E-Cigarettes and Tobacco Harm Reduction: Regulatory Policy and the Public Good
Globally, tobacco use is the foremost cause of preventable disease and death and may increase the risk of both coronary heart disease and stroke by up to four times. In the 20th century, tobacco use was attributed to an estimated 100 million premature deaths globally and is expected to claim the lives of some one billion people this century.1 In the U.S., smoking still accounts for some 400,000 deaths annually. Even non-smokers share this heavy health burden: each year more than 33,000 non-smokers in the U.S. die prematurely from coronary heart disease caused by exposure to secondhand smoke.2 Nonetheless, broad-based tobacco control prevention efforts over the past five decades have led to dramatic reductions in the prevalence of tobacco use and its associated adverse health outcomes. It is in the context of this critical stage in the global public health pandemic that e-cigarettes have arrived.
Since their introduction to the U.S. in 2007, e-cigarettes have generated attention as novel devices for the delivery of nicotine.3 E-cigarettes have the potential to limit exposure to the harmful compounds that promote disease while providing the nicotine desired by smokers. Their design allows nicotine, suspended in a reservoir of propylene glycol, to be volatilized and inhaled when the user activates a heating element by "puffing." E-cigarettes are convenient for consumers because emissions are limited; many are willing to use e-cigarettes in indoor environments. They may also be cost-effective compared with highly-taxed, conventional cigarettes. Despite a relatively high financial outlay for a starter pack, e-cigarettes deliver many more "puffs" per unit price compared with conventional cigarettes. However, the overwhelming advantage of e-cigarettes to consumers is that they represent a means of reducing exposure to the harmful constituents of tobacco smoke. Smokers prefer this inhalable means of delivering nicotine, known as vaping, than nicotine patches or gum. Vapers regard e-cigarettes as posing much lower health risks compared with conventional, combustible cigarettes.4
Despite these apparent advantages, many in the public health community have raised concerns about the proliferation of e-cigarettes and the current lack of regulatory oversight. The concerns regarding e-cigarettes are based upon their potential to undermine the substantial gains made in tobacco control over recent decades. For example, the wide implementation of clean indoor air laws, which have eliminated smoking in many public places, has provided protection for non-smokers. Yet clean indoor air laws have also been attributed with "de-normalizing" smoking, leading to important changes in the social acceptability of tobacco use. In the current limited regulatory environment, e-cigarette marketing and promotion has utilized approaches no longer available to manufacturers of conventional cigarettes. Television and radio advertising is currently widespread, together with celebrity endorsements, and are highly visible to youth. Many jurisdictions in the U.S. have no constraints on sale of e-cigarettes to minors, and there are few restrictions on the sale of e-cigarettes via the internet. A highly active "vaping" community has supported marketing efforts by advocating the perceived benefits of e-cigarettes via social media.
Extensive youth-oriented marketing and lowered perceptions of risk have prompted concerns that consumers who otherwise would be dissuaded from using conventional tobacco products because of the health risks may find e-cigarettes a viable option. This concern is especially relevant for adolescents, among whom a sharp rise in e-cigarette use has been observed.5,6 Unregulated (and largely unsubstantiated) claims for the efficacy of e-cigarettes as a cessation device may prompt current smokers to take up e-cigarette use rather than quitting, while reduced risk claims provide an incentive for former smokers to return to nicotine use. These scenarios raise concerns that e-cigarette use may lead to sustained dual use of conventional cigarettes, thus negating the potential harm reduction benefits of a potentially clean nicotine delivery product.7,8
Are E-Cigarettes Less Risky?
E-cigarettes have generated enormous attention in part because of their perceived potential to reduce tobacco-related harm. Of course, the elimination of combusted tobacco offers the potential to lower individual risk, and, indeed, e-cigarettes have documented lower levels of major toxic constituents found in conventional cigarette emissions. However, the limited regulation of e-cigarettes in the U.S. has resulted in sale of products with contaminants, including diethylene glycol, carbonyl compounds, and toxic metals in concentrations lower than conventional cigarettes but greater than pharmaceutical nicotine replacement products.9,10
The advent of a burgeoning e-cigarette market has prompted some members of the public health community to advocate the use of e-cigarettes to promote broad-scale tobacco harm reduction. This approach emphasizes tobacco harm reduction as a means to end the tobacco epidemic. The availability of a product with strong consumer appeal with lowered health risks may provide an unprecedented public health opportunity to protect those who are unable or unwilling to quit. However, others have cautioned against this approach, emphasizing the potential for the proliferation of e-cigarette use to undermine hard-won gains in tobacco control. Of major concern is the potential for e-cigarettes to re-normalize tobacco use, reduce concerns about health risks, encourage adoption by youth, and dissuade quitting among current smokers.
