International Journal of
`Environmental Research
`and Public Health
`
`
` a!a ee
`
`
`
`
`Discussion
`
`
`The Case in Favor of E-Cigarettes
`for Tobacco Harm Reduction
`
`
`
`Joel L. Nitzkin
`
`Special Issue
`Electronic Cigarettes as a Tool in Tobacco Harm Reduction
`
`Edited by
`Dr. Konstantinos Farsalinos
`
` .
`
`ne
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`Int. J. Environ. Res. Public Health 2014, 11, 6459-6471; doi:10.3390/jerph1 10606459
`
`_OPENACCESS|
`international Journal of
`Environmental Research and
`Public Health
`ISSN 1660-4601
`www.mdpi.com/journal/ijerph
`
`Discussion
`
`The Case in Favor of E-Cigarettes for Tobacco Harm Reduction
`
`Joel L. Nitzkin
`
`JLN, MD Associates, Limited Liability Corporation (LLC), 4939 Chestnut Street, New Orleans,
`LA 70115, USA; E-Mail: jlnitzkin@gmail.com; Tel.: +1-504-899-7893; Fax: +1-504-899-7557
`
`Received: 10 April 2014; in revisedform: 19 May 2014 / Accepted: 9 June 2014 /
`Published: 20 June 2014
`
`
`Abstract: A carefully structured Tobacco Harm Reduction (THR) initiative, with e-cigarettes
`as a prominent THR modality, added to current tobacco control programming, is the most
`feasible policy option likely to substantially reduce tobacco-attributable illness and death in
`the United States over the next 20 years. E-cigarettes and related vapor products are the
`most promising harm reduction modalities because of their acceptability to smokers.
`There are about 46 million smokers in the United States, and an estimated 480,000 deaths
`per year attributed to cigarette smoking. These numbers have been essentially stable since
`2004. Currently recommended pharmaceutical smoking cessation protocols fail in about
`90% of smokers who use them as directed, even under the best of study conditions,
`when results are measured at six to twelve months. E-cigarettes have not beenattractive to
`non-smoking teens or adults. Limited numbers non-smokers have experimented with them,
`but hardly any have continued their use. The vast majority of e-cigarette use is by current
`smokers using them to cut down or quit cigarettes. E-cigarettes, even when used in
`no-smoking areas, pose no discernable risk to bystanders. Finally, addition of a THR
`component to current tobacco control programming will likely reduce costs by reducing
`the need for counseling and drugs.
`
`Keywords: e-cigarettes; ENDS devices; tobacco harm reduction; smoking cessation
`
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`Int. J. Environ. Res. Public Health 2014, 11
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`1. Introduction
`
`This paper makes the case for tobacco harm reduction (THR) with e-cigarettes as a prominent THR
`modality being the
`only
`feasible policy
`option with the potential
`to substantially
`reduce
`tobacco-attributable illness and death in the United States over the next twenty years, and do so without
`adversely effecting initiation or quit rates,
`Both of these papers are in support of the proposition that THR is the most feasible policy option
`likely to substantially reduce tobacco-attributable illness and death in the United States over the next
`20 years. E-cigarettes and related vapor products, sometimes referred to as electronic nicotine delivery
`systems (ENDS) products are the most promising harm reduction modalities because of their
`acceptability to smokers.
`It is important to note that THR is being proposed as an addition to, not a substitute for current
`tobacco control policy and programming. Retention and expansion of other tobacco control program
`elements will continue to be of value and offer the potential of yet
`further
`reductions in
`tobacco-attributable addiction, illness and death. Such program elements include but are not limited to
`health education, prohibition of marketing and sales to minors, packaging,
`labeling, warnings,
`and prohibition of smoking in multiple settings.
`The question as to whether or not FDA regulation of cigarettes and other tobacco products will
`further enhance or possibly harm addiction,
`illness and death rates is yet
`to be determined.
`FDAfunding of health education initiatives and modification of combustible product labeling seems
`likely to have a minor effect on these outcomes. If, however, FDA regulation of lowerrisk alternative
`products is so stringent that it restricts their continuing evolution and marketing of e-cigarettes,
`it could have negative effects on future rates of illness and death while doing nothing to reduce
`continuing addiction of minors.
