PUBLIC HEALTH POLICY BRIEF
Electronic Cigarettes: Smoke-Free Laws, Sale Restrictions, and the Public Health Consumer use of e-cigarettes is rising despite a lack of rigorous safety testing, manufacturing controls, and a well-understood risk profile. Many states and municipalities have prohibited e-cigarette sale to minors or amended their smokefree laws to restrict public use. I discuss the public health impact of e-cigarettes and the current lack of Food and Drug Administration regulation, and advocate that states and localities reexamine their smoke-free laws and sale restrictions to appropriately regulate public use and youth access. (Am J Public Health. 2014; 104:e17–e18. doi:10.2105/AJPH. 2014.301890)
Jordan Paradise, JD
SMOKING CONSISTENTLY accounts for nearly 5.4 million deaths worldwide1 and approximately 443 000 in the United States each year.2 Heeding the significant health warnings and deadly statistics, smokers are increasingly turning to a new mode of nicotine intake: the electronic cigarette, or e-cigarette. Public awareness and use of e-cigarettes is skyrocketing as a result of targeted marketing tactics.3 The Centers for Disease Control and Prevention (CDC) report that e-cigarette use quadrupled in a 1-year period and continues to rise.4 Twenty-one percent of adult smokers in the United States have used e-cigarettes, 6% of all adults have tried e-cigarettes, and general awareness of e-cigarettes has risen to 60% of all adults, up from 40% the previous year.4 The CDC also report that use among US youths is staggering, having doubled among highschool students between 2011 and 2012.5 This most recent figure has led many nonsmoking advocates and health officials to question whether a troubling gateway effect of e-cigarettes for subsequent youth cigarette smoking is emerging after decades of decline in cigarette use by minors.6 A core feature of the e-cigarette is that it looks and feels like a cigarette, satisfying psychological and behavioral stimuli for users who smoke. E-cigarettes, however, are smokeless, consisting of a replaceable nicotine cartridge, an atomizer that vaporizes the nicotine when the user inhales, and a battery that powers the device. The
June 2014, Vol 104, No. 6 | American Journal of Public Health
nicotine cartridge contains nicotine and various secondary chemical ingredients. When screwed together, the nicotine liquid from the cartridge contacts the atomizer and is carried to a metal coil heating element. The intake of air triggers a current from the battery through the atomizer, which heats up the nicotine liquid. Often, a light-emitting diode at the base mimics the burning ash at the end of traditional cigarette as the user inhales. Many products resemble a traditional cigarette, yet some are marketed in the shape of other household accessories such as pipes, pens, and lipstick. A single cartridge can hold the nicotine equivalent of an entire pack of cigarettes or more, and there is tremendous variation in the composition, strengths, and flavoring of the nicotine liquid. 7 E-cigarette advertisements, and the celebrities that frequent them, have emphasized the freedom to smoke anywhere; a lack of smell, tar, smoke, or toxic chemicals; an absence of social stigma; cost savings; and health advantages, often specifically reaching out to smokers aiming to quit or cut down. 8 Some distributors also advertise their products as not emitting secondhand smoke or as ecologically friendly.8 The accuracy of these claims is unclear and contested. In fact, the Food and Drug Administration (FDA) and health care professionals alike have raised concern about the novel method of nicotine delivery, product ingredients, nicotine levels, safety of the various mechanical and electrical parts, dearth of data
on product performance, and both explicit and implicit messages to users regarding health benefits.9 Scientific and clinical publications have only begun to target issues related to e-cigarette use. Consumer use, marketing and promotional claims, and technological characteristics of e-cigarettes have also raised decades-old questions of when the FDA can assert authority over particular products as drugs or medical devices. The 2010 DC Circuit case of Sottera v. FDA limited the FDA’s authority to regulate e-cigarettes as drugs or medical devices to instances where the manufacturer makes explicit health or diseaseprevention claims for its products.10 Examining the language and congressional intent of the Family Smoking Prevention and Tobacco Control Act of 2009 (TCA), the court held that e-cigarettes fall within the literal definition of tobacco products because nicotine is “derived from tobacco,” as set forth in the TCA definitions. The FDA declined to appeal that decision and is currently assessing appropriate regulation and enforcement activities; the agency has issued a statement that it plans to assert regulatory authority over e-cigarettes as tobacco products.11 While the FDA struggles to determine how to regulate these products at the federal level, state and local governments also have a role to play. The TCA, coupled with previous legislative authority, gives broad latitude to states and localities to enact laws and regulations relating to the sale, distribution, possession, and use of
