The FDA Center for Tobacco Products recommends assessment of the public health impact of new tobacco products, either in a simulated use setting or a real-world environment, to understand how U.S. adult consumers actually use the products. We designed a multi-site, open-label, 8-week, prospective observational study, conducted at sites geographically dispersed within the U.S. Adult tobacco consumers between 21 and 60 years of age who are regular smokers of at least 5 cigarettes per day are provided the Study IP for ad libitum use over a 6-week Actual Use Period (AUP) in their real-life environments. The study consists of a pre-screening period, a screening/enrollment visit (SEV), a 1-week baseline assessment period (BAP), a 6-week AUP, and a 1-week close-out period (COP). At SEV, participants review the Study IP, and those who indicate an intention to use the Study IP are consented and enrolled. Participants complete interviewer-led surveys on subjective ratings and future use intentions during four site visits. Participants are allowed to select Study IP for use at home during site visit 1 and are resupplied at subsequent site visits. Participants self-report their daily use of all combustible cigarettes (CC) and any other tobacco and nicotine product (TNP) use during BAP. Study IP use, as well as the use of CCs and any other TNPs during the AUP, are collected with an eDiary via a smartphone app. Study IP use and eDiary data collection are stopped at the end of the AUP. Adverse health experiences are collected through passive surveillance via a hotline throughout the study. In AU studies we have conducted to date, target recruitment was achieved with low attrition, and eDiary compliance was high.