May 2019

ERS Position Paper on Tobacco Harm Reduction

Statement prepared by the ERS Tobacco Control Committee

What is harm reduction?

The International Harm Reduction Association, in line with the World Health Organization (WHO),
defines harm reduction as “policies, programs and practices that aim primarily to reduce the adverse
health, social and economic consequences of the use of psychoactive drugs without necessarily
reducing drug consumption”1 2. Harm reduction began to be discussed after the threat of HIV spreading
among drug users was first recognised. Harm reduction prioritises a public health perspective aiming
to stop or reduce immediate harms when at-risk individuals do not respond to treatment. The question
of long-term abstinence from drug use is either unaddressed or left open 3.

Why it is important to discuss harm reduction and what is meant by harm reduction in tobacco
control?
The epidemic of disease caused by smoking in the 20th century ranks among the greatest public health
catastrophes of the last century, and it has been estimated that smoking will kill around one billion
people in the 21st century 4. Smoking is not a lifestyle choice or a bad habit, but a chronic disorder 4.
Cigarettes are addictive, similarly to heroin and cocaine, and nicotine, a psychoactive substance, is the
primary agent of addiction 5. Changes in tobacco manufacturing have significantly increased the risk
of nicotine addiction among smokers 5.
A harm reduction strategy for smokers includes recommending the use of alternative nicotine delivery
products such as smokeless tobacco, e-cigarettes or new heated tobacco products to smokers instead
of conventional cigarettes, thus replacing a very harmful product with a less, but still, harmful product.
The concept is intuitive and attractive and therefore very tempting for smokers, health professionals
and politicians. Unfortunately, it is much more complex.
While opioid substitution therapies such as methadone are given only to those who are addicted and
at the highest risk and are administered by a health professional, the nicotine-containing alternatives
to smoking, such as e-cigarettes and heated tobacco, are mass-marketed consumer products. In most
countries they are easily accessible for the general population, including those who were never
addicted to nicotine. While the average prevalence of high-risk opioid use among adults is estimated at
0.4 % of the EU population 6 almost every fifth adult European is a smoker 7.

We present seven arguments for why a harm reduction strategy should not be used as a population-
based strategy in tobacco control.

1. The tobacco harm reduction strategy is based on incorrect claims that smokers cannot or
will not quit smoking
This premise is simply wrong – in reality the majority of smokers want to quit 8 9. A large European study
showed that only ten percent of smokers definitely did not want to stop 10. A high proportion of smokers
also dislike being nicotine dependent and want to quit smoking in order to “regain control of their life”
11 12
. Worldwide, millions of smokers have quit and most have stopped by will-power only 13, without
the use of nicotine replacement therapy (NRT) or any smoking cessation medication. Therefore,
14
regarding tobacco addiction, the main goal is to motivate and support tobacco users to quit .
Evidence-based tobacco dependence treatments exist and are safe and cost-effective. The goal is
cessation and relapse prevention to achieve long-term abstinence 15. Most nicotine-delivery products,
including heated tobacco and e-cigarettes, are devices of nicotine inhalation. This administration route
reaches the brain remarkably rapidly, resulting in a high risk of maintenance of addiction and posing
challenges to smoking cessation treatment 16.

In conclusion, the majority of smokers want to quit and a high proportion dislike being nicotine
dependent. Alternative nicotine containing products are highly addictive. Evidence-based tobacco
dependence treatment exists and is safe and cost-effective - we should not give up on smokers.

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 2. The tobacco harm reduction strategy is based on undocumented assumptions that alternative
nicotine delivery products are highly effective as a smoking cessation aid