`In practical terms,all of the potential benefits of THR accrue to smokers. Since no nicotine delivery
`product can be considered totally risk free, there is no potential benefit to non-smokers or persons who
`otherwise would not have initiated smoking. The potential harm of a THR initiative is the possibility
`that the initiative will attract to nicotine use a significant number of persons who otherwise would
`never have initiated smoking use. Some have even speculated that a THR initiative would likely
`do more harm than good because many of those newly attracted to nicotine use would then progress
`to cigarettes [1,2].
`There are three major sets of issues to be considered in articulating the cases for and against THR
`and e-cigarettes as a harm reduction modality. The first is the safety of the product in terms of
`potential to cause seriousillness in both users and bystanders. The secondis the efficacy of the product
`in getting smokers to reduce or quit cigarettes. The third is the potential of the e-cigarette or other
`harm reduction modalities to recruit teens to nicotine use, and eventually to cigarettes.
`The purpose of this paper is to set the stage for additional scientific study, policy dialogue and
`regulation development to confirm or deny current impressions and proceed with development of
`policies and regulations that would enable us to capture the public health benefits e-cigarettes can offer
`to smokers while not increasing, and likely decreasing teen initiation of tobacco use.
`There are about 46 million smokers in the United States, and an estimated 480,000 deaths per year
`attributed to cigarette smoking. Despite our best efforts, these numbers have been essentially stable
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`Int. J. Environ. Res. Public Health 2014, 11
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`since 2004 [3,4]. Reducing the number of smokers and numbers of deaths will require adding one or
`more new elements to current tobacco control programming.
`The most recent Surgeon General Report [4] upped annual estimates of tobacco-attributable deaths
`in the United States from 443,000 to 480,000 per year, due to new research showing yet additional
`diseases to be attributable to cigarette smoking. All of the 480,000 estimated tobacco-attributable
`deaths each year in the USA are due to a single tobacco product—the machine-madecigarette [4].
`Deaths from all other tobacco products are so low in number and so hard to distinguish from
`backgroundthat they are not tracked by American federal agencies.
`If the currentflat trend continues, as it appearslikely to do, an estimated 9,600,000 Americans will
`die of a cigarette-related illness over the next 20 years (480,000 deaths per year =< 20 years).
`Since there is a 15-20 year delay between initiation of cigarette use and onset of potentially fatal
`tobacco-attributable cancer, heart, lung and other disease, and another 10-20 year delay from onset of
`illness to death—the vast majority of the 9.6 million deaths due to cigarette use in the USA over the next
`20 years will be in current adult smokers who are now over 35 years of age. This meansthat reduction in
`teen smoking will not measurably reduce the numbers of deaths until 25—40 years from now.
`The best we now have to offer current smokers is a set of pharmaceutical-based smoking cessation
`protocols that we know will fail about 90% of smokers who use them underthe best of study conditions,
`with results measured at six to twelve months [5,6]. The flawsin the current “evidence-based”policies are
`fairly obvious. They do notsatisfy the urge to smoke in the majority of smokers, the dose is too low,
`the duration of treatment too short and there is no built-in provision for self-reinforcement when the
`urge to smokereturns.
`
`1.1. Tobacco Harm Reduction (THR)
`
`“Harm reduction” does not mean “harmless”. All of these products, including the pharmaceutical
`nicotine products pose more of a potential health risk than usually accepted in other consumer
`products. Noneare risk free. It is only in comparisonto cigarettes that they can be considered very low
`risk. THR differs from smoking cessation medical
`therapy in that “therapy” implies a short-term
`(usually 12 weeks) course of medication, while THR implies use of the substitute product as long as
`the user feels the need for the product in question.
`Tobacco harm reduction is envisioned in the United States as an educational initiative by which
`smokers who are unable or unwilling to quit are advised that they can lowertheir risk of a potentially
`fatal tobacco-attributable illness by 98% or better by switching to any one of the smokeless products now
`on the American market. These data are based on long-term epidemiological studies of Snus use in
`Sweden and on use of “smokeless tobacco” in the USA since the mid 1980’s [7,8]. Since e-cigarettes are
`basically a nicotine-only product with only the smallest traces of the carcinogens and other toxins
`found in smokeless tobacco product, e-cigarettes likely carry even lessrisk.
