By Timothy S. Donahue
Update: Hours after this article was published, the U.S. Food and Drug Administration on Friday authorized the marketing of six On! Plus nicotine pouch products, issuing the first decisions under a pilot program launched to accelerate the review of nicotine pouch premarket tobacco product applications.
Top Takeaways:
- Haypp Group’s Laura Leigh Oyler said that preserving consumer choice is critical to preventing an illicit nicotine pouch market.
- She expects FDA action on nicotine pouch PMTAs soon, with authorizations and denials likely to trigger tighter enforcement.
- Oyler warned that prolonged regulatory uncertainty risks repeating the illicit e-cigarette market experience.
For nicotine pouches, “consumer choice” is not a conceptual policy debate. It is the dividing line between a regulated, lawful marketplace and the predictable expansion of black markets and illicit supply, according to Laura Leigh Oyler, Haypp Group’s vice president of Regulatory Affairs.
“As long as consumers have a validated choice of options,” Oyler told Nicotine Insider, “that illicit market doesn’t have to emerge to meet their needs.”
Oyler believes the U.S. Food and Drug Administration is approaching a long-delayed inflection point on nicotine pouches—one that could occur before, during, or shortly after the year-end holiday period. Her expectation is not rooted in optimism about agency timelines, but in what she sees as shifting signals within the regulatory agency and a growing recognition that prolonged regulatory paralysis has real-world consequences.
“I think the FDA decision-making process has an impact on the marketplace for consumers,” Oyler said. “And I believe that they have a mission to make sure that pouches don’t become the illicit market enforcement nightmare that the e-cigarette market has become.”
She pointed specifically to remarks by Dr. Bret Koplow, acting director of the FDA’s Center for Tobacco Products, at a Food & Drug Law Institute (FDLI) seminar this fall. Oyler said Koplow discussed not only the current nicotine pouch pilot program but also a second round of pilot applications expected to begin in January—a signal she interprets as evidence that the FDA intends to learn from and act on the first pilot.
“If they’re going to start a second one, you would think they would want to take the learnings and the results from the first into that second one,” Oyler said. “The fact that they’re even contemplating a next round of this gives me some hope that the rumor I’m hearing is true, which is that the agency has been given the directive to get the first pilot out the door by the end of the year.”
For an industry that has watched thousands of nicotine pouch premarket tobacco product applications (PMTAs) sit in regulatory limbo for years, the implications extend beyond which brands receive early marketing authorizations. At stake, Oyler argues, is whether the FDA demonstrates a viable, repeatable pathway that preserves adult access, supports a competitive legal market, and prevents illicit alternatives from filling the gaps.
“When I come back to the value proposition of Haypp in the marketplace,” she said, “it is that we have an abundance of choice—more than retail shelf constraints often allow for. Preserving that range of options best serves our customers. Without those choices, consumers will move towards the illicit market.”
Start Simple
Oyler frames the FDA’s new nicotine pouch pilot as a pragmatic effort to fix a system that has become slow, opaque, and increasingly disconnected from market realities.
“I think it’s a little bit of all of the above,” she said when asked what FDA is trying to solve—scientific uncertainty, review capacity, political pressure, or consistency across applications. “But I think pouches are the easiest thing to start with.”
Unlike e-cigarettes, which encompass a wide range of devices, technologies, and e-liquids, nicotine pouches are relatively uniform. “Pouches are simpler and tend to be similarly constructed across the category,” Oyler said. E-cigarettes, by contrast, vary widely across “concentrations and batteries and flavors,” a level of complexity she described as functionally infinite.
“This kind of gets endless there,” she said. “But the pouch is a bit more simple, and I think easier to compare and easier to assess scientifically.”
That relative simplicity makes pouches an attractive test case for the FDA as it seeks to refine its internal processes. Oyler said Koplow’s remarks at FDLI suggested the agency may apply lessons from the pouch pilot to other categories of tobacco and nicotine products.
But for now, she cautioned, the industry still lacks concrete insight into how the pilot has changed operations.
