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CORESTA Congress, Online, 2022, Smoke Science/Product Technology Groups, ST 36

A 12-month stability study on JUUL2 Virginia tobacco and crisp menthol flavoured aerosols using targeted analytical methods

COOK D.K.; JEONG L.N.; WANG J.; BATES A.L.; ULLAH S.; CARTER K.M.; SCHWARTZ V.
JUUL Labs, Inc., Washington, D.C., U.S.A.

The JUUL2® is a temperature-regulated, electronic nicotine delivery system (ENDS) designed to provide reduced-risk alternatives to adult smokers who would otherwise continue to smoke cigarettes. The JUUL2® System was launched within the United Kingdom in September 2021. The objective of this study was to characterize select chemicals and harmful and potentially harmful constituents (HPHCs) contained within the JUUL2® Virginia Tobacco and Crisp Menthol 18 mg/mL JUULpod aerosol over a 12-month period and to monitor resulting changes in chemistry and stability. Samples were manufactured, placed under long-term (25 °C / 60 % relative humidity [RH]) storage conditions, and removed from storage at 0, 3, 6, 9 and 12 months for analysis. Aerosols were collected using intense and non-intense puffing regimens and analysed for select chemicals and HPHCs based on the United States Food and Drug Administration Premarket Tobacco Application (USFDA; June 2019) and European Tobacco Products Directive (EUTPD; April 2014) guidance using validated methodologies. After 12-months of long-term storage, regardless of puffing regimen, the majority (36 out of 54) of the measured aerosol constituents were not present at levels above the limit of quantification. Nicotine, pH, water and other primary constituents remained consistent, exhibiting no more than a 20 % change from T0 levels. Thermal degradants increased slightly, and nicotine degradants remained below United States Pharmacopeia (USP) percent impurity limits. These results support at least a 12-month shelf-life for JUUL2® Virginia Tobacco and Crisp Menthol 18 mg/mL JUULpods.