Letter to the ICF
April 2020. ETHRA wrote to the ICF and MEP’s to protest at consumers being locked out of the TPD review process. ICF is an external consultancy firm contracted by DG SANTE to carry out a support study as part of the TPD review. This included questionnaires /surveys, sent to Member States, industry and to Civil Society & Health Experts.
We are writing on behalf of European Tobacco Harm Reduction Advocates (ETHRA).
ETHRA is a group representing 21 consumer associations across Europe, supported by four scientific partners. We are mostly ex-smokers who have used safer nicotine products to quit smoking. We have been following the progress of the TPD review with keen interest, as we know from our own experience that prudent regulation of safer products can offer huge gains to health, at population and individual level. We note, and have experienced, that countries where safer products are popular and regulated sensibly have seen huge drops in smoking prevalence
We are writing with a view to making the following points about the questionnaire submitted to member states on the review of TPD2:
- The TPD promises to ensure a high level of health protection.
- Smoking kills but reduced risk products are far safer
- The Member States Questionnaire on the Assessment of the Tobacco Products Directive does NOT examine whether the TPD has fulfilled the purposes for which it was intended (instead, it focuses solely on policing)
- Regulations that make reduced risk products more inconvenient, less satisfying, or which increase perceptions of harm or addiction may cause harm through continued smoking and counteract the aims of the regulations.
We believe that the Questionnaire should be investigating the potential unintended consequences of the TPD with regards to its provisions for safer nicotine products. A failure to regulate vaping and other safer nicotine products well is a win for the incumbent combustible tobacco trade and could trigger more smoking.
We would like to draw attention specifically to these five areas of the Questionnaire:
- Who is using safer nicotine products? What is the relationship between use of safer nicotine products and smoking?
The Questionnaire asks about national data on the level of prevalence of use in under 25’s and whether the TPD has changed tobacco and related product use in young people (1.4.1 Effectiveness). It also asks whether Member states have evidence that electronic cigarette use “is a gateway to nicotine addiction and ultimately traditional tobacco consumption among young people and non-smokers” (1.5.12 Article 20).
The questions do not examine the relationship between smoking and safer nicotine use. Are smoking rates decreasing as electronic cigarette use is increasing? This is a crucial consideration. There is evidence to show that vaping is displacing smoking, from countries which are collecting data, for example, France, Ireland and the UK.
The question on whether electronic cigarettes are “a gateway to nicotine addiction and ultimately traditional tobacco consumption” is a leading one and presupposes an effect that is not supported by the evidence. This is a highly controversial policy area and this question lacks neutrality. It would be more beneficial for public health if there was also a call for evidence that vaping is a gateway away from traditional tobacco consumption. There is, indeed, considerable evidence demonstrating this.
A headlong approach to restricting youth access - while worthy - will have far greater negative effects on health if it also restricts adult access and deters smokers from switching to a safer alternative. It is important to note that a key influence on why children begin to smoke is whether their parents do. Encouraging adults to move to less harmful products will have a knock-on effect in discouraging youth to embark on a lifetime of smoking a deadly product. Vaping and other harm-reduced products are in the region of at least 20 times less harmful than smoking, is it therefore sensible to throw the baby out with the bath water rather than study the issue more diligently?
We believe the questionnaire does not adequately ask for evidence to balance risks against benefits in this vital area of policy.
- Is the TPD relevant and future proof?
The TPD should be a beacon of good policy-making taking into account the nicotine market as it is currently evolving. An exciting recent development has been the emergence of oral nicotine pouches onto some markets in Europe. These products are of huge benefit to smokers and are generally very safe. However, we have had reports that some nicotine pouches are being manufactured and sold in Russia with extremely high nicotine levels, which is putting consumers at risk. Regulating to limit the nicotine concentration is therefore appropriate and the limits should be set to benefit consumers, allowing them to benefit from the nicotine but without the potentially harmful effects. A test of whether the TPD is relevant and future proof will be in whether it can respond to this market development in a way which maximises the potential to replace smoking whilst minimising any risks to consumers.
