1 Dear Ms Jakab, ECIV briefing on the WHO report on vaping The

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1 Dear Ms Jakab, ECIV briefing on the WHO report on vaping The
Dear Ms Jakab,
ECIV briefing on the WHO report on vaping
The European Coalition for Independent Vape (ECIV) is a coalition at the European Union and wider international
level. Through the provision of credible knowledge and guidance, ECIV supports the independent vape trade and
promotes constructive interaction between this industry sector and the scientific community, vapers, policy makers,
and the general public. ECIV fosters research and manufacturing excellence in order to deliver a proportionate
consumer regulatory landscape that adequately reflects the needs of vaping stakeholders and recognises vaping
as a sector in its own right.
Every two years, the Conference of the Parties (COP) of the WHO Framework Convention on Tobacco Control
(WHO FCTC), gathers to discuss a range of issues relating to tobacco control. In recent years vaping has been
added to these discussions. Prior to this meeting a report is produced setting out the WHO’s latest position on
vaping. This report forms the basis of the discussions around vaping at the WHO FCTC COP7 meeting which, this
th
th
year, takes place in Delhi, India from the 7 – 12 of November.
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In the EU, there are now around 15 million regular vapers , of whom 99.9 per cent are adult current or former
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smokers . Vaping is regarded by Public Health England (PHE) and the Royal College of Physicians as being at
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least 95 per cent less harmful than smoking . In addition to this PHE now acknowledges that vaping is the number
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one tool used by smokers to help them quit . The recently updated Cochrane review confirmed that vaping helped
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smokers quit with no significant side effects . Finally, vaping is contributing to record low numbers of smokers
across the EU.
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This briefing sets out ECIV’s considered response to the latest WHO report on vaping. With the exception of the
first heading, all others are drawn from those used in the actual WHO report.
The good news!
ECIV welcomes the fact that in paragraph five of the WHO’s report that for the first time you encourage smokers to
switch to vaping:
‘If the great majority of tobacco smokers who are unable or unwilling to quit would switch without delay to using an
alternative source of nicotine with lower health risks, this would represent a significant contemporary public health
achievement.’
Furthermore, and again for the first time, paragraph 11 of the WHO’s report acknowledges, albeit in an unjustifiably
measured way, that vaping is less harmful than smoking: ‘Based mostly on the levels and number of toxicants
produced during the typical use of unadulterated ENDS/ENNDS made with pharmaceutical-grade ingredients, it is
very likely that ENDS/ENNDS are less toxic than cigarette smoke.’
This is a significant step forward considering the WHO’s previous positions on vaping. ECIV does not believe this
would have happened were it not for the independent research and data gathering, undertaken by many in the
1
http://www.ecigarette-research.org/research/index.php/research/research-2016/241-eurob
http://www.ons.gov.uk/ons/rel/ghs/opinions-and-lifestyle-survey/adult-smoking-habits-in-great-britain--2013/stb-opn-smoking-2013.html
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https://www.gov.uk/government/news/e-cigarettes-around-95-less-harmful-than-tobacco-estimates-landmark-review and
https://www.rcplondon.ac.uk/projects/outputs/nicotine-without-smoke-tobacco-harm-reduction-0
4
https://www.gov.uk/government/news/quitting-smoking-sweeps-the-nation-as-stoptober-returns
5
http://www.bmj.com/content/354/bmj.i4993
6
http://www.who.int/fctc/cop/cop7/FCTC_COP_7_11_EN.pdf?ua=1
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ECIV – European Coalition for Independent Vape – November 2016
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European public health community and academia. Furthermore, it is right to thank those officials within the public
health community who have spoken out and called on the WHO to take a more proportionate attitude towards
vaping based on credible evidence.
Health risks of exclusive vaping (paragraphs 7 – 12)
Whilst acknowledging that the ‘number and level of known toxicants generated by the typical use of unadulterated
ENDS/ENNDS is on average lower or much lower than in cigarette smoke’, the WHO go on to make a number of
statements that are either incorrect or out of date. For example, the report states that e-liquid contains a toxicant
called glyoxal. Whilst this might have been true historically, it is certainly not true now. The report also states that
the levels of toxicants in some brands of e-liquid reach higher levels than it cigarette smoke, something that is
simply factually incorrect.
