OUR SCIENCE STORY

This stage of our NGP assessment covers a broad range of areas. It includes analysing our NGP to understand their specific chemical composition and stability, before comparing them to combusted cigarette smoke to demonstrate they contain fewer and lower levels of these harmful chemicals.

Further elements include ingredient analysis, device safety certification, indoor air quality studies (for those NGP that produce aerosols) and broader elements of product characterisation; for instance, demonstrating that our heated tobacco device does indeed heat – and not burn – tobacco.

As part of our holistic product stewardship, we also only use high-quality, high-purity ingredients and materials in our NGP. We conduct in-depth toxicological risk assessments on our NGP ingredients to ensure we’re meeting both regulatory expectations and our own duty of care obligations to safeguard consumers.

We build upon this assessment via assays that explore whether the reduced levels of harmful chemicals in our NGP translate directly to reduced in-vitro biological responses, and therefore potential reductions in smoking-related disease risk. Given that cigarette smoking is a cause of heart disease, lung cancer and emphysema in smokers, we focus on understanding the impact of our inhalable NGP on these smoking disease-related endpoints.

Our scientists use a mixture of recognised regulatory toxicology testing methods and cutting-edge techniques based on the US National Academy of Science’s innovative blueprint for Toxicity Testing in the 21st Century (TT21C), devised to help predict longer-term health outcomes in a humane way.

Our Alternatives to Animal Testing approach is endorsed by PETA Science and involves using human-relevant cells as a more ethical substitute for traditional in-vivo animal testing. This philosophy is consistent with our wider corporate position to not test our products on animals.

Human studies are conducted to understand how the reductions in harmful chemicals and cell toxicity measured in the laboratory translate in adult smokers when they use our NGP in a controlled clinical setting. We do this by measuring biomarkers of exposure to harmful chemicals in their blood and urine.

Our assessments also explore:

• How adult smoker subjects use our NGP, by analysing puffing behaviours.
• Whether our NGP have good safety profiles and are well tolerated.
• If our NGP offer a satisfying alternative to cigarettes by delivering nicotine efficiently to subjects’ bloodstreams (Pharmacokinetic, or PK, studies).
• Whether they reduce the desire to smoke/use nicotine (Pharmacodynamic, or PD, studies).

The results of these assessments help us to consider the abuse liability potential of our NGP and contribute to our understanding of the impact on individual and population health.

This stage of our assessment can be broken down into two subcategories: perceptions of our NGP, and actual NGP use.

• Perceptions: Here we aim to understand consumers’ – and non-consumers’ – main reasons for being interested in, and/or intending to use, our NGP; for example, to reduce the health risks associated with smoking.
• Actual Use: By understanding the in-market prevalence of NGP and conducting consumer switching studies to observe the behaviours of former adult smokers after they begin using our NGP, we aim to demonstrate our products are making a meaningful contribution to tobacco harm reduction by reducing and replacing cigarette smoking.

We also conduct research around packaging and labelling comprehension to confirm whether adult smokers and non-smokers properly understand our NGP contain nicotine and are not risk-free, as well as how to use the products and the audiences they are intended for.

This section of our framework employs sophisticated mathematical and computational modelling of the prevalence and wider potential population health impact of our NGP. Before launch, we base our models on perceptions and intentions to use data collected via our behavioural studies. Once NGP are in market, we refine these models by inputting actual product usage switching data.

This important real-life information reflecting rates of NGP initiation and usage, including reducing and replacing smoking, is crucial to evaluating the overall impact of our products on wider population health. We also feed these insights back into our innovation pipeline to continue to evolve our NGP to better appeal to adult smokers and increase product acceptance.

As a responsible manufacturer, our commitment to fully understanding consumer NGP usage, and monitoring all aspects of consumer safety, continues once products are in-market through a multifaceted surveillance programme.

Our processes ensure any consumer-reported adverse events associated with NGP usage are captured and assessed in accordance with relevant regulatory guidelines. These events are then monitored to allow the rapid identification of any potential safety trends or emerging issues.

We proactively monitor available medical and scientific literature, as well as publications by health authorities, around both our own – and wider category – products, that can potentially provide insight into adverse events, product usage and prevalence.

In addition to our safety surveillance methods, we’ll also perform additional scientific studies once NGP are in-market to mitigate any remaining gaps in the data, if required. All these activities underpin the longer-term assessment of our NGP.

We understand consumers demand the highest quality NGP, and continually assess our products. To build and maintain this vital trust, our rigorous product safety assessment ensures any potential safety risks related to NGP design, manufacture and usage are identified, quantified and resolved across their lifecycle.

The continuous, dynamic process involves a comprehensive review of the data generated across all stages of the SAF, including our Standard of Care testing, to ensure any potential risks have been mitigated – both before products appear in-market and post-launch.