On September 2, 2026, a group of tobacco product manufacturers and retailers filed a complaint in federal court, the U.S. District Court for the Northern District of Texas, challenging the U.S. Food and Drug Administration’s (FDA) 2021 premarket tobacco product application (PMTA) rule. Plaintiffs take aim at a regulation they say has made it virtually impossible for the FDA to authorize new tobacco products within the timeline Congress set more than 15 years ago. The case raises fundamental questions about whether a federal agency can adopt a regulatory process that, by design, cannot meet its own statutory deadlines.
Background
The lawsuit revolves around the Family Smoking Prevention and Tobacco Control Act (TCA), which Congress passed in 2009. The TCA gave the FDA authority to regulate tobacco products and established a system under which any “new tobacco product”—meaning any product introduced after February 15, 2007, or any modification to an existing product—must receive FDA authorization before it can be legally sold. To get that authorization, a manufacturer files what is called a Premarket Tobacco Product Application, or PMTA, which must demonstrate that marketing the product is “appropriate for the protection of the public health.”
Crucially, the TCA includes a hard deadline: the FDA must act on each application—either granting or denying it—”as promptly as possible, but in no event later than 180 days after the receipt of an application.” That 180-day clock is at the heart of the entire dispute.
In October 2021, the FDA finalized a rule setting out the detailed requirements for what must be included in a PMTA and how the agency would review those applications. Plaintiffs argue that this rule—referred to throughout the complaint as the “2021 PMTA Rule”—violates federal law.
Plaintiffs’ Claims
The complaint asserts two counts, both brought under the Administrative Procedure Act (APA)—the federal law that governs how agencies make rules and how courts review those rules.
Count One alleges that the 2021 PMTA Rule exceeds the FDA’s statutory authority and is “contrary to law” under the APA. The core argument is straightforward: Congress said the FDA must act within 180 days of “receipt” of an application, but the 2021 PMTA Rule redefines “receipt” in a way that lets the agency delay indefinitely. The 2021 PMTA Rule breaks the review process into multiple stages—an “acceptance” phase, a “filing” phase, and then a substantive review phase—and does not start the 180-day clock until the FDA decides it has received the “last piece of information necessary to complete the submission.” In practice, this means the FDA controls when the clock starts. For example, the 2021 PMTA Rule prohibits applicants from submitting product samples with their initial applications; the FDA requests samples only after it has “accepted” the application, and the statutory clock does not begin ticking until those samples arrive. Plaintiffs say this is a “procedural gimmick” that guts the statutory deadline. Plaintiffs argue that the ordinary meaning of “receipt” is the moment the FDA receives the application, not some later date the agency chooses. Because the 2021 PMTA Rule expressly contemplates that applications will not be decided within 180 days of actual receipt, Plaintiffs contend it violates the plain text of the TCA.
Count Two alleges that the 2021 PMTA Rule is “arbitrary and capricious” under the APA. The complaint identifies at least six reasons why. First, even if the FDA’s interpretation of “receipt” were legally permissible, it was unreasonable to adopt a process that routinely starts the statutory clock long after an application arrives, creating incentives for the agency to delay.
Second, the FDA failed to adequately respond to comments on the proposed rule that warned FDA that the proposed rule would make it impossible to meet the 180-day deadline, especially given the massive backlog of pending applications that already existed at the time.
Third, the agency failed to consider reasonable alternatives—such as creating a streamlined pathway for smoke-free products—and dismissed commenters’ proposals with only conclusory explanations.
Fourth, the FDA did not adequately account for the material differences among tobacco product categories when deciding to funnel all products through the same demanding PMTA process.
Fifth, the FDA improperly attributed the costs of the 2021 PMTA Rule to its earlier 2016 rule deeming all new tobacco products to be subject to FDA’s authority rather than conducting a proper cost analysis.
Sixth, the FDA failed to put its internally developed “comparative-efficacy test” for flavored vapes through notice-and-comment rulemaking, a point the Fifth Circuit Court of Appeals recently addressed (be on the lookout for a blog post from us on this case very soon).
Plaintiffs’ Requested Relief
Plaintiffs ask the court for several remedies. They want the court to declare the 2021 PMTA Rule unlawful, vacate it, and send it back to the FDA with instructions to create a new review process that complies with the TCA’s 180-day deadline. They also want the court to require FDA to consider the TCA’s more streamlined authorization pathways—such as the substantial-equivalence process—and to factor in illicit market conditions when designing any replacement.
Plaintiffs also seek an injunction that would prevent the FDA from enforcing the TCA’s premarket-review requirements against two of Plaintiffs’ products that have had a pending PMTA for more than 180 days. In practical terms, this would allow those products to remain on the market while the FDA develops a lawful process. Plaintiffs cite a precedent in which a federal court granted similar relief in a case involving the FDA’s treatment of premium cigars. They also seek attorneys’ fees and costs.
Why it Matters
The FDA has recently acknowledged the problems with the PMTA process that Plaintiffs describe—launching a pilot program in late 2025 to fast-track reviews of certain nicotine pouches and issuing new enforcement guidance in May 2026. But Plaintiffs argue these are temporary patches, not structural fixes, and that the underlying 2021 PMTA Rule remains fundamentally broken. The pilot program has already been discontinued, and even its fastest authorization still took 361 days, nearly double the statutory limit.
If the court agrees with Plaintiffs and vacates the 2021 PMTA Rule, the FDA would need to revisit the process for reviewing tobacco product applications—one that can realistically comply with the 180-day deadline Congress enacted in 2009. That could have ripple effects across the entire tobacco industry, potentially opening the door for faster authorizations of smoke-free products while forcing the agency to confront its longstanding inability to keep pace with the applications it receives.
However, if the court sides with the FDA, the current regulatory framework—with its extensive requirements and multistage review process—would remain in place, and the agency’s interpretation of when the statutory clock begins to run would receive judicial endorsement. We will continue to monitor and report on updates in this case.