The U.S. Food and Drug Administration today announced that a laboratory analysis of electronic cigarette samples has found that they contain carcinogens and toxic chemicals such as diethylene glycol, an ingredient used in antifreeze.
Electronic cigarettes, also called “e-cigarettes,” are battery-operated devices that generally contain cartridges filled with nicotine, flavor and other chemicals. The electronic cigarette turns nicotine, which is highly addictive, and other chemicals into a vapor that is inhaled by the user.
These products are marketed and sold to young people and are readily available online and in shopping malls. In addition, these products do not contain any health warnings comparable to FDA-approved nicotine replacement products or conventional cigarettes. They are also available in different flavors, such as chocolate and mint, which may appeal to young people.
Public health experts expressed concern that electronic cigarettes could increase nicotine addiction and tobacco use in young people. Jonathan Winickoff, M.D., chair of the American Academy of Pediatrics Tobacco Consortium and Jonathan Samet, M.D., director of the Institute for Global Health at the University of Southern California, joined Joshua Sharfstein, M.D., principal deputy commissioner of the FDA, and Matthew McKenna, M.D., director of the Office of Smoking and Health for the Centers for Disease Control and Prevention, to discuss the potential risks associated with the use of electronic cigarettes.
“The FDA is concerned about the safety of these products and how they are marketed to the public,” said Margaret A. Hamburg, M.D., commissioner of food and drugs.
Because these products have not been submitted to the FDA for evaluation or approval, at this time the agency has no way of knowing, except for the limited testing it has performed, the levels of nicotine or the amounts or kinds of other chemicals that the various brands of these products deliver to the user.
The FDA’s Division of Pharmaceutical Analysis analyzed the ingredients in a small sample of cartridges from two leading brands of electronic cigarettes. In one sample, the FDA’s analyses detected diethylene glycol, a chemical used in antifreeze that is toxic to humans, and in several other samples, the FDA analyses detected carcinogens, including nitrosamines. These tests indicate that these products contained detectable levels of known carcinogens and toxic chemicals to which users could potentially be exposed.
The FDA has been examining and detaining shipments of e-cigarettes at the border and 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 FDA has been challenged regarding its jurisdiction over certain e-cigarettes in a case currently pending in federal district court. The agency is also planning additional activities to address its concerns about these products.
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)
Summary of Results: Laboratory Analysis of Electronic Cigarettes Conducted By FDA (click here for the complete PDF of the 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 ß-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.
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