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TSRC, Tob. Sci. Res. Conf., 2023, 76, abstr. 40

Leachable testing to evaluate effect of an alternate transport mode on ENDS pod integrity

Juul Labs, Inc., Washington, DC, USA

The JUUL® System is a pre-filled, closed pod Electronic Nicotine Delivery System (ENDS) that delivers nicotine via an inhalable aerosol. The pod is considered the container closure system since it contains the e-liquid. Simulated leachable studies were used to support an alternate mode of pod transportation by comparing chemical leachable profiles and conducting a toxicological risk evaluation when differences were noted.

Simulated leachable studies were conducted on empty pods shipped by air and ocean, during winter and summer, and subsequently filled with neutral flavor-free e-liquid. To identify volatile and non-volatile organic leachable compounds semi-quantitative methods (GC-MS & LC-MS with +/- ion mode) were used while quantitative methods (ICP-MS) were used to identify metals. Leachables were reported based on method-specific analytical evaluation threshold calculated with a dose-based threshold of 1.5 µg/day. Shipping mode differences were determined based on percent change (>100%) for non-targeted organic compounds and p-value <0.05 for metals. Risk assessment using (Q)SAR to detect alerts for toxicological endpoints including mutagenicity and sensitization, then chemical-specific permissible daily exposures (PDE) or TTC for Cramer Class-derived thresholds for inhalation exposures were used to calculate a margin-of-exposure (MOE).

Comparing results of transportation modes and seasons indicated that levels of only a few compounds were changed, showed statistical difference, or were uniquely identified in ocean shipped pods. None that exceeded the acceptable change were classified as mutagenic or sensitizers. Risk assessment resulted in MOEs greater than unity indicating no toxicological concerns. None of the statistically significant increases in metals (Fe, Cu, Ni, Zn) exceeded USP <232> relevant inhalation PDE limits. Overall, the risk assessment indicated minimal impact from ocean shipping on pod quality and integrity when compared to air shipping.