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TSRC, Tob. Sci. Res. Conf., 2023, 76, abstr. 43

Lessons learned from the in vitro/in vivo toxicological assessment of the JUUL system

(1) Juul Labs, Inc., Washington, DC, USA; (2) Charles River Laboratories, Skokie, IL, USA

Juul Labs, Inc (JLI) evaluated the toxicological risks of the JUUL System with Virginia Tobacco (VT) and Menthol (ME) JUULpods using standard toxicological assays as part of our product stewardship program. These assays were conducted and interpreted consistent with internationally recognized guidelines. Ultimately, the results of these studies were included in JLI’s 2020 Premarket Tobacco Product Application (PMTA) for the JUUL System. JLI received a Marketing Denial Order (MDO) in June 2022 for the JUUL System although the product remains on the market under enforcement discretion while the MDO undergoes administrative review. The purpose of this presentation is to share JLI’s in vitro toxicological assessment of the JUUL System in light of our recent MDO.

JLI conducted the standard battery of in vitro toxicological assays recommended by CORESTA; Neutral Red cytotoxicity assay, Ames mutagenicity assay, and micronucleus (MN) assay for genotoxicity per OECD guidelines on e-liquid and aerosol condensates collected using two puffing regimens. Results of the neutral red and AMES assays were negative for all JUULpod variants tested (VT 3.0% and 5.0% nicotine and ME 3.0% and 5.0% nicotine). In the MN assay, VT 5.0% and ME 5.0% e-liquids yielded positive results and the VT 3.0% aerosol condensate yielded positive results using manual counting. To determine the biological significance of these in vitro results, an in vivo MN and in vivo comet assay (nasal, lung and liver tissue) per OECD guidelines on VT 3.0% and ME 5.0% was performed. Aerosol exposures utilized the maximum tolerated dose. All MN and comet assays for both VT 3.0% and ME 5.0% were negative. JLI concluded on the weight of evidence, that JUUL System aerosols were not genotoxic.