Monday, 14 February 2022

Science has marched on: it is time to update the advice to Canadians

Published in 2018.
Out of date in 2022
A year ago we reported on the scientific progress that had been made since 2018, when the National Academies of Science, Engineering and Medicine (NASEM) issued its conclusions on the Public Health Consequences of E-cigarettes.  

This post provides a further update on key research findings, offering further evidence for our governments to stop suggesting that "the long-term consequences of vaping are unknown" and instead acknowledge that we now know that commercial products cause specific and severe damage to users.

The NASEM conclusions were founded on less than one-third of the evidence now available. 

The NASEM report was commissioned by the U.S. Food and Drug Administration in 2016. The committee looked at literature that was indexed for publication before August 31, 2017. Of the more than 10,000 articles indexed on PUBMED mentioning e-cigarettes or vaping, more than two-thirds have been published AFTER the committee had released its conclusions.


The NASEM committee acknowledged that it did not have sufficient evidence to address many questions about conclusions were founded on less than one-third of the evidence now available. 

The NASEM panel of experts explored the scientific evidence behind 47 conclusions, finding that there was conclusive or substantial scientific evidence for only 18, moderate evidence for 8, and limited to no evidence for 21. Fifteen of the 18 conclusions for which there was strong or substantial level of confidence confirmed potential harms from these products and only two related to potential benefits of vaping. These were the committee's conclusions that e-cigarette users who abandoned tobacco were exposed to fewer of the chemicals found in cigarette smoke and that these former-smokers who vaped experienced short-term health consequences in some organ systems.

Since 2018, other governments have assigned committees of scientists to conduct reviews of the growing body of evidence. From these, a scientific consensus is emerging that vaping is dangerous and not especially useful as a smoking cessation method. While no single authoritative document has brought together these systematic reviews, meta-analyses and report of health authorities, it is now apparent that:
  1. E-cigarettes have increased the number of young nicotine users in some countries. 
  2. Young people who use e-cigarettes are more likely to smoke conventional cigarettes.
  3. Dual use is common and harmful.
  4. When purchased as consumer products, e-cigarettes are not effective cessation aids. 
  5. E-cigarettes cause damage to respiratory and circulatory systems.
  6. Other governments have provided more recent scientific assessments.
  7. Health Canada's messaging on e-cigarettes is out-dated. .
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1. E-cigarettes have increased the number of young nicotine users in some countries.

The NASEM committee found there was substantial evidence that using e-cigarettes led to dependence, but did not directly address the extent to which these products had resulted in use or dependence among young people. Their modelling to assess the risks and benefits of marketing e-cigarettes did not factor in either addiction or the other health risks of vaping, but assessed only at the impact of vaping on smoking behaviour.

Their lack of attention to this health issue may be because at the time of their literature review, the 'youth vaping epidemic' had not yet been recognized. JUUL - the high-nicotine/high-fashion product that fueled the epidemic had its major launch in the summer of 2017 - only a few months before NASEM's evidence cut-off.


After the NASEM report was published, it became evident that e-cigarettes had increased the number of American teenagers hooked on nicotine. By 2019, one-quarter of U.S. high school students were vapers. [A] 

Vaping products reversed the downward trend in youth nicotine use. That is the key finding of a study by MeLisa Creamer and colleagues [B] that analyzed data from the US National Youth Tobacco Survey, conducted annually from 2004 to 2018 among a representative sample of US middle school and high school students. While cigarette use declined, e-cigarette use increased markedly. The net effect was more nicotine users in high schools. This was true both for ever use and current use of nicotine, as shown in the graphs below. By 2019, 15% of American high school students were current nicotine users.

Prevalence of cigarette and e-cigarette use, 2004-2018
USA NYTS. From Creamer, M et al


In Canada, the rate of nicotine use continues to be high. Data from the 2020-2021 Canadian Tobacco and Nicotine Survey (CTNS) [C ] confirm that one in seven teenagers and young adults (14% and 13% respectively) is a past-month vaper, and that one-third of high-school age kids have tried nicotine. These numbers underestimate the problem among 17-19 year-olds, as they include the younger ages (15 and 16) where prevalence is lower. Larger surveys of Canadian youth allow a closer look at each grade, and show that the child who enters high school in grade 9 as likely as not to have tried vaping before graduating. [D]

E-cigarettes are now the main product that is getting kids hooked on nicotine. The decline in cigarette smoking among young Canadians, for example, reflects a shift in the products they are recruited to use, not a decrease in initiation. 


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2. Young people who use e-cigarettes are more likely to smoke conventional cigarettes

The NASEM committee found "moderate" evidence that young people who used e-cigarettes were more likely to subsequently smoke cigarettes. 

It is now better understood that young e-cigarette users are 3-4 times more likely to become cigarette smokers than adolescent non-users of nicotine. This increased susceptibility, combined with the large number of young vapers, raises concerns that we may see a reversal of the downward trend in youth vaping. This appears to have already happened in another country with relaxed vaping regulations. In the most recent cycle of the Year 10 school survey, as reported by New Zealand's ASPIRE 2025 research team [E] both cigarette smoking and vaping had risen.


Multiple studies have now confirmed that adolescents who use e-cigarettes are at least three times more likely to take up smoking than non-users of e-cigarettes. Significant reviews and meta-analyses which confirm this association include a systematic review and meta-analysis conducted by researchers based in Australia, using studies that were published before October 2020.  Sze Lin Yoong and colleagues restricted their analysis to longitudinal studies only, thus strengthening the certainty of the findings. Their meta-analysis of 17 such studies of e-cigarette use at baseline and subsequent ever cigarette use ( found a relative risk of cigarette uptake of 3.01. All 17 studies showed a positive relationship. [F] 

This study builds on the conclusions of other recent meta-analyses, including those published 2020 by British researchers (Kouja et al. based on evidence up to November 2018) [G] and another Australian team (Baenziger et al. based on evidence up to April 2020). [H] 
  


And newer studies provide consistent results. After the October 2020 cut-off date for the Yoong meta-analysis, more longitudinal studies appeared were published that provide consistent conclusions.

In July 2021, Jeremy Staff and colleagues reported on their study using longitudinal data on British youth who were questioned at age 14 and followed at age 17. They found that young people who were using e-cigarettes at age 14, but not smoking, were more than five times more likely to have started smoking tobacco cigarettes by age 17.  The reverse was true too. Those who started smoking tobacco cigarettes at age 14 were three times more likely take up e-cigarettes by age 17.  Their results counter the proposition that the young people who vape would otherwise be smokers (the 'common liability' theory) as they found distinct risk factors for tobacco-use and vaping. [I]

Also in July 2021, a paper written by the Netherlands' research team lead by Thomas Martinelli  reported on e-cigarette use and tobacco smoking among Dutch-speaking high school students in the Netherlands and Belgium. [J] This longitudinal study collected follow-up information after six and twelve months and found that those who were using e-cigarettes were 5.63 times more likely to be using tobacco a year later. They also found that those who were smoking tobacco were 3 times more likely to be using e-cigarette at the year's end. These findings are very like those of British youth reported by Staff et al., cited above. 

A few weeks earlier, Elizabeth Hair and colleagues reported on a longitudinal study of youth and young adults (15-21 year-olds in 2017) who were contacted after one year. This study found that users of e-cigarettes in 2017 were more than three times more likely to become users of cigars, little cigars or cigarillos (CLCCs) by 2018.  Young people who were cigarette smokers or marijuana users in 2017 were also more likely to become users of CLCCs by 2018. [K] 

California researchers lead by John Pierce analyzed data from 4 waves of the American longitudinal PATH study, finding that e-cigarette use tripled the risk of becoming a daily smoker over the period of the data collection. [L] . 
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3. Dual use of combustible cigarettes and e-cigarettes is common and harmful

Health Canada's vaping web page provides the optimistic proposition: "There are short-term general health improvements if you completely switch from smoking cigarettes to vaping products."  [M] 

 The problem with this proposition in Canada is that only one-third of vapers are smokers who "completely switch." A much larger proportion (38%) of Canadian vapers are people who both smoke and vape. [C] (Data from the Canadian Tobacco and Nicotine Survey and the U.K. Office for National Statistics are shown below).

Researchers using data from heart studies [N, O] and general population studies have concluded that using both e-cigarettes and conventional cigarettes is likely more harmful than only smoking or only vaping. [P] 



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4. When purchased as consumer products, e-cigarettes are not effective cessation aids. 

The NASEM committee concluded that "There is moderate evidence from randomized controlled trials that e-cigarettes with nicotine are more effective than e-cigarettes without nicotine for smoking cessation." 

A number of studies have been published since then which emphasize the difference between real-world use of these products and the results in clinical settings. It is becoming clear that e-cigarettes used as consumer products are not effective as smoking cessation devices, while e-cigarettes given therapeutically in controlled clinical settings may help some people quit smoking.

