SCHEER Preliminary Opinion on electronic cigarettes

: Published: 23 February 2021

October 2020. ETHRA submitted to the Scientific Committee on Health, Environmental and Emerging Risks Preliminary Opinion on electronic cigarettes public consultation.

47 (3-9)

The SCHEER begins this section by stating, incorrectly, that there is a large scientific body of studies suggesting that electronic cigarettes’ use can pose various risks to the user. This directly contradicts what was said in the same paragraph on page 46: “The health impacts of electronic cigarette’s use are still difficult to be established due to the lack of long-term data from epidemiological studies or clinical trials”.

Mouth and throat irritation 47 (12-25)

Minor throat irritation and coughs are common short term, minor side effects that are experienced when switching from smoking to vaping. Hajek et al (2019) reported in their randomised control trial, e-cigarettes vrs NRT, that “65.3% of e-cig users 51.2% of NRT users experienced this minor irritation. However, the e-cig group reported greater declines in the incidence of cough and phlegm production from baseline to 52 weeks than did the nicotine-replacement group.”Miler JA, Mayer BM, Hajek P (2016) also concluded that the switch from smoking to vaping was associated with a reduced incidence of self-reported respiratory infections.

References

Astrid Miler, J. and Mayer, B. (2016) ‘Changes in the Frequency of Airway Infections in Smokers Who Switched To Vaping: Results of an Online Survey’, Journal of Addiction Research & Therapy, 7(4). doi: 10.4172/2155-6105.1000290
Hajek, P. et al. (2019) ‘A randomized trial of E-cigarettes versus nicotine-replacement therapy’, New England Journal of Medicine, 380(7), pp. 629–637. doi: 10.1056/NEJMoa1808779

You can download our submission on acute effects here (PDF)

Flavours

Page 64 line 35 – 57

Page 65 line 1 - 57

The studies cited in this section that purport to show an increase risk to cardiovascular health have not assessed risks from e-cigarettes use, but harms from smoking and from past smoking history. Chen (2013) reports on 36 events that occurred as far back as 1980, this has no relevance to e-cigarettes as they were not invented at the time. Similarly, the studies by Qasim et al (2017), Vlachopoulos et al (2016), and Antoniewicz et al (2016) report on adverse effects of smoking. Another issue with some of the studies cited in this report is the assessing only of acute effects that disappear in a short time.

Since e-cigarettes do not contain tobacco and there is no combustion involved it stands to reason that those who switch to e-cigarettes will substantially reduce their exposure to the harmful chemicals found in the smoke from combustible tobacco. This is borne out in the evidence from a growing body of high-quality studies, including long term studies conducted over a number of years, which have found significant benefits to smokers who have switched from smoking to using e-cigarettes. As Farsalinos and Polosa said in their 2014 safety evaluation and risk assessment of e-cigarettes, “Due to their unique characteristics, ECs represent a historical opportunity to save millions of lives and significantly reduce the burden of smoking-related diseases worldwide.”

An assessment of the health impacts of e-cigarettes should include comparisons with the effects of smoking. The report fails to do this and has chosen instead to compare health impacts from vaping with non-smokers. The majority of e-cigarette users in the EU are former or current smokers (Farsalinos, K. E., Poulas, K., Voudris, V., and Le Houezec, J. 2016), and so the risks of vaping compared to those from continued smoking should be the focus for a health impact assessment of e-cigarettes.

The assumption made in the Opinion that the cardiovascular effects of nicotine obtained via smoking can also be applied to vaping does not stand to reason. The harms from smoking are due to combustion and not to nicotine. Long term epidemiological studies into using nicotine without combustion, such as in snus and NRT, show that nicotine does not pose any serious long-term risks. Lee (2013) carried out an evaluation of health effects of switching from cigarettes to snus. They concluded that “the findings consistently demonstrate that switching from cigarettes to snus is associated with a clearly lower risk of CVD and cancer than in continuing to smoke. The risk in switchers is no different from that in smokers who quit smoking. The findings are consistent with other evidence that adverse health effects of snus are at most minimal.”