Is nicotine, when consumed by a vaper in e-liquid dangerous? According the WHO’s report it is. However in reality
we know that this is not the case.
Pure nicotine is a toxic substance and should be handled with care. However, the literature LD50 (5 to 50 mg/kg) for
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humans is highly contentious and there is significant data indicating the true LD50 value is far higher . The vast
majority of e-liquid on the European market is below 2.0 per cent nicotine strength. Warnings of serious
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toxicological incidents resulting from e-liquid exposure are unjustified and not supported by available studies . Eliquid has a very low level of toxicity whether it is 18mg/ml or 36mg/ml.
The vast majority of e-liquids contain pharmaceutical grade nicotine, primarily European Pharmacopoeia (EP) or
United States Pharmacopeia (USP). It is for example MHRA and FDA approved and the same as that used in NRT
products.
Nicotine is addictive when consumed via cigarette smoke. However, as Professor Linda Bauld and others have
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made clear, nicotine when consumed in a form other than tobacco is not a particularly addictive substance.
Robert West, Professor of Health Psychology and Director of Tobacco Studies at University College London’s
Department of Epidemiology and Public Health said, “E-cigarettes are about as safe as you can get. We know
about the health risks of nicotine. Nicotine is not what kills you when you smoke tobacco. Vaping is probably about
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as safe as drinking coffee.”
Recently a number of bodies including ASH and the Royal Society of Public
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Health called for more to be done to ensure the public understand that nicotine is ‘not the deadly component in
cigarettes.’
The National Institute for Health and Care Excellence (NICE) and the MHRA in the UK have ruled that long term
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use of nicotine is not detrimental to the health of the user. A ruling that was specifically sought to allow clinicians
to prescribe nicotine containing products to pregnant women.
A major characteristic of the vaping market is the availability of a large number of different flavoured e-liquids. This
causes concern for the WHO who worry that certain flavours may be specifically targeted at young people and that
ultimately this could lead to young people taking up vaping and then going on to smoke actual cigarettes.
There is no evidence to support these concerns.
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Mayer, B. Arch toxicol. (2014), 88: 5-7
Epidemiological trends in electronic cigarette exposures reported to U.S. Poison Centers J. P. Vakkalanka , L. S. Hardison, Jr. , C. P.
Holstege, Clinical Toxicology, June 2014, Vol. 52, No. 5 : Pages 542-548; Chatham-Stephens K, Law R, Taylor E, Melstrom P, Bunnell R, Wang
B, Apelberg B, Schier JG (2014) Notes from the field: calls to poison centers for exposures to electronic cigarettes - United States, September
2010-February 2014. MMWR Morb Mortal Wkly Rep 63: 292-293; and Ordonez JE, Kleinschmidt KC, Forrester MB (2014) Electronic Cigarette
Exposures Reported to Texas Poison Centers. Nicotine Tob Res
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http://www.scottishparliament.tv/category.aspx?id=19&page=1&sort=date
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The Guardian newspaper 05 June 2013
http://www.ash.org.uk/:ash-supports-calls-for-more-to-be-done-on-public-understanding-of-nicotine
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http://www.theguardian.com/society/2015/aug/13/health-bosses-promote-e-cigarettes-harmful-tobacco-smoking-experts
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http://www.nice.org.uk/guidance/ph45
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ECIV – European Coalition for Independent Vape – November 2016
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Deborah Arnott, Chief Executive of the UK anti-smoking charity ASH, has said previously: “There is no evidence
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from our research that vaping is acting as a gateway into smoking.” This same research showed that regular use
of vape products amongst children and young people is rare and is confined almost entirely to those who currently
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or have previously smoked . Research undertaken by Queen Mary University in London found that a child trying
a tobacco cigarette for the first time is 50 per cent more likely to become a regular smoker. The same research
found no evidence that a child trying vaping for the first time goes on to become a regular vaper.
We also know from recent research that flavours are not enticing children to vaping either.
Evidence produced by a variety of organisations including ASH and the American Cancer Society (ACS) clearly
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shows that flavours do not entice non-smokers to use vape products either. Researchers from the ACS found that
flavours did not increase the attractiveness of vaping to teenagers. Rather, ‘Even after controlling for other
statistically significant correlates, the odds of a smoker being willing to try a vaping were 10 times those of a nonsmoker.’
However, for those adults who have switched to e-cigarettes, flavours are important. Why?
