News: Questions about e-cigarettes’ safety raised amid calls for regulation

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June 2009, Volume 28, No. 5

Questions about e-cigarettes’ safety raised amid calls for regulation

The electronic cigarette, or e-cigarette, is a relatively new product for sale in the United States that resembles cigarettes but does not contain tobacco. Little is known about this unregulated product—touted as a smoking alternative—which is why its use is raising a number of red flags worldwide.

E-cigarettes, which were invented in China and first marketed there in 2004, are battery-powered devices that look like real cigarettes. A slender stainless-steel tube holds a battery and a cartridge containing nicotine dissolved in propylene glycol. When a person puffs on an e-cigarette, a pressure sensor in the cartridge switches on an electric heating coil that vaporizes the propylene glycol and nicotine and releases what resembles smoke, which users can then inhale. A light-emitting diode at the end of the device even lights up to resemble a glowing cigarette tip.

E-cigarettes are sold by several firms online and in stores, and the nicotine cartridges are sold in different doses as well as flavors including tobacco, coffee, and strawberry. Advertisements for the devices emphasize that they look just like cigarettes but claim they are safe to use, tar-free, and a healthier alternative.

There is, however, very little scientific information about e-cigarettes’ safety. Although the FDA reportedly has begun investigating them and is refusing to allow importation of several brands into the United States, citing their status as new drugs that have not been approved, it does not formally regulate them. Says FDA Spokesperson Rita Chappelle, “We’re concerned about the potential for addiction to and abuse of these products. Some people may mistakenly perceive these products to be safer alternatives to conventional tobacco use.” Debbie Elliott, Officials Probe E-Cigarettes’ Health Claims, NPR (Apr. 17, 2009), available at http://www.npr.org/.

While the federal government’s policy on e-cigarettes is still undetermined, others have already taken a stance. The World Health Organization (WHO) issued a statement that e-cigarettes are not proven nicotine replacement therapy, and marketers should not imply that in their ads, as there is no scientific evidence proving the product’s safety and efficacy. Douglas Bettcher, interim director of WHO’s Tobacco Free Initiative, said “[i]f the marketers of the electronic cigarette want to help smokers quit, then they need to conduct clinical studies and toxicity analyses and operate within the proper regulatory framework.” News Release, Marketers of Electronic Cigarettes Should Halt Un­proved Therapy Claims, WHO (Sept. 19, 2008), available at http://www.who.int/.

One of several brands available in the United States, Ecigarettes, claims on its Web site, www.ecigarettesusa.com, for instance, that smokers can quit smoking by “smoking” Ecigarettes. It calls its product “[a] healthier way to smoke . . . without all the harmful effects.” The company even claims it will give users $50 if they quit smoking in three weeks or less by using its e-cigarettes.

Australia has gone further than WHO by banning the sale of e-cigarettes. In Australia, nicotine is classified as a poison, and only certain forms may be deemed exempt from this classification and sold, including nicotine-replacement therapy products such as patches and chewing gum. In October 2008, the country’s Department of Health and Ageing (DHA) voted to classify the nicotine in e-cigarettes as a poison, making it subject to regulatory control and ensuring that it cannot be sold anywhere in Australia. National Drugs and Poisons Schedule Committee Record of Reasons, DHA (Oct. 14-15, 2008), available at http://www.tga.gov.au/.

Nicotine is a highly addictive drug found in tobacco leaves. It acts on the brain’s “reward pathways,” which regulate feelings of pleasure by increasing, among other chemicals, the release of the neurotransmitter dopamine. Research Report Series—Tobacco Addiction, Natl. Inst. on Drug Abuse, available at www.nida.nih.gov. While nicotine’s pleasurable experience can reach the brain within 10 seconds of inhaling a cigarette, this acute feeling disappears within minutes, and withdrawal includes symptoms such as irritability, attentional deficits, sleep disturbances, and increased appetite.