Public Health England has been consistent in their message to smokers about the harm reduction potential of switching from smoking to vaping, and the need for accurate information of the relative risks to be conveyed to the public. In their comprehensive literature review in 2018 they stated that “vaping poses only a small fraction of the risks of smoking and switching completely from smoking to vaping conveys substantial health benefits over continued smoking.” With relation to cardiovascular risk and lung disease in particular they said, “Comparative risks of cardiovascular disease and lung disease have not been quantified but are likely to be also substantially below the risks of smoking.”

George et al (2019) found significant improvements in cardiovascular health in smokers that had completely switched to e-cigarettes. The conclusion of Benowitz et al (2016), a study cited in this opinion, was that completely substituting e-cigarettes for combustible tobacco would substantially reduce the harms from smoking, and result in a net benefit for cardiovascular health. A further study by Benowitz (2017), also cited in this opinion, came to the same conclusion, stating: “the cardiovascular risk of EC use is likely to be much less than that of cigarette smoking”

References

Benowitz, N. L. and Burbank, A. D. (2016) ‘Cardiovascular toxicity of nicotine: Implications for electronic cigarette use’, Trends in Cardiovascular Medicine, 26(6), pp. 515–523. doi: 10.1016/j.tcm.2016.03.001
Benowitz NL and Fraiman JB (2017) Cardiovascular effects of electronic cigarettes. Nature Reviews Cardiology 14(8): 447–456
Farsalinos, K. E. and Polosa, R. (2014) ‘Safety evaluation and risk assessment of electronic cigarettes as tobacco cigarette substitutes: A systematic review’, Therapeutic Advances in Drug Safety, 5(2), pp. 67–86. doi: 10.1177/2042098614524430
Farsalinos, K. E., Poulas, K., Voudris, V., and Le Houezec, J. (2016) Electronic cigarette use in the European Union: analysis of a representative sample of 27-460 Europeans from 28 countries. Addiction, 111: 2032– 2040. doi: 10.1111/add.13506
George, J. et al. (2019) ‘Cardiovascular Effects of Switching from Tobacco Cigarettes to Electronic Cigarettes’, Journal of the American College of Cardiology, 74(25), pp. 3112–3120. doi: 10.1016/j.jacc.2019.09.067
Lee, P.N. (2013). The effect on health of switching from cigarettes to snus—A review. Regul. Toxicol. Pharmacol., 66, 1–5.
McNeill, A. et al. (2018) ‘E-cigarettes and heated tobacco products: evidence review Annual update of Public Health England’s e-cigarette evidence review by leading independent tobacco experts.’, Public Health England, pp. 1–243

You can download our submission on flavours here (PDF)

Human evidence for health impacts of electronic cigarettes CVD

Page 47 lines 27-54

Page 48 lines 1 - 45

References

Benowitz, N. L. and Burbank, A. D. (2016) ‘Cardiovascular toxicity of nicotine: Implications for electronic cigarette use’, Trends in Cardiovascular Medicine, 26(6), pp. 515–523. doi: 10.1016/j.tcm.2016.03.001
Benowitz NL and Fraiman JB (2017) Cardiovascular effects of electronic cigarettes. NatureReviews Cardiology 14(8): 447–456
Farsalinos, K. E. and Polosa, R. (2014) ‘Safety evaluation and risk assessment of electronic cigarettes as tobacco cigarette substitutes: A systematic review’, Therapeutic Advances in Drug Safety, 5(2), pp. 67–86. doi: 10.1177/2042098614524430
Farsalinos, K. E., Poulas, K., Voudris, V., and Le Houezec, J. (2016) Electronic cigarette use in the European Union: analysis of a representative sample of 27460 Europeans from 28 countries. Addiction, 111: 2032– 2040. doi: 10.1111/add.13506
George, J. et al. (2019) ‘Cardiovascular Effects of Switching from Tobacco Cigarettes to Electronic Cigarettes’, Journal of the American College of Cardiology, 74(25), pp. 3112–3120. doi: 10.1016/j.jacc.2019.09.067
Lee, P.N. (2013). The effect on health of switching from cigarettes to snus—A review. Regul. Toxicol. Pharmacol., 66, 1–5.
McNeill, A. et al. (2018) ‘E-cigarettes and heated tobacco products: evidence review Annual update of Public Health England’s e-cigarette evidence review by leading independent tobacco experts.’, Public Health England, pp. 1–243