Very few randomised trials have been conducted to test whether e-cigarettes are more effective than
established smoking cessation medication 17 18. A randomised controlled trial (RCT) from the United
Kingdom found that e-cigarettes were twice as effective as NRT after one year, when combined with
intensive smoking cessation counselling 17. However, 80% of ex-smokers continued to use e-cigarettes
after they quit conventional cigarettes, and of those who continued to smoke, at least 25% also used
e-cigarettes at the end of the study 17. Another RCT, aimed at smoking reduction, also found an effect
on smoking cessation. On the other hand, two large pragmatic (not clinic-based) randomised trials
comparing e-cigarettes to NRT 19 20 or pharmacotherapy 20 found no significant difference in six-month
abstinence rates 19 20. Furthermore, a meta-analysis of longitudinal studies on the effectiveness of e-
cigarettes also showed that while two clinical trials indicated beneficial effects of e-cigarettes on
smoking cessation rates, 14 out of 15 longitudinal real-life studies showed that use of e-cigarettes
significantly undermined abstinence 21. It seems that the effect depends on whether e-cigarettes are
used in a clinical setting combined with professional advice, or in a “real-life” setting. The same has
22 23
been observed with NRT: high-quality evidence from RCTs and smoking cessation clinics exists,
which shows that all forms of NRT increase smoking cessation rates, whereas the use of NRT bought
over-the-counter is associated with significantly lower odds of abstinence than no use of smoking
cessation medication 23.
A prospective study, based on a sample of the general population in the United Kingdom, found that
daily use of e-cigarettes while smoking appears to be associated with subsequent increases in rates of
attempting to stop smoking and reducing smoking, but not with smoking cessation 24. This finding is
mirrored in other prospective studies of smokers’ use of e-cigarettes 25 21 26 27 28. The reason could be
that e-cigarettes are promoted as being “safe” and therefore a means to enjoy nicotine anywhere,
which could discourage cessation.

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Some argue that alternative nicotine containing products are a much better smoking cessation aid than
no aid. A large representative population-based study showed that e-cigarettes users were less likely
to report abstinence than users of established quitting methods and that they were not more likely to
report abstinence than those using no aid 29.
E-cigarettes only seem to be effective in a clinical setting combined with repeated counselling; however,
less than 5% of all smokers in the United Kingdom and approximately 1% of smokers in Denmark (two
countries with well-developed and free-of-charge smoking cessation services) use the national smoking
30 31
cessation services . In many parts of the world professional guidance is even less prevalent,
indicating that there will be no effect, or a negative effect, on smoking cessation. Even though some
smokers who use e-cigarettes may not go to cessation clinics, it does not seem that this would result in
more smokers quitting.
Few randomised trials have tested long-term efficacy of smokeless tobacco as a smoking cessation tool
32 33 34
and they have shown no effect; one tobacco company actually abstained from publishing the
results of a negative randomised trial of snus due to very low quit rates 35. No independent studies
have tested the effect of heated tobacco on long-term smoking cessation, and two major manufacturers
of e-cigarettes and heated tobacco state that their product is not intended for smoking cessation 36 37.
In conclusion, there is lack of evidence proving the effect of alternative nicotine delivery products as
effective smoking cessation tools. In a real-life setting, use seems to undermine smoking cessation
instead.

3. The tobacco harm reduction strategy is based on incorrect assumptions that smokers will
replace conventional cigarettes with alternative nicotine delivery products

A majority of e-cigarette users (typically 60-80%) continue to smoke 38 39 40 41 42 43 and there may not
be a significant reduction in their consumption of conventional cigarettes 44 45 46. It is claimed that
dual use of conventional and e-cigarettes is just a short transition period. However, it seems that even
though dual users are more likely to try to quit cigarettes in the general population, they are no more
likely to become completely abstinent of cigarettes or other tobacco products in the longer term 47. A

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large population-based study from the United Kingdom concluded that: “If use of e-cigarettes while
smoking acted to reduce cigarette consumption in England between 2006 and 2016, the effect was
likely very small at a population level” 48. There is little evidence for health effects of dual use of e-
and conventional cigarettes. One study found that dual use was not associated with a reduction in
carcinogen or toxin levels 49, while another large study found that toxicant exposure was higher (10%
to 36%) among dual users than among smokers of conventional cigarettes only 43. Dual use is also
very frequent in smokeless tobacco users 42 50.
We have limited evidence on heated tobacco products, but an independent study found that all current
51
users continued to use cigarettes . In a study among young Korean adults, all users of heated tobacco
stated to be triple users of both conventional cigarettes, e-cigarettes and heated tobacco 51. The effects
of this cocktail are unknown. Also, alternative nicotine delivery products are very different from
conventional cigarettes and might generate unique toxicant exposures or exposures to toxicants not
presently designated as harmful, such as those associated with e-cigarette flavourings.

In conclusion, most persons use alternative nicotine delivery products as a supplement to conventional
cigarettes, not as an alternative to smoking. Therefore, there will be no health benefit for the majority
of smokers, and for some there might even be an increased risk of harm.