The World Health Organization (WHO) issued strong guidelines for regulation of e-cigarettes.11 The WHO's recommendation received vigorous responses in support from leading figures in the tobacco control, substance abuse, and public health fields. However, many others expressed concern that the harm reduction potential of e-cigarettes was not sufficiently recognized as a tobacco control strategy and that overly rigorous regulations might impede public access to a safer product.
Regulation of E-Cigarettes
In the U.S. since 2009, the Food and Drug Administration (FDA) has had regulatory authority for the manufacture, sale, and marketing of tobacco products. In April 2014, the FDA issued a notice of intention to regulate e-cigarettes.12 Following review of over 70,000 public comments received in response to its notice of intention to deem e-cigarettes tobacco products, the FDA will hand down final rules on e-cigarettes in due course. While the planned regulations will cover warning labels, youth access, and sale by vending machines, there is no plan for restriction of marketing, especially to adolescent audiences, internet sales, or the use of candy flavors that appeal to youth.
In the face of a global tobacco pandemic, it might seem reasonable to utilize any reasonable option to lessen the vast harms being observed globally. E-cigarettes provide an appealing means of delivering nicotine to users while eliminating exposure to most of the harmful constituents associated with cigarette emissions. A current lack of regulatory oversight of the e-cigarette industry has seen targeting of youth with sophisticated marketing and exotic flavors, as well as unsupported claims as a cessation device. In this limited regulatory environment, there is a strong possibility that the proliferation of e-cigarette use could undermine many of the public health benefits that hard-won tobacco control initiatives achieved. To fully realize the harm reduction potential of e-cigarettes, effective and farther reaching FDA regulation is required. Bans on marketing to youth, restrictions on access to e-cigarettes by minors, elimination of flavors designed to appeal to youth, and the implementation of product performance standards requiring elimination of all known toxicants are needed to maintain progress in tobacco control. With thoughtful, evidence-based regulation, e-cigarettes may be a game changer for the tobacco epidemic. Without such regulation, a critical phase in the history of the tobacco epidemic may be lost for generations to come.
- World Health Organization (WHO). WHO Report on the Global Tobacco Epidemic, 2008: The MPOWER package (WHO website). 2008. Available at: http://www.who.int/tobacco/mpower/mpower_report_full_2008.pdf. Accessed 2/18/15.
- U.S. Department of Health and Human Services. The Health Consequences of Smoking —50 Years of Progress: A Report of the Surgeon General, 2014 (SurgeonGeneral.gov website). 2014. Available at: http://www.surgeongeneral.gov/library/reports/50-years-of-progress/. Accessed 2/18/15.
- Noel JK, Rees VW, Connolly GN. Electronic cigarettes: a new "tobacco" industry? Tob Control 2011;20:81.
- Pearson JL, Richardson A, Niaura RS, Vallone DM, Abrams DB. e-Cigarette awareness, use, and harm perceptions in US adults. Am J Public Health 2012;102:1758-66.
- Cho JH, Shin E, Moon SS. Electronic-cigarette smoking experience among adolescents. J Adolesc Health 2011:49:542-6.
- Choi K, Forster JL. Beliefs and experimentation with electronic cigarettes: a prospective analysis among young adults. Am J Prev Med 2014;46:175-8.
- Benowitz NL. Emerging nicotine delivery products. Implications for public health. Ann Am Thorac Soc 2014;11:231-5.
- Benowitz NL, Goniewicz ML. The regulatory challenge of electronic cigarettes. JAMA 2013; 310:685-6.
- Goniewicz ML, Knysak J, Gawron M, et al. Levels of selected carcinogens and toxicants in vapour from electronic cigarettes. Tob Control 2014;23:133-9.
- Bekki K, Uchiyama S, Ohta K, Inaba Y, Nakagome H, Kunugita N. Carbonyl compounds generated from electronic cigarettes. Int J Environ Res Public Health 2014;11:11192-200.
- World Health Organization (WHO). Tobacco Free Initiative (TFI): Electronic cigarettes (e-cigarettes) or electronic nicotine delivery systems. Available at: http://www.who.int/entity/tobacco/communications/statements/eletronic_cigarettes/en/. Accessed 2/18/15.
- Department of Health and Human Services. Food and Drug Administration. Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products (Federal Register website). 2014. Available at: https://www.federalregister.gov/articles/2014/04/25/2014-09491/deeming-tobacco-products-to-be-subject-to-the-federal-food-drug-and-cosmetic-act-as-amended-by-the. Accessed 4/25/15.
Keywords: Adolescent, Coronary Disease, Electronic Cigarettes, Ethylene Glycols, Gingiva, Harm Reduction, Marketing, Minors, Mortality, Premature, Nicotine, Pandemics, Propylene Glycol, Public Health, Smoking, Social Media, Stroke, Tobacco, Tobacco Use Cessation, Tobacco Use Disorder, Tobacco Products, United States Food and Drug Administration
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