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  • Electronic Nicotine Delivery Systems: Under Scrutiny


    Research and related debate continues to intensify regarding the safety of e-cigarettes. Often called "vaping," use of an e-cigarette involves inhaling through a battery-powered device to trigger a heating element that vaporizes a liquid solution contained in a cartridge. The vaporized solution usually contains propylene glycol and/or glycerol, nicotine, flavor, and other chemicals.


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    Gauging the safety of e-cigarettes requires taking into consideration the addictive nature of nicotine, including the withdrawal symptoms that can occur when stopping the drug. Since it is not necessary to burn tobacco to deliver the nicotine, the risks that come with inhaling traditional cigarette smoke are eliminated; however, the inhaled nicotine can still be dangerous due to its cardiovascular and other adverse effects. While it is possible that e-cigarettes are less harmful than cigarettes, there is not yet enough information about the effects of long-term use or secondhand exposure.

    Potential risks include e-cigarettes becoming a gateway for nonsmokers, including children and adolescents, to begin using tobacco. Relatively little research has been completed on the human health effects of e-cigarettes. Most studies have only included healthy people with short-term exposure. There are no studies about the safety of e-cigarette use in patients with cardiovascular disease, and larger studies are needed to evaluate the efficacy of e-cigarettes as a cessation aid and in people with asthma and chronic obstructive pulmonary disease.

    Common minor side effects have been documented through spontaneous reports and clinical trial data, and have included throat and mouth irritation, dry cough, nausea, and vomiting. There have been no serious adverse effects reported in clinical trials with >6 months of e-cigarette use compared with nicotine patches, with no difference between groups. Further controlled and long-term research studies are required in order to evaluate the benefits and risks of e-cigarette use.

    The FDA has proposed extension of its authority to cover not only cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco, but also additional products, such as e-cigarettes. Similar to the existing federal ban on selling cigarettes and smokeless tobacco products to minors under the Family Smoking Prevention and Tobacco Control Act, the FDA's proposed rule on "Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act" would ban the sale of e-cigarettes to individuals who are under the age of 18.

    Today, it is still unclear if e-cigarettes are effective as smoking-cessation aids. A recent policy statement from the American Heart Association (AHA) cautions that not enough evidence exists yet for clinicians to counsel patients on using e-cigarettes as a primary cessation aid. The AHA does mention supporting the attempt of a patient to use e-cigarettes if all other clinically proven approaches have been attempted but failed. At this time, e-cigarettes are not an alternative to conventional smoking-cessation, and clinicians should continue to offer available cessation pharmacotherapy (such as Nicotrol NS, Nicotrol Inhaler, or one of the OTC products listed in PDR's Smoking Cessation Products table, which was based on FDA-approved labeling [as of March 2014] as part of the 2015 PDR Nurse's Drug Handbook).

    PDR Network is a valuable resource for smoking-cessation aids, as well as thousands of other available products, offering alerts and specific product labeling. Keep current by using PDR.net and by providing updated contact information. If you use the electronic health record channel, please ask for it to include PDR drug data feeds, including PDR BRIEF. Updated drug information, full labeling, and safety warnings will be integrated into your electronic prescribing system automatically, and at no cost to you.

    Salvatore Volpe, MD, FAAP, FACP, CHCQM
    Chief Medical Officer
    PDR Network