FDA Allows More Comments on Proposed Requirements for Tobacco Premarket Applications

The Food and Drug Administration is extending until Dec. 16 the period for comments on its proposed new regulations on premarket tobacco product applications (PMTAs). An FDA proposed rule issued Sept. 25 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 (see 1909200032). It would also require that manufacturers maintain records establishing that their tobacco products are legally marketed. Comments had originally been due Nov. 25.