September 9, 2018

Stanton A. Glantz, PhD

Canadian Ministry of Health proposes to authorize e-cig sellers to make claims that ignore recent understanding of health risks

The Canadian Ministry of Health has invited public comment on marketing statements that it proposes to allow e-cigarette companies to make to seel their wares.

The big problem is that these claims ignore everything we have learned about the dangers and use patterns of e-cigarettes in the last year or so.

Here is the comment I sent in.  You can download a PDF of it here.

 

September 11, 2018

Mathew Cook

Manager, Regulations Division
Tobacco Products Regulatory Office
Tobacco Control Directorate

[email protected]

RE:  Authorized statements regarding e-cigarettes 

Dear Mr. Cook,

It has come to my attention that you are seeking comments  on the List of Statements for Use in the Promotion of Vaping Products.  I am pleased to offer some comments on these statements.

The scientific evidence on the health and behavioral effects of e-cigarettes is an area that is rapidly developing, particularly with growing evidence that e-cigarettes are much more dangerous than previously thought.  As a result, the proposed List of Statements for Use in the Promotion of Vaping Products are badly out of date and will put the Government in Canada in the likely position of authorizing statements that mislead and harm the citizens of Canada.

The most current and complete authoritative summary of the evidence on the effects of e-cigarettes was released by the European Public Health Association (attached to this comment and available at https://eupha.org/repository/advocacy/EUPHA_facts_and_fiction_on_e-cigs.pdf). [1]

The Ministry should carefully review this summary and the research it summarizes and revise these statements accordingly.

Below I summarize some of the problems with these statements based on the evidence summarized in the EUPHA evidence summary.

1. If you are a smoker, switching completely to vaping is a much less harmful option

There are two problems with this statement.  First, growing evidence shows that use of e-cigarettes is associated with adverse cardiovascular[ii] [iii] and pulmonary effects[iv] [v] [vi] [vii]similar to cigarettes to the point that epidemiological studies have shown risks of myocardial infarction and COPD and respiratory disease similar to that of smoking cigarettes, even after controlling for the effects of concurrent or former smoking.2 4  While some of the epidemiology studies are cross-sectional, which precludes drawing formal causal conclusions based on the epidemiology alone, the results are precisely what one would predict based on the biological and short-term clinical studies.  At the very least, they argue against making such a sweeping statement.

Second, the statement presumes complete switching from cigarettes to e-cigarettes when the great majority of smokers who use e-cigarettes remain dual users.[viii] [ix] 

2. While vaping products emit toxic substances, the amount is significantly lower than in tobacco smoke

This statement is based on assessment of a very limited number of substances, all of which are based on toxins identified in tobacco smoke.  E-cigarettes are different products with different chemistry and physics.  There needs to be a much broader investigation of the possible toxicants in e-cigarette aerosol before such a sweeping statement can be made by the Government.[x]

3. By switching completely to vaping products, smokers are exposed to a small fraction of the 7,000 chemicals found in tobacco smoke

This statement suffers from the same problem as statement 2.  In addition, it ignores the fact that e-cigarette aerosol consists of ultrafine particles at levels comparable to or higher than cigarettes.  These particles cause cardiovascular and pulmonary disease.  In addition, the particle size in e-cigarettes are often smaller than those generated by cigarettes, which are likely more dangerous.[xi]

4. Switching completely from combustible tobacco cigarettes to e-cigarettes significantly reduces users’ exposure to numerous toxic and cancer-causing substances

This statement suffers from all the problems described above.  While the current consensus is that e-cigarettes expose users to lower levels of the carcinogens that have been studied, this statement ignores the fact that two-thirds of smoking-induced deaths are caused by cardiovascular and pulmonary disease where the risks of e-cigarettes may approach cigarette smoking.[xii]

5. Completely replacing your cigarette with a vaping product will significantly reduce your exposure to numerous toxic and cancer causing substances

This statement suffers from the same problems as statement 4.

6. Switching completely from smoking to e-cigarettes will reduce harms to your health

This statement suffers from the same problems as the earlier statements.  It also ignores the fact that switching to e-cigarettes could still increase risks because the risk of current e-cigarette use is compounded with the risk of past smoking.

7. Completely replacing your cigarette with an e-cigarette will reduce harms to your health

This statement suffers from the same problems as statement 6.

There is also a concern that these statements could be misread by consumers and potential consumers as indicating that e-cigarettes are safe.  Has the Ministry done message testing to ensure that these messages will be understood (and not misunderstood) by users?

