US Nicotine Regulations & PMTA Updates: Key Insights from ATNF 2025

The inaugural ATNF conference, held from 15–17 April 2025, brought together stakeholders across the US reduced-risk product (RRP) landscape for a focused few days of scientific, technical, and regulatory dialogue. This newly rebranded event, formerly known as the TMA conference, distinguished itself from global events like GTNF by concentrating specifically on US market dynamics, challenges, and opportunities.

Regulatory Uncertainty and Industry Outlook

One of the dominant themes was the ongoing uncertainty surrounding the regulatory future of the US nicotine market. With leadership changes at the Center for Tobacco Products (CTP), many participants expressed cautious optimism about a more constructive regulatory environment for RRPs. However, there remains a lack of clear direction, with speculation around who will take over at CTP, how regulatory timelines may shift and potential changes to the current PMTA process.

There was broad consensus that the current backlog of existing PMTA submissions continues to frustrate the industry. Stakeholders advocated for a more streamlined 180-day FDA review process and, more ambitiously, for a shift toward a post-market regulatory model. Such a model would rely on real-world use and behavioural data, particularly impactful for oral nicotine formats like pouches. However, for now, these ideas remain speculative.

Declining Youth Use and Category-Specific Insights

Encouraging data shared at the conference by Andrew Joyce of regulatory consultancy firm Sanova and reinforced by Brian Erkkila from Swedish Match showed that youth use of nicotine pouches in the US is now below 2%, reinforcing the perception that pouches may represent a lower-risk product format with limited youth appeal. This aligns with the broader public health goal of harm reduction while continuing to meet adult consumer demand for smoke-free alternatives.

Final Thoughts

ATNF 2025 successfully established itself as a focused and valuable forum for US-based dialogue around next-generation nicotine products. While regulatory clarity remains a work in progress, the event’s discussions highlighted the sector’s resilience, its commitment to harm reduction, and the potential for collaborative progress.

ATNF 2025 drew a crowd of approximately 300 attendees, spanning traditional tobacco, RRP manufacturers, academia, and contract research organisations. The event served as a valuable platform for technical exchange, relationship building, and exploring collaborative opportunities.

For more information on how Broughton can support your regulatory submissions , get in touch with one of our experts.