E-Cigarettes and Youth: An examination of the public health and policy concerns over increased youth use and exposure to e-cigarettes Second Edition – July 2014 (Originally published November 2013)

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E-Cigarettes and Youth:

An examination of the public health and policy concerns over increased rates of youth use and exposure to e-cigarettes

Todd D. Fraley, JD

Kate Sheridan, MPH

Joel J. Africk, JD

Matt Maloney

Electronic cigarettes (e-cigarettes) have grown dramatically in popularity over the last

half-decade. As e-cigarette popularity has risen, so have rates of e-cigarette use among

youth and young adults. A September 2013 report by the U.S. Centers for Disease

Control and Prevention reported that youth use of e-cigarettes doubled between 2011

and 2012. E-cigarettes are available in a large variety of sweet flavors, can be sold in

youth-accessible locations, and can be widely advertised without running afoul of

tobacco advertising restrictions. These factors have caused concern in the public health

community that e-cigarettes may be a gateway for youth nicotine addiction and/or

traditional tobacco use, and may act to “re-normalize” cigarette use as a social norm.

While there is great concern over youth exposure to e-cigarettes, little is known about

the long-term health effects of e-cigarette use. In April 2014, the U.S. Food and Drug

Administration (FDA) announced a proposed rule that will bring e-cigarettes under their

regulatory authority. However, there are a number of public health concerns with the

implementation of the rule and with several youth-access issues that went unaddressed

by the FDA. Given the regulatory gaps that will still exist after the rule goes into effect,

e-cigarette regulation will need to continue to be pursued at the state and local level.

The purpose of this paper is to provide local health officials and policymakers a summary

of the public health concerns and policy issues regarding e-cigarettes. The public health

concerns highlighted by the paper include: increased youth use and exposure to e-

cigarettes; the unknown health effects of long-term e-cigarette use; the lack of

universal product standards; and the devices’ unknown efficacy as a cessation tool.

Finally, the paper examines the current state of e-cigarette regulation and outlines

several potential local policy options.

This paper was made possible by a grant from the Centers for Disease Control and Prevention (CDC) (Grant Number:

1H75DP004181-01) to the Chicago Public Schools (CPS) Office of Student Health and Wellness, Healthy CPS. The views expressed

in this publication do not necessarily reflect the views, opinions and official policies of CDC.

This paper has been written with a general audience in mind and is provided for educational purposes only and is not to be

construed as legal opinion. Policymakers considering regulating youth exposure e-cigarettes in their municipalities should

consult with their city law departments or other legal counsel.

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I. INTRODUCTION

Electronic cigarettes (e-cigarettes, e-cigs) are at a pivotal crossroads. The devices’ popularity continues

to enjoy a meteoric rise and tobacco control policies have struggled to keep up with the ever-evolving

technology. However, in April 2014, the U.S. Food and Drug Administration announced a long-

anticipated proposed rule that would extend its authority to cover additional tobacco products,

including electronic cigarettes.1 Despite public health officials and policymakers clamoring for FDA

action on e-cigarettes for over five years, the eventual announcement of the rule was met with arguably

as much criticism as support. While the rule is seen as a much-needed first step toward ensuring the

safety of the devices for their intended use, the rule is also notable for what it omitted. Among the

areas of concern not addressed by the FDA rule were flavorings, marketing and advertising, and internet

sales – factors with documented connections to youth tobacco initiation, generally. These omissions

come shortly on the heels of a U.S. Centers for Disease Control and Prevention (CDC) report finding that

youth use of e-cigarettes doubled between 2011 and 2012. A report by Legacy published after the

announcement of the FDA rule indicated that the rate of use youth is even higher for 2014.2

E-cigarettes are battery-powered devices that produce an inhalable vapor by heating an internal

cartridge that is filled with a solution that often contains nicotine and/or flavoring.3 Many e-cigarettes

physically resemble traditional cigarettes and the vapor they emit provides a similar flavor and sensation

to that of inhaled tobacco smoke. While some brands of e-cigarettes are disposable, many can be

reused with refillable nicotine solutions and batteries that can be recharged via wall outlet or USB cord.4

The term “e-cigarette” can refer specifically to these cigarette-resembling devices, but can also be an all-

encompassing term for a wide variety of vapor products. There is a large class of vapor products that do

not resemble cigarettes, but work in generally the same manner and produce the same form of vapor as

the cigarette-resembling devices. These products can be referred to as personal vaporizers, vapors,

tanks, mods, e-hookahs, vape pens, or electronic nicotine delivery systems (ENDS).5 The use of these

products, e-cigarette or otherwise, is known as “vaping.”6

First produced in China, e-cigarettes entered the U.S. around 2006.7 Although they have only been

available in the U.S. for less than a decade, the popularity of the devices has risen dramatically. The

current e-cigarette market is estimated to be approximately $2.2 billion.8 While that is a small fraction

of the market compared to traditional cigarettes ($90 billion), the e-cigarette market is projected to

reach $10 billion by 2017.9 Recent Wells Fargo analysis estimated that the non-cigarette resembling

variety of vapor products (personal vaporizers, vape pens, etc.) are the fastest growing portion of the

vapor market and account for approximately one third of all vapor product sales ($800M of

$2.2billion).10 Once seen as a threat to traditional cigarette sales, approximately half of e-cigarette sales

in the U.S. are now from brands owned by “Big Tobacco.”11 Riding the heels of the success of Lorillard’s

Blu brand of e-cigarette, the world’s other major cigarette manufacturers, including RJ Reynolds, Philip

Morris, British American Tobacco and Imperial Tobacco, have all recently acquired and/or developed

their own brands of e-cigarette.12

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Many public health officials, including the director of the CDC, have expressed concern that the

abundance of candy and dessert-like flavors of e-cigarettes may serve to lure youth to e-cigarettes,

which in turn could result in youth eventually transitioning to regular tobacco.13 E-cigarettes are

currently available in such enticing flavors as: Cinnamon Toast Crunch, Fruit Loops, chocolate chip

cookies, brownie, bubble gum, and gummi bear.14 Likewise, because e-cigarettes are unregulated

federally, manufacturers can circumvent the otherwise strict restrictions on advertising of traditional

cigarettes. While cigarette advertising has been greatly marginalized over the last two decades, markets

are now flooded with highly stylized e-cigarette ads featuring celebrity endorsements and “retro”

imagery harkening back to the golden age of cigarette marketing.15 In 2012, e-cigarette advertising

expenditures reached approximately $18.3 million, a three-fold increase from 2011.16 These marketing

tactics led several members of Congress17 and 40 state Attorneys General18 to issue a statement warning

that e-cigarette manufacturers are exploiting the lack of marketing restrictions to “target young users . .

