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e-Cigarettes—The Roles of Regulation and Clinicians

e-Cigarettes—The Roles of Regulation and Clinicians e-Cigarettes are a rapidly evolving category of battery-operated devices that heat nicotine, flavor additives, and chemicals to the point of areolation. Users generally refer to the inhalation of the aerosolized nicotine and chemicals as “vaping.” According to a recent survey by the Centers for Disease Control and Prevention, more than 13% of high school students in the United States have tried e-cigarettes.1 In our research, we found substantial annual increases in e-cigarette use among adults from 2010 to 2013. The prevalence of having tried an e-cigarette increased from 1.8% to 13.0%, and the prevalence of current e-cigarette use increased from 0.3% to 6.8%.2 e-Cigarettes do not combust tobacco; thus, many of the toxic and carcinogenic byproducts of combustion are either absent or present at substantially lower levels in their aerosol than in cigarette smoke. The absence of combustion has led to speculation that e-cigarettes could be beneficial for current smokers who are able to switch from combustible cigarettes to a product that may be less harmful. The rapid growth in the use of electronic cigarettes in the absence of regulation by the US Food and Drug Administration (FDA) has split the public health and medical communities. On the one hand, some argue for the value of providing nicotine through any means other than cigarette smoking. The popularity of nicotine delivery through e-cigarettes compared with FDA-approved nicotine replacement therapies creates an opportunity for some smokers to switch from cigarettes to a presumably less dangerous electronic product. On the other hand, clinicians worry that use of unregulated e-cigarettes might be seen as adequate therapy by patients and dissuade some users from first trying a full complement of the most effective approved medications including nicotine replacement therapies in combination (eg, a nicotine patch plus gum or lozenge), bupropion, or varenicline. The health impact of e-cigarettes on both users and bystanders is also a cause for concern; the use of e-cigarettes as well as conventional cigarettes may actually frustrate cessation attempts. The recent investments by leading cigarette manufacturers in e-cigarette products (eg, Philip Morris’ Mark Ten and R. J. Reynolds’ Vuse) reinforce these concerns. e-Cigarettes can produce volatile organic compounds, heavy metals, and other aerosolized toxins, albeit at lower levels than in combustible tobacco.3 Although e-cigarettes entered the US market in 2007, the federal government has yet to regulate them. In 2010, a federal appeals court ruled that the FDA may regulate e-cigarettes as tobacco products, as an alternative to the more rigorous approval process for drug delivery devices.4 Thus, unless a manufacturer chooses to seek such marketing approval, these devices will not be approved for smoking cessation. As of July 2015, the FDA had not finalized its authority to regulate e-cigarettes as tobacco products. The FDA’s proposed rule, issued in 2014 and under review at the Office of Management and Budget, would give the agency the authority to require health warning labels, restrict sales to people 18 years or older, and prohibit free samples.5 The proposed rule, however, does not address marketing to people younger than 18 years, the use of menthols and other flavors in e-cigarettes that make the produce more appealing, child safety issues, or prohibit the of use of the devices in places that are smoke-free. The debate over the potential for e-cigarettes to reduce harms to smokers, however, overlooks an obvious public health issue, that people who do not smoke may initiate and maintain e-cigarette use. As Kalkhoran and Glantz6 report in this issue of JAMA Internal Medicine, the health effects of expanding e-cigarette sales will depend on whether these products divert current or potential smokers from using cigarettes or attract users who were otherwise unlikely to start smoking. The features and marketing designed to make e-cigarettes more attractive to smokers than other nicotine replacement therapies are also likely to broaden their appeal to nonsmokers. In our research, we found that at least 20% of current users of e-cigarettes had either never smoked or were former smokers who had successfully quit before e-cigarettes were first marketed.2 Thus, a substantial segment of the current market for e-cigarettes is composed of people who were not using combustible tobacco when they initiated use. Successful regulation of e-cigarettes requires that the clear harms to nonsmokers be balanced against the potential reduction in harms for smokers. In our view, the final FDA regulations for e-cigarettes should address product design, flavors, and marketing that appeal to younger individuals. In addition, the Consumer Product Safety Commission should require child-proof containers for “e-juice,” which contains nicotine, glycol, and flavors, to prevent nicotine poisoning of children. In April 2015, more than 30 medical and health groups formally requested that the federal government finalize the proposed regulations for e-cigarettes.7 At the local and state levels, the use of e-cigarettes should be prohibited in places where smoking is not allowed. At present, only 3 states—North Dakota, New Jersey, and Utah—have enacted such laws, although hundreds of municipalities have done so.8 e-Cigarettes primarily emit a toxic aerosol, formed by propylene glycol, not harmless water vapor.7 Although the FDA has approved propylene glycol