i

IMPROVING PENNSYLVANIA HEALTH POLICY REGARDING ELECTRONIC CIGARETTES

by

Ravi Indra Choudhuri

BA, BS, University of California, Riverside, 2012, 2012

Submitted to the Graduate Faculty of

Behavioral and Community Health Sciences

Graduate School of Public Health in partial fulfillment

of the requirements for the degree of

Master of Public Health

University of Pittsburgh

2015

ii

UNIVERSITY OF PITTSBURGH

GRADUATE SCHOOL OF PUBLIC HEALTH

This essay is submitted

by

Ravi Indra Choudhuri

on

April 21, 2015

and approved by

Essay Advisor:Jeanette Trauth, PhDAssociate Professor, Behavioral and Community Health SciencesAssociate Professor, Health Policy and Management Graduate School of Public HealthUniversity of Pittsburgh

Essay Reader:Brian Primack, MD, PhDAssociate Professor of Medicine, Pediatrics, and Clinical and Translational Science School of MedicineUniversity of Pittsburgh

iii

Copyright © by Ravi Indra Choudhuri

2015

Electronic cigarettes (i.e. e-cigarettes) are battery-powered devices that deliver nicotine and other

additives such as flavoring in an aerosolized form to an individual. Although originally

developed as a smoking cessation device, e-cigarettes are currently marketed as an alternative to

tobacco use. There has been a sharp increase nationwide in the use of e-cigarettes in recent years

—particularly among adolescents. This is of particular concern because of the adverse health

effects of nicotine on adolescent development. Currently, forty of the fifty states prohibit the

sales of e-cigarettes to minors. Pennsylvania is one of the ten states that do not restrict youth

access to e-cigarettes.

The purpose of this master’s essay is to present an argument for the regulation of e-

cigarettes in Pennsylvania. In order to achieve this goal, I reviewed the current literature on: the

health consequences of e-cigarette use, attitudes and intentions of youth toward e-cigarette use

and the policy issues related to the regulation of this product. As a result of this review, I have

proposed a strategy for the development of an e-cigarette policy for Pennsylvania. The first step

in this strategy involves gathering information from policy makers in order to determine their

knowledge of: e-cigarettes, current regulations governing e-cigarettes and their thoughts on the

need for future policy in this domain. It is necessary for policy makers to have accurate

knowledge and an in-depth understanding of e-cigarette issues in order to inform the

iv

Jeanette Trauth, PhD

IMPROVING PENNSYLVANIA HEALTH POLICY REGARDING ELECTRONIC CIGARETTES

Ravi Indra Choudhuri, MPH

University of Pittsburgh, 2015

ABSTRACT

development of policies that will protect the health of Pennsylvania residents. This is the public

health significance of this study.

v

TABLE OF CONTENTS

1.0 INTRODUCTION………………………………………………………………………...1

2.0 BACKGROUND………………………………………………………………………….4

2.1 THE DEVELOPMENT OF ELECTRONIC CIGARETTES……………………..4

2.2 CURRENT USERS OF E-CIGARETTES………………………………………..5

2.3 THE CURRENT REGULATORY ENVIRONMENT……………………………6

2.4 UNDERSTANDING ADOLESCENT SMOKING BEHAVIOR………………...8

3.0 METHODS………………………………………………………………………………10

4.0 FINDINGS……………………………………………………………………………….11

4.1 HEALTH CONSEQUENCES OF E-CIGARETTE USE……………………….11

4.2 ATTITUDES AND INTENTIONS……………………………………………...12

4.3 POLICY ISSUES………………………………………………………………...13

5.0 DISCUSSION……………………………………………………………………………15

5.1 IMPLICATIONS OF THE RESULTS…………………………………………..21

5.2 A PROPOSED STRATEGY FOR THE DEVELOPMENT OF E-CIGARETTE

HEALTH POLICY FOR PENNSYLVANIA…………………………………...22

5.2.1 A PROPOSED STUDY SAMPLE………………………………………22

6.0 CONCLUSION…………………………………………………………………………..25

6.1 SUMMARY OF MAJOR FINDINGS…………………………………………..25

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6.2 STUDY LIMITATIONS………………………………………………………...26

APPENDIX A: PUBMED SEARCH LITERATURE...................................................................28

APPENDIX B: INTERVIEW SAMPLE QUESTIONS................................................................43

BIBLIOGRAPHY..........................................................................................................................44

vii

1.0 INTRODUCTION

The largest preventable cause of death and disease in the United States is smoking and related

tobacco use. Over 440,000 Americans die prematurely from smoking-related illness such as

cancer, COPD, heart disease, and stroke each year. An estimated 49,000 of these deaths are

related to secondhand smoke exposure1. The naturally addictive properties of tobacco are

delivered to users in the form of nicotine—which is the underlying cause of long-term

dependence, morbidity and mortality.

According to the CDC, the prevalence of cigarette smoking among adults in the United

States ranges from 9.3% to 26.53%1,2. In Pennsylvania 21.3% of the adult population currently

smoke cigarettes. Among youth aged 12–17 years, the prevalence of smoking across the United

States ranges from 6.5% to 15.9%”1. In Pennsylvania, 11.8% of this age group smokes cigarettes.

Although there are states that have a higher percentage of adults who smoke, Pennsylvania still

has more adults who smoke compared to other states such as California and New York, where

only 13.7% and 18.1% of adults respectively smoke.

Research shows that nearly 90% of smokers started smoking by age 18, and 99% started

by age 261. Each day in the United States, more than 3,200 people 18 years of age or younger

smoke their first cigarette. And an estimated two thirds of this population become daily cigarette

smokers1. In order to reduce the total number of people who smoke, initiation rates among first-

time users must be reduced. This goal is problematic given the emergence in recent years of new

1

tobacco-free smoking products such as electronic cigarettes (i.e. e-cigarettes) and hookah vapes.

There has been a sharp increase nationwide in the use of e-cigarettes in recent years—

particularly among adolescents.

E-cigarettes are battery-powered devices that deliver nicotine in an aerosolized form to an

individual. Other additives such as flavoring can also be included in order to enhance the

acceptability and desirability of the product. Although originally developed as a smoking

cessation device, e-cigarettes are also currently marketed as an alternative to tobacco use. While

e-cigarettes can be beneficial to smokers who are trying to quit, there are still health

consequences associated with their use. Of particular concern are the adverse health effects of

nicotine on adolescent brain development3.

Currently, forty of the fifty states prohibit the sales of e-cigarettes to minors.

Pennsylvania is one of the ten states that do not restrict youth access to e-cigarettes. Although

clean indoor air policies and regulations related to the sale of cigarettes to minors do exist in

Pennsylvania, they do not address electronic cigarettes.

The purpose of this master’s essay is to present an argument for the regulation of e-

cigarettes in Pennsylvania which are currently not included under the existing tobacco regulatory

framework. In order to achieve this goal, I reviewed the current literature on: the health

consequences of e-cigarette use, attitudes and intentions of youth toward e-cigarette use and the

policy issues related to the regulation of this product. As a result of this review, I have proposed

a strategy for the development of an e-cigarette policy for Pennsylvania.

The first step in this strategy involves gathering information from policy makers (i.e.

legislators, tobacco-free organizations and local health department officials) in order to

understand how they are thinking about this issue. This can be accomplished by means of

2

qualitative interviews to explore their knowledge of electronic cigarettes, current regulations

governing e-cigarettes and their thoughts on the need for future policy in this domain. Policy

makers in Pennsylvania need to have accurate knowledge and an in-depth understanding of

electronic cigarette issues in order to inform the development of policies that will ultimately

decrease the initiation of electronic cigarette use and that will protect the health of all

Pennsylvania residents. Second paragraph.

3

2.0 BACKGROUND

2.1 THE DEVELOPMENT OF ELECTRONIC CIGARETTES

E- cigarettes were first developed and patented in 2003 by a Chinese pharmacist named Hon Lik.

They were originally created as a smoking cessation device rather than for recreational use4.

