1

Introduction 3

Organization of the Report 4

Preparation of this Report 4

Scientific Basis of the Report 5

Major Conclusions 5

Chapter Conclusions 6

Chapter 1. Introduction, Conclusions, and Historical Background Relative to E-Cigarettes 6

Chapter 2. Patterns of E-Cigarette Use Among U.S. Youth and Young Adults 6

Chapter 3. Health Effects of E-Cigarette Use Among U.S. Youth and Young Adults 6

Chapter 4. Activities of the E-Cigarette Companies 7

Chapter 5. E-Cigarette Policy and Practice Implications 7

Historical Background 8

Early Efforts to Modify Cigarettes 8

Filters, Tar Reduction, and Light and Low-Tar Cigarettes 8

The Role of Nicotine and Nicotine Delivery 9

FDA and Nicotine Regulation 9

The E-Cigarette 10

Invention of the E-Cigarette 10

E-Cigarette Products 11

Components and Devices 11

Flavors and E-Cigarettes 11

E-Cigarette Devices 11

E-Cigarette Product Components and Risks 13

E-Cigarette Companies 14

Federal Regulation of E-Cigarettes 15

A “Two-Pronged” Approach to Comprehensive Tobacco Control 15

Legal Basis for Regulating E-Cigarettes as Tobacco Products 16

Deeming Rule 17

Future Regulatory Options 17

Summary 18

References 19

Chapter 1 

Introduction, Conclusions, and Historical Background 

Relative to E-Cigarettes

Introduction, Conclusions, and Historical Background Relative to E-Cigarettes 3

E-Cigarette Use Among Youth and Young Adults

Introduction

Although conventional cigarette smoking has 

declined markedly over the past several decades among 

youth and young adults in the United States (U.S. 

Department of Health and Human Services [USDHHS] 

2012), there have been substantial increases in the use of 

emerging tobacco products among these populations in 

recent years (Centers for Disease Control and Prevention 

[CDC] 2015c). Among these increases has been a dramatic 

rise in electronic cigarette (e-cigarette) use among youth 

and young adults. It is crucial that the progress made 

in reducing cigarette smoking among youth and young 

adults not be compromised by the initiation and use of 

e-cigarettes. This Surgeon General’s report focuses on the 

history, epidemiology, and health effects of e-cigarette use 

among youth and young adults; the companies involved 

with marketing and promoting these products; and 

existing and proposed public health policies regarding the 

use of these products by youth and young adults.

E-cigarettes include a diverse group of devices that 

allow users to inhale an aerosol, which typically contains 

nicotine, flavorings, and other additives. E-cigarettes vary 

widely in design and appearance, but generally operate in 

a similar manner and are composed of similar components 

(Figure 1.1). A key challenge for surveillance of the products and understanding their patterns of use is the diverse 

and nonstandard nomenclature for the devices (Alexander 

et al. 2016). These devices are referred to, by the companies 

themselves, and by consumers, as “e-cigarettes,” “e-cigs,” 

“cigalikes,” “e-hookahs,” “mods,” “vape pens,” “vapes,” 

and “tank systems.” In this report, the term “e-cigarette” 

is used to represent all of the various products in this rapidly diversifying product category. The terms may differ 

by geographic region or simply by the prevailing preferences among young users. For example, some refer to all 

cigarette-shaped products as “e-cigarettes” or as “cigalikes,” 

and some may refer to the pen-style e-cigarettes as “hookah 

pens” or “vape pens” (Richtel 2014; Lempert et al. 2016).

Figure 1.1 Diversity of e-cigarette products

Source: Photo by Mandie Mills, CDC.
A Report of the Surgeon General

4 Chapter 1

This report focuses on research conducted among 

youth and young adults because of the implications of 

e-cigarette use in this population, particularly the potential for future public health problems. Understanding 

e-cigarette use among young persons is critical because 

previous research suggests that about 9 in 10 adult 

smokers first try conventional cigarettes during adolescence (USDHHS 2012). Similarly, youth e-cigarette experimentation and use could also extend into adulthood; 

however, e-cigarette use in this population has not been 

examined in previous reports of the Surgeon General. 

The first Surgeon General’s report on the health consequences of smoking was published in 1964; of the subsequent reports, those published in 1994 and 2012 focused 

solely on youth and young adults (USDHHS 1994, 2012). 

More recently, the 2012 report documented the evidence 

regarding tobacco use among youth and young adults, 

concluding that declines in cigarette smoking had slowed 

and that decreases in the use of smokeless tobacco had 

stalled. That report also found that the tobacco industry’s 

advertising and promotional activities are causal to the 

onset of smoking in youth and young adults and the continuation of such use as adults (USDHHS 2012). However, 

the 2012 report was prepared before e-cigarettes were as 

widely promoted and used in the United States as they are 

now. Therefore, this 2016 report documents the scientific 

literature on these new products and their marketing, 

within the context of youth and young adults. This report 

also looks to the future by examining the potential impact 

of e-cigarette use among youth and young adults, while 

also summarizing the research on current use, health 

consequences, and marketing as it applies to youth and 

young adults.

Evidence for this report was gathered from studies 

that included one or more of three age groups. We defined 

these age groups to be young adolescents (11–13 years of 

age), adolescents (14–17 years of age), and young adults 

(18–24 years of age). Some studies refer to the younger 

groups more generally as youth. Despite important issues 

related to e-cigarette use in adult populations, clinical and 

otherwise (e.g., their potential for use in conventional 

smoking cessation), that literature will generally not be 

included in this report unless it also discusses youth and 

young adults (Farsalinos and Polosa 2014; Franck et al. 

2014; Grana et al. 2014).

Given the recency of the research that pertains to 

e-cigarettes, compared with the decades of research on 

cigarette smoking, the “precautionary principle” is used 

to guide actions to address e-cigarette use among youth 

and young adults. This principle supports intervention 

to avoid possible health risks when the potential risks 

remain uncertain and have been as yet partially undefined 

(Bialous and Sarma 2014; Saitta et al. 2014; Hagopian et al. 

2015). Still, the report underscores and draws its conclusions from the known health risks of e-cigarette use in 

this age group.

Organization of the Report

This chapter presents a brief introduction to this 

report and includes its major conclusions followed by the 

conclusions of the chapters, the historical background of 

e-cigarettes, descriptions of the products, a review of the 

marketing and promotional activities of e-cigarette companies, and the current status of regulations from the U.S. 

Food and Drug Administration (FDA). Chapter 2 (“Patterns 

of E-Cigarette Use Among U.S. Youth and Young Adults”) 

describes the epidemiology of e-cigarette use, including current use (i.e., past 30 day); ever use; co-occurrence of using 

e-cigarettes with other tobacco products, like cigarettes; 

and psychosocial factors associated with using e-cigarettes, 

relying on data from the most recent nationally representative studies available at the time this report was prepared. 

Chapter 3 (“Health Effects of E-Cigarette Use Among U.S. 

Youth and Young Adults”) documents the evidence related 

to the health effects of e-cigarette use, including those that 

are associated with direct aerosol inhalation by users, the 

indirect health effects of e-cigarette use, other non-aerosol 

health effects of e-cigarette use, and secondhand exposure 

to constituents of the aerosol. Chapter 4 (“Activities of the 

E-Cigarette Companies”) describes e-cigarette companies’ 

influences on e-cigarette use and considers manufacturing 

and price; the impact of price on sales and use; the rapid 

changes in the industry, particularly the e-cigarette companies; and the marketing and promotion of e-cigarettes. 

