Fact Sheet

Attachment 5
Electronic Nicotine Delivery Systems (ENDS) in the 2014 Surgeon General’s Report:
The Health Consequences of Smoking—Fifty Years of Progress
A Fact Sheet
Purpose: In January 2014, the Surgeon General released the 32nd report on tobacco use and health titled The Health Consequences of Smoking—
Fifty Years of Progress. Broadly, the report explores the potential for public health benefits and harms associated with electronic nicotine
delivery systems (ENDS), including e-cigarettes, e-hookahs, hookah pens, vape pens, e-cigars, and others. This fact sheet synthesizes key themes
discussed in the SGR on the topic of ENDS, including excerpts from the report that contain supporting statements for each theme.
Theme
Tobacco control measures must
employ a public health standard.

Source
Ch. 16, p.
873

ENDS have a range of potential
impacts on individual and
population health. Significant
questions remain regarding their
safety and impact on patterns of
tobacco use.

Ch. 15, p.
859

Ch. 16 p. 873

Ch. 14, p.
780
The impact of ENDS on
population health is more likely

Executive
Summary, p.

Supporting Statement(s)
“A public health standard is critical because strategies that reduce potential harm from
toxicant exposure to individual users of tobacco products could adversely affect other
individuals and public health by increasing the number of new users and by reducing the
number of quitters.”
“This shift in patterns of tobacco use could have a number of potential impacts, ranging from
the positive effect of accelerating the rate at which smokers quit smoking cigarettes
completely to a negative effect of slowing down the decrease in the use of all tobacco
products, especially cigarettes. Availability of these products may reduce or increase harm to
the population.”
“Although these new products are entering the marketplace rapidly, and will soon be
marketed by all three major tobacco manufacturers in the United States , significant questions
remain about (1) how to assess the potential toxicity and health effects of the more than 250
electronic cigarette brands; (2) the magnitude of the potential reduced risk from electronic
versus continuing use of conventional cigarettes for individual smokers; (3) the need to weigh
the potential individual benefits and risks versus population benefits and risks; (4) how the
advertising and marketing of these new products should be regulated; and (5) even assuming
that electronic cigarettes could be sufficiently safe to users and offer net public health
benefits, there are significant questions about the manner in which they should be regulated
(Benowitz 2013).”
“Studies and assessments by FDA and independent scientists have demonstrated enormous
variability in design, operation, and contents and emissions of carcinogens, other toxicants,
and nicotine from ENDS.”
“The burden of death and disease from tobacco use in the United States is overwhelmingly
caused by cigarettes and other combusted tobacco products; rapid elimination of their use will

Page 1 of 5

Theme
to be beneficial only if cigarettes
and other combusted tobacco
products are rapidly eliminated.
In the current context cigarettes
are still widely marketed and
used.

Source
4, Major
Conclusion
#9
Ch. 16, p.
871
Ch. 15, p.
859

Ch. 15, p.
858
Conclusion 2
Ch. 16, p.
874
Ch. 16, p.
873

ENDS are being aggressively
promoted and use is increasing
rapidly among youth and adults.
Among youth and adults,
patterns of use of e-cigarettes
concurrently with cigarettes (i.e.
“dual use”) are being observed.

Ch. 15, p.
859
Ch. 14, p.
780
Ch. 13, p.
742

Supporting Statement(s)
dramatically reduce this burden.”

“It has been stated that ‘The cigarette is also a defective product, meaning not just dangerous
but unreasonably dangerous, killing half its long-term users. And addictive by design’ (Proctor
2013, p. i27).”
“The impact of the noncombustible aerosolized forms of nicotine delivery on population
health is much more likely to be beneficial in an environment where the appeal, accessibility,
promotion, and use of cigarettes and other combusted tobacco products are being rapidly
reduced especially among youth and young adults. For example, other end game strategies
which could involve greater restrictions on sales, particularly at the local level, could
significantly alter the strategic environment for tobacco control.”
“Evidence-based tobacco control interventions that are effective continue to be
underutilized.”
“The promotion of noncombustible products is much more likely to provide public health
benefits only in an environment where the appeal, accessibility, promotion, and use of
cigarettes and other combusted tobacco products are being rapidly reduced.”
“Even those who concur that the use of noncombustible tobacco products may not constitute
a large direct risk to individual health propose that a strategy based on their use would
increase total tobacco-related harm to health. Proponents of this position argue that the
availability of noncombustible products can have adverse consequences, especially under
current conditions with the widespread marketing and use of cigarettes.”
“A variety of unregulated noncombustible products with potential modified risk or reduced
harm are being developed and aggressively marketed.”
“…all three major cigarette manufacturers plan to have electronic cigarettes on the market
(Sizemore 2013).”
“During 2011–2012, data from the National Youth Tobacco Survey (NYTS) suggested a doubling
of electronic cigarette use among U.S. middle and high school students. Among all students in
grades 6–12, ever use of electronic cigarettes increased from 3.3% to 6.8% (Tables 13.17–
13.18); current electronic cigarette use increased from 1.1% to 2.1%, and current use of both
electronic-cigarettes and conventional cigarettes increased from 0.8% to 1.6%. […]In 2012,
among current electronic cigarette users, 76.3% reported current conventional cigarette
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Theme