4. The tobacco harm reduction strategy is based on undocumented assumptions that

alternative nicotine delivery products are generally harmless

Conventional cigarettes have devastating health consequences; therefore, all products we compare it
with will be less harmful. Less harmful, however, is not the same as harmless. Using only e-cigarettes
instead of combustible cigarettes will probably reduce users’ exposure to toxicants 52, but a reduction
in exposure to toxicants does not necessarily lead to significant reduction in harm in humans. Evidence
supports a significant effect of very low dose combustible tobacco smoke exposure (i.e. a few cigarettes
per day or occasional use) in causing ischemic heart disease 53; there is a non-linear dose-response and

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 54
the excess risk in smokers of only five cigarettes per day is about 50% . Reducing smoking-related
health risks requires complete cessation. Moreover, in relation to tobacco use, long-term follow-up of
smokers provides no evidence that heavy smokers who cut down their daily cigarette consumption
reduce their risk of premature death significantly 55 56. There is no safe use of tobacco.
We have considerable evidence that e-cigarette aerosols contain metals, that aerosols can induce
acute endothelial cell dysfunction and promote formation of reactive oxidative stress/inflammation,
and that chemicals present in aerosols are capable of causing DNA damage and mutagenesis 52. In vivo
experiments as well as animal studies demonstrate airway inflammation and remodelling/scarring 57
58 59 60 61
and impairments in lung function 62 63. Exposure to e-cigarette fluid promoted respiratory
viral infection 64 and bacteria became more virulent when exposed to e-cigarette vapour 60. Human
experiments have shown airway obstruction65 and dysregulation in normal human lung homeostasis
after short-term inhalation 66. In addition, there is moderate evidence from population based studies
for increased cough and wheeze in adolescents and an increase in asthma exacerbations 52, even
when only exposed to second-hand vapour from e-cigarettes 67. Thus, most independent studies
indicate potential harm 68 69 52, but evidence is so far limited and we have no evidence on the long-
term health effects of using e-cigarettes.
There is some evidence on the long-term use of smokeless tobacco, which shows an increased risk of
fatal myocardial infarction among users, and the increase in risk has been calculated to be highest in
the European region, based on the use of Swedish moist snuff/snus 70. All smokeless tobacco products
71
contain carcinogenic tobacco-specific nitrosamines, though the levels differ between products .
72 73
Smokeless tobacco is responsible for a large number of cancer deaths worldwide , while the
evidence of risk of cancer due to use of Swedish moist snuff/snus is inconclusive 74 75 76 77 78-80 71.
We have very little knowledge of the health effects of heated tobacco devices and most studies have
been performed by the tobacco industry. Industry animal data showed pulmonary inflammation 81
and human data showed no improvement of lung function after switching from combustible to
heated tobacco 82. The tobacco industry’s own data also fail to show a consistently lower risk of harm
in humans using a heated tobacco product instead of a conventional cigarette 82. Independent
researchers found that heated tobacco products, in a manner very similar to cigarette smoke, have

6
the potential to increase oxidative stress and inflammation, infections, airway remodelling, and
initiate other changes in the airways of users of these devices related to chronic lung disease 59. Other
independent studies have shown that harmful substances are not reduced by 95%, as often claimed
by the tobacco industry 83 84 85, and in fact the concentrations of some harmful constituents were
instead found to be higher. A combination of animal and human data indicate potential liver injury 86
and lung injury 87.
As studies with a conflict of interest find no harm significantly more often than studies without a conflict
of interest 68, it is important that more independent high-quality studies are conducted.

In conclusion, there is no evidence that alternative nicotine delivery products are safe – on the
contrary, many studies have documented adverse health effects and the uncertainty seems to be
around the degree of harm rather than the presence of harm related to these products.

5. Alternative nicotine delivery products can have a negative impact on public health even if
“stick-by-stick” they turn out to be less harmful than conventional cigarettes

The harm reduction strategy focuses strictly on smokers, but smokers are a minority in the population.
The impact of use of alternative nicotine delivery products on the non-smoking majority of the
population, the never- and ex-smokers, must be considered – as well as the potential risk of re-
normalisation of smoking in society. Even though the long-term impact of alternative nicotine delivery
88 89 90
products on population health is hard to predict , widespread promotion may have a range of
negative population-level health effects 91.
A quarter of young e-cigarette users in Australia have never smoked 17. E-cigarettes with candy or fruit
flavours strongly appeal to children and adolescents 92 and have appealed to youth at low risk of taking
up smoking 93. Some parts of the world have seen a significant spread of e-cigarettes amongst youth 94
95 17
. The Food and Drug Administration (FDA) Commissioner stated that the United States are
experiencing epidemic-level rises in youth e-cigarette use 96. It is also important to note that use of e-

7
cigarettes does not prevent smoking. On the contrary, there is substantial evidence that adolescents’
e-cigarette use increases their risk of smoking initiation of conventional cigarettes 52 97 98.
A repeated face-to-face survey on smoking in a representative sample of the Italian general population
showed that among e-cigarette users, those (re)starting smoking after using e-cigarettes outnumbered
those who stopped smoking after using e-cigarettes 99. Among ever users, 13% stopped smoking after
trying e-cigarettes while 22% started smoking or relapsed after using e-cigarettes. The corresponding
estimates among regular users were 25% and 28%, respectively 99.