Chapter 5 (“E-Cigarette Policy and Practice Implications”) 

discusses the implications for policy and practice at the 

national, state, and local levels. The report ends with a Call 

to Action to stakeholders—including policymakers, public 

health practitioners and clinicians, researchers, and the 

public—to work to prevent harms from e-cigarette use 

and secondhand aerosol exposure among youth and young 

adults.

Preparation of this Report

This Surgeon General’s report was prepared by 

the Office on Smoking and Health, National Center for 

Chronic Disease Prevention and Health Promotion, CDC, 

which is part of USDHHS. The initial drafts of the chapters were written by 27 experts who were selected for their 

knowledge of the topics addressed. These contributions 

are summarized in five chapters that were evaluated by 
Introduction, Conclusions, and Historical Background Relative to E-Cigarettes 5

E-Cigarette Use Among Youth and Young Adults

approximately 30  peer reviewers. After peer review, the 

entire manuscript was sent to more than 20 scientists 

and other experts, who examined it for its scientific integrity. After each review cycle, the drafts were revised by the 

report’s scientific editors on the basis of reviewers’ comments. Subsequently, the report was reviewed by various 

institutes and agencies within USDHHS. 

Scientific Basis of the Report

The statements and conclusions throughout this 

report are documented by the citation of studies published 

in the scientific literature. Publication lags have prevented an up-to-the-minute inclusion of all recently published articles and data. This overall report primarily cites 

peer-reviewed journal articles, including reviews that integrate findings from numerous studies and books that were 

published through December 2015. However, selected 

studies from 2016 have been added during the review process that provide further support for the conclusions in 

this report. When a cited study has been accepted for publication, but the publication has not yet occurred because 

of the delay between acceptance and final publication, the 

study is referred to as “in press.” This report also refers, on 

occasion, to unpublished research, such as presentations 

at a professional meeting, personal communications from 

a researcher, or information available in various media. 

These references are employed when acknowledged by 

the editors and reviewers as being from reliable sources, 

which add to the emerging literature on a topic.

Major Conclusions

1. E-cigarettes are a rapidly emerging and diversified 

product class. These devices typically deliver nicotine, flavorings, and other additives to users via an 

inhaled aerosol. These devices are referred to by a 

variety of names, including “e-cigs,” “e-hookahs,” 

“mods,” “vape pens,” “vapes,” and “tank systems.”

2. E-cigarette use among youth and young adults has 

become a public health concern. In 2014, current 

use of e-cigarettes by young adults 18–24 years of 

age surpassed that of adults 25 years of age and older.

3. E-cigarettes are now the most commonly used 

tobacco product among youth, surpassing conventional cigarettes in 2014. E-cigarette use is strongly 

associated with the use of other tobacco products 

among youth and young adults, including combustible tobacco products.

4. The use of products containing nicotine poses dangers to youth, pregnant women, and fetuses. The use 

of products containing nicotine in any form among 

youth, including in e-cigarettes, is unsafe.

5. E-cigarette aerosol is not harmless. It can contain harmful and potentially harmful constituents, 

including nicotine. Nicotine exposure during adolescence can cause addiction and can harm the 

developing adolescent brain.

6. E-cigarettes are marketed by promoting flavors 

and using a wide variety of media channels and 

approaches that have been used in the past for marketing conventional tobacco products to youth and 

young adults.

7. Action can be taken at the national, state, local, tribal, 

and territorial levels to address e-cigarette use among 

youth and young adults. Actions could include 

incorporating e-cigarettes into smokefree policies, 

preventing access to e-cigarettes by youth, price and 

tax policies, retail licensure, regulation of e-cigarette 

marketing likely to attract youth, and educational initiatives targeting youth and young adults.
A Report of the Surgeon General

6 Chapter 1

Chapter Conclusions

Chapter 1. Introduction, 

Conclusions, and Historical 

Background Relative to 

E-Cigarettes 

1. E-cigarettes are devices that typically deliver nicotine, flavorings, and other additives to users via an 

inhaled aerosol. These devices are referred to by a 

variety of names, including “e-cigs,” “e-hookahs,” 

“mods,” “vape pens,” “vapes,” and “tank systems.”

2. E-cigarettes represent an evolution in a long history 

of tobacco products in the United States, including 

conventional cigarettes.

3. In May 2016, the Food and Drug Administration 

issued the deeming rule, exercising its regulatory 

authority over e-cigarettes as a tobacco product.

Chapter 2. Patterns of E-Cigarette 

Use Among U.S. Youth and Young 

Adults

1. Among middle and high school students, both ever 

and past-30-day e-cigarette use have more than tripled since 2011. Among young adults 18–24 years 

of age, ever e-cigarette use more than doubled from 

2013 to 2014 following a period of relative stability 

from 2011 to 2013.

2. The most recent data available show that the prevalence of past-30-day use of e-cigarettes is similar 

among high school students (16% in 2015, 13.4% in 

2014) and young adults 18–24 years of age (13.6% 

in 2013–2014) compared to middle school students 

(5.3% in 2015, 3.9% in 2014) and adults 25 years of 

age and older (5.7% in 2013–2014).

3. Exclusive, past-30-day use of e-cigarettes among 

8th-, 10th-, and 12th-grade students (6.8%, 10.4%, 

and 10.4%, respectively) exceeded exclusive, 

past-30-day use of conventional cigarettes in 2015 

(1.4%, 2.2%, and 5.3%, respectively). In contrast—

in 2013–2014 among young adults 18–24 years of 

age—exclusive, past-30-day use of conventional cigarettes (9.6%) exceeded exclusive, past-30-day use of 

e-cigarettes (6.1%). For both age groups, dual use of 

these products is common.

4. E-cigarette use is strongly associated with the use 

of other tobacco products among youth and young 

adults, particularly the use of combustible tobacco 

products. For example, in 2015, 58.8% of high 

school students who were current users of combustible tobacco products were also current users of 

e-cigarettes.

5. Among youth—older students, Hispanics, and 

Whites are more likely to use e-cigarettes than 

younger students and Blacks. Among young 

adults—males, Hispanics, Whites, and those with 

lower levels of education are more likely to use 

e-cigarettes than females, Blacks, and those with 

higher levels of education.

6. The most commonly cited reasons for using 

e-cigarettes among both youth and young adults are 

curiosity, flavoring/taste, and low perceived harm 

compared to other tobacco products. The use of 

e-cigarettes as an aid to quit conventional cigarettes 

is not reported as a primary reason for use among 

youth and young adults.

7. Flavored e-cigarette use among young adult current 

users (18–24 years of age) exceeds that of older adult 

current users (25 years of age and older). Moreover, 

among youth who have ever tried an e-cigarette, a 

majority used a flavored product the first time they 

tried an e-cigarette.

8. E-cigarette products can be used as a delivery 

system for cannabinoids and potentially for other 

illicit drugs. More specific surveillance measures are 

needed to assess the use of drugs other than nicotine 

in e-cigarettes.

