On Friday, 23rd October 2020, Vape Business Ireland submitted the below response to the public consultation on the European Commission Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) Preliminary Opinion on electronic cigarettes.
Response to the abstract
The abstract is neither informative nor fit for purpose. It does not contain the information one would normally expect to see in an abstract for a report of this size such as background, objectives, and results. The abstract takes the form of a list conclusions stated as being supported by a weight of evidence that is rated ‘low’, ‘moderate’ etc. There is no explanation in the report, including in the methodology, as to what these ratings mean and how they were determined.
Some of the conclusions presented in this abstract are at odds with the information and conclusions in the main body of the report. For example, in the case of second-hand exposures, the abstract states (page 2, line 13) that the overall weight of evidence for long-term effects on the cardiovascular system, are strong. However, in the body of the report (page 47, line 28), they cite a European Heart study as concluding that ‘the long-term effects on the cardiovascular system are still unknown due to a lack of relevant data’.
An abstract should be clear, concise, unbiased and reflect the contents of the report it describes. The abstract is the most visible part of the report, so inconsistencies between the abstract and main body of the report increase the likelihood that inappropriate erroneous conclusions will disproportionately influence readers of this report.
Response to the summary
The SCHEER opinion dismisses the fact that vaping products are commonly used as less harmful alternatives to smoking. A fundamental acknowledgement of the difference in comparative risk between vaping products and combustible cigarettes is entirely absent in this opinion. In particular, that vaping products are a less harmful alternative to smoking and switching can significantly reduce a smoker’s exposure to the harmful toxicants found in cigarette smoke. A 2015 expert independent evidence review, E-cigarettes: an evidence update, published by Public Health England concluded that vaping products are significantly less harmful to health than tobacco and have the potential to help smokers quit smoking, estimating that vaping is around 95% less harmful than smoking
The 2017 European Commission Special Eurobarometer 458 on Attitudes of Europeans towards tobacco and electronic cigarettes shows 26 per cent of EU citizens’ smoke. They are at most serious risk of disease and premature death, with 700,000 of them dying each year. If the Commission is serious about reducing smoking prevalence, then acknowledging the positive public health role that vaping products could play in a healthier Europe is fundamental to making that plan a success.
Response to the methodology
There is a lack of transparency as to the methodology used in this report. The described methodology does not provide information on basic elements such as how relevant literature was identified and justified for inclusion. There is no information on what defines ‘weak’ or ‘moderate’ evidence and there is a heavy reliance on review articles and a use of dubious citation chains that in some cases lead to dead ends. For example, a citation to a paper citing the results of another paper that are not published or accessible.
Primary resources were used only very rarely. Much of the cited literature is old involving old products no longer available. For example, papers published in 2014 likely involved products bought in 2012; products sold pre-TPDII when there was no EU regulation of vaping products; or US products, which are not TPD compliant and not available to EU citizens in any event.
This approach means that the ‘most recent scientific and technological evidence’ (as stated in the terms of reference) have not been brought to bear on the creation of this report, as per the request from the Commission.
Page 19, Lines 17-31: The report references (SCHEER 2018) a previous memorandum on weight of evidence (WOE) but does not explain how this is implemented here.
In addition, studies by relevant bodies in member states where TPD-compliant products are sold to EU citizens are not included in this report. For example, studies by Public Health England.
Response to the role in the initiation of smoking (particularly focusing on young people)
There needs to be greater objectivity in the debate regarding the uptake of vaping among young people. The picture varies across the globe and the wider regulatory environment is a critical context that needs to be borne in mind. The literature that is cited in the SCHEER Preliminary Opinion relates to the situation in the USA. However, the regulations that control the sale of vaping products in the USA are quite different to the regulatory environment in, Europe. The broader policy environment and regulations covering the sale, presentation and purchase of these products needs to be considered.
The report focuses on nicotine concentration in vaping products as a concern for the TPD. Nicotine levels in vaping products are already set at a level that means they can’t compete with cigarettes despite the TPD specifying that nicotine levels be allowed at levels sufficient to allow vaping products to deliver nicotine at a comparable level as a cigarette.
Vaping products in general contain far less nicotine than a cigarette and are far less effective at delivering it. Several studies (e.g. Hajek 2015) show that TPD compliant vaping products do not deliver nicotine at the same rate as cigarettes, even at levels much higher than in EU vaping products.
Flavours play an important role in keeping smokers smoke-free. Studies show that when smokers start vaping, they often instinctively start with a tobacco flavour. But long-term studies show that flavour preference changes over time. A landmark study (Hajek 2015) showed that when smokers initially given tobacco-flavour e-liquids could choose their own flavour, approximately 60 per cent chose non-tobacco or menthol flavours.
