The Trump administration is reportedly preparing changes to the FDA's premarket tobacco application (PMTA) process that could accelerate reviews of flavored vapes and nicotine pouches, according to a Sept. 24 Tobacco Reporter report summarizing reporting by The Wall Street Journal.
The exact changes have not been made public. Tobacco Reporter said Reuters could not independently verify the report, although an HHS spokesperson said the administration wants to keep nicotine away from minors, remove counterfeit vaping products, and provide alternatives for adults who smoke.
The FDA's current ENDS PMTA guidance, revised in 2023, points to the final PMTA rule published in 2021, which sets application content, format, and recordkeeping requirements. The statutory standard also remains unchanged: FDA must determine whether marketing a new tobacco product is appropriate for the protection of public health.
FDA has already been reconsidering how it reviews some noncombustible products. A March 2026 draft guidance for flavored electronic nicotine delivery systems describes a risk-proportionate approach to weighing adult switching benefits against youth-use risks. The document is still labeled draft and "not for implementation."
The agency has also tested faster review methods without changing the underlying legal standard. In August, FDA said its nicotine pouch pilot program had shortened issue resolution and scientific review times, and that some of those efficiencies were being applied to other PMTAs. In July, FDA also expanded its CTP Portal NextGen system to reduce submission burdens for PMTA applicants.
One key question is whether the reported overhaul would change the scientific evidence FDA expects from applicants. The agency's marketing-order list shows several major authorizations in 2026, including JUUL2 products and new nicotine pouches. In May, FDA also authorized four Glas products, including its first ENDS authorizations for flavors other than tobacco or menthol, after evaluating device-based youth access controls.
Vape manufacturer Charlie's Holdings welcomed the report. In a Sept. 24 company statement, the company said it has sought authorization for tobacco-derived nicotine e-liquids since 2020 and hundreds of synthetic nicotine products since 2022. Charlie's says it retains 678 timely filed PMTA assets.
For now, the reported changes remain a policy plan rather than an adopted FDA rule or final guidance. Any formal proposal will show whether the administration intends to change evidentiary expectations, internal review procedures, the 2021 rule itself, or some combination of the three.
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