Sundhedsudvalget 2020-21
L 61 Bilag 2
Offentligt
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21
st
of August 2020
Dear Magnus Heunicke, Minister for Health and the Elderly,
European Tobacco Harm Reduction Advocates (ETHRA) is a group of 21 consumer
associations in 16 European countries, representing approximately 27 million consumers
1
across Europe and supported by scientific experts in the field of tobacco control or nicotine
research. We are mostly ex-smokers who have used safer nicotine products, such as vapes
and snus, to quit smoking and to remain smoke free. ETHRA is not funded by the tobacco or
vaping industry, in fact we are not funded at all as our grouping is a voice for our partners
who arrange their own revenue and who give their time to ETHRA for free. Our mission is to
give consumers of safer nicotine products a voice and to ensure that the full harm reduction
potential of safer nicotine products is not hindered by inappropriate regulation.
Dansk e-Damper Forening (DADAFO),
the Danish consumer organisation, is a partner for
ETHRA and DADAFO’s chairman Kim Dabelstein Petersen and treasurer Peter Stigaard
have signed this letter on behalf of all of us. ETHRA is listed in the EU Transparency
Register at: 354946837243-73 and DADAFO is listed at: 220201831871-76.
We are writing today to comment on the
Bill amending the Act on the ban on tobacco
advertising etc
2
with regards to its provisions for safer nicotine products, to outline why these
measures are detrimental to public health. We are also submitting this as a contribution to
the TRIS notification for the Bill: 2020/0228/DK.
We are concerned that the Bill will deny Denmark’s 786.000 adult smokers a route away
from the deadly combustible cigarette and will also make it very difficult for Denmark’s
250.000 vapers to remain smoke free.
Several provisions in the Bill seek to regulate safer nicotine products as strictly as
combustible tobacco products, despite the huge difference in risks to health. The ban on
flavourings, the display ban, the stricter ban on advertising and sponsorship, the introduction
of standardised packaging and various measures which will make vaping more expensive
will prevent adults from switching to safer alternatives and so will prolong smoking.
Main points in this letter:
1.
The disproportionate focus on youth will lead to unintended consequences for
adults.
2.
Regular youth vaping is rare and youth experimentation with safer nicotine
products does not result in increased youth smoking
3.
Flavours are crucial for winning smokers over to safer products
4.
Combustion is the problem, not nicotine
5.
Smokers have a right to accurate information about safer products.
6.
Making safer products more expensive will deter smokers from switching
Estimate of 27 million consumers provided by ECigIntelligence/TobaccoIntelligence. The actual figure is likely to
be far higher because the data for smokeless tobacco is taken from research (Leon et al 2016) using data
gathered in 2010 in only 17 countries.
1
Bill amending the Act on the ban on tobacco advertising etc., Act on tobacco products etc., Act on electronic
cigarettes etc. and various other acts (Implementation of the national action plan against smoking by children and
young people) TRIS notification detail [access]
2
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1. The disproportionate focus on youth will lead to unintended consequences for
adults
It has long been known that “people smoke for the nicotine and die from the tar”
3
. The
harms from smoking are caused by combustion - the method of delivery used to get nicotine
- and not by nicotine itself. Nicotine in regulated safer nicotine products is not harmful: the
risk profile for vaping nicotine in e-liquids is similar to that of drinking coffee
4
. Safer nicotine
products do not involve combustion and so avoid most of the harms associated with
smoking. Popular safer nicotine products include vapes, snus, nicotine pouches (included
as “tobacco substitutes” in the Bill) and heated tobacco products. “Tobacco harm reduction”
refers to use of these products by people like us, smokers and former smokers who wish to
reduce their exposure to the harms of smoking.
Quitting smoking can be very difficult and relapse to smoking is common: for many smokers
it can take up to 30 quit attempts before being successful
5
. This is why it is imperative that
all smoking cessation options are available to smokers. Safer nicotine products have the
potential to reach more smokers if they are widely available as a consumer product.
Safer nicotine products are effective. Vaping has been shown to be 83% more effective than
nicotine replacement therapy (NRT) for smoking cessation
6
and has successfully displaced
smoking in countries where it is widely available
7
Snus is a pasteurised smokeless tobacco
product that has been used in Scandinavia for centuries. Snus has replaced smoking at such
an extraordinary rate in Sweden, Norway and Iceland that these countries are now close to
the point of being smoke free (having a smoking prevalence of 5% or lower). Swedish snus
is far less risky to health than smoking. This has been recognised by the US FDA which
granted Modified Risk Orders to snus products in October 2019
8
. The Global Burden of
Disease Study summarises the health risks of snus as follows:
9
Based on available evidence, for chewing tobacco Risk Ratios were significantly
higher than one for oral cancer and oesophageal cancer, while for snus or snuff we
did not find sufficient evidence of a Risk Ratio greater than one for any health
outcome.”
