13 October 2022
- New study designed to identify differences in important early indicators associated with smoking-related disease between Velo users and smokers
- Results will provide important new data and insights about Velo and its role in facilitating tobacco harm reduction
- Demonstrates BAT’s focus on science and innovation to deliver A Better Tomorrow™ and reduce the health impact of its business
BAT has conducted an innovative cross-sectional clinical study of Veloi, which is designed to provide new insights into the real-world health impact of its modern oral nicotine pouch product compared to smoking. Protocol details explaining the design have been published in the journal JMIR Research Protocols .
The study evaluates exposure to certain toxicants and early indicators associated with smoking-related disease in people who have been exclusively using Velo for over six months and compares them with groups of smokers, former smokers, and never-smokers.
Watch the animation below to learn more about the study:
The biomarkers selected are important indicators that include:
- Biomarkers of Exposure: a person’s exposure to certain toxicants or chemicalsii
- Biomarkers of Potential Harm: indicators of potential harm related to several smoking-related diseases, such as respiratory or cardiovascular disease
It is hoped that the results, which are currently being analysed and will be published by the end of the year, will provide further supportive evidence that using Velo may reduce relative risk for certain diseases among adult consumers compared to smoking. These data would add to the growing body of evidence demonstrating Velo’s potential as a reduced-risk product.*†
Watch an interview with Dr Sharon Goodall, BAT’s Head of Regulatory Science, who talks about the significance of the study and why it is so important:
Dr Sharon Goodall, BAT’s Group Head of Regulatory Sciences, said: “Modern oral nicotine pouches are an exciting product category, which build upon the extensive scientific evidence available for snus, but are designed to offer adult consumers an improved, tobacco-free reduced-risk alternative. We have already generated data that shows Velo has a toxicant profile better than snus and is comparable to Nicotine Replacement Therapy (NRT)iii. However, we wanted to generate further evidence to demonstrate the important contribution it can make to tobacco harm reduction. I believe the results of this study will provide important new information and we look forward to sharing them once available.”
About the study
The study includes participants who have been using Velo exclusively for over six months, as well as current smokers, former smokers and never-smokers. For the Velo users and current cigarette smokers, usage patterns and overall consumption were not controlled whilst in the clinic as the aim was to assess the impact among people using the products in their ‘normal’ way rather than in a controlled manner. Four different groups were enrolled and studied.
- Current smokers who had been smoking at least 10 cigarettes per day for at least one year prior to screening
- Exclusive Velo consumers for at least six months
- Former smokers who had quit for at least six months
- Never smokers
Participants were based in Denmark and Sweden, aged between 19-55 years old, and in good general health.
Unlike longitudinal studies where participants attend multiple clinic visits over an extended period of time, participants in this study made a single clinic visit where samples of blood, urine and breath were collected, and other clinical measurements were performed. These samples and measurements were then assessed for “Biomarkers of Exposure” (to selected toxicants) and “Biomarkers of Potential Harm”. Differences in the biomarker levels between the groups were compared and analysed.
In addition, to ensure compliance with reported product usage, the Velo and former smoker groups were tested for the biomarker, CEVal, and the exploratory biomarkers anatabine and anabasine, to indicate whether or not they had smoked cigarettes during the preceding six months.
Results from the completed study will be published by the end of the year.
* Based on the weight of evidence and assuming a complete switch from cigarette smoking. These products are not risk free and are addictive.
† Our products as sold in the US, including Vuse, Velo, Grizzly, Kodiak, and Camel Snus, are subject to Food and Drug Administration (FDA) regulation and no reduced-risk claims will be made as to these products without FDA clearance.
i The study was conducted using Lyft, since re-branded as Velo.
ii WHO Study Group on Tobacco Regulation. Report on the Scientific Basis of Tobacco Product Regulation: Fifth Report of a WHO Study Group. 2015.
iii David Azzopardi, Chuan Liu & James Murphy (2021) Chemical characterization of tobacco-free “modern” oral nicotine pouches and their position on the toxicant and risk continuums, Drug and Chemical Toxicology, DOI: 10.1080/01480545.2021.1925691
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NOTES TO EDITORS
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