. using many of the exact same advertising and promotion techniques used for decades by cigarette

manufacturers to hook teenagers on their products.”19 These congressmen’s concerns are not

unwarranted – in June 2014 it was reported that adolescent exposure to e-cigarette marketing had

increased by 256 percent over the previous two years.20

Until comprehensive regulations to limit youth access and exposure are in effect, it is important that

public health organizations continue to educate policymakers and citizens alike on the issues

surrounding e-cigarettes. Unfortunately, given the newness of the e-cigarettes, relatively little is known

about the impact of the devices, including the long-term health effects of breathing the vapor, their

efficacy as a cessation device, and whether they “re-normalize” traditional tobacco and cigarette use. If

youth exposure to e-cigarettes is to be limited, more public health and policy information needs to be

made readily available. It is with that necessity in mind that Respiratory Health Association has

published this white paper highlighting the important public health concerns and available local policy

options regarding e-cigarettes. Respiratory Health Association hopes that this paper will enable

policymakers to make well-informed decisions on e-cigarettes, as well as give public health educators a

more thorough understanding of both sides of the e-cigarette debate.

II. PUBLIC HEALTH CONCERNS

Increased Youth Use

As the availability of e-cigarettes has risen, so have the rates of use by youth and young adults.

According to the CDC, adolescent use of e-cigarettes doubled between 2011 and 2012. As of 2012,

nearly two million middle and high school students reported using electronic cigarettes.21 In general, 21

percent of smokers have reported trying e-cigarettes, which is more than double the percentage

reported in 2010.22 As mentioned above, e-cigarettes are available in a wide array of youth enticing

flavors, are highly marketed in areas and publications popular with youth, and in many places are not

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required to be kept behind the counter or sold with age verification. Because e-cigarettes are

unregulated, youth can be exposed to and obtain these products from easy sources such as specialty

retail shops, mall kiosks, and even online.23 Responding to these concerns, as of July 2014, 38 states –

Illinois included – have acted to prohibit the sale of e-cigarettes to minors.24 As e-cigarette use

continues to trend upwards in the absence of comprehensive federal regulation, public health officials

warn that e-cigarettes may be a new gateway to nicotine addiction and may “re-normalize” smoking-

behaviors and traditional cigarette use.25

In September 2013, the CDC reported that the percentage of U.S. middle and high school

students who use electronic cigarettes doubled between 2011 and 2012.26 As highlighted by the

report, the percentage of high school students who reported ever using electronic cigarettes

rose from 4.7 percent in 2011 to 10 percent in 2012; the percentage of high school students

who reported current e-cigarette use rose from 1.5 percent to 2.8 percent between 2011 and

2012, and; 76.3 percent of those students who reported current e-cigarette usage also reported

current conventional cigarette usage.27

Two studies commissioned by Legacy in 2014 indicated that current use of e-cigarettes among

13 to 17 year olds was at nine percent and ever use was even higher at 14 percent.28 The study

also found that awareness of e-cigarettes was at 89 percent among the same age group.

In March 2014, the first ever analysis of the relationship between adolescent e-cigarette use and

smoking was published. The analysis, based on survey data from the 2011 and 2012 National

Youth Tobacco Survey, suggested that e-cigarette use by adolescents may be a gateway to

conventional tobacco use and nicotine addiction, rather than serve as a cessation aid.29 The

research found that e-cigarettes were associated with higher odds of progression from

experimenting with cigarettes to becoming established cigarette smokers. The study also found

that teenagers who used both traditional cigarettes and e-cigarettes smoked more cigarettes

per day than non-e-cigarette users. While the study was not able to determine to what degree,

if any, adolescent smoking is initiated by e-cigarette use, the survey data did show that 20

percent of middle school students and seven percent of high school students who had tried e-

cigarettes had never tried traditional cigarettes.

A 2014 longitudinal study of how young adult beliefs about e-cigarettes affect behavior found

that the belief that e-cigarettes help you quit or the belief that they are safer than traditional

cigarettes was positively associated with e-cigarette experimentation.30 Of the young adults

surveyed, nearly 12 percent of participants who had quit smoking before study began had

started using e-cigarettes by the time the study ended and nearly three percent of the

nonsmokers were using e-cigarettes. As highlighted by one noted tobacco control

commentator, for that 15 percent of participants, “e-cigarettes were a pathway to renewed or

new nicotine addiction.”31

A 2012 focus group study found that young adults have positive perceptions of novel tobacco

products, including electronic cigarettes.32 In particular, young adults responded positively

towards the choice of flavors. Other young adult perceptions of the products included that they

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are less harmful than normal cigarettes and that they could be a gateway to cigarette smoking.

Finally, young adults reported that they would try the products if offered by a friend.

Unknown Health Effects

While e-cigarette vapor almost certainly contains fewer chemicals than the 7,000 found in traditional

tobacco smoke,33 that fact alone does not mean that breathing e-cigarette vapor is “safe.” No one

contends that e-cigarette vapor is chemical-free, and there is not enough evidence to allow anyone to

conclude there are no long-term effects of breathing e-cigarette vapor. Only recently have research

efforts begun to identify the chemicals found in e-cigarette vapor and examine the short-term health

effects of e-cigarette use.

E-cigarette vapor has been found to contain detectable levels of known carcinogens and toxins,

both in mainstream34 and in sidestream vapor.35 However, one study found that the levels of

the toxins common between e-cigarette vapor and cigarette smoke were between 9 and 450

times lower in the e-cigarette vapor than in traditional cigarette smoke.36

Compounds found in mainstream (MS) and sidesteam (SS) e-cigarette vapor have included:

Acetaldehyde (MS); Benzene (SS); Cadmium (MS); Formaldehyde (MS,SS); Isoprene (SS); Lead

(MS); Nickel (MS); Nicotine (MS, SS); N-Nitrosonornicotine (MS, SS); and Toluene (MS, SS).37

Limited preliminary research conducted by the FDA in 2009 found that among the e-cigarette

cartridges tested, a majority contained diethylene glycol, a chemical used in antifreeze that is

toxic to humans.38 Several other samples were found to contain tobacco-specific nitrosamines,

which are human carcinogens. In addition, harmful tobacco-specific impurities – anabasine,

myosmine and B-nicotyrine – were also found in a majority of the samples tested by the FDA.39

A 2012 study from Greece on the short-term effects of e-cigarette usage found that use of e-

cigarettes, “caused an instant increase in airway resistance that lasted for over 10 minutes.”40

A 2012 German study found that use of e-cigarettes causes detectable levels of volatile organic

compounds to be emitted into indoor air, leading the authors to conclude that “’passive vaping’

must be expected from consumption of e-cigarettes.”41

A 2014 study by RTI International found that, at least among youth users, the particles in e-

cigarette vapor may worsen acute respiratory diseases such as asthma and bronchitis.42

According to the findings of the study, up to 40 percent of the particles in e-cigarette vapor can

deposit in the deepest areas of children’s lungs. The chemicals in these particles have the

potential to irritate airways or exacerbate pre-existing respiratory diseases.

