A Review of the Ontario Tobacco Research Unit’s Webinar on Regulating E-cigarette Flavours

Summary

The Ontario Tobacco Research Unit (OTRU) hosted a webinar discussing the need to regulate flavoured vape products. The consensus among the panelists was that all flavours should be banned to protect youth. OTRU’s recommendation to ban flavours was presented using a curated selection of the research on vaping, with the sole objective of protecting youth.

The Canadian Vaping Association (CVA) fundamentally believes that youth and nonsmokers should not use vape products, and regulation should exist to protect youth, but vaping regulation must balance youth protection with the needs of adult smokers. OTRU’s recommendation fails to consider any of the science supporting vaping as the most effective quit aid, as well as the crucial role that flavours play in the transition process. OTRU’s failure to be objective in its recommendation will come at the cost of hundreds of thousands of lives.

Total youth prevention is a noble but unattainable goal that negates the value of the lives of adult smokers. Smoking is a global epidemic that requires the government to embrace all quit aids available. Failure to support smokers that have chosen vaping to reduce their harm is a public health debacle. Statistics paint a vivid picture of the true cost of tobacco use. 

This year:

 45,000 Canadian will die (100 deaths each day)

 Countless smokers are living with severe smoking related illnesses

 17% of all deaths will be smoking related

 Smoking is responsible for more deaths than obesity, physical inactivity or high blood pressure

 100 infant deaths will be caused by smoke exposure

 831 adult deaths will be caused by second-hand smoke

Smoking is a global health crisis, and it must be treated as such. Policy recommendations that limit vaping’s effectiveness and result in slow adoption are grossly negligent. The data is clear that flavour bans push vapers back to smoking and greatly reduce vaping adoption by adult smokers. Effectively, this policy recommendation will kill people. The CVA’s response summarizes the opposing data and highlights the flawed and misrepresented research currently used to justify harmful policy. Responsible regulation should consider the macro impact of policy, yet this guiding principle is ignored due to vaping’s visual likeness to smoking. If regulators continue to create policy to achieve an unattainable goal, hundreds of thousands of Canadian lives will be lost.

Introduction

The Ontario Tobacco Research Unit (OTRU) has stated through its webinar and policy recommendations that they believe Canadian’s are best served by a full flavour ban. After a thorough review of the webinar and the research presented therein, it is apparent that the OTRU has cherry picked data and twisted statistics to fit this narrative. The Canadian Vaping Association (CVA) has developed this response to ensure regulators and stakeholders are presented with all the research to enable well informed decisions for vaping regulation.

Flavours are not driving youth use

The webinar begins with David Eisenkraft citing the following studies as evidence that flavours lure youth:

 Association with enticing youth users (WHO, 2019)

 Most important factor in youth’s decision to try e-cigs (Zare et al, 2018)

 Sweet flavours more favoured by youth than adults (Hoffman et al, 2016)

 Sweet flavours considered less harmful (Zare et al, 2018)

The CVA does not refute the existence of these studies but opposes the exclusion of the contradictory findings. The most notable study on the reason for youth use was completed by researchers at the Centers of Disease Control and Prevention (CDC). According to the CDC report1, “Tobacco Product Use and Associated Factors Among Middle and Highschool Students”, 77.7% of young people indicated their primary reason for vaping to be other than “because e-cigarettes are available in flavours, such as mint, candy, fruit or chocolate.” The most common primary reason provided for youth experimentation with vaping is, “I was curious.”

Additionally, the International Tobacco Control Youth Tobacco and Vaping Survey2 indicates that, of youth in Canada aged 16–19 who had vaped in the past 30 days, the top 5 reasons for use, where multiple reasons were selected, were:

 “for the nicotine” (24%)

 “to deal with stress or anxiety” (35%)

 “curiosity/to try something new” (39%)

 “for the flavour” (40%)

 “for fun/I like it” (50%)

It is apparent from the data, that youth are not vaping for a single reason. There are multiple factors at play a role in youth’s decision to try vaping. Flavours, as a reason for use, is less common than “I like it”, and as common as “curiosity”. The data suggests that the focus to prevent youth use, should begin with education on vaping, and should include access to mental health supports to assist youth in managing growing anxiety trends.

