E-Cigarettes: Policy Options and Legal Issues Amidst Uncertainty Nancy Kaufman and Margaret Mahoney

Introduction E-cigarettes, sometimes referred to as ENDS (Electronic Nicotine Delivery Systems), include a broad range of products that deliver nicotine via heating and aerosolization of the drug. ENDS come in a variety of forms, but regardless of form generally consist of a solution containing humectant (e.g., propylene glycol or glycerol), flavorings, and usually nicotine (some solutions do not contain nicotine); a batterypowered coil that heats the solution into an aerosol (usually referred to as vapor) in an atomizing chamber; and a mouthpiece through which the user draws the vapor into the mouth and lungs. The devices may be closed systems containing prefilled cartridges, or open systems, where the user manually refills a 1-2 ml. tank with solution. What started as closed-system cigarette-shaped devices marketed as an adjunct for smoking cessation, has transitioned rapidly to literally thousands of hip and funky-designed open-system hookah pens, vape pens, and modifiable devices. For younger people, these forms are the “in” thing, while traditional cigarette-shaped devices are “out.” The ENDS business has grown rapidly, generating $2 billion in 2013,1 and the big tobacco companies, small independent shops, and Internet dealers all participate in the sector. Marketing pervades traNancy Kaufman, R.N., M.S., is the President of The Strategic Vision Group. She served as Vice President at the Robert Wood Johnson Foundation (RWJF) from 1991-2003, leading its public health, tobacco control and health reform efforts. From 1982-1991, she was Deputy Director of Public Health in Wisconsin. Margaret Mahoney, J.D., is a staff attorney with the Public Health Law Center. She serves as deputy director of the Tobacco Control Legal Consortium, a network of legal centers supporting tobacco control policy change throughout the United States.

ditional and social media, using many tactics now banned for cigarettes such as free samples, billboard ads, event (e.g., auto racing, music festivals) or cause sponsorships, and television ads in prime time. Like cigarette ads of old, television, online, and print ads feature catchy slogans and celebrity endorsers, including Jenny McCarthy for blu (Lorillard) and Bruno Mars and Robert Pattinson for NJOY (independent). Ads feature rugged men (reminiscent of the Marlboro Man), sexy, scantily-clad women, or cartoon characters. And, although Section 907(a)(1)(A) of the federal Food, Drug, and Cosmetic Act banned fruit and candy flavored cigarettes as of September 2009, the ENDS industry filled the void with thousands of flavors, including cotton candy, almond joy, gummy bear, liquid candy, and cupcake.

Potential for Benefit ENDS could potentially benefit public health if they were responsibly marketed and properly regulated to significantly reduce the number of people who smoke conventional cigarettes. ENDS aerosol usually contains some carcinogens and other toxicants at average levels of one to two orders of magnitude lower than in tobacco smoke, but higher than in a prescription inhalation device delivering nicotine in gradually diminishing doses. Although not risk-free, it is likely that exclusive ENDS use generates lower exposure to toxicants than use of combustible products.2 Smokers try repeatedly to quit. Most eventually do, but some do not and some take a very long time. Few studies have systematically examined whether ENDS are effective for quitting tobacco smoking, but the initial evidence is not promising. The only randomized control trial that compared use of ENDS (with or without nicotine) to nicotine patches without con-

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current counseling in the general population showed similar, low efficacy for quitting smoking.3 A recent longitudinal study of e-cigarette use among patients with cancer found that users were as likely to be smoking at the time of follow-up as nonusers.4 Five population-based studies of all smokers using comparable methods showed that use of ENDS resulted in fewer smokers quitting.5 Thus, at currently known levels of efficacy, ENDS may help some smokers to switch completely from cigarettes. However, for a sizeable number of smokers, ENDS use will result in the reduction of cigarette use rather than in quitting (dual use). 6 Roughly 64 percent of current adult ENDS users also smoke cigarettes.7

Potential for Harm While switching to ENDS may be less harmful on an individual level as compared to using combustible tobacco products, ENDS pose potential risks to public health if they cause more people, particularly adolescents and young adults, to begin using nicotine products; are not used by smokers to quit using combustible tobacco products altogether; or they renormalize smoking in public places. An estimated 1.78 million youth (middle and high school students) had used e-cigarettes as of 2012.8 More than one-quarter million youth who had never smoked a cigarette used electronic cigarettes in 2013.9 These youth were twice as likely to have intentions to smoke conventional cigarettes.10 The number of youth who used ENDS but have never smoked a regular cigarette tripled over the past three years, from 79,000 in 2011 to over 263,000 in 2013.11 Exposure to ENDS television ads increased 256 percent in 12-17 year olds and 321 percent among young adults (1824 years) from 2011 to 2013.12 Established adolescent smokers (>100 cigarettes) who use ENDS are half as likely to quit,13 and 50 percent of youth ENDS users also use cigarettes.14 Thus, e-cigarettes are causing youth to become exposed and maintain an addiction to nicotine, including in the form of combustible tobacco products. In addition to the known dangers of combustible products, the Surgeon General cautions that it is likely that nicotine exposure during adolescence adversely affects cognitive function and brain development.15 Heating e-liquids produces chemical and particulate matter, reaching the user and the surrounding environment (secondhand vaping). Nicotine exists in ENDS emissions, and non-users absorb nicotine.16 Super-heating via user modification of devices may change some chemicals into more harmful forms and exact user and secondhand effects of this type of modification remain unknown. Other concerns include 24

