News & Events
Electronic 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.
e-Cigarettes may contain ingredients that are known to be toxic to humans, and may contain other ingredients that may not be safe. Additionally, these products may be attractive to young people and may lead kids to try other tobacco products, including conventional cigarettes, which are known to cause disease and lead to premature death.
Because clinical studies about the safety and efficacy of these products have not been submitted to FDA, consumers currently have no way of knowing
- whether e-cigarettes are safe for their intended use,
- what types or concentrations of potentially harmful chemicals are found in these products, or
- how much nicotine they are inhaling when they use these products.
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
FDA did not appeal the decision by the U.S. Court of Appeals for the D.C. Circuit in Sottera, Inc. v. Food & Drug Administration, holding 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. Therefore, FDA intends to develop regulations for electronic cigarettes.
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.
Public Health Experts Announce Potential Health Risk Posed by e-Cigarettes
In July 22, 2009, public health experts discussed the potential health risks associated with electronic cigarettes:
- Summary of FDA Analyses
- Final Report on FDA Analyses [PDF - 237KB]
- Transcript for FDA's Media Briefing on Electronic Cigarettes
July 22, 2009 [PDF - 65KB] Audio [MP3 - 11MB]
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
- Call 1-800-QUITNOW (1-800-784-8669)
- For the hearing impaired: TTY 1-800-332-8615
- Get Instant Messaging Live Help
- Visit Smokefree.gov for online resources to help you quit.