`Several studies indicate, that, in addition to be less hazardousthan cigarettes, the smokeless tobacco
`products currently available on the American and Scandinavian markets are also easier to quit [9,10].
`One recent study shows a striking increase in quit attempts associated with the proliferation of
`electronic cigarettes [11].
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`According to Joel L. Nitzkin’s calculations [12], amended to reflect the new Surgeon General
`estimate, a modestly successful THR initiative, if added to current tobacco control programming
`would likely save the lives of 1.5 to 4.8 million of these Americans, with the numbers dependent on
`the rate of switching from cigarettes to lower risk smoke-free products. In Year 20 of such an
`intervention, again, depending on the actual switch rates, numbers of smokers and numbers of deaths
`would be down 30% to 80%, from current year estimates.
`There is no other feasible tobacco control policy that has the potential to secure public health
`benefits of this magnitude. It would consist of simply telling the truth to the American public about the
`differences in risk, comparing cigarettes to lower risk smoke-free options. There would be no drugs to
`buy and no additional health education programming. THR would be an addition to, not a replacement
`for current
`tobacco control programming. Prohibition of sales to minors,
`strict
`regulation of
`manufacture and marketing, clean indoor air regulations, tax policy and control of contraband would
`remain in place, and hopefully be strengthened.
`The health education component of the THR initiative would be of very low cost or free to the
`taxpayer as much,if not all the cost would be carried by the manufacturers and vendors. There would
`be some additional cost to evaluate the impact of the THR initiative. It seems likely that this cost
`would be borne by licensure fees paid by manufacturers to the FDA.
`
`2. Methods
`
`The data and narrative reported herein are based on published literature, media reports, blogs and
`internet sites supplemented with policy analysis.
`
`3. Results and Discussion
`
`3.1. E-cigarettes/Nicotine Vaporizers
`
`including e-cigarettes and related products, show substantial promise as a
`Nicotine vaporizers,
`vehicle for THR. Skyrocketing sales of e-cigarettes, consumer advocacy for
`these products,
`and a flood of new scientific papers relating to these products suggest the possibility that e-cigarettes
`may be the greatest advance in reducing tobacco-attributable illness and death in decades.
`Moreover, progress to date has been accomplished at no cost to the taxpayer and with little or no
`recruitment of teen non-smokers [11,13-18].
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`3.2. Step-downin Riskfrom Cigarette Smoking to L-cigarette Vapor
`
`3.2.1. Cigarettes
`
`The Centers for Disease Control and Prevention estimates there are 480,000 tobacco-related deaths
`annually in the United States and all are from cigarette use [3,4]. Deaths from other forms to tobacco
`are so small and so hard to estimate that they are not estimated or tracked by the CDC.
`Tobacco cigarettes are the most hazardous and addictive of tobacco products, and the product most
`attractive to teens. There was no pandemic of tobacco-related addiction, illness and death until the
`advent of the machine-madecigarette.
`
`3.2.2. Environmental Tobacco Smoke (ETS)
`
`Tobacco smoke is a witch’s brew of toxic chemical substances from the incomplete combustion of
`tobacco. The main component
`is carbon monoxide, but
`it also includes other gasses and tarry
`particulate residue containing most of the nicotine and the worst of the carcinogens[19].
`About 85% of environmental
`tobacco smoke (ETS), commonly called “second hand smoke”,
`is the smoke that curls off the end of a cigarette when no-oneis puffing on it. Solid particles make up
`about 10% ofthe smoke, including the tar and most ofthe nicotine [20]. The mainstream smoke exhaled
`by the smokerincludes only what is left after much of what wasinhaled is absorbed by the smoker.
`ETSincreases the risk of lung cancer and other cancers; heart and lung disease; the risk of low birth
`weight; and is suspected of increasing the risk of birth defects. CDC estimates that approximately
`50,000 non-smokers die in the United States from exposure to ETS [3]. In addition, ETS is knownto
`irritate the eyes, throat, and respiratory mucous membranes [20].
