There has been a growing interest in the non-combustible tobacco products, including e-cigarettes and heated tobacco products. Reductions in biomarkers of exposure associated with selected harmful and potentially harmful constituents (HPHCs) have been reported in adult smokers when switching from conventional cigarettes (CC) to non-combustible tobacco products.

We conducted a clinical study with two types of non-combustible tobacco products. Test products were a cig-a-like e-cigarette (eDNC1.0a) with three different flavour variants and a novel heated tobacco product (IT2.0b) with three different flavour variants. This study was a multi-centre, randomized, open-label, controlled, 8-arm parallel-group study conducted in U.S. healthy adult smokers who either 1) continued to smoke CC, 2) switched to each flavour variant of eDNC1.0a, 3) switched to each flavour variant of IT2.0b, or 4) stopped smoking for 60 days. The objectives of the study were to investigate the reduction in exposure to selected HPHCs when smokers switched to the various eDNC1.0a and IT2.0b flavour variants and to characterize nicotine uptake relative to CC over a 60-day period with 5-day confinement and 55-day ambulatory conditions.

485 subjects were randomized to the study and used the assigned products or stopped smoking. 361 subjects completed the study. Following 60-day switching, statistically significantly lower values for most measured BoE were observed for the eDNC1.0a and IT2.0b groups compared to the CC group. No marked differences were noted for most BoE measured as compared to the cessation group.