You can download our submission on cardiovascular risk here (PDF)

Injuries due to burns and explosion

Page 52 lines 52 – 57

Page 53 lines 1 - 40

The Opinion deems the risk of injury due to battery explosion to be strong but the incidence to be low. Li-on batteries are used in phones, laptops, electric cars and in powerpacks for power tools. Li-ion batteries can become volatile if they are misused due to overcharging, overstressing, or as a result of poor manufacturing processes. They are used by millions of people every day, yet the instances of explosion and fire are relatively low. This issue is not specific to e-cigarettes.

As with so much of this report, there is a failure to compare the risks associated with vaping with the risks associated with the behaviour which vaping is replacing, i.e. smoking combustible cigarettes.

Public Health England’s 2018 evidence review stated that between 2015 and 2017 there were 3527 fires due to cigarettes and 44 deaths, and in the same timeframe there were 13 fires due to e-cigarettes and no deaths (McNeill et al). The US National Fire Protection Association reported that between 2012 and 2016 there was 18000 fires annually caused by smoking, and just 15 fires caused by e-cigarettes in 2015 (Ahrens, 2019). Vaping is therefore far less of a fire risk than smoking combustible cigarettes.

References

Ahrens, M. (2019) ‘Home Fires Started by Smoking’, National Fire Protection Association (NFPA), 590(January), pp. 7–9.
McNeill, A. et al. (2018) ‘E-cigarettes and heated tobacco products: evidence review Annual update of Public Health England’s e-cigarette evidence review by leading independent tobacco experts.’, Public Health England, pp. 1–243

You can download our submission on risks of injury due to burns and explosions here (PDF)

Lung diseases

Page 49 lines 1 - 20

The main area of concern in this section is an overreliance of in vitro studies, and the omission of studies that examine the effects of vaping on the whole-body system. These in vitro studies invariably involve mega dosing or submerging cells in e-liquid and recording the results, and are in no way indicative of the real-world effects of e-cigarettes.

Numerous important studies that directly address the health impacts of e-cigarettes were omitted from this section, and once again no assessment was made in relation to the health benefits experienced when smokers switched to e-cigarettes. This is the most important factor that should be assessed. Polosa et al (2014) identified 18 smoking asthmatics (10 single users, eight dual users) and found that overall, there were significant improvements in spirometry data, asthma control and AHR.

Another study by Polosa (2016) confirmed that EC use ameliorates objective and subjective asthma outcomes and shows that these beneficial effects may persist in the long term. The most significant finding of this study was that the reversal of harm from tobacco smoking in asthma patients was observed.

A key study relating to e-cigarette use and COPD has just been published by Polosa et al (2020). Presenting findings from a 5-year assessment of COPD patients who had switched to e-cigarettes, the study concludes that “EC use may ameliorate objective and subjective COPD outcomes, and that the benefits gained appear to persist long term. EC use for abstinence and smoking reduction may ameliorate some of the harm resulting from tobacco smoking in COPD patients.” These findings were consistent with findings at 24- and 36-month assessments of the same cohort.

Cibella et al (2016) found symptoms of cough/phlegm and shortness of breath disappeared in smokers who had switched from smoking to vaping. Those who abstained from smoking by vaping experienced improvements in respiratory function, suggesting that as e-cigarette use aids smoking cessation, it can help to reverse harms caused to the lungs from smoking.

