The proposed regulatory changes could advance harm-reduction goals by tackling a substantial backlog that has led to repeated violations of a statutory deadline.
The Food and Drug Administration (FDA) this week signaled a rethinking of its method for approving nicotine products, such as vaporizers and nicotine pouches. The Wall Street Journal indicates that FDA officials intend to clear a path for more tobacco products, including flavored vapes, to enter the market legally by adjusting the rules to speed up the authorization process.
That would be welcomed by makers of nicotine products, who for years have grappled with regulatory bottlenecks, burdensome requirements that do not apply to cigarettes, and lengthy delays in obtaining premarket approval. It would also be favorable for current and former cigarette smokers, as it could preserve access to a wide range of alternatives that pose far lower health risks than burning tobacco.
The envisaged reforms would build on progress the FDA has achieved over the past few years, such as approving nicotine pouches and flavored vapes that former smokers particularly prefer. These decisions acknowledge that concerns about underage use should not override the interests of adults who might significantly lower their health risks by switching to nicotine habits that do not involve lighting plant matter and inhaling smoke. Yet if the FDA is serious about tobacco harm reduction, it must overhaul a dauntingly intricate, expensive, time-consuming, and frustrating system that makes it extremely difficult to legally market such alternatives.
A Department of Health and Human Services (HHS) spokeswoman told Journal that the Trump administration is committed to keeping nicotine away from young people, removing counterfeit vaping products from the streets, and offering safer options for adults who want to quit smoking. Regulate Smarter, a trade group chaired by former U.S. Sen. Richard Burr (R–N.C.), hailed the FDA’s announcement in an emailed press release, calling it “an encouraging and long-overdue course correction.”
The need for such a correction is underscored by a lawsuit Helix Innovations, an Altria subsidiary that makes nicotine pouches, and NJOY, the company’s vaping business, filed this month in the U.S. District Court for the Northern District of Texas. The complaint, joined by two Texas retailers and the Texas Food & Fuel Association, contends that the FDA has failed to “comply with its obligations” under the Family Smoking Prevention and Tobacco Control Act (TCA), the 2009 statute that grants the agency regulatory authority over tobacco products.
That law “expressly requires the FDA to authorize the marketing of new tobacco products (including alternatives to cigarettes) as ‘appropriate for the protection of the public health,'” Helix and others note. “To facilitate such authorizations, the statute requires the FDA to grant or deny new product applications as promptly as possible, and ‘in no event later than 180 days after the receipt of an application.'” Yet the FDA “has never complied with this deadline.”
The problem intensified in 2016, when the FDA issued a “deeming” rule that brought numerous nicotine products under premarket approval, including vapes. In response to the resulting backlog, the FDA repeatedly extended submission deadlines. But in May 2019, a federal judge in Maryland struck down those extensions, ruling that applications would have to be submitted by September 9, 2020, with enforcement against products lacking approval delayed for another year.
In September 2019, the FDA proposed a rule that “set forth requirements related to the content and format” of premarket applications and “the procedure by which FDA would review” them. According to the lawsuit, that rule, which the FDA finalized in October 2021, “disregarded comments, evidence, and obvious alternatives that would have facilitated” the processing of applications.
Under the TCA, a premarket submission is supposed to include product samples, proposed labeling, a “full description” of manufacturing and packaging, a “full statement” of the product’s ingredients and operation, a “full report” of available information on the product’s “health risks,” and an “identifying reference” to any relevant FDA standard, along with “adequate information” about the product’s compliance with it. The TCA also states that applicants must provide “such other information relevant to the subject matter” that HHS “may require.”
The FDA’s 2021 rule, according to Helix and co-plaintiffs, “made it impossible for the FDA to issue orders on the vast majority of [applications] within 180 days.” It “did not establish a viable path for timely application of the statutory-authorization criteria to the large number of new product applications demanded by the Deeming Rule. Instead of addressing the backlog the FDA had created for itself,” the plaintiffs argue, the agency “demanded vast amounts of additional information from applicants—well beyond the TCA’s requirements.”
The FDA’s demands included “granular descriptions of ‘product formulation’ that bore little relation to any plausible public health concern,” the suit states. The agency also required “extensive supporting materials,” including “all studies concerning” the product’s “pharmacological profile” and behavioral data indicating how the product might affect tobacco-use behavior among both users and nonusers of tobacco products.
Critics have cautioned that the process mandated by the FDA was far more onerous than the requirements for approving a new prescription drug or medical device, effectively setting an unachievably high standard for manufacturers. And the FDA’s procedures guaranteed that processing time would exceed the 180-day limit. Among other practices, the agency said the clock would not begin on that limit until it had received the “last piece of information necessary to complete the submission.”
