Ethical Considerations and the Regulation of Electronic Cigarettes



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Ethical Considerations and the Regulation of Electronic Cigarettes

Dr. Shalah Watkins-Bailey

Public Health Ethics

MPH 560


Allison Erickson

February 2013



Abstract

Public health ethics has a responsibility upholding and improving the health and well-being of communities. Throughout its history, public health has faced challenges and celebrated successes that have furthered the human right to health across the world. Creating a foundation of health improvement has been seen greatly in the United States and other nations through the ongoing regulation of harmful substances and products, like tobacco use. Today, however, public health faces a new product, electronic cigarettes, and the unknown health risks the product produces. With many unknowns, there is clear evidence that youth and adults in the United States are increasing the use of e-cigarettes. This increase in prevalence has alerted public health officials and policy makers throughout states and the country in seeking ethical means to regulate a product with little evidence of physical harm, yet great evidence of increased popularity.



Introduction

Public Health Ethics

Definition and Principles

The World Health Organization (WHO) (2014) explains that public health refers to, “all organized measures (whether public or private) to prevent disease, promote health, and prolong life among the population as a whole.” Public health aims to improve health and reduce the prevalence of disease across a total system whether local, state, national, or across the world. Ensuring populations and communities live and have access to health is one of the most prominent responsibilities in public health. Public health ethics focuses on, “the principles and values that help guide actions designed to promote health and prevent injury and disease in the population” (Gostin, 2003, p. 14). Within the realm of public health ethics, there is a balance between professional, applied, and advocacy ethics. Professional ethics concerns itself with professionalism and moral trust in which societies bestow on public health professionals to uphold common welfare. Applied ethics is applying appropriate skills and knowledge to make important health decisions that will impact a community. Advocacy ethics, finally, is thought of as the “single overriding value of a healthy community” (Gostin, 2003, p. 14). Here, public health officials advocate for a desired outcome that will serve to improve some aspect of a community’s health.



Within the realm of public health ethics, there is a need to balance the principles of medical ethics with the principles of public health ethics. Medical ethics prides itself on upholding four prominent principles: autonomy, nonmaleficence, beneficence, and justice. Among those four principles, the balance of respecting autonomy, while promoting a collective good, can often clash in public health. Thomas (n.d.) explains, “The principle of autonomy causes us to remember that we need to be careful about coercion. But in a population of people, there will inevitably be some who disagree with a public policy and will feel coerced.” Continuing, Thomas (n.d.) shares that autonomy is not about the good of the community, but rather the good of the individual, which therefore creates tension between public health and medical ethics. The American Public Health Association (APHA) (2002) describes twelve values and beliefs that produce the principles of public health ethics. From those twelve values and beliefs, Thomas (n.d.) describes three overarching themes that assist public health officials in making ethical public health decisions and creating ethical public health policy. These three themes include interdependence, participation, and scientific evidence. Interdependence means that one person is not alone or an island and that the decisions one person makes often impact others. Participation draws upon the realization that multiple institutions must participate and collaborate together to impact public health goals and missions. In this case, the community and its members are also considered an institution in being an impactful voice during public health change. Lastly, scientific evidence is a necessary aspect of public health decision making and policy development because it allows public health officials to way pros and cons with applicable evidence and research. Scientific evidence encourages public health professionals and policy makers to move past opinion and conjecture to make appropriate decisions.