toxic overdoses from skin absorption of nicotine during tank handling, poisoning from e-liquids drunk by children, and overdoses due to self-mixed tank liquids.

Policy Options and Legal Issues ENDS and their marketing evolve faster than the scientific evidence about harms and any possible benefits, some of which may take decades. ENDS policies should address what is known or likely to be a serious concern. They can be adapted if any evidence of benefits emerges. Regulating Marketing Current ENDS marketing practices mimic the decades of misleading cigarette marketing. Minimally, marketing restrictions in place for cigarettes should extend to ENDS. Every state and some local governments have consumer protection or unfair trade practice laws in place to control false or misleading product claims; these laws may be enforceable against e-cigarette marketing efforts. In conjunction with a law prohibiting sales to minors, limits on targeted marketing of e-cigarettes to minors should be considered. While some limits to restrictions on commercial speech exist, legal counsel could consider how e-cigarettes are promoted in a community and the extent to which restrictions can be placed on those efforts.17 Regulating Sale A government could consider prohibiting the sale of ENDS anywhere within its jurisdiction; prohibiting the sale of ENDS to minors; requiring ENDS to be kept behind the counter in stores; requiring e-cigarette stores and “vaping lounges” to be licensed as tobacco retailers; prohibiting the sale of certain ENDS-related products, such as flavored e-cigarette liquid; or allowing ENDS to be sold only in places where minors are not permitted to enter. Regulating Use Because e-cigarettes emit aerosol rather than secondhand smoke, many existing smoke-free laws or policies do not restrict the use of these products in public or in places of employment. Recent scientific research on negative health effects related to secondhand exposure to ENDS emissions caused a growing number of state and local governments to prohibit ENDS use in various public places and places of employment — under existing or new smoke-free laws. Regulating Price All states and those localities with taxing powers should consider imposing a tax on e-cigarettes and journal of law, medicine & ethics

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related products to offset health expenses and costs related to tobacco control programs or enforcement. In addition, prohibiting the distribution of all free samples of ENDS and the use of coupons, rebates, or other discounting practices for ENDS may be politically feasible options.

the proposed regulation would restrict minors from purchasing e-cigarettes, prohibit free samples, require ingredient disclosure and premarket review of new products, and prohibit most vending machine sales. Some requirements the FDA has authority to impose, such as requiring that products be kept behind the

ENDS have significant potential to harm population health, given the tobacco industry’s use of former cigarette marketing tactics for ENDS, the appeal of these products to youth and young adults, and the fact that most youth and adult ENDS users continue smoking conventional cigarettes (dual use), and some who never used conventional products are now starting to use ENDS, which are addictive products. Waiting years to regulate ENDS until possible evidence exists to support claims that, on a whole, ENDS produce a populationlevel benefit is not prudent. Regulating Packaging and Disposal Governments could require that ENDS and e-liquids be sold in child-resistant packaging. Also, because improper disposal of e-cigarette cartridges, batteries, and related devices could result in nicotine exposure to children, adults, and animals, the contamination of soil and water, and other adverse impacts on the environment, policy options for ensuring environmentally responsible disposal of e-cigarette waste could be considered. The tobacco industry and its allies often challenge in court state and local measures regulating the sale, use, marketing, or price of tobacco products, alleging constitutional violations, including preemption by other laws. The industry’s challenges attempt to dissuade other communities from adopting similar provisions. Industry-proposed legislation that purports to regulate ENDS needs to be reviewed carefully because it may undermine effective policies via exempting ENDS from other tobacco product regulations or severely limit local authority through preemption provisions.

