13 December 2022
- Study shows Velo consumers had significantly better results for several indicators linked to smoking-related diseases compared with smokers
- Results provide important new data and insights into the real-world health impact that underscores the Tobacco Harm Reduction potential of oral nicotine pouches
- Study adds to the weight of evidence that supports Velo as a reduced-risk* product for smokers who completely switch from smoking
- Results reinforce BAT’s ability to deliver A Better Tomorrow™ by reducing the health impact of its business
New results from an innovative cross-sectional clinical study of Veloi, BAT’s flagship modern oral nicotine pouch product, have been published today in Biomarkers Journal . In the study, consumers exclusively using Velo for over six months had significant favourable differences in several biomarkers of exposure and biomarkers of potential harm relevant to smoking-related diseases compared to the adults who smoked.
The results showed that the levels for the biomarkers of exposure, based on priority toxicants as defined by the WHOii, were substantially lower in Velo consumers compared with smokers. The data also showed favourable differences between the Velo consumers and smokers in the majority of the biomarkers of potential harm, with four achieving statistical significance, and the others having similar levels across the Velo consumers, former and never smoker groups.
The study provides important new data and insights into the real-world health impact in Velo consumers compared to smokers, former smokers and never smokers. A single set of samples of blood, urine and other clinical measurements was tested for certain toxicants and a range of biomarkers thought to be linked to the development of diseases such as cancer and cardiovascular disease (CVD).
Dr David O’Reilly, Director, Scientific Research at BAT, said: “These results are very important for Velo and the modern oral nicotine product category. They build on the extensive scientific evidence, including epidemiological data, that already exists for oral tobacco and add to the weight of evidence that supports our belief that Velo is a reduced-risk*† product for smokers who completely switch from cigarettes as compared to continued smoking. We have already generated data that shows Velo has a toxicant profile better than snus and comparable to Nicotine Replacement Therapy (NRT)iii. These results add further evidence that supports the important contribution Velo can make to Tobacco Harm Reduction.
“I’d like to thank everyone who participated and helped deliver this study. It is another important step forward in our journey to building A Better Tomorrow.”
Based on the biomarkers measured, compared to smokers, Velo consumers who had been using the product exclusively showed:
- Significantly lower levels in biomarkers of exposure to priority tobacco toxicants
- Significant favourable differences in a biomarker of potential harm relevant to lung cancer risk
- Significant favourable differences in a number of biomarkers of potential harm relevant to cardiovascular disease
- Significant favourable differences in a biomarker of potential harm relevant to general inflammation
For the biomarkers that showed no significant difference between the Velo consumers and smokers, similar levels were observed between the Velo and former and never smoker groups.
About the study
The study included participants who had been using Velo exclusively for over six months, as well as current smokers, former smokers and never smokers. For the Velo consumers and current cigarette smokers, usage patterns and overall consumption were not controlled under the study protocol as the aim was to assess the impact among people using the products in their ‘normal’ way rather than in a controlled way. Four different groups were enrolled and studied.
- Current smokers who had been smoking 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, to indicate whether or not they had smoked cigarettes during the preceding six months.
* 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 agency clearance.
This press release is not intended as a piece of promotional material for any products, very notably in the US where claims of a certain type are subject to FDA clearance. This update relates to new scientific data and is not aimed at a specific market. It is intended to provide further scientific evidence to underpin our products.
- The study was conducted using Lyft, since re-branded as Velo.
- WHO Study Group on Tobacco Regulation. Report on the Scientific Basis of Tobacco Product Regulation: Fifth Report of a WHO Study Group. 2015.
- 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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