- Tobacco for oral use (1.5.9 Article 17)
The Questionnaire asks whether Member States have encountered any difficulties in implementing the ban on tobacco for oral use and whether they are aware of efforts to circumvent the ban.
A huge opportunity is being missed here. Snus is a smokeless tobacco product which is widely used in some parts of Scandinavia. In Sweden, where snus use has been displacing smoking, adult daily smoking prevalence has already fallen to five percent. The disease burden from tobacco is almost entirely due to smoking. People smoke for the nicotine in cigarettes but die from the tar and toxic gases inhaled from burning tobacco. So, the key point is not whether a product contains tobacco but whether there is combustion involved.
The Questionnaire focuses on the policing of a ban which is detrimental to health and fails to examine whether the ban is denying smokers access to a safer nicotine product and preventing them from quitting. The Questionnaire starts with an assumption that the ban on snus is justified when the evidence shows that it clearly is not. It would be far better for the health of Europeans if the ban on snus was revisited and the evidence examined as to whether it should be lifted. It is important to note that snus is not only legal in the US but has now been granted reduced risk status.
The EU is ignoring evidence and lagging behind much of the world by banning snus. A review of the TPD should necessarily examine the evidence on snus but the questionnaire does not do so.
- Nicotine limit for e-cigarette refills, refill bottle sizes, advertising
These are referred to in the background to the questions on Article 20 but, again, the approach is solely as an issue of enforcement and neglects to examine the potential unintended consequences of the limit being set to 20mg/ml. This is a controversial area of the TPD and the scientists whose evidence was cited wrote at the time to complain that they had been misrepresented.
The right questions to ask are
- Does the 20mg/ml limit reduce satisfaction and increase the chances of smokers relapsing?
- Does the limit send the false message that nicotine is harmful?
- Does the limit result in compensatory behaviour which increases the user’s exposure to toxins?
Why are these questions not being asked? Why are we at the stage of reviewing the TPD yet no data has been harvested on these issues from TPD2? The EU had a chance to evaluate how the nicotine limit was effective or otherwise but has singularly failed to do so.
Issues around the 10ml limit on refill containers should also be examined. Mandating small bottles is problematic in many ways:
- It leads to more frequent refilling, therefore more chance of spillage
- It increases the cost to the user for no discernible benefit
- It results in more packaging waste, most of which is plastic and in direct conflict with the EU’s environmental campaigns.
Again, why does the questionnaire not weigh up the benefits and disadvantages of the 10ml limit? Why has data not been studied and why is this review not attempting to do so?
Why, also, has there been no examination of TPD2’s draconian approach to advertising? Vastly safer nicotine products are on the market which could have a dramatic positive effect on smoking prevalence by publicising alternatives. By restricting advertising on the same level as combustible tobacco, the EU is hiding safer products from smokers who could otherwise choose to reduce their risk if they were aware of them, and how to use them.
As a side note, at 1.5.12 there is a reference to “unit packets of electronic cigarettes”. Combustible cigarettes are sold in packets, but we have never seen units of electronic cigarettes referred to in this way. This betrays a deep misunderstanding of vaping products and accessories and does not inspire confidence that those drafting the questionnaire are fully knowledgeable about what is being regulated.
- Health warnings on electronic cigarettes
The Questionnaire asks whether Member States have faced issues implementing various packaging provisions, including health warnings. Again, the focus is on policing and fails to explore whether the health warnings are actually doing more harm than good.
There is clear evidence that alarmist health warnings can be misleading and misunderstood by the public. Data shows that the nicotine addiction warnings are scaring smokers away from using e-cigarettes and that the proportion of adults incorrectly perceiving e-cigarettes to be as harmful or more harmful than smoking is increasing.