for use in consumable products, it has not approved propylene glycol for inhalation. Heating propylene glycol changes its chemical composition. The aerosol contains submicron particles that are a lung irritant, as well as nicotine, toxins, and carcinogens. Whereas the levels of these harmful chemicals are lower in e-cigarette aerosol than in tobacco smoke, the relevant comparator should be clean indoor air, not tobacco smoke. In the absence of objective evidence that the exhaled aerosol is safe to bystanders, the precautionary principle of requiring proof that a plausibly harmful action is not harmful supports restricting e-cigarette use where smoking is prohibited. The pollution of indoor air by e-cigarette users should be no more tolerable or permissible than pollution by cigarette smokers. As use increases, physicians and other clinicians are likely to counsel more patients about e-cigarettes. Despite the increased interest in these products as part of strategies to reduce or eliminate smoking, counseling patients to use e-cigarettes is a practice that is currently not supported by evidence. Thus, it should be considered off-label advice. Although the priority is to get tobacco users to completely stop using combusted tobacco, clinicians should also consider treating people who use e-cigarettes with nicotine replacement therapies that have been approved by the FDA. Moreover, every state has a “quit line” program that offers free counseling and often provides some nicotine replacement therapies at no cost to the consumer. According to the treating tobacco use and dependence guidelines from the US Public Health Service, the simultaneous use of 2 forms of nicotine replacement therapy increases the chances that a patient will stop using tobacco products.9 Thus, clinicians should recommend the use of safe forms of these therapies in combination. Nicotine replacement therapies should also be used to safely reduce the amount of smoking; cutting back on smoking behavior is often more acceptable to smokers who resist quitting entirely and increases quit rates in the long term. If research demonstrates health benefits to smokers who are able to completely switch from combustible tobacco products to e-cigarettes, these products could yet be approved for smoking cessation. Until then, the FDA and state and local authorities should impose a strict public health standard in determining whether or how these products should be sold and used. At a minimum, federal e-cigarette regulations should improve quality control, protect children from accidental poisonings, restrict marketing and appeal to youth, and protect nonusers from indoor air pollution. Back to top Article Information Corresponding Author: Robert C. McMillen, PhD, Social Science Research Center, Mississippi State University, 103 Research Park, Ste 103, Starkville, MS 39759 (rcm19@msstate.edu). Published Online: August 31, 2015. doi:10.1001/jamainternmed.2015.4436. Conflict of Interest Disclosures: None reported. Funding/Support: Support for this article has been provided in part by Legacy and the Flight Attendant Medical Research Institute. The authors are supported by the American Academy of Pediatrics Julius B. Richmond Center of Excellence. Role of the Funder/Sponsor: The funding sources had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. Disclaimer: The information, views, and opinions contained herein are those of the authors and do not necessarily reflect the views and opinions of Legacy or the Flight Attendant Medical Research Institute. References 1. Arrazola RA, Singh T, Corey CG, et al; Centers for Disease Control and Prevention (CDC). Tobacco use among middle and high school students: United States, 2011-2014. MMWR Morb Mortal Wkly Rep. 2015;64(14):381-385.PubMedGoogle Scholar 2. McMillen RC, Gottlieb MA, Shaefer RM, Winickoff JP, Klein JD. Trends in electronic cigarette use among US adults: use is increasing in both smokers and nonsmokers [published online November 6, 2014]. Nicotine Tob Res. doi:10.1093/ntr/ntu213.PubMedGoogle Scholar 3. Offerman F. The hazards of e-cigarettes.ASHRAE Journal.http://bookstore.ashrae.biz/journal/download.php?file=2014June_038-047_IAQ_Offerman_rev.pdf. Accessed July 13, 2015. 4. Sottera Inc v US Food & Drug Administration, 627 F3d 891 (DC Cir. 2010). 5. US Food and Drug Administration. Deeming Tobacco Products to be Subject to the Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations Restricting the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Product Packages and Advertisements. Docket No. FDA-2014_n_0189. 2014.http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM394933.pdf. Accessed July 13, 2015. 6. Kalkhoran A, Glantz SA. Modeling the health effects of expanding e-cigarette sales in the United States and United Kingdom: a Monte Carlo analysis [published online August 31, 2015]. JAMA Intern Med. doi:10.1001/jamainternmed.2015.4209.Google Scholar 7. Henley DE, Mueller K, Denneny JC, et al. Letter to President Obama; April 28, 2015.http://www.tobaccofreekids.org/content/press_office/2015/2015_04_28_obama.pdf. Accessed July 13, 2015. 8. States and municipalities with laws regulating use of electronic cigarettes: Americans for Nonsmokers’ Rights, April 2, 2015.http://no-smoke.org/pdf/ecigslaws.pdf. Accessed June 19, 2015. 9. Fiore C. Treating tobacco use and dependence: 2008 update: clinical practice guideline. 2008. http://www.ahrq.gov/professionals/clinicians-providers/guidelines-recommendations/tobacco/clinicians/update/index.html. Accessed July 13, 2015. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA Internal Medicine American Medical Association