It should also be noted that this research, conducted by Dr. Hammond, is unpublished and was provided to Health Canada for Canada Gazette, Part 1, Vol 154, No. 51. While this may be common practise, it is concerning given Hammond’s track record on vaping research. Another of Hammond’s studies3, “Prevalence of vaping and smoking among adolescents in Canada, England, and the United States: repeat national cross-sectional surveys,” concluded that vaping was a gateway to tobacco use, since youth smoking rates had risen as a result of youth vaping; however, the release of Health Canada’s “Canadian Student Tobacco, Alcohol and Drugs Survey (CSTADS)4”, resulted in a correction to the study. The correction stated, “In the original paper in The BMJ, changes in past 30 day smoking prevalence between 2017 and 2018 in Canada were reported as 10.7% to 15.5% (a statistically significant increase), which was revised after reweighting to 10.7% to 10.0% (no significant change).” Hammond’s bias against nicotine is well documented, and any research that has not been subject to peer-review, should be evaluated with warranted skepticism.

One must also consider the American Cancer Society’s research5 into youth use, following JUUL’s voluntary removal of flavours in the United States. When Eisenkraft discusses JUUL’s removal of flavours in the webinar, the data is misconstrued to be used as justification for a full flavour ban. Eisenkraft conveniently excluded specific findings of the American Cancer Society’s study, which conclude that JUUL’s removal of flavours had no impact on youth use. Instead of quitting vaping, youth simply switched to tobacco, mint or menthol flavours. This clearly demonstrates that, regardless of whether youth enjoy flavours, they are not the driver for youth use. 

Although Eisenkraft fails to mention the youth specific data following JUUL’s removal of flavours, he provides the following statistics, while perverting their true meaning to support his own biased conclusions:

 28% indicated flavour restrictions affected their use of vaping

 46% stopped using JUUL

 27% obtained pods online

 25% switched to mint or tobacco flavours

 JUUL experienced no loss of sales

Eisenkraft concludes that, because a significant number of JUUL users either switched to another product or obtained pods online, flavours are not essential for adult use, and policy prohibiting flavours must be enacted to prevent youth from acquiring flavours from other brands. However, if we analyse the data presented, it is clear that at least 75% of adults use a flavoured product. Eisenkraft also fails to acknowledge the significance of the 28% of users who indicated disruptions in their use of vaping. This is extremely concerning since there is now conclusive evidence that vaping is significantly less harmful than traditional smoking6. National smoking reduction success is measured in single percentage points. Accordingly, health organizations should be alarmed that the removal of flavours impacted the use of vaping in 28% of JUUL users, since these users were then more at risk of returning to smoking; a significantly more harmful way of obtaining nicotine. Lastly, the statement that JUUL experienced no change in sales is not an indication that flavours are unnecessary for adults. Of all vape brands, JUUL has the greatest brand awareness, loyalty and accessibility. To understand the full impact of removing flavours on JUUL’s sales would require a more focused study over a longer time period.

Data from a study conducted by Cynthia Callard is also presented. The CVA has been unable to locate the study referenced by Eisenkraft and, as such, will examine the data presented at face value. Callard’s study found that only 28% of adult vapers use fruit flavours, compared to 34% of youth ages 15-19. Eisenkraft presents this data as evidence that youth prefer flavours over that of adult vapers. However, one would expect a greater variance in the rates to support such a conclusion. In addition, this data loses much of its credibility when it is compared to the report commissioned by Health Canada7, “Study of Market Size, Characteristics, and Growth Trends of the Vaping Product Market in Canada.” 

The survey used within the report gathered responses from 38,000 participants and found:

 62% of users (both freebase and salt nicotine products) use a fruit flavour

 6% of freebase users use a tobacco flavour

 11% of salt nicotine users use a tobacco flavour

This report is far more comprehensive and has drastically different findings that are further supported by direct industry sales data. The industry has offered to provide Health Canada with this data, but this offer has not been accepted. This begs the question, why are survey responses being relied upon when direct sales data is available?

