So almost a year ago to the day, I wrote this report for Health Canada in response to their request for consultation on potential regulatory measures to reduce youth access and appeal of vaping products.

The points I made are still valid.

Due to formatting issues trying to bring it over from its original format, some portions are recreated as images. Anyone who is interested can request the PDF copy and I will pass it along.

No really... the formatting is a disaster. If you want a clean pdf... get a hold of me

Declaration of Competing Interests

The author of this report is the CEO and 50% shareholder of Alternatives & Options – Vapourizers and E- Liquids Ltd. An incorporated (Alberta) small business venture that sells vapour technology to a targeted consumer group consisting of adult smokers and adult former smokers.

The author of this report is a former director on the board of the Electronic Cigarette Trade Association, and still works closely with that association and its board.

The author is active in harm reduction advocacy circles.

The author is a former smoker of 30+ years, who had his first cigarette at the age of 9 and did not stop

smoking until he was in his early 40’s.

Introduction

In order to effectively understand the potential public health impacts of any proposed restrictions or prohibitions we need to understand the dynamic of three subjects.

· We need to understand the public health risks of combustible tobacco product use (smoking).
· We need to understand the public health risks of vaping in comparison to smoking.
· We need to understand the impacts our potential regulatory measures would have on both.

The public health risks of combustible tobacco use are very well understood and conveyed to the Canadian public effectively, if in a largely and sometimes overly ideological or dramatic fashion (Graphic images on cigarette packages and television commercials that use CGI techniques; intended to evoke an emotional response over a logical one).

The Government of Canada website, based on 2002 data, estimated that 17% of 230,000 deaths a year were contributable to smoking ⁽¹⁾.

The Canadian Cancer Society, on their web page ⁽²⁾, cites a 2017 report published by The Conference

Board of Canada, titled “The Costs of Tobacco Use in Canada, 2012” ⁽³⁾ which provides the following data from a decade later:

45,464 deaths attributable to smoking in Canada in 2012 (If we applied that mortality to a time weighted average, it is the equivalent of a Canadian dying every 11.56 minutes.)
Direct health care costs were estimated to be $6.5 billion for that year.
Indirect costs were tabulated at $9.5 Billion.
The total costs of tobacco use in Canada according to this report equated to $16.2 Billion.

45,464 deaths in 2012 attributed to smoking. There are very few comparators that could place that mortality rate in a reasonable frame of reference that the average Canadian citizen could conceptualize:

Deaths attributable to automobile accidents in 2017 – 1,841 ⁽⁴⁾ (4.05%) Deaths attributable to the “Opioid Crisis” in 2017 – 4,034 ⁽⁵⁾ (8.87%)
Deaths of Canadian Military Service Members (active) from 1939-1947 (World War II) ⁽⁶⁾ – 44,090 (96.98%)

If we compile the aggregate mortality of 8 years of highly elevated military activity and combat operations, we can provide a reasonable frame of reference for the attributed mortality rate of smoking on the Canadian population in the year of 2012.

This is the ultimate endpoint of public health impact of smoking. It doesn’t need to be dramatized; it

simply needs to be communicated.

This is the primary concern for advocates of tobacco harm reduction strategies – 45,464 and 11.5 minutes. This is also a point not reflective of current media efforts in telling “the news” of vaping.

The public health risks of vaping in comparison to smoking are often not communicated as effectively due to the primary focus continually being redirected to the potential (and in some cases, theoretical) absolute risks of vaping; particularly with regards to youth.

However, this does not mean that we are bereft of information on both the absolute, and the comparative risks of vaping.

The Tobacco Advisory Group of the Royal College of Physicians in London, England, reviewed existing evidence in 2015 and the very early portion of 2016. In April of 2016 their report “Nicotine without smoke: Tobacco harm reduction” ⁽⁷⁾ was published. At the time of it’s release, and even though it’s overall purpose was to discuss tobacco harm reduction in a broad sense, it was the most comprehensive document relating to vapour technology of it’s time. At 191 pages, with at least 121 direct references to e-cigarette related scientific inquiry and discussion, policy (both government and corporate), and articles. The RCP report is still the only report to date that estimated the relative risk between vapour technology and combustion-based delivery systems based on a numeric value:

"Although it is not possible to precisely quantify the long-term health risks associated with e-cigarettes, the available data suggest that they are unlikely to exceed 5% of those associated with smoked tobacco products and may well be substantially lower than this figure"

This statement has been the subject of significant debate since it was issued, however it has not been amended and has in fact been repeated in subsequent releases from the RCP ⁽⁸⁾⁽⁹⁾. No other entity to my knowledge, including those who adamantly insist that this reference is not or cannot be accurate, have offered their own number for consideration.

The report was not all roses for vaping as a harm reduction tool. It referenced the comparatively short period of existence for vapour technology in comparison to decades of data on the long-term effects of smoking. The report noted the need to monitor youth, and non smoker uptake and specifically referenced responsible regulation to limit potential public health impacts from contaminants, constituents of concern, and predatory marketing. However, this report was overall, very supportive for vapour technology and its potential to reduce the public health impacts of combustible tobacco products as a nicotine delivery system.