e-Cigarettes—The Roles of Regulation and Clinicians

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American Medical Association
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Copyright © 2015 American Medical Association. All Rights Reserved.
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2168-6106
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2168-6114
DOI
10.1001/jamainternmed.2015.4436
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Abstract

e-Cigarettes are a rapidly evolving category of battery-operated devices that heat nicotine, flavor additives, and chemicals to the point of areolation. Users generally refer to the inhalation of the aerosolized nicotine and chemicals as “vaping.” According to a recent survey by the Centers for Disease Control and Prevention, more than 13% of high school students in the United States have tried e-cigarettes.1 In our research, we found substantial annual increases in e-cigarette use among adults from 2010 to 2013. The prevalence of having tried an e-cigarette increased from 1.8% to 13.0%, and the prevalence of current e-cigarette use increased from 0.3% to 6.8%.2 e-Cigarettes do not combust tobacco; thus, many of the toxic and carcinogenic byproducts of combustion are either absent or present at substantially lower levels in their aerosol than in cigarette smoke. The absence of combustion has led to speculation that e-cigarettes could be beneficial for current smokers who are able to switch from combustible cigarettes to a product that may be less harmful. The rapid growth in the use of electronic cigarettes in the absence of regulation by the US Food and Drug Administration (FDA) has split the public health and medical communities. On the one hand, some argue for the value of providing nicotine through any means other than cigarette smoking. The popularity of nicotine delivery through e-cigarettes compared with FDA-approved nicotine replacement therapies creates an opportunity for some smokers to switch from cigarettes to a presumably less dangerous electronic product. On the other hand, clinicians worry that use of unregulated e-cigarettes might be seen as adequate therapy by patients and dissuade some users from first trying a full complement of the most effective approved medications including nicotine replacement therapies in combination (eg, a nicotine patch plus gum or lozenge), bupropion, or varenicline. The health impact of e-cigarettes on both users and bystanders is also a cause for concern; the use of e-cigarettes as well as conventional cigarettes may actually frustrate cessation attempts. The recent investments by leading cigarette manufacturers in e-cigarette products (eg, Philip Morris’ Mark Ten and R. J. Reynolds’ Vuse) reinforce these concerns. e-Cigarettes can produce volatile organic compounds, heavy metals, and other aerosolized toxins, albeit at lower levels than in combustible tobacco.3 Although e-cigarettes entered the US market in 2007, the federal government has yet to regulate them. In 2010, a federal appeals court ruled that the FDA may regulate e-cigarettes as tobacco products, as an alternative to the more rigorous approval process for drug delivery devices.4 Thus, unless a manufacturer chooses to seek such marketing approval, these devices will not be approved for smoking cessation. As of July 2015, the FDA had not finalized its authority to regulate e-cigarettes as tobacco products. The FDA’s proposed rule, issued in 2014 and under review at the Office of Management and Budget, would give the agency the authority to require health warning labels, restrict sales to people 18 years or older, and prohibit free samples.5 The proposed rule, however, does not address marketing to people younger than 18 years, the use of menthols and other flavors in e-cigarettes that make the produce more appealing, child safety issues, or prohibit the of use of the devices in places that are smoke-free. The debate over the potential