Harm-reduction progress depends on science-based policy, transparent regulation, fair taxation, strong legal markets, clear communication, and coordinated action against illicit trade. Photo credit: Geoffrey Whiteway, Stockvault.
During a major tobacco industry conference in Brussels held in early October, speakers from regulatory, scientific, technological, and commercial sectors delivered a consistent message: tobacco harm reduction isn't halted by a lack of innovation but by policy confusion, misconceptions about nicotine, high tax rates, illicit trade, and regulatory systems that struggle to keep pace with consumer behavior.
Panels at the week-long, nicotine industry sponsored event emphasized that global progress depends on risk-based regulation, clear communication, effective market pathways, and coordinated efforts to encourage adults to make the switch from combustible products to less risky alternatives.
Clive Bates, director of Counterfactual, held a keynote address that set the tone for nearly every session that followed. He said, "The mission remains the same: lower smoking, disease, and death." However, the world is not on track. Although smoking rates are declining in many regions, global population growth means the total number of smokers stays high, especially in Eastern European and Asian countries.
Bates urged policymakers to focus on the real disruption—non-combustible nicotine products that deliver nicotine without smoke—and to recognize that their risk is "one or even two orders of magnitude lower" than cigarettes. He used Sweden and Germany as examples. Sweden's higher nicotine use but much lower smoking rates, due to snus use, are linked to significantly reduced lung and oral cancer cases. "Separate nicotine from smoke," Bates said, and develop pathways that help adult consumers transition toward less risky products.
Bates warned that governments and institutions are being misled by 5 persistent misconceptions: the false idea that new products are as risky as cigarettes; an overemphasis on nicotine rather than disease; a focus on youth that ignores adult switching; anti-industry litmus tests that undermine harm-reduction tools; and the spread of bans that increase illicit markets. Bates called for risk-based regulatory standards, expedited legal pathways, joint enforcement against criminal networks dealing in illegal nicotine products, and adult-oriented communication through trusted channels such as medical doctors and pharmacists. "Make nicotine use safer and succeed in [harm reduction goals] through consent, not coercion," he stated.
That framing set the stage for one of the forum's most closely watched sessions: the panel on the US regulatory landscape. Moderated by Paige Magness of Altria Client Services, the discussion explained how implementation gaps, political swings, and inconsistent communication have left the world's largest nicotine market in flux. "We have a marketplace kind of run amok," Magness said. "Dysfunctional product pathways, and a regulatory system falling far short of what was intended."
Haypp Group's Laura Leigh Oyler noted the growing clash between federal and state authorities. Flavor bans and registry bills have spread across states, often using marketing tactics to circumvent FDA's authority over nicotine products. "We can confidently forecast that the 2 states with flavor bans today will likely become 10 or 12 next cycle," she said, despite evidence that flavors help adult smokers switch away from combustion.
Beth Oliva of Fox Rothschild cautioned that California's flavor ban and new registry model show how state-level actions can weaken federal systems. "The FDA is the barrier to entry; the states are the barrier to the shelf," she said. Meanwhile, FDA review criteria—including the "appropriate for the protection of public health (APPH)" standard—change with political priorities, leading to inconsistent authorization outcomes and delays.
Dr. Jessica Zdinak, founder and chief research officer at Applied Research and Analysis Company (ARAC), confronted the growing gap between regulatory assumptions and consumer understanding. She said that many smokers misunderstand warnings, distrust institutions, and often believe that nicotine pouches and/or vaping products are just as harmful as combustible cigarettes.
She also pointed out that medical professionals frequently share these misconceptions with their patients. "They trust their nurse and their physician," Zdinak said. "And many physicians keep confusing nicotine with smoking." She then explained that without clear, consistent communication, both adult switching and regulatory understanding will continue to struggle.
Reynolds American's Valerie Briggs Solomon described the US environment as "sobering," with misperceptions worsening even as FDA finally acknowledges the harm-reduction potential of nicotine pouches. She, Zdinak, and Oliva agreed that FDA's recently announced pilot to expedite nicotine pouch authorizations is encouraging but risks creating "another Wild West" if standards are inconsistent or communication is unclear.
Combating black markets
Illicit trade—created or worsened by regulatory fragmentation—dominated another high-profile industry panel. Moderator Rohan Pike opened with breaking news of overnight fire-bombings in Melbourne, illustrating the growing violence tied to illegal nicotine product trafficking in Australia.
Theo Foukkare, c.e.o. of the Australian Association of Convenience Stores, described a market "under siege" in which prohibitionist policies pushed traditional cigarette retail prices so high—AU$32 (US$20) a pack—that adults overwhelmingly turned to black-market suppliers. Illicit market shares for vaping, shisha, and nicotine pouches are "in the high 90s to 100 percent," he said, and organized crime now controls farms, distributes illegal products, and extorts shop owners. "Make lawful faster than illicit," Foukkare urged, noting that lawful channels in Australia could disappear within two years without reform.