As a recent Cochrane review explains it: "key questions about e-cigarettes mainly lie outside the realm in which randomized controlled trials (RCTs) are useful, and relate to the population impact of policies that promote their use for people who smoke compared with alternative policy positions that try to restrict their use.... increasing rates of continued use and use by people who have never smoked show that there is also potential for population harm." [Q] 

A number of research teams have identified very different results for e-cigarette use in real-world settings than in clinical contexts. Key studies include a meta-analysis published in January 2021 by Richard Wang and associates, [R] which collected data from studies published up to January 2020, including 55 observational studies and 9 randomized control trials (RCTs). The study found that overall  e-cigarettes, as consumer products, are not associated with increased smoking cessation in the adult population, although in randomized control trials, provision of free e-cigarettes as a therapeutic intervention was associated with increased smoking cessation. 

This analysis confirmed the trend found in analyses of longitudinal data from the United States, (some reported here earlier). In February 2022, Ruifeng Chen and colleagues used more recent waves of the PATH study and found that smokers trying to quit using e-cigarettes were 7% less likely to succeed than those using other methods of quitting.[S]    

New research is showing that "normal" or "typical" use of e-cigarettes is not associated with successA longitudinal survey in the  United Kingdom found that daily e-cigarette users were significantly more likely to quit smoking than were people who were using NRT or going "cold turkey", while non-daily e-cigarette users were significantly less likely to quit smoking than people using other methods or no method at all. More than half (60%) of all e-cigarette users were in the category of less-successful non-daily. [T]  Other researchers have found similar associations. [U] 

A 2021 meta-analysis by Zhang and colleagues [V] with data from 35 studies also found an association with intensiveness of e-cigarettes use or clinical settings and success. (A secondary finding was that adolescent e-cigarette users were three times more likely to become cigarette smokers, consistent with the data reported above). [E to L] 

Additional concerns about 'typical' use of e-cigarettes by former smokers include the increased chance of relapse to smoking cigarettes. A small number of studies have been directed at this consequence (as reviewed by a Brazilian research team led by Laura Barufaldi).[W They found smoking relapse was twice as likely among people who had quit smoking but subsequently started using e-cigarettes.

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5. E-cigarettes cause damage to respiratory and circulatory systems.

The NASEM committee found very little published science on which they could assess whether e-cigarettes caused significant harm to the respiratory, heart or other body systems. The absence of knowledge at that time was the basis of the take-away from the report that the 'long-term consequences of vaping were unknown'. 

It is now known that there are significant long-term health risks associated with these products. Since the NASEM report, there have been hundreds of studies published that have examined adverse health consequences of e-cigarette use using laboratory studies of animals and humans. Studies on animals and human tissue have lead researchers to conclude that the damage caused by e-cigarettes is the type that leads to lung and heart disease and strokes. 

A useful such summary was published in March 2021 by two American researchers who reviewed the Cardiovascular and immunologic effects of electronic cigarettes. [X] (Their references are linked) 

In summary, the weight-of-evidence discussed above warrants the view that the use of e-cigarettes has multiple adverse health effects. Acute use of e-cigarettes leads to an increase in heart rate and blood pressure [40], as well as obstruction of conducting airways [39], and arterial stiffness [61]. Flow-mediated dilation is diminished [69], transcutaneous oxygen tension is decreased [106], and a characteristic immune response [40, 41, 81] is activated. Chronic use of e-cigarettes has been found to be associated with a shift in cardiac autonomic balance towards sympathetic predominance [64] and dysregulation of immune-related genes [82]. In animal models, long-term exposure to e-cigarette aerosols lead to DNA damage and inhibition of DNA repair and the development of adenocarcinoma and bladder urothelial hyperplasia [28]. Lipid-laden macrophages accumulate in the lung, accompanied by extensive changes in lipid metabolism and transport [100]. Taken together, these observations raise the possibility that habitual use of e-cigarettes could cause tissue injury, which could compromise lung function and increase the risk of developing heart disease and stroke. The use of e-cigarettes could also compromise the ability to remove microbial pathogens and thereby increase susceptibility to viral, fungal, and bacterial infection. Data from experimental models also support the notion that the use of e-cigarettes could increase the risk of developing several types of cancer. Nevertheless, it remains to be seen whether long-term use of e-cigarettes is indeed associated with such adverse events in humans.

Similar findings have been made by other research teams:

In January 2020, Buchanan et al., in their comprehensive review of cardiovascular effects reported "...recent studies have also suggested that e-cigarette use is associated with inflammation, oxidative stress, and haemodynamic imbalance leading to increased cardiovascular diseases risk." [Y] 

In 2019, Kennedy et al., in their review of 38 studies of cardiovascular effects of e-cigarettes reported, "Most studies suggest potential for cardiovascular harm from electronic cigarette use, through mechanisms that increase risk of thrombosis and atherosclerosis." [Z] 


In 2020, Wills et al. reported the results of a review and meta-analyses of respiratory effects of e-cigarettes. They showed that e-cigarette use was associated with a 39% increase in the risk of asthma and a 51% increase in the risk of chronic obstructive pulmonary disease. They also concluded; "Laboratory studies consistently show an effect of e-cigarettes on biological processes related to respiratory harm and susceptibility to illness." [AA] 

The work by Wills et al. extended the 2019 review by Gotts et al. of the respiratory effects of e-cigarettes. At that time, Jeffery Gotts and his colleagues concluded: "Studies show measurable adverse biologic effects on organ and cellular health in humans, in animals, and in vitro." [AB] 

More recent 2021 reviews and studies have confirmed and updated the findings of the works discussed above. Stella Tommasi and colleagues further investigated gene dysregulation in smokers and vapers. They found that genes that control mitochondria (Mitochondria are cells' energy factories. Their disruption is an early sign of long-term disease development.) were disrupted both by smoking and vaping. While there was some overlap, there many cases of dysregulation that were vape-specific and others that were tobacco-specific. [AC] 

Lauren Davis and colleagues published a review of the pulmonary effects of long-term e-cigarette use early in 2022 that updated earlier reviews of the respiratory effects of e-cigarettes. Davis and colleagues concluded: "Chronically, these changes are likely to result in irreversible parenchymal lung tissue damage and impaired gas exchange, contributing to chronic lung conditions in long-term vapers." [AD] 

While not a review article, the 2022 report by Poonam Rao and colleagues adds to our understanding of how e-cigarette vapour impairs vascular functioning.  In a 2022 study, the researchers showed that a wide range of e-cigarettes impaired blood flow in mice (as measured by flow-mediated dilation) in much the same way and to approximately the same degree as combustible cigarettes. [AE]

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6. Other governments have provided more recent scientific assessments than NASEM.

The NASEM committee was one of the earlier scientific panels established by government health authorities to review the science related to e-cigarette regulation. Since then a number of other governments or inter-governmental organizations have commissioned reports. Except for reports from the United Kingdom (Public Health England, National Institute for Health and Care Excellence), that continue to recommend e-cigarettes for smoking cessation, at least eight other recent national and intergovernmental reports conclude that e-cigarettes are hazardous and are not recommended for smoking cessation. 

The European Commission. A year after the NASEM report was published, the European Union asked its scientific advisers (the Scientific Committee on Health, Environmental and Emerging Risks - SCHEER) to provide an opinion three aspects of e-cigarettes: their use and adverse effects, and their role as a 'gateway' to smoking. With their cut off date of April 2019, this committee had 9 more months of evidence to consider than did the NASEM committee. After making their preliminary assessment available for public input and reviewing comments, SCHEER adopted its  "Final Opinion on Electronic Cigarettes" last year (April 2021). [AF] 

This report strengthens concerns about the risks associated with e-cigarette use, while failing to find more than weak evidence that they help smokers quit. SCHEER concluded:
  • evidence supporting e-cigarettes as an effective smoking cessation device was "weak". 
  • evidence that second-hand exposure to e-cigarette vapour posed risks was "weak to moderate".
  • evidence that e-cigarettes helped smokers cut down on the amount smoked was "weak to moderate".
  • evidence that e-cigarettes could cause cancer in the respiratory tract was "weak to moderate".
  • evidence that e-cigarettes posed risks for coronary disease was "moderate".
  • evidence that e-cigarettes were a gateway to smoking for young people was "moderate"
  • evidence that e-cigarettes with nicotine were addictive was "strong"
  • evidence that flavours in these products contribute to initiation was "strong".
Other American scientific committees. In January 2020, the U.S. Surgeon General issued a report on smoking cessation, in which the efficacy of e-cigarettes to aid quitting attempts was reviewed based on evidence published into 2019. The report found that this assessment was made more difficult because of the wide variety of products that were in the market, and that "there is presently inadequate evidence to conclude that e-cigarettes, in general, increase smoking cessation." [AG] The following year, in January 2021, the United States Preventive Services Task Force also recommended against counselling smokers to use e-cigarettes. "The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of e-cigarettes for tobacco cessation in adults, including pregnant persons. The USPSTF recommends that clinicians direct patients who use tobacco to other tobacco cessation interventions with proven effectiveness and established safety." [AH]

Review commissioned for the Irish government. In June 2020 the Irish Health Research Board reported on its assessment of scientific papers published until February 2020 that addressed the effectiveness of e-cigarettes as cessation products [AI] and the role they played in the initiation of conventional cigarette smoking by adolescents. [AJ] In these two reports. that "e-cigarettes were not more effective for smoking cessation than approved nicotine replacement therapies (NRTs), which questions the need for e-cigarettes as a smoking cessation intervention. In the second review, we found that e-cigarettes were associated with initiation of conventional cigarette smoking among adolescents, which identifies a potentially serious harm."