References

Cibella, F. et al. (2016) ‘Lung function and respiratory symptoms in a randomized smoking cessation trial of electronic cigarettes’, Clinical Science, 130(21), pp. 1929–1937. doi: 10.1042/cs20160268
Polosa, R. et al. (2014) ‘Effect of smoking abstinence and reduction in asthmatic smokers switching to electronic cigarettes: Evidence for harm reversal’, International Journal of Environmental Research and Public Health, 11(5), pp. 4965–4977. doi:10.3390/ijerph110504965
Polosa, R. et al. (2016) ‘Persisting long term benefits of smoking abstinence and reduction in asthmatic smokers who have switched to electronic cigarettes’, Discovery Medicine, 21(114), p. AB5. doi: 10.1016/j.jaci.2015.12.017
Polosa R, Morjaria JB, Prosperini U, et al. (2020). COPD smokers who switched to e-cigarettes: health out comes at 5-year follow up. Therapeutic Advances in Chronic Disease. doi:10.1177/2040622320961617

You can download our submission on lung disease here (PDF)

SCHEER Preliminary Opinion on electronic cigarettes https://ethra.co/submissions/67-scheer-preliminary-opinion-on-electronic-cigarettes

Nicotine LD50

Page 40 lines 10 - 15

The median lethal dose of nicotine is referred to in the opinion as being 60mg (page 40 lines 10-15), which equates to 0.8mg/kg for oral ingestion, a figure that is considerably lower than the LD50 of nicotine for mice and rats. This is a highly contested figure and is based on data from over 100 years ago, obtained from questionable experiments. Assuming the figure is correct, which it is not, that would imply nicotine has a similar toxicity as cyanide, which we know is not the case. Mayer (2014) defined the median lethal dose of nicotine to be 20 times higher than the 60mg figure that is stated in the opinion. Since one of the main symptoms of nicotine intoxication due to ingestion is vomiting, it can be safely assumed that an even higher volume of nicotine would need to be consumed. The EU already has precautions in place, via the TPD, to prevent against nicotine intoxication, i.e. child-proof caps and a 20mg/ml upper nicotine limit for e-liquids.

Mayer, B. (2014) ‘How much nicotine kills a human? Tracing back the generally accepted lethal dose to dubious self-experiments in the nineteenth century’, Archives of Toxicology, 88(1), pp. 5–7. doi: 10.1007/s00204-013-1127-0

You can download our submission on nicotine LD50 here (PDF)

6.6 Role in the initiation of smoking (particularly focusing on young people)

Pages 62, 63 & 64

SCHEER acknowledges in this section that most of the included studies were carried out in the USA, and acknowledges that USA data may not reflect the situation in the EU (lines 50-52). SCHEER are comparing apples and oranges, as there are significant differences in e-cigarette use between the US and the EU. The different regulatory systems and variance in product availability render the US data irrelevant in the EU context. USA youth usage data includes use of products not available in the EU: high nicotine pods and cannabis products. Past 30-day use, or experimentation, is the main driver of increased vaping prevalence in the USA, which is less likely to lead to smoking than regular use. European smoking prevalence data is not considered in the report, however, to prove the “gateway effect” in youth, smoking prevalence would need to be shown to have increased.

Data from the CDC found that “From 2014 to 2018, the percentage of adults aged 18–24 years who currently smoked cigarettes decreased from 16.7% to 7.8%. The percentage of adults in this age group who currently used electronic cigarettes increased from 5.1% to 7.6%” (Survey and States, 2019). A forensic examination of the National Youth Tobacco Survey by Jarvis et al (2020) found that “frequent use and signs of e-cigarette dependence remained rare in students who had only ever used e-cigarettes and never any other tobacco product”. Highlighting once again the falling smoking prevalence among US youth, Levy et al (2019) conclude that “While trying electronic cigarettes may causally increase smoking among some youth, the aggregate effect at the population level appears to be negligible given the reduction in smoking initiation during the period of vaping’s ascendance.”. The Opinion acknowledges there was a decline in youth smoking during the same timeframe as there was an increase in youth e-cigarette use in the USA (page 17 lines 30-32).

