ORIGINAL RESEARCH article
Front. Toxicol.
Sec. Regulatory Toxicology
Volume 7 - 2025 | doi: 10.3389/ftox.2025.1589480
Assessment of a Heated Herbal Product's Tobacco Harm Reduction Potential: Pre-Clinical and Clinical Studies
Provisionally accepted
Álvaro Marinas-Lacasta1
Ian M Fearon2
Matthew Stevenson1*
Tasnim Abusalem1
Fiona Chapman1Edgar Trelles-Sticken3Roman Wieczorek3Sarah Jean Pour3Ole Dethloff3
Ourania Komini1Mike Brown1Liam Simms1Thomas Nahde3- 1Imperial Brands PLC, Bristol, United Kingdom
- 2whatIF? Consulting Ltd, Harwell, United Kingdom
- 3Reemtsma Cigarettenfabriken GmbH, Hamburg, Hamburg, Germany
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Data from pre-clinical and clinical studies form part of an integrated assessment of the tobacco harm reduction (THR) potential of novel products which may act as cigarette alternatives for adult smokers. We report data from pre-clinical (emissions chemistry and in vitro toxicology) and clinical (nicotine pharmacokinetics and subjective effects) studies conducted with the iSENZIA™ heated herbal system (HHS; PULZE ™ 2.0 device with iSENZIA™ sticks), which utilises electronic heating of a tea-based substrate to generate an inhalable nicotine-containing aerosol. The aerosols from the iSENZIA™ HHS contained significantly lower levels, by up to 99.9%, of the nine World Health Organization Study Group on Tobacco Product Regulation (WHO TobReg) analytes compared with 1R6F reference cigarette smoke, and elicited significantly lower in vitro cytotoxicity, genotoxicity and mutagenicity responses. The clinical study demonstrated that the iSENZIA™ HHS delivers satisfactory levels of nicotine to users and has lower abuse liability than cigarettes. Overall, our data suggest that iSENZIA™ has the potential to offer substantially reduced toxicant exposure, as well as a reduction in toxicity, compared to cigarettes, whilst delivering satisfactory levels of nicotine. These findings support the THR potential of the iSENZIA™ HHS as a reduced risk, acceptable alternative product for adult smokers.
Keywords: cigarette smoking, Tobacco harm reduction, heated herbal product, Analytical Chemistry, Toxicology, abuse liability
Received: 12 Mar 2025; Accepted: 20 Jun 2025.
Copyright: © 2025 Marinas-Lacasta, Fearon, Stevenson, Abusalem, Chapman, Trelles-Sticken, Wieczorek, Pour, Dethloff, Komini, Brown, Simms and Nahde. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Matthew Stevenson, Imperial Brands PLC, Bristol, United Kingdom
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.