Why does the questionnaire not examine if the warnings are having a positive or negative effect on public health? There is no justification for the warnings to be exactly the same size and as those for far more dangerous tobacco products. It is also baffling - and embarrassing to the EU - that hardware including batteries and glass tanks should carry a warning that they contain nicotine when they quite clearly do not. Why is there no investigation as to why those products require a warning at all?
Consumers are stakeholders
On a final note, ETHRA is a Europe-wide advocacy organisation, collectively representing thousands of association members and many millions of consumers in 21 countries. We are the people who use the products which are being regulated and have great knowledge about them. We are the public.
We are not funded by the tobacco or vaping industry; our only motivation is to ensure that products we have found to be vastly beneficial to our health are not regulated irresponsibly. We see from the covering letter that consumers are not included in the list of stakeholders who will be formally consulted. If the EU purports to engage with the public, ensure transparency, and regulate with the consent of Europeans, why are consumers not invited for their input?
We hope that ETHRA - and consumers in general - will be included in the list of stakeholders for future consultations, and we would be willing to discuss any of the issues we have raised above at any time of your convenience.
Sources
Vaping is displacing smoking Vaping in England: evidence update March 2020, Public Health England,https://www.gov.uk/government/publications/vaping-in-england-evidence-update-march- 2020
Baromètre de Santé publique France 2017. Usage de la cigarette électronique, tabagisme et opinions des 18-75 anshttps://www.santepubliquefrance.fr/determinants-de-sante/tabac/documents/enquetes- etudes/barometre-de-sante-publique-france-2017.-usage-de-la-cigarette-electronique- tabagisme-et-opinions-des-18-75-ans
Healthy Ireland Summary Report 2019. Section 3: Smoking. November 2019.
https://assets.gov.ie/41141/e5d6fea3a59a4720b081893e11fe299e.pdf
Children are more likely to smoke if their parents smoke Action on Smoking and Health Young people and smoking, September 2019https://ash.org.uk/information-and-resources/fact-sheets/young-people-and-smoking/
Youth vaping rates England: Vaping in England: 2020 evidence update summary. Section 3: Vaping among young people. March 2020.https://www.gov.uk/government/publications/vaping-in-england-evidence-update-march- 2020/vaping-in-england-2020-evidence-update-summary
Does e-cigarette experimentation increase the transition to daily smoking among young ever-smokers in France?https://www.sciencedirect.com/science/article/pii/S0376871620300181
Oxford Academic. Nicotine and Tobacco Research. Youth Vaping and Tobacco Use in Context in the United States: Results From the 2018 National Youth Tobacco Survey. 13 January 2020.https://academic.oup.com/ntr/advance-article- abstract/doi/10.1093/ntr/ntaa010/5701081?redirectedFrom=fulltext
Vaping and other harm-reduced products are significantly less harmful than smoking Royal College of Physicians: Promote e-cigarettes widely as substitute for smoking. 28 April 2016.https://www.rcplondon.ac.uk/news/promote-e-cigarettes-widely-substitute-smoking-says- new-rcp-report
Sweden’s adult daily smoking prevalence 5% Special Eurobarometer 458, Attitudes of Europeans towards tobacco and electronic cigarettes, March 2017https://ec.europa.eu/commfrontoffice/publicopinion/index.cfm/Survey/getSurveyDetail/instru ments/SPECIAL/surveyKy/2146
Snus is far less harmful to health than smoking Foulds J, Ramstrom L, Burke M, Fagerström K. Effect of smokeless tobacco (snus) on smoking and public health in Sweden. Tob Control. 2003 Dec;12(4):349–59.https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1747791/
Ramström L, Borland R, Wikmans T. Patterns of Smoking and Snus Use in Sweden: Implications for Public Health. Int J Environ Res Public Health. Multidisciplinary Digital Publishing Institute (MDPI); 2016 Nov 9;13(11).https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5129320/
FDA grants modified risk status to snus U.S Food and Drug Administration. FDA grants first-ever modified risk orders to eight smokeless tobacco products. October 22, 2019.https://www.fda.gov/news-events/press-announcements/fda-grants-first-ever-modified-risk- orders-eight-smokeless-tobacco-products
