By Timothy S. Donahue

A standing-room crowd during a seminar at InterTabac, held in Dortmund, Germany, from Sept. 18 to 20, listened to a quick, data-rich review of oral nicotine’s future as moderator Dr. Nveed Chaudhary led a panel through nicotine pouch regulation, toxicology, and product development from an industry-first perspective.

Chaudhary, director at NexCentra Consulting and chair of the Science & Standards Committee at the Global Institute for Novel Nicotine (GINN), introduced the session by connecting oral nicotine to its long history and modern harm-reduction reasoning.

“All nicotine is not new,” he said, noting that oral use long predates vaping and heat-not-burn. He urged the sector to think beyond cigarette smokers: “There’s a massive market of oral tobacco users out there that can also benefit from switching to nicotine pouches.”

Chaudhary summarized the risk continuum commonly used in tobacco control: eliminate combustion, then tobacco, then inhalation—after which nicotine pouches approach risk profiles similar to pharmaceutical nicotine replacement therapies (NRTs). The ongoing question, he said, is why pouches are treated differently than medicines in many markets.

The regulatory patchwork

Dr. Sydney Hiller, a senior scientist at Sanova, mapped the quickly changing regulatory landscape. In the United States, she said, pouches go through the U.S. Food and Drug Administration’s premarket tobacco product application (PMTA) process, which is currently in flux due to a pilot program to speed up some reviews. “We’re hoping to see some decisions by the end of the year,” she noted, referencing filings from major manufacturers.

In Europe, products are regulated under the TPD, “although that is undergoing some revisions,” she added. Hiller pointed out differing national actions—some “going above and beyond” EU standards—citing France‘s attempt at a full pouch ban and Sweden as an example of “very successful regulation,” with adult smoking rates below 5%.

Elsewhere, Australia (and now Canada, through a different route) guide pouches toward medicinal pathways. “We’re seeing those regulations evolve quite quickly,” she said, “and, as we’re seeing, not always based in the science and harm reduction.”

Chaudhary clarified the confusion: do regulators blend nicotine with the risks of cigarette smoke? Pawel Woznicki of Chemnovatic called for a clear distinction. “In the minds of a lot of people, the toxicity of nicotine is related to tobacco,” he said. Combustion causes cigarette carcinogenicity; tobacco itself contains psychoactive compounds that can influence nicotine’s effects.

In contrast, pouches “just have nicotine itself.” Regarding risk, he said, “we should mainly focus on its cardiovascular effects,” which are influenced by adrenaline and blood pressure changes. “How much they use directly impacts how it affects them,” he added.

Innovation, differentiation and self-policing

Focusing on product strategy, Joel Rubenstein, a GINN member and seasoned commercial leader in the pharmaceutical nicotine industry, stated that sustainable differentiation can’t rely solely on taste. “I’ve spoken to about 12 or 13 pouch companies…all of them but two said ‘flavors’ [are what separates them form the pack) If everyone’s main point of difference is the same, that’s not a good category to be in,” he said.

He emphasized the importance of “common sense” in delivery strength and duration—meeting adult smokers’ needs without extremes—and cautioned against chasing “super high strength,” which can lead to regulatory backlash. “The long-term sustainability of the category depends on self-regulation,” he stated. “Something bad is going to happen, and everyone in the oral nicotine category is going to suffer” if outlier practices continue.

On the pharmaceutical side, constraints are different and more restrictive. Outside the UK, oral NRTs are usually 4 mg, with some markets allowing 6 mg, and certain regions require prescriptions even at 4 mg. Consumer needs are similar, however, because “they want faster craving relief,” Rubenstein said.

With a strict limit, innovation becomes dynamic. “Given a four-milligram ceiling, how do I deliver that four milligrams faster… and deliver more of the four milligrams over the 15–20 minutes” of use? He pointed out chewing gum’s inefficiency—“about a quarter of the nicotine is still in the gum”—and challenged the industry to replicate a nicotine spray’s fast PK curve “in an oral format without the negatives.”

Perception vs. chemistry

Rubenstein emphasized that consumers do not evaluate products in isolation. In a Nordic study he conducted, respondents rated the risk of cigarettes as 100 percent and nicotine-free products as 0. A recreational nicotine pouch received a 44 percent rating, while a pharmaceutical nicotine pouch with nearly identical specifications scored only 14 percent. “That is a huge gap for two products that are scientifically identical,” he noted. Packaging, claims, and context influence perceptions (and impact usage) independently of lab data.

Woznicki returned to the fundamentals. “Nicotine is not a carcinogen itself,” he said, emphasizing that the message must reach smokers if switching is to succeed.

