FDA Summary of Adverse Events on Electronic Cigarettes

Abstract

The Center for Tobacco Products (CTP), Food and Drug Administration (FDA), oversees the implementation of the Family Smoking Prevention and Tobacco Control Act (TCA). As part of its responsibility in implementing the TCA, CTP receives and reviews voluntary communications from consumers, health care professionals, and concerned members of the public regarding a variety of tobacco products. Surveillance of adverse event (AE) reports allows regulatory agencies (1) to identify previously undetected safety concerns and take appropriate action to prevent further adverse events and (2) or to educate consumers about health and safety risks. Since the late 1980s, over 100 AE reports on tobacco products have been submitted to FDA (electronic cigarettes, n = 47; cigarettes, n = 36; smokeless tobacco, n = 14; other tobacco, n = 5). Notably, approximately half of all tobacco-related AE reports concern electronic cigarettes, the first of which was submitted in 2008.