The New York Times reported in May 2014 that two forthcoming studies on the levels of certain

carcinogens in e-cigarette vapor found the tank system variety of e-cigarettes can produce the

carcinogen formaldehyde in levels “approach[ing] the concentration in [traditional]

cigarettes.”43 The formaldehyde is formed when the e-liquid is subjected to high temperatures.

Compared to standard e-cigarettes, which often mimic the size and feel of traditional cigarettes,

tank systems are larger and use higher voltage batteries. The high levels of formaldehyde occur,

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in particular, when users opt to pour the e-liquid directly onto the heating unit rather than fill

the tank – a practice known as “dripping.” The toxin levels “increased markedly” when the

voltage of the internal battery was upped to 4.8 volts from 3.2 volts.

Preliminary results of an ongoing study on the impact of e-cig vapor exposure on the

carcinogenic potential of human bronchial cells indicate that cells exposed to e-cig vapor with

high nicotine concentrations have similar patterns of gene expression as cells exposed to

traditional tobacco smoke.44 While researchers called the similarities “striking,” the research is

still in the very early stages, so the researchers are unable to conclude at this point whether e-

cig exposure can cause lung cancer. However, according to one of the authors of the study, “[e-

cigarettes] may be safer [than traditional cigarettes], but [the] preliminary studies suggest that

they may not be benign.”45

Lack of Product Standards

Equally troubling to public health officials as the lack of health information on e-cigarettes use is the lack

of uniform e-cigarette product standards. Because e-cigarettes are currently unregulated at the federal

level, consumers do not have uniform access to accurate information on e-cigarette ingredients, product

quality, and safe product usage. While some e-cigarette companies list product ingredients on their

websites, that is not the equivalent of reporting quality control procedures to a regulatory body charged

with ensuring consumer safety. Several studies, including preliminary FDA research, have found

potentially dangerous inconsistencies in the manufacturing of e-cigarettes.46 These inconsistencies led

the FDA to conclude that “quality control processes used to manufacture these products are

substandard or nonexistent.”47

In a limited lab study, the FDA found that certain cartridges labeled as ‘no nicotine’ actually

contained nicotine and that other cartridges labeled as containing identical amounts of nicotine

contained “markedly different” amounts of nicotine.48

E-cigarette nicotine cartridges are advertised to typically contain between 6 and 24mg of

nicotine. However, some have been found to contain more than 100 mg.49 Excessive doses

(0.5-1.0 mg per kg of weight of the person) of nicotine can be fatal.50 The estimated lethal dose

of nicotine for a child is 10mg.51 As e-cigarette use has increased, more incidents of nicotine

poisoning are being reported. A CDC report published in April 2014 found that poison control

center calls relating to e-cigarette liquid nicotine solutions rose from one a month in September

2010 to 215 per month in February 2014.52 More than half of the calls (51 percent) were

regarding ingestion, inhalation, or skin exposure of the liquid by children under the age of five.

There has been at least one reported death from a child ingesting e-cigarette liquid.53

A 2010 University of California Riverside study of design features, labeling, and instructions for

six leading e-cigarette brands found numerous design flaws, lack of adequate labeling and other

quality control issues.54 Among the findings were that the nicotine solution commonly leaked; it

was difficult to assemble most e-cigarettes without touching the nicotine solution; labeling of

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the cartridges was “very poor” compared to the wrappers and packaging; most brands lacked

cartridge content and health warning information; there was a lack of information on how to

safely dispose of used cartridges; the devices’ safety features did not always function properly;

and print and internet material often made unsupported claims of health and safety.55

At least 17 explosions caused by faulty e-cigarette batteries have been reported since 2012.56

According to fire officials, the lithium-ion battery in an e-cigarette does not contain a built-in

default setting (like in cell phones) to switch off when the battery is full; this can cause the coil

to continue to draw heat until the lithium-ion inside explodes.57 Such explosions have injured

not only e-cigarette users, but nearby individuals, including children and restaurant workers.58

The exploding e-cigarettes have been described by injured users as “rockets,” “roman candles,”

and “flamethrowers” and have resulted in third-degree burns, smoke-inhalation, and major

property loss.59

Unproven as a cessation tool

E-cigarettes have not been approved by the FDA as safe and effective for the purpose of smoking

cessation. Limited studies that tested the effectiveness of e-cigarettes as a cessation device have led to

mixed results. Some studies found that using e-cigarettes, with or without nicotine, genuinely helped

smokers reduce smoking or fully quit smoking; other studies found that e-cigarettes did not aid

cessation and may actually prolong users’ nicotine addictions. Because e-cigarettes are currently

unregulated, individuals using e-cigarettes for cessation have no way of knowing with confidence

whether e-cigarettes are safe for that specific use, how much nicotine or other potentially harmful

chemicals are being inhaled during use, or what, if any, objective benefits are associated with using the

products. While certain studies have shown positive results, the efficacy of e-cigarettes as an aid for

sustained smoking cessation has not been proven conclusively.60 Taken together, the body of research

suggests that e-cigarette use among all e-cigarette users is associated with lower odds of quitting

smoking, but that for e-cigarette users who are using the products to quit smoking, e-cigarette use may

increase the odds of a successful attempt. In the meantime, many e-cigarette manufacturers have

opted to include a disclaimer on e-cigarette packaging and websites stating that the devices are not

intended for the purpose of cessation.61

A longitudinal study of US smokers published in JAMA in March 2014 found that e-cigarette use

was not associated with quitting smoking one year later or smoking fewer cigarettes.62 While

the study’s strong conclusion added to the growing body of literature suggesting that e-

cigarettes are not effective cessation aids, the authors of the study cautioned the broad

application of the conclusion given the sample size; the strong conclusion given the study’s

limitations was also criticized by certain public health advocates.63

A population-based cross-sectional study published in Addiction in 2014 examined the

association between e-cigarette use and quitting smoking among smokers in England.64 The

study found that smokers who used e-cigarettes in an attempt to quit smoking without

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professional support were more likely to have reported abstinence from cigarettes than those

who used over-the-counter cessation aids or no aids at all.