Importantly, all the proposed statements ignore the reality that most people who use e-cigarettes continue to smoke cigarettes8 9 as well as the evidence that for most (but not all) smokers, use of e-cigarettes depresses the likelihood of smoking cessation.[xiii]  These realities need to be reflected in the required statements.  E-cigarette promotion should include these warnings:

  • Most people who use e-cigarettes continue to smoke; doing so will increase your overall chance of getting sick.2 4
  • You must stop smoking cigarettes when you use this product or your risk of disease will increase. 2 4
  • E-cigarettes make it harder to stop smoking cigarettes for most people.8 9
  • People who start with e-cigarettes are likely to go on to smoke cigarettes.[xiv]

As you know there are many contentious issues surrounding e-cigarettes, so it is important that the Ministry obtain advice from a wide range of experts; a cursory review of the members of the SAB suggests that it is dominated by people who believe in e-cigarettes.  There is also a dearth of people with expertise in cardiovascular and pulmonary disease etiology.

Thank you for your consideration.

Sincerely yours,

        

Stanton A. Glantz, PhD

Professor of Medicine (Cardiology)

Truth Initiative Distinguished Professor in Tobacco Control

Director, Center for Tobacco Control Research and Education

 

[1] Facts and fiction on e-cigs.  European Public Health Association.  https://eupha.org/advocacy-by-eupha . August 30, 2018.

 

[ii] Alzahrani, T., Pena, I., Temesgen, N., & Stanton Glantz, S. A. Association Between Electronic Cigarette Use and Myocardial Infarction. Am J Prev Med 2018; doi: 10.1016/j.amepre.2018.05.004.
 

[iii] Cardinale A, Nastrucci C, Cesario A, Russo P. Nicotine: specific role in angiogenesis, proliferation and apoptosis. Crit Rev Toxicol. 2012 Jan;42(1):68-89.
 

[iv] M. F. Perez, N. Atuegwu, E. Mead, C. Oncken, E. M. Mortensen. E-Cigarette Use Is Associated with Emphysema, Chronic Bronchitis and COPD. Abstract A6245/402.  Presented at the International Conference of the American Thoracic Society. San Diego, California. May 18-23, 2018.
 

[v] Scott A, Lugg ST, Aldridge K, Lewis KE, Bowden A, Mahida RY, Grudzinska FS, Dosanjh D, Parekh D, Foronjy R, Sapey E, Naidu B, Thickett DR. Pro-inflammatory effects of e-cigarette vapour condensate on human alveolar macrophages. Thorax. 2018 Aug 13. pii: thoraxjnl-2018-211663. doi: 10.1136/thoraxjnl-2018-211663.
 

[vi] Viswam D, Trotter S, Burge PS, Walters GI. Respiratory failure caused by lipoid pneumonia from  vaping e-cigarettes. BMJ Case Rep. 2018 Jul 6;2018. pii: bcr-2018-224350. doi: 10.1136/bcr-2018-224350.
 

[vii] Miyashita L, Suri R, Dearing E, Mudway I, Dove RE, Neill DR, Van Zyl-Smit R, Kadioglu A, Grigg J. E-cigarette vapour enhances pneumococcal adherence to airway epithelial cells. Eur Respir J. 2018 Feb 7;51(2). pii: 1701592. doi: 10.1183/13993003.01592-2017.
 

[viii] Berry, K.M., Reynolds, L.M., Collins, J.M., et al. (2018).  E-cigarette initiation and associated changes in smoking cessation and reduction: the Population Assessment of Tobacco and Health Study, 2013-2015. Tobacco Control. http://dx.doi.org/110.1136/tobaccocontrol-2017-054108.
 

[ix] Coleman B, Rostron B, Johnson SE, Persoskie A, Pearson J, Stanton C, Choi K, Anic G, Goniewicz ML, Cummings KM, Kasza KA, Silveira ML, Delnevo C, Niaura R, Abrams DB, Kimmel HL, Borek N, Compton WM, Hyland A. Transitions in electronic cigarette use among adults in the Population Assessment of Tobacco and Health (PATH) Study, Waves 1 and 2 (2013-2015). Tob Control. 2018 Apr 25. pii: tobaccocontrol-2017-054174. doi: 10.1136/tobaccocontrol-2017-054174.

 

[x] St.Helen G. FDA should reject the tobacco industry’s efforts to guide e-cigarette manufacturing standards and instead formulate their own science-driven tough regulations to protect public health. Comment submitted to the USA Food and Drug Administration.  Docket Number FDA-2013-N-0227. Tracking number: 1k1-90hj-dh4t.  December 21, 2017.
 

[xi] Fuoco FC, Buonanno G, Stabile L, Vigo P. 2014. Influential parameters on particle concentration and size distribution in the mainstream of e-cigarettes. Environ. Pollut. 184:523–29.
 

[xii] US DHHS (Dep. Health Hum. Serv.). 2014. The Health Consequences of Smoking—50 Years of Progress.

A Report of the Surgeon General. Rockville, MD: US DHHS, Public Health Serv. Off. Surg. Gen.

https://www.surgeongeneral.gov/library/reports/50-years-of-progress/full-report.pdf.