3
4
5
Tobacco harm reduction, Wikipedia [access]
Britton J. E-cigarettes and the precautionary principle. BMJ Opinion. 20 Sept 2019 [access]
Chaiton M, Diemert L, Cohen JE, et al. Estimating the number of quit attempts it takes to quit smoking
successfully in a longitudinal cohort of smokers. BMJ Open. 2016;6: e011045n[access]
6
Hajek P, Phillips-Waller A, Przulj D, et al. A Randomized Trial of E-Cigarettes versus Nicotine-Replacement
Therapy. N Engl J Med. 2019;380(7):629-637. doi:10.1056/NEJMoa1808779 [access]
Interview on Tobacco Products Directive: notes by ETHRA, pps 8-9 Impact of e-cigarettes on smoking
cessation [access]
7
8
9
FDA Authorizes Modified Risk Tobacco Products, FDA website accessed 18 August 2020 [
access
]
Gakidou E, Afshin A, Abajobir AA, Abate KH, Abbafati C, Abbas KM, et al. A systematic analysis for the Global
Burden of Disease Study 2016. Lancet. 2017 Sep 16;390(10100):1345–422. [access]
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Like snus, vaping products have also been shown to be far safer than smoking. The Royal
College of Physicians stated in its 2016 report Nicotine Without Smoke
10
that
“the available data suggest that they are unlikely to exceed 5% of those associated
with smoked tobacco products, and may well be substantially lower than this figure”.
(Section 5.5 page 87).
Regulations for safer products should therefore be based on risk in relation to combustible
cigarettes, not according to whether products contain nicotine or tobacco. Inappropriate
regulations that make safer nicotine products (SNPs) less desirable to adults, more
inconvenient or expensive to use, and increase misperceptions of harm can themselves
cause harm by deterring smokers from switching – and so prolong smoking.
The Royal College of Physicians in the UK warned that making vaping products harder to
access results in increased smoking:
“However, if [a risk-averse, precautionary] approach also makes e-cigarettes less
easily accessible, less palatable or acceptable, more expensive, less consumer
friendly or pharmacologically less effective, or inhibits innovation and development of
new and improved products, then it causes harm by perpetuating smoking.”
11
(Section 12.10 page 187).
We regret that the Bill will do all these things and so deny Denmark’s 780,000 smokers and
250,000 vapers the right to improve their own health.
2. Regular youth vaping is rare and youth experimentation with safer nicotine
products does not result in increased youth smoking
The key intention for the Bill is to “reduce the number of smokers, particularly for fewer
young people to start smoking or become addicted to other nicotine products”
12
. However,
there is no evidence that youth vaping gives rise to youth smoking.
In the United States, more detailed analysis of the headline numbers driving the concern
about youth vaping
13
shows that most adolescent vaping is infrequent and by far the majority
of frequent adolescent e-cigarette users had previously smoked. For them, the uptake of
vaping may be beneficial if it forms a short- or long-term diversion from smoking. The data
suggest that despite the sharp rise in youth vaping, it is not adding substantially to overall
nicotine dependence:
10
11
Royal College of Physicians (London). Nicotine without smoke: tobacco harm reduction. April 2016 [access]
Royal College of Physicians (London). Nicotine without smoke: tobacco harm reduction. April 2016.
Section
12.10 page 187
[access]
12
See Impact Assessment [access]
West R, Brown J, Jarvis M. Epidemic of youth nicotine addiction? What does the National Youth Tobacco
Survey reveal about high school e-cigarette use in the USA? (Preprint). Qeios. 2019 Oct
7;
https://www.qeios.com/read/745076.3
13
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"Data from the NYTS [US National Youth Tobacco Survey] do not support claims of a
new epidemic of nicotine addiction stemming from use of e-cigarettes, nor concerns
that declines in youth tobacco addiction stand to be reversed after years of progress.
Among current e-cigarette users who had never tried tobacco products, responses
consistently pointed to minimal dependence."
While any teenage use of nicotine is undesirable, infrequent vaping is among the least
concerning of youth risk behaviours when compared, for example, to smoking, illicit drug
use, teenage pregnancy, binge drinking, or drink-driving or to the other problems that afflict
young people, such as bullying, or mental health problems.
