The U.S. Food and Drug Administration (FDA) announced on September 28, 2026, that it intends to evaluate changes to the Premarket Tobacco Product Application (PMTA) regulatory framework. The decision comes as the agency reviews its experience implementing the 2021 rule, the emergence of an illicit and unregulated market, and the pace of new product introductions.
FDA officials stated that a modern framework reflecting current market realities and providing greater clarity is critical to maximizing public health protection. This evaluation includes the initiation of new rulemaking to replace the current framework.
The agency cited recent judicial developments as a factor in this review, specifically noting a federal lawsuit filed in the U.S. District Court for the Northern District of Texas challenging the current regulatory framework.
Despite the planned review, the FDA affirmed that it will continue to process PMTA submissions, conduct premarket reviews, and issue regulatory decisions on new tobacco products in accordance with statutory requirements established by Congress. The agency remains committed to applying the statutory appropriate standard for the protection of public health (APPH) when reviewing PMTAs. Any future changes to the regulatory framework will be undertaken consistent with applicable law and with opportunities for public input.
