The Premarket Tobacco Product Applications (PMTA) guidance issued by the FDA for electronic nicotine delivery systems (ENDS) recommends that in addition to other stability information, manufacturers submit chemical changes (e.g. aerosol constituents) to support the product’s shelf-life. Although aerosols from e-vapor products are considerably less complex than aerosols from heat-not-nurn (HNB) or mainstream smoke from cigarettes, there are still challenges that arise from the chemical composition of the matrix, variety of flavors used, and the potential for chemical interactions to occur during storage and heating. There is additional complexity associated with efficiently collecting both volatile and semi-volatile compounds delivered in the aerosol from e-vapor products.

This non-targeted analysis (NTA) method is a semi-quantitative approach to evaluate the chemical composition of e-vapor products and can be used to characterize the aerosol and changes over time. We have developed a gas chromatography-mass spectrometry (GC-MS) based non-targeted analysis method for evaluation of volatile and semi volatile compounds. The data processing includes an automated data analysis that includes both Agilent MassHunter Unknowns Analysis software for mass spectral deconvolution, peak detection, and library searching and reporting. This method was able to accurately identify > 99 % of known compounds using mass spectral matching with a custom library. Our library contains over 1100 unique compounds, with approximately 600 confirmed with reference standards, to aid in identification. The performance characteristics of our method were validated for accuracy, precision, repeatability, and selectivity. This semi-quantitative method provides estimated concentrations which are 0.5 to 2.0-fold compared to the actual value. A limit of detection was established at approximately 0.7 ppm. This approach is applicable for the evaluation of volatile and semi volatile compounds in e-vapor products allowing for chemical characterization of e-vapor aerosol and e-liquids to support development of reduced risks products.