Chapter 3. Health Effects of 

E-Cigarette Use Among U.S. Youth 

and Young Adults

1. Nicotine exposure during adolescence can cause addiction and can harm the developing adolescent brain.
Introduction, Conclusions, and Historical Background Relative to E-Cigarettes 7

E-Cigarette Use Among Youth and Young Adults

2. Nicotine can cross the placenta and has known effects 

on fetal and postnatal development. Therefore, nicotine delivered by e-cigarettes during pregnancy can 

result in multiple adverse consequences, including 

sudden infant death syndrome, and could result in 

altered corpus callosum, deficits in auditory processing, and obesity.

3. E-cigarettes can expose users to several chemicals, 

including nicotine, carbonyl compounds, and volatile organic compounds, known to have adverse 

health effects. The health effects and potentially 

harmful doses of heated and aerosolized constituents 

of e-cigarette liquids, including solvents, flavorants, 

and toxicants, are not completely understood.

4. E-cigarette aerosol is not harmless “water vapor,” 

although it generally contains fewer toxicants than 

combustible tobacco products.

5. Ingestion of e-cigarette liquids containing nicotine 

can cause acute toxicity and possibly death if the 

contents of refill cartridges or bottles containing 

nicotine are consumed.

Chapter 4. Activities of the 

E-Cigarette Companies

1. The e-cigarette market has grown and changed 

rapidly, with notable increases in total sales of 

e-cigarette products, types of products, consolidation of companies, marketing expenses, and sales 

channels.

2. Prices of e-cigarette products are inversely related 

to sales volume: as prices have declined, sales have 

sharply increased.

3. E-cigarette products are marketed in a wide variety 

of channels that have broad reach among youth and 

young adults, including television, point-of-sale, 

magazines, promotional activities, radio, and the 

Internet.

4. Themes in e-cigarette marketing, including sexual 

content and customer satisfaction, are parallel to 

themes and techniques that have been found to be 

appealing to youth and young adults in conventional 

cigarette advertising and promotion.

Chapter 5. E-Cigarette Policy and 

Practice Implications

1. The dynamic nature of the e-cigarette landscape 

calls for expansion and enhancement of tobaccorelated surveillance to include (a) tracking patterns 

of use in priority populations; (b) monitoring the 

characteristics of the retail market; (c) examining 

policies at the national, state, local, tribal, and territorial levels; (d) examining the channels and messaging for marketing e-cigarettes in order to more 

fully understand the impact future regulations 

could have; and (e) searching for sentinel health 

events in youth and young adult e-cigarette users, 

while longer-term health consequences are tracked.

2. Strategic, comprehensive research is critical to 

identify and characterize the potential health risks 

from e-cigarette use, particularly among youth and 

young adults.

3. The adoption of public health strategies that are precautionary to protect youth and young adults from 

adverse effects related to e-cigarettes is justified.

4. A broad program of behavioral, communications, 

and educational research is crucial to assess how 

youth perceive e-cigarettes and associated marketing messages, and to determine what kinds of 

tobacco control communication strategies and 

channels are most effective.

5. Health professionals represent an important 

channel for education about e-cigarettes, particularly for youth and young adults.

6. Diverse actions, modeled after evidence-based 

tobacco control strategies, can be taken at the 

state, local, tribal, and territorial levels to address 

e-cigarette use among youth and young adults, 

including incorporating e-cigarettes into smokefree policies; preventing the access of youth to 

e-cigarettes; price and tax policies; retail licensure; 

regulation of e-cigarette marketing that is likely to 

attract youth and young adults, to the extent feasible 

under the law; and educational initiatives targeting 

youth and young adults. Among others, research 

focused on policy, economics, and the e-cigarette 

industry will aid in the development and implementation of evidence-based strategies and best 

practices.
A Report of the Surgeon General

8 Chapter 1

Historical Background

Understanding the role of e-cigarettes requires 

understanding the long history of tobacco use in the United 

States, including the role of nicotine delivery, the multiple examples of “reduced-harm” products and associated 

health claims, and the impact of using tobacco products on 

the public’s health. Since the late nineteenth century, when 

the “modern” cigarette came into use, scientists and public 

health officials have linked cigarette smoking to a remarkable number of adverse effects, and it is now recognized as 

the primary cause of premature death in the United States 

(USDHHS 2014). Correspondingly, for a century, manufacturers, scientists, entrepreneurs, and public health leaders 

have promoted or recommended product changes that 

might remove some of the harmful elements in cigarette 

smoke. E-cigarettes are among the latest products.

E-cigarettes are designed for users to inhale nicotine, flavorings, and other additives through an aerosol. 

The claims and marketing strategies employed by the 

e-cigarette companies, and the efforts made by others to 

develop scientific and regulatory tools to deal with these 

new products, both contribute to the current discourse 

on e-cigarettes. Many lessons for assessing the potential (and future) consequences of these products can be 

learned from examining the relevant experiences of the 

past century, especially the introduction of novel products (including e-cigarettes as well as other tobacco and 

nicotine products) and the claims of reduced exposure to 

toxins made by the industry and elsewhere.

Early Efforts to Modify Cigarettes

In the 1880s and 1890s, entrepreneurs promoted 

novel products that allegedly blocked nicotine and other 

constituents of conventional cigarettes believed to be 

poisonous. Dr. Scott’s Electric Cigarettes, advertised 

in Harper’s Weekly, claimed not only to light without 

matches but also to contain a cotton filter that “strains 

and eliminates the injurious qualities from the smoke,” 

including nicotine (Harper’s Weekly 1887). Nicotine 

delivery was essential to the development of the modern 

cigarette in the twentieth century; early on, this substance 

was thought to be addicting and thus vital to retaining 

customers. In 1913, the Camel brand was a new kind of 

cigarette that introduced high-nicotine content by using 

burley tobacco, which was generally too harsh to inhale 

into the lungs, but was made more inhalable through the 

addition of casings (e.g., sugars, licorice) (Tindall 1992; 

Proctor 2011). In 1916, American Tobacco introduced 

its Lucky Strike blended cigarette, and in 1918 Liggett & 

Myers (L&M) reformulated its Chesterfield brand to make 

it more palatable to users. As the market grew, advertisements for major brands routinely included health-related 

statements and testimonials from physicians. During 

the 1930s and 1940s, prominent advertising campaigns 

included claims like “Not a cough in a carload” (Old Gold) 

(Federal Trade Commission [FTC] 1964, p. LBA-5); “We 

removed from the tobacco harmful corrosive ACRIDS 

(pungent irritants) present in cigarettes manufactured 

in the old-fashioned way” (Lucky Strike) (FTC 1964, 

p. LBA-2); and “Smoking Camels stimulates the natural 

flow of digestive fluids ... increases alkalinity” (Camel) 

(FTC 1964, p. LBA-1a). Thus, early modifications to the 

cigarette were made so that it was more palatable, had a 

higher nicotine delivery and uptake, and could be marketed as “safe” (FTC 1964; Calfee 1985).

Filters, Tar Reduction, and Light and 

Low-Tar Cigarettes

The landmark 1964 Surgeon General’s report on 

smoking and health concluded that cigarette smoking 

contributed substantially to mortality from certain specific diseases, including lung cancer (U.S. Department of 

Health, Education, and Welfare 1964). Although the 1964 

report considered the topic, it found the evidence insufficient to assess the potential health benefits of cigarette filters. Cigarettes with filters became the norm by the 1960s, 

and marketing them with an overt message about harm 

reduction became the standard (National Cancer Institute 

[NCI] 1996). However, the Surgeon General convened 

another group of experts on June 1, 1966, to review the 

evidence on the role played by the tar and nicotine content in health. The group concluded that “[t]he preponderance of scientific evidence strongly suggests that the 

lower the ‘tar’ and nicotine content of cigarette smoke, 

the less harmful are the effects” (Horn 1966, p. 16,168). 

