FDA Proposes New Requirements for Tobacco Premarket Applications

The Food and Drug Administration is proposing new regulations on premarket tobacco product applications (PMTAs). FDA’s proposed rule would codify general procedures FDA would follow when evaluating PMTAs, including application acceptance, application filing, and inspections, and would also create postmarket reporting requirements for applicants that receive marketing orders. It would also require that manufacturers maintain records establishing that their tobacco products are legally marketed. While FDA has been evaluating PMTAs for years, the new regulations would clarify requirements for applicants and reduce the costs of having to file follow-up submissions when their original applications aren’t accepted by FDA. Comments are due Nov. 25.