How tobacco scrutiny can drive product assessment

While there is broad consensus around the harms associated with combustible cigarettes, discussions surrounding alternative nicotine products often remain complex, nuanced and, at times, polarised.

This is particularly relevant as restrictions on NGP continue to increase in many markets. Products such as vapes, heated tobacco products and nicotine pouches are frequently subject to evolving regulatory requirements despite growing evidence suggesting they may potentially offer significantly reduced risk compared to continued smoking. As a result, there has never been a greater need for manufacturers, independent researchers and regulators to contribute to a robust scientific evidence base that helps inform policy decisions and public understanding.

For responsible manufacturers, this means going beyond regulatory requirements to fully understand the composition, performance and potential impact of products throughout their lifecycle. It is not enough to simply demonstrate that a product meets technical standards at launch. Manufacturers must also assess how products are used in real-world settings, monitor their ongoing performance and continue generating evidence that supports informed decision-making among regulators, public health bodies and consumers alike.

Manufacturers must also assess how products are used in real-world settings, monitor their ongoing performance and continue generating evidence that supports informed decision-making

This growing demand for comprehensive evidence generation has helped drive the development of multidisciplinary scientific assessment frameworks (SAFs) that combine laboratory science, toxicology, clinical research, behavioural science and post-market surveillance to build a more complete understanding of NGP and their potential role in THR.

From product testing to lifecycle assessment

Historically, product assessment has focused heavily on laboratory testing and controlled studies conducted before products reach consumers. However, regulators are increasingly recognising that these studies represent only part of the overall picture. For example, the U.S. Food and Drug Administration’s (FDA) Real-World Evidence Program highlights the value of collecting and analysing more data beyond pre-market studies to support regulatory decision-making and build a more comprehensive understanding of product performance throughout its lifecycle, while the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) continues to explore how real-world evidence can support robust, data-driven oversight.

For NGP, laboratory testing remains the foundation of scientific assessment. Analytical chemistry, emissions testing, toxicology and clinical studies provide critical information on product composition, biological impact and technical performance under controlled conditions. These studies help manufacturers and regulators identify potential concerns before products enter wider use. 

However, products are ultimately used in real-world settings, where factors such as consumer behaviour, product preferences and patterns of use can all influence outcomes. Understanding these variables is becoming increasingly important as researchers seek to develop a more complete picture of how NGP perform throughout their lifecycles.

As a result, scientific assessment is increasingly moving beyond individual studies towards more integrated approaches that combine laboratory science, behavioural research and post-market evidence generation. Together, these different evidence streams help build a more comprehensive understanding of product performance and potential impact over time.

The framework spans six complementary areas of research: product characterisation, biological science, clinical studies, behavioural science, computational science and post-market surveillance

This growing emphasis on lifecycle evidence generation has led to the development of multidisciplinary SAFs that bring together multiple sources of evidence to better holistically understand product performance, consumer use and potential public health impact. 

A broader evidence base

To support this more holistic approach to scientific assessment, following a robust SAF is a must. Designed to evaluate the NGP throughout their lifecycles, the framework brings together multiple scientific disciplines to build a broader understanding of product quality, consumer use and tobacco harm reduction potential relative to combustible cigarettes.

The framework spans six complementary areas of research: product characterisation, biological science, clinical studies, behavioural science, computational science and post-market surveillance. Together, these disciplines enable researchers to assess products from multiple perspectives, generating evidence that extends from laboratory testing through to real-world use.

This multidisciplinary approach is important because no single study can provide a complete picture of product performance or potential THR impact. Analytical chemistry may identify the presence of specific compounds, while toxicological studies help assess biological effects under controlled conditions. Clinical studies can provide insight into consumer exposure and product acceptance, while behavioural research and post-market surveillance help researchers understand how products are actually used once they reach consumers.

By combining these different forms of evidence, researchers can begin to build a more comprehensive understanding of NGP and validate findings across multiple scientific disciplines. Rather than relying on any one dataset, conclusions are informed by the cumulative weight-of-evidence generated throughout the assessment process. 

This weight-of-evidence approach is increasingly important when evaluating products that continue to evolve over time. As new technologies emerge, consumer behaviours change and additional scientific data becomes available, evidence can be incorporated into the framework to continually strengthen understanding and support ongoing product assessment.

