The FDA says it will rewrite the rule that decides which vapes reach store shelves

The Food and Drug Administration said on Sept. 28, 2026 that it intends to start new rulemaking to replace the premarket review rule it finalized in 2021 for new tobacco and vaping products. No proposed text exists yet, and the agency gave no timetable.

For anyone who sells, makes or regulates e-cigarettes, the announcement matters because that rule governs how a product earns the right to be marketed in the United States at all.

What the 2021 premarket rule asks of applicants

In its announcement, FDA said it is reviewing its experience implementing the premarket tobacco application rule and that it intends to evaluate changes “including through initiation of new rulemaking to replace the current framework.” The rule in question was published in the Federal Register on Oct. 5, 2021 as Premarket Tobacco Product Applications and Recordkeeping Requirements (86 FR 55300), and it took effect on Nov. 4, 2021. It sets the content and format of an application, requires detailed information about a new product’s physical characteristics along with full reports of health risk investigations, and requires electronic submission unless a waiver is granted. The same rule covers supplemental applications for modified versions of already authorized products, resubmissions after a marketing denial order, amendments, withdrawals and ownership transfers, and postmarket reporting for products that receive a marketing granted order. FDA’s own regulatory impact summary said at the time that the rule would make review of applications more efficient and reduce the number submitted, while raising applicants’ costs to prepare applications for electronic nicotine delivery products.

The underlying legal test sits in the statute rather than the rule. On its premarket application page, FDA says an applicant must supply scientific data showing the product “is appropriate for the protection of public health,” weighing risks and benefits for both users and nonusers, including whether current smokers would be more likely to quit and whether people who do not use tobacco would be more likely to start. Any replacement rule would change the paperwork and procedure around that test, not the test itself, because Congress wrote it into law.

The Altria lawsuit in Lubbock

FDA named the litigation as one reason for the shift, referring to a lawsuit in the U.S. District Court for the Northern District of Texas but supplying no case details. Trade outlet Vaping Post reported that the suit, Altria v. FDA, was filed Sept. 2, 2026 in the court’s Lubbock Division. The plaintiffs are Helix Innovations, maker of on! nicotine pouches, and NJOY, both Altria subsidiaries, joined by the Texas Food & Fuel Association and two Texas retailers.

According to that report, the plaintiffs argue that the 2021 rule effectively delays the start of the Tobacco Control Act’s 180-day review period and is arbitrary and capricious. They ask the court to vacate the rule, order FDA to adopt a process compatible with the 180-day deadline, and bar enforcement against Helix and NJOY products whose applications have been pending longer than that. Vaping Post reported no ruling and noted the court could still decide the request to vacate. The plaintiffs also estimate that about 130,900 applications were still awaiting a decision as of March 31, 2026, according to the same report. That figure is the plaintiffs’ estimate, not an FDA count, and it frames the backlog as the practical problem a faster framework would need to address.

The illicit market and other legal pressure

The second reason FDA gave was market conditions. Alongside its own implementation experience and the court developments, the agency cited “the widespread development of an illicit and unregulated market” and the pace at which new products arrive. FDA said it believes a modern framework reflecting current market realities is critical to public health. The release does not say what such a framework would look like, how it would treat flavored products, or whether it would alter the review clock.

Other legal fronts are open as well. Vaping Post reported that public health groups, pediatricians and parents sued FDA in Maryland on July 14, 2026 over a May 2026 enforcement guidance, arguing it lets products with pending applications stay on the market unlawfully. It also reported that on Aug. 19, 2026 the Fifth Circuit held in NicQuid v. FDA that the agency’s “comparative efficacy” standard for flavored e-cigarettes is a substantive rule that must be adopted through rulemaking, and vacated the denial orders at issue. Those accounts come from the trade report, not from FDA’s announcement. The same report puts the number of authorized e-cigarettes at 48 products from five manufacturers: Glas, JUUL Labs, Logic, NJOY and R.J. Reynolds Vapor, with the Juul2 device and two new Juul pods the most recent additions in August 2026.

What stays the same while the rewrite is pending

FDA said that in the meantime it will keep processing premarket submissions and issuing decisions as the statute requires, and that it remains committed to carrying out its responsibilities under the Tobacco Control Act. It also said any changes will follow applicable law and include opportunities for public input. In practice that means the 2021 rule governs every pending and future application until a new one is finalized, and a proposal would have to be published for comment before it could replace the current text.

Several things are unknown as of Oct. 11, 2026. FDA has not said when a proposal might appear, whether it would narrow or loosen the information applicants must submit, or how it would interact with the Texas court’s eventual decision on the plaintiffs’ request to vacate. Vaping Post noted that Bret Koplow was named permanent director of FDA’s Center for Tobacco Products a few weeks earlier, and said harm reduction advocates see that as a possible shift toward risk-proportionate regulation; that is the outlet’s characterization of advocates, and FDA did not link the two events.

For shoppers, the shelf looks unchanged today: the authorized list is the same and enforcement priorities have not been rewritten by this announcement. For manufacturers, the open question is whether a replacement rule shortens the wait, raises the evidence bar, or both. The only thing the agency has committed to is that it will evaluate changes, with new rulemaking as one stated path.

This article was produced with the assistance of AI and reviewed by Morning Overview editors prior to publication.

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