Ethical Topic

As aforementioned, public health has a history of improving the quality of life, health, and well-being of communities across the world for over a century. From the development of life-saving vaccination to the regulation of tobacco products, public health as seen tremendous success, as well as struggle in its time. Upholding and advocating for basic human rights throughout its history has been another success and struggle area for public health worldwide. The Universal Declaration of Human Rights (2013) states in Article 25, “Everyone has a right to a standard of living adequate for the health and well-being of himself and for his family, including food, clothing, housing, and medical care and necessary social services…” Here, the declaration explains that every human has a right to live in environments that promote health, rather than cause detriment to one’s health. This upholding of human rights has been evident in the regulations of tobacco use across many countries, including the United States. More specifically, regulations on tobacco use in public places have become more and more appealing and wide-spread due to the known facts around inhaling second-hand smoke. The American Cancer Society (ACS) (2014) shares that second-hand smoke is classified as a known human carcinogen consisting of thousands of gases and particles known to be detrimental to human health. Every year, second-hand smoke is responsible for worsening the asthma and asthma-related problems of over one million children per year, as well as being the cause of 3400 non-smoking lung cancer deaths (ACS, 2014). Such information has been a backbone of support for public health regulation of cigarettes. New debate, however, has begun around the ethical regulations of a relatively new product on the market, electronic cigarettes, also called e-cigarettes or electronic nicotine delivery systems (ENDS). In the following sections, there will be discussion around ethical considerations for enacting regulation on these new products and what these products will do to either help or hurt public health efforts in regulating tobacco cigarettes.

Electronic Cigarettes

Background and History

The products were invented in the 1960s, but did not begin to appear more frequently until about a decade ago. Since becoming increasingly more popular, Neporent (2013) reports that there are over 250 different brands of e-cigarettes. The report continues to explain that in 2013, there were a reported four million e-cigarette users in the United States and are said to produce a gross profit of one billion dollars (Neporent, 2013). E-cigarettes are a cartridge of liquid nicotine that is battery powered and heated through an atomizer. These parts work together to turn the liquid in the cartridge into a vapor which is inhaled by the user. On some products, as an individual inhales, the end of the e-cigarette will light up, usually blue or orange, giving a similar effect to a tobacco burning cigarette. Since e-cigarettes are electronically burning devices that do not use regular or traditional tobacco leaves, as found in tobacco cigarettes, developers and manufactures claim the products are safer than the traditional products. “Because of the lack of combustion involved in an e-cigarette, the device does not deliver tar or chemical elements that are present in regular cigarettes that are known to cause and increase the risk of developing cardiovascular and pulmonary diseases” (Lee, Kimm, Eun Yun, & Ha Jee, 2011, p. 237). The cost of these products ranges from $30 to $100 for a starter kit with replacement cartridges ranging in price (Neporent, 2013).

Research Findings

Chemical Additives

After completing a systematic review of the chemical contaminants of e-cigarettes, Burstyn (2014) reports that there was an excess of 9,000 determinants of single chemicals found in the e-cigarettes tested. Those 9,000 chemicals were reported after a combination effort from previous research studies. In many of the studies, however, there was a sequence of chemicals continually reported. These chemicals included propylene glycol, glycerin, nicotine, polycyclic aromatic hydrocarbons, and tobacco-specific nitrosamines (Burstyn, 2014). Expanding on the nitrosamines found, Lee et al. (2011) reports that chemicals suspected to harm humans were anabasine, myosmine, and beta-nicotyrine. Inhalation or consumption of nitrosamines has been reported to increase the risk for different types and severities of cancer (Burstyn, 2014).

Current Data about E-Cigarette Use

As aforementioned, the number of individuals currently reporting using e-cigarettes is reaching four million in the United States (Neporent, 2013). Of these four million users, public health officials have become increasingly concerned about the use of an e-cigarette in youth, particularly middle and high school students. The Centers for Disease Control and Prevention (CDC) (2013) reports, “The findings from the National Youth Tobacco Survey … show that the percentage of high school students who reported ever using an e-cigarette rose from 4.7 percent in 2011 to 10.0 percent in 2012.” Continued report indicates that in 2012 1.78 million middle and high-school students reported having tried an e-cigarette (CDC, 2013). Not only do the numbers of youth who have tried e-cigarettes continue to rise, but the CDC (2013) reports that of those that have tried e-cigarettes in 2012, 76.3 percent have also used regular tobacco cigarettes. This also concerns public health officials due to the fact that 90 percent of tobacco users begin in the youth ages, thus indicating that a rise in e-cigarette use among youth today, may lead to an increase in lifelong nicotine addiction from other tobacco products. King, Alam, Promoff, Arrazola, and Dube (2013) report that, “in 2011, 6.2% of all adults and 21.2% of current smokers had ever used e-cigarettes, representing an approximate doubling of 2010 estimates” (p. 4).

