Altria Group, the maker of Marlboro, filed a lawsuit against the U.S. Food and Drug Administration in a Texas federal court. The company seeks a complete overhaul of the agency’s review system for new tobacco and nicotine products.
Altria argues the current premarket authorization process suffers from extreme delays that block innovative products from the market. The lawsuit claims the FDA violates a legal requirement to decide on applications within 180 days.
The company states the FDA has never met this statutory 180-day deadline. This backlog reportedly stalls the approval of products like On! nicotine pouches.
Altria contends these delays stifle growth while allowing unauthorized foreign products to capture market share. The suit asks the court to compel the FDA to develop a more efficient review system.