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In research carried out by Dr Konstantinos Farsalinos and others, vapers stated that the availability of flavours
was ‘very important’ in their effort to reduce or quit smoking. This research also found that the majority of vapers
would find vaping ‘less enjoyable’ or ‘boring’ if flavours were restricted, while 48.5 per cent of vapers stated that it
would increase their cravings for tobacco cigarettes and 39.7 per cent of vapers said that without flavours it would
have been less likely for them to reduce or quit smoking.
This major piece of research concluded:
•
•
•
•
That far from marketing flavours to attract children, flavours are marketed to ‘satisfy vapers’ demand’,
Flavours contribute to both perceived pleasure and a reduction in the effort required to reduce or quit
smoking,
Restrictions on flavours could cause harm to current vapers, and
Current flavour variability must be maintained.
The proliferation of flavours reinforces that view that these are recreational consumer products, not smoking
cessation aids, medicines or tobacco products.
The WHO are concerned that certain flavours are created with children in mind and they actually recommend
banning such flavours in paragraph 29 (e); again this fear is unfounded. Research actually shows that adult vapers
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(18 – 65) prefer supposedly “juvenile” flavours , a point acknowledged by the WHO’s report in paragraph 23. Any
ban, as we have demonstrated would be counterproductive and unnecessary.
The WHO report also raises concerns about the safety of certain flavours of e-liquid, specifically cinnamon and
popcorn. Again, as with glyoxal, historically diacetyl (used to provide the popcorn flavour) was used in some eliquids. Following research showing its potential to cause harm it has now been removed by all responsible e-liquid
manufacturers. The quality and the safety of vapour products are also enhanced through the multilateral work
started in the standardisation’ activities, both at the European level (CEN/TC 437 Electronic cigarettes and eliquids) and at the international level (ISO/TC 126/SC 3 Vape and Vapour Products). This once again demonstrates
that the industry can be trusted to carry out routine research and respond to any findings.
Health risks to bystanders from exposure to second hand vapour (paragraphs 13 – 15)
14
http://metro.co.uk/2014/04/27/e-cigs-cleared-of-being-route-into-smoking-4710734/
http://www.ash.org.uk/files/documents/ASH_891.pdf
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Research undertaken by Professor Peter Hajek, Director of the Tobacco Dependence Research Unit at Queen Mary University of London
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http://www.jahonline.org/article/S1054-139X(12)00409-0/fulltext
http://www.mdpi.com/1660-4601/10/12/7272
http://www.forbes.com/sites/jacobsullum/2014/07/17/survey-shows-adults-who-use-e-cigarettes-to-quit-smoking-prefer-allegedly-juvenileflavors/
ECIV – European Coalition for Independent Vape – November 2016
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The WHO’s report is inconclusive when looking at the health risks to bystanders from passive vaping. Based on
the latest research, ECIV believes that passive vaping is not harmful to the health of non-vapers. This is a position
that was publicly supported by a wide-range of public health bodies across the UK who united to oppose plans by
the Welsh Assembly Government to ban vaping in public; plans that were defeated due to the lack of any credible
evidence base to support such a ban.
In a recent House of Lords debate the UK Government made its position on this subject clear: “The levels of
toxicants in e-cigarette vapour were very much lower than those found in conventional cigarette smoke and not
considered to pose any significant passive inhalation risk.” In France, the Conseil d’Etat stated that it is not possible
to consider that the use of Vape products represents a recognized scientific risk that justifies a general public ban
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assimilated to conventional tobacco products .
A major scientific study undertaken by Dr Konstantinos Farsalinos and Professor Riccardo Polosa concluded that
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the ‘effects of vaping on by standers are minimal compared with conventional cigarettes.’
A review of the
available literature conducted in 2014 by researchers at the Drexel University School of Public Health in
Philadelphia concluded that ‘exposures of bystanders pose no apparent concern.’ Finally, the US Food and Drug
Administration conclude that all other substances measured for vaping was far below allowable levels for human
inhalation. They state that levels are so low that it is more hazardous to an individual’s health to breathe the air in
any major metropolitan city during rush hour.
Paragraph 30 (b) i. of the WHO’s report recommends including vaping in public smoking bans. Based on the
evidence above the ECIV believes that this is unnecessary and would be counterproductive from a public health
view point, a view that is supported by a wide range of organisations and government bodies.