Interestingly, most studies find that salt nicotine is the product preferred by youth, and yet sales of freebase tobacco flavours are lower than that of salt products. The CVA is not suggesting that youth prefer tobacco flavours, but merely pointing out the ease with which data can be manipulated to fit a narrative. It should also be noted that, until 2014, Cynthia Callard was the registered lobbyist of Physicians for a Smoke-Free Canada. Callard has witnessed first-hand the irresponsible and often unethical practises of traditional tobacco companies. As a result, Callard has a bias against nicotine. Many of Callard’s statements to media8 highlight her distain for vaping and her inability to separate nicotine from tobacco.

Finally, there is the testimony of the 23,000 vapers that submitted postcards to Health Canada stating the importance of flavours in their transition from smoking. Historically, this has been dismissed as anecdotal or unscientific, so we ask, how many vapers need to testify to the importance of flavours for this data to be considered with the significance it deserves?

We could debate whether mint and menthol should be banned along with fruit flavours, but there has yet to be any compelling data to suggest that banning any flavour would prevent youth vaping. Ironically, there is research9 that suggests that the messaging from anti-vape organizations has been a greater motivator for youth use than any vape advertisement. Anti-vape organizations have repeatedly told curious youth that there is “a kid’s menu”, how cool vaping looks in ads, and that all their friends are doing it. Long after the Tobacco and Vapour Products Act was implemented to prohibit advertising that might be seen by youth, ads such as the ones below continued to inform youth of the flavours available to them.

No evidence to support the gateway theory

The only historical evidence to support the gateway theory, a report prepared by Dr. Hammond, has since been debunked and withdrawn, as discussed above. There is, however, evidence to suggest that vaping acts as a gateway to draw people away from tobacco10. In a collaborative piece prepared by numerous researchers, titled “Scientific Errors in Proposed EU Tobacco Products Directive”, it is stated that “The evidence is instead that the gateway effect is out of tobacco use, as at least some smokers of all ages reduce or end smoking when moving over to electronic cigarette.”

Additionally, the study, “Electronic cigarettes, nicotine use trends and use initiation ages among US adolescents from 1999 to 201811,” has found that vaping may have prevented harm to youth by transitioning nicotine use to a less harmful delivery system. The study concluded, “Electronic cigarettes may have offset conventional smoking among US adolescents between 2010 and 2018 by maintaining the total nicotine use prevalence and diverting them from more harmful conventional smoking. Additionally, electronic cigarette users appear to initiate at older ages relative to conventional smokers, which is associated with lower risk.” Smoking rates among all age brackets continue to decline. Removing the most effective12 stop smoking aid from the market will undoubtedly slow or reverse this progress. Should OTRU’s recommendation be implemented, both youth and adult smokers will be pushed to a significantly more harmful product.

Science supports flavours as a key factor in vaping’s success

While flavours are not the cause of youth uptake, they are a significant factor in what makes vaping more successful in the fight against smoking than other nicotine replacement therapy (NRT) products. This phenomenon is not unique to vapour products, and is well documented with other NRTs, that flavours reduce cravings and increase success rates. There has been no connection made between flavours and increased abuse potential. According to a study by the Behavioural Pharmacology Research Unit13, John Hopkins University School of Medicine, “Both flavors of nicotine gum decreased craving during 2 h of abstinence. These effects were more pronounced in the adult group and mint gum was more effective than original gum. Younger subjects reported fewer withdrawal symptoms and lower ratings for drug effects and flavor. Improved flavor of nicotine gum does not increase abuse liability but may be associated with enhanced craving reduction.”

Additionally, the study14, “Associations of Flavored e-Cigarette Uptake With Subsequent Smoking Initiation and Cessation”, conducted by Yale researchers concluded that, “adults who began vaping nontobacco-flavored e-cigarettes were more likely to quit smoking than those who vaped tobacco flavors. More research is needed to establish the relationship between e-cigarette flavors and smoking and to guide related policy.” Subsequent commentary observed that “while proposed flavour bans are well intentioned, they have disastrous outcomes. Legislation on vaping flavours must take the facts of smoking cessation and harm reduction into account, and we urge legislators against the widespread implementation of such bans.”