Longitudinal studies indicate that use of smokeless tobacco, like e-cigarette use, does not prevent later
smoking but on the contrary increases the likelihood of smoking initiation 100 101 102. A large longitudinal
study showed that use of snus/snuff had no beneficial effect on cessation, reduction or prevention of
101
smoking initiation among young men in Switzerland . Longitudinal studies from the United States
indicate that switching behaviours from smoking to smokeless tobacco use is very uncommon, while it
103
is very common to switch from smokeless tobacco to smoking (in up to every fourth user) . The
tobacco industry always highlights Sweden as a role model in harm reduction: as the country has very
low smoking prevalence, a high prevalence of snus use, and lung cancer rates of half or a third of that
of other European countries. Elements that are “overlooked” by the tobacco industry includes that
Sweden already had much lower lung cancer rates in the 1950s-1970s prior to the increase in men’s
use of snus; that Swedish women’s smoking prevalence has decreased without use of snus; and that an
increasing proportion of snus/snuff users are never-smokers 104. In the United States, high prevalence
of snuff use has been found in states with high smoking prevalence 105. Thus, there is no indication that
smokeless tobacco is an effective way to decrease smoking at a population level.
In Italy, nearly half of users of heated tobacco and over half of the people interested in heated
tobacco are never smokers 106. The smart design and the claims of being a generally harmless product
most likely appeals to adolescents and young adult smokers, as well as non-smokers.

In conclusion, when evaluating the pros and cons of alternative nicotine delivery products we must
consider their impact on the whole population, not only on the smokers, who are a minority. From a

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public health point of view, these products may have an unfavourable net effect, especially because
of increasing uptake by never smokers. There is substantial evidence that youths’ use of alternative
nicotine containing products increases their risk of future smoking.

6. Smokers see alternative nicotine delivery products as a viable alternative to the use of
evidence based smoking cessation services and smoking cessation pharmacotherapy

Effective evidence based smoking cessation medication and services exist and are effective 107 108. A
large survey in 28 countries in the European Union showed that the use of e-cigarettes for smoking
cessation assistance had increased in the last five years, while the use of pharmacotherapy (including
109
NRT) and of smoking cessation services had simultaneously declined . In the United Kingdom, the
number of smokers making a quit attempt using the NHS smoking cessation services has decreased by
66% in the last six years 30, and while e-cigarette use for harm reduction (not cessation) has increased,
NRT use among smokers has decreased 110. Trends might be independent, but we cannot rule out that
e-cigarettes have displaced the use of evidence-based smoking cessation services and medically tested
pharmacotherapy. We have no information on the impact of smokeless tobacco and heated tobacco on
the use of smoking cessation services and medically tested pharmacotherapy.

In conclusion, a decrease in use of smoking cessation services and medically tested pharmacotherapy
has been observed in parallel with an increase in the use of e-cigarettes, indicating that alternative
nicotine containing products may be replacing evidence based, effective smoking cessation tools.

7. The tobacco harm reduction strategy is based on incorrect claims that we cannot curb the
tobacco epidemic

Many effective strategies exist to reduce smoking at a population level 111 8. The decline of smoking due
to tobacco control measures is surely one of public health’s greatest successes 5. Countries with strong

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tobacco control (i.e. high prices on tobacco, plain packaging, point of sale display ban, strong
enforcement of minimum age of purchase, comprehensive marketing bans, intensive anti-smoking
campaigns, free national smoking cessation services) have experienced impressive and rapid declines
in smoking prevalence. Daily smoking prevalence between 10-12% is a reality in countries with
previously high smoking rates, for example Norway, Sweden, Canada, Brazil, Hong Kong and the state
112
of California. In countries with weak tobacco control, such as Denmark , a stagnation in smoking
prevalence has been reported for many years. In France one million smokers have quit in a single year
due to improved tobacco control (higher cigarette pricing, plain packaging, campaigns, national
tobacco-free month and a dedicated national smoking reduction programme), and a decline in smoking
among teenagers and those on low incomes has also been observed 113.