Paradise | Peer Reviewed | Public Health Policy Brief | e17
PUBLIC HEALTH POLICY BRIEF
tobacco products.12 State and local regulatory efforts have focused on smoke-free laws and restrictions on use and sale. Thirty-six states and 3931 municipalities have laws in place restricting or prohibiting smoking in public places and workplaces.13 The scope of the laws varies, commonly directed at a combination of locations such as nonhospitality workplaces, restaurants and bars, and public areas. The overwhelming majority of the laws were drafted with cigarettes and traditional tobacco products in mind, with many specifically using the word “smoke” or “smoking” to define the restricted or prohibited action. However, e-cigarettes do not produce smoke; they produce vapor. States and localities must reexamine their smoke-free laws and access restrictions to appropriately regulate the use of e-cigarettes. As of September 2013, 27 states and localities have amended their smoke-free laws to explicitly include e-cigarettes within the ban on smoking in public places.14 For example, the New Jersey SmokeFree Air Act prohibits smoking in indoor public places, workplaces, and in buildings or grounds of any public or nonpublic elementary or secondary school. It was amended in 2010 to include within the scope of smoking “the inhaling or exhaling of smoke or vapor from an electronic smoking device.”15 An electronic smoking device is further defined as “an electronic device that can be used to deliver nicotine or other substances to the person inhaling from the device, including, but not limited to, an electronic cigarette, cigar, cigarillo, or pipe.”15 Likewise, New York bans e-cigarette use within 100 feet of entrances and exits to public or private schools.16 In addition to the state laws, Somerset, Massachusetts; King County, Washington;
Madison County, Kentucky; Savannah, Georgia; and Petaluma, California, are just a few cities and counties, among others, that have passed ordinances explicitly including e-cigarettes within the scope of their smoking bans.14 Both California and Oregon have settled in court with leading e-cigarette manufacturers and distributors, making the sale of their specific e-cigarette products unlawful in those states.14 Thirty-four states and municipalities have also enacted laws banning sales of e-cigarettes to minors, although the age limitations vary from younger than 18 to younger than 21 years.14 Dozens of states include both a ban on smoking in public settings and a ban on sale to minors, and other laws contain individual nuances.14 For example, Hawaii prohibits the sale of e-cigarettes to minors younger than 18 years, and also requires in-person sales rather than sales through the Internet.14 Tacoma--Pierce County, Washington, includes a ban on free sampling unless within an e-cigarette retail store.14 In a September 2013 letter to the FDA, lawmakers joined the call, urging the agency to act swiftly at the federal level to address the epidemic of youths’ use of e-cigarettes.17 Federal legislators have also advocated hearings on the health risks and scope of FDA authority.17 These state and local laws are merely a stopgap measure and fail to establish a uniform national policy for e-cigarettes. The best outcome to ensure the protection of the public health, and youths in particular, would be for the FDA to initiate rulemaking proceedings to deem e-cigarettes within the definitional scope of the TCA. This would allow the FDA to develop manufacturing requirements, reporting mechanisms, product
e18 | Public Health Policy Brief | Peer Reviewed | Paradise
standardization, ingredient listings, limitations on marketing claims, and various other procedures to install proper oversight of product development and distribution. As with any effort at content regulation, First Amendment challenges may arise. However, states and local governments also have a role in regulation and should proactively reassess their existing smoking bans, sale to minors, and other restrictions and decide whether to amend the language to include e-cigarettes. Failing to include a clear statutory definition leaves use and access to e-cigarettes as a significant loophole, and may thwart even the most well-intended public health laws. j
About the Author Jordan Paradise is with Seton Hall University Law School, Newark, NJ. Correspondence should be sent to Jordan Paradise, JD, Associate Professor of Law, Seton Hall University Law School, One Newark Center, Newark, NJ 07102 (e-mail: jordan. [email protected]). Reprints can be ordered at http://www.ajph.org by clicking the “Reprints” link. This article was accepted January 16, 2014.