Subsequent studies have repeatedly failed to demonstrate 

health benefits of smoking light and low-tar cigarettes 

versus full-flavor cigarettes (Herning et al. 1981; Russell 

et al. 1982; Benowitz et al. 1983, NCI 2001).

Over the years, the tobacco industry used multiple 

methods to reduce the machine-tested yields of tar and 

nicotine in cigarettes as a way to claim “healthier” cigarettes. Beginning in the 1970s, tobacco companies advertised the tar and nicotine levels for their cigarettes, which 

encouraged smokers to believe, without substantiation, 
Introduction, Conclusions, and Historical Background Relative to E-Cigarettes 9

E-Cigarette Use Among Youth and Young Adults

they could reduce their risk of exposure to these constituents (Cummings et al. 2002; Pollay and Dewhirst 2002). 

In 1996, the FTC issued a statement that it would allow 

cigarette companies to include statements about tar and 

nicotine content in their advertising as long as they used a 

standardized machine-testing method (Peeler 1996).

The Role of Nicotine and Nicotine 

Delivery

Although the public health community understood early on that nicotine was the primary psychoactive ingredient in cigarette smoke, before the 1980s, 

little was known about the importance of nicotine in the 

addiction process beyond what the cigarette manufacturers had learned from their own research. Some scientists warned that due to nicotine addiction, a reduction 

in nicotine yields, along with decreases in tar, could lead 

smokers to change their smoking behavior, such as by 

smoking a greater number of cigarettes to maintain their 

nicotine intake or changing their behavior in more subtle 

ways, such as varying the depth of inhalation or smoking 

more of the cigarette (Jarvis et al. 2001; National Cancer 

Institute 2001; Thun and Burns 2001). Not until the 1970s 

and 1980s, as researchers studying other forms of drug 

abuse began to apply their research methods to cigarette 

smoking, did it become apparent that nicotine was similar 

in its addictive capability to other drugs of abuse, such as 

heroin and cocaine (USDHHS 1981, 1988). As described 

in the 1988 Surgeon General’s report and in subsequent 

research, symptoms associated with nicotine addiction 

include craving, withdrawal, and unconscious behaviors 

to ensure consistent intake of nicotine (USDHHS 1988; 

al’Absi et al. 2002; Hughes 2007).

Although the tobacco industry has long understood 

the importance of nicotine to maintain long-term cigarette smokers through addiction, public health officials 

did not fully appreciate this in a broad sense until the 

1988 Surgeon General’s report, The Health Consequences 

of Smoking: Nicotine Addiction (USDHHS 1988).

FDA and Nicotine Regulation

In 1988 (and again in 1994), the Coalition on 

Smoking OR Health and other public-interest organizations petitioned FDA to classify low-tar and nicotine 

products as drugs and to classify Premier, the shortlived “smokeless cigarette product” from R.J. Reynolds, 

as an alternative nicotine-delivery system (Stratton et al. 

2001). The Coalition on Smoking OR Health cited indirect 

claims made through advertising and marketing as evidence of R. J. Reynolds’s intent to have the product used 

for the mitigation or prevention of disease (Slade and 

Ballin 1993). Meanwhile, FDA launched an investigation 

into the practices of the tobacco industry, including the 

manipulation of nicotine delivery. FDA asserted its jurisdiction over cigarettes and smokeless tobacco and issued 

certain rules governing access to and promotion of these 

products (Federal Register 1996). On March 21, 2000, the 

U.S. Supreme Court ruled 5-4 that Congress had not yet 

given FDA the necessary statutory authority to issue any 

rules pertaining to tobacco products (Gottleib 2000; FDA 

v. Brown & Williamson Tobacco Corp. 2000). The subsequent debate over control of nicotine products, including 

their potential impact on youth, ultimately led to the passage of the 2009 Family Smoking Prevention and Tobacco 

Control Act, which gave FDA authority to regulate tobacco 

products. Thus, discussions about the introduction of 

novel nicotine-containing tobacco products in the market 

during the 1980s and 1990s helped shape the current regulation of tobacco and nicotine products.

New products introduced in the 1990s or later 

included modified tobacco cigarettes (e.g., Advance, 

Omni); cigarette-like products, also called cigalikes 

(e.g.,  Eclipse, Accord); and smokeless tobacco products 

(e.g., Ariva, Exalt, Revel, snus). Advance, made by Brown 

and Williamson, was test-marketed with the slogan “All 

of the taste ... Less of the toxins.” Vector launched a 

national advertising campaign for its Omni cigarette 

with the slogan “Reduced carcinogens. Premium taste.” 

In addition to the question of whether the claims were 

supported by sufficient evidence, scientists and tobacco 

control leaders raised concerns about the potential for 

adverse consequences associated with novel nicotine and 

tobacco products marketed for harm reduction, such as a 

reduction in cessation rates or increased experimentation 

by children (Warner and Martin 2003; Joseph et al. 2004; 

Caraballo et al. 2006). Studies have shown that smokers 

are interested in trying novel “reduced-exposure” products 

and perceive them to have lower health risks, even when 

advertising messages do not make explicit health claims 

(Hamilton et  al. 2004; O’Connor et al. 2005; Caraballo 

et al. 2006; Choi et al. 2012; Pearson et al. 2012).

At FDA’s request, the Institute of Medicine (IOM 

[now the National Academy of Medicine]) convened a 

committee of experts to formulate scientific methods and 

standards by which potentially reduced-exposure products 

(PREPs), whether the purported reduction was pharmaceutical or tobacco related, could be assessed. The committee concluded that “[f]or many diseases attributable to 

tobacco use, reducing risk of disease by reducing exposure to tobacco toxicants is feasible” (Stratton et al. 2001, 

p. 232). However, it also cautioned that “PREPs have not 
A Report of the Surgeon General

10 Chapter 1

yet been evaluated comprehensively enough (including to less harm reduction for a population (as well as less risk 

for a sufficient time) to provide a scientific basis for con- reduction for that individual) than would occur without 

cluding that they are associated with a reduced risk of dis- the PREP, and possibly to an adverse effect on the populaease compared to conventional tobacco use” (Stratton et al. tion” (Stratton et al. 2001, p. 235). Subsequently, in 2006, 

2001, p. 232). The committee added that “the major con- Judge Kessler cited these findings in her decision which 

cern for public health is that tobacco users who might demanded the removal of light and low-tar labeling due 

otherwise quit will use PREPs instead, or others may ini- to the misleading nature of these claims (United States v. 

tiate smoking, feeling that PREPs are safe. That will lead Philip Morris 2006).

The E-Cigarette

Invention of the E-Cigarette

An early approximation of the current e-cigarette 

appeared in a U.S. patent application submitted in 1963 by 

Herbert A. Gilbert and was patented in August 1965 (U.S. 

Patent No. 3,200,819) (Gilbert 1965). The application was 

for a “smokeless nontobacco cigarette,” with the aim of 

providing “a safe and harmless means for and method of 

smoking” by replacing burning tobacco and paper with 

heated, moist, flavored air. A battery-powered heating element would heat the flavor elements without combustion 

(Gilbert 1965). The Favor cigarette, introduced in 1986, 

was another early noncombustible product promoted 

as an alternative nicotine-containing tobacco product 

(United Press International 1986; Ling and Glantz 2005).

