Altria has filed a lawsuit against the U.S. FDA in federal court, seeking to force the agency to overhaul its tobacco product review system, which the company says has become a major barrier to growth in the U.S. market.
The company argues that lengthy review delays — including applications remaining pending for years — disadvantage compliant manufacturers while unauthorized products continue to gain market share.
Altria’s claims against the FDA review process
The lawsuit is the latest industry challenge to the FDA’s premarket review regime, which requires new tobacco products to demonstrate a net public health benefit before they may be sold. Altria says the agency has failed to meet the statutory 180-day review deadline.
Altria also contends that recent FDA changes, including a fast-track pathway for nicotine pouches, have not resolved the backlog. The company says those delays and procedural issues impede growth for compliant manufacturers in the U.S. market.
The filing asks the court to compel changes to how the FDA evaluates tobacco products, framing the disputes around review timeliness and the competitive effects of the current system.