 

[xiii]Glantz S, Bareham D.  E-Cigarettes: Use, Effects on Smoking, Risks, and Policy Implications. 

Annual Review of Public Health 2018 39:1, 215-235.  https://www.annualreviews.org/doi/10.1146/annurev-publhealth-040617-013757

 

[xiv] Byrne S, Brindal E, Williams G, Anastasiou K, Tonkin A, Battams S, Riley M. E-cigarettes, smoking and Health : A Literature Review Update. Canberra : CSIRO, 2018.

Comments

Comment: 

PSC highlights more problems with proposed Canadian marketing statements for e-cigarettes.

In particular, they raise issues about he Ministry of Health cherry picking conclusions from the NASEM report on e-cigarettes.

You can view a PDF of this letter here.

 

September 14, 2018

Mr. Mathew Cook, Manager

Scientific Regulations Division

Tobacco Products Regulatory Office

Tobacco Control Directorate

Health Canada

Address Locator 0301A

150 Tunney’s Pasture Driveway

Ottawa, Ontario

Canada K1A 0K9

[email protected]

 

Re: Draft comparison statements for use in the promotion of vaping products

 

Dear Mr. Cook,

I am pleased to offer some comments on the proposed comparison statements for use in the promotion of vaping products.

The commentary submitted by Professor Stanton Glantz.

Professor Stanton Glantz has drawn our attention to the commentary he submitted to you on these draft comparison statements (https://tobacco.ucsf.edu/canadian-ministry-health-proposes-authorize-e-cig-sellers-make-claims-ignore-recent-understanding-health-risks).   We fully endorse all that Professor Glantz has said on this subject, and ask you to note that our views are aligned with his. Like Professor Glantz, we recommend against using any of the seven proposed promotional statements for vaping products.  Professor Glantz raised the possibility that somewhat hopeful statements about switching completely may be misunderstood to mean that the products are safe and that the advice to switch completely would not be followed.  Recent research indicates this is likely to be the case.[1]  We invite Health Canada to require health warning statements on vaping products along the lines of the four warning statements proposed by Professor Glantz.

In making these recommendations, we would ask you to consider the historic and scientific importance of this decision in light of the following:

  1. Perhaps for the first time in public health history, the federal government is taking a position that tobacco industry products are less harmful than the public position of the companies.

Imperial Tobacco voluntarily places strong warnings of health hazards in its promotional material for its vaping products.[2]  Instead of requiring mandatory warnings, you are currently seeking input on comparative statements that invite use and abuse of vaping products.

  1. Health Canada relied on just three conclusions of the (now out-of-date) NASEM report, while ignoring other key conclusions.

Health Canada has relied on conclusions 5-3, 18-1 and 18-2 of the report of the US National Academies of Science, Engineering and Medicine (NASEM).  As Professor Glantz has pointed out, the science of vaping products is fast-moving and this report, published in early 2018, is already out of date. 

The NASEM report has 47 conclusions and careful consideration of the whole report and all its conclusions would lead to a much more precautionary approach than that chosen by Health Canada.  Here are a few examples of other conclusions from the NASEM report that should have led to a more precautionary approach:

Conclusion 7-1. There is substantial evidence that e-cigarette aerosols can induce acute endothelial cell dysfunction, although the long-term consequences and outcomes on these parameters with long-term exposure to e-cigarette aerosol are uncertain.

Conclusion 10-4. There is substantial evidence that some chemicals present in e-cigarette aerosols (e.g., formaldehyde, acrolein) are capable of causing DNA damage and mutagenesis. This supports the biological plausibility that long-term exposure to e-cigarette aerosols could increase risk of cancer and adverse reproductive outcomes. Whether or not the levels of exposure are high enough to contribute to human carcinogenesis remains to be determined.

Conclusion 16-1. There is substantial evidence that e-cigarette use increases risk of ever using combustible tobacco cigarettes among youth and young adults.

In addition, the NASEM report listed five conclusions (9-1, 10-1, 11-1, 13-1 and 18-3) that stated there was no available evidence to associate e-cigarettes with clinical cardiovascular outcomes, intermediate cancer endpoints, respiratory disease in humans, or pregnancy outcomes.  Conclusion 18-3 stated:

Conclusion 18-3. There is no available evidence whether or not long-term e-cigarette use among smokers (dual use) changes morbidity or mortality compared with those who only smoke combustible tobacco cigarettes.

In four of the five cases, evidence has emerged since the publication of the NASEM report pointing to links between e-cigarette use disease outcomes.  While there is no new evidence on e-cigarettes and pregnancy outcomes, nicotine has long been known as a reproductive toxin.  Specific references to new evidence on the hazards of dual use and links to cardiovascular, cancer and lung disease outcomes can be found in Professor Glantz’ commentary and the report from the European Public Health Association (both attached).

