As the nicotine product landscape evolves, scientific assessment must evolve with it. For Next-Generation Nicotine Products (NGPs), understanding performance, biological effects, and real world use requires more than a single laboratory test or clinical study.
Thomas Nahde, Head of Harm Reduction and Engagement at Imperial Brands Science, explains why multidisciplinary Scientific Assessment Frameworks (SAFs) are increasingly important in helping researchers, regulators, and public health stakeholders evaluate NGP.
Building a robust evidence base
As restrictions on NGP continue to increase in many markets, there is a growing need for manufacturers, researchers, and regulators to contribute to a robust evidence base. For responsible manufacturers, this means going beyond meeting technical requirements at launch to understand product composition, performance, and potential impact throughout a product’s lifecycle.
Rather than relying on isolated studies, SAFs bring together complementary evidence streams to assess products from laboratory development through to real world use and post market monitoring. A robust SAF evaluates NGP across six complementary areas: product characterisation, biological science, clinical studies, behavioural science, computational science, and post market surveillance.
Each discipline answers different questions. Analytical and toxicological studies can characterise products and biological responses, while clinical research can provide insight into exposure and consumer experience. Behavioural research and post market surveillance can add context from use outside controlled laboratory conditions.
This weight of evidence approach allows findings to be considered collectively rather than relying on any single dataset. It also provides a structure that can incorporate new evidence as products, technologies, and consumer behaviours evolve.
New tools for laboratory testing
Laboratories are assessing technologies such as vapes, heated tobacco products, and nicotine pouches, creating new analytical and toxicological challenges. Alongside established assays, researchers are adopting human relevant approaches such as 3D airway tissue models, air liquid interface systems, organ on a chip platforms, and high throughput screening. These methods can provide mechanistic insight into biological responses while complementing established toxicological testing.
As product technologies become more sophisticated, testing methods need to remain fit for purpose. Combining established and emerging approaches can help researchers address different aspects of exposure and biological response without placing undue weight on any single experimental model.
Beyond the laboratory
Laboratory evidence is only one part of the picture. Clinical studies, behavioural research, and post market surveillance can help researchers understand product performance, consumer use, emerging trends, and reported complaints or adverse events. Together, these sources can provide a more realistic picture of how products are used beyond controlled conditions while allowing new information to be incorporated into future assessments.
The value of a multidisciplinary SAF lies in bringing these perspectives together. By combining evidence from different study types, researchers can validate observations, identify gaps, and build a broader understanding of product performance under both controlled and real world conditions. As NGP evolve and scientific and regulatory expectations develop, this structured approach can help ensure that decisions are informed by cumulative evidence rather than individual findings or assumptions.
Imperial Brands Science’s framework
Imperial Brands Science has developed its own multi stage, multi discipline scientific assessment framework for evaluating product safety and tobacco harm reduction potential, aligned with guidelines from leading global public health authorities and regulators. The framework aims to rigorously assess NGP safety profiles throughout their lifecycles while examining their benefits and relative risks compared with cigarettes, with a focus on individuals and wider adult smoking populations.
Individual studies provide important findings, but considered together, they contribute to a weight of evidence on the potential of these products. This approach supports continuous improvement, with each stage helping to assess safety, generate scientific proof points, and strengthen the overall evidence base. Comprehensive scientific assessment of the relative risks of NGP compared with cigarette smoking is viewed as a foundation for risk proportionate, evidence based regulation.