Source
Ch. 13 p. 750

Evidence from the 2012 Surgeon
General’s Report, Preventing
Tobacco Use Among Youth and
Young Adults, indicates that
current tobacco industry
practices raise concerns.

Ch. 16, pp.
873-4

Ch. 14, p.
784

Ch. 15, p.
852

Supporting Statement(s)
smoking.”
“Although nationally representative surveillance data on [adult] awareness and use of
electronic cigarettes remains limited, all available data show rapid increases in recent years.
[…] Data from the HealthStyles Survey show that […] ever use of electronic cigarettes nearly
doubled among all adults during 2010–2011, from 3.3% to 6.2%. During the same period, the
prevalence of ever electronic cigarette use among current cigarette smokers increased from
9.8% to 21.2%, while the prevalence among former cigarette smokers increased from 2.5% to
7.4%. Prevalence remained unchanged among never cigarette smokers (1.3%).”
“Even those who concur that the use of noncombustible tobacco products may not constitute
a large direct risk to individual health propose that a strategy based on their use would
increase total tobacco-related harm to health. Proponents of this position argue that the
availability of noncombustible products can have adverse consequences, especially under
current conditions with the widespread marketing and use of cigarettes. These consequences
include (a) encouraging children to experiment with tobacco products (with the expectation
that a percentage of those who become regular users of noncombustible products will
graduate to smoking); (b) helping smokers maintain their addiction by using noncombustible
products in environments where they cannot smoke; (c) acting as a non-risk-free substitute for
cigarettes for smokers who otherwise would have quit; and (d) giving smokers an alternative
means of satisfying their addiction that may lead to higher levels of recidivism to smoking. The
evidence indicates that current industry practices raise concerns about all of these potential
adverse consequences (USDHHS 2012). One study found that transnational tobacco companies
promote less harmful tobacco products in order to maintain and extend the sales of cigarettes
and to create alternative forms of tobacco use among young people who are no longer
smoking (Peeters and Gilmore 2013).
“Many changes in tobacco product form and marketing have been documented as efforts by
the tobacco industry to contribute to tobacco use and addiction by fostering initiation among
young people; making products easier and more acceptable to use; making and marketing
products so as to address health concerns; and making and marketing products to perpetuate
addiction through the use of alternate products, when smoking is not allowed or is socially
unacceptable (Federal Register 1995, 1996; Kessler 2001; Philip Morris 449 F. Supp. 2d at 908;
WHO 2001, 2007, 2012b; USDHHS 2012).”
”The pace of social norm change could be slowed by […] the aggressive marketing and
promotions for electronic cigarette brands (U.S. House of Representatives 2013).”
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Theme
Claims that ENDS will lead
cigarette smokers to completely
quit smoking rest on several
unproven assumptions.

Source
Ch. 14, p.
780

Ch. 16, p.
873

Several FDA-approved
prescription and non-prescription
cessation products are available,
including nicotine replacement
therapies (NRT), and are safe
when used as directed.
Because of the harmful effects of
nicotine, evidence is already
sufficient to caution youth and
pregnant women about ENDS.
Evidence is needed on the health
effects of long-term exposure to
nicotine.

