FDA Says It Will Replace the 2021 E-Cigarette PMTA Rule in Regulatory Overhaul
The U.S. Food and Drug Administration said on September 28 that it intends to replace the 2021 rule governing every new e-cigarette, e-liquid and nicotine pouch in the country, opening the way to the broadest restructuring of its premarket tobacco product application (PMTA) system since the 2016 deeming rule made authorization a condition of sale.
In a short statement, FDA said it would evaluate changes to the framework "including through initiation of new rulemaking to replace the current framework," without a timetable or outline. The agency will keep accepting, reviewing and deciding applications under the existing rule in the meantime.
The four stated drivers are the agency's experience implementing the 2021 rule, recent court developments, "the widespread development of an illicit and unregulated market," and the pace of new product introductions. Two commitments frame the process: the statutory "appropriate for the protection of the public health" standard stays, and any change will follow notice-and-comment rulemaking with public input.
The legal pressure is already specific. On September 2, two Altria subsidiaries — Helix Innovations, maker of on! pouches, and NJOY — joined the Texas Food & Fuel Association and two Texas retailers in suing FDA in the Northern District of Texas over the 2021 rule. Their central argument is that the rule's acceptance-then-filing sequence effectively postponed the start of the statutory 180-day decision clock. By the plaintiffs' own count, about 130,900 applications were still pending as of March 31, 2026.
The backlogs are independently documented. A November 2023 audit by the HHS Office of Inspector General found that as of October 19, 2022, more than 53,000 products remained undecided and that none of the 15 authorized products it examined had received a marketing order within 180 days.
A second front opened in August, when the Fifth Circuit ruled in NicQuid v. FDA that the "comparative efficacy" test the agency used to deny flavoured e-cigarettes is a substantive rule that must be adopted through formal rulemaking, vacating the denials at issue. Separately, a coalition of public health groups, paediatricians and parents is challenging FDA's May guidance that deprioritises enforcement against certain unauthorized products with filed applications.
The stakes are visible in the data: six years after the 2020 compliance deadline, FDA's authorised e-cigarette list holds 48 products from five manufacturers — Glas, JUUL Labs, Logic, NJOY and R.J. Reynolds Vapor — with a nicotine-pouch pilot review running since September 2025. The new director of FDA's Center for Tobacco Products, Bret Koplow, was recently appointed, an installation harm-reduction advocates have read as a signal toward risk-proportionate review.
A new rule cannot amend the Tobacco Control Act: the 180-day deadline and the public-health standard are fixed by Congress. What a rewrite can reorganise is how FDA receives and sorts applications, when the review clock starts and what evidence applicants must file. Until a proposed rule is published, applicants remain bound by the current framework.