A randomized clinical trial published in Lancet in 2013 found that e-cigarettes, either with or

without nicotine, were modestly effective at helping smokers quit, as compared to nicotine

patches.65

In a 2013 study of e-cigarette users across four countries, 75 percent of respondents said that

they used e-cigarettes to help reduce smoking and 85 percent said they were using e-cigarettes

to help them quit smoking.66 However, one commentator noted that based on the study’s

results, the e-cigarette users in the study were no more likely to have quit conventional

cigarettes than non e-cigarette users.67

While some studies have posited that e-cigarettes may be an effective cessation aid, the

University of California San Francisco – Center for Tobacco Control and Research Education has

noted that based on available research, e-cigarettes may deliver “14 times as much

formaldehyde, 7 times as much actaldehyde, 6 times as much o-methylbenzene, 3 times as

much cadmium and twice as much lead as . . . nicotine inhaler[s],” which are devices actually

approved for use in smoking cessation.68

A 2013 study of e-cigarettes use among cessation quitline callers found that the callers who

used e-cigarettes were, “significantly less likely to be tobacco abstinent” than the callers who

had never tried e-cigarettes.69

One study examining the delivery of nicotine by e-cigarettes found that compared to approved

cessation aids such as nicotine gum or patches, e-cigarettes did not deliver nicotine effectively

and were less effective at suppressing users’ cravings.70 This study led other commentators in

the New England Journal of Medicine to warn that “[s]mokers attempting to use e-cigarettes for

smoking cessation will most likely find them ineffective; indeed, their use may instead

perpetuate smokers’ addiction.”71

III. REGULATION OF E-CIGARETTES

History of E-Cigarette Regulation

In April 2014, the FDA announced a proposed rule that would bring electronic cigarettes under its

regulatory power. The FDA originally planned to announce the proposed rule in October 2013,72

however, the rule was stalled in review for six months by the White House Office of Management and

Budget.73 While federal regulation of e-cigarettes has been several years in the making, some actions

were attempted between the enactment of the FSPTCA and the ultimate announcement of the FDA’s

deeming rule.

In 2009, the FDA voiced numerous concerns over e-cigarettes, including: the devices do not contain any

health warnings comparable to FDA-approved nicotine replacement products or conventional

cigarettes; the products may contain ingredients that are known to be toxic to humans; the risks of

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increased nicotine addiction and initiation to traditional tobacco use among young people; and the lack

of health and safety information available to consumers.74 That same year, the FDA attempted to ban

certain e-cigarettes as unapproved drug delivery devices; however, the U.S. Courts of Appeals for the

District of Columbia ruled that the e-cigarettes in question were properly regulated as tobacco

products.75

In 2010, the FDA issued warning letters to several e-cigarette distributors regarding alleged violations of

the Food, Drug, and Cosmetic Act, including, “violations of good manufacturing practices, making

unsubstantiated drug claims, and using the devices as delivery mechanisms for active pharmaceutical

ingredients.”76

In response to the delayed FDA regulations, in December 2013, a group of Senate Democrats called on

the Federal Trade Commission (FTC) to investigate the marketing tactics of e-cigarette companies –

specifically, to address allegations that they are deliberately targeting kids and making unsupported

health claims.77 The same group of Senators in April 2014 again appealed to the FTC and the FDA to use

their existing authority to reprimand e-cigarette companies that make the unsubstantiated claims that

their products can help users quit smoking.78 The Senators also pushed for the use of e-cigarettes to be

prohibited on the grounds of the U.S. Capitol.79

Supplementary to the FDA deeming rule, as of July 2014, three states (North Dakota, New Jersey, Utah)

and nearly 200 municipalities across the U.S. have added e-cigarettes to their smoke-free venue laws.80

Among the cities that have included the use of vapor products in their clean indoor air law are Chicago,

IL, Los Angeles, CA, New York, NY, Philadelphia, PA, and San Francisco, CA. In addition, eleven states

have prohibited the use of e-cigarettes in other venues such as schools, government offices, correctional

facilities, and public transportation.81

Other countries have also struggled with the appropriate scope of regulation for e-cigarettes. In July

2013, the World Health Organization issued a warning to consumers regarding e-cigarettes and

encouraged governments to regulate the sale of the devices.82 A few months later, the European

Parliament opted not to regulate the products as pharmaceuticals.83 Instead, the European Union

announced it will establish 18 as the minimum age to purchase e-cigarettes, prohibit e-cigarette

advertising, limit e-cigarette nicotine content to 20mg/ml, require childproofing, and mandate warning

labels on the products’ addictiveness and potential toxicity.84 In March 2014, the New York Times

editorial board called on the FDA to model its e-cigarette regulations on the ones passed by the EU.85

FDA Deeming Rule

As mentioned above, in April 2014, the FDA announced its proposed rule regarding e-cigarettes.86 The

FDA’s authority to regulate these products derives from a provision of the Family Smoking Prevention

and Tobacco Control Act of 2009 (FSPTCA) that enables the agency to regulate other tobacco products

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(i.e., products that aren’t cigarettes, cigarette tobacco, smokeless tobacco, and roll-your-own tobacco)

that the agency “deems to be subject” to the Act.87 However, before the agency can begin regulating

other tobacco products, it needs to create a rule extending its authority over the specific products in

question and have the rule pass through a formal rulemaking process. The rule is referred to as a

“deeming” rule because the FDA is “deem[ing] [the products] to be subject” to the FSPTCA.

As the deeming rule stands in its proposed form, the rule will:

Establish 18 as the minimum age to purchase e-cigarettes and require age verification for

purchasers under 27;

Require e-cigarette manufacturers to register with the FDA and disclose product lists,

ingredients, substances, compounds, additives, potentially harmful constituents, and certain

other health-related information;

Require all new products to be submitted for FDA review before entering the marketplace;

Prohibit free samples;

Prohibit false and misleading advertising (Will only allow direct and implied claims of reduced

risk if the FDA confirms that scientific evidence supports the claim and that marketing the

product will benefit public health as a whole);

Regulate adulterated products;

Mandate a health warning on the packaging relating to nicotine content; and

Prohibit sale of e-cigarettes via vending machine, except in adult-only facilities.88

While the deeming rule lays the groundwork for federal regulation of e-cigarettes, there are areas of

concern both with what’s included in the rule and with several major issues that went unaddressed by

the FDA. Some of the leading public health concerns with the FDA’s deeming rule include:

The deeming rule does not restrict the marketing and advertising of e-cigarettes;

The deeming rule does not restrict flavors of disposable e-cigarettes or liquid nicotine refills;

The rule does not prohibit internet sales of e-cigarettes or require age verification for internet

purchases;

The rule does not require e-liquid to be sold in sealed, child-proof containers;

The deeming rule’s pre-market review requirement will have a two-year grandfather clause

after the rule goes into effect in which manufacturers can still market new tobacco products so

long as they submit an FDA application; and

The rule does not contain a single citation to the findings of the 2014 Surgeon General’s Report,

The Health Consequences of Smoking: 50 Years of Progress.89

Given the rising rates of youth use and exposure to e-cigarettes, public health officials are concerned

that known youth enticing tactics, including sweet flavored products and targeted advertising and

marketing campaigns were not addressed at this time. This concern is especially valid given the heavy

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restrictions on traditional cigarette advertising and the federally-imposed ban on flavored cigarettes. In

addition, there is concern that the rates of youth use and exposure to e-cigarettes will continue to climb

both while the rule is being finalized, and then once implemented, during the two-year grandfather

period in which existing products can remain on the market while being reviewed by the FDA.