  1. The lack of transparency on the part of Health Canada regarding the May 2018 meeting of the Scientific Advisory Board and the subsequent public opinion research.

We have learned that the Vaping Products Scientific Advisory Board (SAB) met in May 2018 and that there was public opinion research earlier this year to test perceptions of the draft statements.  However, members of the public cannot evaluate the results of the SAB meeting nor the results of the public opinion research since the reports of these activities have not been made public.

The results of the longitudinal Environics study on vaping reveals serious public health problems that are not being addressed by Health Canada.

  • 17% of vapers never smoked cigarettes.

Most of these were young people.  Moreover, there is very strong evidence that e-cigarettes serve as a gateway drug to regular cigarettes.  This observation was made by Professor Glantz, by the EUPHA report and the NASEM report.  The problem has grown so serious in the USA that on September 12, 2018, the US FDA launched a crackdown on the sale of e-cigarettes to adolescents (https://www.nytimes.com/2018/09/12/health/juul-fda-vaping-ecigarettes.html?action=click&module=Top%20Stories&pgtype=Homepage).

  • More than half of vapers are dual users of cigarettes and vaping products.

The Environics report shows that 55% of vapers are also current smokers.  In addition, an unknown proportion of former smokers have relapsed to nicotine use some time after they successfully quit smoking.  This is consistent with the observation made both by Professor Glantz and by the EUPHA report that dual use is both very hazardous and the predominant form of use of e-cigarettes.

  • For most people, vaping does not aid smoking cessation.

The Environics report states that vaping has helped only a minority of vapers to reduce their smoking.  Once again this is consistent with most studies that show vaping does not increase quitting; it depresses quitting (https://tobacco.ucsf.edu/while-several-studies-have-been-published-showing-some-e-cig-users-quit-more-overall-picture-remains-negative).

  1. Health Canada has failed to establish a clearly-articulated harm reduction strategy for tobacco.

The proposed statements reflect a harm-reduction approach to tobacco reduction, but are not supported by a stated policy in this direction. Nor have any consultations on the overarching approach to harm reduction been extended to our organization or, to our knowledge to others. To establish such a significant policy shift without public consultation is inconsistent with transparent and open government philosophies.

The Health Minister has set a goal of achieving less than 5% tobacco use prevalence by 2035 (“less than 5 by ‘35”).  The proposed promotional statements are intended to increase the use of vaping products, but no bold and innovative measures are being undertaken to substantially reduce the use of the most dangerous product of all – the combustible cigarette. It is unlikely that the proposed comparative risk statements would stop uptake of e-cigarettes by young people, nor contribute to a substantial net decrease in combustible cigarette use.  The prospect of more, not less, nicotine addiction in the population will work against ever achieving the goal of “less than 5 by 35.”

It may be that some time in the future, we may find a way to integrate vaping products into a comprehensive and effective harm reduction strategy.  In the meantime, ways to mitigate the adverse health effects of vaping products must be found.  Even more importantly, bold and innovative measures are needed to sharply reduce both the supply and demand for combustible cigarettes.  Many such measures were proposed in a recent report to the Ontario government by the Smoke-Free Ontario Scientific Advisory Committee.[3]

Rather than seeking to create a series of ill-advised comparative risk statements, Health Canada is encouraged to take effective action to mitigate serious public health problems associated with e-cigarette use.  The problems are numerous:
 

  • Youth who never smoked are taking up vaping products.  They are then at increased risk for taking up cigarette smoking.
  • Dual use of vaping products and conventional cigarettes is the dominant form of e-cigarette use.  It is far more hazardous than using just one of these hazardous products.
  • For most people e-cigarette use is not an effective smoking cessation strategy.  Overall, they do not enhance quitting; e-cigarettes depress smoking cessation.
  • Adopt a comprehensive and effective approach to nicotine harm reduction that will achieve the Minister’s goal of less than five percent tobacco use by 2035.  

In revising your approach to the regulation of vaping and tobacco products, I hope you will give serious consideration to the report of the European Public Health Association, the comments made by Professor Glantz, as well as our own comments contained in this letter.

Yours sincerely,

Neal Collishaw

Research Director

neilsigns

Neil E. Collishaw

Research Director

 

[1]  McKelvey K, Popova L, Kim M, et al. Tob Control Epub ahead of print: [please include Day Month Year]. doi:10.1136/ tobaccocontrol-2018-054333. https://tobaccocontrol.bmj.com/content/tobaccocontrol/early/2018/08/27/tobaccocontrol-2018-054333.full.pdf

 

 

[2]         The text of these warnings and illustration of the packages containing them can be found at: http://smoke-free-canada.blogspot.com/2018/06/see-vype-go.html.

Add new comment

Plain text

  • No HTML tags allowed.
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.