Ethical Considerations in E-Cigarette Regulation

Current Regulation in Other Countries

Legal status of e-cigarettes varies across the world; however, some countries, such as Denmark, Canada, Israel, Singapore, and Australia, regulate the sale, import, or marketing of the product (British Medical Association (BAM), 2013). In Canada, for example, the use of an e-cigarette is not illegal. However, Canada has regulated the import, marketing, and sales of all e-cigarette devices across the country (Ligaya, 2013). A reason for such regulation in Canada has come from the lack of scientific study on the risk of the e-cigarettes and has many policy makers and anti-smoking activists wary about the potential harm. Additional concerns come from the increased prevalence of e-cigarette use among middle and high school aged youth. Such increase has caused Canada to enact more strict policy on the marketing of such products due to the addictive nature of nicotine. Under the Therapeutic Goods Administration (TGA) in Australia, e-cigarettes and liquid nicotine cartridges are not approved. “Therefore, it is illegal to sell or import as such here without an appropriate license as nicotine is classed as a dangerous poison. The delivery device itself is also illegal to sell in South Australia if it resembles a tobacco product” (QuitSA, n.d.). Finally, in Brazil, Norway, and Singapore, there are complete bans on the use of the products.

Ethics and Regulating E-Cigarettes

Marketing E-Cigarettes in America

Total bans on cigarette advertising in the United States began in the 1980s. This created much debate around the place for commercial speech in the First Amendment. Bayer (2003) indicates that this total ban was initiated by the American Medical Association (AMA) with help from the American Heart Association (AHA) and the American Lung Association (ALA). The AHA is quoted saying, “’Advertisements should be to promote good health products and not products that kill’” (Bayer, 2003, p. 151). As the debate continued through the 1980s, proponents of the ban on advertising cigarettes began to advocate for the ban on behalf of children and youth who, “were incapable of making determinants on their own behalf and needed protection from manipulation by those who sought to stimulate their desires for harmful goods” (Bayer, 2003, p. 152). This discussion also leads the public health professional to the tenth value and belief that underlie the Principles of Public Health Ethics: “People are responsible to act on the basis of what they know” (APHA, 2002, p. 3). With this statement and applying it to marketing of e-cigarettes today, many would argue the marketing attempts of e-cigarette companies is manipulating the knowledge of the product to youth using similar tactics as tobacco companies used in the 20th century.

Continuing, Bayer (2003) indicates that restrictions on advertising around tobacco use are justified if the advertisements are directed at youth and it such marketing tactics affect patterns of smoking. Using that information, it is difficult to say who specifically e-cigarette companies are marketing to. However, Tobacco Free Kids (2013) reports that e-cigarette advertisements mimic tobacco advertisements used in the 1920s through 1960s. For example, an e-cigarette advertisement that was published in Sports Illustrated, In Style, and US Weekly showed a model sitting seductively and smoking an e-cigarette. The caption reads, “Smoke in style with blu electronic cigarettes” (Tobacco Free Kids, 2013). Next to that example, Tobacco Free Kids (2013) shows a similar advertisement with a woman in a black dress from the 1980s with a caption for tobacco cigarettes reading, “You’ve come a long way, baby.” These examples show the challenge that public health professionals face when making ethical decisions around regulating the marketing of e-cigarettes. Should these advertisements, found in magazines and seen on television, be banned or strictly enforced because of the number of youth being influenced by such marketing? Is there enough support and research to ethically ban the advertisements that are impacting the rate of e-cigarette use among American youth?

Regulation in Public Places

Throughout the United States, there have been continued discussion and action taken to regulate the use of e-cigarettes. In the 50 states, three have enacted a ban on e-cigarettes in venues and places that are 100% tobacco free environments. These states include North Dakota, New Jersey, and Utah (American Nonsmokers’ Rights Foundation (ANRF), 2014). Nine other states have current regulation of e-cigarettes in certain venues. For example, Arkansas prohibits the use of the e-cigarette on any school district property, Delaware has prohibited the use on all State grounds and property indoors and outdoors, and Oklahoma has prohibited the use on all Department of Corrections property and grounds (ANRF, 2014). There are many states that have yet to enact specific regulations statewide, but many counties have begun to enact regulations. In California, there are 11 counties that have regulated a total ban or partial ban of e-cigarettes in public places that are smoke free venues. Also, 24 counties in Massachusetts have banned the use of e-cigarettes in all smoke free venues.