Scientists complain that their work was misrepresented in the TPD Scientific Errors in the Tobacco Products Directive, A letter sent by scientists to the European Union E Cigarette Research, Dr Farsalinos’ scientific bloghttp://www.ecigarette-research.org/research/index.php/whats-new/whatsnew-2014/149-tpd- errors
Guest blog: Lynne Dawkins puts the Commission straight The Counterfactualhttps://www.clivebates.comguest-blog-lynne-dawkins-puts-the-commission-straight/
20mg/ml nicotine limit for e-liquids, 10ml bottle limit E-Cigarettes: Promises & Pitfalls of Policy, Lynne Dawkins’ presentation at the SRNT-E 2019 conference in Oslohttps://www.slideshare.net/LynneDawkins/ecigarettes-promises-pitfalls-of-policy
E-cigarette health warnings
Kimber C, Frings D, Cox S, Albery IP, Dawkins L. Communicating the relative health risks of E-cigarettes: An online experimental study exploring the effects of a comparative health message versus the EU nicotine addiction warnings on smokers’ and non-smokers’ risk perceptions and behavioural intentions. Addict Behav. 2020https://www.sciencedirect.com/science/article/pii/S0306460319308846?via%3Dihub
Kimber C, Frings D, Cox S, Albery I, Dawkins L. The effects of the European e-cigarette health warnings and comparative health messages on non-smokers’ and smokers’ risk perceptions and behavioural intentions 11 Medical and Health Sciences 1117 Public Health and Health Services. BMC Public Health. 2018.https://bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-018-6161-7
You can read more about the TPD review in our article here.
You can downlaod our letter here
European Tobacco Harm Reduction Advocates Interview on Tobacco Products Directive: note by ETHRA
Who we are
European Tobacco Harm Reduction Advocates (ETHRA) is a group of 21 consumer associations in 16 European countries, representing approximately 27 million consumers1 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. Damian Sweeney, who represented ETHRA in the phone interview, is the chair of the New Nicotine Alliance Ireland. ETHRA is listed in the EU Transparency Register at: 354946837243-73.
Key areas where the TPD fails to ensure a high level of health protection
Failure to consider the effect of TPD e-cigarette measures on smoking
It is impossible to evaluate European Union policy on vaping and other low-risk products without reference to the effect these policies have on smoking, the far riskier behaviour. Regulations for safer products should 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 prolonging smoking. We have seen little sign that the Commission and the most vocal public health activists and academics have understood the likely unintended consequences of excessively restrictive policies on vaping or other low risk products and how these can cause extra harm by deterring switching and prolonging smoking.
In our experience there are several key areas where the TPD is prolonging smoking through inappropriate regulation of safer alternatives to smoking and is therefore failing to ensure a high level of health protection for EU citizens. We would like to highlight the following:
20mg/ml limit on nicotine concentration in e liquids
Article 20(3)(b) of the TPD requires that the nicotine-containing liquid does not contain nicotine in excess of 20 mg/ml (about 2% nicotine). This limit is far too low and has no scientific basis. There are very successful and effective products on the market outside the European Union with nicotine strengths approaching 60mg/ml. The EU’s nicotine limit is a contentious issue: when TPD2 was drafted the scientists whose research had been cited wrote to the Commission to complain that their findings had been misrepresented2 .
The 20mg/ml limit is too low to satisfy many dependent smokers. These smokers are the people who vaping could help, yet they are being deprived of the level of nicotine that many of us consumers found to be critical in initially moving us away from smoking. Restricting nicotine limits to 20mg/ml takes away the ‘hook’ for many smokers in deciding to switch. Nicotine obtained via vaping has a different delivery profile to that obtained by smoking so it can take some getting used to and using e-liquids with a reasonable nicotine concentration can help with that.
