Assessing Risk with Scientific Rigor
The multi-targeted scientific studies are designed specifically to assess the risk profile of our new category products
Measuring the Impact of Menthol and Tobacco-Flavored Vapor Product Use on Cigarette Smoking Cessation and Reductions
We know that sustained and lasting changes to adult consumer behavior offer the greatest hope for making cigarettes obsolete, and we believe that providing viable alternatives to smoking is in the public interest. Reynolds initiated a 24-month study, termed the Longitudinal Tobacco Use and Transitions Survey (LTTS), in support of the Company’s Pre-Market Tobacco Product Application (PMTA) for Vuse Alto. The aim of this study is to measure the impact of Vuse vapor products on specific adult populations in the U.S., specifically the decline or elimination of cigarette use when adult smokers who do not wish to quit switch to Vuse. In the video to the right, Dr. James Murphy, Global Director, Research & Science and Dr. Chris Junker, Vice President, Science & Regulatory Affairs, provide an overview of the study’s importance and interim results. Read more about the survey by clicking on the arrow below.
A weight of evidence approach
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to assess risk
Putting Our Science to Test
We use rigorous, multi-targeted scientific studies to assess emissions, exposure, and the risks of our products. This unique framework builds a comprehensive set of scientific evidence and a more holistic picture of tobacco products.
01 Emission Studies
The combustion of tobacco in cigarettes at temperatures of around 900oC generate smoke toxicants. A series of analytical techniques is used to assess if combustion occurs in our new category products.
The analytical laboratories at our Bowman Gray Technical Center focus on the emissions studies for our products, measuring the identities and levels of toxicants present in the emissions from a new category product and comparing the results with those of a reference combustible cigarette or other comparator products. Our capabilities and technologies include chromatography, spectroscopy, mass spectrometry, microscopy, physical testing, microbiological testing, and materials characterization.
Our Nonclinical Studies group assesses the potentially toxic or other disease-relevant biological harms of a product’s emissions through a variety of standardized historical and contemporary cell- or tissue-based test methods. To do this, living cells (or tissue) are exposed to tobacco product emissions or extractions and then assessed for signs of damage, cell death, or changes in cellular/molecular biological activity associated with tobacco-related disease in humans. Such endpoints are often compared across product categories or to historical products to demonstrate a scientific basis for risk differentiation.
02 Exposure Studies
Our Clinical Studies group conducts clinical studies with current adult tobacco consumers to understand how consumers use the product and how often they use it. This information helps assess users’ exposure to product emissions and informs the design of our laboratory and clinical studies, which aim to mimic actual usage patterns.
Clinical: Pharmacokinetic (PK) studies
These studies involve sampling blood of adult tobacco consumers to understand nicotine pharmacokinetics and metabolism before, during, and after product use.
These adult tobacco consumer studies examine exposure to toxicants by measuring biomarker levels in smokers who switch to new category products in comparison to smokers who continue to smoke and smokers who quit. Biomarkers that indicate product exposure to certain toxicants are measured in the user’s urine and bloodstream. We also gather data to understand if the user experienced negative side effects due to the product’s use.
03 Risk Studies
Clinical: Individual risk
These are medium-term studies of 6 months to a year duration. In a similar manner to exposure studies, these adult tobacco consumer studies measure biomarker levels in smokers who switch to new category products in comparison to smokers who continue to smoke and smokers who quit. 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 biomarkers of potential harm. We also gather data to understand if the user experienced negative side effects due to the product’s use in these longer clinical studies
Population risk (Post Market Surveillance)
The natural consumption behavior of a population over time is monitored to understand potential effects relevant to tobacco harm reduction. Post-marketing surveillance is a part of the PMTA process once FDA issues marketing authorization for a new tobacco product.
Epidemiological modelling data
Our Population Effect group estimates population health effects that may result from the market authorization of a new product using statistical population modeling. We have developed and validated a modeling tool to assess a wide range of scenarios that consider potential benefits and harms from changes in tobacco use patterns resulting from the availability of alternative products.1,2 For example, we can investigate if there is a potential survival benefit in groups whose health would be improved by using the new product (such as smokers who switch to the new product instead of continuing to smoke) versus the risk of never- and former smokers adopting the new product. These types of studies evaluate human health risks using large populations and help to show how these risks change over time, whether due to regulatory interventions, introduction of new products or shifts in consumer behavior.
1 Bachand, A. M., & Sulsky, S. I. (2013). A dynamic population model for estimating all-cause mortality due to lifetime exposure history. Regulatory Toxicology and Pharmacology, 67(2), 246–251.
2 Bachand, A. M., Sulsky, S. I., & Curtin, G. M. (2018). Assessing the likelihood and magnitude of a population health benefit following the market introduction of a modified-risk tobacco product: Enhancements to the Dynamic Population Modeler, DPM(+1). Risk Analysis: An Official Publication of the Society for Risk Analysis, 38(1), 151–162.
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