Evaluation of e-cigarettes

Subject: Evaluation of e-cigarettes Background: 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).

Test Products: 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 Conclusions: 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. A sparging apparatus (see figure in Attachment A) and headspace GC (HS-GC) analysis were utilized to simulate actual use of these products. With the sparging apparatus, nicotine was detected in cartridges claiming to contain nicotine and quantitated by LC-UV; cotinine was also found in some products by this procedure. Repeat testing of 3 different cartridges with the same label (menthol high) gave varying results from 26.8 to 43.2 mcg nicotine/100 mL puff. HS-GC detected nicotine in both products and â-Nicotyrine was detected in all Njoy cartridges (see Table 2).

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