The U.S. compliance conundrum

Chaudhary then asked whether the U.S. PMTA regime can coexist with rapid innovation. Rubenstein predicted dramatic change. He described a game of poker between major tobacco companies and the FDA over timelines and enforcement. “The FDA has not followed through on what they said they would do, and companies are calling their bluff right now,” he said. Winning in the U.S., he added, cannot be flavors and branding; it must be a defensible delivery benefit.

Hiller outlined the legal friction under Section 910 of the Food, Drug, & Cosmetics Act. The FDA is supposed to review PMTAs within 180 days. “We all know that’s not the case,” she said. Big Tobacco challenges the status quo with “substantive scientific findings…These are true PMTAs.” The standoff could go to court or be settled if the FDA chooses not to enforce pending decisions, but either option will clarify expectations “pretty soon,” she said, which could also benefit smaller companies.

In a Q&A, Hiller explained that if the FDA does not enforce regulations after 180 days, the market could operate like a notification system used in other countries—still requiring “substantive scientific information,” but without formal approval before marketing. Chaudhary added that if companies “have the data” on reduced risk and “market it in an appropriate way,” it would be “very difficult for the FDA to enforce” against launches after 180 days.

Tobacco vs. synthetic nicotine

Chaudhary also asked whether the previous vape debate (tobacco-derived vs. synthetic nicotine) is happening again with pouches. “The short answer is, we should treat all forms of nicotine the same,” Woznicki said—chemically, S-nicotine is S-nicotine whether it comes from plants or is synthesized. But he warned that R-nicotine and racemic (50/50 S and R) mixtures make pharmacology more complicated.

S-nicotine is roughly 10 times more potent at nicotinic receptors; R-nicotine may inhibit acetylcholinesterase, which has different neurobiological effects. Quality, not source, is the main factor for safety. “You can have a high-quality tobacco-based nicotine [or] synthetic nicotine…or a very impure nicotine” from either source. Process controls and impurity removal are the most important aspects.

The $50 million question

Chaudhury asked the panelists how they’d deploy a hypothetical $50 million to launch a nicotine pouch product:

• Rubenstein would improve NRT’s poor real-world effectiveness (“a three to five percent success rate…is pathetic”). He would invest in behavior-change personalization to identify the reasons behind why people smoke—whether chemical, social, behavioral, or stress triggers—and match tools accordingly. “People try to deal with one trigger for a five- or six-trigger problem, and it just doesn’t work,” he said. NRT would be integrated into a customized quit journey, not the entire solution.
• Hiller plans to invest in product stewardship and modular science—covering HPHC profiles, toxicology, and stability—aimed at supporting multiple markets and accelerating revenue. “There is a way to design studies so that they can be used, not just for your PMTA,” she said. Maintaining a consistent user experience is essential. “Otherwise, that’s going to drive those consumers away.”
• Woznicki planned to build a research center to “discover the truth and then show this truth to the people,” and hire experienced operators for finance, strategy, and marketing. The goal: rigorous science that communicates clearly.

Chaudhary endorsed a consumer-first approach: start with the lowest-risk option and escalate only if necessary. “My advice…would be to say to them: if you smoke, you should quit…[but] go for the nicotine pouches. And if nicotine pouches don’t work…then begin to escalate up the risk scale.” He also highlighted extreme strengths he’d seen—“80, 90, 150 (mg/mL) in some cases”—contrasting with GINN guidance that 20 mg/mL should be the ceiling and that 14–16 mg/mL “seems to be the sweet spot for really heavy smokers.”

Shifting public perception

Regarding societal views, Woznicki observes a positive trend but notes a significant lack of reliable resources for the public. Hiller highlighted ongoing misinformation, stating that “over 80% of physicians still believe that nicotine is a carcinogen,” and argued that third parties must translate science for consumers and regulators. Rubenstein cautioned that relying on brand marketing for education won’t be effective. “The ROI of educating consumers is infinitely smaller than the ROI on TV advertising,” he said, adding that independent voices need to deliver the message.

Availability also matters. “It’s really important to stop the trends that we’re seeing with outright bans,” he said, because removing pouches takes away a viable option for adult smokers. With TPD3 on the horizon, Hiller urged “using science” to oppose blanket prohibitions and flavor bans.

The landing spot

Chaudhary wrapped up with a clear summary for an industry audience: Nicotine pouches “are the future for the category, but survival hinges on responsibility and data. The consumer market “has to stay,” he said, along with self-policing to “call out the players…not behaving in the interests of the industry.”

In the U.S., the pathway might be shifting toward submitting the PMTA, waiting 180 days, then launching, but only for companies that “have confidence in the data set” and “market appropriately.” Above all, he said, the sector must keep educating consumers, regulators and politicians “about what pouches actually are, what they mean, what the risk profile really is,” to move the needle on harm reduction.