Vaping as an aid to quitting smoking (paragraphs 16 – 17)
The WHO’s report remains inconclusive as to whether or not vaping actually helps smokers quit. The report
concludes:
‘It cannot be determined whether ENDS may help most smokers quit or prevent them from doing so.’
In reality, there is a wealth of anecdotal and credible independent research showing that vaping makes a significant
contribution to helping smokers quit and the results are available for all to see.
Between 1998 and 2007, the smoking rate in the UK dropped by a quarter — from 28 per cent of adults to 21 per
cent. At this point the Government introduced a range of measures to persuade smokers to quit: advertising
campaigns, public smoking bans, vending machine bans, and the tobacco duty escalator. As a result of all of this
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smoking rates fell between 2007 and 2012 by only 0.5 per cent .
It was at this point that vaping really began to become popular amongst smokers. Between 2011 and the beginning
of 2013, the number of people vaping rose from virtually zero to five per cent of the population. In 2013 vaping
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replaced NRT products as the most popular tool for helping smokers quit, a fact recognised by PHE . It was at this
point that smoking rates in the UK seriously began to fall. As vaping has increased in popularity the smoking rate
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has continued to decline. Figures produced this week by PHE and the Scottish Health Survey show record low
levels of smoking prevalence across the UK.
Moreover, vape product use in the European Union does not only appear to be largely confined to current or former
smokers, while current use and nicotine use by people who have never smoked is rare. Based on a representative
sample of 27,460 Europeans from 28 countries, more than one-third of current vapers polled reported smoking
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cessation and reduction .
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Avisrelatifàl’interdictiondel’utilisationdelacigaretteélectroniquedansleslieuxàusagecollectif,ConseilD’Etat,17octobre2013
Safety evaluation and risk assessment of electronic cigarettes as tobacco cigarette substitutes: a systematic review:
Konstantinos E. Farsalinos and Riccardo Polosa
published online 13 February 2014 Therapeutic Advances in Drug Safety
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https://health.spectator.co.uk/the-governments-great-triumph-on-smoking-it-left-e-cigarettes-alone/
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https://www.gov.uk/government/news/quitting-smoking-sweeps-the-nation-as-stoptober-returns
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http://www.bbc.co.uk/news/health-37406105
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http://www.gov.scot/Publications/2016/09/4029/1
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Electronic cigarette use in the European Union: analysis of a representative sample of 27 460 Europeans from 28 countries, Farsalinos,
Poulas, Voudris, Le Houezec, Addiction. 2016 Nov
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ECIV – European Coalition for Independent Vape – November 2016
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Vaping is also recognised as being at least 60 per cent more effective in helping smokers to quit
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conventional NRT products which have a recognised failure rate of around 90 per cent.
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than
Professor Robert West points out, there is a link between a rise in vaping and a fall in tobacco sales. Further to
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this, PHE state that vaping has contributed to the current record low levels of smoking in England and the
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recently updated Cochrane review confirmed that vaping helped smokers quit with no significant side effects .
Ability of vaping to initiate youth into nicotine use and smoking (paragraphs 18 – 20)
Despite evidence to the contrary, including some cited in their own report, the WHO remain concerned that growing
numbers of young people vape, and that this could act as a gateway to smoking.
The key issue is all of this is not how many children try vaping, but how many vape regularly and how many having
tried vaping, go on to smoking.
31
Recent research produced by ASH demonstrated that children are not vaping in significant numbers. The survey
found that regular use of vape products amongst children and young people is rare and is confined almost entirely
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to those who currently or have previously smoked . Of those young people that do vape, the majority use nicotine
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fee products .
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Research undertaken by Queen Mary University in London found that a child trying a tobacco cigarette for the
first time is 50 per cent likely to become a regular smoker. The same research found no evidence that a child
trying vaping for the first time goes on to become a regular vaper. A recent study by John Moores University found
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that, ‘Overall seven out of eight young people had never accessed vape products’ .
Welsh Assembly Government funded research from Cardiff University concluded: ‘Vape products are popular with
teens, including those who have never smoked, but few of those who try them become regular users, with most of
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those who do so also being smokers.”
Cancer Research UK looked in detail at two major studies into vaping amongst young people in Wales, they
concluded, “Looking specifically at two studies dedicated the use of vaping devices amongst young people in
Wales only a minority of teenagers who try vaping go on to become regular users. And the majority of those who
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do use the devices regularly were already smokers.”
