Altria announced that it 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. Altria argues that lengthy review delays, including applications remaining pending for years, disadvantage compliant manufacturers while unauthorized products continue to gain market share.
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 sale. Altria says the agency has failed to meet the statutory 180-day review deadline and argues that recent FDA changes—including a fast-track pathway for nicotine pouches—still have not resolved the backlog.