Here are some findings from countries where - as in Denmark - the EU Tobacco Products
Directive applies:
Belgium: The 2018 Health Survey
14
on the use of electronic cigarettes concludes that the
majority of experimenting with electronic cigarettes by youth (15 to 24 years old) does not
seem to lead to regular use and that daily use is relatively low (0,6%). In the overall
population 90% of vapers used to smoke cigarettes.
France: The OFDT monitoring of high school students
15
shows that daily smoking dropped
from 23.2% in 2015 to 17.5% in 2018, while almost daily vaping reached 2.8% in 2018.
Using this data a study examined specifically if vaping among adolescents is associated with
subsequent smoking initiation:
“Among ever-smokers, adolescents who declared having
ever used e-cigarettes were less likely than those who did not to transition to daily smoking
at 17. We found similar results for those who experimented with e-cigarettes before initiating
smoking”,
concluded the researchers.
UK: Data from the 2019 ASH YouGov Smokefree youth GB survey
16
suggest that while
some young people, particularly those who have tried smoking, experiment with e-cigarettes,
regular use remains low. Regular use of e-cigarettes remains largely confined to current or
ex-smokers. Not a single never smoker reported vaping daily and only 0.1% vaped more
than once a week. We would like to note here that the UK has restricted sales of vaping
products to over-18’s since 2018, which could be a factor in the low youth vaping
prevalence.
Ireland: Youth smoking in Ireland has fallen to 5.9%.
17
There is no official data for youth
vaping rates in Ireland but the Healthy Ireland survey participants are from 15 years up.
14
15
Sciencsano (Belgium). 2018 Health Interview Survey on the use of electronic cigarettes [access][PDF]
S. Chyderiotis, T. Benmarhnia, F. Beck, S. Spilka, S. Legleye. Does e-cigarette experimentation increase the
transition to daily smoking among young ever-smokers in France? Drug and Alcohol Dependence. 208 (2020).
Article 107853, 10.1016/j.drugalcdep.2020.107853 [access]
Action on Smoking and Health (UK). Use of e-cigarettes among young people in Great Britain. 2019 [access]
16
17
Health Service Executive (Ireland). Youth Smoking in Ireland: A special analysis of the Health Behaviour in
School-aged Children (HBSC) study. 2018 [access]
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Healthy Ireland 2019 data finds that never smokers that vape is 1% and has been
consistently <1% since the survey started in 2015.
The available data show that in Denmark too young people are not very interested in vaping
and that youth smoking rates are low:
Denmark: The Survey of School Children 2014
18
found that 19.75% of 11 to 15-year olds
had experimented with vaping (ever use). In 2018 that figure had fallen to 11%
19
. The same
surveys found that the percentage of youths that were ‘ever smokers’ was 14.3% in 2014
and 12.8% in 2018. Daily youth smoking has remained very low at 2.66% (2014) and 2.83%
(2018). Daily vaping prevalence for 15 to 29-year olds is 2% according to data in Danish
people’s smoking habits 2019. Daily smoking prevalence for the same age group is 13%.
There is a real danger that focusing on youth use, without taking into account falling smoking
rates or factoring in that the majority of young adults using safer nicotine products are
already smokers, will lead to unnecessary overregulation that will be harmful to adult
consumers of safer nicotine products. The main risk factor for a young person to become a
smoker is whether family and friends smoke
20
. Making it easier for parents to stop smoking
prevents their children from becoming smokers.
We appreciate that there are concerns about youth initiation but there is no evidence that
non-smoking young people are becoming dependent on vaping nor that vaping is leading to
young people smoking.
3. Flavours are crucial to winning smokers over to safer products
The Bill seeks to restrict e-liquid flavours, only tobacco and menthol flavours will remain on
the market. The rationale given is that flavours “may entice children and young people into
using tobacco products and electronic cigarettes”. However, the evidence shows that
flavours are not associated with youth smoking initiation but that flavours are essential for
drawing adult smokers away from combustible cigarettes.
