Use Behaviour and Pharmacokinetic Studies
Through laboratory tests we understand that the emissions of our Smokeless Products are simpler than cigarette smoke and proven to be less toxic. However, it is important that we understand how adult consumers may use our products to confirm they do not use them in a manner that offsets these reductions. To understand consumer use behaviour we carry out studies that assess the following five criteria:
“Our ‘use behaviour’ studies indicate that adult consumers use our Smokeless Products in ways which are consistent with emissions generated under laboratory conditions. These findings provide confidence that reductions in emissions versus cigarettes will also be reflected in clinical biomarkers of exposure.”
Dr Chris Junker
Group Head of Life Sciences
01 Puffing Topography
The puffing behaviours of our Heated Product and Vapour Product adult consumers have identified differences and similarities to how adult consumers use cigarettes[39],[82],[83],[84]. Our Heated Product adult consumers are reported to take bigger and more frequent puffs. Our data shows that our Vapour Product adult consumers use the product in a similar manner to cigarettes when considering puff volume. Overall, puffing topography data for Heated Products and Vapour Products clarify how adult consumers use our products; however, we need MLE, PK and ADC data to obtain a more complete picture.
02 Mouth Hold Time
For mouth hold time, our benchmark is Oral Tobacco Products, e.g. snus, because of their history of significant use and epidemiological data showing reduced risk*† of smoking-related disease compared to smoking. Average data for our Oral Nicotine Pouches show that adult consumers hold these in the mouth for less than the time of an Oral Tobacco Product consumer[85]. Mouth hold time varies between consumers in different markets, for example data in a more mature oral product market like Sweden demonstrates a higher average mouth hold time compared to a more nascent market such as Denmark[38].
03 Mouth Level Exposure/Transfer
Our puffing topography and mouth hold time studies also afford us the opportunity to gather data on potential consumer exposure to certain chemicals. Optical and gravimetric measurements of the aerosol and products, respectively, allows for the estimation of how much nicotine has been consumed during use[39],[86],[87],[88]. Measuring estimated nicotine consumption of our Smokeless Products is important as it provides the opportunity to compare these values to cigarette data. For our Smokeless Products to be effective alternatives to smoking they need to deliver satisfactory levels of nicotine.
Overall, while there is large individual variability, our data for mouth level exposure/ transfer gives us confidence that adult smokers can receive levels of nicotine comparable to smoking.
04 Pharmacokinetic Studies
Inclusive of lab-based studies, we conduct controlled clinical pharmacokinetic (PK) studies to understand the speed and amount of nicotine uptake into the consumer’s bloodstream. Our studies have shown that for our Heated Products and Vapour Products, the timing of the peak nicotine concentration in the blood is comparable to cigarette smoking (Figure 1)[89],[90]. This peak timing is important as it shows that, through using either a Heated Product or Vapour Product, that the nicotine experience for a smoker should be familiar.
Our Oral Tobacco Products and Oral Nicotine Pouches have different nicotine PK profiles compared to cigarettes (Figure 2). Driven by the different mode of absorption (buccal mucosa vs. lung), the time taken to reach maximum nicotine blood concentration for our Oral Products is slower than a cigarette[91]. This slower nicotine peak delivery for Oral Products provides adult smokers with an unfamiliar initial experience compared to cigarettes. Overall, the unfamiliar nicotine experience of Oral Products can still offer adult smokers an acceptable alternative to cigarettes, as shown by countries such as Sweden.
Figure 1. Pharmacokinetic Profiles - Inhalable (Cigarettes, Heated Product and Vapour Product)
Figure 2. Pharmacokinetic Profiles - Oral (Nicotine Pouch, Tobacco - Loose and Tobacco - Pouch)
05 Actual Use and Average Daily Consumption
Our final method in understanding consumer use is to conduct an “actual use” home study[93]. Typically, a six-week study that lets adult smokers use our Smokeless Products in their real-life/home environment. During these studies participants record daily data, which includes how much of the product they use. This data allows us to understand a consumer’s average daily consumption of our Smokeless Product, which we compare to their previously reported smoking use.
Footnotes
^The Vapour Product’s study had a fixed number of 10 puffs.
^^Per puff data multiplied by average cigarette puff number for direct Vapour Product versus cigarette comparison.
^^^ Equivalent to 4.8±3.7mg of estimated nicotine consumption. Cigarette daily estimated nicotine consumption is 20.9±12.3mg.
* Based on the weight of evidence and assuming a complete switch from cigarette smoking. These products are not risk free and are addictive.
† Products sold in the U.S., including Vuse, Velo, Grizzly, Kodiak, and Camel Snus, are subject to FDA regulation and no reduced-risk claims will be made as to these products without agency clearance.
References
A full list of references for this page can be found in the section 11. References.
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