Review commissioned for the Spanish government. Spain's public health agency concluded in 2020 that "To date, no toxicological or drug studies have been performed on the long-term safety of e-cigarette use in humans; without these data it is impossible to say with certainty that e-cigarettes are safer than cigarettes. With this in mind it is impossible to recommend these devices as a useful tool against the cessation of traditional tobacco consumption." (machine translation) [AK] 

Review commissioned for the Australian government.  The Australian  National Centre for Epidemiology and Public Health concluded that e-cigarettes did not help people quit smoking, but did increase the probability of a young person starting to smoke.[AL]   (The evidence review was separately published.) [H] 

For the Netherlands government, the Trimbos Institute reviewed the literature and found that e-cigarettes were effective as cessation products for only a small group of smokers, and that success rates were comparable to "regular" methods. Because most e-cigarette users in that country also continued to smoke, it cautioned about the additional risks of dual use. [AM]  

At the request of the French government, the French High Council for Public Health reconsidered its 2016 conclusion that e-cigarettes were a useful tool to help people quit smoking. After reviewing new evidence, they issued a revised finding in November 2021: "Evidence-based knowledge in insufficient to propose to health professionals that they use electronic nicotine delivery systems to help thier patients quit smoking." [unofficial translation].[AN]  

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7. Health Canada's messaging on e-cigarettes is outdated.

Unlike the governments cited above, Health Canada has not updated its assessment of the risks of vaping for several years, and cites no research on risks or cessation more recent than 2018. 

Despite the accumulating evidence to the contrary, the department  continues to encourage smokers to believe that "using e-cigarettes is linked to improved rates of success,"  [M] Despite the accumulating evidence of specific and serious long-term consequences, it continues to make its primary preventive message that  "The long-term health impacts of vaping are unknown." [AO]

While ALL the long-term effects of vaping are yet to be documented, it is no longer accurate to suggest that such effects are not known. The short-term adverse health effects are known and that these short-term impacts will almost certainly lead to long-term increases in the risk of disease and death among addicted vapers who continue to vape throughout their lives.While some of the early adverse health effects identified in recent research are unique to vaping, broadly speaking, the same classes of adverse health effects occur when people start smoking combustible cigarettes.  Our long experience with cigarette smoking has taught us that these early physiological changes inevitably lead to higher risks of disease and death from heart disease, stroke, lung diseases and cancer among those who continue to smoke.  And, because of nicotine addiction, a great many people who started to smoke at a young age continue to smoke throughout their lives.

E-cigarettes contain nicotine and, like combustible cigarettes, are highly addictive.  There is every reason to believe that the adverse health effects that have been observed in mostly young vapers will lead to higher risks of disease and death later in life among those who continue to vape.  The tragic slow-acting epidemic of smoking-related disease and death after decades of smoking will almost certainly be repeated, perhaps only approximately, among those who continue to vape throughout their lives.

So the true meaning of sentence “The long-term health impacts of vaping are unknown” is that the short-term adverse health effects are known and that these short-term impacts will almost certainly lead to long-term increases in the risk of disease and death among addicted vapers who continue to vape throughout their lives.

Statements like this made by health authorities allow manufacturers to further minimize the risks of using their products, encourage smokers to use a cessation aid that for most will be less effective than traditional and safer products, and encourage young people and other users to think that vaping is a mostly harmless buzz-producing experience.

A more truthful, blunter message to young people is warranted. Something like: Smoking kills, and vaping almost certainly kills too.

And for smokers who are trying to quit on their own? Health Canada should advise: using e-cigarettes will likely decrease the chances of success and increase health risks when compared with approved smoking cessation aids.

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Publications cited

[A] King BA et al. The EVALI and Youth Vaping Epidemics — Implications for Public Health. New England Journal of Medicine. February 20, 2020. https://www.nejm.org/doi/full/10.1056/NEJMp1916171#article_references

[B] Creamer ME et al. Effects of e-cigarette use on cigarette smoking among U.S. youth, 2004–2018. Preventive Medicine. Volume 142, January 2021, 106316. https://www.sciencedirect.com/science/article/abs/pii/S0091743520303406?via%3Dihub.

[C] Physicians for a Smoke-Free Canada. The Canadian Tobacco & Nicotine Survey, 2020-21. http://www.smoke-free.ca/SUAP/2021/CTNS-2020-results.pdf

[D] Health Canada. Summary of results for the Canadian Student Tobacco, Alcohol and Drugs Survey 2018-19. https://www.canada.ca/en/health-canada/services/canadian-student-tobacco-alcohol-drugs-survey/2018-2019-summary.html

[E] ASPIRE 2025. Submission on Smokefree Environments and Regulated Products (Vaping) Amendment Bill. https://aspire2025.files.wordpress.com/2020/04/aspire-vaping-bill-submission-final.pdf

[F] Yoong SL et al. Association between electronic nicotine delivery systems and electronic non-nicotine delivery systems with initiation of tobacco use in individuals aged < 20 years. A systematic review and meta-analysis. Plos One September 8, 2021
https://journals.plos.org/plosone/article/metrics?id=10.1371/journal.pone.0256044

[G] Khouja JN et al.  Is e-cigarette use in non-smoking young adults associated with later smoking? A systematic review and meta-analysis. Tob Control. 2020 Mar 10;30(1):8–15. doi: 10.1136/tobaccocontrol-2019-055433. https://pubmed.ncbi.nlm.nih.gov/32156694/

[H] Baenziger ON et al. E-cigarette use and combustible tobacco cigarette smoking uptake among non-smokers, including relapse in former smokers: umbrella review, systematic review and meta-analysis, BMJ Open 2021. https://bmjopen.bmj.com/content/11/3/e045603

[I] Staff J et al. Adolescent electronic cigarette use and tobacco smoking in the Millennium Cohort Study. Addiction, 2021. https://onlinelibrary.wiley.com/doi/10.1111/add.15645

[J] Martinelli T et al. Exploring the gateway hypothesis of e-cigarettes and tobacco: a prospective replication study among adolescents in the Netherlands and Flanders. Tobacco Control Published Online First: 05 July 2021. https://tobaccocontrol.bmj.com/content/early/2021/08/18/tobaccocontrol-2021-056528

[K] Hair EC et al. A longitudinal analysis of e-cigarette use and cigar, little cigar or cigarillo initiation among youth and youth adults: 2017–2019. Drug and Alcohol Dependence,
Volume 226, 2021. https://pubmed.ncbi.nlm.nih.gov/34218009/

[L] Pierce JP et al. Use of E-cigarettes and Other Tobacco Products and Progression to Daily Cigarette Smoking. Pediatrics January 2021, e2020025122; DOI: https://doi.org/10.1542/peds.2020-025122.
https://publications.aap.org/pediatrics/article/147/2/e2020025122/36274/Use-of-E-cigarettes-and-Other-Tobacco-Products-and

[M] Health Canada. Vaping and quitting smoking. https://www.canada.ca/en/health-canada/services/smoking-tobacco/vaping/smokers.html

[N] Wang JB et al. Cigarette and e-cigarette dual use and risk of cardiopulmonary symptoms in the Health eHeart Study.  PLOS One. July 25, 2018. https://doi.org/10.1371/journal.pone.0198681.

[O] Alzahrani T, Pena I, Temesgen N, Glantz S. Association between electronic cigarette use and myocardial infarction. American Journal of Preventive Medicine. 2018 October; 55(4): p. 455- 461.https://doi.org/10.1016/j.amepre.2018.05.004. 

