Electronic Cigarettes

The Food and Drug Administration (FDA) has joined other health experts to warn consumers about potential health risks associated with electronic cigarettes.

Also known as "e-cigarettes," electronic cigarettes are battery-operated devices designed to look like and to be used in the same manner as conventional cigarettes.

Sold online and in many shopping malls, the devices generally contain cartridges filled with nicotine, flavor, and other chemicals. They turn nicotine, which is highly addictive, and other chemicals into a vapor that is inhaled by the user.

FDA Warning

“The FDA is concerned about the safety of these products and how they are marketed to the public,” says Margaret A. Hamburg, M.D., commissioner of food and drugs.

The agency is concerned that:

• E-cigarettes can increase nicotine addiction among 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
• The products may contain ingredients that are known to be toxic to humans
• Because clinical studies about the safety and efficacy of these products for their intended use have not been submitted to FDA, consumers currently have no way of knowing 1) whether e-cigarettes are safe for their intended use, or 2) about what types or concentrations of potentially harmful chemicals or what dose of nicotine they are inhaling when they use these products.

The potential health risks posed by the use of e-cigarettes were addressed in a July 22, 2009, phone conference between Joshua M. Sharfstein, M.D., principal deputy commissioner of food and drugs; Jonathan Winickoff, M.D., chair of the American Academy of Pediatrics Tobacco Consortium; Jonathan Samet, M.D., director of the University of Southern California's Institute for Global Health; and Matthew T. McKenna, M.D., director of the Office on Smoking and Health at the national Centers for Disease Control and Prevention.

Conference participants stressed the importance of parents being aware of the health and marketing concerns associated with e-cigarettes. It was stated that parents may want to tell their children and teenagers that these products are not safe to use.

Of particular concern to parents is that e-cigarettes are sold without any legal age restrictions, and are available in different flavors (such as chocolate, strawberry and mint) which may appeal to young people.

In addition, the devices do not contain any health warnings comparable to FDA-approved nicotine replacement products or conventional cigarettes.

During the phone conference, which was shared with the news media, FDA announced findings from a laboratory analysis that indicates that electronic cigarettes expose users to harmful chemical ingredients.

FDA’s Division of Pharmaceutical Analysis—part of the agency's Center for Drug Evaluation and Research—analyzed the ingredients in a small sample of cartridges from two leading brands of e-cigarette samples.

One sample was found to contain diethylene glycol, a toxic chemical used in antifreeze. Several other samples were found to contain carcinogens, including nitrosamines.

Agency Actions

FDA has been examining and detaining shipments of e-cigarettes at the border and has found that the products it has examined thus far meet the definition of a combination drug device product under the Federal Food, Drug, and Cosmetic Act. The agency has been challenged regarding its jurisdiction over certain e-cigarettes in a case currently pending in federal district court.

FDA is planning additional activities to address its concerns about electronic cigarettes.

Meanwhile, health care professionals and consumers may report serious adverse events or product quality problems with the use of e-cigarettes to FDA through the MedWatch program, either online or by phone at 1-800-FDA-1088.

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

Laboratory Analysis of Electronic Cigarettes Conducted By FDA Summary of Results

FDA conducted a preliminary analysis on some samples of electronic cigarettes and components from two leading brands. Due to the variability among products, this analysis should not be used to draw conclusions about what substances are or are not present in particular electronic cigarettes or brands of electronic cigarettes.

FDA's Center for Drug Evaluation, Office of Compliance purchased two samples of electronic cigarettes and components from two leading brands. These samples included 18 of the various flavored, nicotine, and no-nicotine cartridges offered for use with these products. These cartridges were obtained in order to test some of the ingredients contained in them and inhaled by users of electronic cigarettes.

FDA's Center for Drug Evaluation, Division of Pharmaceutical Analysis (DPA) analyzed the cartridges from these electronic cigarettes for nicotine content and for the presence of other tobacco constituents, some of which are known to be harmful to humans, including those that are potentially carcinogenic or mutagenic.