Moreover, the FDA split its process into three stages: an “acceptance” phase, a “filing phase,” and a substantive review. The agency “would often refuse to accept [an] application on non-substantive grounds,” such as “failure to ‘comply with the applicable format requirements,'” Helix and colleagues note. The FDA’s forms “sometimes lacked the necessary fields for all products,” they add, causing acceptance to be refused for “purely administrative reasons.”
In itself, the “acceptance” phase “often extends beyond the agency’s 180-day statutory deadline,” the lawsuit contends. “For example, under the 2021 Final Rule, Helix’s [applications] for certain of its [flavored nicotine pouches] were submitted on September 25, 2024, but were not ‘accepted’ until August 12, 2025—321 days later.”
Once an application is accepted, the FDA conducts a “filing review” to decide whether it contains “sufficient information to permit a full substantive review.” That phase, Helix and co-plaintiffs say, “typically takes even longer than the ‘acceptance’ review.” Even after “an application had been accepted and filed,” the FDA “would sometimes require additional information from the applicant—including product samples that applicants had provided with their initial submissions” yet the FDA refused to accept them at that point.
In short, the FDA asserted the authority to “unilaterally determine when Congress’s 180-day review period began.” The plaintiffs argue that this plainly violates the TCA.
Following the FDA’s proposed rules on nicotine products but before they were finalized, the mandated deadline for applications produced thousands of submissions covering 4.8 million products, primarily nicotine vapes. Although “this flood of reports and applications was entirely predictable,” the lawsuit states, “the FDA was completely unprepared” for it.
By January 2021, the FDA had managed to review only 0.6 percent of the applications. The next month, it acknowledged the “unprecedented number of applications” and said it was unlikely to review them by September 9, 2021. That was when the protection against enforcement for companies with pending applications was scheduled to expire, and it came six months after the 180-day limit.
“Given the unprecedented volume of applications,” the FDA conceded in June 2021, the probability of reviewing all of them within the statutory and judicial time limits was “extremely low.” It noted that the “number of applications exceeds anything we’ve seen by orders of magnitude” and that reviewing them had been “very challenging due to the size, complexity and diversity of these submissions.”
Helix and co-plaintiffs argue that the backlog was almost inevitable due to the FDA’s onerous requirements. Critics of the agency’s rules predicted precisely this kind of bottleneck.
As of October 2022, the HHS Office of the Inspector General reported that the FDA still carried a backlog of more than 53,000 vape applications that it had received two years earlier, routinely missing the 180-day deadline. A 2022 analysis by the Reagan-Udall Foundation noted that the FDA had “struggled to function as a regulator in part because of some of its policy choices,” including the “scope of the product review regulations,” which “have been difficult for both stakeholders and [the FDA] to apply in practice.” As of the lawsuit’s latest update, the FDA “still faced a massive backlog” of roughly 130,000 premarket applications.
In September 2025, the FDA launched a pilot program intended to facilitate the approval of nicotine pouches. The initiative “got off to a promising start,” leading to the December 2025 clearance of six Helix products, according to the plaintiffs. “But the pilot program’s limited progress merely confirmed the need for permanent, structural regulatory changes to fix the problems” that the 2021 rule “codified and exacerbated.”
Last May, the FDA “again acknowledged the statutory and other problems with the backlog of applications” by issuing guidance to deprioritize enforcement actions against products in certain categories, the lawsuit states. “But the FDA’s discretionary enforcement moratoria on certain (thus far unidentified) products are no substitute for the decisions that the TCA requires the FDA to make within 180 days.”
The FDA is reportedly weighing reforms to address the problems described in the lawsuit. “The agency is considering more flexibility for companies to obtain authorization for additional products,” the Journal notes. “One possible approach would be to simplify the requirements for scientific studies and accelerate review timelines… The administration wants to see products it regards as less harmful for smokers, such as flavored vapes, reach the market with greater ease.”
In an interview with Nicotine Insider, Azim Chowdhury, a tobacco and nicotine expert at the law firm Keller and Heckman, argues that “there is a substantial amount of duplication” in premarket submissions. He questions the need to repeat the same fundamental information in applications for every product variation.
“There are many companies in this industry—including numerous small businesses—that want to comply,” Chowdhury says. “They are asking FDA to provide clear and predictable requirements.” The current process can cost businesses “millions or even tens of millions of dollars,” he notes. “That creates a system that, in practice, tends to be navigated more easily by the largest tobacco companies and multinational corporations than by smaller producers.”
Chowdhury highlights the harm-reduction potential of alternative nicotine products, which the FDA has repeatedly recognized. “If the goal is a regulated marketplace, there has to be a realistic path from the marketplace we have today to the marketplace the FDA envisions,” he explains. “If we build a regulated market that is too narrow to reflect what adult consumers actually want, we’ll miss opportunities to move people away from combusting cigarettes.”