The EU has a comprehensive regulatory regime for e-cigarettes, the TPD, so it is necessary to examine data from Europe to assess e-cigarette use within Europe. Here are three examples of relevant European studies, with their findings: The German Cancer Research Centre report (DKFZ, 2020) found that: “Even if numerous studies suggest a connection between e-cigarette consumption and smoking, this has apparently only had little and different effects at the population level”. A French study by Chyderiotis et al (2020) concluded that “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.” And, in the UK, Bauld et al (2017) found that “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”

Public Health England has cautioned against using gateway terminology: “We strongly suggest that use of the gateway terminology be abandoned until it is clear how the theory can be tested in this field.” (McNeill et al., 2015). Population level data from across Europe shows a continual decline in smoking rates across all ages group.

SCHEER concludes that there is strong evidence that e-cigarettes are a gateway to smoking but without examining smoking prevalence data it is not possible to reach this conclusion. Associations between e-cigarette use and smoking are treated as causal in the report when a more realistic explanation might be that both behaviours share a common liability. Chan et al (2020) carried out an extensive systematic review and meta-analyses, examining association between youth e-cigarette use and future smoking. They found that “the evidence is limited by publication bias, high sample attrition and inadequate adjustment for potential confounders.”

Lee, Coombs and Afolalu, (2019) summed up the gateway theory with regards to e-cigarette use: “if a true gateway effect were to exist, it would probably have little effect on smoking prevalence. No available evidence exists that increasing e-cigarette use has slowed the decline in smoking prevalence; indeed, the decline appears to have accelerated.”

It is very possible that e-cigarettes are lessening youth initiation of smoking, but the report fails to examine this.

References

Bauld, L. et al. (2017) ‘Young people’s use of e-cigarettes across the United Kingdom: Findings from five surveys 2015–2017’, International Journal of Environmental Research and Public Health, 14(9). doi: 10.3390/ijerph14090973.
Chan, G. C. K. et al. (2020) ‘Gateway or common liability? A systematic review and meta-analysis of studies of adolescent e-cigarette use and future smoking initiation’, Addiction, pp. 0–3. doi: 10.1111/add.15246
Chyderiotis, S. et al. (2020) ‘Does e-cigarette experimentation increase the transition to daily smoking among young ever-smokers in France?’, Drug and Alcohol Dependence, 208(November 2019), p. 107853. doi: 10.1016/j.drugalcdep.2020.107853.F
DKFZ. (2020) ‘E-Zigaretten und Tabakerhitzer – ein Überblick’.
Jarvis, M. et al. (2020) ‘Epidemic of youth nicotine addiction? What does the National Youth Tobacco Survey 2017 2019 reveal about highschool >e-cigarette use in the USA?’, Qeios, pp. 1–11. doi: 10.
Lee, P. N., Coombs, K. J. and Afolalu, E. F. (2019) ‘Considerations related to vaping as a possible gateway into cigarette smoking: An analytical review’, F1000Research, 7, pp. 1–24. doi: 10.12688/f1000research.16928.3
Levy, D. T. et al. (2019) ‘Examining the relationship of vaping to smoking initiation among US youth and young adults: A reality check’, Tobacco Control, 28(6), pp. 629–635. doi:10.1136/tobaccocontrol-2018-054446
McNeill, A. et al. (2015) ‘E-cigarettes: an evidence update’, Public Health England, p. 38.
Survey, I. and States, U. (2019) ‘ QuickStats: Percentage of Adults Aged 18–24 Years Who currently Smoke Cigarettes* or Who Currently Use Electronic Cigarettes, † by Year — National Health Interview Survey, United States, 2014–2018§’, MMWR. Morbidity and Mortality Weekly Report, 68(39), p. 870. doi: 10.15585/mmwr.mm6839a6

You can download our submission on the role of e-cigarettes in initiation of smoking here (PDF)

6.7 Role of electronic cigarettes in the cessation of traditional tobacco smoking and dual use

Page 70 line 21 – 55

Page 71 line 1 - 34

SCHEER states that data at individual and population level will be taken into consideration in their analysis, at page 10 lines 24-26: “The scientific opinion should address considerations relevant both at individual level and at a population level, from a public health perspective.” However, the report fails to do this.