As of the publishing of this white paper, the FDA deeming rule is in a public comment period extending

to August 8, 2014.90 After the public comment period closes, the FDA may make changes to the rule

based on the feedback it received. The FDA then publishes the final rule to the Federal Register and also

publishes a response to the public comments. It is likely that the final rule will take over a year to be

implemented given the number of public comments the agency will receive and the likelihood of

litigation that the agency could ultimately face.

State and Local Policy Options

Given the novelty of e-cigarettes, state and local policymakers have had to search for equally innovative

policy solutions to limit youth use and exposure to the products. The struggle with regulating e-

cigarettes has derived not just from uncertainty of viable policy options, but also how to correctly define

the products. As mentioned above, both the FDA and EU were unsuccessful in attempting to regulate e-

cigarettes as medical devices. Even with that option curbed for now, there has been significant debate

whether e-cigarettes should be defined as “tobacco products,” “alternative tobacco products,”

“alternative nicotine products,” “nicotine delivery devices,” “vapor products,” or something else

entirely. Many tobacco control advocates argue that defining e-cigarettes as “tobacco products” will

enable the strongest level of regulation and will prevent certain regulatory loopholes that could result

from defining them as “alternative tobacco products,” “alternative nicotine products,” “vapor products,”

or “nicotine delivery devices.”91

In July, 2013, the governor of Rhode Island vetoed legislation to ban the sale of e-cigarettes to minors

that would have defined e-cigarettes as “vapor products.”92 According to Governor Lincoln Chafee, by

defining e-cigarettes as “vapor products” as opposed to “tobacco products,” the legislation would have

enabled e-cigarettes to evade existing ID, signage and licensing requirements, as well as tobacco taxes.93

Finally, by defining e-cigarettes as anything other than a “tobacco product,” it is possible that states and

municipalities could be subject to legal challenge for essentially defining a new class of tobacco

products, which is a power exclusively reserved for the FDA and would, therefore, be preempted by the

FSPTCA. There has been some outcry among the tobacco control community that other poorly worded

e-cigarette bills have been “Trojan Horses” planted by the tobacco industry.94 Several states, including

Vermont, Minnesota and New Hampshire, have included e-cigarettes in their respective definitions of

“tobacco products.”95 Illinois currently defines e-cigarettes as “alternative nicotine products” in its law

prohibiting the sale of e-cigarettes to minors.96

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The issue of accurate definitions aside, the following list represents several of the leading policy options

that states and local governments could explore to reduce youth exposure to e-cigarettes:

Adding e-cigarettes to existing smoke-free laws. Three states and over 140 municipalities have

either added e-cigarettes to their existing smoke-free laws or have created new smoke-free laws

including e-cigarettes.97 The primary justification of this policy option is to “minimize the use of

products that pose unknown health risks.”98 In addition, adding e-cigarettes to smoke-free laws

is believed to assist with enforcement of smoke-free laws. Since e-cigarettes physically

resemble traditional cigarettes and e-cigarette vapor resembles tobacco smoke, it can be

confusing for enforcement officials to identify whether or not the product being used is legal.

Adding e-cigarettes to existing smoke-free laws would eliminate that confusion and enable

equal enforcement against e-cigarettes and traditional tobacco products. Finally, by restricting

exposure to e-cigarettes in public places, this policy option helps reinforce smoke-free lifestyles

as a social norm with youth and young adults. As previously discussed, the primary difficulty

with this policy option is in accurately defining e-cigarettes so as to enable the strongest level of

cross-regulation.

Minimum sales age. Another popular policy option for states and municipalities is to limit the

sale of e-cigarettes by the age of the purchaser. As of April 2014, 28 states (including Illinois)

and the District of Columbia have enacted laws establishing 18 as the minimum age to purchase

e-cigarettes.99

Limiting youth access. In addition to establishing a minimum sales age, municipalities could

consider other options to limit youth access to e-cigarettes, such as restricting sales of the

products to adult-only retailers or requiring e-cigarettes to be kept behind the counter.100

Licensing. If a municipality is able to successfully define e-cigarettes as tobacco products, then it

may be possible to add e-cigarettes into existing tobacco licensing schemes. By requiring

businesses to have a tobacco retail license to sell e-cigarettes, cities could limit the number of

total sellers in the jurisdictions, as well as limit the location of e-cigarette retailers, such as

around schools or other areas frequented by youth.

Marketing regulation. Potential policy options around e-cigarette marketing include restricting

point-of-sale advertising, requiring the posting of health warnings at point-of-sale locations, or

imposing a total prohibition on the sale of the products.101 These options, however, do not

come without significant obstacles. While governments have an interest in shielding consumers

from false or misleading claims, commercial speech, including truthful advertising, is protected

free speech under the First Amendment.102 The enactment of such options would undoubtedly

result in litigation. For that reason, the regulation of e-cigarette marketing, perhaps more than

13

any of the other policy options, would require a municipality to conduct a thorough legal

analysis into the viability of such a policy within their jurisdiction.

Taxation. While taxing e-cigarettes at the levels of traditional cigarettes is a politically popular

idea, the ability of a state or municipality to tax e-cigarettes also hinges on how the products are

defined in the statute.103 Federal law reserves for states and local governments the power to

tax tobacco products; however, unless e-cigarettes are defined as tobacco products, then they

may not be able to be taxed.

Limiting Free Samples, Rebates, Discounts, and Coupons. The FSPTCA prohibited tobacco

companies from engaging in certain pricing discounting activities, including: free samples of

cigarettes, mail-order coupon redemption, and giving away free non-tobacco products with the

purchase of tobacco products.104 The FSPTCA does not, however, restrict pricing discounts

through the use of coupons or rebates. In addition, the FSPTCA allows the sampling of

smokeless tobacco products in qualified adult-only locations.105 Nevertheless, the FSPTCA does

preserve state authority to further restrict the sale and distribution of tobacco products.106 The

U.S. Court of Appeals for the First Circuit recently upheld a local ordinance (Providence, RI)

prohibiting licensed tobacco retailers from selling discounted tobacco products via multi-pack

offers and coupon redemption.107 Regarding e-cigarettes, while any regulation would hinge

upon defining e-cigarettes as tobacco products, if a state or municipality were to define e-

cigarettes as tobacco products, then they could potentially be able to restrict the redemption of

coupons for e-cigarettes, as well as rebates, free samples and pricing discounts.