Flavours belong in age‐restricted environments

During the Q&A period, the panelists were vocal about their distrust of specialty vape stores, stating that specialty stores have a poor track record of selling to youth, and a much higher rate of compliance infractions. When asked if possession fines or similar types of enforcement could be effective, panelists said that laws should penalize the structures that produce vaping products instead of the result.

There is no data to suggest that vape retailers are selling to minors at a rate exceeding that of convenience outlets. Prior to any law regulating the age of sale, the vast majority of industry retailers self regulated and enforced age of majority sales. This is because vape shops were founded by ex-smokers who used vaping to quit. These businesses began as a grass roots movement to provide an alternative to smokers who failed to quit smoking using existing cessation products. Specialty vape shops are independent businesses with no affiliation with Big Tobacco. It is ridiculous for panelists to have more trust in traditional tobacco outlets than in independent businesses that were founded with the mission to destroy the tobacco industry.

The CVA has proposed software solutions to prevent minors from accessing vape products and has recommended their use for every transaction. The software works by cross-referencing various databases to ensure identification validity. This is an additional operating cost for vape shops, and the willingness to incur such costs signals the independent vape industry’s commitment to keeping vape products out of the hands of youth.

Bad actors, though in the minority, do exist within the industry. The CVA has repeatedly called on government to consistently enforce the existing laws and to implement strong reporting channels. Without a legitimate reporting mechanism, there is no pathway for the industry to eliminate offenders to ensure the trust of regulators and the public.

Comparing TVPA compliance infractions between vape shops and convenience stores as evidence that vape shops are irresponsible retailers misrepresents the facts. Yes, vape shops had a much higher infraction rate during inspections, but this comparison failed to give viewers an accurate representation of the unique challenges that changing regulations posed to vape shops. At the time of enforcement, convenience stores had approximately 15 SKUs that they purchased through a single distributor, whereas vape shops carried thousands of SKUs, sourced from multiple international vendors. The independent vape industry had the additional challenge of working with international manufacturers to create Canadian compliant products within a relatively short time frame. Upon inspection, only one non-compliant product out of possibly thousands resulted in an infraction citation.

Youth vaping rates increased upon the addition of thousands of convenience store access points. Limiting access points in combination with consistent enforcement of government laws and industry standards is the key to curbing youth vaping rates. Convenience outlets are not equipped to provide product recommendations (choosing a device type and matching nicotine content to a smoker’s daily nicotine intake), or to provide guidance to smokers throughout their transition to vaping. Vape products require a specialized knowledge of the various product offerings and an understanding of the transition process that non-specialty stores are ill-equipped to provide. High nicotine and a full range of flavoured products should only be available in age-restricted specialty stores.

Prohibition strengthens dangerous illicit channels

When asked about the black-market, panelists stated that it is likely that a parallel market will exist, like after tobacco flavours were banned, but this further supports the need for regulatory changes. Vape products are significantly different from traditional combustible tobacco products, much more easily produced by illicit channels. The illicit channels that manufacture vape products, through simple home set-ups, have already shown their ignorance and apathy towards the use of dangerous additives to cut costs.

The lung illness outbreak EVALI (e-cigarette or vaping product use-associated lung injury) should serve as warning of the danger the unregulated market poses to public health. The CDC found the cause of EVALI to be vitamin E acetate15, a prohibited ingredient in regulated Canadian e-liquid. It was discovered that illicit cannabis products were using vitamin E acetate as a thickening agent. While this outbreak was not related to nicotine vaping products, it demonstrates the danger in creating an environment for illicit products to flourish.

Additionally, research from the Yale School of Public Health16, found in their study, “Association of Vaping-related Lung Injuries with Rates of E-cigarette and Cannabis Use across US States,” that the outbreak was more pronounced in areas with a cannabis prohibition. This further demonstrates that prohibition is not effective and is a direct cause of flourishing black markets. Blanket bans on flavours will eliminate responsible regulated manufacturers from the market, leaving a void to be filled by unregulated and potentially dangerous products. E-liquid consists of few ingredients and is relatively simple to manufacture. These factors, combined with the demand for flavours and high nicotine, make e-liquid an attractive product for black-market sellers. Illicit products will not be subject to manufacturing standards, and their sale would not be regulated by Tobacco Enforcement and Public Health.