Lik’s original design of the electronic cigarette is still used today. It consists of a reusable

cigarette-like device, nicotine liquid extracted from tobacco plants, and an extremely small

piezoelectric ultrasound-emitting element that vibrates to produce heat and convert the liquid

nicotine into an inhalable aerosol4. Since 2003, the e-cigarette has undergone various design and

nicotine delivery modifications in order to adjust to users across the globe. Lik’s design is

currently referred to as the first generation of electronic cigarettes; a single unit resembling a

regular cigarette that contains a battery, heating mechanism, and nicotine liquid to be used and

disposed of after the battery dies or the liquid is depleted4, 5. In addition to being able to refill the

nicotine liquid, this design also allows users to change the battery or recharge it for continual

use.

A second-generation electronic cigarette has subsequently been developed. This device is

larger and deviates from the look and feel of a regular cigarette. It allows for a higher delivery of

nicotine liquid as well as extended use because of a larger rechargeable battery. This second

generation of the e-cigarette is used among more experienced electronic cigarette users and can

4

also be refilled with nicotine liquid at the user’s discretion4, 5. A third generation of e-cigarette is

also now available. This version of the product allows the user to tailor the device to meet their

own preferences rather than complying with standard operating procedures. This modification

process may involve the user adjusting the heat control of the internal heating mechanism in

order to produce a larger or smaller amount of nicotine aerosol delivery, change the flavoring of

the nicotine, or change the physical appearance of the device. This third generation is growing in

popularity because of the ability to adjust the heating device, allowing users to have control of

nicotine delivery4, 5.

2.2 CURRENT USERS OF E-CIGARETTES

Due to the fairly recent development of electronic cigarettes, there is limited research on user

demographics and projected future users. However, current evidence indicates that the largest

population of sustained electronic cigarette users are current smokers who believe that e-cigarette

use will help them quit smoking5. In addition, further evidence shows that the largest population

of first-time e-cigarette users are adolescents experimenting with tobacco products5. Although

current smokers predominantly use electronic cigarettes as a harm reduction tool, electronic

cigarette manufacturers are beginning to market and advertise their products commercially in a

way that targets adolescents and other younger populations4, 5. Because of the paucity of research

on this emerging product, health policies regulating the manufacture and marketing of e-

cigarettes are largely absent.

Furthermore, few studies have been undertaken on the long-term effects of continuous

electronic cigarette use. A number of smaller studies have explored whether electronic cigarettes

5

are a healthy alternative to regular tobacco products because of their lack of actual tobacco and

carcinogens5. However, studies have not been done examining the long-term health effects of e-

cigarettes. A number of emerging studies have shown that electronic cigarettes may still cause

lung cancer, as well as continuing the nicotine-dependence the user already has from other

tobacco products5. The overall health implications of electronic cigarette use is that users will

still be addicted to nicotine, and thus all forms of tobacco products that they may or may not use.

2.3 THE CURRENT REGULATORY ENVIRONMENT

In 1906 the Food and Drug Administration (FDA) issued the first federal level legislation within

the United States. Since then, many forms of legislation at the federal level have been passed to

control products that could be consumed by the American people. Specifically in tobacco

control, the FDA has regulated the distribution and marketing of tobacco products since the

1940s. More recently in 2009, the FDA has passed the Family Smoking Prevention and Tobacco

Control Act. This regulation has allowed the FDA to regulate all tobacco products. Although the

FDA does impose this federal regulation over defined tobacco products, it has not extended this

regulatory power over emerging tobacco products such as electronic cigarettes. Currently, the

FDA proposed to extended their Family Smoking Prevention and Tobacco Control Act to also

cover products such as electronic cigarettes3. Although this will help regulate e-cigarette use

substantially in the future, it currently does nothing in a regulatory capacity because it is only a

proposal.

State regulation of tobacco products differs from federal regulation in various forms.

States mainly regulate tobacco use through taxation of tobacco products, sales to minors,

6

licensure for those that sell tobacco products, and clean indoor air acts. States such as New

Jersey have imposed heavy taxes on tobacco products in order to increase state revenue as well

as tobacco desirability among users. Although this is effective in reducing tobacco use, not all

states tax tobacco products equally, which widens the tobacco user disparity across the nation.

Currently, only 40 states in the U.S. prohibit e-cigarette sales to minors while 10 other states

(including Pennsylvania) and DC have no regulation in this context3. Furthermore, states vary in

their use of clean indoor air acts. Some states regulate indoor air quality very strictly and prohibit

all forms of tobacco use while others regulate it loosely and only regulate indoor air in some

regards. The CDC reports that only 27 states, not including Pennsylvania, have a comprehensive

smoke-free air law in place at this point in time3.

Although municipal, county, and state clean indoor air policies and regulations related to

cigarettes are being rapidly introduced across the U.S, these laws have not adequately addressed

electronic cigarettes. For example, over two-thirds of the largest cities in the U.S. no longer

allow any smoking in bars, but electronic cigarette use is allowed in nearly all of these cities,

often related to various exemptions which are deeply embedded in legal codes. Because of this

variability and complexity, it is important to comprehensively characterize and better understand

U.S. policies as they apply to electronic cigarettes. Development of policies, which apply to

cigarette smoking but exempt electronic cigarette smoking, may unintentionally fuel increased

interest in and experimentation with electronic cigarettes. If increased electronic cigarette use is

an unintended consequence of current clean air legislation, this would have important

implications for current and future policies related to tobacco use.

As the prevalence of electronic cigarettes has increased in the U.S. and evidence of its

potential toxicity have emerged, many epidemiologic studies assessing prevalence of and

7

associations with electronic cigarettes have been conducted. While these reviews point out

important policy concerns related to the practice, systematic policy assessments have been

sparse.

2.4 UNDERSTANDING ADOLSCENT SMOKING BEHAVIOR

A number of theories have been used to help understand and explain adolescent smoking

behavior. In order to understand how smoking behavior is initiated and subsequently becomes a

long-term habit, research has focused on the individual’s biology and neuropharmacology as

well as social and behavioral factors. With regard to the latter issue, several theories from the

disciplines of psychology, sociology and public health have informed the design of studies of

smoking behaviors. With this in mind, smoking behavior and eventual addiction can be

explained through the lens of social-cognitive theory, theory of planned behavior, and the trans-

theoretical model.

Social-cognitive theory states that an individual derives their knowledge and thought

processes in accordance to their social surroundings and interactions that occur daily6, 7, 8. In

regard to smoking among adolescents, interventions have discussed social-cognitive theory and

how adolescents who are exposed more in their daily routines to smoking cues will increase their

likelihood of initiating smoking as well8. Theory of planned behavior posits that one’s beliefs

will lead to an eventual action or behavior. Adolescents that are influenced by various external

cues such as social media and marketing strategies have undergone a shift in their beliefs about

smoking and therefore may initiate smoking behavior9, 10.

8

The trans-theoretical model assesses an individual’s motivation and openness to change

and lead a healthier lifestyle overall. This model has been used numerously throughout

interventions in order to effectively shift an adolescent’s mindset about smoking towards

healthier alternatives11. All of these various models and theories have been implemented over

time throughout interventions aimed towards reducing the amount of adolescents that initiate

smoking. By continuing this effort, science and health education can greatly increase the odds of

preventing the younger population in such risky behaviors and live a healthy lifestyle for future

generations to follow.

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3.0 METHODS

In order to make an argument regarding the need for regulating youth access to e-cigarettes in

Pennsylvania, I reviewed the recent literature that has a bearing on this issue. Working with

faculty on my essay committee, a total of 21 articles published in 2014 and 2015 were identified

from the PubMed database.

After carefully reading each article, the following process was used to organize and

analyze this literature. Appendix 1 was created in WORD that contains the following

information: author(s) and year of publication, title of article, study methods, study results and

conclusions. The purpose of creating the table was to be able to synthesize the results across the

various studies. The results of this analysis are found in the following section of this essay.

