• Claims of e-cigarette safety unproven at best, experts say

    September 2009

    Electronic cigarettes – or e-cigarettes – may not be as safe as manufacturers claim. That’s what the U.S. Food and Drug Administration (FDA) found after analyzing a sampling of these products that are promoted as safe alternatives to smoking as well as stop-smoking aids.


    “No studies have been done on e-cigarettes to date regarding their health effects or their effectiveness as cessation aids.”


    E-cigarettes are electronic nicotine delivery systems. These rechargeable battery-operated cigarettes, cigars or pipes generally contain cartridges filled with nicotine – which is highly addictive – plus flavor and other chemicals. As the smoker inhales, the battery is triggered to heat the small cartridge containing the liquid ingredients. The mixture is vaporized so it can be inhaled into the smoker's lungs. As the user exhales, the vapor is released, mimicking the smoking process.

    The FDA is concerned about the potential risks associated with the use of electronic cigarettes. Many other health organizations have voiced similar concerns, including the American Academy of Pediatrics Tobacco Consortium, the American Legacy Foundation, the Institute for Global Health at the University of Southern California, the World Health Organization (WHO), and the Office of Smoking and Health for the Centers for Disease Control and Prevention.

    A joint statement by the American Cancer Society, American Heart Association, American Lung Association and the Campaign for Tobacco-Free Kids concluded: “Makers and retailers of these products have been making unproven health claims … 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.”

    The FDA is concerned that these products are being promoted to young people and are easily obtained online and at shopping malls. They do not contain any health warnings comparable to FDA-approved nicotine replacement products or conventional cigarettes. The FDA is also concerned that because the e-cigarettes are available in flavors such as chocolate and mint, they may appeal to young people.


    “In one sample, diethylene glycol was detected – a chemical used in antifreeze that is toxic to humans.”


    How the study was conducted

    The FDA launched its own laboratory analysis of electronic cigarette samples to determine the safety of the ingredients. The FDA's Division of Pharmaceutical Analysis tested a small sample of cartridges from two leading brands.

    What the study found

    In one sample, diethylene glycol was detected. This is a chemical used in antifreeze that is toxic to humans. In several other samples, the FDA analyses detected cancer-causing agents such as nitrosamines, as well as toxic chemicals to which users could be exposed. Researchers also found inconsistencies in the amount of nicotine levels in the cartridges tested. For example, three different e-cigarette cartridges with the same label emitted markedly different amounts of nicotine with each puff. These and other inconsistencies indicate problems with quality control and raise serious concerns regarding potential for harm.

    Other concerns

    The FDA has been examining and detaining shipments of e-cigarettes at U.S. borders(they are manufactured in China and elsewhere) and says that the products examined thus far meet the definition of a combination drug-device product under the federal Food, Drug and Cosmetic Act. This would mean that FDA approval is required before the product can be legally sold in the United States. However, a case challenging the FDA's jurisdiction is pending in federal district court. The product has been banned in Canada and Australia.

    Study limitations

    The FDA analysis was limited to a small sampling. The various health organizations voicing concern about electronic cigarettes are calling for more rigorous testing of these products to determine their safety and efficacy.

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Page last updated: 5/22/2014 3:23:19 PM
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    What the news means for you

    Toxic chemicals found in FDA tests of device

    Audrey Darville, ARNP
    Tobacco Cessation

    Wright, Heather, MD This relatively new product called an electronic cigarette is causing a good deal of controversy. The battery-operated cigarettes, cigars or pipes are being promoted both as a safer alternative to smoking and as a way to help smokers quit. But these claims are unsubstantiated.


    “Don't fall for the unproven claims of product promoters.” 


    The Food and Drug Administration's limited analysis discussed to the left that showed the presence of harmful chemicals is the only independent research on e-cigarettes available to date.

    These smokeless devices are appealing to many considering the major push nationwide to ban tobacco use (the University of Kentucky campus and all UK HealthCare campuses are tobacco-free) and the undisputable evidence that smoking is harmful. But don't fall for the unproven claims of product promoters.

    FDA seeks to regulate

    The Food and Drug Administration(FDA) asserts that e-cigarettes fall under their regulatory jurisdiction, and they are detaining shipments into the United States based on safety concerns. However, the product is easily obtained on the Internet and in shopping malls. The FDA is being challenged in court by supporters of e-cigarettes who do not believe the FDA should regulate these devices.


    “Public health experts are also worried that e-cigarettes may increase nicotine addiction among young people.” 


    E-cigarettes are relatively new

    Developed in China in 2004, the e-cigarette is a refillable tube with a rechargeable battery that lets the smoker inhale and exhale a nicotine vapor. A small cartridge heats the liquid nicotine and propylene glycol mixture, turning it into the vapor that is inhaled into the lungs.

    Nicotine is known to be a highly addictive substance. It is the "hook" that makes tobacco products addictive. Little is known about how much nicotine is absorbed into the brain and bloodstream from e-cigarettes. In fact, the FDA study showed there is great variation in the amount of nicotine contained in each cartridge, even when the cartridges are from the same brand. That raises red flags for quality-control concerns.

    Contents of vapor troublesome

    Public health experts are also worried that e-cigarettes may increase nicotine addiction among young people. They may also lead kids to try other tobacco products, such as conventional cigarettes that we know can cause disease and premature death.

    The other major component of the vaporized mixture is propylene glycol. While this is generally recognized as being safe, the Agency for Toxic Substances and Disease Registry reports both human and animal evidence of irritation from repeated exposure to this chemical.

    The FDA analysis also found signs of cancer-causing agents and toxic chemicals, including an ingredient found in antifreeze, in the product samples they tested. Even though the product does not contain most of the nearly 4,000 chemicals found in traditional cigarettes, there is still concern about safety of the device. More testing needs to be done to determine whether these products are safe and whether they are effective in helping smokers to stop tobacco use.

    Wait until safety is proven

    Be wary of Internet marketing pitches and testimonials that make unproven statements about the safety and effectiveness of e-cigarettes. If you are a parent, you may want to tell your children and teenagers that these products are not safe to use. Until we know more, we advise against their use.

    Trying to quit?

    If you would like help in quitting the use of tobacco, check out Tobacco Treatment Resources available online at ukhealthcare.uky.edu/tobaccotreatment. 

    Audrey Darville, ARNP, is a certified tobacco treatment specialist at UK HealthCare.

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