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Emissions

Combustion studies

These are designed to investigate whether an alternative product functions in the predicted manner. For inhaled products, studies analyse whether or not combustion takes place, as combustion causes the majority of toxicants in cigarette smoke.

Emissions studies

These laboratory studies measure the identities and levels of toxicants present in the emissions from an alternative product and compare them with those of a reference cigarette or other comparator products.

Toxicological studies

These laboratory studies assess the possible adverse effects of products’ emissions on cells and compares them to effects of a reference cigarette or other comparator products. These studies use assays and endpoints defined by regulators or identified in the literature, such as cytotoxicity and mutagenicity, to assess potential cell damage, as well as toxicological studies that assess pathways of diseases. These studies may also assess the composition, concentration, and possible toxicological effects of a products’ environmental emissions.

Exposure

Use behaviour

These are human studies that examine adult consumer behaviour and help us understand how they use the products. This information helps assess users’ exposure to product emissions and also informs the design of our laboratory and clinical studies, which aim to mimic actual usage patterns.

Clinical: Pharmacokinetic (PK) studies

These are short-term human studies where volunteers have their blood sampled to assess nicotine levels, before, during and after product use.

Clinical: Exposure

These are human studies where volunteers stay in a clinic for a defined period of days during which one portion of volunteers continue to smoke, another portion switches completely to an alternative product and a third portion quit using tobacco and nicotine entirely. Blood, urine and/or breath are tested for biomarker levels to indicate exposure to certain toxicants.

Risk

Clinical individual risk

These are medium-term studies of 6 months to a year duration. The purpose of these studies is to assess whether any toxicant exposure reductions found in short-term studies are maintained over a longer period and also to evaluate any changes in biomarkers of biological effect (chemicals in blood, urine and/or breath) linked to disease pathways, also known as biomarkers of potential harm. These studies compare data from subjects who continue to smoke with data from people who have switched completely to the alternative product being studied, who have stopped smoking altogether or are never-smokers.

Populations risk (Post-marketing surveillance)

These studies survey a defined population (including smokers, former smokers and never-smokers) to estimate the population-wide effects of the introduction to the market of a new tobacco or nicotine product. The natural consumption behaviour of a population over time is monitored to understand potential effects relevant to tobacco harm reduction.

Epidemiological modelling data

Using available health and consumer behaviour data from previous years, algorithmic models are developed to predict the possible public health impact of the introduction of particular alternative products to the market using a variety of assumptions (based on the previous eight steps of the framework) to map out likely scenarios.

Long-term: Epidemiological data

The key to understanding consumer use and public health impact of alternative products is epidemiological data, which can only be gathered over the long-term i.e., several decades in the case of Snus usage in Sweden. These types of studies determine human health risks using large populations and help to show how these change over time, whether due to regulatory interventions, introduction of new products or shifts in consumer behaviour.

For substantiation of the potential for significant tobacco harm reduction, the most compelling evidence that currently exists is from Sweden where males have the lowest rates of smoking in Europe, as over 66% of former smokers have switched to the oral smokeless product Snus. Based on availability of robust long-term data scientists have been able to track disease rates on a yearly basis and today Sweden has the lowest incidence of lung cancer in the whole of the EU1.