10

4.0 FINDINGS

A total of 21 articles published in 2014 and 2015 pertaining to electronic cigarettes were

reviewed for this study. These articles generally fell into three categories. The first type of article

described the health consequences of e-cigarette use—both the positive and negative

consequences. These articles also addressed who uses e-cigarettes and why. There were 9

articles that fell into this category.

4.1 HEALTH CONSEQUENCES OF E-CIGARETTE USE

Various articles addressed the benefits of electronic cigarette use in the short term. Adrianes et al

conducted lab sessions to test how effective electronic cigarettes were in reducing normal

tobacco use among regular users12. They found that electronic cigarettes were effective in

immediately reducing cigarette cravings and over time lead to cigarette abstinence or reduction

in cigarette use among these regular users12. Biener & Hargraves found that daily use of

electronic cigarettes in just a month is associated with quitting tobacco use in general13. Although

Hummel et al reported that more long-term research on electronic cigarettes must be done, they

also reported that electronic cigarette use might be a safer alternative to cigarette use14.

11

The article written by Dutra & Glantz found that use of electronic cigarettes were among

those that currently use or have ever used cigarettes as well as being associated with users that

want to quit cigarette use15. However, they also found that electronic cigarettes may encourage

cigarette use among adolescents in the United States15. Hamilton et al found that adolescents in

Ontario, Canada were using electronic cigarettes that contained nicotine and devices without

nicotine16. Electronic cigarette use has been shown to be used among those that want to quit their

normal cigarette use, but do not do so because the user is dissatisfied with the electronic cigarette

compared to their regular product17. Pepper et al say that to reduce the effect that electronic

cigarettes have as a gateway product, there needs to be a higher satisfaction rate among regular

tobacco users18. Shihadeh & Eissenberg discuss the flux, or inhalation amount done by users of

electronic cigarettes26. Their study shows that various devices can deliver different amounts of

nicotine and that this poses a challenge for regulation to be in place for electronic cigarettes26.

Willis et al reports that there is a high dual use among adolescent cigarette users and electronic

cigarettes, and that electronic cigarettes are most likely attracting averaged-risk adolescents into

tobacco use19.

4.2 ATTITUDES AND INTENTIONS

The second types of articles were those that described survey data on the attitudes and intentions

of current and future smokers. These articles described the attitudes and intentions of a range of

individuals along the spectrum from non-smokers to occasional to regular users. Berg et al

reported that the marketing strategies in place by electronic cigarette and hookah groups target

the idea that they are safe to use and are socially acceptable20. These authors state that future

12

studies need to be done in order to communicate the health risks involved with these emerging

tobacco products with adolescents20. Burnell et al surveyed over quarter million adolescents and

found that there is an association between electronic cigarette use and having a greater desire to

try normal cigarettes21. Coleman et al continued where Burnell et al was in reporting that

electronic cigarette use was associated with a more openness to smoke cigarettes22. Coleman et al

stresses the importance to conduct longitudinal research on the subject to understand emerging

tobacco products even more22.

4.3 POLICY ISSUES

Finally, a third type of article discussed policy issues and offered recommendations regarding

how e-cigarettes should be regulated. Brandon et al went through the health policy statements

released by the AACR and ASCO in regards to the lack of regulatory framework for electronic

cigarettes23. These authors discuss the importance of understanding the current regulations and

how we can improve them to reduce health effects among adolescents23. Kadowaki et al also

delve into the regulation side of electronic cigarettes and how electronic cigarettes over time can

cause adverse health effects if no regulation is instilled in the United States24. Lempert et al

discussed the health policy regulation in regard to electronic cigarette definitions and how these

definitions play an important role in how they are regulated state by state25. Lempert et al

continues their discussion of electronic cigarettes and how policymakers must create legislation

that has strict and careful definitions of all electronic cigarette products in a broad sense in order

to reduce any loopholes to being formed25.

13

Shihadeh & Eissenberg go on to discuss how flux of nicotine inhalation among users

must be regulated in order to stop increases of nicotine uptake, which can cause an increase in

addiction and other health effects26. Tan et al reports that research on electronic cigarette

advertising must be increased to find out if electronic cigarette media portrayal has an effect on

adolescents as well as bypassing current legislative rules for advertising27. Yong et al discuss

how the UK and Australia are affected by current policy that is in place for each respective

country28. These authors state that current smokers also use electronic cigarettes because there

are no federal regulations in place to reduce electronic cigarette28.

In summary, the policy articles discussed the current regulations and the need for

extended regulations on emerging tobacco products. The consensus of these articles shows that a

more strict regulation on electronic cigarettes must be in place in order to reduce e-cigarette use.

All the articles reviewed, their study methods, and results can be found in Appendix 1.

14

5.0 DISCUSSION

Cigarette smoking is still a difficult task to relinquish due to its very complex nature and constant

variation between individuals and context6. Smoking can be initiated by a myriad of variables

such social and physical environments, social groups, socioeconomic status, cognitive processes,

biological and genetic factors, exposure to tobacco and frequency of exposure, age of exposure,

family influence, and many other factors. The complexity lies in the interaction of all these

variables and how one may increase the effect of another.

Regardless of how the behavior is initiated, after habitual use, the nicotine content in the

cigarette forms a biological addiction within the brain, which makes it extremely difficult to stop.

After this initial addiction is formed and continued over a long period of time, habit is made to

smoke cigarettes even when one does not want to6. The cues related to smoking the cigarette can

now trigger a craving on their own in addition to withdrawal from nicotine deprivation between

cigarettes. In order to prevent this habit and addiction formation, resources must be concentrated

to target adolescents that initiate smoking and continue to smoke due to whatever reward

pathway is activated in their personal context.

Although e-cigarettes have been on an exponential rise in the past 10 years, little is still

known about their effects and their intended use. The CDC reports that the lack of e-cigarette

regulation across the United States could be caused by the lack of knowledge that policy makers

have in regard to e-cigarettes and their potential health effects3. As mentioned previously, the

15

formation of the e-cigarette was originally to be used as a type of nicotine replacement treatment

among current long-term users. However, tobacco marketing has advocated e-cigarette use to a

much wider population that encompasses not only current tobacco users, but also occasional and

non-users as well. Yet, because of its original idea to replace normal cigarettes among regular

users, this label as a type of health benefit has continued. Although this may seem promising at

first, this may be due to the labeling of e-cigarettes as a smoking cessation method when in

actuality it is not. The long-term cigarette using population might benefit from electronic

cigarette use, although it does not reduce their ability to quit the habit of smoking. Because the

perceived notion that using an e-cigarette means a user wants to quit, they may be more likely to

say they do want to abstain from smoking after repeated use.

Apart from the population of adult long-term smokers that want to quit but have not been

able to, a third of e-cigarette users are adolescent non-smokers17. With this population in mind,

an association is established between e-cigarette use and continuation to normal tobacco products

among non-smoking adolescents around the world. After the use of electronic cigarettes,

adolescents show an openness to try regular cigarettes if given the opportunity22. Adolescents

that partake in e-cigarette use tend to use them for the sake of trying a new emerging product

rather than its implied use of nicotine delivery16. A rationalization behind this may be that

adolescents that want to try and use something new and risky will try it, but will opt for a less

risky option when given one. However, in the context of the real world, when a non-smoking

adolescent is given an e-cigarette, that e-cigarette most likely contains nicotine because of its

wider availability in the market, which will then lead to addiction with consistent use.

Through these research findings, there appears to be two distinct groups of e-cigarette

users: non-smoking adolescents that are experimenting and long-term adult smokers that are

16

trying to quit smoking18. Because e-cigarettes have the notion of helping people quit their

cigarette smoking habits, adult smokers try them for said purpose; yet because e-cigarettes are

marketed towards adolescents they are also used among non-smoking populations.

The emergence of new tobacco products can have a great effect on the overall population,

not because of past knowledge on cigarette use, but the ignorance associated with these new

products. Without knowing what the risks or potential risks associated with products like e-

cigarettes are, more people will be willing to use the products even though they may have

detrimental health implications later on20. One associated risk with e-cigarettes is the potential to

ingest a large amount of nicotine from the cartridge delivery mechanism and overdose thereafter.

