Altria Sues FDA Over Tobacco Product Review Process
Altria argued that the FDA's approach violates a requirement to decide on applications within 180 days of receiving them.
Sep 03, 2026 | 2 min read
Altria is suing the U.S. Food and Drug Administration (FDA), seeking to force the agency to “overhaul a product review process that tobacco companies say has stifled their growth in the key U.S. market,” Reuters reported.
Under U.S. law, the FDA must review new tobacco products before they can be sold, assessing whether they provide a net public health benefit, such as helping smokers quit, without also creating significant risk of new addiction among young people.
“But the system has been plagued by a huge backlog of applications and a booming illegal market of products sold without FDA authorization. Altria's lawsuit marks the latest industry challenge to a regime that has become one of the biggest obstacles facing tobacco companies in the $22 billion U.S. market,” Reuters wrote.
Filed in the federal court in Lubbock, Texas, Altria's complaint said the FDA's approach buried products such as its On! nicotine pouches in regulatory red tape, while allowing foreign competitors that ignored the rules to gain market share. Altria argued that the FDA's approach violates a legal requirement that the agency decide on applications within 180 days of receiving them, a deadline Altria's complaint said the FDA has never met.
The plaintiffs, including two Altria subsidiaries and the Texas Food and Fuel Association, asked the court to set aside the current system and require the FDA to develop a new one.
Altria's complaint also argued that some of the FDA's recent changes bolster its case. Applications for Altria nicotine pouches in the fast-track program, for example, remained under review despite the agency's target of deciding them by December 2025, the complaint said.