Human Participant Protection Institutional review board approval was not necessary because the article did not involve human participants research.
References 1. World Health Organization. Tobacco Free Initiative: tobacco facts. Available at http://www.who.int/tobacco/mpower/ tobacco_facts/en/index.html. Accessed October 18, 2013. 2. Centers for Disease Control and Prevention. Current cigarette smoking among adults—United States, 2011. JAMA. 2013; 309(6):539-- 541. 3. Elliot S. E-cigarette makers’ ads echo tobacco’s heyday. New York Times. August 29, 2013:B1.
cigarettes use among middle and high school students—United States, 2011--2012. MMWR Morb Mortal Wkly Rep. 2013;62(35):729---730. 6. Tavernise S. Rise is seen in students who use e-cigarettes. New York Times. September 5, 2013:A12. 7. New England Law School, Center for Public Health and Tobacco Policy. E-cigarettes fact sheet. Available at: http://www.tobaccopolicycenter.org/ documents/CPHTP%20e-cig%20fact% 20sheet%2010-17-2013%20(2).pdf. Accessed October 18, 2013. 8. Rutgers University School of Public Health. Trinkets and trash: artifacts of the tobacco epidemic. Available at: http:// www.trinketsandtrash.org. Accessed October 18, 2013. 9. Letter from B.J. Westenberger, deputy director, Division of Pharmaceutical Analysis, FDA, to Michael Levy, supervisor regulatory counsel, Office of Compliance, Division of New Drugs and Labeling Compliance, FDA. May 4, 2009. Available at: http://www.fda.gov/downloads/ Drugs/ ScienceResearch/UCM173250. pdf. Accessed October 18, 2013. 10. Sottera v. FDA, 627 F3d 891 (DC Cir 2010). 11. Food and Drug Administration. RIN 0910---AG38. Spring 2013. Available at: http://www.reginfo.gov/public/do/ eAgendaViewRule?pubId=201304& RIN=0910-AG38. Accessed October 18, 2013. 12. Family Smoking Prevention and Tobacco Control Act, Pub L No. 111---31, §2, 123 Stat 1776 (2009) (codified as amended in scattered sections of 5 USC, 15 USC, and 21 USC). 13. American Nonsmokers Rights Foundation. Overview list—how many smokefree laws? 2013. Available at: http:// www.no-smoke.org/pdf/mediaordlist.pdf. Accessed October 18, 2013. 14. Global Advisors Smokefree Policy. Electronic smoking devices. 2013. Available at: http://www.njgasp.org/E-Cigs_ White_Paper.pdf. Accessed October 18, 2013. 15. NJ Stat Ann §26:3D-57 (2010). 16. NY Pub Health Law §1399 (2013). 17. Hattem J. House Dems call for cigar, e-cigarette regulations over “kid-friendly” products. The Hill. September 16, 2013.