Current research has shown an increase in calls to poison control centers regarding nicotine

overdose, particularly young children29. An explanation to this increase in nicotine overdose

prevalence can be attributed to e-cigarette users leaving their nicotine cartridges out for children

to obtain and ingest because they are unaware of what it is they are ingesting.

Another risk associated with e-cigarette use is the nicotine delivery system itself. Because

users typically like to increase their nicotine delivery to match their normal tobacco product

amount, they can suffer toxic side effects or abuse the use of the device more frequently26.

Furthermore, adolescents and other users that use e-cigarettes may be compensating for their

inability to smoke tobacco products in public currently, but when able to do so they will continue

smoking their usual brands. This dual use can increase their overall nicotine dependence and

requirements to the point of either toxicity or long-term dependence of tobacco products19. With

these various risks in mind, and ones that are still under investigation, e-cigarette use may cause

more harm than what is understood by the general population.

17

The emergence of the electronic cigarette from China sparked an interest from tobacco

companies within the United States to add to their already extensive list of tobacco products.

However in 2008 the FDA responded to this increased interest from U.S. tobacco companies by

blocking all imports of the electronic cigarette under the Federal Food, Drug, and Cosmetic Act

of 1938 (FDCA), which states that the FDA can regulate all drug delivery devices within the

U.S25. However, a company that imports electronic cigarettes (Sottera, Inc.) argued in federal

court that electronic cigarettes are purely tobacco products because of their nicotine content and

are not meant for pharmaceutical purposes like it was originally intended when created in

China25. In 2010 the federal court sided with Sottera and classified the electronic cigarette as a

tobacco product, and therefore could not be blocked by the FDA under the FDCA (Sottera, Inc.

v. FDA 2010). After this ruling, the FDA would increase their regulatory power for tobacco

products to include emerging items such as hookah tobacco and electronic cigarettes under the

2009 Family Smoking Prevention and Tobacco Control Act (TCA) 25. Although the FDA

strengthened their grip on overall tobacco product regulation, there are currently no federal laws

regulating electronic cigarettes in terms of sale, production, or usage25.

Although there is no federal regulation of electronic cigarettes, various states and

municipalities within the U.S. are passing restriction on public electronic cigarette usage. For

example, some states and counties ban use of electronic cigarettes in schools or county buildings

while others may include public parks as well. Clean indoor air acts, such as Pennsylvania’s,

enforce the rule of having bars, restaurants, workplaces, or a combination of the three to be

smoke-free. However, with emerging tobacco products such as the electronic cigarette and a lack

of updated regulation, these clean air acts are bypassed through various loopholes. Currently,

only New Jersey, Utah, and North Dakota have statewide bans on electronic cigarette usage in all

18

public places25. It is understood that statewide restrictions are more difficult to attain than lower-

level legislative progression. While only a few states have varying degrees of electronic cigarette

bans in place, more municipalities are much more common25. Because of this bottom-up

approach of tobacco regulation within the states, large cities such as Chicago, New York City,

and Los Angeles all passed comprehensive bans on electronic cigarettes by adjusting their clean

air acts25.

One of the methods used by tobacco companies to avoid direct regulation on their

electronic cigarette products is by the stated definition of the product. Tobacco companies

collectively offer a myriad of brands, flavorings, and nicotine levels, which ultimately produces

varied terminology and definitions for a specific product. For example, a tobacco company can

alter the cartridge amount and design of all their electronic cigarette products and therefore have

many types of tobacco products that may or may not fall under the regulatory demands set by the

FDA. With the many combinations and permutations set by tobacco companies regarding

electronic cigarettes, state regulation efforts fall short because they are not all-inclusive

regarding tobacco products. Research has shown that even in countries such as Australia that

prohibit sale, possession, and/or use of nicotine-containing electronic cigarettes without a permit,

43% of electronic cigarette owners have nicotine in their devices without possession of a

permit28. This is another example of how tobacco companies shift the definition of their products

in order to increase use and sales.

To correct this issue, researchers have suggested that state regulation should include the

term “electronic smoking device or vapor product” anywhere the term “tobacco product” appears

in laws that have already been passed27. This change to already existing laws to include current

and future devices regardless of nicotine content will allow for tighter regulation and less

19

loopholes for electronic cigarette usage. By expanding existing definitions of electronic

cigarettes and other tobacco products to include “any product that requires inhaling or exhaling

of smoke and/or vapor from an electronic smoking device”, as New Jersey, Utah, and North

Dakota have, will ensure stronger regulation on electronic cigarettes without the need to expand

existing smoke-free laws completely27.

Another example of how health policy and regulations are avoided by tobacco companies

is how these electronic cigarette products are advertised and flavored. Currently there are more

than 7,700 electronic cigarette flavors available24, 26. Additionally, electronic cigarette television

advertising has increased youth exposure to electronic cigarettes by 257% and adult exposure by

321% from 2011 to 201324, 26. To combat this rising exposure and usage among adolescents, the

FDA has tried to prohibit the distribution of electronic cigarette free samples, sales to

adolescents, and sales through vending machines24, 26. Although this is a great step in the right

direction for the FDA, these restrictions do not impede the advertisement, marketing, or

promotion of electronic cigarette products in general, which can still be targeted towards

adolescents even if they are not explicitly done so. Flavors of electronic cigarettes have a similar

low threshold for regulation under the FDA even though flavor bans are in place for regular

tobacco products such as cigarettes25, 27.

The impact of media communication with the public has a significant role in forming

contrasting opinions about emerging tobacco products. Over the years, public interest in

electronic cigarettes has gained momentum with the increase of media coverage for electronic

cigarettes. With the original stigma and tobacco companies advertising electronic cigarettes as

healthy alternatives to regular tobacco, public opinion about electronic cigarettes have been

geared towards a safer option for people who want to smoke27. Studies have shown that this is

20

especially true in lower income and lower education populations because there is a higher

exposure rate to electronic cigarette media campaigns compared to areas of higher income and

education27. Furthermore, studies have shown that the public population has lower support for

electronic cigarette regulation due to the stigma that they are safe to use27. This increasing trend

in public opinion is directly related to the advertising techniques of tobacco companies as well as

a lack of policy to limit or ban these misguiding media campaigns.

5.1 IMPLICATIONS OF THE RESULTS

The purpose of this master’s essay is to argue that there is a need to develop health policies in

Pennsylvania to regulate electronic cigarettes, which are currently not regulated under the

existing tobacco regulatory framework. In order to develop such policies, it is recommended that

information be collected via in-depth interviews with policy makers, public health officials and

tobacco-free health advocates (Appendix 2).

The rationale for obtaining interview data is to explore the level of awareness and beliefs

regarding electronic cigarettes with individuals involved in tobacco-related legislation and/or

tobacco knowledge in Pennsylvania (PA). In order to attain this objective, the research staff and I

will conduct and qualitatively analyze individual interviews with legislators and/or staff; public

health officials who are familiar with tobacco use; and tobacco control advocacy group members.

The knowledge gained from these interviews will allow us to further enhance our understanding

of development and barriers involved in proposing regulations within PA that will impact those

within a societal and political context in regard to electronic cigarettes.

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Qualitative interviewing methodologies have expanded in use over recent years to fully

assess information from a specific entity and/or organization. While quantitative measures have

been utilized for a large proportion of all scientific studies, quantitative analysis lacks the insight

that qualitative analysis provides when properly utilized. Qualitative interviews can provide the

researcher with comprehensive information regarding the subjects’ experiences and perspective

regarding a specific topic30. Because quantitative and qualitative analysis alone cannot

comprehensively find answers to a particular topic, using both in a mix methods approach can

provide the researcher with a broad collection of information to analyze further30.