How lab science is evolving

The shift towards NGP has also transformed the role of the research laboratory. While traditional tobacco testing focused primarily on combustible products, modern laboratories are now required to assess a growing range of technologies, including vapes, heated tobacco products and nicotine pouches, each presenting their own analytical and toxicological challenges.

To support this transition, laboratory capabilities have expanded significantly. As product technologies continue to evolve, laboratories must generate robust scientific and ensure testing methodologies remain capable of accurately assessing increasingly sophisticated devices and aerosol systems.

Traditional tobacco testing focused primarily on combustible products, modern laboratories are now required to assess a growing range of technologies... each presenting their own analytical and toxicological challenges

One example is the development of the Smoke/Aerosol Exposure In-Vitro System 2 (SAEIVS2), a purpose-built platform designed to support more advanced testing of NGP. Unlike systems originally developed for combustible cigarettes, SAEIVS2 was specifically designed to capture and assess aerosols generated by modern nicotine products. The system offers improved aerosol collection efficiency and increased testing capacity, helping researchers generate high-quality in-vitro exposure data that better reflects contemporary product designs.

Alongside advances in testing equipment, toxicological assessment methods are also evolving. While stabiles assays such as AMES, in-vitro mammalian cell assays and Neutral Red Update testing remain important tools, researchers are increasingly adopting more human-relevant approaches to better understand biological responses to product exposure. This shift reflects a broader movement within toxicology following the U.S. National Research Council’s Toxicity Testing in the 21^st Century framework, which advocates the use of mechanistic, human-relevant methods to improve the prediction of biological responses while reducing reliance on animal testing.

These newer methodologies include 3D airway tissue models, air-liquid interface exposure systems, organ-on-a-chip platforms and high-throughput screening technologies. By recreating aspects of human physiology more accurately than traditional laboratory models, these approaches can provide greater mechanistic insight into how biological systems respond to exposure while supporting more predictive assessments of product impact.

For researchers assessing NGP, such techniques offer the opportunity to better understand potential biological responses at a cellular level and generate evidence that complements established toxicological testing. They also form part of a broader weight-of-evidence approach, helping scientists evaluate potential long-term health effects in situations where epidemiological data may not yet be available.

The continued evolution of laboratory science is therefore helping to build a more comprehensive picture of product performance and potential impact. Combined with advances in analytical chemistry, aerosol science and computational modelling, these emerging technologies are providing researchers with increasingly sophisticated tools to assess NGP and support evidence-based decision-making.

Beyond the lab

While laboratory science remains fundamental to product assessment, understanding how products are used outside controlled environments is equally important. Clinical studies, behavioural research and post-market monitoring all contribute valuable insights that cannot be generated through laboratory testing alone. 

Clinical studies provide an opportunity to assess product performance, tolerability and consumer acceptance under more realistic conditions. They can also help researchers understand changes in exposure to harmful chemicals when adult smokers switch from combustible cigarettes to alternative nicotine products.

Behavioural science adds another important dimension by exploring how consumers interact with products in their daily lives. Factors such as product preferences, usage patterns and adoption rates can all influence outcomes and provide valuable context for laboratory findings. These studies can also help identify whether products are appealing to their intended audience of adult smokers and existing nicotine consumers.

Once products enter the market, evidence generation continues. Post-market surveillance enables researchers to monitor product quality, track emerging trends and review any reported consumer complaints or adverse events. Together, these activities help ensure that scientific understanding continues to develop throughout product lifecycles and that new information can be incorporated into future assessments.

The challenge facing researchers is understanding how different forms of evidence fit together. Analytical testing, toxicology, clinical research, behavioural science and post-market monitoring each provide valuable perspectives, but no single discipline can answer every question relating to product performance or potential public health impact.

This is why multidisciplinary assessment frameworks are increasingly important. By combining findings from multiple scientific disciplines, researchers can validate observations across different study types and build a broader understanding of how products perform under both controlled and real-world conditions.

Pic: Sierra Alpha Juliet

Thomas Nahde is head of harm reduction & engagement at Imperial Brands Science