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Altria Sues FDA to Develop New PMTA Review System

On Sept. 2, 2026, Altria Group, Inc. and other plaintiffs filed a lawsuit against the U.S. Food and Drug Administration (FDA) in a Texas federal district court seeking to set aside the agency’s current system of reviewing pre-market tobacco applications and require the agency to develop a new system.

The lawsuit was filed due to continued delays in the FDA reviewing and finalizing actions on pending pre-market tobacco applications, which has been one factor in the growth of an illicit market in non-authorized tobacco products. Read more here.