[P] Okunna N.  A Comparison of Mental and Behavioral Health Risks Factors Associated With Current Dual Use of Electronic Cigarette and Conventional Tobacco Cigarettes With Exclusive Tobacco Cigarette Use and Nonuse Among Adults in the United States.  American Journal on Addictions. 03 December 2020 https://doi.org/10.1111/ajad.1311

[Q] Livingstone-Banks J et al. Effects of interventions to combat tobacco addiction: Cochrane update of 2019 and 2020 reviews. Addiction 2021. https://onlinelibrary.wiley.com/doi/epdf/10.1111/add.15769

[R] Wang RJ et al.  E-Cigarette Use and Adult Cigarette Smoking Cessation: A Meta-Analysis. American Journal of Public Health, https://doi.org/10.2105/AJPH.2020.305999

[S]  Chen R et al. Effectiveness of e-cigarettes as aids for smoking cessation: evidence from the PATH Study cohort, 2017–2019Tobacco Control Published Online First: 07 February 2022. doi: 10.1136/tobaccocontrol-2021-056901

[T]  McDermott MS et al. The effectiveness of using e‐cigarettes for quitting smoking compared to other cessation methods among adults in the United Kingdom. Addiction. 09 March 2021. https://doi.org/10.1111/add.15474

[U] Kasza KA et al. Association of e-Cigarette Use With Discontinuation of Cigarette Smoking Among Adult Smokers Who Were Initially Never Planning to Quit. JAMA Network. 2021. 

[V] Zhang YY et al. The effect of e-cigarettes on smoking cessation and cigarette smoking initiation: An evidence-based rapid review and meta-analysis. Tob. Induc. Dis. 2021;19(January):4 https://doi.org/10.18332/tid/131624.
http://www.tobaccoinduceddiseases.org/The-effect-of-e-cigarettes-on-smoking-cessation-and-cigarette-nsmoking-initiation,131624,0,2.html

[W] Barufaldi LA et al. Risk of smoking relapse with the use of electronic cigarettes: A systematic review with meta-analysis of longitudinal studies. Tob Prev Cessat. 2021;29:29. Published 2021 Apr 27. doi:10.18332/tpc/132964

[X] Keith R and Bhatnagar A. Cardiorespiratory and Immunologic Effects of Electronic Cigarettes. Curr Addict Rep. 2021 Mar 5:1-11. doi: 10.1007/s40429-021-00359-7. Epub ahead of print. PMID: 33717828; MCID: PMC7935224.

[Y] Buchanan N et al. Cardiovascular risk of electronic cigarettes: a review of preclinical and clinical studies, Cardiovascular Research, Volume 116, Issue 1, 1 January 2020, Pages 40–50, https://doi.org/10.1093/cvr/cvz256

[Z] Kennedy CD et al. The cardiovascular effects of electronic cigarettes: A systematic review of experimental studies. Prev Med. 2019 Oct;127:105770. doi: 10.1016/j.ypmed.2019.105770. Epub 2019 Jul 22. PMID: 31344384.

[AA] Wills TA et al. E-cigarette Use and Respiratory Disorder: An Integrative Review of Converging Evidence from Epidemiological and Laboratory Studies. European Respiratory Journal 2020; DOI: 10.1183/13993003.01815-2019.

[AB] Gotts JE et al. What are the respiratory effects of e-cigarettes? BMJ 2019; 366 :l5275 doi:10.1136/bmj.l5275

[AC] Tommasi S et al. A novel role for vaping in mitochondrial gene dysregulation and inflammation fundamental to disease development. Sci Rep 11, 22773 (2021). https://doi.org/10.1038/s41598-021-01965-1.

[AD] Davis LC et al. Predicting the pulmonary effects of long-term e-cigarette use: are the clouds clearing? European Respiratory Review Mar 2022, 31 (163) 210121; DOI: 10.1183/16000617.0121-2021.

[AE] Poonam Rao, Daniel D Han, Kelly Tan, Leila Mohammadi, Ronak Derakhshandeh, Mina Navabzadeh, Natasha Goyal, Matthew L Springer.  Comparable Impairment of Vascular Endothelial Function by a Wide Range of Electronic Nicotine Delivery Devices, Nicotine & Tobacco Research, 2022;, ntac019, https://doi.org/10.1093/ntr/ntac019.

[AF] European Union. SCHEER (Scientific Committee on Health, Environmental and Emerging Risks), Scientific Opinion on electronic cigarettes, 16 April 2021. https://ec.europa.eu/health/system/files/2021-04/scheer_o_017_0.pdf

[AG] US Department of Health and Human Services. Smoking Cessation A Report of the Surgeon General. 2020. https://www.hhs.gov/sites/default/files/2020-cessation-sgr-full-report.pdf

[AH] US Preventive Services Task Force. Interventions for Tobacco Smoking Cessation in Adults, Including Pregnant Persons. US Preventive Services Task Force Recommendation Statement.JAMA. 2021;325(3):265-279. January 19, 2021 doi:10.1001/jama.2020.25019. https://jamanetwork.com/journals/jama/fullarticle/2775287

[AI] Quigley J et al.  Electronic cigarettes and smokingcessation: An evidence review. Health Research Board. 2020. https://www.hrb.ie/fileadmin/2._Plugin_related_files/Publications/2020_publication-related_files/2020_HIE/Evidence_Centre/Electronic_cigarettes_and_smoking_cessation_systematic_evidence_review.pdf

[AJ] O’Brien D et al. Electronic cigarette use and tobacco cigarette smoking initiation in
adolescents: An evidence review. May 2020. 
https://www.hrb.ie/fileadmin/2._Plugin_related_files/Publications/2020_publication-related_files/2020_HIE/Evidence_Centre/Electronic_cigarette_use_and_tobacco_cigarette_smoking_initiation_in_adolescents.pdf

[AK] Spain. Ministerio de Sanidad. Direccion general de salud publica. Inform sobre los cigarrillos electronicos: situacion actual, evidencia disponible y regulacion. 2020. https://www.mscbs.gob.es/ciudadanos/proteccionSalud/tabaco/docs/InformeCigarrilloselectronicos.pdf.

[AL] Banks E et al. Summary report on use of e-cigarettes and relation to tobacco smoking uptake and cessation, relevant to theAustralian context. 2020. https://openresearch-repository.anu.edu.au/bitstream/1885/211618/3/E-cigarettes%20smoking%20behaviour%20summary%20report%20final%20200924.pdf

[AM] Netherlands. Nationaal Expertisecentrum Tabaksontmoediging (NET). Trimbos Institutt. Facktsheet Elektronische Sigaretten (E-Sigaretten). April 2020. https://www.trimbos.nl/docs/160d6402-233a-426e-9343-b10d1c5f5b39.pdf

[AN]  France. Haut Conseil de la santé publique. Avis. relatif aux bénéfices-risques de la cigarette électronique. November 2021. https://www.hcsp.fr/Explore.cgi/Telecharger?NomFichier=hcspa20211126_bnridelacileacdelavdufv.pdf

[AO] Health Canada. Risks of Vaping.  Date modified: 2020-06-11. https://www.canada.ca/en/health-canada/services/smoking-tobacco/vaping/risks.html

Wednesday, 2 February 2022

Flavourings make e-cigarettes more harmful. Another good reason to ban them.

Most Canadian governments which have banned flavoured e-cigarettes have done so in order to reduce the number of young people who are brought into nicotine use through the use of attractive flavourings. Vaping manufacturers have objected to these measures, and are claiming that flavours "save lives" because they encourage smokers to switch to e-cigarettes.

Missing from this discussion has been a consideration of the additional health risks that flavouring additives introduce to vaping, and the benefits to the health of vapers if the types and quantities of these ingredients were reduced. 

Most e-liquids sold in Canada are flavoured. The Vaping Industry Trade Association last year reported to Health Canada that there are "400,000 unique flavouring compounds being utilized in the manufacture of e-substance manufacture in Canada." That's about one unique ingredient for every 4 of Canada's 1.5 million vapers. (They did not provide a list of these compounds, and their estimate is higher than other published information.) [1] Yet current restrictions on e-cigarette ingredients are minimal and often vague.

This post presents background information on (1) current approaches to regulating e-liquid flavours and other ingredients, including Health Canada's ground-breaking proposals, (2) the flavourants that are currently in use, (3) the risks these chemicals can pose and (4) implications for public health decision-makers.

Part 1: How flavours and ingredients are currently regulated.  

Restrictions on what e-vapours smell or taste like

In Canada, three provinces have already implemented prohibitions on selling e-cigarettes that have a flavour or aroma of anything other than tobacco, and two territories have taken steps in this direction. None of these governments have imposed bans on any specific ingredients, but have instead chosen to allow manufacturers to decide what ingredients they can use without causing a "characterizing" flavour.

