The Food and Drug Administration said on September 28 that it plans to move away from the rulebook that governs how new tobacco products reach the U.S. market. In a short announcement, the agency said it “intends to evaluate changes to the PMTA regulatory framework, including through initiation of new rulemaking to replace the current framework.” It gave no timetable and no draft language.
Three pressures are named in the statement: the agency’s experience implementing the 2021 rule, a federal lawsuit filed in Texas, and what it called “the widespread development of an illicit and unregulated market.” Until a replacement exists, the current premarket review system stays in force and applications keep moving through it.
The FDA announcement in detail
The announcement, posted as a press announcement on the FDA’s website, runs to two paragraphs. The first says the agency is “carefully reviewing its experience implementing the Premarket Tobacco Product Application (PMTA) rule, as well as recent judicial developments, including a federal lawsuit filed in the U.S. District Court for the Northern District of Texas challenging the current regulatory framework.”
The wording is a statement of intent and not a rule. The FDA says it will “evaluate” changes and that this evaluation includes starting new rulemaking. Any new regulation would have to follow the usual process, and the agency wrote that changes will follow applicable law and include “opportunities for public input.” No proposed rule has been published. The agency also argued that a “modern framework that reflects current market realities and provides greater clarity and predictability is critical to maximizing the protection of public health.” That sentence is the only stated goal for the rewrite.
The 2021 rule that would be replaced
The framework in question is the premarket tobacco product application rule, a final rule the FDA published in the Federal Register on October 5, 2021, effective November 4, 2021. It sets out what manufacturers must submit so the agency can decide whether a marketing order should be issued. According to the rule’s own summary, it “will help ensure that PMTAs contain sufficient information for FDA to determine whether a marketing granted order should be issued for a new tobacco product.” It also requires makers to keep records showing that their products are legally marketed.
The legal bar for approval sits in the statute. On its premarket tobacco product applications page, the FDA says any person may submit an application for any new tobacco product seeking a marketing order, and that applicants must show the product is “appropriate for the protection of public health.” Reviewers weigh risks and benefits to users and non-users, the likelihood that current users switch, and manufacturing controls.
The FDA said it will keep that machinery running in the meantime. “FDA will continue to process PMTA submissions, conduct premarket reviews, and issue regulatory decisions on new tobacco products in accordance with the statutory requirements established by Congress,” the second paragraph reads.
The Texas lawsuit behind the announcement
The case the FDA points to was filed on September 2. According to Nicotine Insider’s report on the filing, the plaintiffs are Altria Group, its subsidiaries Helix Innovations and NJOY, the Texas Food and Fuel Association, GWT Distributing LLC, which operates Brady’s Package Store, and Hometown Liquor LLC. The suit was filed in the Northern District of Texas in Lubbock.
The plaintiffs challenge how the agency administers the review process. They say the FDA has repeatedly missed the statutory 180-day deadline to decide on an application, and that this hands an advantage to unauthorized competitors while compliant manufacturers wait. The same report says fewer than 100 applications have been approved out of millions filed, and that some have been pending for more than six years. Laura Leigh Oyler of Nicokick.com, quoted in that coverage, put the argument this way: “The FDA has 180 days from the day a PMTA is filed to make a decision. That is clear in statute, and yet the agency has failed to meet their deadline even once in the more than 15 years since the Tobacco Control Act took effect.”
A second account, from RTTNews, frames the dispute around timing. It says the plaintiffs contend the framework conflicts with statutory deadlines because the agency conducts a preliminary review before treating a submission as a complete application, and that “the case focuses on when the Tobacco Control Act’s 180-day review period begins.” It reports that some nicotine pouch applications waited more than 2,200 days for a decision.
What stays unsettled
The FDA’s statement does not say the lawsuit is the reason for the rewrite, only that the suit is one of the developments under review. It does not describe the illicit market in numbers, and it does not say which parts of the 2021 rule would change. Whether a replacement would loosen the application requirements, tighten them, or reshape the review clock that the Texas plaintiffs are contesting is not addressed anywhere in the announcement.
The court has not ruled on the September 2 complaint in any source reviewed for this article. The next concrete markers would be a response from the agency in the Lubbock case and, if the FDA follows through, a proposed rule with a public comment period. The agency’s media line for the announcement is 202-690-6343.
This article was produced with the assistance of AI and reviewed by Morning Overview editors prior to publication.
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