Researchers use various forms of qualitative analysis to understand and extract the

correct type of data and responses from their subjects. For example, there are such interview

methods that fall under neopositivist, romanticist, or localist categories. For most qualitative

interview methods, researchers utilize the localist approach in order to obtain alternative28

understandings of the interview responses that are obtained from research subjects 30. Qualitative

interviewing allows a varying degree of freedom and flexibility in receiving information from

the study subject that normal conversations or quantitative analysis cannot provide30.

5.2 A PROPOSED STRATEGY FOR THE DEVELOPMENT OF E-CIGARETTE

HEALTH POLICY FOR PENNSYLVANIA

5.2.1 Proposed Study Sample

Our sample will be differentiated by PA’s regions in order diversify geopolitical ideologies

within PA. For each region, we will interview at least 3 different individuals within the specified

22

categories previously mentioned (policy maker and/or staff, public health official, and advocacy

group member), for a total of 24 interviews. The research team and I believe 24 interviews across

the state will be sufficient, but if deemed necessary we will continue to recruit and interview

individuals that pertain to the relative background categories. These individuals will be recruited

with the assistance of the research team’s connections and already established networks across

PA. If a legislator is unavailable for the interview, county staff members are appropriate

replacements because they tend to be very aware of any current legislative process.

Contrary to the standard quantitative methodology most health research undergoes,

qualitative methods provide researchers with the ability to describe the familiarity, concern, and

certainty of these interviewed individuals35, 36. With this method of data collect we can reduce

any limitations that other typical methods (first person surveys or questionnaires) may produce32,

33.

In this qualitative interview portion of the study, interviewees will participate in two

separate interviews one month apart. The initial interview is to gather the majority of

information. The second interview of the study will be shorter and only a follow up because

policy makers, health officials, and advocacy members often review pertinent material brought

up in the initial interview to increase their understanding and awareness of the subject.

Furthermore, thoughts may change or new insights may be gained after individuals have had an

opportunity to consider issues introduced during initial interviews.

Each interview will be conducted via a recorded phone call to capture all verbal

communication. An important benefit of using this method is that it provides ideal data archiving

of all interview material so that interviews can be easily accessed at any time and analyzed

correctly. We have constructed a series of questions in the form of a template to conduct the in-

23

depth interviews. These questions may range from being broad, open-ended questions about

tobacco-control legislation to more detailed questions relating to tobacco awareness. We will

then ask about particular issues, such as (1) knowledge, attitudes, and beliefs related to electronic

cigarettes; (2) understanding of prior legislation related to tobacco products; and (3) perceived

consequences of any legislation passed. Because certain legislation varies between

municipalities, we will develop different templates based on findings prior to conducting a

specific interview. For example, for municipalities that have passed legislation, we will explore

issues related to enforcement of existing policies, whereas this will not be relevant to regions

with no relevant legislation. For the follow up second interview, we will assess changes since the

initial interview and revisit questions left unanswered. We will also explore participants’

perception of how participating in this study may have affected their knowledge, attitudes, or

beliefs regarding electronic cigarettes. We expect each initial interview to last between 20 to 30

minutes. Compensation will be made based on successful interviews with $50 for each

interviewee.

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6.0 CONCLUSION

6.1 SUMMARY OF MAJOR FINDINGS

Overall, our research aims to control emerging tobacco products such as electronic cigarettes at a

direct source. By targeting health policy and communication between high-ranking individuals in

various municipalities across PA, we are able to direct our efforts of reducing electronic cigarette

use and exposure to the maximum percentage. Because various legislators, health officials, and

tobacco-free advocates already know the dangers of smoking and are aware of increasing

prevalence of electronic cigarettes, we do not need to entice them to enact change through

quantitative analysis and correlations. Rather, by performing qualitative interviews that target

each study subject’s immediate awareness and opinions on electronic cigarettes (Appendix 2),

we can fully understand the relationship that communication between officials have and how

legislation is passed at the county and eventually state level.

Communication between these officials is of utmost importance regarding municipality

legislation because if officials do not agree on a certain topic, legislation will not be passed.

Because state legislation regarding tobacco policy is a bottom-up approach, municipality

legislation is highly desirable in that it eventually leads to state legislation being passed that

concerns tobacco policy. PA must act like other states such as California and New York in the

sense that passing tobacco free legislation that includes new emerging tobacco products at the

25

county level will eventually spread to other counties in the state and cover all localities in the

future. Our study is geared towards understanding communication barriers and advantages that

these counties and municipalities have.

By assessing health policy at the local level that eventually leads to the state and federal

levels of tobacco control, our research endeavors hope to adjust PA’s tobacco legislation against

emerging tobacco products as a whole. If this is done, an array of public health objectives will be

met including but not limited to reducing smoking initiation rates among adolescents, increasing

education and information dissemination about electronic cigarettes, and reducing the amount of

infant mortalities related to nicotine liquid ingestion. Tobacco dependence still remains the

number one preventable cause of death in the U.S. and one of the leading tactics to combat this

statistic is a reform in health policy. If we act now we can reduce adolescent and adult exposure

to electronic cigarettes, which may prevent them from a lifetime of tobacco and nicotine

dependence.

6.2 STUDY LIMITATIONS

Various counties and municipalities are exempt due to a clause within the PA Clean Indoor Air

Act, however there are exceptions that allow us to still examine these municipalities in order to

affect statewide tobacco reform. For example, Philadelphia County has its own restrictions on

who can access tobacco products. In addition, youth access laws created before January 1 st, 2002

are not exempt from the clause within the PA Clean Indoor Air Act, and therefore are subject to

change in the future without any legal conflicts. Because of these various problems within the

legal system regarding municipality legislation and tobacco reform exist, it may be difficult to

26

obtain relevant data. However, our research will offer insight to how federal, state, and municipal

regulations apply to electronic cigarettes.

Another possible limitation to our research study is that of actually obtaining responses

from the various individuals within each municipality and/or county. Legislators, county

officials, and health department heads tend to be very busy with many things and may not find

time right away to sit and exchange responses in the form of a qualitative interview. Although

this is currently the problem we are facing in our research study, we are still confident that we

will obtain responses from the various officials that we set out to find across the state because of

various reasons. One reason is that tobacco reform and control within PA is a very active issue

that tends to attract attention from legislators and health department officials alike. Secondly, we

have a list of names and contacts provided to us that have already shown interest in our study and

will participate when able to.

Another limitation that may occur is that of selection bias. Because we have a certain list

of officials that we have chosen to interview, this may create a bias of responses that are already

geared towards protecting public health via tobacco regulation. However, to avoid this bias, we

are utilizing the qualitative interview methodology in order to remain highly attuned to responses

that individuals make and analyze them accordingly.

27

APPENDIX A

PUBMED SEARCH LITERATURE

Authors Article Title

Methods Results Conclusions

Adriaens K, Van Gucht D, Declerck P, Baeyens F.

Effectiveness of the electronic cigarette: An eight-week flemish study with six-month follow-up on smoking reduction, craving and experienced benefits and complaints.

After the lab sessions, the control group also received an e-cig. The RCT included several questionnaires, which repeatedly monitored the effect of ad libitum e-cig use on the use of tobacco cigarettes and the experienced benefits/complaints up to six months

From the first lab session on, e-cig use after four hours of abstinence resulted in a reduction in cigarette craving which was of the same magnitude as when a cigarette was smoked, while eCO was unaffected. At the end of the eight-month study, 19% of the e-cig groups and 25% of the control group were totally abstinent from smoking, while an overall reduction of 60% in the number of cigarettes smoked per day was observed (compared to intake). eCO levels decreased, whereas cotinine levels were the same in all groups at each moment of measurement. Reported benefits far outweighed the reported

In a series of controlled lab sessions with e-cig naïve tobacco smokers, second generation e-cigs were shown to be immediately and highly effective in reducing abstinence induced cigarette craving and withdrawal symptoms, while not resulting in increases in eCO. Remarkable eight-month reductions in, or complete abstinence from tobacco smoking was achieved with the e-cig in almost half (44%) of the participants.

28

after the last lab session.

complaints.