  • Nova Scotia extended the prohibitions in the Tobacco Access Act to include e-cigarettes, effective April 2020 1. Its ban covers tobacco or e-cigarettes which have "a characterizing scent or flavour, other than tobacco, that is noticeable before or during use, or both." 
  • Prince Edward Island's restrictions, which came into force on March 1, 2021. Its Tobacco and Electronic Devices Sales and Access Act Regulations establishes that the flavour bans in its law apply to "an agent added to tobacco or an electronic smoking device to produce an aroma or taste other than the aroma or taste of tobacco, including the aroma or taste of candy, chocolate, fruit, a spice, an herb, an alcoholic beverage, vanilla or menthol."
  • New Brunswick's Tobacco and Electronic Cigarette Sales Act was modified to ban the sale of any e-liquids that have a "noticeable flavour" other than tobacco. This came into effect on September 1, 2021. 
  • The Nunavut legislature adopted a new Tobacco and Smoking Act last June which would forbid the sale of e-cgiarettes that "contains an ingredient or combination of ingredients that imparts a distinguishing aroma or flavour, including that of a spice or herb, but not including that of tobacco." The government has yet to sign this law into effect.
  • In late December, the Northwest Territories circulated draft Tobacco and Vapour Products Control Regulations which would ban all vapour products that "impart an aroma or flavour, including that of a spice or herb.. except flavoured vapour products that impart a distinguishing aroma or flavour of tobacco and no other distinguishing aroma or flavour."

In other parts of the world, seven countries have used the same 'characteristic flavour' approach to regulate e-liquid s. That is, they prohibit the sale of vaping products which produce a flavour or aroma that is characteristic of something other than tobacco.

  • Finland was the first to introduce this measure (in 2016). The Finnish Tobacco Act (s. 24) prohibits characterizing flavours other than tobacco-flavour in e-cigarettes. 
  • The two other European countries to have implemented similar restrictions are Hungary (May 2020) and Estonia (2019). Estonia's law originally banned all flavours but tobacco, but this was amended to allow menthol in 2020, coinciding with the EU-wide removal of menthol from tobacco. 
  • The four other countries which have adopted flavour restrictions are Denmark (all flavours other than tobacco and menthol, effective April 1, 2022), the Netherlands, (All flavours other than tobacco, effective July 1, 2022), Ukraine (all flavours but tobacco, effective July 2023), and Lithuania's (ban on flavourings other than tobacco by July 2022).

Four U.S. states (New York, Massachusetts, New Jersey and Rhode Island)  have also implemented bans on e-liquid flavourings other than tobacco-flavour. California's law is suspended pending the results of a referendum. 

Restrictions on flavouring ingredients

Canada's federal government has proposed a different approach to regulating flavouring ingredients. Instead of only prohibiting flavouring ingredients purely on the characteristics they give to the product, they also propose to limit the ingredients that can be used. Health Canada's draft regulations, circulated in June 2021, would set a list ('schedule') of approved flavouring ingredients (40 flavouring ingredients permitted in tobacco-flavoured e-liquids and 42 different ingredients permitted in mint-menthol flavoured e-liquids). This list is the belt for the suspenders of an additional proposed ban on any "sensory perception other than one that is typical for mint, menthol or a combination of mint and menthol."

If this regulation is adopted, it will extend the promotional restrictions on flavours that have been in effect since the law came into force in May 2018. Schedule 3 of the federal Tobacco and Vaping Products Act, in force since May 2018, identifies five flavour categories that cannot be promoted in Canada: confectionery, dessert, cannabis, soft drink and energy drink. In Canada it is not illegal to sell an e-liquid that tastes like Cotton Candy, but it is illegal to use a label or promotion for that flavour. This is why such flavours are sold with eupheumistic names "Blue Fluff - Carnival Snack".

Restrictions for other ingredients in Canada and elsewhere

Governments in several countries have adopted some restrictions on e-cigarette ingredients on the basis that they are inherently harmful or on the basis that they might lead people to think that these products produce certain health benefits.

Canada's Tobacco and Vaping Products Act  (Schedule 2)  bans the use amino acids, caffeine, colouring agents, essential fatty acids, glucuronolactone, probiotics, taurine, vitamins and mineral nutrients. A different federal law, the Consumer Product Safety Act (CPSA) imposes a general prohibition on the manufacture or sale of products which are "a danger to human health or safety" and requires manufacturers to report adverse incidents. (Tobacco manufacturers are exempted from the requirements of this law). 

The Tobacco Directive of the European Union requires member states to ban the use of vitamins, caffeine, taurine and other stimulants and colouring agents. Unlike Canada, the EU also bans the use of additives that have CMR properties (carcinogenic, mutagenic or reprotoxic) and requires that "ingredients may not pose a risk to human health in heated or unheated form." 

New Zealand prohibits the use of several chemicals in vaping liquids in its Smokefree Environments and Regulated Products Regulations 2021 (Schedule 5). These include a ban on carcinogenic, mutagenic, reprotoxic chemicals, those which have specific organ toxicities (STOT-RE, with exceptions for benzoic acid and nicotine salts), and other chemical categories. 

Requirements for ingredient disclosure 

No country is known to require e-liquid manufacturers to list all ingredients on the product labels, but some countries require manufacturers to provide governments with that information.

Neither consumers nor governments know the entirety of the ingredients of the e-liquids sold in Canada. There is currently no requirement for manufacturers to provide Health Canada with a list of ingredients in their vaping liquids and no obligations to identify the flavouring compounds on packaging. The federal Vaping Products Labelling and Packaging Regulations require manufacturers to provide consumers with limited information on e-liquid ingredients. If flavourings are included, the manufacturer need only indicate that they contain "flavour". That said, Health Canada has signaled its intention to develop reporting regulations for vaping products since 2017, and more recent indications suggest/state that draft regulations might be published in winter 2022.

No provincial government requires vaping product manufacturers to provide ingredient list. British Columbia's E-substance regulation requires that manufacturers provide notice about the product before marketing, but does not require information on ingredients.

Nevertheless, in Canada some manufacturers voluntarily identify the presence of certain harmful ingredients. In packages for VUSE pods, BAT-Imperial Tobacco lists the presence of the toxic compounds (2-) hexanol (blueberry) and furaneol (strawberry) . 




In the European Union manufacturers of e-cigarettes must provide notification to governments 6 months before placing a product on market. There is an EU-wide common gateway for these reports. There is a standard reporting form which requires companies to provide details on each ingredient. Manufacturers are required to report on toxicity of ingredients and on the emissions produced. 

In New Zealand, manufacturers must (by February 2022) provide notification of all products that they intend to sell, and they must report all adverse reactions. They must provide government with information on each chemical ingredient (name and amount). 


Part 2. The chemicals that give flavour to e-cigarettes

Flavouring additives currently used Canada


Between 2017 and 2019, Health Canada purchased 825 samples of vaping liquids in major Canadian cities and analyzed these liquids using chromotography. This Open Characterization project was cited as background to the proposed flavour restrictions. [2]

This analysis identified over 1,500 unique chemical compounds (a smaller number than the 400,000 compounds reported by the Vaping Industry Trade Association) . Many of these compounds appeared in a small number of products and only 4 compounds (nicotine, propylene glycol and glycerol and Î²-Nicotyrine) were found in more than half of the e-liquids. The chemicals detected were in a wide range of chemical families, with alcohol and organooxygen being the most common. 

This study found that tobacco-flavoured e-liquids had somewhat fewer flavouring ingredients than did those marketed as fruit, mint-menthol, desert or confectionary. It also found significant variation over time, but whether this reflected differences in the e-liquids sampled or changes to the formulation was not made clear. Flavouring chemicals were also found in the "unflavoured" category, and the 5 most frequently detected flavour chemicals had sweetening properties (vanillin, ethyl maltol, ethyl vanillin, vanillin propylene glycol acetal and cyclotene). 

Health Canada: Open Characterization 

Flavouring additives used in other countries

Because e-cigarette manufacturers are required to disclose their ingredients to governments in the European Union, it is possible to identify which compounds are most commonly used with which flavours. Analyses of e-cigarette ingredients been conducted on behalf of governments in Europe, including the Netherlands [3] and France [4]. For the almost 17,000 products reported to the Netherlands' government, 213 unique flavouring compounds were identified, of which only 25 were found in more than 10% of the products. The most common flavouring chemicals used in tobacco-flavoured e-cigarettes were: Ethyl maltol, Methyl cyclopentenolone, Vanillin, 2,3,5-Trimethylpyrazine and Furaneol. For mint-menthol flavours, the 5 most common ingredients were: Menthol, Menthone, Ethyl maltol, Vanillin and Eucalyptol. The figure from Krusemann et al [5] below identifies the use of 79 chemicals in various flavour categories.



Part 3: The health effects of e-cigarette flavourings (including those Health Canada proposes to authorize)

Many e-liquids produce toxic compounds, some of which are not present in cigarette smoke

A number of reports have been published which raise concerns about the toxicity of e-cigarette ingredients, including flavourings. These include studies of e-cigarette liquids purchased in Ontario [6] which found that one fifth contained chemicals associated inhalation toxicity. this study found that 70% of e-liquids had measurable levels of tobacco-specific nitrosamines (TSNAs). Health Canada's subsequent study found no nitrosamines,[2] but did identify other compounds which are thought to cause cancer, including one (Naphthalene) which was found in 1 in 8 samples.