Vaping is successful at helping adult smokers - like so many of us - to quit. This is borne out
by data from Belgium, France, Ireland and the UK
21
. Having a wide variety of flavours is
intrinsic to the success of vaping products: the ability to tailor vaping to individual tastes
plays a very important role in its effectiveness at drawing people away from smoking. The
evidence in this area is clear, showing that whilst many people start vaping with a tobacco
18
19
Syddansk Universitet. Skolebørnsundersøgelsen 2014 [access]
Sundhedsstyrelsen. Danskernes rygevaner 2019 [access]
20
Leonardi-Bee J, Jere ML, Britton J. Exposure to parental and sibling smoking and the risk of smoking uptake in
childhood and adolescence: a systematic review and meta-analysis. Thorax 2011;66:847-855 [access]
Interview on Tobacco Products Directive: notes by ETHRA, pps 8-9 Impact of e-cigarettes on smoking
cessation [access]
21
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flavour, over time they gravitate towards fruit, dessert and sweet flavours
22
.
A recent study published in JAMA
23
concludes that
“adults who began vaping non-tobacco
flavored e-cigarettes were more likely to quit smoking than those who vaped tobacco
flavors.”
The same study also found that flavours are not associated with youth smoking
initiation: “Relative
to vaping tobacco flavors, vaping non tobacco-flavored e-cigarettes was
not associated with increased youth smoking initiation but was associated with an increase
in the odds of adult smoking cessation.”
Banning or restricting flavours will have a disastrous effect on smoking cessation, effectively
removing the products responsible for huge reductions in smoking prevalence from the
market. Non tobacco flavours help to disassociate smokers from the taste of tobacco and so
lessen the chances of relapse to smoking. 77% of Danish vapers use non tobacco flavours,
will these people go back to smoking when their flavours disappear from the legal market?
24
The added danger with limiting or banning flavours is that consumers are then forced to use
the grey market to obtain the product they need. This was the experience in Estonia, where
a flavour ban and high taxation led to an explosion of grey-market products, reported to
account for 62-80% of all sales
25
. In response, Estonia has recently amended its legislation.
States in the USA that have banned flavours have also seen thriving grey markets develop
as ex-smokers seek out the only products that have successfully kept them smoke free.
Black market sales of flavoured vaping products are reported
26
to be a regular occurrence in
car parks around Long Island New York. Prohibition hasn’t eliminated the product; it has
simply driven it underground and criminalised those whose only crime is wanting to remain
free from cigarette smoking.
There are also health risks associated with banning flavours, as consumers turn to
unregulated products or mix their own e-liquids with food flavourings not suited for vaping.
Oil based flavours in particular could present a significant health hazard. Inexperienced
vapers driven to mix their own flavoured liquids may not be aware that e-liquid flavourings
are water soluble, and in their desperation could add oil-based food flavourings to their
liquids, without realising the inherent danger this poses.
A study
27
looking at the impacts of a flavour ban in California found that while flavour bans
may reduce overall use of vapour products, they also may increase cigarette smoking.
22
Russell C, McKeganey N, Dickson T, Nides M. Changing patterns of first e-cigarette flavor used and current
flavors used by 20,836 adult frequent e-cigarette users in the USA.
Harm Reduct J.
2018 Jun 28;15(1):33
[access]
Friedman AS, Xu SQ. Associations of Flavored e-Cigarette Uptake With Subsequent Smoking Initiation and
Cessation. JAMA Netw open. 2020 Jun 1;3(6): e203826. [access]
23
24
25
Sundhedsstyrelsen. Danskernes rygevaner 2019 [access]
Baltic Times. Estonian FinMin looking into prospect of lowering excise duty for e-cigarettes. 25 Nov 2019
[access]
26
27
Filter. Vape Bans Are Creating a Thriving Illicit Market. 8 July 2020 [access]
Yang Y, Lindblom EN, Salloum RG, Ward KD. The impact of a comprehensive tobacco product flavor ban in
San Francisco among young adults. Addict Behav Rep. 2020 Apr 1;11:100273
[access]
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Comparing before and after the ban, cigarette smoking increased in 18 to 24-year olds from
27.4% to 37.1%.
4. Combustion is the problem, not nicotine
We are concerned by the Danish Ministry of Health’s assertion that nicotine is highly
addictive, and that nicotine can affect the further development of immature brains. In fact,
use of e-cigarettes appears to be consistently associated with lower nicotine dependence
than cigarette smoking
28
and there are no reports of people getting addicted to nicotine
replacement therapies. We would be very interested in seeing the evidence behind the
claim that nicotine affects human adolescent brain development, as to our knowledge no
such evidence exists.
5. Smokers have a right to accurate information about safer products
Safer nicotine products are effective at helping adults to quit smoking, but it is crucial that
smokers are aware of safer products and that accurate information on these safer
alternatives to smoking is made accessible to them. It is particularly important that smokers
are aware that non-combustible products are far less dangerous to health and that they
would benefit from switching. The Bill’s provisions with regards to restricting
communications around safer products - standardised packaging, display restrictions and
health warnings - are therefore very concerning to us.
