Discussion
criticality
This study examined factors related to AL as well as likelihood of use for two tobacco-flavored ENDS products (Vuse Ciro [1.5% nicotine] and Vuse Vibe [3.0% nicotine]) in current smokers. Similar to previous studies of other ENDS, the results indicate that Vuse Ciro and Vuse Vibe have AL profiles below that of combustible cigarettes and either similar to or slightly higher than nicotine gum. After a single 10-min ad libitum use, a time frame selected to be consistent with previous AL studiesNicotine uptake in the first 15 min after the start of product use was significantly higher and the median TThe maximum and overall nicotine uptake after using Vuse Vibe and Vuse Ciro was similar to after use of nicotine gum. Notably, overall nicotine uptake after use of Vuse Ciro was statistically significantly lower than after use of nicotine gum. Despite the similar (or lower) maximum and overall nicotine uptake for the ENDS products compared to nicotine gum, faster nicotine uptake and higher scores for product liking and intent to use again support the conclusion that Vuse Vibe and Vuse Ciro have a sufficient nicotine pharmacokinetic profile to support continued use and higher overall positive subjective effects profile supporting product use than nicotine gum. From a tobacco harm reduction perspective, this may increase the likelihood of product use and switching compared to nicotine gum in current smokersThe FDA has acknowledged the criticality of information related to the nicotine pharmacological profiles of new tobacco and nicotine-containing productsThe study had several strengths as well as limitations. Among its strengths, the study design included product acclimation sessions for familiarization with use of the product prior to the test sessions in which the PK, subjective measures, and physiological effects endpoints were assessed. The short 10-min test session use periods after compulsory nicotine abstention periods and the ad libitum puffing patterns more accurately represent ‘real-life’ nicotine uptake than would prescribed usage or initial product use without any prior experienceThe evidence demonstrated highest positive subjective effects measures scores for cigarettes, followed by the Vuse ENDS, and nicotine gum with the lowest scores. All nicotine uptake measures for the Vuse ENDS products were lower than that of UB cigarette, including peak nicotine uptake and overall nicotine uptake. These same measures for Vuse ENDS were either similar to or lower than nicotine gum, and the time course of nicotine uptake after use of the ENDS was more similar to that of combustible cigarettes than nicotine gum. In conclusion, the results indicate that the AL of each Vuse ENDS product tested is substantially lower than that of UB cigarettes and similar to that of nicotine gum.