The first device in the recent innovation in 

e-cigarettes was developed in 2003 by the Chinese pharmacist Hon Lik, a former deputy director of the Institute of 

Chinese Medicine in Liaoning Province. Lik’s patent application described a kind of electronic atomizing cigarette 

(Hon 2013). With support from Chinese investors, in 2004 

the product was introduced on the Chinese market under 

the company name Ruyan (Sanford and Goebel 2014). The 

product gained some attention among Chinese smokers 

early on as a potential cessation device or an alternative 

cigarette product.

The e-cigarette was part of the U.S. market by the 

mid-2000s, and by 2010 additional brands started to 

appear in the nation’s marketplace, including Ruyan and 

Janty (Regan et al. 2013). Ruyan gained a U.S. patent for 

its product with the application stating that the product 

is “an electronic atomization cigarette that functions as 

substitutes (sic) for quitting smoking and cigarette substitutes.” (U.S. Patent No. 8,490,628 B2, 2013). In August 

2013, Imperial Tobacco Group purchased the intellectual 

property behind the Ruyan e-cigarette for $75 million. 

As of 2014 an estimated 90% of the world’s production 

of e-cigarette technology and products came from mainland China, mainly Guangdong Province and Zhejiang 

Province (Barboza 2014).

Sales of e-cigarettes in the United States have risen 

rapidly since 2007. Widespread advertising via television 

commercials and through print advertisements for popular brands, often featuring celebrities, has contributed 

to a large increase in e-cigarette use by both adults and 

youth since 2010 (Felberbaum 2013; King et al. 2013; 

Regan et al. 2013). Additionally, marketing through social 

media, as well as other forms of Internet marketing, has 

been employed to market these devices (Huang et al. 2014; 

Kim et al. 2014).

In 2013, an estimated 13.1 million middle school 

and high school students were aware of e-cigarettes 

(Wang et al. 2014). According to data from the National 

Youth Tobacco Survey, in 2011 the prevalence of current 

e-cigarette use (defined as use during at least 1 day in 

the past 30 days) among high school students was 1.5%; 

prevalence increased dramatically, however, to 16% by 

2015, surpassing the rate of conventional-cigarette use 

among high school students (CDC 2016b; see Chapter 

2). This equates to 2.4 million high school students and 

620,000 middle school students having used an e-cigarette 

at least one time in the past 30 days in 2015 (CDC 2016b).

These trends have led to substantial concern and 

discussion within public health communities, including 

state and national public health agencies, professional 

organizations, and school administrators and teachers. 

A primary concern is the potential for nicotine addiction 

among nonsmokers, especially youth and young adults, 

and that this exposure to nicotine among youth and young 

adults is harmful. The diversity and novelty of e-cigarette 

products on the market and ongoing product innovations make assessments of the biological effects of current 

e-cigarettes under actual conditions of use—such as their 

long-term harmfulness—difficult to measure. Unanswered 

questions remain about the risk profile of these devices, 

their potential use by young people as a first step to other 

nicotine products, and their total impact on public health. 

There are diverging opinions about the potential public 

health impact of these new products. Some public health 

scientists have highlighted the potential for alternative 
Introduction, Conclusions, and Historical Background Relative to E-Cigarettes 11

E-Cigarette Use Among Youth and Young Adults

nicotine products to serve as a substitute for conventional 

cigarettes and thus a harm reduction tool (Henningfield 

et al. 2003; Abrams 2014). Others have cautioned that 

the use of alternative nicotine products might become 

a bridge that may lead to greater tobacco product use—

including dual- or multiple-product use—or initiate nicotine addiction among nonsmokers, especially youth (Cobb 

et al. 2010; Wagener et al. 2012; Benowitz and Goniewicz 

2013; Britton 2013; Chapman 2013; Etter 2013; USDHHS 

2014). Current evidence is insufficient to reject either of 

these hypotheses.

E-Cigarette Products

Components and Devices

E-cigarette devices are composed of a battery, a reservoir for holding a solution that typically contains nicotine, a heating element or an atomizer, and a mouthpiece 

through which the user puffs (Figure 1.2). The device 

heats a liquid solution (often called e-liquid or e-juice) 

into an aerosol that is inhaled by the user. E-liquid typically uses propylene glycol and/or glycerin as a solvent for 

the nicotine and flavoring chemicals

Flavors and E-Cigarettes

The e-liquids in e-cigarettes are most often flavored; 

a study estimated that 7,700 unique flavors exist (Zhu 

et al. 2014) and that most of them are fruit or candy flavors (Figure 1.3). A content analysis of the products available via online retail websites documented that tobacco, 

mint, coffee, and fruit flavors were most common, followed by candy (e.g., bubble gum), unique flavors (e.g., 

Belgian waffle), and alcoholic drink flavors (e.g., strawberry daiquiri) (Grana and Ling 2014). Some retail stores 

are also manufacturers that create custom flavors, which 

increases the variety of flavors available.

The widespread availability and popularity of flavored e-cigarettes is a key concern regarding the potential 

public health implications of the products. The concern, among youth, is that the availability of e-cigarettes 

with sweet flavors will facilitate nicotine addiction and 

simulated smoking behavior—which will lead to the 

use of conventional tobacco products (Kong et al. 2015; 

Krishnan-Sarin et al. 2015). Flavors have been used for 

decades to attract youth to tobacco products and to mask 

the flavor and harshness of tobacco (USDHHS 2012). 

Industry documents show that tobacco companies marketed flavored little cigars and cigarillos to youth and to 

African Americans to facilitate their uptake of cigarettes 

(Kostygina et al. 2014). Companies also intended flavored 

smokeless tobacco products to facilitate “graduation” to 

unflavored products that more easily deliver more nicotine to the user (USDHHS 2012). Various studies have 

shown that youth are more likely than adults to choose 

flavored cigarettes and cigars (CDC 2015b). Concern over 

these findings led Congress to include a ban on characterizing flavors for cigarettes, other than tobacco or menthol, 

in the Tobacco Control Act. A similar concern exists about 

e-cigarettes, and this concern is supported by studies indicating that youth and young adults who have ever used 

e-cigarettes begin their use with sweet flavors rather than 

tobacco flavors (Kong et al. 2015; Krishnan-Sarin et al. 

2015). Notably, 81.5% of current youth e-cigarette users 

said they used e-cigarettes “because they come in flavors I 

like” (Ambrose et al. 2015).

E-Cigarette Devices

First-generation e-cigarettes were often similar in 

size and shape to conventional cigarettes, with a design 

that also simulated a traditional cigarette in terms of the 

colors used (e.g., a white body with tan mouthpiece). 

These devices were often called cigalikes, but there were 

other products designed to simulate a cigar or pipe. Other 

cigalikes were slightly longer or narrower than a cigarette; 

they may combine white with tan or may be black or colored brightly. These newer models use a cartridge design 

for the part of the device that holds the e-liquid, which is 

either prefilled with the liquid or empty and ready to be 

filled. The user then squeezes drops of the e-liquid onto a 

wick (or bit of cotton or polyfil) connected to the heating 

element and atomizer (Figure 1.4). As e-cigarettes have 

become more popular, their designs have become more 

diverse, as have the types of venues where they are sold 

(Noel et al. 2011; Zhu et al. 2014).