In our own extensive experience, the inadequate nicotine concentration limit is forcing consumers to buy e-liquids from outside the EU, from countries which do not have the same quality standards as the EU. As with the mandatory warning labels, discussed below, the 20mg/ml nicotine limit sends a false message to consumers that there is an inherent danger to using nicotine, when in fact the risk profile for vaping nicotine in e-liquids is similar to that of drinking coffee3.
In relation to the 20mg/ml limit, the key recital to the TPD (38) shows the legislators had a sound policy intention for a single market directive:
This concentration allows for a delivery of nicotine that is comparable to the permitted dose of nicotine derived from a standard cigarette during the time needed to smoke such a cigarette.
Allowing comparable nicotine delivery to cigarettes is a reasonable and fair basis for a single market directive like the TPD and clearly the intention of the legislators. However, the 20mg/ml limit does not achieve this because it is measuring the wrong quantity and places limits on the design of more compact devices that are more likely to suit novice vapers. The Directive is based on a misunderstanding – stronger e-liquids do not mean higher nicotine exposure. Users control their exposure to nicotine by modifying how deeply and how often they puff on the device – a well understood process known as ‘self-titration’4. But if the nicotine concentration is too low it becomes harder for users to achieve a satisfactory nicotine dose5 without taking in a larger quantity of liquid, which requires a more powerful battery, larger devices and potentially a greater exposure to toxicants6. There are three main consequences of the limit, and none are positive.
First, the 20mg/ml limit works against more compact devices that use low volumes of liquid at higher strength to deliver the same amount of nicotine as larger devices using higher power and larger volumes of weaker liquids. It makes it impossible to make more compact and convenient devices with sufficient nicotine delivery to appeal to many of those making the first steps away from smoking.
Second, it will mean some users are forced to consume greater quantities of weaker liquids with potentially greater toxicant exposure. While these elevated risks remain very low compared to smoking, there is no justification to increase them using EU regulation.
Third, it provides an unjustified regulatory advantage to cigarettes, the more harmful product. The nicotine delivery of cigarette to the user is not significantly limited by the nicotine yield limits imposed by Article 3 of the Directive, as most smokers can compensate and self-titrate to achieve the nicotine dose they want. This effect has been well understood for several decades.78 The 20mg/ml limit is, however, a significant constraint for the e-cigarette category.
This is an internal market failure that has the effect of protecting cigarettes from competition from easy-to-use e-cigarettes that would provide comparable nicotine delivery if this limit was not in place. For this reason, it does not achieve the internal market goal of a level-playing field for competition and innovation and is strongly biased in favour of the more harmful products, cigarettes. It does the opposite of providing a high level of health protection. In our view this limit should be removed or replaced with a limit that is much higher, for example, allowing liquids up to seven percent nicotine strength.
Mandatory health warnings on vaping products
The excessive mandatory health warnings overstate the risks of vaping and are deterring smokers from trying vaping. 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 only represent a fraction of the risk of combustible tobacco products and the warning labels should reflect this difference in risk.
A note on the risk profile of vaping in relation to combustible cigarettes: The Royal College of Physicians stated in its 2016 report Nicotine Without Smoke9 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).
Public Health England’s 2018 evidence review10 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”.
The warning labels do not reflect this huge difference in risk and scare people away from vaping. This is a missed opportunity: instead of labels which deter smokers from trying the far safer alternative, labelling could be used instead to encourage smokers to switch and to inform about relative risk. In a recent study into consumers’ reaction to the TPD11, lead researcher Dr Emma Ward, suggested that “harm reduction messages on packaging, comparing e-cigarettes to tobacco could also nudge smokers to switch to less harmful vaping”.
In a survey for Action on Smoking and Health (UK)12, smokers were asked to give reasons why they would not switch to e-cigarettes. The most common response was “I do not want to substitute one addiction for another”, a damaging and distracting risk perception nurtured and reinforced by the EU warnings.
