Speaker: Dr Sydney Hiller, Inter-Scientific
As Europe considers further regulation of nicotine pouches, the experience of the United States offers important lessons about balancing product oversight with an effective and manageable authorisation system.
During GINN’s October 2026 webinar, Dr Sydney Hiller of Inter-Scientific reflected on the US Food and Drug Administration’s Premarket Tobacco Product Application (PMTA) framework, highlighting both its regulatory strengths and the difficulties encountered during implementation.
Her central concern was that even well-intentioned requirements can produce unintended consequences when regulatory processes become difficult to administer or fail to distinguish adequately between complete, evidence-supported applications and less substantive submissions.
The Value of Product Standards and Scientific Review
Hiller acknowledged several strengths of the US framework, particularly its emphasis on consistent manufacturing, product testing and regulatory assessment.
These requirements provide a basis for evaluating product characteristics and manufacturing controls before products receive marketing authorisation. They also reflect issues raised throughout the GINN webinar, including the importance of reproducible production processes and reliable quality standards.
However, Hiller cautioned that regulatory design must be considered alongside practical implementation.
In her assessment, difficulties within the US authorisation system have contributed to conditions in which unauthorised products can continue circulating, complicating enforcement and market oversight.
When Application Systems Become Overburdened
A particular concern raised by Hiller was the large number of applications submitted before regulatory deadlines in the United States.
She described how the volume of submissions, including applications she characterised as lacking substantive supporting material, created significant administrative backlogs.
According to Hiller, this slowed the assessment of more complete applications containing the scientific and technical information required for meaningful review.
Her observations raise a practical question for European regulators: how can an authorisation framework maintain rigorous scientific requirements without creating procedural obstacles that undermine timely decision-making?
Application quality, administrative capacity and realistic implementation periods all warrant consideration. A demanding regulatory system can provide important safeguards, but its effectiveness also depends on whether authorities can process applications and enforce decisions consistently.
Implications for European Nicotine Regulation
Europe has an opportunity to examine the strengths and limitations of existing regulatory systems before introducing additional requirements for nicotine pouches.
Hiller’s remarks suggest that clear product standards should be accompanied by workable submission procedures, appropriate review capacity and transparent expectations for manufacturers.
The relationship between authorisation delays and illicit trade also requires careful assessment. While regulatory bottlenecks may create opportunities for unauthorised suppliers, the scale of that effect depends on market conditions, enforcement and consumer behaviour.
For GINN, the broader lesson is that regulatory effectiveness cannot be measured solely by the strictness of the rules. Implementation matters equally.
A proportionate European framework should protect consumers, prevent youth access and support credible product oversight while ensuring that compliant manufacturers have a realistic pathway through the regulatory process.
The US experience provides a useful case study of why these objectives need to be considered together as Europe develops its approach to nicotine pouch regulation.