Second-generation devices include products that 

are shaped like pens, are comparatively larger and cylindrical, and are often referred to as “tank systems” in a nod 

to the transparent reservoir that holds larger amounts 

of e-liquid than previous cartridge-containing models. 

Third- and fourth-generation devices represent a diverse 

set of products and, aesthetically, constitute the greatest 

departure from the traditional cigarette shape, as many 

are square or rectangular and feature customizable and 

rebuildable atomizers and batteries. In addition, since the 

beginning of the availability of e-cigarettes and their component parts, users have been modifying the devices or 

building their own devices, which are often referred to 

as “mods.” The differences in design and engineering of 

the products are key factors in the size, distribution, and 

amount of aerosol particles and the variability in levels of 

chemicals and nicotine present in the e-liquid/aerosol and 

delivered to the user (Brown and Cheng 2014).
A Report of the Surgeon General

12 Chapter 1

Figure 1.2 Parts of an e-cigarette device

Source: Photo by Mandie Mills, CDC.
Introduction, Conclusions, and Historical Background Relative to E-Cigarettes 13

E-Cigarette Use Among Youth and Young Adults

Figure 1.3 Examples of e-liquid flavors

Source: Photo by Mandie Mills, CDC.

Figure 1.4 E-liquids being poured into an e-cigarette device

Source: Photo by Mandie Mills, CDC.

E-Cigarette Product Components 

and Risks

One of the primary features of the more recent generation of devices is that they contain larger batteries and are 

capable of heating the liquid to a higher temperature, potentially releasing more nicotine, forming additional toxicants, 

and creating larger clouds of particulate matter (Bhatnagar 

et al. 2014; Kosmider et al. 2014). For instance, one study 

demonstrated that, at high temperatures (150°C), exceedingly high levels of formaldehyde—a carcinogen (found to 

be 10 times higher than at ambient temperatures)—are 

present that are formed through the heating of the e-liquid 

solvents (propylene glycol and glycerin), although the level 

of tolerance of actual users to the taste of the aerosol heated 

to this temperature is debated (Kosmider et al. 2014; CDC 

2015a; Flavor and Extract Manufacturers Association of 

the United States 2015; Pankow et al. 2015). There is also 

concern regarding the safety of inhaling e-cigarette flavorings. Although some manufacturers have claimed their 

flavorants are generally recognized as safe for food additives (i.e., to be used in preparing foods for eating), little is 

known about the long-term health effects of inhaling these 

substances into the lungs (CDC 2015a).

Many devices can be readily customized by their 

users, which is also leading to the concern that these 

devices are often being used to deliver drugs other than 

nicotine (Brown and Cheng 2014). Most commonly 

reported in the news media, on blogs, and by user anecdote 
A Report of the Surgeon General

14 Chapter 1

is the use of certain types of e-cigarette-related products 

for delivering different forms of marijuana (Morean et al. 

2015; Schauer et al. 2016). The tank systems, for example, 

have been used with liquid tetrahydrocannabinol (THC) 

or hash oil. Some personal vaporizer devices can be used 

with marijuana plant material or a concentrated resin 

form of marijuana called “wax.” One study describes the 

use, in Europe, of e-cigarette devices to smoke marijuana 

(Etter 2015).

The various e-cigarette products, viewed as a group, 

lack standardization in terms of design, capacity for safely 

holding e-liquid, packaging of the e-liquid, and features 

designed to minimize hazards with use (Yang et al. 2014). 

All of these design features may have implications for the 

health impact of e-cigarette use. Notably, from 2010 to 

2014, calls to poison control centers in the United States 

about exposures related to e-cigarettes increased dramatically. According to the American Association of Poison 

Control Centers (2015), 271 cases were reported in 2011, 

but 3,783 calls were reported in 2014. Among all calls, 

51%  involved exposure among children younger than 

5 years of age (CDC 2014). Most poisonings appear to have 

been caused by exposure to nicotine-containing liquid 

(CDC 2014). The lack of a requirement for child-resistant 

packaging for e-liquid containers may have contributed to these poisonings. Since these data were released, 

one death in the United States has been confirmed in a 

child who drank e-liquid containing nicotine (Mohney 

2014). Additionally, serious adverse reactions, including 

at least two deaths, have been reported to FDA in cases 

that could be attributed to the use of e-cigarettes (FDA 

2013). This increase in poisonings prompted the Child 

Nicotine Poisoning Prevention Act of 2015 (2016), which 

was enacted in January 2016. This law requires any container of liquid nicotine that is sold, manufactured, distributed, or imported into the United States to be placed 

in packaging that is difficult to open by children under 

5 years of age.

Secondary risks are also of concern regarding 

e-cigarettes, including passive exposure to nicotine and 

other chemicals, and adverse events due to device malfunction. Nicotine is a neuroteratogen, and its use by 

pregnant women exposes a developing fetus to risks that 

are well documented in the 50th-anniversary Surgeon 

General’s report on smoking (USDHHS 2014) and include 

impaired brain development (England et al. 2015) and 

other serious consequences. Finally, another consequence 

of the lack of device regulation is the occurrence of battery 

failures and subsequent explosions. Explosions have typically occurred during charging, resulting in house and car 

fires, and sometimes causing injuries to those involved. 

From 2009 to late 2014, 25 incidents of explosions and 

fires involving e-cigarettes occurred in the United States 

(Chen 2013; U.S. Fire Administration 2014; FDA 2013).

E-Cigarette Companies

E-cigarette companies include manufacturers, 

wholesalers, importers, retailers, distributors, and some 

other groups that overlap with these entities (Barboza 2014; 

Whelan 2015). Currently, most of the products are manufactured in Shenzhen, Guangdong Province, China (Cobb 

et al. 2010; Grana et al. 2014; Zhu et al. 2014). One study 

placed the number of brands at 466 in January 2014 and 

found a net increase of 10.5 brands per month (Zhu et al. 

2014). All the major tobacco companies (e.g.,  Reynolds 

American, Altria; Table 1.1) and many smaller, independent companies are now in the business. When e-cigarettes 

first entered the U.S. market, they were sold primarily by 

independent companies via the Internet and in shopping 

malls at kiosks where those interested could sample the 

products. A unique feature of the e-cigarette industry, 

compared to other tobacco and nicotine products, is the 

recruitment of visitors to their websites as “affiliates” or 

distributors to help market the products and, in turn, 

receive commissions on sales (Grana and Ling 2014; Cobb 

et al. 2015). For example, some companies offer a way for 

users to earn a commission by advertising the products 

(e.g., a banner ad is placed on one’s website, and when 

someone clicks on the link and subsequently purchases 

a product, the website owner gets a percentage commission). Some companies also offer rewards programs for 

recruiting new customers or for brand loyalty, with website users earning points for free or reduced-price products (Richardson et al. 2015).

E-cigarettes are now in widespread national distribution through convenience stores, tobacco stores, pharmacies, “big box” retail chains such as Costco, online retailers, 

and shops devoted to e-cigarette products (often called 

“vape shops”) (Giovenco et al. 2015; Public Health Law 

Center 2015). The “vape shops” offer a place to buy customizable devices and e-liquid solutions in many flavors and 

sometimes include a café or other elements that promote 

socializing, essentially making such places like a lounge. 