A recent longitudinal study (Ping Du et al 2020) showed that at the beginning of the study, tobacco and fruit were the most preferred flavours followed by mint/menthol. Preference for tobacco flavour decreased significantly over time as preference for sweet flavours increased significantly. About 40 per cent of participants maintained their initial flavour preferences. All age groups showed significant migration away from tobacco flavour towards sweet flavours. Preference for tobacco flavour also decreased nearly two-fold among groups 60 years or younger. About 50 per cent of participants in this study reported they would “find a way to buy my preferred flavour” or “add flavouring agents myself” if their preferred flavour were banned. Approximately 10 per cent reported they would return to smoking traditional tobacco cigarettes if all non-tobacco flavours were banned.
Restrictions on flavours would likely cause harm to vapers and adult smokers who are yet to make the switch by reducing the less harmful alternatives available to them. The results of these and other studies suggest that rather than attracting people to vaping, flavours play an important in keeping smokers who have chosen to smoke away from cigarettes.
The SCHEER report conclusion that vaping is a gateway to smoking is not evidenced-based and is a misleading statement which, if adopted as a policy, would cause untold damage to the public health of smokers across Europe.
Bauld et al. 2017 reported that ‘surveys across the UK show a consistent pattern: most e-cigarette experimentation does not turn into regular use, and levels of regular use in young people who have never smoked remain very low.’
A rise of vaping in the UK and US has been accompanied by rapid falls in adult smoking, and there is no compelling evidence that vaping causes smoking (Kozlowski et al 2017).
2015 McNeil A, Hajek P, 2015
Du P, Bascom R, Fan T, et al. Changes in Flavor Preference in a Cohort of Long-term Electronic Cigarette Users
Response to the role of e-cigarettes in the cessation of traditional tobacco smoking
We disagree that “The evidence is inadequate to infer that e-cigarettes, in general, increase smoking cessation” (Page 71, Line 21)
In spite of the fact that “the authors noted that there is evidence from two trials that electronic cigarettes help smokers to stop smoking in the long term compared with placebo electronic cigarettes” (Page 70, Line 45-51), the Opinion states that confidence in the results of the Cochrane Review are low due in part to wide confidence intervals and low event rates. Importantly however, this review examined early generation vaping products, which do not deliver nicotine as effectively as newer generation devices (Yingst, Hajek) which can affect success in quitting.
The most recent review by the Cochrane Collaboration (Jamie Hartmann-Boyce et al. 2020) considered the results of 50 studies in 15 countries and confirm their earlier finding that vaping products help people quit smoking and that they are safe to use and increased their confidence to moderate.
A recent analysis of 13,057 current and former smokers in 28 EU countries, which is not cited in the report, found that current vaping product users were almost five times more likely to have quit smoking in the last two years than non-vapers and more than three times more likely to have quit in the last three to five years (Farsilinos and Barbouni 2020).
A 2019 study (Beard et al.) showed that, as vaping product use has increased in England, so too has the rate of successful quit attempts, as well as the overall number of quit attempts. Notably the country with the lowest smoking rate in the EU, Sweden (7%) has a regulatory environment which is supportive of reduced-risk alternatives to cigarettes, such as e-cigarettes and snus.
In several places, SCHEER appears to down-play and mischaracterise smokers use of vaping products. For example, on Page 70, LINE 31, Filippidis 2019 is incorrectly cited as reporting that during the study time frame “experimentation with the use of electronic cigarettes for smoking cessation increased…” This is a mischaracterisation of the data. Filippidis did not question participants regarding experimentation, but instead asked smokers which methods they used to quit smoking.
Page 70, line 38 of the Opinion reads, “…use of cessation assistance among a cohort of smokers from eight European countries indicated that experimentation with electronic cigarettes as a smoking cessation device in the last quit attempt differed substantially across different European Member states…” citing Hummel et al 2018. Here too the use of the word “experimentation” misrepresents and mischaracterises the data in Hummel’s study. Experimentation may infer a lack of seriousness, frivolity, or even recreational use. None of these concepts were part of the official study.
We agree that strategies to help smokers quit are essential to public health as stated on Page 70, Line 27-29, but current strategies are clearly inadequate and do not effectively address the EU’s high levels of smoking (26%).
SCHEER’s conclusion is arrived by pooling findings from different studies, not adjusting for population/race differences, age and sex, and different durations of cessation (seven days to 12 months). A 12-month abstinence differs substantially from seven days. A thorough objective and unbiased scientific evaluation of the weight of evidence for vaping products and their role in cessation and effectiveness in helping smokers move away from smoking therefore should have arrived at ‘strong’ conclusion instead of ‘weak’.
Beard et al. 2019:
Hartmann Boyce et al. 2020:
Farsalinos KE, Barbouni A (2020). Association between electronic cigarette use and smoking cessation in the European Union in 2017: analysis of a representative sample of 13,057 Europeans from 28 countries Tobacco Control.