Lastly, the warning labels nonsensically require a nicotine warning on products intended for vaping, whether or not they contain nicotine. This leads smokers to falsely believe that nicotine must be very hazardous, as warnings even appear on hardware such as batteries13.
The ban on advertising e-cigarettes and other low risk products
Article 20(5) prohibits advertising of vaping products in most forms not in a fixed location. This is a form of regulatory protection to the market incumbent, the cigarettes. Advertising is essential for entrants and innovators to gain a hold on a market dominated by a more harmful rival. We are concerned that bans on advertising mean fewer smokers will be aware of the products and attracted to trying to switch to the lower risk products. There is emerging evidence that bans on e-cigarette advertising cause increases in smoking1415.
We believe that e-cigarette manufacturers and vendors should be subject to controls on content and placement of advertising, sponsorship and promotion, but not an outright ban.
10 ml refill bottle limit and 2ml tank size limit
This regulation again favours cigarette smoking by making life more inconvenient for e-cigarette users for no purpose whatsoever. This regulation also makes vaping more expensive for consumers and the little bottles are difficult to open for those with dexterity issues. In no other consumer product is control of poison risk done by limiting container size. The conventional approach is to have child resistant packaging, warnings and instructions on what to do if exposed. With child proof caps now the industry standard, even the flawed justification for the 10ml limit has gone. The 2ml tank limit means that consumers have to refill more frequently, contributing to making vaping fiddly, and deterring older smokers and others with dexterity issues from switching. The restriction on refill bottle capacity to 10ml increases plastic waste, going against EU environmental commitments on single use plastics.
Flavours
Given the purpose of the TPD is to harmonise regulation with a high level of health protection, it allows member states too much room for manoeuvre with regards to regulation of safer products. Several member states have already implemented flavour bans for e-liquids and there are more in the pipeline. These flavour bans destroy the appeal of vaping products to smokers, so favour the combustible cigarette trade and thereby prolong smoking and undermine both the internal market and health objectives of the TPD.
Having a wide variety of flavours is intrinsic to the success of vaping products: the ability to tailor the product to each individual's tastes plays a very important role in the effectiveness of vaping. The evidence in this area is very clear and shows that whilst many vapers start with a tobacco flavour, over time they gravitate towards fruit, dessert and sweet flavours16.
A survey into the flavour preferences of 69,000 adult vapers who had quit smoking found that over 95% of those surveyed most commonly used flavours other than tobacco or menthol17 . Public Health England’s 2020 Evidence Update also found that fruit flavours are the most popular flavours for adult vapers18. A recent study published in JAMA19 concluded that:
“adults who began vaping non-tobacco flavored e-cigarettes were more likely to quit smoking than those who vaped tobacco flavors.”
Relative to vaping tobacco flavors, vaping nontobacco-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. The added danger with limiting or banning flavours is that consumers are then forced to use the black 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 black-market products, reported to account for 62-80% of all sales20.
Snus
The TPD prohibits the sale of snus throughout the EU, except in Sweden, which obtained an exemption when joining. Lifting the snus ban represents a huge opportunity to reduce the burden on health from smoking. 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 smokefree (smoking prevalence of 5% or lower).
It’s been known for decades that people smoke for the nicotine but die from the tar, it is the release of toxic and carcinogenic gases from the combustion of tobacco that causes harm.
Swedish snus is far less risky to health than smoking. The Global Burden of Disease Study summarises the health risks of snus as follows21:
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.”
There is clear evidence that snus not only lowers the smoking prevalence22, but that this translates to a lower burden of disease23.
This has been recognized in the USA where the FDA granted Swedish Snus the first ever modified risk order in 2019. The FDA stated that24
“the modified risk products, as actually used by consumers, will significantly reduce harm and the risk of tobacco-related disease to individual tobacco users and benefit the health of the population as a whole.”