Restricting the sale of flavors. E-cigarettes are available in a wide array of flavors, including in

an abundance candy, dessert and alcohol-themed options. The FDA has exclusive authority, via

the FSPTCA, to regulate product standards,108 which includes product flavoring; however, states

are preserved the right to regulate the sale and distribution of tobacco products. While a state

or local government could not ban e-cigarette flavoring itself, they could potentially prohibit the

sale or distribution of flavored e-cigarettes. New York, NY109 and Providence, RI110 both recently

enacted ordinances prohibiting the sale of flavored non-cigarette tobacco products, except in

tobacco bars. These ordinances were challenged on federal preemption and First Amendment

grounds, but each was ultimately upheld in federal court.111 While no state or municipality has

attempted to prohibit the sale of flavored e-cigarettes, these two rulings could potentially be

supportive of more expansive regulation of flavored tobacco products.i

i For more information on the implications of these cases, see, Todd Fraley et al., Reducing Youth Exposure to

Flavored Tobacco: An analysis of U.S. Smokeless Tobacco Mfg. Co. v. City of New York and Nat’l Ass’n of Tobacco

Outlets v. City of Providence and what they mean for the future of youth tobacco prevention, Respiratory Health

Association (Nov. 2013), available at: http://www.lungchicago.org/library/.

14

Emerging Issues in E-Cigarette Regulation

Recently, some e-cigarette retailers and users have claimed that their e-liquid does not contain nicotine

derived from tobacco, but instead uses nicotine from another source: tomatoes, eggplant and potatoes.

Like tobacco, these plants are all members of the nicotine-producing nightshade family of plants.112

While all of these plants produce nicotine, the tobacco plant produces it in significantly larger quantities

than other plants in the nightshade family.113 Thus far, there has been no scientific evidence to support

the claims of the existence of liquid nicotine derived from vegetables. However, arguably, if the nicotine

in e-liquid was not derived from tobacco plants, then e-liquid couldn’t be fairly classified as a tobacco

product and might thus evade federal, state, and local e-cigarette laws.

For the most part, the existence of non-tobacco sourced nicotine has been a matter of conjecture,

raised mainly in e-cigarette user and manufacturer comments in testimony opposing municipal e-

cigarette laws, public comments for the FDA deeming rule, and on e-cigarette user message boards.114

Assuming the authenticity of the products is genuine, it is currently unknown to what degree tomato or

eggplant derived liquid nicotine exists in the marketplace. It is likewise unknown whether this form of

nicotine can be mass produced in a cost-effective manner. However, local surveillance of e-cigarette

retail shops and online marketplaces has found an increasing number of e-liquid bottles labeled as

containing non-tobacco derived nicotine, suggesting that knowledge of the potential loophole is quickly

spreading among the e-cigarette community.

To complicate the matter, some e-liquids contain vegetable glycerin. This does not necessarily mean

that the nicotine itself was derived from non-tobacco sources, simply that the base for the e-liquid was

derived from vegetables. Marketing of these products as being “100% from vegetables” has contributed

to the confusion over non-tobacco sourced liquid nicotine.

The existence of non-tobacco derived nicotine could potentially hinder the enforcement of regulations

pertaining to tobacco retailer licensing, youth access, and excise tax. These regulations generally

revolve around statutory definitions of “tobacco products” and “tobacco retailer.” If these new varieties

of e-liquid do not meet the statutory definition of “tobacco product,” then any law relying on such a

definition would arguably be inapplicable as to those products. For example, according to Forbes, the e-

cigarette company, GreenSmartLiving, used the marketing of non-tobacco derived nicotine to attempt

to circumvent Minnesota’s excise tax.115

It has been suggested by tobacco control scholars that the deeming rule presents an opportunity for the

FDA to clarify that the rule covers all forms of nicotine, regardless of the source.116 The potential

necessity for rulemaking or legislative correction aside, all states and municipalities that currently

regulate e-cigarette sales (or are planning on adopting such regulations) will need to allocate additional

tobacco surveillance and enforcement resources as retailers attempt to evade tobacco excise taxes and

licensing schemes. In addition, more scientific and economic research is needed to determine whether

15

these forms of e-liquid are in fact authentic and how much they would cost to mass produce. Should

these products prove to be inauthentic, options should be explored to enforce consumer deception laws

via the state attorneys general or the Federal Trade Commission, or alternatively, through the FDA’s

power to regulate misbranded products.

IV. CONCLUSION

The e-cigarette industry continues to evolve at a rapid rate. Policymakers and health officials will need

to respond to the changing environment in order to ensure that youth exposure to e-cigarettes is limited

and that young e-cigarette users have adequate access to health information and cessation resources.

Because the e-cigarette industry and the regulatory landscape is are in state of flux, policymakers and

health officials will need to stay informed of the growing body of scientific literature on e-cigarettes.

Studies of vapor composition and short term health effects of e-cigarette use are currently ongoing, but

little is known about the long-term health effects of e-cigarette use. Likewise, studies of e-cigarettes’

efficacy as cessation devices have thus far been mixed. While the FDA has proposed rules regarding e-

cigarette sales, product standards, and health warnings, the rules do not address several issues

surrounding youth access and in all likelihood will take upwards of a year to be implemented. In the

meantime, state and local policymakers have a number of viable policy options to reduce youth use and

exposure to e-cigarettes, including adding e-cigarettes to smoke-free laws and establishing a minimum

sales age.

16

ADDITIONAL E-CIGARETTE POLICY RESOURCES:

Electronic Cigarettes [webpage]. (last updated, July 2014). Americans for Nonsmokers’ Rights.

Available at: http://www.no-smoke.org/learnmore.php?id=645.

E-Cigarettes [fact sheet]. (last updated, January 2014). American Academy of Pediatrics. Available at:

http://www2.aap.org/richmondcenter/pdfs/ECigarette_handout.pdf.

U.S. State and Local Laws Regulating Use of Electronic Cigarettes [fact sheet]. (last updated, July 2014).

American Nonsmokers’ Rights Foundation. Available at: http://www.no-smoke.org/pdf/ecigslaws.pdf.

How to Regulate E-Cigarettes and Other Electronic Smoking Devices in Your Community [flow chart].

(June 2013). ChangeLab Solutions. Available at: http://changelabsolutions.org/publications/e-cig-ord.

Model Ordinance Regulating Electronic Smoking Devices. (June 2014). ChangeLab Solutions. Available

at: http://changelabsolutions.org/publications/e-cig-ord.

Electronic Cigarettes (E-Cigarettes) [fact sheet]. (May 2014). American Legacy Foundation. Available at:

http://www.legacyforhealth.org/content/download/582/6926/file/LEG-FactSheet-eCigarettes-

JUNE2013.pdf.

Electronic Cigarettes – An Overview. (April 2013) Red Series Tobacco Control and Prevention. German

Cancer Research Center, Heidelberg. Available at: http://www.dkfz.de/en/presse/download/RS-Vol19-

E-Cigarettes-EN.pdf.

Regulatory Options for Electronic Cigarettes [fact sheet]. (February 2013). Tobacco Control Legal

Consortium. Available at: http://www.publichealthlawcenter.org/sites/default/files/resources/tclc-fs-

regulatory-options-e-cigarettes-2013.pdf.

Electronic Cigarettes: How They Are – and Could Be – Regulated [fact sheet]. (October 2011).