for e-cigarettes to reduce harms to smokers, however, overlooks an obvious public health issue, that people who do not smoke may initiate and maintain e-cigarette use. As Kalkhoran and Glantz6 report in this issue of JAMA Internal Medicine, the health effects of expanding e-cigarette sales will depend on whether these products divert current or potential smokers from using cigarettes or attract users who were otherwise unlikely to start smoking. The features and marketing designed to make e-cigarettes more attractive to smokers than other nicotine replacement therapies are also likely to broaden their appeal to nonsmokers. In our research, we found that at least 20% of current users of e-cigarettes had either never smoked or were former smokers who had successfully quit before e-cigarettes were first marketed.2 Thus, a substantial segment of the current market for e-cigarettes is composed of people who were not using combustible tobacco when they initiated use. Successful regulation of e-cigarettes requires that the clear harms to nonsmokers be balanced against the potential reduction in harms for smokers. In our view, the final FDA regulations for e-cigarettes should address product design, flavors, and marketing that appeal to younger individuals. In addition, the Consumer Product Safety Commission should require child-proof containers for “e-juice,” which contains nicotine, glycol, and flavors, to prevent nicotine poisoning of children. In April 2015, more than 30 medical and health groups formally requested that the federal government finalize the proposed regulations for e-cigarettes.7 At the local and state levels, the use of e-cigarettes should be prohibited in places where smoking is not allowed. At present, only 3 states—North Dakota, New Jersey, and Utah—have enacted such laws, although hundreds of municipalities have done so.8 e-Cigarettes primarily emit a toxic aerosol, formed by propylene glycol, not harmless water vapor.7 Although the FDA has approved propylene glycol for use in consumable products, it has not approved propylene glycol for inhalation. Heating propylene glycol changes its chemical composition. The aerosol contains submicron particles that are a lung irritant, as well as nicotine, toxins, and carcinogens. Whereas the levels of these harmful chemicals are lower in e-cigarette aerosol than in tobacco smoke, the relevant comparator should be clean indoor air, not tobacco smoke. In the absence of objective evidence that the exhaled aerosol is safe to bystanders, the precautionary principle of requiring proof that a plausibly harmful action is not harmful supports restricting e-cigarette use where smoking is prohibited. The pollution of indoor air by e-cigarette users should be no more tolerable or permissible than pollution by cigarette smokers. As use increases, physicians and other clinicians are likely to counsel more patients about e-cigarettes. Despite the increased interest in these products as part of strategies to reduce or eliminate smoking, counseling patients to use e-cigarettes is a practice that is currently not supported by evidence. Thus, it should be considered off-label advice. Although the priority is to get tobacco users to completely stop using combusted tobacco, clinicians should also consider treating people who use e-cigarettes with nicotine replacement therapies that have been approved by the FDA. Moreover, every state has a “quit line” program that offers free counseling and often provides some nicotine replacement therapies at no cost to the consumer. According to the treating tobacco use and dependence guidelines from the US Public Health Service, the simultaneous use of 2 forms of nicotine replacement therapy increases the chances that a patient will stop using tobacco products.9 Thus, clinicians should recommend the use of safe forms of these therapies in combination. Nicotine replacement therapies should also be used to safely reduce the amount of