The other major substance found in e-cigarettes is propylene glycol. Propylene glycol is a synthetic liquid substance that absorbs water and is a generally recognized as safe food additive. It is added to food, cosmetics, and pharmaceutical products to maintain moisture. Propylene glycol is also used as a base for deicing solutions and to create artifical smoke or fog used in music concerts or theatrical productions. According to the Agency for Toxic Substances & Disease Registry (ATSDR), it can cause poisoning in rare circumstances when large doses are absorbed, resulting in metabolic acidosis or coma. Case Studies in Environmental Medicine (CSEM): Ethylene Glycol and Propylene Glycol Toxicity: What is Propylene Glycol?, ATSDR (Oct. 3, 2007), available at www.atsdr.cdc.gov.

Regarding the content of e-cigarettes, the American Cancer Society (ACS) notes that “[t]here may also be questions about how safe it is to inhale some of the flavorings and other substances in the nicotine mists into the lungs. Even substances that are safe to eat can harm delicate tissues inside the lungs.” Guide to Quitting Smoking, ACS (Jan. 12, 2009), available at www.cancer.org.

One of the only studies conducted to date on the safety of e-cigarettes has been by Murray Laugesen, a researcher on smoking policy and cigarettes and former principal medical officer of New Zealand’s Ministry of Health and Public Health Commission. Laugesen’s health consulting company contracted with seven laboratories to conduct independent tests on the nicotine cartridges of the Ruyan brand of e-cigarettes, which Laugesen then analyzed. The study—sponsored by Ruyan, the company that invented e-cigarettes—has a disclaimer stating that the findings are those of the author, who holds no stock in Ruyan and derives no financial benefit from the company. Murray Laugesen, Safety Report on the Ruyan® E-Cigarette Cartridge and Inhaled Aerosol, Health N.Z. Ltd. (Oct. 21, 2008), available at www.healthnz.co.nz.

The study analyzed the composition of the “smoke” emitted from the e-cigarettes and the cartridge liquid, as well as the presence of volatile compounds in the headspace above the cartridge liquid, among other measurements. The data showed that each puff contained one-third to one-half the nicotine found in a puff of a tobacco-containing cigarette, and the inhalation toxicity of propylene glycol is “not an issue.” It also found that carcinogenic heavy metals such as chromium, arsenic, and nickel, which have been found in cigarette tobacco, are not present in the cartridge liquid.

Analysis of the headspace of the e-cigarette cartridge found low levels—1.2 parts per million (ppm)—of the gas benzene. Benzene is a highly flammable chemical used to make other chemicals. Breathing very high levels of it can result in death, and long-term, lower-level exposure affects human blood, leading to anemia and in severe cases, cancer. The U.S. Occupational Safety and Health Administration has set limits of 1 ppm for workplace air for a standard workweek. ToxFAQs™ for Benzene CAS: 71-43-2, ATSDR (Aug. 2007), available at www.atsdr.cdc.gov. After the benzene finding, Ruyan allegedly conducted independent tests that determined that the source of the contaminant was the nicotine flavoring, and the company then changed the formula, resulting in no detectable level of benzene.

The study ultimately found that the Ruyan brand of e-cigarette is a safe alternative to cigarettes and “appears to be safe in absolute terms on all measurements” applied.

Apart from Laugesen’s study, there have been no clinical studies performed on e-cigarettes, and no other company has provided information about the safety of its e-cigarettes, which has prompted much concern. Senator Frank Lautenberg sent a letter to the FDA in March, urging the agency to take “immediate enforcement action” to remove e-cigarettes from the market. Ltr. from Sen. Frank R. Lautenberg to Hon. Frank M. Torti, Acting Commr., FDA (Mar. 23, 2009), available at http://lautenberg.senate.gov. The American Lung Association (ALA) has also called for FDA action, noting that e-cigarettes are being marketed to young people and that health claims made about the products without scientific evidence “are in blatant violation of FDA rules.” Press Release, American Lung Association Joins Public Health Advocates to Urge FDA to Pull E-Cigarettes from Marketplace, ALA (Mar. 24, 2009), available at www.lungusa.org.


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