4. Centers for Disease Control and Prevention. About one in five US adult cigarette smokers have tried an electronic cigarette. 2013. Available at: http://www.cdc.gov/media/releases/ 2013/p0228_electronic_cigarettes. html. Accessed October 18, 2013. 5. Centers for Disease Control and Prevention. Notes from the field: electronic
American Journal of Public Health | June 2014, Vol 104, No. 6
Electronic Cigarettes: Smoke-Free Laws, Sale Restrictions, and the Public Health Consumer use of e-cigarettes is rising despite a lack of rigorous safety testing, manufacturing controls, and a well-understood risk profile. Many states and municipalities have prohibited e-cigarette sale to minors or amended their smokefree laws to restrict public use. I discuss the public health impact of e-cigarettes and the current lack of Food and Drug Administration regulation, and advocate that states and localities reexamine their smoke-free laws and sale restrictions to appropriately regulate public use and youth access. (Am J Public Health. 2014; 104:e17–e18. doi:10.2105/AJPH. 2014.301890)
Jordan Paradise, JD
SMOKING CONSISTENTLY accounts for nearly 5.4 million deaths worldwide1 and approximately 443 000 in the United States each year.2 Heeding the significant health warnings and deadly statistics, smokers are increasingly turning to a new mode of nicotine intake: the electronic cigarette, or e-cigarette. Public awareness and use of e-cigarettes is skyrocketing as a result of targeted marketing tactics.3 The Centers for Disease Control and Prevention (CDC) report that e-cigarette use quadrupled in a 1-year period and continues to rise.4 Twenty-one percent of adult smokers in the United States have used e-cigarettes, 6% of all adults have tried e-cigarettes, and general awareness of e-cigarettes has risen to 60% of all adults, up from 40% the previous year.4 The CDC also report that use among US youths is staggering, having doubled among highschool students between 2011 and 2012.5 This most recent figure has led many nonsmoking advocates and health officials to question whether a troubling gateway effect of e-cigarettes for subsequent youth cigarette smoking is emerging after decades of decline in cigarette use by minors.6 A core feature of the e-cigarette is that it looks and feels like a cigarette, satisfying psychological and behavioral stimuli for users who smoke. E-cigarettes, however, are smokeless, consisting of a replaceable nicotine cartridge, an atomizer that vaporizes the nicotine when the user inhales, and a battery that powers the device. The
June 2014, Vol 104, No. 6 | American Journal of Public Health
nicotine cartridge contains nicotine and various secondary chemical ingredients. When screwed together, the nicotine liquid from the cartridge contacts the atomizer and is carried to a metal coil heating element. The intake of air triggers a current from the battery through the atomizer, which heats up the nicotine liquid. Often, a light-emitting diode at the base mimics the burning ash at the end of traditional cigarette as the user inhales. Many products resemble a traditional cigarette, yet some are marketed in the shape of other household accessories such as pipes, pens, and lipstick. A single cartridge can hold the nicotine equivalent of an entire pack of cigarettes or more, and there is tremendous variation in the composition, strengths, and flavoring of the nicotine liquid. 7 E-cigarette advertisements, and the celebrities that frequent them, have emphasized the freedom to smoke anywhere; a lack of smell, tar, smoke, or toxic chemicals; an absence of social stigma; cost savings; and health advantages, often specifically reaching out to smokers aiming to quit or cut down. 8 Some distributors also advertise their products as not emitting secondhand smoke or as ecologically friendly.8 The accuracy of these claims is unclear and contested. In fact, the Food and Drug Administration (FDA) and health care professionals alike have raised concern about the novel method of nicotine delivery, product ingredients, nicotine levels, safety of the various mechanical and electrical parts, dearth of data
on product performance, and both explicit and implicit messages to users regarding health benefits.9 Scientific and clinical publications have only begun to target issues related to e-cigarette use. Consumer use, marketing and promotional claims, and technological characteristics of e-cigarettes have also raised decades-old questions of when the FDA can assert authority over particular products as drugs or medical devices. The 2010 DC Circuit case of Sottera v. FDA limited the FDA’s authority to regulate e-cigarettes as drugs or medical devices to instances where the manufacturer makes explicit health or diseaseprevention claims for its products.10 Examining the language and congressional intent of the Family Smoking Prevention and Tobacco Control Act of 2009 (TCA), the court held that e-cigarettes fall within the literal definition of tobacco products because nicotine is “derived from tobacco,” as set forth in the TCA definitions. The FDA declined to appeal that decision and is currently assessing appropriate regulation and enforcement activities; the agency has issued a statement that it plans to assert regulatory authority over e-cigarettes as tobacco products.11 While the FDA struggles to determine how to regulate these products at the federal level, state and local governments also have a role to play. The TCA, coupled with previous legislative authority, gives broad latitude to states and localities to enact laws and regulations relating to the sale, distribution, possession, and use of