ChangeLab Solutions. Available at: http://changelabsolutions.org/sites/default/files/E-

cigarette_FactSht_FINAL_%28CLS_20120530%29_October21_2011_0.pdf.

Regulating E-Cigarettes [tips and tools]. (May 2011). Tobacco Control Legal Consortium. Available at:

http://www.publichealthlawcenter.org/sites/default/files/resources/tclc-guide-regecigs-2011.pdf.

17

ENDNOTES:

1 Press Release, U.S. Food and Drug Administration, FDA Proposes to extend its tobacco authority to additional

tobacco products, including e-cigarettes (Apr. 24, 2014), available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm394667.htm. 2 Am. Legacy Found., Vaporized: E-Cigarettes, Advertising, and Youth (2014), available at:

http://www.legacyforhealth.org/newsroom/press-releases/new-report-on-electronic-cigarettes-underscores-critical-need-for-advertising-restrictions-to-limit-product-s-appeal-to-youth. 3 See, Am. Acad. Pediatrics, E-Cigarettes (2013), available at:

http://www2.aap.org/richmondcenter/pdfs/ECigarette_handout.pdf; Am. Legacy Found., Electronic Cigarettes (E-Cigarettes) (2013), available at: http://www.legacyforhealth.org/content/download/582/6926/file/LEG-FactSheet-eCigarettes-JUNE2013.pdf; Am. Cancer Soc’y Cancer Action Network, E-Cigarettes – Are They Safe? Will They Help Smokers Quit? (2011), available at: http://www.acscan.org/pdf/smokefree/smokefree-e-cigarette.pdf; World Health Org., Tobacco Free Initiative, Questions and answers on electronic cigarettes or electronic nicotine delivery systems (ENDS) (2013), available at: http://www.who.int/tobacco/communications/statements/eletronic_cigarettes/en/. 4 Id.

5 Tom Gara, Are E-Cigarettes Losing Ground in the Vapor Market?, Wall St. J., Apr. 13, 2014, available at:

http://blogs.wsj.com/corporate-intelligence/2014/04/14/are-e-cigarettes-losing-ground-in-the-vapor-market/. 6 Am. Acad. Pediatrics, supra note 3; Am. Cancer Soc’y, supra note 3; Am. Legacy Found., supra note 3; World

Health Org., supra note 3. 7 Adriana Barton, Why doctors are raising the alarm over e-cigarettes, The Globe and Mail, Oct. 9, 2013, available

at: http://www.theglobeandmail.com/life/health-and-fitness/health/doctors-raise-the-alarm-over-e-cigarettes/article14763867/?cmpid=rss1. 8 Gara, supra note 5; Reid Wilson, Awaiting FDA, states pursue their own e-cigarette rules, Wash. Post, Oct. 29,

2013, available at: http://www.washingtonpost.com/blogs/govbeat/wp/2013/10/29/awaiting-fda-states-pursue-their-own-e-cigarette-rules/. 9 Wilson, supra note 8.

10 Gara, supra note 5.

11 Melissa Vonder Haar M, Logic, Vuse, and MarkTen Shake Up Nielsen, CSPnet.com, Jan. 22, 2014, available at:

http://www.cspnet.com/category-management-news-data/tobacco-news-data/articles/logic-vuse-and-markten-shake-nielsen. 12

Andrew Goodman, E-Cigarettes Are Smoking Hot – Four Ways to Invest in Them, Forbes, Dec. 5, 2013, available at: http://www.forbes.com/sites/agoodman/2013/12/05/e-cigarettes-are-smoking-hot-4-ways-to-approach-them/. 13

Liz Szabo, CDC: Makers of e-cigarettes, little cigars target kids, USA Today, Nov. 6, 2013, available at: http://www.usatoday.com/story/news/nation/2013/11/06/e-cigarettes-cigars-target-kids/3457719/; Am. Acad. Pediatrics, supra note 3; Campaign for Tobacco Free Kids, Big Tobacco’s Tricks Not Treats, Tobacco Unfiltered Blog (Oct. 31, 2013), available at: http://www.tobaccofreekids.org/tobacco_unfiltered/post/2013_10_31_halloween; FDA Warns of Health Risks Posed by E-Cigarettes, Consumer Update (U.S. Food and Drug Administration, Jul. 2009), available at: http://www.fda.gov/downloads/ForConsumers/ConsumerUpdates/UCM173430.pdf; 14

Campaign for Tobacco Free Kids, supra note 13. 15

7 Ways E-Cigarette Companies Are Copying Big-Tobacco’s Playbook, Tobacco Unfiltered Blog (Campaign for Tobacco Free Kids, Oct. 2, 2013), available at: http://www.tobaccofreekids.org/tobacco_unfiltered/post/2013_10_02_ecigarettes. 16

Annice E Kim et al., E-Cigarette Advertising Expenditures in the U.S., 2011-2012, 46 Am J Prev Med 4, 409-412 (2014). 17

Press Release, Dick Durbin – US Senator for Illinois, Assistant Majority Leader, Durbin, Harkin, Rockerfeller, Waxman & Members of Congress Call on E-Cigarette Makers to Explain Marketing Tactics Targeting Kids (Sep. 26,

18

2013), available at: http://www.durbin.senate.gov/public/index.cfm/pressreleases?ID=fafe1d70-0a2c-429c-9372-c5ca201cb261. 18

Letter from Nat’l Ass’n Att’ys Gen., Re: FDA Regulation of E-Cigarettes, (Sep. 24, 2013), available at: http://www.naag.org/assets/files/pdf/E%20Cigarette%20Final%20Letter%20%285%29%281%29.pdf. 19

Press Release, U.S. House of Representatives, Committee on Energy and Com., Ranking Members Warn of Dangers of E-Cigarette Advertising (Nov. 4, 2013), available at: http://democrats.energycommerce.house.gov/index.php?q=news/ranking-members-warn-of-dangers-of-e-cigarette-advertising. 20

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Am. Acad. Pediatrics, supra note 3; Campaign for Tobacco Free Kids, supra note 13. 24

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Id. 28

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19

42

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Matt Richtel, Some E-Cigarettes Deliver a Puff of Carcinogens, N.Y. Times., May 3, 2014, available at: http://www.nytimes.com/2014/05/04/business/some-e-cigarettes-deliver-a-puff-of-carcinogens.html?ref=health&_r=1. 44

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Id. 48

Id. 49

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Id. 51

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Id. 56

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Liebelson supra note 56. 60

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20

65

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Cobb, supra note 51. 72

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U.S. Food and Drug Admin., supra note 38. 75

Sottera, Inc. v Food & Drug Administration, 627 F.3d 891 (D.C. Cir. 2010). 76

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Id. 79

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Id. 82

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Jacob Sullum, E.U. Decides Not to Interfere with E-Cigarette Sales; Will the FDA Follow Suit?, Forbes., Oct. 9, 2013, available at: http://www.forbes.com/sites/jacobsullum/2013/10/09/e-u-decides-not-to-interfere-with-e-cigarette-sales-will-the-fda-follow-suit/. 84

