The Center for Drug Evaluation and Research through the Office of Compliance (OC) has requested that the Division of Pharmaceutical Analysis (DPA) evaluate two brands of electronic cigarettes (e-cigarettes) for nicotine content and other impurities. An e-cigarette is advertised as an alternative to smoked tobacco products. It is a battery-powered device that provides inhaled doses of nicotine by delivering a vaporized propylene glycol/nicotine mixture as shown in Figure 1. The Center is concerned that in addition to nicotine delivery, the vapor may also provide other potentially harmful volatile components. DPA was asked to quantitate the amount of nicotine present in each brand and to evaluate each brand for the presence of tobacco specific nitrosamines (TSNA), certain tobacco specific impurities, ethylene glycol (EG) and diethylene glycol (DEG).
Njoy e-cigarette (Reference 1) with various cartridges Smoking Everywhere Electronic Cigarette (Reference 2) with various cartridges Nicotrol Inhaler, 10mg cartridge was used as a control for some test methods.
Nicotine is present in both products. The Smoking Everywhere Electronic Cigarette cartridges listed as containing no nicotine in some cases had very low amounts of nicotine present. Tobacco specific nitrosamines and tobacco specific impurities were detected in both products at very low levels. DEG was identified in one cartridge, Smoking Everywhere 555 High. See Table 1 for results of analyses of entire cartridges after extraction.
Note: Extraction method for DEG testing has been redacted in the public document
Related: Key Issue: Revision of Excipient Monographs Related to DEG & EG Adulteration | U.S. Pharmacopeial Convention, Web Page, USP (2009)
Related: Key Issue: Glycerin | U.S. Pharmacopeial Convention, Web Page, USP (2009)