A Black Buffalo Novel Nicotine Pouch Product is Bioequivalent to 4 mg Nicorette Gum

Abstract: The Glas G2 ENDS (Glas) is a temperature-regulated nicotine salt pre-filled disposable pod connected system with two power settings, and age-gated technology, designed to minimize the combustion byproducts across a range of operating environments. Comparatively, combustible cigarettes can reach temperatures of 1000 degrees Celsius and consequently generate over seven thousand identified thermal degradation products including compounds characterized as Harmful and Potentially Harmful Constituents (HPHCs). Seven different Glas e-liquids (three tobacco, two menthol, two non-characterizing; 50 mg/ml nicotine) were analyzed for HPHCs and compared to a 3R4F Kentucky Reference Cigarette and the market leading tobacco cigarette, Marlboro Gold. The Glas e- liquids and combustible tobacco cigarettes were vaped under intense puffing conditions. No significant increase in the HPHC profile was observed with the two power settings, vaped under non-intense and intense conditions, therefore presenting minimal risk to the consumers. On a per day use basis (total e-liquid consumption for Glas pods and cigarette use for tobacco products), there was a significant reduction in minor nicotine alkaloids (98%), carbonyl compounds (95-99%), volatile organic compounds (VOCs) (99%), metals (45- 95%). On a product use per mg nicotine basis, carbonyl compounds, nicotine alkaloids, VOCs, and metals (cadmium and lead) levels were 95% to 99% lower and nickel was 25%-60% lower in the Glas pods compared with the 3R4F reference cigarette and Marlboro Gold. This comparative HPHC analysis demonstrated that Glas test products in combination testing with the Glas G2 device with two power settings yielded significantly lower HPHC compared to combustible tobacco cigarettes.