, which requires manufacturers to obtain marketing authorization before legally selling new tobacco products in the United States.
The Texas Food and Fuel Association joined Altria’s subsidiaries as a plaintiff in the case, accorrding to Reuters.
The Tobacco Control Act directs the FDA to act on PMTAs within 180 days of receiving an application. Altria alleges that the agency has never met that deadline and has instead allowed some applications to remain pending for years.
The company argues that those delays have created a regulatory system that punishes companies that follow the FDA’s rules while allowing competitors selling unauthorized products to establish themselves in the market.
Altria specifically pointed to its On! nicotine pouch portfolio, which has products awaiting FDA decisions even as the U.S. nicotine pouch market has expanded rapidly.
Some tobacco product applications across the industry have remained pending for more than six years. At the same time, the FDA has rejected tens of millions of applications, particularly those involving electronic cigarettes, while struggling to control a large market of unauthorized products.
The plaintiffs ask the court to set aside the FDA’s current approach and require the agency to establish a new system that complies with federal law.
The lawsuit comes despite several recent changes at the FDA intended to accelerate tobacco product reviews.
The agency established a pilot program to expedite reviews of nicotine pouch applications, including those from Altria. But the complaint says some of Altria’s applications in that program remained undecided even after FDA’s targeted December 2025 completion date. Altria argues that the experience demonstrates that incremental changes have failed to solve the underlying problem.
The Trump administration has also overseen other significant shifts in tobacco regulation, including the first FDA marketing authorizations for flavored vaping products and changes to enforcement priorities for certain unauthorized products.
An FDA official said the agency remains committed to making potentially less harmful alternatives available to adult smokers while protecting young people from nicotine addiction and harmful exposure.
“FDA takes seriously this legal challenge … and will carefully review the issues raised,” the official said.