Furthermore, there is no evidence of vaping acting as a gateway to smoking. If there were smoking rates would be
rising as vaping has become more popular, instead smoking rates are at their lowest levels, including amongst
children. According to ASH, the most recent survey found the lowest recorded smoking rates among children ever:
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only 18 per cent of 11 to 15-year-olds had tried smoking in 2014 compared with 42 per cent in 2003 .
In France, Professor Bertrand Dautzenberg highlights that vaping has led to a decrease in smoking rates amongst
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young people in Paris .
27
Study carried out on 5,000 smokers, by Professor Robert West looking at the success rate of different methods to stop smoking: nicotine
gum, nicotine patches, nothing, or e-cigarettes. Reported on BBC Breakfast 28 April 2014
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Dr Jed Rose, Director of the Duke Center for Smoking Cessation and a Professor in the Department of Psychiatry and Behavioral Sciences
th
at Duke University Medical Center, speaking at the Global Forum on Nicotine (Warsaw, Saturday 6 June 2015):
http://gfn.net.co/downloads/2015/Plenary%202/Jed%20Rose.pdf
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http://www.bbc.co.uk/news/health-37406105
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http://www.bmj.com/content/354/bmj.i4993
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http://metro.co.uk/2014/04/27/e-cigs-cleared-of-being-route-into-smoking-4710734/
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http://www.ash.org.uk/files/documents/ASH_891.pdf
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http://www.usnews.com/news/articles/2015-12-16/most-teen-e-cigarette-users-dont-vape-nicotine
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Research undertaken by Professor Peter Hajek, Director of the Tobacco Dependence Research Unit at Queen Mary University of London
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John Moores University – ‘Young People’s Perceptions and Experiences of Electronic Cigarettes’
http://www.cardiff.ac.uk/news/view/93573-e-cigarette-use-among-welsh-teenagers
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http://www.cancerresearchuk.org/about-us/cancer-news/news-report/2015-04-16-regular-e-cigarette-use-low-among-teens-analysis-suggests
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https://www.theguardian.com/society/2016/sep/06/e-cigarette-vaping-ads-children-underestimate-smoking-risks-study-tobacco-cigarettes
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Paris sans tabac, Professor Bertrand Dautzenberg, 2012 – 2015.
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ECIV – European Coalition for Independent Vape – November 2016
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Sales of vape products to those under the age of 18 is against the law in the UK, France, and many EU member
states, a move that ECIV fully supports and expects all its members to comply with.
Marketing of vape products (paragraphs 21 – 24)
In the EU, the advertising of vape products is highly restricted as a result of the Tobacco Products Directive. ECIV
believes that many European countries had previously taken a sensible approach to advertising and that the
previous guidelines were working well.
The responsible marketing of vape products is vital in making smokers aware of a significantly less harmful
alternative. The new restrictions imposed across the EU as a result of the TPD, will only make it more difficult for
smokers to find information about a product that would be beneficial to their health.
Again, the WHO’s report is inconclusive when it comes to the advertising of vape products. ECIV would urge the
WHO and all governments to introduce proportionate regulations for such advertising that allows the industry to
legitimately and responsibly advertise their products across all forms of media and at the same time make it clear
to adult smokers that vaping is at least 95 per cent less harmful than smoking.
Commercial interests (paragraphs 25 – 27)
The WHO’s report highlights the organisation’s concern about the role of the tobacco industry in this sector. In the
EU ECIV estimates that 30 per cent of the market for vape products is for products from tobacco owned vape
companies. However, the remaining 70 per cent is for products from independent companies. In recent years we
have seen a move away from products produced by tobacco owned companies towards those produced in the
independent sector.
This is reflected in the sales data.
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Recently, PHE published a report which showed that 71 per cent of vapers use a product that is NOT a cig-a-like.
According to the same report cig-a-like or pen-type devices with pre-filled cartridges are used by 23 per cent of
vapers and only 3 per cent use a disposable product. The decrease of cig-a-like use is also very high in mostly all
EU countries and in the USA, and is currently consolidating, following a trend in which users are choosing open
systems vapour products.
“Tobacco owned” vaping companies still predominantly sell the cig-a-like or pen-type devices, with a couple of
notable exceptions. It is the independent sector that produces the wide range of devices and products that are
proving so popular with vapers.