In conclusion, tobacco control is one of public health’s greatest successes and countries with strong
tobacco control have experienced impressive declines in smoking prevalence. We know what works.
We need brave leaders to implement the evidence-based effective methods.

Alternative nicotine delivery products are the tobacco industry’s adaptation to declining tobacco
consumption and acceptability of smoking, and increased regulation of cigarettes

It must be acknowledged that many health professionals, tobacco control professionals and decision
makers who recommend the harm reduction strategy have very good intentions. They see harm
reduction as a pragmatic way of reducing the devastating health effects of the tobacco epidemic.
However, good intentions must always be supported by strong evidence before a large-scale
implementation. We have seen catastrophic consequences when this is ignored 114. Evidence on the
safety and the effectiveness of alternative nicotine delivery products as a smoking cessation tool is
still lacking, while use of nicotine containing products is spreading to non-smokers, which is very
alarming. Harm reduction in tobacco control should be reserved for a minority of high-risk smokers; it
is not a population-based strategy.

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Another fact that cannot be ignored is that alternative nicotine delivery products are primarily
manufactured by the tobacco industry, and the tobacco industry has a strong economic interest in
spreading these products to as many individuals as possible - smokers as well as non-smokers. The
tobacco industry has manufactured so called “safer” tobacco products (i.e. filter, light, mild, ultra-light,
low tar cigarettes etc.) since the 1950s. Publicly available internal tobacco industry documents show
that the tobacco companies have attempted to deter smokers from quitting by developing products
that appeared to be less harmful, less addictive or more socially acceptable: “Quitters may be
discouraged from quitting, or at least kept in the market longer… The safe cigarette would have wide
115
appeal, limited mainly by the social pressures to quit.” . The industry had knowledge that such
products had no health advantage 116. Further, even though a tobacco industry scientist warned that:
“The effect of switching to a low tar cigarette may be to increase, not decrease, the risks of smoking”
117
, the tobacco industry still launched and marketed the product as being much safer. The industry also
had knowledge that such products did not help smokers to quit 116. It is very naïve to believe that the
tobacco industry has changed since then.
After the launch of their heated tobacco products, a major tobacco company last year announced that
they plan to phase out the manufacturing of cigarettes and move into other smoke-free products 118.
The tobacco industry is attempting to rehabilitate its reputation, to appear as responsible members of
society and as a part of the solution, so that they can more effectively influence decision makers.
Internal industry documents show that the tobacco companies have no intention to stop manufacturing
conventional cigarettes, as they claim 119. On the contrary, they are using vast resources against efforts
120
to reduce conventional smoking and to expand the sale of conventional cigarettes in low income
countries 119 121
.

Many smokers are tempted by alternative nicotine containing products. Instead of seeking
professional assistance to quit in a smoking cessation service, they switch to one of these so-called
safer products, in the belief that these are safe. When a person quits smoking completely (but not
partially) he or she will experience many health benefits, as there is no longer any exposure to
harmful substances. Smokers who switch to alternative products will still have a long-term exposure

11
to toxic and carcinogenic substances. Although reduced, this continued exposure to toxicants is a bad
alternative to quitting smoking.

What does ERS recommend?

The tobacco harm reduction strategy is based on well-meaning but incorrect or undocumented claims
or assumptions. Emergent tobacco and nicotine delivery devices with alleged harm reduction
potential are examples of inadequate harm reduction approaches. In her keynote speech at the
opening of the eighth session of the Conference of the Parties (COP8), Vera Luiza da Costa, Head of
the World Health Organization’s Framework Convention on Tobacco Control (WHO FCTC) Secretariat
stated on new emerging products: “Parties should expedite implementation of article 5.3 Guidelines
and ensure that it’s applicable to all commercial and vested interests of the tobacco industry,
including addressing unproven claims of harm reduction” 122. Almost 40 countries have already
banned e-cigarettes and/or nicotine e-liquid.

The Hippocratic Oath requires a physician to swear to uphold specific ethical standards and “first do no
harm”. The human lungs are created to breathe clean air, not “reduced levels of toxins and
carcinogens”, and the human body is not meant to be dependent on addictive drug. ERS cannot
recommend any product that is damaging to the lungs and human health. Therefore, ERS strongly
supports implementation of WHO’s FCTC, and cannot recommend tobacco harm reduction as a
population-based strategy.

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