Sullum, supra note 83; Editorial, Regulating Electronic Cigarettes, N.Y. Times, March 1, 2014, available at: http://www.nytimes.com/2014/03/02/opinion/sunday/regulating-electronic-cigarettes.html?hp&rref=opinion&_r=3. 85

Editorial, supra note 84. 86

Press Release, U.S. Food and Drug Admin., FDA Proposes to extend its tobacco authority to additional tobacco products, including e-cigarettes (April 24, 2014), available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm394667.htm. 87

21 U.S.C. § 387a(b). 88

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

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Required Warning Statements for Tobacco Products, 79 Fed. Reg. 23141 (proposed April 25, 2014) (to be codified at 21 C.F.R. 1100, 1140, 1143). 89

Stanton A Glantz, FDA should use information in the 2014 Surgeon General’s Report when finalizing its deeming rule, Stanton Glantz, PhD’s Blog, University of California, San Francisco, Center for Tobacco Control Research and Education (May 4, 2014), available at: http://www.tobacco.ucsf.edu/fda-should-use-information-2014-surgeon-general-report-when-finalizing-its-deeming-rule. 90

U.S. Food and Drug Admin., supra note 86. 91

Matthew L Myers, President, Campaign for Tobacco Free Kids, Statement: Rhode Island Governor Chafee Does the Right Thing by Vetoing Legislation to Exempt E-Cigarettes from Health Regulations (Jul. 18, 2013), available at: http://www.tobaccofreekids.org/press_releases/post/2013_07_18_ri. 92

Gavin Brody, Veto Sinks RI Ban On E-Cigarette Sales To Minors, Law360, Jul. 19, 2013, available at: http://www.law360.com/articles/458615/veto-sinks-ri-ban-on-e-cigarette-sales-to-minors. 93

Myers, supra note 91. 94

Stanton A Glantz, Big Tobacco trying to block progress on controlling e-cigs in Florida with Trojan Horse youth access bill, Stanton Glantz, PhD’s Blog, University of California, San Francisco, Center for Tobacco Control Research and Education (April 17, 2014), available at: http://www.tobacco.ucsf.edu/big-tobacco-trying-block-progress-controlling-e-cigs-florida-trojan-horse-youth-access-bill. 95

Myers, supra note 91. 96

720 ILCS 675/1.5, as amended by Public Act 098-0350. 97

Am. Nonsmokers’ Rights Found., supra note 80. 98 Tobacco Control Legal Consortium, Regulatory Options for Electronic Cigarettes (Feb. 2013), available at:

http://www.publichealthlawcenter.org/sites/default/files/resources/tclc-fs-regulatory-options-e-cigarettes-2013.pdf. 99

Alex Stuckey, Minors banned from buying e-cigarettes under bills passed by Missouri lawmakers, St. Louis Post-Dispatch, Apr. 17, 2014, available at: http://www.stltoday.com/news/local/govt-and-politics/political-fix/minors-banned-from-buying-e-cigarettes-under-bills-passed-by/article_7e427296-8a94-5f20-880b-30e5d17d972c.html. 100

Tobacco Control Legal Consortium, supra note 98. 101

Id. 102

See generally, Cent. Hudson Gas & Elect. Corp. v. Pub. Serv. Comm’n of New York, 447 U.S. 557 (1980); Liquormart, Inc. v. Rhode Island, 517 U.S. 484 (1996). 103

Tobacco Control Legal Consortium, supra note 98. 104

Id. 105

21 U.S.C. § 387a-1(a)(2)(G). 106

21 U.S.C. § 387p(a)(1). 107

Nat’l Ass’n of Tobacco Outlets v. City of Providence, (1st

Cir. 2013). 108

21 U.S.C. § 387p(a)(2)(A). 109

New York City Administrative Code § 17-713. 110

Providence, R.I., Code of Ordinances § 14-308. 111

U.S. Smokeless Tobacco Mfg. Co., et al. v. City of New York, No. 11-5167-cv (2d Cir., decided February 26, 2013); Nat’l Ass’n of Tobacco Outlets v. City of Providence, No. 13-1053 (1st Cir. 2013). 112

Edward F. Domino et al., The Nicotine Content of Common Vegetables, 329 New Eng. J. Med. 437 (1993). 113 Id. 114 See e.g., Alisa Hauser, Vape Shop Owners Relieved By City Exemption from Indoor Smoking Ban, DNAinfo Chicago, January 29, 2014, available at http://www.dnainfo.com/chicago/20140129/wicker-park/vape-shop-owners-relieved-by-city-exemption-from-indoor-smoking-ban (“[Larry Eng, owner of Level Vape] claims he ‘has a legal way to circumvent [Chicago’s e-cigarette ordinances]” but declined to share his strategy with a reporter.”); Ryan Murray, E-cigarette regulation concerns local health officials, Daily Inter Lake, May 11, 2014, available at http://www.dailyinterlake.com/members/e-cigarette-regulation-concerns-local-health-officials/article_06a799f8-d951-11e3-805d-001a4bcf887a.html (“Some of the companies making the e-cigarette liquids, such as those sold by [Ryan Bliss, owner of The Vapor Depot], contain nicotine not derived from tobacco. ‘Our mixture contains vegetable glycerin,

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distilled water and nicotine from eggplants, tomatoes and potatoes,’ [Bliss] said. ’98 percent of all the nicotine comes from tobacco, but ours doesn’t.”); Matt Richtel, Where Vapor Comes Sweeping Down the Plain, N.Y. Times, April 26, 2014, available at http://www.nytimes.com/2014/04/27/business/e-cigarettes-take-hold-in-oklahoma.html?_r=0 (“[S]upporters . . . argue that nicotine isn’t a tobacco product because it can be derived from eggplants.”); Jim Siegel, E-cigarette bill draws flak, but vote in Ohio Senate is near, Columbus Dispatch, February 5, 2014, available at http://www.dispatch.com/content/stories/local/2014/02/05/e-cigarette-bill-draws-flak-but-vote-is-near.html (“[O]ne e-cigarette company advertises that it gets it nicotine from eggplant and tomatoes.”). 115 Daniel Fisher, Who Needs Legislation? Dems Want to Extend Tobacco Settlement to E-Cigarettes, Wall St. J., February 2, 2014, available at http://www.forbes.com/sites/danielfisher/2014/02/24/who-needs-legislation-dems-want-to-extend-tobacco-settlement-to-e-cigarettes/ (“[O]ne e-cig, Greensmart, has avoided . . . Minnesota’s excise tax on e-cigs because it derives its nicotine from eggplants.”). 116

Comment from Robert K. Jackler, MD, Comment on the Food and Drug Administration (FDA) Proposed Rule: 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, Comment Tracking Number 1jy-8c40-if0z, Jun. 11, 2014.