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TSRC, Tob. Sci. Res. Conf., 2021, 74, abstr. 13

A 12 month stability study on JUUL Virginia tobacco flavored aerosols using a two non-targeted analytical methods

CROSSWHITE M.R.; JEONG L.N.; JAMESON B.; LIOUBOMIROV A.; YANGA C.; OZVALD A.; GILLMAN G.
JUUL Labs, Washington, DC, USA

Combustible cigarette (CC) smoking is the leading cause of preventable human death. The United States Food and Drug Administration (FDA) Family Smoking Prevention and Tobacco Control Act, protects public health by regulating the manufacturing, distribution, and marketing of tobacco products. Beyond the analysis of target compounds, the FDA Premarket Tobacco Product Application guidance recommends that applicants evaluate chemical changes over the product’s shelf-life. Samples were aged using International Conference on Harmonization’s climate zones III and IV long term conditions and aerosols were collected from three replicates, each from three production batches of JUUL Virginia Tobacco 5.0 % nicotine by weight (VT5) using intense and non-intense puffing conditions. The objectives of this study were to 1) thoroughly chemically characterize the aerosols over a 12-month stability study and monitor the changes in aerosol chemistry, and 2) compare the chemical complexity of aerosols to combustible cigarette smoke (CCS). Therefore, two non-targeted analytical methods were applied to initial aerosol (T=0); remaining samples were stored in their original packaging and aerosolized and analyzed at six months (T=6) and again at 12 months (T=12). Trends from T=0 through T=12 show an increase in the total number of compounds detected, from 91 rising to 114 and spanning approximately 0.2 % - 0.4 % of the total aerosol mass. There were 24 compounds formed comparing combined T=0 and T=6 results to T=12 results – which amounted to only 0.04 % by mass. After thoroughly evaluating VT5 for unique constituents it was observed that during the 12-month stability study there were only minimal chemical changes to the aerosols, and the chemical complexity increased with storage time, but remained approximately 35-fold less chemically complex than CCS.