DPA's analysis of the electronic cigarette samples showed that the product contained detectable levels of known carcinogens and toxic chemicals to which users could potentially be exposed.

DPA's testing also suggested that quality control processes used to manufacture these products are inconsistent or non-existent.

Specifically, DPA's analysis of the electronic cigarette cartridges from the two leading brands revealed the following:

• Diethylene glycol was detected in one cartridge at approximately 1%. Diethylene glycol, an ingredient used in antifreeze, is toxic to humans.

• Certain tobacco-specific nitrosamines which are human carcinogens were detected in half of the samples tested.

• Tobacco-specific impurities suspected of being harmful to humans—anabasine, myosmine, and β-nicotyrine—were detected in a majority of the samples tested.

• The electronic cigarette cartridges that were labeled as containing no nicotine had low levels of nicotine present in all cartridges tested, except one.

• Three different electronic cigarette cartridges with the same label were tested and each cartridge emitted a markedly different amount of nicotine with each puff. The nicotine levels per puff ranged from 26.8 to 43.2 mcg nicotine/100 mL puff.

• One high-nicotine cartridge delivered twice as much nicotine to users when the vapor from that electronic cigarette brand was inhaled than was delivered by a sample of the nicotine inhalation product (used as a control) approved by FDA for use as a smoking cessation aid.

Concerns Voiced by the Public Health Experts About Electronic Cigarettes

No Demonstrated Public Health Benefit

“The electronic cigarette is not a proven nicotine replacement therapy. WHO has no scientific evidence to confirm the product's safety and efficacy.”

-World Health Organization, Press Release, “Marketers of electronic cigarettes should halt unproved therapy claims” (September 19, 2008)

“Makers and retailers of these products have been making unproven health claims about their products, claiming that they are safer than normal cigarettes and asserting that they can help people to quit smoking. Absent scientific evidence, these claims are in blatant violation of FDA rules. In fact, no studies have been done on e-cigarettes to date regarding their health effects or their effectiveness as cessation aids.”

-Statement of the American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, and Campaign for Tobacco-Free Kids (March 24, 2009)

“We basically don't know anything about them [electronic cigarettes]. They've never been tested for safety or efficacy to help people stop smoking.”

-Dr. Richard Hurt, Director, Nicotine Dependence Center, Mayo Clinic (June 2, 2009)

“We do not know yet how the ‘smoking' technology these products use affects human health. We do not yet know all of the ingredients in these products and, accordingly, the impact of those ingredients on the health of people who 'smoke' e-cigarettes or the people around them. We do not know what ingredients these products actually deliver (nicotine or otherwise) and what the risks of these products might be. We have seen no studies regarding whether e-cigarettes actually help smokers quit or, instead, delay cessation attempts by providing smokers with a way to continue their smoking behaviors when they cannot smoke a tobacco product.”

-American Legacy Foundation, Statement, “Electronic Cigarettes” (May 2009)

Marketing of E-Cigarettes May Appeal to Young People

“E-cigarettes are also being marketed towards young people, who can purchase them in fruit flavors and online, without having to verify their ages.”

-Statement of the American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, and Campaign for Tobacco-Free Kids (March 24, 2009)

“It looks like a cigarette and is marketed as a cigarette. There's nothing that prevents youth from getting addicted to nicotine.”

-Dr. Jonathan Winickoff, Chairman, American Academy of Pediatrics Tobacco Consortium (June 2, 2009)

“Finally, and of critical importance, information is not yet available as to whether e-cigarettes might actually encourage children and teens and young adults to take their first step toward smoking cigarettes, drawn in by the products' novelty and variety of flavors, including strawberry, banana and chocolate.”

-American Legacy Foundation, Statement, “Electronic Cigarettes” (May 2009)

Related Videos

In this video, the FDA is examining the safety of new electronic cigarette devices.

For More Information

• FDA and Public Health Experts Warn About Electronic Cigarettes
• Electronic Cigarettes