`
`3.2.3. Smokeless Tobacco Products on the U.S. Market
`
`The smokeless tobacco products which have been on the U.S. market since the 1980s are estimated
`to pose a risk of potentially fatal illness less than 2% the risk posed by cigarettes[7].
`E-cigarettes are one of a number of smoke-free tobacco/nicotine alternatives to cigarettes
`that can reduce the risk of tobacco-attributable illness and death by 98% or better, while satisfying
`the smoker’s urge for nicotine. These include chewing tobacco; snus and other snuff products;
`dissolvables (sticks, strips and orbs), and e-cigarettes. Options also include use of pharmaceutical
`nicotine replacement
`therapy (NRT) products such as patches, gum,
`lozenges, and inhalers on
`a long-term basis in a harm-reduction mode.
`
`3.2.4. E-cigarettes and Other ENDS Devices
`
`E-cigarettes and related devices are currently the most promising THR option. These metal or
`plastic tubes use a battery, heating element and small amount of nicotine-containing fluid to give
`smokers nicotine without the high concentration of thousands of other toxic chemicals that exist in
`cigarette smoke. These devices also emulate the cigarette-handling ritual and the feel of cigarette
`smoke in the mouth andthroat.
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`These devices are unique in the U.S. marketplace in that they are the only smoke-free tobacco
`products that do not carry mandated warnings about cancer or other diseases. They are also unique in
`terms of their skyrocketing sales. Bonnie Herzog, Wells Fargo’s managing director for beverage,
`tobacco and conveniencestore research, predicted in January 2013 that “consumption of e-cigs may
`overtake traditional cigarettes in the next decade [21]”. At that time, e-cigarette sales were projected at
`$1 billion for 2013. In mid-September, Herzog upped her projection to “around $2 billion by the end
`of the year and up to $10 billion by 2017”, adding that she expects electronic products would overtake
`tobacco cigarettes within the next decade [22].
`
`3.2.5. Environmental E-cigarette Vapor
`
`The e-cigarette vapor inhaled by users consists mainly of water, propylene glycol and glycerin,
`with small amounts ofnicotine and flavoring. There is no carbon monoxide, no tar, and no products of
`combustion. There is no side-stream smoke or vapor. Propylene glycol and glycerin are generally
`recognized as safe. Propylene glycol has been used as the propellant in asthmainhalers and is the main
`ingredient in theatrical fog. There is a question about the safety of intense of pulmonary propylene
`glycol exposure from e-cigarettes. This is a question in need of additional research.
`E-cigarettes have no products of combustion. Nothing curls off the end of an e-cigarette when no
`one is puffing on it. The mainstream vapor exhaled by the user includes only the tiniest traces of
`chemical contaminants.
`
`E-cigarette vapor, as exhaled by the e-cigarette user, poses no significant risk to bystanders [23].
`A number of studies have been published dealing with the concentration of organic chemicals in
`exhaled e-cigarette vapor. Basically, these studies show that when the e-cigarette user exhales into a
`glass tube or similar container, trace quantities of a variety of organic chemicals can be detected,
`but, when in an 8 cubic meter test chamber or similar room, for a half hour or more, e-cigarette use
`does not measurably increase the trace quantities of these chemical substances above background
`levels, while cigarettes cause dramatic rapid increases [24-27].
`An October 2012 study published in /nhalation Toxicology foundthat, for all byproducts measured,
`e-cigarettes produced very small exposures relative to tobacco cigarettes, indicating no apparent risk to
`human health from e-cigarette emissions [28]. Further research presented to Europe’s Society for
`Research on Nicotine and Tobacco compared total organic carbons in a test chamberfive hours after
`smoking or vaping, finding no detectable levels of acrolein, toluene, xylene and polycyclic aromatic
`hydrocarbons (PAH)in the e-cigarette vapor comparedto high levels in the cigarette chamber [26].