Panelist Dr. Alexander Kupatadze told conference attendees that black box detection tools are ineffective without contextual intelligence, as criminal networks are diverse, politically connected, and able to exploit blind spots in customs enforcement. British American Tobacco's (BAT's) Nick Hodsman pointed to extreme disparities between export and import declarations—China declaring five times more outbound e-liquid volume than the U.S. records inbound—and explained how free-trade zone relabeling obscures origin data.
Former FDA enforcement official Lillian Ortega, founder and c.e.o. of WOW Solutions LLC, explained that misdeclared shipments never appear in FDA surveillance systems. "Criminals thrive off confusion," she said. The panel agreed that slow authorizations and unclear legal options push adult consumers toward illicit channels, supporting Bates' warning that prohibition can lead to unintended consequences.
Another major session, "Angle of Approach: Consumers, Combustion, Nicotine," examined practical ways for industry and institutions to speed up switching. Moderator Nick Kadysh encouraged panelists to identify stakeholders who can eliminate combustion. Saudi Arabia's national "quality of life" framework, said Badael's Atheer Al Bin Ali, has helped promote harm-reduction discussions by linking consumer behavior with government mandates. "The moment consumers see a product that is less harmful and still delivers nicotine well, they go right to it," she said. Institutional adoption, however, is "slower and data-dependent."
Australian clinician Dr. Carolyn Beaumont warned that global progress is slowing because institutions have shifted their focus from tobacco control to nicotine elimination. "It's deliberately making the solution—the safer products—part of the problem," she said. Doctors respond to clear, outcome-driven facts: "Tell any doctor their patient's cardiovascular risk drops 50% within a year of quitting smoking." Australia's prescription-only model, she argued, "doesn't work at all," forcing nearly all vape use into the black market.
Emplicure's Håkan Engqvist put a spotlight on the importance of early-stage nicotine delivery and discreet nicotine pouch design to support realistic switching. Pivot Health Technologies c.e.o. Dr. David Utley argued that pairing products with measurable biomarker feedback and behavioral coaching can help most dual users (traditional cigarette and vape and/or nicotine pouch use) either quit or reduce their use by 50%. "Zero is the end game," he said. "Pair every can, every device, every pouch with scalable digital support."
Clearing the air
Beyond these lead sessions, the conference also hosted a series of panels that emphasized its central themes. During the "Correcting Nicotine Misperceptions" panel, experts agreed that large amounts of misinformation among both consumers and healthcare providers remain a significant obstacle to tobacco harm reduction. Altria's Dr. Mohamadi Sarkar cited NIH PATH analyses showing 94% of smokers believe vaping is as harmful or more harmful than combustible cigarettes, and 63% believe nicotine causes cancer. His modeling indicates that up to 800,000 premature deaths could be avoided over 50 years if these misperceptions were corrected.
During a keynote address that emphasized the same urgency, Philip Morris International's (PMI) head of US regulatory and public policy, Erin Warren, described regulatory delays as a public health risk. "Every unclear decision prolongs the moment when someone might step away from cigarettes," she said, urging clearer product standards, independent oversight, and harmonized risk communication.
Other conference sessions focused on structural issues. A taxation panel, led by Tim Phillips of Tamarind Intelligence, warned that high excise burdens and inconsistent EU rules are widening the gap between regulatory goals and consumer behavior. BAT's Christa Pelsers criticized the EU's fragmented nicotine tax proposals; PMI's Stefano Santi called for proportional tax rates that help guide smokers toward lower-risk options; and Socotab's Maria Angelova warned that high excise taxes on raw tobacco leaf threaten the livelihoods of farmers and their families and encourage illegal sourcing.
A track-and-trace panel demonstrated how AI-driven authentication, microscopic barcodes, and real-time data systems can safeguard consumers and manufacturers from counterfeit products. Honeywell's Maria Levanova stressed that "being compliant isn't enough—you have to use the data your system generates."
A supply-chain ESG panel highlighted the need for enforceable, measurable standards. Pyxus' Miranda Kinney pointed out that "every product comes from a seed cared for by a farmer," while Greenbutts' Tadas Lisauskas warned that ESG rules without enforcement "are just a suggestion."
Youth access prevention, another global priority, was addressed through digital solutions. Yoti's Rhodri James said digital ID systems will soon become mainstream; IKE Tech's John Patterson promoted blockchain-based point-of-sale systems; Haypp Group's Jasmin Widholm argued that properly regulated e-commerce can outperform brick-and-mortar stores at preventing youth access.
The conference ended with stark warnings about prohibition. In his keynote address, Tim Andrews, director of Consumer Issues for Americans for Tax Reform, called global bans "profoundly immoral," arguing that cartels—not public health—benefit from prohibitionist policies. "Prohibition doesn't work—it never has," he said, highlighting how Brazil, Germany, and Mexico have experienced bans that drove black market growth and increased smoking rates.
Throughout the forum, the consensus was clear. Progress in tobacco harm reduction relies on practical, science-based policies, transparency in regulations, fair taxation, well-structured legal markets, clear communication, and globally coordinated efforts to combat illegal trade. As Bates stated on Day 1 of the event, the way forward is simple: "Make safer options visible, trusted, and affordable—and adults will choose them."