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CORESTA Congress, Berlin, 2016, Smoke Science/Product Technology Groups, ST 36 (also presented at TSRC 2016)

An evaluation of electronic cigarette formulations and aerosols for HPHCs typically derived from combustion

WAGNER K.A.; AVERY K.C.; BALLENTINE R.M.; BROWN A.P.; FLORA J.W.; JIN X.; MELVIN M.S.
Altria Client Services LLC, Richmond, VA, U.S.A.

In May 2016, the U.S. Food and Drug Administration (FDA) published draft guidance entitled Premarket Tobacco Product Application for Electronic Nicotine Delivery Systems. In this document, FDA recommends reporting the quantities of designated harmful and potentially harmful constituents (HPHCs) in e-cigarettes and formulations (e-liquids). This list contains both tobacco derived constituents such as nicotine and tobacco-specific nitrosamines (TSNAs) and combustion related constituents such as benzo[a]pyrene (B[a]P) and benzene. E-cigarette formulations and aerosols are known to contain trace levels of tobacco derived constituents; however, combustion related HPHCs are not likely to be found due to the relatively low operating temperatures of an e-cigarette relative to a tobacco cigarette. The objective of this work was to utilize highly sensitive and selective methods to determine if three classes of combustion related HPHCs were detectable in e-cigarette formulations and aerosols. These compounds include three aromatic amines, five volatile organic compounds, and B[a]P. Results from a set of internally prepared reference products and commercially available e-cigarettes and formulations will be presented. The observations from our analysis demonstrate that these compounds are not present at measurable levels in e-cigarette formulations or aerosols. FDA may want to consider results from this and other studies as it makes decisions regarding inclusion of such compounds in a potential HPHC list for e-cigarettes.