Using science to build A Better Tomorrow™
Robust science is essential if reduced-risk products* are to fully contribute to tobacco harm reduction.
We never stand still. We are always innovating, experimenting, and delivering new Tobacco Harm Reduction solutions. This is why our Research and Development is so important to the business, accelerating pioneering approaches to scientific innovation.
Demonstrating the reduced-risk status, compared to smoking, of non-combustible products can only be achieved through science.
It’s why we invest almost £350 million a year to find innovative new ways to contribute to Tobacco Harm Reduction, and aim to have 50 million consumers of our non-combustible products by 2030.The main focus of this investment is in our RRPs*†.
Testing our products: our nine-step risk assessment framework
As alternative tobacco and nicotine products are relatively new to the market, they lack the long-term epidemiological data, observed over many years, that could show the overall impact on public health. That is why it’s necessary to take a weight of evidence approach, using the best available data to draw conclusions.
Using the work of the U.S. Institute of Medicine, BAT developed a nine-step scientific assessment framework. The framework evaluates the emissions, exposure and risk of our New Category products and compares them to smoking cigarettes or other comparators, such as nicotine replacement therapy.
The graph shows the weight of importance of each of the steps in demonstrating the reduced-risk*† potential of the alternative tobacco and nicotine products.
Using this framework, our scientists have conducted and published more than 210 peer-reviewed studies on our New Category products assessing different aspects. In addition to our own research, our scientists are constantly monitor and review external publications to ensure they have a holistic view of the evidence base.
A weight of evidence approach to assess risk
To further consumer choice, we have three New Categories – Vapour Products, Tobacco Heating Products and Modern Oral Products. All adhere to strict product quality standards, undergoing thousands of hours of testing before they reach the consumer.
3. Toxicological studies
6. Clinical: Exposure
9. Epidemiological modelling
3. Toxicological studies
6. Clinical: Exposure
9. Epidemiological modelling
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.
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.
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.
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.
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.
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.
It’s our job to demonstrate the positive effects our research can have. We place great value on robust, evidence-based and independent scientific findings and we think our science should be judged on its merits.
There are several myths around tobacco and nicotine products that only science can help to dispel. For example, it’s now widely acknowledged that it’s largely the toxicants in tobacco smoke which cause the majority of smoking-related disease – and not the nicotine in tobacco.
We are working to develop reduced-risk* products and to secure the support of public health professionals and regulators as we bring them to market.
Tobacco companies, scientists and regulators need to work together to ensure a science-based approach to assessing new products that potentially pose less risk than conventional cigarettes. This will provide consumers with the assurance that the product information they receive is based on sound, evidence-based science and allow them to make an informed choice based on the risk profile of different products.
We do not routinely test our ingredients or products on animals. We have invested many years in the research and development of suitable alternatives aimed at developing non-animal based in vitro tests within our research centres and with external research organisations.
The vast majority of our assessments relies on scientific literature, chemical analyses and/or by using in vitro techniques including human 3D tissues, systems biology and cutting edge robotics. Where there is no recognised alternative, animal testing may be necessary to meet safety, legal and / or regulatory requirements.
We have received recognition from the PETA International Science Consortium Ltd for our significant contribution to help advance non-animal testing.
* Based on the weight of evidence and assuming a complete switch from cigarette smoking. These products are not risk free and are addictive.
† Our Vapour product Vuse (including Alto, Solo, Ciro and Vibe), and certain products, including Velo, Grizzly, Kodiak, and Camel Snus, which are sold in the U.S., are subject to FDA regulation and no reduced-risk claims will be made as to these products without agency clearance.