“We’re really not going to know the answer to that for sure until we get some TPLs,” Oyler said, referring to technical project lead reports. “And I’m assuming we’re going to get some market granted orders (MGOs) by the end of the year. So, the technical project lead reports that get issued with those will give us the agency’s best scientific thinking on this topic.”
Until those documents are released, Oyler said much of the industry is operating on secondhand information. She has heard that the FDA may be reviewing certain scientific classifications on a category-wide basis.
“It was leaked out of the agency that a certain subset of science was apparently going to be reviewed from a category-wide perspective,” she said. “That list would be epidemiology, literature reviews, social sciences—data that sort of come into the category.”
If formalized, that approach could significantly reduce duplication and costs associated with PMTA submissions. “It doesn’t make sense for the agency to receive multiple versions of the same published literature,” Oyler said. “Everybody’s really looking at the same landscape.”
She emphasized, however, that the FDA is still required to make product-specific determinations. “Given that the agency is required to make an individual assessment of the product,” she said, “you’re still going to have to have a basic amount of science going in to help the FDA assure that the products are fit for purpose.”
One unresolved question, she added, is how many of the expensive scientific studies the FDA truly needs to consider. “How many PK (pharmacokinetic) studies does the agency need to review before we have a pretty good sense of the design space these products fall within from an abuse liability perspective?” Oyler asked.
Backlog Math
When asked what the FDA’s end-of-year actions might look like, Oyler pointed to the agency’s review metrics as evidence of mounting pressure.
“To date—and this is since 2020, because that’s all that’s posted in the review metrics right now—the agency has received over 4,000 applications in the ‘other’ category,” she said, noting that the other category “definitely includes all of the nicotine pouches.”
Of those, “around 2,000 have entered the acceptance phase,” Oyler said. “Three hundred sixty-nine were refused to accept (RTA). Two hundred fifty-one have been filed. And zero have received a refuse to file (RTF) as of September 30 of this year.”
She cautioned that those numbers do not tell the whole story. “The agency doesn’t necessarily make a refuse-to-file order public,” she said, because applicants are encouraged to refile.
Still, Oyler said there have been credible reports circulating in the industry about additional recent activity. “I’ve heard that several RTFs have been issued in the past couple of weeks,” she said. “They appear to be trickling slowly out of the agency.”
Taken together, she said, the figures suggest “five years of backlog starting to emerge.” When backlogs reach that scale, she noted, the FDA has historically sought ways to narrow the field.
“When the agency gets this sort of pileup,” Oyler said, “they have found a fatal flaw, or they have taken some administrative rule and used it to sort of clear the deck.”
The FDA’s “fatal flaw” in many flavored vaping premarket tobacco product applications (PMTAs) was the lack of sufficient scientific evidence (such as RCTs, longitudinal studies, or environmental studies) demonstrating that the product’s benefit to adult smokers outweighed the known, substantial risk of youth uptake or environmental concerns related to disposal. Because companies didn’t meet the “appropriate for the protection of public health” (APPH) standard, the FDA issued mass denials, though courts criticized the FDA for shifting requirements and a lack of fair notice.
The possible FDA filters from the Center for Tobacco Products (CTP) could take several forms. One potential “fatal flaw” in nicotine pouch PMTA submissions is packaging. “The child-resistant packaging announcement that came out earlier this year is interesting,” Oyler said. “It’s not an official requirement, but the FDA’s statement is a strong indicator of its views.”
Another question is whether applications must include pharmacokinetic (PK) studies. PK studies are a core part of pharmacology that examine how a living organism affects a drug. They analyze the movement of drugs into, through, and out of the body over time.
“Those are very expensive and take a long time to do,” Oyler said. “If brands haven’t invested in that next level of science, that could be another filter.”
The risk, she argued, is that pilots dominated by large manufacturers harden into a system that favors incumbents unless the FDA proves the pathway works for others.