Advocates for tobacco free venues are continuing to fight for increased regulation across counties, states, and the nation. The question, however, is who has the right to regulate the use of e-cigarettes? Does this responsibility lie on the federal, state, or local government? When answering these questions, one may respond that all have a responsibility to regulate the use. At the federal level, specifically the Food and Drug Administration (FDA), regulation can come in the form of what nicotine replacement therapies are found to be successful tobacco cessation aids. More specifically, the FDA is currently in the appeals process with a lawsuit that stated e-cigarettes are not considered drug delivery devices (Cobb, Byron, Abrams, & Shields, 2010, p. 2341). When discussing further regulation of e-cigarettes throughout the United States, Cobb et al. (2010) suggests, “to allow [e-cigarettes] unregulated sale on presumption is not protecting public health. ENDS should be removed from the market and permitted back only if and when it has been demonstrated that they are safe” (p. 2341-2342).

Within the previous statement, public health officials are, again, faced with a dilemma, one that goes back to the aforementioned themes that surround principles of public health ethics. The one theme under scrutiny when advocating or opposing e-cigarette regulation is the principle of scientific evidence. “One of the key and difficult issues in public health is determining when evidence is sufficient for public health action (in the form of a specific program or policy) and what the specific action should entail” (Brownson, Gurney, & Land, 1999, p. 90). There are two different forms of evidence Brownson et al. (1999) discusses: the condition’s magnitude and the relative effectiveness of particular interventions. Here, it is important to distinguish what the term condition may refer to. In the sense of cigarette use, whether tobacco or electronic, condition may include addiction to nicotine and other harmful effects. Therefore, making an ethical decision on policy and regulation of e-cigarettes requires seeking the prevalence rates, severity, and preventability of engaging in the behaviors (Brownson et al., 1999). In regards to the effectiveness of interventions, this is a grey area involving e-cigarettes. Little scientific and research studies have been completed that offer effective solutions for intervening on the use of the products. However, some would argue that tobacco cessation programs that use FDA regulated nicotine replacement therapy and behavior change have shown to be effective in assisting individuals in quitting tobacco use. Brownson et al. (1999) finalizes by stating, “In the end, public health decisions must integrate the full array of considerations regarding risks and benefits of different courses of action. These considerations should not be limited to the scientific evidence but also social, cultural, economic, and political factors” (p. 90).

Finally, public health has an inherent responsibility to protect the health and wellbeing of communities. In some cases this responsibility overrides individual autonomy. However, in the context of ethical e-cigarette regulation, public health has a duty to provide environments that benefit the good of the community. Burstyn (2014) writes,

However, exposure of vapors to propylene glycol and glycerin reaches the levels at which, if one were considering the exposure in connection with a workplace setting, it would be prudent to scrutinize the health of exposed individuals and examine how exposures could be reduced. (n.p)
Public health officials have a responsibility to study the effects of the exhaled contaminants that are found in the e-cigarettes to determine the risk on those around an e-cigarette user. “Monitoring upper airway irritation of vapors and experiences of unpleasant smell would also provide early warning of exposure to compounds like acrolein because of known immediate effects of elevated exposures” (Burstyn, 2014, n.p). Therefore, with concern that the exhaled vapor from the e-cigarette user may cause the inhalation of known contaminants from others, may create the ethical obligation of public health officials to advocate for the regulation of e-cigarette use in public places. The risk of future health concerns, not only for the e-cigarette user, but also for those who inhale the second-hand vapors, are ones that need and require continued research and study. Lawmakers and public health officials have a responsibility to monitor the increased prevalence of e-cigarette use among youth and adults and how this increase will affect health and wellbeing of individuals and communities over time. Additionally, surveillance regarding correlations of tobacco use and e-cigarettes is needed to provide ethical reasoning for continued regulation through the United States.