`Perhaps the most interesting findings have been studies showing that persons not using any form of
`tobacco routinely exhale trace amounts of acetone, ethane, pentane and isoprene and other endogenous
`volatile organic compounds[29-32].
`In tests comparing the effects of e-cigarette vapor to cigarette smoke on cell cultures of myocardial
`cells, the vapor had minimal impact on the cells, while the smokekilled almost all of them [33].
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`3.2.6. Pharmaceutical Nicotine Replacement Therapy Products
`
`such as Nicorette, Commit,
`therapy products,
`Use of pharmaceutical nicotine replacement
`and others, is perceived by public health authorities to pose no risk of tobacco-attributable illness and
`death, despite the presence of many of the same trace contaminantsthat exist in e-cigarettes.
`Nitrosamine levels in e-cigarettes and related devices have been foundto be similar to the levels in
`Nicorette gum and NicoDerm patches, but less than one-hundredth to one-thousandth the level in a
`wide range of smokeless tobacco and cigarette products [34].
`therapy
`The major problem with current
`reliance on pharmaceutical nicotine replacement
`“evidence-based” protocols is that they fail about 90% of the smokers who use them, even under the
`best of study circumstances [5]. The need to add a THR element
`to current
`tobacco control
`programmingis largely based on experience to-date that large numbers of smokers whoare unable or
`unwilling to quit using the pharmaceutical products. A smoker can eliminate almost all exposure to the
`many toxins in cigarettes by switching to e-cigarettes [23,28].
`
`3.3. Lack ofAttractiveness of F-cigarettes to Non-smoking Teens and Adults
`
`Two recently published studies conducted by public health non-profits—one in the U.S. and the
`other in the United Kingdom show that teens are very aware of e-cigarettes, but researchers were
`unable to find even a single non-smoking teen who had taken them up. One study published online in
`the Journal of Environmental and Public Health and co-authored by Dr. Jonathan Winickoff,
`chairman of the American Academy of Pediatrics’ Tobacco Consortium, was able to find
`only six nonsmokers who had ever used e-cigarettes in a national
`survey of 3240 adults,
`including 1802 non-smokers [35].
`The American study noted above did not include children, but a concurrent study in Great Britain did.
`A second study from Action on Smoking and Health (ASH-UK), also contradicts the anti-smoking
`groups’ contention that electronic cigarettes appeal to nonsmokers, especially youth. ASH-UK were
`unable to find a single nonsmoker in Great Britain—either youth or adult—who regularly uses
`electronic cigarettes
`[14]. The group’s study was based on a survey of 12,171 adults and.
`The ASH-UK survey of 2178 children ages 11-18 in February and March of 2013 study found
`awareness of electronic cigarettes was 67% among those between the ages of 11 and 18 and 83%
`among those between the ages of 16 and 18. Nevertheless, it found that, among young people who had
`never smoked, “O% report continued e-cigarette use and 0% expect to try an e-cigarette soon”.
`They surveyed 12,171 adults. The study also found that, among adults who had never smoked,
`nonereported current electronic cigarette use [14].
`In early September 2013, CDC published a study showing that e-cigarette use among middle and
`high school students had doubled from 2011 to 2012 [36]. In response to these data, CDC Director
`Thomas Frieden proclaimed: “The increased use of e-cigarettes by teens is deeply troubling.
`Manyteens whostart with e-cigarettes may be condemnedto struggling with a lifelong addiction to
`nicotine and conventional cigarettes”. A similar sentiment was restated in a 2014 re-analysis of this
`same CDCsurveillance data [37]. Despite the hype surrounding these publications, the survey data
`equally support
`the opposite conclusion,
`that e-cigarettes are not attractive to teens and that
`e-cigarettes are likely to result in future declines in teen smoking [18,38,39]. Most importantly,
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`the dramatic increase in e-cigarette use by middle and high school students
`in the CDC data,
`co-occurred with a further reduction in teen smoking [36].
`The surveys noted above show that the currently unregulated e-cigarettes attract almost no non-smokers.
`This, in turn, suggests that it should be possible to endorse these products to smokers without fear that
`large numbersof teen and other non-smokerswill be attracted by such endorsement.