By ignoring the scientific evidence on smokeless tobacco, and upholding the ban on snus, the EU is falling behind other countries in not taking advantage of the health benefits which Swedish snus could bring to smokers. In June 2017, eighteen international tobacco control experts wrote to the European Commission highlighting the multiple absurdities in the EU snus ban and setting out the public health and policy case to lift the ban25.
The evidence on snus should be reassessed and the ban overturned.
Impact of e-cigarettes on smoking cessation
We were asked during the interview for evidence that e-cigarettes have contributed to declines in smoking prevalence. The most directly applicable study draws on the EU’s Eurobarometer survey2627.
An estimated 6.1 and 9.2 million EU citizens had quit and reduced smoking with the use of ecigarettes respectively.
This relates to 2014 survey data, so we would expect far more by now. However, this cannot tell us whether the TPD has increased or decreased smoking cessation compared to not having the TPD. Our view is that the TPD will have depressed this figure compared to the regulatory environment in place in 2014 (i.e. before the TPD came into effect).
Here we give some information from a number of countries:
Ireland: The Healthy Ireland Survey commissioned by HSE (public health) shows that the smoking rate in 2015 and 2016 was 23%. This is about the time that vaping products were becoming popular. From 2017 until last year smoking rates plummeted to 17%. The survey shows that over those years 39% of successful quit attempts were made by people using e-cigarettes. Vaping prevalence in Ireland was 3% in 2015 and rose to 5% last year28.
France: In the French Baromètre de santé public France29 vapers aged 18 to 75 have almost all used tobacco, as current or former smokers. Between 2014 and 2017, the proportion of daily smokers decreased among vapers (from 64.5% to 39.7%), while that of ex-smokers increased (from 23.5% to 49.5%). The number of daily ex-smokers who have quit smoking for more than six months and who think that vaping helped them quit is estimated at around 700,000 since the availability of e-cigarettes on the French market.
UK: Public Health England’s 2020 review30 found that smoking among adults in England has continued to decline over the past ten years and in 2019 was around 15%. The same review found that “Vaping remains most common among smokers and former smokers, with less than 1% of people who have never smoked currently vaping”, and that “data from stop smoking services in England suggests that when a vaping product is used in a quit attempt, either alone or with licensed medication, success rates are comparable to, if not higher than, licensed medication alone.”
ASH’s Use of e-cigarettes (vaporisers) among adults in Great Britain31:
“However, the Smoking Toolkit Study (an ongoing series of monthly surveys of the adult population of England) has shown a clear association between changes in population rates of quitting smoking and prevalence of e-cigarette use after adjusting statistically for a range of potential confounding factors. If the association is causal, e-cigarettes were responsible for an estimated 69,930 additional ex-smokers in England in 2017. Furthermore, recent evidence from a randomised controlled trial showed that vaping was nearly twice as effective as NRT in helping smokers quit in a Stop Smoking Service setting in England.”
Initiation of consumption by young people
Article 28 states that initiation of consumption by young people is to be examined in the report, so we provide some information about that here.
Belgium: The 2018 Health Survey32 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 students33 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 survey34 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.
Ireland: Youth smoking in Ireland has fallen to 5.9%.35 There is no official data for youth vaping rates in Ireland but the Healthy Ireland survey participants are from 15 years up. Healthy Ireland 2019 data finds that never smokers that vape is 1% and has been consistently <1% since the survey started in 2015.
The safer products remain less available than the dangerous ones
It is a failure of TPD2 that combustible cigarettes remain so easy to buy yet safer nicotine products do not. The new COVID-19 restrictions have made this very evident, consumers in Austria and Belgium could not buy vaping products when shops closed, because those countries have a ban on online sales. A new survey from Belgium36 examines the effects of this, one effect was that previously ex-smokers had to return to smoking.
Throughout Europe the COVID-19 restrictions affected access to safer products but we are not aware that there were any difficulties with obtaining combustible products.
More generally, in Estonia, Finland and other member states with strict measures, some products are now illegal in those countries but remain available in other EU countries. As a result of such differences in the level of regulation there are now sizeable black markets in some member states.