Berg CJ, Stratton E, Schauer GL, Lewis M, Wang Y, Windle M, Kegler M.

Perceived harm, addictiveness, and social acceptability of tobacco products and marijuana among young adults: marijuana, hookah, and electronic cigarettes win.

10,000 students across two universities in the Southeastern region of the United States were recruited and asked to complete an online survey. Out of these students, 2,002 completed the survey which assessed their personal, parental, and peer use of tobacco and smoking products.

In the past month, marijuana was the most commonly used smoking product used at 19.2%, and hookah at second most common at 16.4%. The least common products used were smokeless tobacco products at 2.6% and electronic cigarettes were used among only 4.5% of surveyed participants. Rates were high across all participants for concurrent usage, especially electronic cigarette users. Tobacco use was related to positive social factors among those surveyed.

After surveying about 2000 college students, it seems that marketing of electronic cigarettes and hookah to be safe and socially acceptable is working. Further research needs to be conducted on the health risks from emerging tobacco products like electronic cigarettes and hookah to communicate risks to targeted youth.

Authors Article Title

Methods Results Conclusions

Biener L, Hargraves JL.

A longitudinal study of electronic cigarette use among a population-based sample of adult smokers: association with smoking cessation and motivation to quit.

Representative samples of adults in 2 U.S. metropolitan areas were surveyed in 2011/2012 about their use of novel tobacco products. In 2014, follow-up interviews were conducted with 695 of the 1,374

At follow-up, 23% were intensive users, 29% intermittent users, 18% had used once or twice, and 30% had not tried e-cigarettes. Logistic regression controlling for demographics and tobacco dependence indicated that intensive users of e-cigarettes were 6 times as likely as non-users/triers to report that they quit smoking (OR: 6.07, 95% CI = 1.11, 33.2). No such relationship was seen for intermittent users. There was a negative association between intermittent e-

Daily use of electronic cigarettes for at least 1 month is strongly associated with quitting smoking at follow up. Further investigation of the underlying reasons for intensive versus intermittent use will help shed light on the mechanisms underlying the associations between e-cigarette use, motivation to quit and smoking cessation.

29

baseline cigarette smokers who had agreed to be re-contacted.

cigarette use and one of two indicators of motivation to quit at follow-up.

Brandon TH, Goniewicz ML, Hanna NH, Hatsukami DK, Herbst RS, Hobin JA, Ostroff JS, Shields PG, Toll BA, Tyne CA, Viswanath K, Warren GW.

Electronic Nicotine Delivery Systems: A Policy Statement from the American Association for Cancer Research and the American Society of Clinical Oncology.

This policy statement was developed by members from the Tobacco and Cancer Subcommittee of the American Association for Cancer Research (AACR) Science Policy and Government Affairs (SPGA) Committee and American Society of Clinical Oncology (ASCO).

The evidence regarding the risks and benefits of ENDS in different segments of the population such as current smokers and nonsmokers is difficult to interpret, because the marketplace of ENDS products is evolving rapidly, and data on the long-term consequences of ENDS use are not yet available. Additional studies are needed to inform ENDS policy and regulation and to guide the decisions of consumers and health care providers related to ENDS use.

There is a lack of data on the public health impact of ENDS on both individuals and the population as a whole, which makes it difficult to develop a comprehensive regulatory framework for these products at the current time. Nonetheless, it is prudent for policymakers to take steps to minimize the potential negative public health consequences of these products, particularly on youth, while taking care not to undermine their potential to reduce the harm caused by combustible cigarettes and other conventional tobacco products.

Authors Article Title

Methods Results Conclusions

30

Bunnell RE, Agaku IT, Arrazola RA, Apelberg BJ, Caraballo RS, Corey CG, Coleman BN, Dube SR, King BA.

Intentions to Smoke Cigarettes Among Never-Smoking US Middle and High School Electronic Cigarette Users: National Youth Tobacco Survey, 2011-2013.

Analyzed data from 2011, 2012, and 2013 National Youth Tobacco Surveys of students in grades 6-12. Youth reporting they would definitely not smoke in the next year, while all others were classified as having positive intention to smoke conventional cigarettes. Demographics, pro-tobacco advertisement exposure, ever use of e-cigarettes, and ever use of other combustibles and non-combustibles were included in assessing associations with smoking intentions among never-cigarette-smoking youth.

Between 2011-2013, the number of never-smoking youth who used e-cigarettes increased three-fold, from 79,000 to over 263,000. Intention to smoke conventional cigarettes was 43.9% among ever e-cigarette users and 21.5% among never users. Ever e-cigarette users had higher adjusted odds of having smoking intentions than never users (Adjusted Odds Ratio: 1.70, 95% Confidence Interval: 1.24-2.32). Those who ever used other combustibles, ever used non-combustibles, or reported pro-tobacco advertisement exposure also had increased odds of smoking intentions.

In 2013, over a quarter million never-smoking youth had used e-cigarettes. E-cigarette use was associated with increased intentions to smoke cigarettes. Enhanced prevention efforts for youth are important for all forms of tobacco, including e-cigarettes.

31

Authors Article Title

Methods Results Conclusions

Chatham-Stephens K, Law R, Taylor E, Melstrom P, Bunnell R, Wang B, Apelberg B, Schier JG; Centers for Disease Control and Prevention (CDC).

Notes from the field: calls to poison centers for exposures to electronic cigarettes--United States, September 2010-February 2014.

E-cigarette exposure calls were compared with cigarette exposure calls by proportion of calls from health-care facilities. Over the course of the study, there was a reported 2,405 e-cigarette and 16,248 cigarette exposure calls from across the United States, the District of Columbia, and U.S. territories.

E-cigarettes accounted for an increasing proportion of combined monthly e-cigarette and cigarette exposure calls, increasing from 0.3% in September 2010 to 41.7% in February 2014. A greater proportion of e-cigarette exposure calls came from health-care facilities than cigarette exposure calls (12.8% versus 5.9%). Cigarette exposures were primarily among persons aged 0–5 years (94.9%), whereas e-cigarette exposures were mostly among persons aged 0–5 years (51.1%) and >20 years (42.0%). E-cigarette exposures were more likely to be reported as inhalations (16.8% versus 2.0%), eye exposures (8.5% versus 0.1%), and skin exposures (5.9% versus 0.1%), and less likely to be reported as ingestions (68.9% versus 97.8%) compared with cigarette exposures.

Given the rapid increase in e-cigarette-related exposures, of which 51.1% were among young children, developing strategies to monitor and prevent future poisonings is critical. Health-care providers; the public health community; e-cigarette manufacturers, distributors, sellers, and marketers; and the public should be aware that e-cigarettes have the potential to cause acute adverse health effects and represent an emerging public health concern.

Coleman BN, Apelberg BJ, Ambrose BK, Green KM, Choiniere CJ, Bunnell R, King BA.

Association Between Electronic Cigarette Use and Openness to Cigarette Smoking Among US Young Adults.

Data from the 2012–2013 National Adult Tobacco Survey, characteristics of adults aged 18–29 who had never established cigarette smoking behavior were examined by ever

Among young adults who had never established cigarette smoking behavior 7.9% reported having ever tried e-cigarettes—14.6% of whom reported current use of the product. Ever e-cigarette use was associated with being open to cigarette smoking as was being male, aged 18–24, less educated, and having ever used hookah or experimented with conventional cigarettes.

Ever use of e-cigarettes, as well as other tobacco products, was associated with being open to cigarette smoking. This study does not allow us to assess the directionality of this association, so future longitudinal research is needed to illuminate tobacco use behaviors over time, as well as provide additional insight on the relationship between ENDS use

32

use of e-cigarettes, demographics, and ever use of other tobacco products.

and conventional cigarette use among young adult populations.

Authors Article Title

Methods Results Conclusions

Dutra LM, Glantz SA.

Electronic cigarettes and conventional cigarette use among U.S. adolescents: a cross-sectional study.

Cross-sectional analyses of survey data from a representative sample of US middle and high school students in 2011 and 2012 that completed the 2011 and 2012 National Youth Tobacco Survey. Experimentation with, ever, and current smoking, and smoking abstinence.

