The closing session of EVO NXT Milan 2025 brought together a remarkable group of experts from across the novel nicotine industry to discuss one of the most pressing questions facing the category: how can innovation thrive under increasing regulatory scrutiny?
Moderated by Robert Burton (Plxsur), the session featured insights from Geir Hammer (Den Norske Snusfabrikken), Ville Henrick Roo (Nano OÜ), Rachel Schmidt (ALINC Consulting), and other leading voices across product development, compliance, and regulation. The tone was clear—growth is coming, but the industry must be smart, unified, and science-driven to avoid repeating mistakes of the past.
Regulation as the Gatekeeper of Growth
Geir Hammer opened with a keynote highlighting Norway’s successful transition from smoking to reduced-risk alternatives. In a country of just 6 million people, nicotine pouch usage now surpasses smoking, proving that well-regulated innovation can deliver real public health outcomes.
However, Hammer warned that aggressive regulation in Europe could derail future progress. With many countries already limiting nicotine content and targeting packaging and flavors, the industry must avoid “poking the bear.” Excessive nicotine strengths, provocative branding, and a lack of product control could trigger a wave of over-regulation—threatening the industry’s very permission to operate.
Learning from the FDA’s Shake-Up
Rachel Schmidt, former Assistant Director at the U.S. FDA’s Center for Tobacco Products, offered a rare insider perspective. She described the recent dismissal of nearly all senior FDA tobacco office leaders as a “clear message” that the U.S. regulatory system is failing to deliver on its mission: reducing harm.
Schmidt emphasized the need for simpler, faster regulatory pathways for reduced-risk products. She also called on industry actors—particularly through GINN—to work collaboratively to define standards, develop scientific dossiers, and build a trusted ecosystem that supports innovation and compliance.
“We need reputable labs, clear science, and a narrative that regulators can work with,” she said. “That’s where organizations like GINN play a crucial role.”
The Future of Innovation: From Pouches to Pods
Ville Henrick Roo (Nano OÜ) provided a manufacturing perspective, highlighting new developments in raw materials and delivery formats, including discreet lozenges and bagless pouches. “The pouch category is evolving,” Ville Henrick Roo explained. “We’re seeing demand for both stronger and smoother nicotine delivery—depending on the consumer profile.”
Panelists agreed that design, accessibility, and convenience will increasingly shape product success. Ideas like rechargeable dispensers, discreet packaging, and user-friendly features could meet consumer needs while complying with child-safety and environmental regulations.
A Call for Common Standards
Throughout the session, one idea kept resurfacing: the need for a standardized reference product. As Chris Allen (Broughton) pointed out, having a universally recognized product—akin to the 3R4F cigarette used in tobacco testing—could simplify regulatory submissions and align the industry around a consistent scientific baseline.
Schmidt suggested that GINN could take the lead by facilitating master files, pre-approved lab networks, and common testing protocols. “If we don’t define the standards, regulators will do it for us—and not necessarily in our favor,” she warned.
Closing Thoughts: Unity, Not Chaos
The session ended with a strong call for industry unity. The future of nicotine innovation will depend on responsible growth, credible science, and collaboration between manufacturers, researchers, and regulators. With organizations like GINN leading the way, the path forward can be both innovative and compliant.
As Rachel Schmidt said, “This is not about gimmicks. It’s about products that people can trust—and systems that support them.”
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