Key facts
- Altria has sued the U.S. Food and Drug Administration.
- The lawsuit challenges the FDA's review process for new tobacco products.
- Altria claims the current system is bogged down by regulatory red tape.
- The company alleges the FDA has not met the legal 180-day deadline for application decisions.
- Altria seeks a court order for the FDA to create a new review system.
Marlboro-maker Altria has filed a lawsuit against the U.S. Food and Drug Administration, seeking to compel the agency to revise its review process for new tobacco products. Altria argues that the current system, which requires FDA review before new tobacco products can be sold to assess their net public health benefit, has become a source of regulatory red tape that hinders the market entry of newer nicotine products.
In its complaint filed in federal court in Lubbock, Texas, Altria contended that this approach has allowed foreign competitors to gain market share by circumventing the established rules. The company is asking the court to invalidate the existing system and mandate the development of a new one. A key argument presented by Altria is that the FDA's current practices violate a legal mandate requiring decisions on applications within 180 days, a deadline the agency has reportedly never met.