In 2011, current cigarette smokers who had ever used e-cigarettes were more likely to intend to quit smoking within the next year. Among experimenters with conventional cigarettes, ever use of e-cigarettes was associated with lower 30-day, 6-month, and 1-year abstinence from cigarettes. Current e-cigarette use was also associated with lower 30-day, 6-month, and 1-year abstinence. Among ever smokers of cigarettes (≥100 cigarettes), ever e-cigarette use was negatively associated with 30-day, 6-month, and 1-year abstinence from conventional cigarettes.

Use of e-cigarettes was associated with higher odds of ever or current cigarette smoking, higher odds of established smoking, higher odds of planning to quit smoking among current smokers, and, among experimenters, lower odds of abstinence from conventional cigarettes. Use of e-cigarettes does not discourage, and may encourage, conventional cigarette use among US adolescents.

Hamilton HA, Ferrence R, Boak A, Schwartz R, Mann RE, O'Connor S, Adlaf EM.

Ever Use of Nicotine and Nonnicotine Electronic Cigarettes Among High School Students in Ontario, Canada.

Data for 2892 high school students were derived from the 2013 Ontario Student Drug Use and Health Survey. Analyses were used to investigate the factors associated

Fifteen percent of high school students reported using e-cigarettes in their lifetime. Most students who ever used e-cigarettes reported using e-cigarettes without nicotine (72%), but 28% had used e-cigarettes with nicotine. Male, White/Caucasian and rural students, as well as those with a history of using tobacco cigarettes, were at greater odds of e-cigarette use. Seven percent of students

More students reported ever using e-cigarettes without nicotine than with nicotine in Ontario, Canada. This underscores the need for greater knowledge of the contents of both nicotine and non-nicotine e-cigarettes to better guide public health policies.

33

with use of e-cigarettes. Use of e-cigarettes was derived from the question, “Have you ever smoked at least one puff from an e-cigarette?”

who had never smoked a tobacco cigarette in their lifetime reported using an e-cigarette. Five percent of those who had ever used an e-cigarette had never smoked a tobacco cigarette.

Authors Article Title

Methods Results Conclusions

Hummel K, Hoving C, Nagelhout GE, de Vries H, van den Putte B, Candel MJ, Borland R, Willemsen MC.

Prevalence and reasons for use of electronic cigarettes among smokers: Findings from the International Tobacco Control (ITC) Netherlands Survey.

Samples of smokers aged 15 years and older from 2008, 2010, 2013, and 2014 as part of the International Tobacco Control (ITC) Netherlands Survey. Reasons for use and characteristics of smokers were examined using the sample from 2014. Logistic regression analyses were conducted to evaluate the associations between smoking-related variables with ever trying e-

In 2014, 91.4% of Dutch smokers reported being aware of e-cigarettes, 40.0% reported having ever tried them, and 15.9% were currently using them. The main reason given for using e-cigarettes was to reduce the number of regular cigarettes smoked per day (79%). Ever trying e-cigarettes among those aware of e-cigarettes was associated with being young, smoking more regular cigarettes per day, having made a quit attempt in the last year, having used smoking cessation pharmacotherapy in the last year, and reporting high awareness of the price of regular cigarettes. Smokers who kept using e-cigarettes had a higher educational background, had higher harm awareness for the health of others, and were less likely to have a total smoking ban at home.

E-cigarettes are increasingly used by Dutch smokers. Commonly endorsed motivations for current e-cigarette use were to reduce tobacco smoking and because e-cigarettes are considered to be less harmful than tobacco cigarettes.

34

cigarettes and current e-cigarette use.

Kadowaki J, Vuolo M, Kelly BC.

A review of the current geographic distribution of and debate surrounding electronic cigarette clean air regulations in the United States.

The lack of federal guidance leaves lower-level jurisdictions to debate the merits of restrictions on use in public spaces without sufficient scientific research. As we show through a geographic assessment of restrictions, this has resulted in an inconsistent patchwork of e-cigarette use bans across the United States of varying degrees of coverage.

From a public health perspective, if the lack of e-cigarette clean air acts renormalizes the act of smoking, young or uninformed users may be at risk of developing nicotine addiction through the use of e-cigarettes and may potentially transition to tobacco use. Further, those who currently reside in areas with tobacco-specific clean air restrictions will experience secondhand exposure to e-cigarettes, adding toxins to the air that would otherwise not be there.

The health effects of vaping are largely unknown. This leaves open the possibility that users could suffer long-term negative health effects from e-cigarettes. However, preliminary research suggests that e-cigarettes may be a much safer alternative to smoking and could possibly serve as an effective smoking cessation therapy.

Authors Article Title

Methods Results Conclusions

Krishnan-Sarin S, Morean ME, Camenga DR, Cavallo DA, Kong G.

E-cigarette Use Among High School and Middle School Adolescents in Connecticut.

Cross-sectional, anonymous surveys conducted in four high schools (HS; n=3614) and two

Among MS students who were lifetime e-cigarette users, 51.2% reported that e-cigarettes were the first tobacco product they had tried. E-cigarettes that were rechargeable and had sweet flavors were most popular. Smokers preferred e-

Longitudinal monitoring of e-cigarette use among adolescents and establishment of policies to limit access are imperatively needed.

35

middle schools (MS; n=1166) in CT in November 2013 examined e-cigarette awareness, use patterns, susceptibility to future use, preferences, product components used (battery type, nicotine content, flavors), and sources of marketing and access.

cigarettes to cigarettes. Current cigarette smokers were more likely to initiate with nicotine-containing e-cigarettes, and ever- and never- cigarette smokers to initiate with e-cigarettes without nicotine. Primary sources for e-cigarette advertisements were televisions and gas stations and, for acquiring e-cigarettes, were peers.

Authors Article Title

Methods Results Conclusions

Lempert LK, Grana R, Glantz SA.

The importance of product definitions in US e-cigarette laws and regulations.

Examined the text of 46 bills that define e-cigarettes enacted in 40 states and characterized how e-cigarettes and similar products were defined. Online survey data was collected from a representative sample of US adults between October

Definitions separating e-cigarettes from other tobacco products are common. Similar to past ‘Trojan horse’ policies, e-cigarette policies that initially appear to restrict sales (eg, limit youth access) may actually undermine regulation if they establish local pre-emption or create definitions that divide e-cigarettes from other tobacco products. Comparable issues are raised by the European Union Tobacco Products Directive and e-cigarette regulations in other countries. Policymakers should carefully draft legislation with definitions of e-cigarettes

Definitions separating e-cigarettes from other tobacco products are common. Similar to past ‘Trojan horse’ policies, e-cigarette policies that initially appear to restrict sales (eg, limit youth access) may actually undermine regulation if they establish local pre-emption or create definitions that divide e-cigarettes from other tobacco products. Comparable issues are raised by the European Union Tobacco Products Directive and

36

and December 2013 and weighted to match the US adult population. They fitted multiple regression models, adjusting for demographic variables, to examine associations between support for policies to restrict vaping and smoking in public venues and self-reported frequency of exposure to e-cigarette communications in the preceding month.

that broadly define the products, do not require nicotine or tobacco, do not pre-empt stronger regulations and explicitly include e-cigarettes in smoke-free and taxation laws.

e-cigarette regulations in other countries. Policymakers should carefully draft legislation with definitions of e-cigarettes that broadly define the products, do not require nicotine or tobacco, do not pre-empt stronger regulations and explicitly include e-cigarettes in smoke-free and taxation laws.

Authors Article Title

Methods Results Conclusions

McMillen RC, Gottlieb MA, Shaefer RM, Winickoff JP, Klein JD.

Trends in Electronic Cigarette Use Among U.S. Adults: Use is Increasing in Both Smokers and Nonsmokers.

Mixed-mode surveys were used to obtain representative, cross-sectional samples of U.S. adults in each of 4 years.