The Tobacco Products Directive (TPD) mandates warnings to be placed on vaping products
and the Bill seeks to apply those products to nicotine pouches too. The TPD mandated
warnings are excessive and deter smokers from using safer products. The prominence
(size, placement, colour and typeface) and the alarming wording suggest far greater risk
than there is. The warnings are similar in style to those used on cigarettes, yet the risk, if
any, is a small fraction of the risk of smoking. This tilts perceptions in favour of the more
dangerous products. The warnings about nicotine have the effect of reinforcing the
widespread misunderstanding that it is nicotine, not smoke, that is the most significant cause
of harm. E-cigarettes and nicotine pouches only represent a fraction of the risk of
combustible tobacco products and the warning labels should reflect this difference in risk.
Public Health England’s 2018 evidence review
29
found that
“vaping is a fraction of the risk of smoking, at least 95% less harmful, and of
negligible risk to bystanders. Yet over half of smokers either falsely believe that
vaping is as harmful as smoking or just don’t know”.
28
Shiffman S, Sembower MA. Dependence on e-cigarettes and cigarettes in a cross-sectional study of US adults
[published online ahead of print, 2020 Mar 20].
Addiction.
2020;10.1111/add.15060 [access]
Public Health England. Evidence review of e-cigarettes and heated tobacco products 2018. A report
commissioned by Public Health England. February 2018 [access]
29
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Safer nicotine products are novel products which are competing against a well-established
incumbent - the combustible cigarette. Consumers need to know that the safer alternative
products are out there. Vaping products in particular are a lot less simple to use than
cigarettes and come in a very wide range of product types. Vape shops and specialist
vendor websites have a crucial role in guiding smokers to find products which suit them and
advising them on how to use the products. The Bill’s display restrictions, standardised
packaging requirements and advertising restrictions will prevent adult smokers from seeing
and learning about the products, which are far less harmful to their health than combustible
cigarettes. The mandatory warnings about nicotine massively overstate the risks and will
prevent smokers from trying products which could have a positive impact on their health.
6. Making safer products more expensive will deter smokers from switching
We are also concerned that Denmark is set to make vaping much more expensive for
consumers, as the increased product notification costs will be passed onto consumers and a
tax on e-liquids is also in the pipeline. In our experience, price is a key factor for consumers
in choosing to use safer products: people want to save money when they stop smoking. A
recent study found that
“higher e-cigarette tax rates increase traditional cigarette use and
reduce e-cigarette use”
30
. Another study found that a 10% increase in e-cigarette prices
caused traditional cigarette sales to jump by 11%
31
. Making safer products more expensive
results in more smoking.
We see that access to Nicotine Replacement Therapy (NRT) will be widened under the Bill
and so would like to remark here that the safer nicotine products we describe are all
consumer products, bought at the individual consumer’s expense - and at no cost to the
state.
Conclusion
The Bill will increase smoking by making safer nicotine products less accessible, more
expensive, and less appealing to adult smokers. 62% of Denmark’s 786,000 smokers want
to quit smoking
32
yet the Danish government wishes to restrict access to the most popular
and successful smoking cessation tool available.
The Bill includes restrictions on the age of sale and requirements for robust age verification
checks, we feel that this measure alone will achieve the objective of restricting youth access,
without denying adult smokers these lifesaving alternatives.
We urge you to consider the welfare and health of Denmark’s adult smokers and to listen to
the experiences of consumers.
Pesko M.F, Courtemanche C.J, & Maclean J.C. The effects of traditional cigarette and e-cigarette tax rates on
adult tobacco product use.
J Risk Uncertain.
2020 [access]
30
Georgia State University. Raising Taxes on e-Cigarettes Increases Cigarette Sales, New Research Shows
Raising Taxes on e-Cigarettes Increases Cigarette Sales, New Research Shows. Georgia State News Hub.
February 17, 2020 [access]
32
Sundhedsstyrelsen. Danskernes rygevaner 2018 [access]
31
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With kind regards, on behalf of the European consumers,
Kim Dabelstein Petersen
Chairman, Dansk e-Damper Forening
[email protected]
[email protected]
Phone: +45 4033 0550 / +45 3045 7516
Peter Stigaard MAA
Treasurer, Dansk e-Damper Forening
[email protected]
[email protected]
Phone: +45 3045 7517
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