Paradise | Peer Reviewed | Public Health Policy Brief | e17
PUBLIC HEALTH POLICY BRIEF
tobacco products.12 State and local regulatory efforts have focused on smoke-free laws and restrictions on use and sale. Thirty-six states and 3931 municipalities have laws in place restricting or prohibiting smoking in public places and workplaces.13 The scope of the laws varies, commonly directed at a combination of locations such as nonhospitality workplaces, restaurants and bars, and public areas. The overwhelming majority of the laws were drafted with cigarettes and traditional tobacco products in mind, with many specifically using the word “smoke” or “smoking” to define the restricted or prohibited action. However, e-cigarettes do not produce smoke; they produce vapor. States and localities must reexamine their smoke-free laws and access restrictions to appropriately regulate the use of e-cigarettes. As of September 2013, 27 states and localities have amended their smoke-free laws to explicitly include e-cigarettes within the ban on smoking in public places.14 For example, the New Jersey SmokeFree Air Act prohibits smoking in indoor public places, workplaces, and in buildings or grounds of any public or nonpublic elementary or secondary school. It was amended in 2010 to include within the scope of smoking “the inhaling or exhaling of smoke or vapor from an electronic smoking device.”15 An electronic smoking device is further defined as “an electronic device that can be used to deliver nicotine or other substances to the person inhaling from the device, including, but not limited to, an electronic cigarette, cigar, cigarillo, or pipe.”15 Likewise, New York bans e-cigarette use within 100 feet of entrances and exits to public or private schools.16 In addition to the state laws, Somerset, Massachusetts; King County, Washington;
Madison County, Kentucky; Savannah, Georgia; and Petaluma, California, are just a few cities and counties, among others, that have passed ordinances explicitly including e-cigarettes within the scope of their smoking bans.14 Both California and Oregon have settled in court with leading e-cigarette manufacturers and distributors, making the sale of their specific e-cigarette products unlawful in those states.14 Thirty-four states and municipalities have also enacted laws banning sales of e-cigarettes to minors, although the age limitations vary from younger than 18 to younger than 21 years.14 Dozens of states include both a ban on smoking in public settings and a ban on sale to minors, and other laws contain individual nuances.14 For example, Hawaii prohibits the sale of e-cigarettes to minors younger than 18 years, and also requires in-person sales rather than sales through the Internet.14 Tacoma--Pierce County, Washington, includes a ban on free sampling unless within an e-cigarette retail store.14 In a September 2013 letter to the FDA, lawmakers joined the call, urging the agency to act swiftly at the federal level to address the epidemic of youths’ use of e-cigarettes.17 Federal legislators have also advocated hearings on the health risks and scope of FDA authority.17 These state and local laws are merely a stopgap measure and fail to establish a uniform national policy for e-cigarettes. The best outcome to ensure the protection of the public health, and youths in particular, would be for the FDA to initiate rulemaking proceedings to deem e-cigarettes within the definitional scope of the TCA. This would allow the FDA to develop manufacturing requirements, reporting mechanisms, product
e18 | Public Health Policy Brief | Peer Reviewed | Paradise
standardization, ingredient listings, limitations on marketing claims, and various other procedures to install proper oversight of product development and distribution. As with any effort at content regulation, First Amendment challenges may arise. However, states and local governments also have a role in regulation and should proactively reassess their existing smoking bans, sale to minors, and other restrictions and decide whether to amend the language to include e-cigarettes. Failing to include a clear statutory definition leaves use and access to e-cigarettes as a significant loophole, and may thwart even the most well-intended public health laws. j
About the Author Jordan Paradise is with Seton Hall University Law School, Newark, NJ. Correspondence should be sent to Jordan Paradise, JD, Associate Professor of Law, Seton Hall University Law School, One Newark Center, Newark, NJ 07102 (e-mail: jordan. [email protected]). Reprints can be ordered at http://www.ajph.org by clicking the “Reprints” link. This article was accepted January 16, 2014.
