FDA intends to evaluate changes to the PMTA regulatory framework

FDA is carefully reviewing its experience implementing the Premarket Tobacco Product Application (PMTA) rule, as well as recent judicial developments, including a federal lawsuit filed in the U.S. District Court for the Northern District of Texas challenging the current regulatory framework. Based on FDA’s learned experience implementing the 2021 rule, the widespread development of an illicit and unregulated market, and the pace of new product introductions, FDA intends to evaluate changes to the PMTA regulatory framework, including through initiation of new rulemaking to replace the current framework. FDA believes a modern framework that reflects current market realities and provides greate...