News & Events
Electronic Cigarettes (e-Cigarettes)
What are electronic cigarettes?
Electronic cigarettes, also known as e-cigarettes, are battery-operated products designed to deliver nicotine, flavor and other chemicals. They turn chemicals, including highly addictive nicotine, into an aerosol that is inhaled by the user.
Most e-cigarettes are manufactured to look like conventional cigarettes, cigars, or pipes. Some resemble everyday items such as pens and USB memory sticks.
E-cigarettes have not been fully studied so consumers currently don’t know:
- the potential risks of e-cigarettes when used as intended,
- how much nicotine or other potentially harmful chemicals are being inhaled during use, or
- if there are any benefits associated with using these products.
Additionally, it is not known if e-cigarettes may lead young people to try other tobacco products, including conventional cigarettes, which are known to cause disease and lead to premature death.
FDA Regulation of e-Cigarettes
Only e-cigarettes that are marketed for therapeutic purposes are currently regulated by the FDA Center for Drug Evaluation and Research (CDER). The FDA Center for Tobacco Products (CTP) currently regulates
- cigarette tobacco,
- roll-your-own tobacco, and
- smokeless tobacco.
FDA intends to issue a proposed rule extending FDA’s tobacco product authorities beyond the above products to include other products like e-cigarettes. For further details, please see the Unified Agenda entry describing this rulemaking.
eCigarettes and Adverse Events
What is an Adverse Event?
An adverse event is an undesirable side effect or unexpected health or product quality problem that an individual believes was caused by the use of a tobacco product.
Reporting an Adverse Event
Anyone can report an adverse event to the FDA. In fact, these reports help us identify safety concerns with tobacco products that could cause health or safety problems beyond those normally associated with tobacco product use.
Adverse Event Reports for e-Cigarettes
We regularly receive voluntary reports1 of adverse events involving e-cigarettes from consumers, health professionals and concerned members of the public. The adverse events described in these reports include hospitalization for illnesses such as
- congestive heart failure,
- hypotension, and
- other health problems.
Whether e-cigarettes caused these reported adverse events is unknown. Some of the adverse events could be related to a pre-existing medical condition or to other causes that were not reported to FDA. You can review the adverse event reports for e-cigarettes4 that were voluntarily reported to FDA from 6/22/2009 to 3/12/14 at the CTP FOIA Electronic Reading Room.
1. Under the Food, Drug and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act, FDA may accept voluntarily submitted information related to tobacco products, even if some of the information concerns tobacco products that are not yet regulated by FDA.