Human Participant Protection Institutional review board approval was not necessary because the article did not involve human participants research.
References 1. World Health Organization. Tobacco Free Initiative: tobacco facts. Available at http://www.who.int/tobacco/mpower/ tobacco_facts/en/index.html. Accessed October 18, 2013. 2. Centers for Disease Control and Prevention. Current cigarette smoking among adults—United States, 2011. JAMA. 2013; 309(6):539-- 541. 3. Elliot S. E-cigarette makers’ ads echo tobacco’s heyday. New York Times. August 29, 2013:B1.
cigarettes use among middle and high school students—United States, 2011--2012. MMWR Morb Mortal Wkly Rep. 2013;62(35):729---730. 6. Tavernise S. Rise is seen in students who use e-cigarettes. New York Times. September 5, 2013:A12. 7. New England Law School, Center for Public Health and Tobacco Policy. E-cigarettes fact sheet. Available at: http://www.tobaccopolicycenter.org/ documents/CPHTP%20e-cig%20fact% 20sheet%2010-17-2013%20(2).pdf. Accessed October 18, 2013. 8. Rutgers University School of Public Health. Trinkets and trash: artifacts of the tobacco epidemic. Available at: http:// www.trinketsandtrash.org. Accessed October 18, 2013. 9. Letter from B.J. Westenberger, deputy director, Division of Pharmaceutical Analysis, FDA, to Michael Levy, supervisor regulatory counsel, Office of Compliance, Division of New Drugs and Labeling Compliance, FDA. May 4, 2009. Available at: http://www.fda.gov/downloads/ Drugs/ ScienceResearch/UCM173250. pdf. Accessed October 18, 2013. 10. Sottera v. FDA, 627 F3d 891 (DC Cir 2010). 11. Food and Drug Administration. RIN 0910---AG38. Spring 2013. Available at: http://www.reginfo.gov/public/do/ eAgendaViewRule?pubId=201304& RIN=0910-AG38. Accessed October 18, 2013. 12. Family Smoking Prevention and Tobacco Control Act, Pub L No. 111---31, §2, 123 Stat 1776 (2009) (codified as amended in scattered sections of 5 USC, 15 USC, and 21 USC). 13. American Nonsmokers Rights Foundation. Overview list—how many smokefree laws? 2013. Available at: http:// www.no-smoke.org/pdf/mediaordlist.pdf. Accessed October 18, 2013. 14. Global Advisors Smokefree Policy. Electronic smoking devices. 2013. Available at: http://www.njgasp.org/E-Cigs_ White_Paper.pdf. Accessed October 18, 2013. 15. NJ Stat Ann §26:3D-57 (2010). 16. NY Pub Health Law §1399 (2013). 17. Hattem J. House Dems call for cigar, e-cigarette regulations over “kid-friendly” products. The Hill. September 16, 2013.
4. Centers for Disease Control and Prevention. About one in five US adult cigarette smokers have tried an electronic cigarette. 2013. Available at: http://www.cdc.gov/media/releases/ 2013/p0228_electronic_cigarettes. html. Accessed October 18, 2013. 5. Centers for Disease Control and Prevention. Notes from the field: electronic
American Journal of Public Health | June 2014, Vol 104, No. 6
