The tobacco and vaping sectors in the US are navigating a complex and fast-changing regulatory environment. The ninth annual Keller and Heckman E-Vapor and Tobacco Law Symposium, held in Las Vegas in January 2025, brought together industry leaders to discuss legal, scientific, and regulatory developments shaping the future of tobacco, nicotine, and CBD products. Chris Allen, CEO, and Andy Mooney, chief commercial officer of Broughton, a testing and regulatory consultancy, attended the two-day event, gaining critical insights into the challenges and opportunities ahead.
As scrutiny of these industries intensifies, the symposium underscored a growing emphasis on reduced-risk nicotine products. Experts debated the potential establishment of a dedicated harm reduction agency to oversee innovations like nicotine pouches and heated tobacco systems. Proponents argue this could streamline oversight and provide clarity for manufacturers. But with pending executive orders and shifting political leadership, the regulatory outlook remains uncertain, leaving businesses in a state of flux.
A pressing concern raised was the influx of flavoured nicotine pouches and electronic nicotine delivery systems (ENDS) flooding the market, many operating outside legal boundaries. Without a robust and consistent Premarket Tobacco Product Application (PMTA) process, coupled with stronger enforcement, compliant companies face unfair competition. The symposium revisited the FDA’s 2019 review of ZYN, a prominent nicotine pouch brand, noting that standards deemed acceptable then may not withstand today’s stricter scientific and regulatory expectations, particularly amid rising concerns over youth access.
Legal experts from Keller and Heckman LLP highlighted the fragmented US regulatory framework. Unlike the European Union’s unified Tobacco Products Directive, American states can impose their own restrictions, creating a patchwork of rules that complicates compliance. They also stressed the significance of the Proposed Rule on Tobacco Product Manufacturing Practices, which is expected to play a pivotal role in future PMTA submissions. With these changes looming, industry stakeholders were urged to anticipate evolving requirements to foster innovation responsibly while meeting compliance demands.
Market trends also took centre stage, revealing a dynamic shift in consumer behaviour and product development. Research presented at the symposium showed that many smokers, previously uninterested in quitting, are successfully transitioning to alternative nicotine products. This trend offers a promising avenue for harm reduction, potentially reducing the public health burden of traditional tobacco use.
But the rapid rise of oral nicotine products has sparked alarm. Experts warned of a surge in illicit nicotine pouches, which, if unchecked, could mirror past public health crises by triggering a new youth epidemic. The symposium called for vigilant monitoring and enforcement to prevent such an outcome.
Regulatory updates provided further clarity on submission processes. The practice of relying solely on submission tracking numbers (STN) was flagged as an inadequate pathway to market legally. Meanwhile, the FDA’s toxicological review process is evolving, moving away from broad assessments of entire products toward a more granular, ingredient-specific evaluation. This shift signals a tougher road ahead for manufacturers seeking approval.
For companies like Broughton, staying ahead of these changes is paramount. By engaging directly with US product innovations, they assist businesses in navigating the labyrinth of compliance and successfully launching new offerings. As the regulatory landscape continues to shift, proactive adaptation remains essential.