Prevalence of use increased significantly across all demographic groups. In 2013, current use among young adults 18–24 was higher than adults 25–44, 45–64, and 65+. Daily smokers and nondaily smokers were the most likely to currently use e-cigarettes, compared to former smokers and never-smokers. However, 32.5% of current electronic

There has been rapid growth in ever and current electronic cigarette use over the past 4 years. Use is highest among young adults and current cigarette smokers. Although smokers are most likely to use these products, almost a third of current users are nonsmokers,

37

cigarette users are never- or former smokers.

suggesting that e-cigarettes contribute to primary nicotine addiction and to renormalization of tobacco use. Regulatory action is needed at the federal, state, and local levels to ensure that these products do not contribute to preventable chronic disease.

Pepper JK, Ribisl KM, Emery SL, Brewer NT.

Reasons for starting and stopping electronic cigarette use.

In March 2013, 17,522 U.S. adult TCME participants completed an online survey. For this study, we report data only from the 3878 participants who reported ever having tried an e-cigarette.

The most common reasons for starting e-cigarette use were curiosity, a friend or family member used, gave, or offered an e-cigarette, and to quit or cut back on smoking. Other common reasons for trying e-cigarettes included believing that e-cigarettes were less harmful to the user than regular cigarettes, could be used in places where smoking is not allowed, or were less harmful to others. Nearly two-thirds of those who had tried e-cigarettes later discontinued use. People whose main reason for trying e-cigarettes was not goal-oriented were more likely to stop using e-cigarettes than those whose main reason was goal-oriented. However, among participants who tried e-cigarettes in order to quit or cut back on smoking, only 48% discontinued use.

Those who try for goal-oriented reasons are more likely to continue using, but when they do stop using, they do so for reasons related to product satisfaction. If e-cigarettes are to serve as a harm reduction tool, smokers who try for cessation will need to be sufficiently satisfied with the product so that they switch completely and not merely experiment with it. Future research should build on this study’s findings and explore adolescents’ and young adults’ reasons for starting and stopping e-cigarette use, as this could help to design programs that prevent e-cigarettes from serving as a gateway to future smoking.

Authors Article Title

Methods Results Conclusions

Shihadeh A, Eissenberg T.

Electronic cigarette effectiveness and

This framework employs “nicotine flux” to

As a result, although its variable voltage and variable nicotine features allow Product A to occupy a large nicotine

ECIGs present a level of complexity that is a challenge to regulation. There clearly is great

38

abuse liability: predicting and regulating nicotine flux.

account for the total dose and rate at which nicotine reaches the user, 2 key factors in drug abuse liability. The nicotine flux is the nicotine emitted per puff second (e.g., mg/s) by a given ECIG design under given use conditions and can be predicted accurately using physical principles.

flux surface, most of the ways that Product A can be used will produce an unacceptably low nicotine flux. Product B is a fixed voltage device that is sold with nonrefillable disposable cartridges of fixed nicotine concentration. With long puff durations, Product B allows the user to obtain potentially unsafe nicotine fluxes (red region). Product C is identical to Product B. However, it is equipped with a microchip that automatically terminates power to the heater coil after a preset puff duration has been reached and that does not allow another puff to be executed prior to the passage of a minimum interpuff interval. As a result, the microchip constrains operation of the product to the desired range of nicotine flux.

variability in the marketplace today, with some ECIGs delivering little or no nicotine to the user and others, under certain conditions, yielding higher doses of nicotine in a few puffs than has been observed for an entire single combustible cigarette. With respect to nicotine yield, we suggest that the concept of flux and the critical functions Z p and Z d will allow regulators to navigate this complexity, charting the range of possible fluxes for various proposed rules.

Tan AS, Bigman CA, Sanders-Jackson A.

Sociodemographic correlates of self-reported exposure to e-cigarette communications and its association with public support for smoke-free and vape-free policies: results from a national survey of US adults.

Online survey data was collected from a representative sample of US adults between October and December 2013 and weighted to match the US adult population. We fitted multiple regression models, adjusting for demographic variables, to

Higher self-reported exposure to advertising, other media, and interpersonal discussion perceived as positive were associated with lower support for vaping restrictions, adjusting for covariates. Exposure to e-cigarette communications was associated with lower support for smoking restrictions in bivariate analyses but was not significant after adjusting for covariates.

Further research is needed to assess whether messages portraying e-cigarettes as a way to circumvent smoking restrictions from advertisements and other media are influencing public support for vape-free policies. These findings provide empirical evidence to inform the policy debate over regulating specific e-cigarette advertising claims.

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examine associations between support for policies to restrict vaping and smoking in public venues and self-reported frequency of exposure to e-cigarette communications in the preceding month. We fitted separate models to assess associations between policy support and frequency of exposures weighted by whether each category of e-cigarette communications was perceived as positive or negative.

Authors Article Title

Methods Results Conclusions

Wills TA, Knight R, Williams RJ, Pagano I, Sargent JD.

Risk factors for exclusive e-cigarette use and dual e-cigarette

School-based survey of 1941 high school students in Hawaii; data collected in

Prevalence for the categories was 17% (e-cigarettes only), 12% (dual use), 3% (cigarettes only), and 68% (nonusers). Dual users and cigarette-only users were highest on risk status (elevated on risk

This study reports a US adolescent sample with one of the largest prevalence rates of e-cigarette only use in the existing literature. Dual use also had a

40

use and tobacco use in adolescents.

2013. The survey assessed e-cigarette use and cigarette use, alcohol and marijuana use, and psychosocial risk and protective variables. Analysis of variance and multinomial regression examined variation in risk and protective variables across the following categories of ever-use: e-cigarette only, cigarette only, dual use, and nonuser.

factors and lower on protective factors) compared with other groups. E-cigarette only users were higher on risk status than nonusers but lower than dual users. E-cigarette only users and dual users more often perceived e-cigarettes as healthier than cigarettes compared with nonusers.

substantial prevalence. The fact that e-cigarette only users were intermediate in risk status between nonusers and dual users raises the possibility that e-cigarettes are recruiting medium-risk adolescents, who otherwise would be less susceptible to tobacco product use.

Authors Article Title

Methods Results Conclusions

Yong HH, Borland R, Balmford J, McNeill A, Hitchman S, Driezen P, Thompson ME, Fong GT, Cummings KM

Trends in E-Cigarette Awareness, Trial, and Use Under the Different Regulatory Environments of Australia and the United Kingdom.

Data analyzed come from Waves 8 and 9 (collected in 2010 and 2013, respectively) of the International Tobacco Control surveys in Australia and the United

Across both waves, EC awareness, trial, and use among current and former smokers were significantly greater in the United Kingdom than in Australia, but all 3 of these measures increased significantly between 2010 and 2013 in both countries, and the rate of increase was equivalent between countries. Seventy-three percent of U.K. respondents reported that their current brands contained nicotine as did

EC awareness and use have risen rapidly between 2010 and 2013 among current and former smokers in both Australia and the United Kingdom despite different EC regulatory environments. Substantial numbers in both countries are using ECs that contain nicotine.

41

Kingdom (approximately 1,500 respondents per wave per country).

43% in Australia even though sale, possession and/or use of nicotine-containing ECs without a permit are illegal in Australia. EC use was greater among smokers in both countries, at least in part due to fewer uptakes by ex-smokers.

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APPENDIX B

INTERVIEW SAMPLE QUESTIONS

1. Please tell me what you know about electronic cigarette smoking.

Mechanics of how it is used Potential health harms (e.g., lead to smoking, toxin load) Potential health benefits (e.g., help people stop smoking) Marketing and industry (e.g., what traditional tobacco companies also market e-cigarettes) Local establishments related to this form of substance use

2. Please tell me how current regulations may or may not apply to electronic cigarette

smoking.

Clean air Taxation Labeling/warnings Flavoring Age restrictions

3. Please tell me what you think should or should not be done in terms of future policy

related to electronic cigarette smoking.

Changes in state or local law Changes in federal law Changes in enforcement Building of infrastructure Changes in education

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