“If the FDA is able to show that applications can be right-sized in a meaningful way to make them cost less—such that a company that doesn’t have cigarette profits can afford to participate—that’s one thing,” Oyler said. “And if they can process these applications in the 180-day window set forth by Congress, now you’re looking at a different viability for smaller operators.”
The Tobacco Control Act’s “180-day rule” requires the FDA to review a PMTA and issue a decision within 180 calendar days of the application’s filing, not just receipt. “I don’t know that that’s the world we live in today,” Oyler said.
Still, she said the inclusion of a mid-sized firm like Turning Point Brands in the first pilot is notable. “It’ll be interesting to see who or what makes it into the second round,” she said. “Those that make it through will be very telling.”
For smaller and international companies weighing their next steps, Oyler’s advice was straightforward. “You’re always going to need stability data to support your shelf-life assertions,” she said. “Don’t wait to get those started. They’re not the most expensive, but they’re the most time-consuming.”
She also encouraged companies to seek experienced U.S. regulatory guidance. “There are consultants in this space who are seeing multiple applications,” she said. “Engaging with one who has handled a few of these with some success would be helpful.”
Choice or Chaos
Oyler was unequivocal when asked whether regulatory uncertainty reduces enforcement risk. “I think it’s only going to increase enforcement risk,” she said.
She described the current environment as a “gray zone,” in which many products have been on the market with explicit or assumed enforcement discretion tied to the 2020 and 2022 PMTA filing deadlines. “Most retailers have reasonably assessed that those cutoff dates are safe harbors,” she said.
But she emphasized that products have also entered the market beyond those bounds. “The agency sees an opportunity to stem illicit product growth in this category before it takes off,” Oyler said, “preventing what happened with e-cigarettes.”
Oyler expects the FDA to pair authorizations with denials—and then tighten enforcement. “I think we’re going to see several marketing granted orders (MGOs) by the end of the year,” she said. “Several more by the middle of next year. And I think we’re going to see a commensurate, or probably larger, number of market denial orders (MDOs) in that same timeframe.”
If the FDA communicates expectations primarily through individual decisions rather than published guidance, Oyler warned that the consequences will fall hardest on smaller and international manufacturers.
“That would be an absolute nightmare,” she said. “There’s a lot of intelligence that happens informally in this space, and it’s difficult for people without resources—or people sitting outside the United States—to capture that.”
She argued that clarity benefits everyone—regulators, manufacturers, retailers, and consumers. In the meantime, Haypp is positioning itself as a quality-focused gatekeeper.
“Haypp takes product selection very seriously and acts as a gatekeeper to the marketplace,” Oyler said. Beyond FDA filing status, she said Haypp conducts its own testing. “We have internal standards for nicotine concentration, heavy metals, and limits,” she said. “We ship products to a laboratory, verify them, and publish the results” on NicoLeaks.com.
“What goes into a PMTA is confidential,” Oyler said. “Unless companies publish their science, consumers don’t see it.”
She also tied regulatory clarity to public understanding of tobacco harm reduction. “The genie’s out of the bottle on nicotine,” she said, noting that persistent misconceptions discourage smokers from switching to lower-risk alternatives.
Oyler said Haypp plans to support Swedish Match’s effort to obtain modified-risk tobacco product (MRTP) authorization for Zyn. “We plan to file a supportive comment,” she said. Oyler also argued that the FDA needs to explain its decisions more clearly. “Most people do not understand what ‘appropriate for the protection of public health’ means,” she said.
MRTP is a tobacco product that a company demonstrates significantly reduces harm or the risk of disease compared to regular tobacco products, allowing specific “lower risk” claims (such as lower nicotine levels or lower cancer risk) in its marketing, but this requires rigorous scientific evidence and FDA approval of the product as APPH.
In Oyler’s view, preserving consumer choice through multiple, timely authorizations is not merely a commercial concern; it is a regulatory necessity. “When consumers have a choice, and the FDA removes that choice,” she said, “an illicit market rises. We have very recent history on this.”
Oyler argues that whether the FDA’s pouch pilot ultimately expands lawful options or constrains them will determine whether that history repeats—or is finally avoided.