`
`3.4. Relative Addictiveness ofDifferent Classes of Tobacco/Nicotine Product
`
`On 14 December 2013, Karl Fagerstrom posted a well referenced essay entitled “Dependence on
`Tobacco and Nicotine” on the Nicotine Science and Policy website [9]. In this essay he makes a very
`strong case for their being a “continuum of dependence” in which cigarettes foster the strongest
`dependence, NRT pharmaceuticals the least, with smokeless products, e-cigarettes and other products
`in-between. Elements relating to the strength of the dependence include other chemical substances in
`cigarette smoke, habituation to the cigarette-handling ritual and social and psychological factors.
`The practical implication of this essay is to the effect that when a smoker switches to a lower risk
`smokeless product or ENDS device, not only does he or she dramatically reduce future risk of
`potentially fatal tobacco-attributable illness, he or she is switching to a product that should be easier to
`quit than cigarettes.
`
`3.5. Contraband
`
`One of the major problems with taxation of cigarettes and possible future steps to make cigarettes
`less desirable to smokers by eliminating menthol or reducing nicotine content
`is contraband.
`Making the legal product more expensive or less desirable is virtually guaranteed to increase sales of
`illicit and contraband product. This response, in turn, has the capability to totally eliminate any public
`health benefit from the intervention in question. The Mackinac Center for Public Policy recently
`estimated smuggling rates in 47 of the 48 contiguous U.S. states, based on 2012 data. New York,
`with the highest cigarette tax had the highest inbound cigarette smuggling rate with an estimated
`56.9% of total cigarettes consumed being smuggled. This was followed by 51.5% for Arizona,
`48.1% for New Mexico, 48% for Washington, and 34.6% for Wisconsin [40].
`A major advantage of THR is that, by makingall cigarettes less desirable to smokers, the benefits of
`a THR initiative cannot be neutralized by increased sale of contrabandcigarettes.
`
`3.6. Consumplion ofCigarettes by Mental Health Patients
`
`Adults who suffer from depression are twice as likely to smoke and also smoke more heavily than
`other adults, according to a survey from the National Center for Health Statistics [41]. Persons with a
`mental disorder in the month prior to a national comorbidity survey consumed approximately 44.3% of
`the cigarettes smoked by this nationally representative sample [42]. In addition, mental health patients
`have a hardertime quitting than others [43].
`A number of studies demonstrate that depressed patients and those with bipolar disorder and/or
`schizophrenia find self-administered nicotine to be highly beneficial.
`It helps them get through
`the day in emotional balance and with substantially fewer side effects than the usually prescribed
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`medications [44-46]. Thus, total elimination of non-prescription nicotine delivery products, as desired
`by many anti-tobacco advocates would be harmful to many mental health patients.
`
`4. Conclusions
`
`The time has come to add a tobacco harm reduction (THR) component to current tobacco control
`programming, with e-cigarettes and related vapor devices as primary THR modalities. THR is the only
`feasible policy option likely to substantially reduce tobacco-attributable illness and death in the
`United States over the next 20 years. THR, with e-cigarettes can help decrease teen initiation of
`nicotine use, and help increase quit rates. THR is especially important for smokers whoare unable or
`unwilling to quit because of the benefit they secure from non-prescription self-administered nicotine.
`
`Acknowledgments
`
`Limited financial support for this research was provided by the R Street Institute.
`
`Conflicts of Interest
`
`The author of this paper declares no conflict of interest, but, due to the author’s affiliation with the
`R Street Institute, the following explanation is provided:
`Joel L. Nitzkin is a public health physician with a Master’s Degree in Public Health and a Doctorate
`in Public Administration. He is board certified in Preventive Medicine as his medical specialty.
`He has been a local health director, state health director and president of two national public health
`organizations. Since the mid-1990s, Joel L. Nitzkin has been in the private practice of public health as
`a health policy consultant. In this capacity, he has taken on a number of research and teaching
`assignments for federal, state and local public health agencies, assisted with accreditation of a
`managed care organization; and done substantial expert witness work related to communicable disease
`control, quality of health care, and tobacco control.