Toxicologists reviewing the evidence on the health effects of specific e-cigarette ingredients [7] express concern that although many e-liquid ingredients are thought to be safe as a food additive, little is known about what happens when they are inhaled. Also unknown are the toxic properties of the chemicals that are produced when flavouring and other e-liquid ingredients are combined and heated. With much left to be learned, it is nonetheless established that many flavouring ingredients used are known to be harmful. [8]

The French government recently reviewed the toxicity of e-cigarette ingredients, developing a priority list with 3 categories for regulatory consideration: (1) those which were known to pose significant risks, (2) those which were known to pose risks, and (3) those whose risks were not established. Fifty of the chemicals that manufacaturers had reported to government as used as ingredients or found in emissions were found to be cancer-causing, mutagenic, reprotoxic, endocrine disruptors, or toxic to specific organs.

Health Canada and other governments have based their decision to liberalize the vaping market on their determination that vaping is less harmful than smoking, in part because "vaping products typically contain ...lower levels of several of the harmful chemicals found in smoke". Equally, however, vaping products typically contain several harmful chemicals that are not found in smoke: the systematic review cited earlier found one-quarter of the harmful compounds found in conventional and e-cigarettes were unique to e-cigarettes.[7] 


Health Canada proposes to restrict flavourants on the basis of their attractiveness to youth, not on the basis of their harms to users.

As mentioned above, Health Canada is the first government to propose regulating the ingredients that will be allowed in e-cigarettes. This creates the potential to block the use of compounds that are known to be harmful. It also creates a more manageable set of ingredients for which health effects can be monitored. Health Canada will allow nicotine and 5 carrier agents and nicotine-modifiers (propylene glycol, glycerol, benzoic acid, citric acid, sorbic acid). It has identified 40 flavouring ingredients that will be permitted for tobacco-flavoured liquids and 42 for mint-menthol flavoured.

This list was created with the intention to "strike a balance between reducing the appeal of vaping products, to protect youth from inducements to use vaping products, and leaving some flavour options for adults who smoke and who have transitioned, or wish to transition, to vaping." Consistent with this aim, the government proposes to prohibit the use of sugar and flavouring compounds that make e-liquids taste sweet (including commonly-used ingredients like Ethyl maltol and Vanillin).

The regulatory aim is not to make vaping liquids less harmful. Reflecting the absence this objective, the list of permitted flavourings includes chemicals that are known to be carcinogenic, mutagenic or reprotoxic, and that are not approved for use even in foods. These are Estragole, Furfuryl alcohol, Pyridine, Isophorone, Alpha-terpinene, Wintergreen oil, Para-cymene, Pulegone, Menthofuran, 4-ethylanisole and methyleneisophorone. Other ingredients on Health Canada's list of authorized ingredients have been identified as the highest priority for regulation in France (including Benzoic Acid, Pyridine) and its second-highest (Propylene Glycol, Ethyl vinyl ketone, Butyric acid, 2-acetylpyridine, Alpha-terpinene, Nonanoic aacid, Glycerol, Thymol and Carvone).

Curiously, it was the Vaping Industry Trade Association which first drew public attention to the potential harms of these flavouring ingredients. In its brief to government, the major manufacturers want government to identify the chemicals that will be banned instead of identifying those that will be permitted. (Our submission recommended that the list of prohibited ingredients be expanded to include the acids which increased the addictiveness of these products by facilitating inhalation).  

Part 4: Implications for public health

A. Provincial governments should not rely on timely federal measures to protect kids from enticingly flavoured e-cigarettes.

It is unlikely that Health Canada's proposed flavour restrictions will survive without a significant fight, and the industry may be able to postpone implementation through legal and other tactics. 

Because this new Canadian approach would set a world precedent and would denying the vaping industry access to an endless source of chemicals to create new flavourings, it will be fiercely opposed. Already this industry is lobbying fiercely to defeat and delay this measure. Because it is a novel regulatory approach, it is more vulnerable to legal and technical challenges. The Canadian Vaping Association reports it has raised $1 million in its legal fund. The "technical issues" raised by the Vaping Industry Trade Association seem to have already caused delays.

Those provinces and territories (or even municipalities) which have not already banned e-liquid flavours should consider doing so soon.

B. Governments should limit flavouring ingredients in order to reduce the harms of vaping products

Flavourings in vaping liquids are harmful to young people who are encouraged by them to try an addictive product. (30% of Canadian vapers have never smoked cigarettes) [10]

For those who are using vaping products to reduce or end smoking vaping flavours unnecessarily add to harmful chemicals they will ingest with their nicotine dose. (One-third of Canadian vapers are former smokers and about 40% are dual users.) [10]

Because people interpret pleasant tasting compounds as safer, and less pleasant compounds as being more harmful, any flavouring that makes e-cigarettes "taste better" will also make it "seem less harmful." Reducing or eliminating flavours will help consumers better comprehend the risks. 

New labelling requirements, such as requiring full disclosure of ingredients and addidtional warning on flavoured products, would assist vapers in understanding how to reduce these risks if they wish to continue vaping. 

A ban on flavourings in e-cigarettes that are sold as recreational drugs need not apply to vaping products which are approved as therapeutic products or smoking-cessation aids under the provisions of the Food and Drugs Act. 

To protect the health of vapors, provinces and territories should adopt the most extensive flavour restrictions possible, including bans on mint-menthol flavours. 

C. Governments should collaborate in developing ingredient standards for e-liquids.

Health authorities across the globe are faced with new regulatory challenges as a result of the introduction of vaping products and other novel nicotine devices.

Many vaping manufacturers operate globally. With their human and financial resources, their trade secrets and their willingness to challenge regulation, they have a significant advantage over national health regulators. This disadvantage can be somewhat addressed if regulators collaborate in understanding these new products and in developing a regulatory response to them.

Health Canada's proposed regulation breaks important new ground, and implementing this approach will provide a precedent for other countries. European health agencies are using mandatory reports on ingredients and emissions to establishing a foundation for some ingredient controls.

Health Canada should accelerate ingredient restrictions by collaborating with European and other countries to identify chemicals which should be banned from e-liquids or their emissions because of their ability to induce young people to  experiment, to facilitate addiction or to exacerbate harms.

References 

[1] Vaping Industry Trade Association. Consultation Response to proposed Order Amending Schedules 2 and 3 to the Tobacco and Vaping Products Act. September 2021

[2] Kosarac I, Kubwabo C, Fan X, et al. Open Characterization of Vaping Liquids in Canada: Chemical Profiles and Trends. Front Chem. 2021;9:756716. Published 2021 Oct 14. doi:10.3389/fchem.2021.756716

[3] Krusemann, EJZ. The role of flavors in attractiveness of electronic cigarettes. Thesis submitted to Wageningen University.

[4] Anses. Declaration des produits du tabac et produits connexes en France. Produits du vapotage - Bilan 2016-2020.

[5] Krüsemann, EJZ, Pennings, JLA et al. GC–MS analysis of e-cigarette refill solutions: A comparison of flavoring composition between flavor categories. Journal of Pharmaceutical and Biomedical Analysis. Volume 188. 2020,

[6] Czoli CD, Goniewicz ML, Palumbo M, Leigh N, White CM, Hammond D. Identification of flavouring chemicals and potential toxicants in e-cigarette products in Ontario, Canada. Can J Public Health. 2019;110(5):542-550. doi:10.17269/s41997-019-00208-1

[7] Armendáriz-Castillo, I, Guerrero, S et al. "Genotoxic and Carcinogenic Potential of Compounds Associated with Electronic Cigarettes: A Systematic Review", BioMed Research International, vol. 2019, Article ID 1386710, 8 pages, 2019. https://doi.org/10.1155/2019/1386710

[8] Barhdadi, S., Rogiers, V., Deconinck, E. et al. Toxicity assessment of flavour chemicals used in e-cigarettes: current state and future challenges. Arch Toxicol 95, 2879–2881 (2021). https://doi.org/10.1007/s00204-021-03080-6

[9] Anses. Priorisation des substances chimiques dans les émissions des produits du vapotage. November 2021.

[10] Statistics Canada. Canadian Tobacco and Nicotine Survey. As reported in Physicians for a Smoke-Free Canada. The Canadian Tobacco & Nicotine Survey, 2020-21

Wednesday, 19 January 2022

NNSW - Progress towards implementing the advice of Canada's Chief Medical Officers of Health

The overarching objectives of these recommendations are to protect young people from inducements to use vaping devices by regulating such devices as equivalent to tobacco products, and to encourage smokers who use vaping devices to use them solely to end or reduce their use of all nicotine-containing products.

