Altria Sues FDA Over Tobacco Product Review Delays
Altria Group (MO) has filed a lawsuit against the U.S. Food and Drug Administration, challenging its premarket tobacco product application system for causing significant delays in approvals. The company argues that these delays hinder smoke-free products like on! nicotine pouches from reaching consumers quickly and put legal alternatives at a disadvantage compared to illicit products. Altria is shifting focus toward smoke-free products as cigarette sales decline. In 2025, shipment volume for its on! brand exceeded 177 million cans with an 8.2% retail share in the oral tobacco category. The FDA has noted improvements, reducing its application backlog by about 70% and authorizing nicotine pouches after a three-month review period. A favorable court outcome could lead to faster approvals for Altria's products, supporting its transition away from cigarettes. However, there is uncertainty as the FDA maintains it has already improved processes significantly.
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