`Beginning in 2007, while serving as co-chair of the Tobacco Control Task Force of the American
`Association of Public Health Physicians (AAPHP), Joel L. Nitzkin played a lead role in exploring
`policy options for reducing tobacco-attributable illness, death and property damage in the United
`States.
`
`It was that analysis and subsequent follow-up work that drew his attention first to tobacco harm
`reduction,
`then to e-cigarettes as the only feasible policy option likely to substantially reduce
`tobacco-attributable illness and death in the United States over the next 20 years.
`Since AAPHP did not have the infrastructure or other resources to get this message out to state and local
`legislatures, Joel L. Nitzkin sought a neutral sponsor that would be willing to help him playthis role.
`Thus,his affiliation with the R Street Institute.
`Joel L. Nitzkin has never received financial support from any tobacco, e-cigarette or pharmaceutical
`enterprise. His affiliation with R Street is based on shared concerns about the direction of federal
`tobacco policy since adoption of the FDA tobacco law. R Street Institute is a Washington-DC based think
`tank that respects the role of government in regulating industry to protect health and the environment,
`but strongly opposes undue governmental interference with market forces. R Street designated tobacco
`
`JLI Ex. 2012, Page 10 of 14
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`harm reduction as one of their priority issues after FDA attempted to remove e-cigarettes from the
`market by declaring them to be an unapproved drug-device combination subject to the provisions of the
`drug law. At the time ofhis initial affiliation with R Street, R Street had no support from any tobacco
`industry entity. Since then R Street has secured a modicum of such support, with the understanding that
`industry representatives would have no role whatever in setting R Street tobacco-related policy and no
`role with regard to the work done by Joel L. Nitzkin or other R Street tobacco policy fellows.
`The views expressedin this paper are entirely those of Joel L. Nitzkin. They do not reflect position
`statements formally adopted by AAPHP (Green Cove Springs, FL, USA), R Street or any other
`organization heis affiliated with.
`Additional bibliographic references dealing with these and other issues are available on request
`from Joel L. Nitzkin at jln@jln-md.com.
`
`References
`
`1.
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`Siegel, M.B. CDC Director Apparently Fabricating More “Scientific Evidence” to Demonize
`Electronic Cigarettes. Available online: http:/Awww.tobaccoanalysis.blogspot.com/2014/05/cdc-
`director-apparently-fabricating html (accessed on 12 May 2014).
`2. Grana, R.; Benowitz, N.; Glantz, S.A. E-cigarettes: A scientific review. Circulation 2014, 129,
`1972-1986.
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`Centers for Disease Control and Prevention. Tobacco-related Mortality, in CDC Fact Sheet-tobacco
`Related Mortality Smoking
`and Tobacco Use. Available
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`tobacco/data_statistics/fact_sheets/health_effects/tobacco_related_mortality/index.htm (accessed on
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`the Health Consequences of Smoking—50 Years of Progress, Office of the Surgeon General
`Public Health Service, Department of Health and Human Services: Rockville, MD, USA, 2014.
`5. Moore, D.; Aveyard, P.; Connock, M.; Wang, D.; Fry-Smith, A.; Barton, P. Effectiveness and
`Safety of Nicotine Replacement Therapy Assisted Reduction to Stop Smoking: Systematic Review
`and Meta-analysis. Available online: http://www.bmj.com/cgi/content/full/338/apr02_3/b1024
`(accessed on 24 September 2009).
`Zhu, S.H; Lee, M.; Zhuang, Y.; Garnst, A.; Wolfson, T. Interventions to increase smoking
`cessation at the population level: How much progress has been madein the last two decades?
`Tob. Control 2012, 2/7, 110-118.
`7. Rodu, B. Thescientific foundation for tobacco harm reduction, 2006-2011. Harm Reduct. J. 2011,
`8, 8-19.
`Lee, P. Epidemiologic evidence relating snus to health—An updated review based on recent
`publications. Harm Reduct. J. 2013, 70, doi:10.1186/1477-7517-10-36.
`Fagerstrom, K. Dependence on Tobacco and Nicotine,
`in Nicotine Science and Policy.
`Availab