FDA moves to replace its 2021 PMTA rule

In a short statement published on its website, the agency says it intends to evaluate changes to the framework “including through initiation of new rulemaking to replace the current framework,” but gives no timetable and no outline of what a new framework would contain. For now, it will keep processing applications, conducting reviews and issuing decisions under the existing rules.

The stakes are high for the whole market: since the 2016 deeming rule, the PMTA pathway is the one through which every new e-cigarette, e-liquid and nicotine pouch must obtain a marketing order before it can be legally sold in the United States.

What FDA actually said

The announcement rests on four stated reasons: the agency’s “learned experience” implementing the 2021 rule, recent court developments (FDA explicitly names a federal lawsuit filed in the Northern District of Texas), the “widespread development of an illicit and unregulated market,” and the pace at which new products are introduced. FDA argues that a modern framework offering “greater clarity and predictability” is needed to maximize the protection of public health.

Two commitments frame the process. First, FDA says it will keep applying the statutory standard of whether marketing a product is “appropriate for the protection of the public health” (APPH). Second, any change will be made “consistent with applicable law and with opportunities for public input” — in practice, a proposed rule published in the Federal Register, a comment period, then a final rule.

The text targeted by this review is the “Premarket Tobacco Product Applications and Recordkeeping Requirements” final rule, published on October 5, 2021, in effect since November 4, 2021, and codified in Part 1114 of the Code of Federal Regulations. It sets out what an application must contain, how FDA reviews it and what postmarket reporting is required once a product is authorized.

The announcement comes a few weeks after Bret Koplow was named permanent director of FDA’s Center for Tobacco Products, an appointment seen by harm reduction advocates as a possible turn toward risk-proportionate regulation.

Ahead of the announcement

On September 23, The Wall Street Journal reported, citing people familiar with the matter, that FDA was preparing measures to speed up authorizations for vapes and nicotine pouches, including revisiting the 2021 rule and possibly simplifying requirements for scientific studies and shortening review times. Reuters relayed the report the same day, noting that it could not verify it.

FDA’s statement five days later confirms only the review of the framework and the intent to start rulemaking. It says nothing about the evidence applicants will be expected to provide, about review times, or about flavored products.

The Altria lawsuit

The lawsuit FDA refers to is a complaint filed on September 2, 2026 in the Lubbock Division of the Northern District of Texas (Case No. 5:26-cv-00199-H). The plaintiffs are two Altria subsidiaries, Helix Innovations (maker of on! nicotine pouches) and NJOY, joined by the Texas Food & Fuel Association and two Texas retailers.

Their central argument concerns the clock. The Tobacco Control Act requires FDA to rule on a PMTA “as promptly as possible, but in no event later than 180 days after the receipt of an application.” According to the complaint, the 2021 rule effectively moved the start of that period: applications first go through an “acceptance” phase, then a “filing” phase, and the 180-day period only begins once FDA has received the last piece of information it requires, such as product samples it requests after acceptance. The plaintiffs also argue the rule is arbitrary and capricious, notably because FDA rejected calls for a streamlined pathway for non-combustible products.

They ask the court to vacate the rule, to order FDA to adopt a process compatible with the 180-day deadline, and to bar enforcement against Helix and NJOY products whose applications have been pending for more than 180 days. By the plaintiffs’ own calculation based on FDA data as of March 31, 2026, about 130,900 PMTAs were still awaiting a decision.

The delays, long criticized by manufacturers, are also documented by an official source. The HHS Office of Inspector General found in a November 2023 audit that, as of October 19, 2022, FDA had yet to decide on 53,128 of the nearly 6.7 million products submitted by the September 9, 2020 deadline, and that none of the 15 authorized products it examined had received an order within 180 days.

Litigation on two fronts

The Texas case is not the only legal pressure. On August 19, 2026, the Fifth Circuit Court of Appeals ruled in NicQuid v. FDA that the “comparative efficacy” standard FDA has used to deny flavored e-cigarette applications is a substantive rule. Because the agency adopted it through individual decisions rather than notice-and-comment rulemaking, the court vacated the marketing denial orders at issue and sent the cases back to FDA. The ruling does not bar FDA from considering comparative efficacy, but it requires the agency to adopt such a standard through formal rulemaking.

FDA’s own enforcement policy is also being litigated, from the opposite side. In May 2026, the agency issued a guidance on enforcement priorities under which it does not intend to prioritize enforcement against certain unauthorized e-cigarettes and nicotine pouches whose applications it has accepted and filed. The guidance took effect immediately, without prior public comment. On July 14, a coalition of public health organizations, pediatricians and parents sued FDA in federal court in Maryland, arguing that the guidance unlawfully allows products with pending applications to stay on the market without authorization.

Narrow authorizations so far

The scale of the gap explains the pressure. Six years after the 2020 deadline, FDA’s list of authorized e-cigarettes counts 48 products from five manufacturers: Glas, JUUL Labs, Logic, NJOY and R.J. Reynolds Vapor. The most recent additions include the Juul2 device and two new Juul pods, authorized in August. The agency has meanwhile tried to speed up some reviews, notably through a pilot program for nicotine pouches launched in September 2025.

What comes next

A new rule cannot change what Congress wrote. The 180-day deadline and the APPH standard are set by the Tobacco Control Act, so any new framework can only reorganize how FDA receives, sorts and reviews applications, and what evidence it asks for within the limits of the law. The rule’s procedural architecture, the acceptance and filing phases, the start of the review clock and the content requirements of Part 1114, is where change is possible.

Rulemaking of this kind typically takes months or years, from the publication of a proposed rule to the end of the comment period and the publication of a final rule. In the meantime, the Texas court could rule on the plaintiffs’ request to vacate the 2021 rule, which would reshape the timetable. Until either happens, applicants remain bound by the current requirements.