Randomised Control Trials and population level data from national surveys across Europe show that

vaping is effective for smoking cessation.

Two randomised control trials are cited in the opinion, Hajek, et al (2019) and Walker et al (2020), both of these studies show e-cigarettes to be significantly more effective than NRT’s. In the case of Hajek et al, e-cigarettes were 83% more effective than NRT’s, and Walker et al found e-cigarettes combined with NRT’s to be 2.5 times more effective than patches alone. The most recent Cochrane review concluded that e-cigarettes were 68% more effective than NRT’s (Hartmann-Boyce et al., 2020). In their study: Moderators of real-world effectiveness of smoking cessation aids: a population study, Jackson et al (2019) conclude that “Use of e‐cigarettes and varenicline are associated with higher abstinence rates following a quit attempt in England”. A recent study by Lucchiari et al (2020) concluded that participants who used e-cigarettes with nicotine smoked fewer tobacco cigarettes than any other group after 6 months. Glasser et al (2020) added further evidence to the efficacy of e-cigarettes in their study which found that smoking cessation was more likely among frequent e-cigarette users.

Data from national surveys provide strong evidence that e-cigarettes have contributed to a reduction in smoking prevalence. The Health Ireland survey for 2019 shows that smoking prevalence fell 6% in 3 years with 38% of successful quitters using e-cigarettes, compared to only 15% using pharmacological products.

Santé Publique France found that more than 700,000 people have used e-cigarettes to stop smoking in the long term in 2017 and that vaping is the most common method used to quit smoking in France (Pasquereau et al., 2017).

Population data from the USA found that “The substantial increase in e-cigarette use among US adult smokers was associated with a statistically significant increase in the smoking cessation rate at the population level” (Zhu S-H et al, 2018)”

References

Department of Health (2019) Healthy Ireland. Summary Report 2019. Available at: https://assets.gov.ie/41141/e5d6fea3a59a4720b081893e11fe299e.pdf.
Glasser, A., et al. (2020). "Patterns of e-cigarette use and subsequent cigarette smoking cessation over two years (2013/2014 to 2015/2016) in the Population Assessment of Tobacco and Health (PATH) Study." Nicotine & Tobacco Research.
Hajek, P. et al. (2019) ‘A randomized trial of E-cigarettes versus nicotine-replacement therapy’, New England Journal of Medicine, 380(7), pp. 629–637. doi:10.1056/NEJMoa1808779.
Hartmann-Boyce, J. et al. (2020) ‘Electronic cigarettes for smoking cessation’, Cochrane Database of Systematic Reviews, (10). doi: 10.1002/14651858.CD010216.pub4.
Jackson, S. E. et al. (2019) ‘Moderators of real-world effectiveness of smoking cessation aids: a population study’, Addiction, 114(9), pp. 1627–1638. doi: 10.1111/add.14656.
Lucchiari et al. (2020) Benefits of e-cigarettes in smoking reduction and in pulmonary health among chronic smokers undergoing a lung cancer screening program at 6 months.
Pasquereau, Anne & Quatremère, Guillemette & Guignard, Romain & Andler, Raphaël & Verrier, Florian & Pourchez, Jeremie & Richard, Jean-Baptiste & Nguyen-Thanh, Viêt. (2019). USAGE DE LA CIGARETTE ÉLECTRONIQUE, TABAGISME ET OPINIONS DES 18-75 ANS Baromètre de Santé publique France 2017
Walker N, Parag V, Verbiest M, Laking G, Laugesen M, Bullen C. Nicotine patches used in combination with e-cigarettes (with and without nicotine) for smoking cessation: a pragmatic, randomised trial. Lancet Respir Med. 2020 Jan;8(1):54-64. doi: 10.1016/S2213-2600(19)30269-3
Zhu, S. H. et al. (2017) ‘E-cigarette use and associated changes in population smoking cessation: Evidence from US current population surveys’, BMJ (Online), 358, pp. 1–8. doi: 10.1136/bmj. j3262.

You can download our submission on the role of e-cigarttes in smoking cessation here (PDF)