Toxicant profile of BAT's modern oral products is comparable to nicotine replacement therapies

New research published today indicates that BAT's modern oral (MO) products in the form of tobacco-free nicotine pouches have a toxicant profile that is comparable to nicotine replacement therapies (NRTs) and much lower than traditional oral snus, a category of products that, when used as the sole nicotine product is already established as a reduced risk product compared with cigarettes.

The study, published in Drug and Chemical Toxicology, analysed four variants of one of BAT's MO nicotine pouch products Lyft+, three snus products, and two different NRT products in a lozenge and a gum format. Each of these products was tested for a range of known harmful and potentially harmful constituents (HPHCs).

The results showed that the MO products had a comparable toxicant profile to NRTs, which are currently considered to be the least risky of all nicotine products. The study also estimated that users of the studied MO products are likely to be exposed to far fewer and significantly lower levels of toxicants than those who use snus.

The findings suggest that MO products, such as Lyft and Velo, should be placed close to NRTs at the lowest exposure end of the nicotine product toxicant delivery continuum.

These results add to the growing body of evidence to support the reduced-risk potential of MO products compared to continuing to smoke."

Dr Aaron Williams, Head of Science, R&D

"They provide important new evidence to support the role of MO products in Tobacco Harm Reduction by demonstrating that they have far fewer and much lower levels of toxicants compared with cigarette smoke and even compared with Swedish-style snus, which is already well established as a reduced risk product when used as the sole nicotine product.

This means smokers looking for a alternative nicotine product have another alternative offering greatly reduced exposure to toxicants that comes in an oral format that some may find convenient and easy to use".

BAT is committed to building A Better TomorrowTM by reducing the health impact of its business through providing a range of enjoyable and lower risk products. The company continues to be clear that combustible cigarettes pose serious health risks, and the only way to avoid these risks is not to start or to quit. BAT encourages those who would otherwise continue to smoke, to switch completely to scientifically substantiated, reduced-risk alternatives.

This study is a part of a comprehensive programme of scientific research designed to assess the reduced-risk potential of non-combustible nicotine products as compared to conventional cigarettes and traditional oral tobacco products.

Study design

The products in the study were analysed for 24-26 compounds relevant to oral tobacco products, including known harmful and potentially harmful constituents (HPHCs) from the FDA smokeless tobacco reporting list, and the GothiaTek® Standard list of toxicants used to ensure the quality of snus products.

Also included were cigarette smoke toxicants (nine smoke constituents prioritised by the WHO's Tobacco Product Regulation Group, 'TobReg9', with the exception of carbon monoxide) not already included in the other lists.

For BAT's MO product, 22 of the 26 compounds tested were below measurable limits, with only moisture, nicotine, formaldehyde and chromium quantified at very low levels. Formaldehyde and chromium were present in some, but not all of the MO variants and only at extremely low levels.

From a toxicological perspective, these extremely low levels of formaldehyde (estimated to be 0.004 mg/day for MO users) are unlikely to cause concern, as typical food consumption levels for adults is between 1.5 and 14 mg/day .

For the NRT lozenge and gum, 22 and 20 of the 25 compounds were below measurable limits, with the others quantifiable at very low levels. In contrast, only 11 of the 24 compounds tested in the snus product were below measurable limits, whereas 13 compounds were present at quantifiable levels.

To evaluate the toxicant content of MO products in comparison to other tobacco and nicotine products on the risk continuum, we also reviewed the emissions data for 20 HPHCs from published studies of conventional cigarettes, a tobacco heating product (THP) and an e-cigarette.

Cigarette smoke contained significant levels of 18 of the 20 measured compounds, THP aerosol contained 12 compounds at quantifiable levels, while e-cigarette vapor contained 7 compounds at quantifiable levels. The MO product had quantifiable levels of only 3 of these 20 HPHCs.

On its own, the toxicant content of a product is insufficient to establish potential health risks to a consumer, so we estimated daily exposure to toxicants for the different products based on average daily consumption of the toxicant. These data indicate that compared with smoking cigarettes, using these MO products would lower daily exposure to 16 of the 18 toxicants, and snus would lower exposure to 10 of the 18 toxicants.

Based on the measured toxicant contents and daily exposure estimates, these data suggest that the studied MO nicotine pouch products would likely fall between snus and NRTs on the toxicant continuum, having substantially lower levels than cigarettes, THPs, snus and vapour products. MO products may therefore provide a lower toxicant-exposure source of nicotine for current smokers who seek a complete substitute for continued smoking.

The publication recognised the need for further research to be conducted to further expand the evidence base and the understanding of how MO products may contribute to Tobacco Harm Reduction.

Source:
Journal reference:

Azzopardi, D., et al. (2021) Chemical characterization of tobacco-free “modern” oral nicotine pouches and their position on the toxicant and risk continuums. Drug and Chemical Toxicology. doi.org/10.1080/01480545.2021.1925691.

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The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
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