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 nicotine, which is highly addictive, and other chemicals into a vapor 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.
As the safety and efficacy of e-cigarettes have not been fully studied, consumers of e-cigarette products currently have no way of knowing:
- whether e-cigarettes are safe for their intended use,
- 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.
Report Adverse Events
Please report adverse events with e-cigarettes by:
- filling out the online form or
- calling 1-800-FDA-1088.
FDA Regulation of e-Cigarettes
Currently, e-cigarettes that are marketed for therapeutic purposes are 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 has stated its intent to issue a proposed rule that would extend FDA’s tobacco product authorities to products that meet the statutory definition of “tobacco product.” For further details, please see the Unified Agenda entry describing this rulemaking: http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201210&RIN=0910-AG38.
Warning Letters Sent to Electronic Cigarette Distributors
In September 2010, FDA issued a number of warning letters to electronic cigarette distributors for various violations of the Federal Food, Drug, and Cosmetic Act including “violations of good manufacturing practices, making unsubstantiated drug claims, and using the devices as delivery mechanisms for active pharmaceutical ingredients.”
More Information FDA’s Authority to Regulate e-Cigarettes
- Letter to Stakeholders: Regulation of e-Cigarettes and Other Tobacco Products
- Federal Food, Drug, and Cosmetic Act
More Information on Safely Quitting Tobacco
- Learn about Smoking Cessation Products
- Talk to a Smoking Cessation Counselor
1. Sottera, Inc. v. Food & Drug Administration held that e-cigarettes and other nicotine-containing products are not drugs or devices unless they are marketed for therapeutic purposes, but that other nicotine-containing products can be regulated as “tobacco products” under the Federal Food, Drug, and Cosmetic Act.