Council of Chief Medical Officers of Health
January 2020 

In early 2020, a few weeks before COVID-19 was declared a pandemic, Canada's Council of Chief Medical Officers of Health (CCMOH) issued their third statement about vaping. The occasion was National Non-Smoking Week, and the focus was on the need to intensify regulations on vaping products and to re-construct the policy approach to this market. 

This post tracks the development of regulations which respond to those recommendations. Over the past 24 months, eight provinces, three territories and the federal government have amended their legislation or regulations in order to strengthen controls on the vaping product market. 

No apparent progress, however, has been observed towards the CCMOH recommendations that a new and broadened regulatory approach towards nicotine products be established, or that nicotine product manufacturers be required to provide evidence that their products will benefit the public before they can be marketed.

Links to additional information, including a downloadable summary of this progress, are provided at the bottom of this post.

MARKET REGULATIONS 

Flavour bans

The CCMOH called for a ban on all flavoured vaping products (with exemptions for some flavours), either by federal or provincial governments. 

At the time of the recommendation only one province (Nova Scotia) had decided to ban all flavours but tobacco, which was put into force on April 1, 2020. Two other provinces followed suit: Prince Edward Island (March 1, 2021) and New Brunswick (September 2021). Nunavut passed legislation to ban flavours in 2021, but this has not yet been proclaimed into law. The Northwest Territories recently initiated a consultation process on the topic. Three provinces now only allow the sale of most flavours in specialty vape shops (Ontario, July 2020; British Columbia, September 2020; Saskatchewan, September 2021).

Last June, Health Canada published draft regulations that would ban flavours other than tobacco, mint, menthol, as well as prohibiting sugars and sweeteners and restricting the flavouring ingredients that could be used.

(In the past two years six European countries have introduced legislation to ban flavours: Denmark, Hungary, Netherlands, Ukraine and Lithuania. Such measures were adopted in Finland in 2016 and Estonia in 2019.) 

Nicotine restrictions

The CCMOH called for the nicotine content in vaping products to be limited to a maximum of 20 mg/ml. It also called for the development of other standards on nicotine delivery, such as temperature or the use of nicotine salts, if evidence supported these measures.

As a result of Health Canada regulations, nicotine concentration of vaping liquids was capped at 20 mg/ml effective July 23, 2021. Two provinces had earlier imposed this standard: British Columbia and Nova Scotia, both in September 2020.

(The 20 mg/ml maximum has been adopted by 41 countries, covering 70% of the population living in countries where e-cigarettes are permitted for sale.)



Safety requirements for ingredients

The CCMOH called for constituents of e-liquids to be regulated on the basis of their potential to cause harm when inhaled rather than oral ingestion.

The federal government is the only Canadian jurisdiction which is proposing to restrict the ingredients that can be used in vaping products, and some ingredients are already banned. These restrictions are based on the impact of the ingredients on flavour sensation or colourings, not on inhalation risk. (In the proposed revised Schedule 2 to the federal law, Health Canada is proposing to permit the use of some flavouring agents which are known to be harmful when swallowed or inhaled, including estragol, furfurl alcohol, pyridine, isophorone and others.)

Taxation 

The CCMOH called for vaping products to be taxed "in a manner consistent with maximizing youth protection while providing some degree of preferential pricing as compared to tobacco products."

Four provinces have imposed specific excise taxes or higher sales taxes on vaping products than on other consumer goods. B.C. increased the PST on vaping products from 7% to 20% (January 2020), Nova Scotia has a tax of $0.50 per millilitre of liquids (September 2020), Newfoundland and Labrador has a 20% tax on devices and liquids (January 2021) and Saskatchewan increased its sales tax on those products from 6% to 20%.(September 2021). 

The federal budget delivered in April 2021 proposed a specific excise tax of $1 per 10 ml of vaping liquids or fraction therefor (effectively a minimum tax of $1 per pod or other unit sold). A consultation on the tax was held, and the government indicated that the tax will come into effect “in 2022”.

Age 21 

The CCMOH called for the minimum age to be sold tobacco or vaping products to be increased to 21 years.

Both federal and provincial governments have minimum age laws. The federal minimum age remains 18, and only Prince Edward Island has raised the minimum age to 21 (March 1, 2020).

(In late 2019, the United States raised the minimum age to be sold tobacco or vaping products to 21, joining at least 7 other countries which ban the sale of tobacco to younger people  - Sri Lanka, Mongolia, Honduras, Uganda, Ethiopia, Philippines, and Singapore).

Age-gating

The CCMOH called for requirements for age-verification of internet purchases of vaping products that are the same as those required for cannabis.

In April 2021, Health Canada included the development of “Amendments to the Tobacco Access Regulations (Age Verification for Online Sales)” in its Forward Regulatory Plan.  The department indicated that the proposed regulation would identify the “mechanisms that must be undertaken to verify age and identity in the context of online sales.”   No further information has been made public.

Promotion

The CCMOH called for the federal government to restrict the advertising/marketing/promotion/ sponsorship of vaping devices in a manner consistent with maximizing youth protection and to allow adult-oriented marketing if aimed solely at supporting adult smokers ending or reducing their use of all nicotine-containing products. It called on provincial governments to ban all point- of-sale advertising other than in adult-only specialty vape shops. 

Since 2020, federal regulations on vaping product promotions have been put in place. These regulations forbid advertisements that can be seen by youth (" a vaping product or a vaping product-related brand element must not be promoted by means of advertising done in a manner that allows the advertising to be seen or heard by young persons."). 

All provincial governments have passed legislation to ban point-of-sale advertising where it can be seen by children. The federal regulation also prohibits these ads.

Federal regulations permit some forms of advertising to adults, but neither they nor provincial regulations restrict ads based on whether they are linked to supporting ending or reducing nicotine use. 

Packaging

The CCMOH called for the federal governments to require plain and standardized packaging along with health risk warnings for all vaping products

Federal government requirements for health warnings on vaping products came into force on July 1, 2020.  The only health risk identified in these warnings is addiction. 

The federal government does not currently propose to require plain packaging of vaping products, but one province has taken steps in this direction. British Columbia's E-Substances Regulation allows the sale of vaping products only when “packaged in a plain manner that does not contain any text or image other than as required or permitted under this section.” 



Pre-market requirements.

The CCMOH called for the federal government to require product manufacturers to disclose all ingredients of vaping devices to Health Canada as a condition of being marketed, including establishing consistency in reporting nicotine levels in both open and closed vaping systems.

Health Canada has indicated its intention to require vaping manufacturers to report such information. In the Forward Regulatory Plan 2021-2023, it identifies that “Vaping Product Reporting Regulations” will be developed, and that draft regulations would made public this winter.   

Retail Licensing

The CCMOH called for provincial governments to require a vendor's licence for those selling vaping products.

Five provinces have adopted requirements for retail licenses or have imposed registration requirements on retailers who wish to sell vaping products: Quebec (2015), British Columbia (July 2020), Nova Scotia (July 2020), Newfoundland and Labrador (2021), New Brunswick (April 2022). In Prince Edward Island, vaping products may only be sold in specialty stores that meet specific requirements, although a license is not required. Ontario requires specialty vape stores to be registered with local health authorities. 

ADMINISTRATION AND GOVERNANCE 

Enforcement 

The CCMOH called for the federal government to enhance compliance, enforcement and public reporting and called on provincial governments to routinely use youth test purchaser.

Health Canada has subsequently made public the result of its enforcement activities, and has reported on the results of three rounds of inspections of vaping retailers. In December 2021, Health Canada disclosed that it “has not pursued any prosecutions against regulated parties manufacturing or selling vaping products under the TVPA.”

As reported earlier this month, there is limited information on the results of compliance activities underway in Canadian provinces. 

Health Education 

The CCMOH called for governments to collaborate to enhance public awareness and educational initiatives on the risks of vaping products, targeted at young, parents, educators and health care professionals.

There is no consolidated report on such activities. Health Canada runs a “Consider the Consequences” campaign directed at young persons, with a 3-year budget of $12 million. Reported expenditures for Health Canada’s Youth Vaping Prevention Campaign were over $6 million in 2019-2020

Cessation support

The CCMOH called for governments to establish comprehensive cessation initiatives for people with nicotine addiction, especially for youth.

There is currently no consolidated report on such activities. Health Canada has provided financial support for the development of programs to support vaping cessation among younger Canadians,  as have some provincial governments.

Health Research

The CCMOH called for governments to monitor and research and short and long-term health effects of vaping products and to research the effectiveness of policy approaches to address youth vaping.

In 2020, the Canadian Institutes for Health Research with the Canadian Cancer Society awarded 27 grants for research directed to the health effects of vaping and policy approaches to address youth vaping. Through its Substance Use and Addictions Program, Health Canada has provided support for the development of youth vaping cessation interventions and research on policy development.

The CCMOH called for governments to research the effectiveness of vaping products in supporting smokers to end or reduce their use of all nicotine-containing products.