There is also the issue of online sales from international vendors. Currently, there is extremely limited enforcement and screening of imports. Prohibition will cause an increase in online transactions from international vendors. Canada now has the strictest regulation on plain, non-youth appealing packaging. Further product restrictions will increase the visibility of products appealing to youth on foreign websites. None of these websites require precise age verification – at most, they only employ “check a box” verification. Upon arrival of the product in Canada, there is no age verification procedure as would be required for regulated Canadian vendors.

Conclusion

The CVA agrees with OTRU that flavours are a moral issue, however we wholeheartedly disagree with their conclusions. Under the guise of morality, they advocate for regulation that would push many former smokers back to an addiction that kills 1 in 2 users. Regulations that prohibit flavours, a crucial component of the most successful harm reduction product available globally, are truly immoral as they effectively condemn 45,000 Canadian smokers each year to a premature death.

Moreover, the CVA deplores the notion that public support should dictate health policies. OTRU states that banning flavours has 60% of the public’s approval. This should never be a primary metric used to determine effective health policy. It is not the public’s job to perform a comprehensive review of the research and weigh the consequences to public health; this responsibility is entrusted to the legislature.

Since its inception, the vape industry has supported reasonable regulation for the protection of youth. The flavour ban proposed by OTRU is unreasonable and rooted in rhetoric, instead of science. A flavour ban will lead to increased smoking rates, and stall or reverse vaping adoption rates, greatly harming public health. By the panelists’ own admission, there is no way to prevent online sales from reaching youth nor to prevent the black-market from filling the void. OTRU must separate nicotine vaping from tobacco and recognize that advocating for a flavour ban on vaping products is in direct contradiction of their mandate, to reduce tobacco use. It is crucial that they review all of the science and research, and acknowledge that such restrictions on the most successful harm reduction product will have a devastating impact on public health.

References

1 https://www.cdc.gov/mmwr/volumes/68/ss/ss6812a1.htm#T6_down

2 Dr. David Hammond, unpublished results, Canada Gazette, Part 1, Vol 154, No. 51

3 https://www.bmj.com/content/370/bmj.m2579

4 https://www.canada.ca/en/health‐canada/services/canadian‐student‐tobacco‐alcohol‐drugs‐survey/2018‐2019‐

summary.html

 

5 https://ajph.aphapublications.org/doi/abs/10.2105/AJPH.2020.305667

6 http:// www.healthscotland.scot/media/1576/e‐cigarettes‐consensus‐statement_sep‐2017.pdf

7 file:///C:/Users/19057/Downloads/EMI_Health%20Canda%20Report_%202.28.2020_FINAL.pdf

8 https://www.huffingtonpost.ca/entry/health‐groups‐vaping‐illness_ca_5d841d84e4b070d468c9e6aa

9 https://cei.org/studies/perverse‐psychology/

10 https://www.nicotinepolicy.net/blogs/guest‐blogs/29‐n‐s‐p/89‐scientific‐errors‐in‐proposed‐eu‐tobaccoproducts‐

directive?fbclid=IwAR0lyL2Zem‐jji9udELElnTXR‐nAymR8Rf5cMEsb66HKyBTTUbK3AGr4RCo

11 https://pubmed.ncbi.nlm.nih.gov/32335976/

12 https://www.gov.uk/government/news/vaping‐better‐than‐nicotine‐replacement‐therapy‐for‐stoppingsmoking‐

evidence‐suggests

13 https://www.ncbi.nlm.nih.gov/pubmed/12175452

14 https://pubmed.ncbi.nlm.nih.gov/32501490/

15 https://www.cdc.gov/tobacco/basic_information/e‐cigarettes/severe‐lung‐disease.html

16 https://onlinelibrary.wiley.com/doi/abs/10.1111/add.15235