smoking; cutting back on smoking behavior is often more acceptable to smokers who resist quitting entirely and increases quit rates in the long term. If research demonstrates health benefits to smokers who are able to completely switch from combustible tobacco products to e-cigarettes, these products could yet be approved for smoking cessation. Until then, the FDA and state and local authorities should impose a strict public health standard in determining whether or how these products should be sold and used. At a minimum, federal e-cigarette regulations should improve quality control, protect children from accidental poisonings, restrict marketing and appeal to youth, and protect nonusers from indoor air pollution. Back to top Article Information Corresponding Author: Robert C. McMillen, PhD, Social Science Research Center, Mississippi State University, 103 Research Park, Ste 103, Starkville, MS 39759 (rcm19@msstate.edu). Published Online: August 31, 2015. doi:10.1001/jamainternmed.2015.4436. Conflict of Interest Disclosures: None reported. Funding/Support: Support for this article has been provided in part by Legacy and the Flight Attendant Medical Research Institute. The authors are supported by the American Academy of Pediatrics Julius B. Richmond Center of Excellence. Role of the Funder/Sponsor: The funding sources had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. Disclaimer: The information, views, and opinions contained herein are those of the authors and do not necessarily reflect the views and opinions of Legacy or the Flight Attendant Medical Research Institute. References 1. Arrazola RA, Singh T, Corey CG, et al; Centers for Disease Control and Prevention (CDC). Tobacco use among middle and high school students: United States, 2011-2014. MMWR Morb Mortal Wkly Rep. 2015;64(14):381-385.PubMedGoogle Scholar 2. McMillen RC, Gottlieb MA, Shaefer RM, Winickoff JP, Klein JD. Trends in electronic cigarette use among US adults: use is increasing in both smokers and nonsmokers [published online November 6, 2014]. Nicotine Tob Res. doi:10.1093/ntr/ntu213.PubMedGoogle Scholar 3. Offerman F. The hazards of e-cigarettes.ASHRAE Journal.http://bookstore.ashrae.biz/journal/download.php?file=2014June_038-047_IAQ_Offerman_rev.pdf. Accessed July 13, 2015. 4. Sottera Inc v US Food & Drug Administration, 627 F3d 891 (DC Cir. 2010). 5. US Food and Drug Administration. Deeming Tobacco Products to be Subject to the Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations Restricting the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Product Packages and Advertisements. Docket No. FDA-2014_n_0189. 2014.http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM394933.pdf. Accessed July 13, 2015. 6. Kalkhoran A, Glantz SA. Modeling the health effects of expanding e-cigarette sales in the United States and United Kingdom: a Monte Carlo analysis [published online August 31, 2015]. JAMA Intern Med. doi:10.1001/jamainternmed.2015.4209.Google Scholar 7. Henley DE, Mueller K, Denneny JC, et al. Letter to President Obama; April 28, 2015.http://www.tobaccofreekids.org/content/press_office/2015/2015_04_28_obama.pdf. Accessed July 13, 2015. 8. States and municipalities with laws regulating use of electronic cigarettes: Americans for Nonsmokers’ Rights, April 2, 2015.http://no-smoke.org/pdf/ecigslaws.pdf. Accessed June 19, 2015. 9. Fiore C. Treating tobacco use and dependence: 2008 update: clinical practice guideline. 2008. http://www.ahrq.gov/professionals/clinicians-providers/guidelines-recommendations/tobacco/clinicians/update/index.html. Accessed July 13, 2015.

Journal

JAMA Internal MedicineAmerican Medical Association

Published: Oct 1, 2015

Keywords: nicotine replacement therapy,smoking cessation,advertising,patient education,tobacco use cessation,united states food and drug administration,propylene glycol toxicity,young adult,regulation,teenage smoking,marketing,electronic cigarettes,government regulations

References