The Canadian Task Force on Preventive Health Care has conducted a systematic review of evidence on ‘Tobacco Smoking in Adults’ and is currently preparing draft guidelines. These are expected to be released in 2022/23. It is not clear that this will address “ending or reducing their use of all nicotine-containing products”, which is not an identified goal of the federal Canada’s Tobacco Strategy.

Monitoring and Surveillance

The CCMOH called for federal and provincial governments to enhance surveillance and reporting of vaping product use and population health impacts.

Since January 2020 national surveys have been established or expanded to include vaping use. These include Statistics Canada’s annual Canadian Tobacco and Nicotine Survey, which was conducted in the winter of 2019-2020, 2020-2021 and is currently in the field for 2021-2022. The results of the first two waves have been made  public. Since 2020, Statistics Canada's annual Canadian Community Health Survey has included questions on e-cigarette use, although this data not yet been released.

Health Canada has supported consumer research on vaping product use, including a vaper panel which has monitored behaviours of some individuals over a two-year period.

Other national surveys were diminished in this period. The formerly bi-annual Canadian Student Tobacco, Alcohol and Drug Survey was last conducted in 2018-2019. It did not take place in the 2020-2021 school year, as an apparent result of a delay in changing suppliers. The contract was awarded in December 2020 to CCI Research and the survey is in the field for the 2021-2022 school year. Federal funding supports the COMPASS survey, which is conducted in selected schools by University of Waterloo. 

Provincial surveys on vaping behaviours in the general population are conducted in some provinces, (including Quebec and Ontario) as are provincial surveys of young person's vaping (QuebecOntarioBritish Columbia).

Policy Revision 

The CCMOH called for governments to work together to develop a broad regulatory approach to all alternative methods of nicotine delivery (i.e. other than tobacco products). They recommended that a component of any such regulatory approach should be the requirement for  manufacturers to demonstrate that marketing new products is in the public interest.

No efforts to develop such a regulatory approach have been made public. 

(Premarket authorization is the approach now required by the U.S. Food and Drug Authority for e-cigarettes and novel tobacco products).

Resources-Fact sheets:

Monday, 10 January 2022

Reporting on enforcement of Canada's tobacco and vaping laws.

This post reports on efforts by Canadian governments to ensure that retailers of vaping products follow provincial and federal laws, and identifies where official and community reports on enforcement action can be found.

VAPING

Federal enforcement of restrictions on vaping marketing. 

Since 2019, Health Canada has proactively disclosed reports on its activities to ensure compliance and enforcement of the federal Tobacco and Vaping Products Act and the Consumer Product Safety Act. These reports are made available on Health Canada's website

  • Between July 2019 and December 2019, Health Canada conducted on-site inspections of 1080 specialty vaping shops and 2083 convenience retailers. Four out of five (84%) vape stores and one in eight (13%) convenience stores failed inspection. Enforcement actions included "seizure" (products remained on-site), and warning letters. Infractions noted were those related to toxic labelling, testimonials or endorsements, child resistance container packaging requirements, promotion of prohibited flavours, and tobacco product-related brand elements.
  • Between July 2020 and March 2021 Health Canada conducted on-line inspections of 304 Instagram accounts, finding that more than half (161, or 53%) were non-compliant with respect to promoting prohibited flavours, providing testimonials or endorsements. No other forms of non-compliance (absence of health warnings, youth access to media, etc) were identified. Warning letters were sent to these businesses.


Low compliance with federal law has been identified by non-governmental bodies in the health and industry sectors. In the summer of 2021, our agency found that vaping industry leaders were frequently non-compliant. The Vaping Industry Trade Association (representing large manufacturers) has issued its own guidelines for compliance, and also commissioned a review of the sales practices of a sample of on-line stores. In this review, 93% of the internet stores inspected were found to contravene federal prohibitions on certain flavours, and that fewer than half posted the mandatory health warning. 

Instagram promotion of a
 dessert-flavoured vaping product
 
There are indications retailers who receive warning letters nonetheless fail to align their business practices with federal law. This month we reviewed the Instagram accounts of the 161 businesses that had received warning letters from Health Canada inspectors. We found that 72 (45%) continued to display testimonial-endorsements or promote prohibited flavours, some of which are shown here. Other infractions, such as the absence of health warnings, the use of lifestyle imagery and youth access to the marketing were observed in many cases. 

Health Canada does not routinely disclose whether it has pursued any prosecutions under these acts, but in 
Instagram promotion 
using testimonial endorsement
December 2021, it disclosed that to date
 it had not "pursued any prosecutions against regulated parties manufacturing or selling vaping products under the TVPA." The decision to escalate enforcement proceedings is explained as follows:

"If compliance cannot be achieved, subsequent enforcement actions are pursued depending on a range of factors, including but not limited to:
• severity/impact of the alleged non-compliance;
• continuation or the probability of reoccurrence of the non-compliance;
• compliance history of the establishment;
• program priorities and available resources. "

Compliance and Enforcement activities by provincial governments

The following governments have made public certain enforcement activities related to vaping retailing. 

Prince Edward Island engaged a dedicated tobacco enforcement officer in 2019, following concerns that inadequate enforcement was leading to increased infractions (with 20% of retailers willing to sell to an underage test shopper).  Nine months after PEI's restrictions on flavoured vaping liquids came into force (in March 2021), three retailers had been taken to court, and charges had been laid against an additional retailer. Outcomes of enforcement activities are not proactively disclosed on the provincial web-site, but are communicated to the media. (This is a significant change from  past years, when PEI was reluctant to disclose the name of offending retailers.)

In December, 2021, the Nova Scotia government made public that on 29 occasions during the year its enforcement officials had seized vaping products which contravened provincial law because they were flavoured or had excessive amounts of nicotine. The retail value of the products seized was $605,000. In November, charges were laid against one of the suppliers (Vaporhub), with a hearing scheduled this month. Nova Scotia charges against individual sellers have also been made public last October.

Every five years, the Quebec government reports on its experience in administering its tobacco laws. The most recent of these is dated November 2020. In the preceding five-year period, the Quebec government found that compliance had grown, but that half of vape stores were non-compliant in their most recent inspections. Compliance rates grew from 27% in 2015-2016 to 51% in 2019-2020. Compliance was higher with respect to sales for minors (90% of stores passed inspection). 



TOBACCO

Routine disclosure of tobacco-related enforcement by federal and provincial governments

Health Canada previously made public annual reports on its compliance activities, but the most recent of these dates from activities now 5 years old (for 2016-2017). In that year the department conducted 6,792 retail inspections, reviewed the adequacy of more than 1,000 regulatory submissions  and analyzed samples of tobacco products. One in ten (11%) of retailers were found to be non-compliant with respect to labelling, promotion or other marketing practices, and one in 10 (11%) of manufacturers did not fully comply with reporting requirements. No charges were laid, and the most recent prosecution identifeid dated from 2006.

Newfoundland's tobacco law is enforced by Digital Government and Service NL. Compliance reports do not appear to be made public. 

New Brunswick's tobacco laws are inspected by the Inspection and Enforcement Branch of the Department of Justice and Public Safety, with some information provided in the department's annual reports. From this we know that the number of inspections has fallen considerably, but not whether compliance has improved.


The Ontario government delegates responsibility for inspection to local boards of health, and has established a guideline and protocol that requires annual inspections of each retail location. Under this protocol, boards of health are required to "publicly disclose a summary report of all retailer/owner convictions". The City of Toronto, for example, provides monthly updates on convictions, and Peel Region provides an ongoing list of retailers who have been found to be selling to youth.

The Quebec government report cited above provides the most extensive detail on tobacco and vaping-related compliance and enforcement activities by any Canadian government. Over a 5 year period the department conducted 32,949 inspections, observing non-compliance on 12,307 occasions (37%). Of the 10,617 charges that were laid as a result, 88% resulted in a guilty plea or verdict. The report also provides information on the inspection results for different aspects of the law.  Overall, slightly more than half (57%) of tobacco retailers were found compliant with respect to signage and displays, and 93% had refused to sell to a minor when tested. 

In December 2021, Saskatchewan's Auditor General raised concerns about enforcement of that province's tobacco and vaping laws. The departmental audit found that one-fifth (19%) of identified retail locations were not inspected, and that many retailers were not tracked at all. The AG noted that there were repeated offenses but that they "found no cases where the Ministry took retailers to court."

As part of its overhaul of tobacco legislation, the Alberta government is establishing a new enforcement procedure and team. Enforcement responsibilities had previously been unassigned.  This past summer the province reported that "the enforcement team is expected to be operational in the second half of 2021." 

The British Columbia government delegates responsibility for enforcement of its tobacco- and vaping-related laws to local health authorities. On its web-site, the province provides some information on enforcement results and practices (including its Compliance and Enforcement Policy Manual. Some tribunal results are also posted.