Federal, State and Local Response On April 25, 2014, the FDA released its proposed regulation that would treat certain ENDS as tobacco products (21 CFR Parts 1100, 1140, and 1143 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; Proposed Rule). Key provisions of

counter, were not included. Over 135,000 comments were submitted to FDA and a final rule is not anticipated for some time. Clean air and taxation policies cannot be adopted by the FDA, so many have been enacted at the state and local levels, and many states and localities are adopting other ENDS-related policies much sooner than federal regulations will be in place. A number of states and localities passed or are in the process of considering policies or actions to limit harm from ENDS, e.g., by regulating: marketing (UT), sale (MN, UT, New York City, Providence RI, Suffolk County NY), use (AR, CO, DE, HI, MD, NH, NJ, ND, OK, OR, SD, UT, VT, Boston, Suffolk County NY), price (MN, NC, Providence RI, Petersburg AK), and packaging (MN, VT).18

Critical Opportunities ENDS have significant potential to harm population health, given the tobacco industry’s use of former cigarette marketing tactics for ENDS, the appeal of these products to youth and young adults, and the fact that most youth and adult ENDS users continue smoking conventional cigarettes (dual use), and some who never used conventional products are now starting to use ENDS, which are addictive products. Waiting years to regulate ENDS until possible evidence exists to support claims that, on a whole, ENDS produce a population-level benefit is not prudent. It is critical that FDA finalize its proposed rule to begin regulating e-cigarettes, by no later than April 2015 (one year post proposal), and strengthen its proposed rule by extending current restrictions on cigarettes, such as those related to mar-

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keting and flavorings, to ENDS. States and localities should not wait for the FDA to act, and instead should address ENDS-related issues in their communities as they do other tobacco products. References

1. B. Herzog, U.S. Tobacco Trends: Disruptive Innovation Should Drive Outsized Growth, presentation at Electronic Cigarette Education Summit by Logic, March 20, 2014. 2. WHO, Electronic Nicotine Delivery Systems, FCTC/COP/6/10 21 July 2014, available at (last visited January 22, 2015). 3. C. B. Bullen, C. Howe, M. Laugeson, H. McRobbie, V. Parag, and J. Williman et al., “Electronic Cigarettes for Smoking Cessation: A Randomized Controlled Trial,” The Lancet 382, no. 9005 (2013): 1629-1637. 4. S. P. Borderud, Y. Li, J. E. Burkhalter, C. E. Sheffer, and J. S. Ostroff, “Electronic Cigarette Use among Patients With Cancer: Characteristics of Electronic Cigarette Users and Their Smoking Cessation Outcomes,” Cancer 120, no. 22 (2014): 3527-3535. 5. R. Grana, N. Benowitz, and S. A. Glantz, “E-Cigarettes: A Scientific Review,” Circulation 129, no. 19 (2014): 1972-1986. 6. See WHO, supra note 5. 7. R. C. McMillen, M. A. Gottlieb, and R. M. Whitmore et al., “Trends in Electronic Cigarette Use among U.S. Adults: Use Is Increasing in Both Smokers and Nonsmokers,” Nicotine and Tobacco Research 16, no. 11 (2014), available at (last visited January 22, 2015). 8. CDC, “Electronic Cigarette Use among Middle and High School Students—United States 2011-2012,” MMWR 62, no. 35 (September 6, 2013): 709-732. 9. R. E. Bunnell, I. T. Agaku, and R. A. Arrazola et al., “Intentions to Smoke Cigarettes among Never-Smoking U.S. Middle and High School Electronic Cigarette Users, National Youth

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Tobacco Survey, 2011–2013,” Nicotine and Tobacco Research 17, no. 2 (2015): 228-235. 10. See Bunnell, supra note 7. 11.  Id. 12. J. C. Duke, Y. O. Lee, and A. E. Kim et al, “Exposure to Electronic Cigarette Television Advertisements among Youth and Young Adults,” Pediatrics 134, no. 1 (2014): 1-8. 13. L. M. Dutra and S. A. Glantz, “Electronic Cigarettes and Conventional Cigarette Use among US Adolescents,” JAMA Pediatrics 168, no. 7 (2014): 610-617. 14. See Dutra, supra note 12. 15. USDHHS, The Health Consequences of Smoking – 50 Years of Progress: A Report of the Surgeon General, 2014, at 122, available at (last visited January 22, 2015). 16. M. Ballbèa, J. M. Martínez-Sáncheza, and X. Sureda et al., “Cigarettes vs. e-Cigarettes: Passive Exposure at Home Measured by Means of Airborne Marker and Biomarkers,” Environmental Research 135 (2014): 76-80. 17.  Tobacco Control Legal Consortium, Restricting Tobacco Advertising – Tips and Tools (2011), available at  (last visited January 22, 2015); Tobacco Control Legal Consortium, Content-Neutral Advertising – Tips and Tools (2011), available at (last visited January 22, 2015); K. Dachille, Tobacco Control Legal Consortium, Regulating Tobacco Advertising and Promotion: A “Commerce Clause” Overview for State and Local Governments 11 (2010), available at  (last visited January 22, 2015). 18. For quarterly updated information, see U.S. State and Local Laws Regulating Use of Electronic Cigarettes, American Nonsmokers’ Rights Foundation, available at (last visited January 22, 2015).

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