If the WHO is genuinely worried about the influence of the tobacco industry in this sector, then they need to
radically change their approach to vaping. Their current approach of recommending restrictions on marketing and
usage of the product, and their desire for increasingly disproportionate regulation plays directly into the hands of
Big Tobacco. Smaller independent companies by comparison do not sell conventional tobacco products and do not
have the deep pockets and regulatory compliance support to deal with disproportionate regulation
Regulatory options (paragraphs 28 – 32)
Based on their concerns and findings, the WHO’s report concludes with a series of regulatory recommendations.
In the opinion of ECIV most of these recommendations are without any evidential base, are disproportionate, and
play directly into the hands of the large corporate entities that do not necessarily have the best interests of the
vaping industry or vapers at heart. Far from encouraging smokers to switch to vaping, these regulations would
make switching harder, by restricting access to information, pushing up prices, and removing some of the more
effective products from the market.
For example, the WHO recommends regulating places, density and channels of sales for vape products, whilst
continuing to allow tobacco products (which kill half of all lifetime users) and NRT products (which have a 90 per
cent failure rate) to be sold anywhere.
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https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/534586/PHE-advice-on-use-of-e-cigarettes-in-public-placesand-workplaces.PDF
ECIV – European Coalition for Independent Vape – November 2016
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Some of the recommendations are sensible, but from an EU perspective, these are already, or soon will be in
force. For example, the testing and notification of e-liquids.
We are deeply concerned that the WHO set out a series of regulatory recommendations (paragraph 32 a. – h.) that
if implemented would effectively ban any constructive engagement between the industry and regulators. For
example, the WHO recommend ‘rejecting partnerships with the industry’ and ‘establishing measures to limit
interactions with the industry’. ECIV is firmly of the opinion that if open and transparent interactions between
Government and industry were restricted or stopped altogether, grey and black markets would proliferate in vaping,
making proportionate regulation of a responsible business sector unachievable.
Finally, and most concerning of all is the WHO’s recommendation that vape products should be subject to
additional taxation (paragraph 29 d.). Vape products are already taxed as the consumer product that they are
(VAT). Any additional taxation would only serve to make the product more expensive and act as a deterrent to
people switching, this would have a particular impact on some of the most vulnerable smokers. In addition, it would
lead to a black market in cheaper, unregulated products that would not only damage the new and independent
industry and put jobs at risk, but could also put consumers’ health at risk and reduce the availability of legitimate
vapour products.
Conclusion
To date, the WHO has taken a disproportionate and unjustifiably negative stance on the subject of vaping. The
WHO has also made irresponsible statements about vaping and proposed draconian regulation for the vape
industry.
The WHO speaks with a perceived authority which means that many governments around the world follow its lead.
Consequently, many countries, including India, where this year’s WHO FCTC COP7 meeting will take place, have
heavily restricted or banned vaping. In India, 25-year-old Parvesh Kumar was jailed for three years for the crime of
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selling vaping products .
The WHO believes that one billion people will die in this century as a direct result of smoking related illnesses. To
try and reduce this figure, the WHO has for many years proposed ever more draconian tobacco control measures.
Despite this, in many parts of the world smoking rates are on the rise. If the WHO really want to reduce the number
of smokers globally, they should look at those places in the world where smoking rates are now at record low
levels.
In the EU, and in England and France in particular, academia, many health charities, and many in the wider public
health community have for many years undertaken research into vaping. They have surveyed users and produced
reams of data as to who actually vapes and why. This wealth of credible independent data has given the UK and
French Governments the confidence to take a more positive position towards vaping and the regulation of vaping.
As a result of this there are now nearly three million vapers in the UK and a similar number in France. There is a
thriving and responsible vape industry serving these consumers, and smoking rates are at a record low level. In
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the words of Professor Robert West: “What is the problem that requires further regulation?”
If the WHO followed the lead of countries like the UK and France, smoking rates globally really could start to fall.
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http://www.indiatimes.com/news/india/india-just-made-its-first-arrest-for-selling-e-cigarettes-but-you-can-buy-them-online-253648.html
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Professor Robert West speaking at the E-cigarette Summit, The Royal Society, London on the 12 of November 2013.
ECIV – European Coalition for Independent Vape – November 2016
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