Conclusion

Promoting and improving health and wellbeing amongst populations is the fundamental goal of public health. When making decisions or enacting policy, public health ethics allows the official to make informed decisions to reach the end goal of improved health and wellbeing. Basic human rights, honored in many countries including the United States, call for everyone, no matter age, sex, religion, or ethnicity, to have adequate living conditions and environments to foster health. History has shown throughout the course of the last century the many successes and challenges that public health has faced. One such success has been the evolving regulation of tobacco use in society. With the known health risks to the smoker and the bystander, governments in counties, states, and the nation continue to seek stricter regulation and rules preventing harm and improving health. Over the last decade, manufactures and marketers of e-cigarettes have attempted to combat the regulations across the world by offering both smokers and non-smokers an opportunity to receive nicotine, without the tar. This development has swept through the United States causing a significant rise in youth and adults using such products. Although some states and many counties across the United States have implemented regulation on the products, public health officials face continued ethical dilemma in advocating for wide-spread regulation. These ethical considerations aforementioned are just a few of the many considerations that require additional discussion in order to uphold the public health responsibility of protecting the health and wellbeing of communities across the nation and world.

Recommendations

This author acknowledges that the issue of e-cigarette regulation is grey. On one hand, there is little scientific evidence around the health effects of using such products. However, on the other hand, there is documented proof that the liquid cartridges contain more than just nicotine. Understanding the tension between both is difficult for this author to make a decision one way or another in regards to regulations. There is, nonetheless, a wide-spread concern around the significant increases in youths using e-cigarettes. This increase brings this author to believe that regulation is needed to reduce the number of youth trying and becoming addicted to a device where harmful effects are still unclear. Not only does the significant number of youth using the products concern this author, the concern should also lie on the chance of youth turning to tobacco cigarettes while on the e-cigarette or after. The multiple flavors of e-cigarettes, like vanilla, cherry, and strawberry, make the device even more tantalizing for youth greatly influenced by media and celebrities. One place that regulation should start, according to this author, is the marketing that e-cigarette companies are using. As mentioned above, the marketing tactics are almost complete replicas of the advertisements and commercials banned in the 1980s. Policy makers and public health officials should see this as a red flag and begin controlling this type of advertising. Next, this author believes that e-cigarette regulation should be controlled and banned in all areas that have been designated as 100% tobacco free. Often times, the device looks similar to a regular cigarette, which leads to confusion and unnecessary difficulties for the owners of the non-smoking establishments. Therefore, this author supports continued urge for regulating the e-cigarette in environments and communities that have become tobacco free for the health and well-being of the general public.

References

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American Nonsmokers’ Rights Foundation. (2014). U.S. state and local laws regulating use of electronic cigarettes. Retrieved from: http://www.no-smoke.org/pdf/ecigslaws.pdf

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Burstyn, I. (2014). Peering through the mist: A systematic review of what the chemistry contaminants in electronic cigarettes tells us about health risks. BMC Public Health, 14(18). doi: 10.1186/1471-2458-14-18

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King, B.A., Alam, S., Promoff, G., Arrazola, R., & Dube, S.R. (2013). Awareness and ever use of electronic cigarettes among U.S. adults, 2010-2011. Oxford University Press. Retrieved from: http://ucanr.edu/sites/tobaccofree/files/175132.pdf

Ligaya, A. (2013). How e-cigarettes have become a ‘very wild west’ industry in Canada. Financial Post. Retrieved from: http://business.financialpost.com/2013/11/16/how-e-cigarettes-have-become-a-very-wild-west-industry-in-canada/

Neporent, L. (2013). 5 things you need to know about e-cigarettes. abc News. Retrieved from: http://abcnews.go.com/Health/facts-cigarettes/story?id=20345463#

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Tobacco Free Kids. (2013). 7 ways e-cigarette companies are copying big tobacco’s playbook: or 7 reasons why FDA should quickly regulate e-cigarettes. Retrieved from: http://www.tobaccofreekids.org/tobacco_unfiltered/post/2013_10_02_ecigarettes

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