Specific products not covered by the TPD
In the interview you asked us to elaborate on specific products not covered by the TPD. We would like to draw your attention to non-tobacco nicotine pouches and non-nicotine containing e-liquids.
Non-tobacco nicotine pouches
Having these low risk products appropriately regulated and widely available to smokers would be of great benefit to public health, by giving smokers another harm reduction option to switch away from deadly combustible tobacco. These products are generally very safe. However, some nicotine pouches manufactured and sold in Russia with extremely high nicotine levels were also introduced on the EU market, which is putting consumers at risk. Regulating to limit the nicotine concentration would be appropriate and the limits should be set to benefit consumers, allowing them to benefit from the nicotine but without the potentially harmful effects.
Non nicotine containing e-liquids – “short fills”
The 10ml limit led to the creation of short fills to both allow consumers to purchase larger volumes that they had previously been used to – which did not create the waste that 10ml bottle sizes do and were more cost effective for consumers - and also to minimise notification costs to industry. If costs of notification were kept to an affordable level and the bottle size limit abandoned, short fills would not be necessary in the market and would disappear.
Is the TPD future proof?
New products are being developed all the time, in response to the high consumer demand for safer alternatives to smoking. When TPD2 was drawn up, less than 10 years ago, the only safer nicotine consumer products in common use at that time were snus and e-cigarettes. Non-tobacco containing nicotine pouches have become popular since then but the TPD has not been sufficiently flexible to accommodate them. So, as the TPD has not adapted to recent developments it seems highly unlikely that in its current form it will adapt to future ones.
The TPD definitions for e-cigarettes need updating and some are no longer relevant. We strongly recommend that expert consumers are invited to give input into reworking those.
The definition for tobacco for oral use is convoluted and absurd. This, together with the ban itself, has led to legal challenges. It is morally indefensible for EU citizens’ money to be used in defending the ban on the sale of snus, a product which could have a huge benefit to public health if the ban was lifted.
Should different categories of products be regulated differently?
Yes, safer products should be regulated differently to combustible tobacco products. If safer nicotine products have to coexist with combustible products within the same directive there should be two categories: one for products which are combustible, and therefore likely to cause significant harm to the user, and one for all non-combustible products, which are far less harmful to the user. The difference in risk between combustible and non-combustible products is significant. However, the difference in risk between the various non-combustible products is negligible in relation to that of smoking, and so for the purposes of the TPD only one distinction should be made.
Conclusion
It is vital that consumers are recognised as essential stakeholders in discussions of policy. We are the people with greatest knowledge about these products and the group most affected by the regulations. We reaffirm here our belief that all consumers should have been given the opportunity to take part in the review process.
We regret that the focus for the TPD evaluation is largely on compliance and there is no examination of whether the regulations themselves are maximising the potential benefit to public health. Do the health warnings, advertising restrictions and nicotine limit deter smokers from switching to safer products? A failure to regulate safer products well is a win for the combustible cigarette trade - is the TPD prolonging smoking by not regulating safer products appropriately? Neither the questionnaire sent out to member states nor the stakeholder questionnaire addressed the issue of unintended consequences and we feel that is a missed opportunity.
We are acutely aware that there are many current smokers who have not yet found a way out of combustible tobacco, who could benefit greatly if appropriate regulation was applied. Perceptions of risk are going in the wrong direction, with many smokers falsely believing that e-cigarettes are as harmful to health as combustible tobacco products. Unfortunately, some of the TPD regulations are contributing to these misperceptions and keeping people smoking. In order to fulfil its purpose of ensuring a high level of health protection for EU citizens the TPD must regulate safer nicotine products appropriately.
1Estimate 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.
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Notes on the TPD review interview
July 2020. ETHRA participated in the TPD review by taking part in a follow up phone interview, based on our answers to the stakeholder questionnaire. We summarised the views we expressed in the interview in our Notes on the TPD interview.