With the rapid increase in distribution and marketing in 

the industry, sales have increased rapidly and were projected to reach $2.5 billion in 2014 and $3.5 billion in 2015, 

including projections for retail and online channels, as well 

as “vape shops” (Wells Fargo Securities 2015).
Introduction, Conclusions, and Historical Background Relative to E-Cigarettes 15

E-Cigarette Use Among Youth and Young Adults

Table 1.1 Multinational tobacco companies with e-cigarette brands

Company E-cigarette brand

Altria (NuMark) MarkTen, Green Smoke

Philip Morris International Heat-not-burn, IQOS brand (Vape Ranks 2014)

E-cigs, Nicolites by Nicocigs (Philip Morris International 2014)

Reynolds (Reynolds Vapor Company) VUSE

Lorillard (Lorillard Vapor Company) blu (until 2015)

Imperial Tobacco (Fontem Ventures) Puritane (formerly Ruyan)

blu (acquired in 2015)

British American Tobacco Vype

Swisher E-swisher

Japan Tobacco International (JTI) E-Lites, offered in the United Kingdom by Zandera Ltd., which 

was acquired by Japan Tobacco Inc. in 2014 (Japan Tobacco Inc. 

2014)

Ploom (tobacco pods in heat-not-burn) and Ploom PAX (used for 

vaporizing marijuana) (Japan Tobacco Inc. 2015)

The advertising and marketing of e-cigarette products has engendered skepticism among public health 

professionals and legislators, who have noted many similarities to the advertising claims and promotional tactics used 

for decades by the tobacco industry to sell conventional 

tobacco products (Campaign for Tobacco-Free Kids 2013; 

CDC 2016a). Indeed, several of the e-cigarette marketing 

themes have been reprised from the most memorable cigarette advertising, including those focused on freedom, 

rebellion, and glamor (Grana and Ling 2014). E-cigarette 

products are marketed with a variety of unsubstantiated 

health and cessation messages, with some websites featuring videos of endorsements by physicians (another 

reprisal of old tobacco industry advertising) (Grana and 

Ling 2014; Zhu et al. 2014). Unlike conventional cigarettes, 

for which advertising has been prohibited from radio and 

television since 1971, e-cigarette products are advertised on 

both radio and television, with many ads featuring celebrities. E-cigarettes also are promoted through sports and 

music festival sponsorships, in contrast to conventional 

cigarettes and smokeless tobacco products, which have 

been prohibited from such sponsorships since the Master 

Settlement Agreement in 1998. E-cigarettes also appear as 

product placements in television shows and movies (Grana 

et al. 2011; Grana and Ling 2014).

Another key avenue for e-cigarette promotion 

is social media, such as Twitter, Facebook, YouTube, 

and Instagram. As is true in the tobacco industry, the 

e-cigarette industry organizes users through advocacy 

groups (Noel et al. 2011; Harris et al. 2014; Saitta et al. 

2014; Caponnetto et al. 2015). The extensive marketing 

and advocacy through various channels broadens exposure to e-cigarette marketing messages and products; 

such activity may encourage nonsmokers, particularly 

youth and young adults, to perceive e-cigarette use as 

socially normative. The plethora of unregulated advertising is of particular concern, as exposure to advertising 

for tobacco products among youth is associated with cigarette smoking in a dose-response fashion (USDHHS 2012).

Federal Regulation of E-Cigarettes

A “Two-Pronged” Approach to 

Comprehensive Tobacco Control

Since the passage of the Tobacco Control Act in 

2009, FDA has had the authority to regulate the manufacturing, distribution, and marketing of tobacco products 

sold in the United States. FDA had immediate jurisdiction over cigarettes, roll-your-own cigarette tobacco, and 

smokeless tobacco. In May 2016, FDA asserted jurisdiction over products that meet the statutory definition of 

a tobacco product, including e-cigarettes, except accessories of these products (Federal Register 2016). That regulation is currently under litigation.
A Report of the Surgeon General

16 Chapter 1

The IOM’s 2007 report, Ending the Tobacco Problem: 

A Blueprint for the Nation, established a “two-pronged” 

strategy for comprehensive tobacco control: (1) full implementation of proven, traditional tobacco control measures 

such as clean indoor air laws, taxation, and countermarketing campaigns; and (2) “strong federal regulation of 

tobacco products and their marketing and distribution” 

(Bonnie et al. 2007, p. 1).

Included in FDA’s broad authority are the restriction of marketing and sales to youth, requiring disclosure of ingredients and harmful and potentially harmful 

constituents, setting product standards (e.g., requiring 

the reduction or elimination of ingredients or constituents), requiring premarket approval of new tobacco products and review of modified-risk tobacco products, and 

requiring health warnings. The standard for FDA to use 

many of its regulatory authorities is whether such an 

action is appropriate for the protection of public health 

(Federal Food, Drug, and Cosmetic Act, § 907(a)(3)(A)). 

The public health standard in the Tobacco Control Act 

also requires FDA to consider the health impact of certain 

regulatory actions at both the individual and population 

levels, including their impact on nonusers, and on initiation and cessation (Federal Food, Drug, and Cosmetic Act, 

§ 907(a)(3)(B)).

Importantly, the Tobacco Control Act preserves the 

authority of state, local, tribal, and territorial governments to enact any policy “in addition to, or more stringent than” requirements established under the Tobacco 

Control Act “relating to or prohibiting the sale, distribution, possession, exposure to, access to, advertising 

and promotion of, or use of tobacco products by individuals of any age” (Federal Food, Drug, and Cosmetic Act, 

§ 916(a)(1)). This preservation of state and local authority 

ensures the continuation of more local-level, comprehensive tobacco control. However, the statute expressly 

preempts states and localities from establishing or continuing requirements that are different from or in addition to FDA requirements regarding standards for tobacco 

products, premarket review, adulteration, misbranding, 

labeling, registration, good manufacturing practices, or 

modified-risk tobacco products (Federal Food, Drug, and 

Cosmetic Act, § 916(a)(2)(A)). But this express preemption provision does not apply to state and local authority 

to impose requirements relating to the “sale, distribution, 

possession, information reporting to the State, exposure 

to, access to, the advertising and promotion of, or use of, 

tobacco products by individuals of any age . . .” (Federal 

Food, Drug, and Cosmetic Act, § 916(a)(2)(b)). The interaction of these complex provisions related to federal preemption of state law has been the subject of challenges 

by the tobacco industry to state and local laws. Thus far, 

courts have upheld certain local ordinances restricting the 

sale of flavored tobacco products (National Association 

of Tobacco Outlets, Inc. v. City of Providence 2013; U.S. 

Smokeless Tobacco Manufacturing Co. v. City of New 

York 2013).

Legal Basis for Regulating 

E-Cigarettes as Tobacco Products

In the United States, e-cigarettes can be regulated 

either as products marketed for therapeutic purposes or 

as tobacco products. Since the advent of e-cigarettes in the 

United States around 2007, manufacturers have had the 

option to apply to FDA’s Center for Drug Evaluation and 

Research (CDER) or Center for Devices and Radiological 

Health (CDRH) for approval to market e-cigarettes for therapeutic purposes; as of August 2016, no e-cigarette manufacturers have received approval through this avenue.

