Analysis of FDA-Authorized and Unregulated E-Liquids

Abstract

The evolution of nicotine delivery systems has responded to consumer and cultural demands, from the Cigalike of the early 2000s to the current day’s disposable vapes. The Food and Drug Administration (FDA) implemented premarket tobacco product applications (PMTAs) for tobacco and nicotine product manufacturers in 2021. Only 34 out of over a million products have been issued Market Granted Orders (MGOs) and are allowed to be marketed, distributed, and sold as “FDA-authorized”. The products deemed as “FDA-authorized” should contain a precise and accurate nicotine concentration, as well as minimal flavorants and additional compounds. In the presented study, 223 FDA-authorized and 13 unregulated e-cigs were acquired for analysis. Gas chromatography – mass spectrometry (GC-MS), headspace gas chromatography – dual flame ionization detection (HS-GC-FID), and liquid chromatography – tandem mass spectrometry (LC-MS/MS) were used to characterize the components of each e-liquid, identify any volatile compounds, and quantify nicotine and 6-methyl-nicotine. Untargeted analysis revealed that the average number of compounds in a product’s e-liquid differed between the FDA-authorized and unregulated sample groups, due to the unregulated products\u27 wider range of flavors with less regulation. Determined nicotine concentrations of three lots of FDA-authorized products (n = 24) varied from the labeled nicotine concentration by 3.9% to 46.8%. Continued surveillance of both FDA-authorized and unregulated vape products will help monitor how manufacturers respond and adhere to regulatory policy changes, track issues with quality assurance practices, and inform and educate consumers about the health and safety risks associated with product use