PouchEx 2025: Industry Insights, Regulatory Shifts, and the Future of Nicotine Pouches

The inaugural PouchEx 2025 conference, dedicated exclusively to nicotine pouches, was a niche event that created an intimate and highly focused atmosphere. With top-tier exhibitors, leading scientists, regulators, and innovative brands all under one roof, the quality of attendees, presentations, and discussions was excellent.

Despite regulatory uncertainty, especially in the EU, the mood was one of cautious optimism, driven by scientific advances and a stronger consumer voice. As the very first edition of its kind, PouchEx felt like a true milestone and the perfect foundation for what could eventually grow into the category’s definitive annual gathering.

Regulatory Uncertainty in Europe – But Opportunity to Lead with Evidence

Lorenzo Guaragna opened the conference by addressing the evolving global regulatory landscape. While some countries continue to implement outright bans or heavily restrict nicotine pouch sales, market demand shows no signs of slowing.

One of the biggest concerns raised was a leaked draft suggesting the next Tobacco Products Directive (TPD) might propose a ban on nicotine pouches. With no final decision expected before 2028–2030, Lorenzo stressed the importance of generating robust data in the meantime, highlighting benefits for adult smokers and reinforcing measures to limit youth access. This data-first approach is likely to be key to shaping more balanced and risk-proportionate regulations in the long term.

Behavioural Science and the Role of the Consumer

Sairah Salim-Sartoni’s session highlighted how behavioural science can be a powerful ally in tobacco harm reduction. A particularly impactful takeaway: eliminating smoking in the UK could free up over 75,000 GP appointments every month, underscoring the wider healthcare benefits of effective reduced-risk alternatives.

She also addressed the persistent stigma around nicotine, which continues to skew public and policymaker perception. Importantly, Sairah reminded attendees that the consumer voice, often absent from regulatory debate, must be central to the conversation if we are to achieve genuine public health gains.

U.S. Regulatory Landscape: Accelerated Reviews, Key Priorities

Sanova’s Sydney Hiller, PhD, MBA delivered a detailed overview of the U.S. FDA’s current stance on nicotine pouches. The FDA has launched an accelerated Premarket Tobacco Product Application (PMTA) review programme for selected applicants, with decisions expected by the end of the year.

Sydney outlined what the FDA is prioritising in current PMTA evaluations:

• High-quality, consistent manufacturing
• Comprehensive nonclinical data (product characterisation, stability)
• Child-resistant packaging (not mandatory, but increasingly influential)
• Abuse liability and real-world use studies
• Openness to bridging data in social, behavioural, and population health submissions

She also clarified that switching to child-resistant packaging using the same materials does not require a new application, though updated scientific data (such as stability) is still expected.

This clear and pragmatic breakdown was praised as one of the most valuable regulatory insights of the event.

Chris Allen - Reduced Risk Nicotine Regulations: ‘Has Anyone Got it Right?’

Our CEO, Chris Allen, delivered a compelling presentation highlighting the widening gap between science and policymaking. Despite years of evidence showing that products like nicotine pouches and vapes can displace smoking, misperceptions persist, fuelled by negative media narratives and misaligned policy agendas.

Chris emphasised the need to focus regulatory efforts not just on youth prevention, but also on adult cessation support. He noted the example of Australia, where prohibition has led to a thriving illicit market, illustrating the risks of overly restrictive approaches.

His message was clear: consumers need access to the products that work for them. Prohibition is not the solution; responsible regulation, informed by science and centred on consumer needs, is.

Final Thoughts

PouchEx 2025 reaffirmed the momentum behind nicotine pouches, both as a product category and a public health opportunity. While challenges remain, particularly in Europe, there is increasing alignment around the importance of data, balanced regulation, and the consumer voice.

The next 12–18 months will be critical, with PMTA decisions from FDA expected soon and further developments on the EU’s regulatory direction. The industry’s ability to generate evidence, engage responsibly, and adapt to evolving frameworks will determine how far and fast we can move towards a smoke-free future.

For more information on how Broughton can support bringing your nicotine pouch products to market with expert analytical testing and regulatory consultancy, get in touch.