Ch. 5, p. 112

Ch. 5, p. 126,
Conclusion 5
Ch. 5, p. 126

Supporting Statement(s)
“The marketing claims for [electronic nicotine delivery systems] ENDS also vary widely and
have included claims of safety, use for smoking cessation, and statements that they are
exempt from clean air policies that restrict smoking (WHO 2009c; Cobb et al. 2010;
Henningfield and Zaatari 2010; American Legacy Foundation 2012; Cheah et al. 2012).”
“Currently, there are varying scenarios being discussed. In one scenario, noncombustible
tobacco products would be substituted for cigarette smoking among a subset of smokers
(people who otherwise would not quit smoking and thus are at high risk for smoking-caused
diseases). Proponents claim that such a switch would significantly reduce the burden of death
and disease attributable to smoking if smokers completely substituted combustible products
with noncombustible products. The perspective rests on the assumption that (a) noncombustible tobacco products, used alone, are far less dangerous to individual users than continued
smoking, a conclusion that appears correct based on current understanding (Levy et al. 2004;
USDHHS 2010b); (b) with proper marketing, differential taxation, and other carefully calibrated
policies, noncombustible products would be adopted as a complete substitute for smoking by
significant numbers of current smokers, a thus far unproven assumption; (c) smokers who
switched to noncombustible products otherwise would continue to smoke (as opposed to
quitting), another area with significant uncertainty; and (d) the net impact on health of all the
various outcomes, intended and unintended, would contribute meaningfully to tobacco harm
reduction, a proposition that has been explored only once in the literature (Mejia et al. 2010).”
“NRT medicines, which are designed to minimize addiction risk, carry a low risk of establishing
addiction, and are generally substantially easier to discontinue than tobacco products
(Henningfield et al. 2011; WHO 2012).”
“The evidence is suggestive that nicotine exposure during adolescence, a critical window for
brain development, may have lasting adverse consequences for brain development.”
“The evidence is already sufficient to provide appropriately cautious messages to pregnant
women and women of reproductive age as well as adolescents about the use of nicotinecontaining products such as smokeless tobacco and electronic cigarettes, and newer forms of
nicotine-containing tobacco products, as alternatives to smoking. All tobacco products contain
toxicants, so all tobacco product use poses some health risks. Because of the potential for fetal
and adolescent nicotine exposure to have long-term detrimental effects on brain
development, measures should be taken to ensure that nicotine is not perceived by the public
as a cognitive-enhancing substance. It also does not have an established role in the
management of people with a severe mental illness.”
Page 4 of 5

Theme

Source
Ch. 14, p.
780

Ch. 5, p. 126

Full implementation of FDA’s
authority for tobacco product
regulation is key to reducing
ENDS’ potential for harm to the
population.

ENDS—in combination with
rigorous surveillance and
aggressive strategies to end
combustible cigarette use—could
help complement “end game”
strategies by allowing nicotine
substitution.

Ch. 15, p.
859

Ch. 15, p.
852
Ch. 15, p.
855

Supporting Statement(s)
“Given the level of evidence linking tobacco product use to ill health, all products containing
tobacco and nicotine should be assumed to be both harmful and addictive, although the risk
from the use of tobacco products depends not only on the type of product but also on how
they are used (i.e., the actual doses of toxins that are taken in, and whether the product is
used in addition to other products, promotes initiation of tobacco use, or delays smoking
cessation) (WHO 2006, 2007).”
“The number of people exposed to nicotine long-term may grow under a number of potential
future scenarios; for example, expanding use of multiple products or the replacement of
conventional combustible cigarettes with other nicotine delivery systems […], or increased
appeal and uptake of nicotine product use because of their apparent relative safety in
comparison to cigarettes. In considering such scenarios, information will be needed on the
risks of long-term exposure to nicotine, including the consequences for reproductive health
and adolescent cognitive development, compared with cigarette smoking, and no tobacco
products use at all.”
“Availability of these products may reduce or increase harm to the population. New regulatory
actions described as end game strategies may offer tremendous opportunities to address
these challenges and transform approaches to ending the tobacco epidemic. In addition to a
product standard reducing the nicotine content to make cigarettes less addictive, FDA has the
authority to establish strict standards for levels of toxicants in tobacco products, as well as
standards to make some or all tobacco products less appealing.”
”The pace of social norm change could be slowed by […] the aggressive marketing and
promotions for electronic cigarette brands (U.S. House of Representatives 2013).”
“End game strategies might be aided by future approaches and devices for nicotine delivery
that better substitute for the cigarette. […]Warner (2013) suggests that the introduction and
marketing of new products like these could complement an end game strategy. However, the
potential risks of continuing the use of addictive levels of nicotine on the population would
need careful consideration (see Chapter 5, “Nicotine”) if users completely switch from
traditional (or conventional) combusted cigarettes to noncombusted products which continue
to deliver high levels of nicotine. Also, as noted in Chapter 13, given the rapid increase in
electronic cigarette use among both adults and adolescents, rigorous surveillance of these
products is particularly important, including their impact on the initiation and cessation of
conventional tobacco use and concurrent use with other conventional tobacco products. “

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