In 2008 and early 2009, FDA detained multiple shipments of e-cigarettes from overseas manufacturers and 

denied them entry into the United States on the grounds 

that e-cigarettes were unapproved drug-device combination products (FDA 2011). Sottera, Inc., which now does 

business as NJOY, challenged that determination (Smoking 

Everywhere, Inc. and Sottera, Inc., d/b/a NJOY v. U.S. Food 

and Drug Administration, et al. 2010; Bloomberg Business 

2015). Between the filing of the lawsuit and a decision on 

the motion for preliminary injunction, Congress passed 

the Tobacco Control Act and the President signed it into 

law. The Tobacco Control Act defines the term “tobacco 

product,” in part, as any product, including component 

parts or accessories, “made or derived from tobacco” that is 

not a “drug,” “device,” or “combination product” as defined 

by the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

321(rr)) (Family Smoking Prevention and Tobacco Control 

Act 2009, § 101(a)). The District Court subsequently 

granted a preliminary injunction relying on the Supreme 

Court’s decision in Brown and Williamson (1996) and the 

recently enacted Tobacco Control Act. FDA appealed the 

decision and the U.S. Court of Appeals for the D.C. Circuit 

held that e-cigarettes and, therefore, other products “made 

or derived from tobacco” are not drug/device combinations 

unless they are marketed for therapeutic purposes, but can 

be regulated by FDA as tobacco products under the Tobacco 

Control Act (Sottera, Inc. v. Food & Drug Administration 

2010).

On September 25, 2015, FDA proposed regulations 

to describe the circumstances in which a product made 

or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device, or 

a combination product. The comment period for this proposed regulation closed on November 24, 2015.
Introduction, Conclusions, and Historical Background Relative to E-Cigarettes 17

E-Cigarette Use Among Youth and Young Adults

Most e-cigarettes marketed and sold in the United 

States today contain nicotine made or derived from 

tobacco. Although some e-cigarettes claim that they 

contain nicotine not derived from tobacco, or that they 

contain no nicotine at all (Lempert et al. 2016), there may 

be reason to doubt some of these claims. Currently, synthetic nicotine and nicotine derived from genetically modified, nontobacco plants are cost-prohibitive for e-cigarette 

manufacturers, although technological advances could 

eventually increase the cost-effectiveness of using nicotine 

that was not derived from tobacco (Lempert et al. 2016). 

The health effects of passive exposure to e-cigarettes with 

no nicotine, as well as their actual use and the extent of 

exposure to these products, have just begun to be studied 

(Hall et al. 2014; Marini et al. 2014; Schweitzer et al. 2015) 

and some states and localities are taking steps to regulate e-cigarettes that do not contain nicotine or tobacco 

(Lempert et al. 2016).

Deeming Rule

The Tobacco Control Act added a new chapter to 

the Federal Food, Drug, and Cosmetic Act, which provides FDA with authority over tobacco products. The new 

chapter applied immediately to all cigarettes, cigarette 

tobacco, roll-your-own tobacco, and smokeless tobacco; 

and the law included “any other tobacco products that 

the Secretary of Health and Human Services by regulation deems to be subject to this chapter” (Federal Food, 

Drug, and Cosmetic Act, §901 (b)). Therefore, to regulate e-cigarettes as tobacco products, FDA was required to 

undertake a rulemaking process to extend its regulatory 

authority to include e-cigarettes.

Consequently, in May 2016, through its Center 

for Tobacco Products (CTP), FDA issued a rule—often 

referred to as the “deeming rule”—to extend its authority 

over all products meeting the definition of a tobacco 

product, except accessories of the newly deemed products. 

This rule extended FDA’s tobacco product authorities to 

include e-cigarettes and their components and parts (e.g., 

nicotine cartridges), but also to such products as cigars, 

pipe tobacco, nicotine gels, waterpipe/hookah tobacco, 

and dissolvables not already regulated as smokeless 

tobacco products (Federal Register 2016). This regulation 

is currently under litigation. The deeming rule subjects 

e-cigarettes to Tobacco Control Act provisions, including:

• Prohibitions on adulterated and misbranded 

products;

• Required disclosure of existing health information, 

including lists of ingredients and documents on 

health effects;

• Required registration of manufacturers;

• Required disclosure of a list of all tobacco products, including information related to labeling and 

advertising;

• Premarket review of new tobacco products 

(i.e., those not on the market on February 15, 2007);

• Restrictions on products marketed with claims 

about modified risk.

In addition to the aforementioned Tobacco Control 

Act provisions applicable to all deemed tobacco products, 

the Tobacco Control Act grants FDA authority to undertake a broad range of other actions on specific classes 

of products. In its deeming rule, FDA included the following additional actions for tobacco products, including 

e-cigarettes:

• Minimum age restrictions to prevent sales to minors;

• Requirements to include a nicotine warning; and

• Prohibitions on vending machine sales, unless in a 

facility that never admits youth.

Future Regulatory Options

E-cigarette manufacturers have the option to apply 

to FDA to authorize the marketing of their products or 

to be able to manufacture and sell tobacco products marketed with modified-risk claims, in addition to the existing 

option to apply to FDA’s CDER or CDRH for approval to 

market their products for therapeutic purposes. FDA also 

has authority to undertake a number of actions if the 

Secretary of USDHHS finds such actions to be appropriate 

for the protection of public health, including:

• Product standards, including restrictions on flavors;

• Restrictions on promotion, marketing, and advertising, and prohibitions on brand-name sponsorship 

of events;

• Minimum package sizes;

• Prohibitions on self-service displays;
A Report of the Surgeon General

18 Chapter 1

• Child-resistant packaging and the inclusion of 

health warnings; and

• Regulation of nicotine levels in products.

Despite this broad authority, FDA is prohibited from 

certain regulatory actions, even if those actions may be 

appropriate for the protection of public health. Specifically, 

FDA generally cannot restrict tobacco use in public places, 

levy taxes on tobacco products, prohibit sales by a specific 

category of retail outlet (e.g., pharmacies), completely eliminate nicotine in tobacco products, require prescriptions 

for tobacco products unless it is marketed for therapeutic 

purposes, or establish a federal minimum age of sale for 

tobacco products above 18 years of age. Thus, even if FDA 

fully exercises all of its existing authority over e-cigarettes, 

regulation will still need to be complemented at the state 

and local levels, including efforts previously shown to be 

effective for conventional tobacco products, such as comprehensive smokefree laws at the state and local levels, pricing 

strategies, raising the minimum age of sales to minors to 

21, and high-impact countermarketing campaigns. In the 

current context of rising rates of use by youth, localities 

and states can also implement policies and programs that 

minimize the individual- and population-level harms of 

e-cigarettes (see Chapter 5).

Summary

This chapter presents the major conclusions of 

this Surgeon General’s report and the conclusions of 

each chapter. E-cigarettes are presented within their historical context, with an overview of the components of 

these devices and the types of products. In 2016, FDA 

announced its final rule to regulate e-cigarettes under the 

Family Smoking Prevention and Tobacco Control Act. The 

chapter outlines options for the regulation of e-cigarettes, 

particularly as they relate to youth and young adults, 

based on successful smoking policies. The need to protect 

youth and young adults from initiating or continuing the 

use of nicotine-containing products forms a strong basis 

for the need to regulate e-cigarettes at the local, state, and 

national levels in the future.
Introduction, Conclusions, and Historical Background Relative to E-Cigarettes 19

E-Cigarette Use Among Youth and Young Adults

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