Given the earlier reference to automobile fatalities, It is appropriate to note here that the Government of Canada website ^(10)(11) quotes the harm reduction value of seatbelts at 47% for fatalities and 52% for serious injury. At these values, seatbelt usage was deemed an effective enough harm reduction tool that seatbelt laws now exist in all Canadian jurisdictions.

The National Academies of Science, Engineering, and Medicine in the United States of America published their own report which Health Canada has publicly recognized and refers to on a regular basis.

The National Academies Press published the NASEM report titled “Public Health Consequences of E- Cigarettes” ⁽¹²⁾ in 2018. This report was more focused on the “absolute” risks of vaping and formulated more as an evidence review and ranking of existing studies and data. In this case the statement could be made that this report was not all pitchforks for vaping as a harm reduction tool. It did state there was a potential for public health benefit of transitioning the smoking population, however that statement was heavily couched by concerns over youth uptake of the product (valid concerns, echoed by RCP) and gateway effect (Youth starts vaping and transitions to the more dangerous product – subject of considerable debate between the ‘gateway’ camp and the ‘correlation vs. causation’ group).

These two reports are as differential in their tone and message as the societies in which they were written. The response to these studies is also reflective of the society of origin.

In England, public health bodies (PHE ⁽¹³⁾, ASH UK ⁽¹⁴⁾, Cancer Research UK ⁽¹⁵⁾, Stop Smoking Services, etc.) and the government funded public medical provider (NHS) ⁽¹⁶⁾ are actively and very publicly encouraging smokers to transition. Vaping is actively included in initiatives like “Stoptober” and other programs used to encourage cessation. Even the London Fire Brigade has a positive outlook on vapour technology ⁽¹⁷⁾ – statistically fires caused by electronic issues and charging of e-cigs are far less numerous than those attributable to smoking materials. England did this without forcing the market into a

“medicines” category (although that is discussed often). Studies have been performed ⁽¹⁸⁾ to ascertain general public perception of vaping harms compared to smoking harms and programs are adjusted to make sure that smokers understand that vaping is the less harmful option for those who cannot or will not quit via other available means.

In the United States, the public message has been largely focused on the perceived “risks” of vaping.

From the various levels of Government. The message, in most optimistic terms, could be called “mixed”

from the Food and Drug Administration.

Former Director of the FDA, Scott Gottlieb, in a single press release ⁽¹⁹⁾, summed up the nature of the administrations conflicted stance on smoking, e-cigarettes, and youth uptake in these quotes:

· “While it’s the addiction to nicotine that keeps people smoking, it’s primarily the combustion, which releases thousands of harmful constituents into the body at dangerous levels, that kills people.”

· “E-cigarettes may present an important opportunity for adult smokers to transition off combustible tobacco products and onto nicotine delivery products that may not have the same level of risks associated with them.”

“The FDA won’t tolerate a whole generation of young people becoming addicted to nicotine as a tradeoff for enabling adults to have unfettered access to these same products.”

· “It’s now clear to me, that in closing the on-ramp to kids, we’re going to have to narrow the off- ramp for adults who want to migrate off combustible tobacco and onto e-cigs.”

The public message in media has been more focused on “Shock and Awe” with FDA sponsored media spots involving parasites and shocking rapid physical deformities ⁽²⁰⁾ ⁽²¹⁾, NGO ads involving vomiting puppets ⁽²²⁾, and somewhat misleading statements about nicotine levels ⁽²³⁾ ( A Juul pod does indeed contain the equivalent nicotine of 20 cigarettes – however it is not, and cannot be, consumed all at once the pod is intended to replace an entire pack of cigarettes and be consumed at the rate one would consume those cigarettes).

Vapour products are a ‘disruptive technology’ to more than just the tobacco industry. Consumer driven advances over the last 10 years are likely one of the reasons that the blind clinical trial performed by Hajek et al. and published in the New England Journal of Medicine ⁽²⁴⁾ on January 30^th of 2019, identified e-cigarette users having a 1 year abstinence rate of 18% in comparison to a rate of 9.9% with nicotine- replacement therapy when both groups received behavioral support. Most vapour technology specialty shops have higher transition rates; however, they offer a wide variety of devices, nicotine strengths, and flavours that would confound a clinical trial’s scientific limitations. They are also financially motivated to work with the consumer to identify the best combination for the consumer to reach their self stated goals. As evidence (anecdotal): a specialty vapour shop in a town of 10,000 could not financially survive on an 18% conversion rate. It should be noted that given the press, the public messaging around vapour technology, and the current promotional restrictions placed upon vendors, it is highly probable that the percentage of smokers who go to a vapour technology shop with the intent of transitioning are more highly motivated and/or self educated on the product before making that decision.

Vapour product technology also disrupts long practiced and well entrenched tobacco control policies and ideologies. For over 50 years, since the publication of the Royal College of Physicians report “Smoking and Health” ⁽²⁵⁾, the message at its foundation, has been relatively straight forward; quit smoking, or die. Abstinence was the only effective response to the fact that the most effective, and popular delivery system for nicotine was combustion based.

Vapour technology is popular with smokers because it maintains the sensation of the original product, delivers the nicotine they are looking for (often in a more palatable fashion), but does so without combustion, thereby providing significant reduction in exposure to the harms associated with cigarettes.

This change will require that our thought process around recreational use of nicotine by Canadians be re-examined because “All Bad, for All Parties, All the Time” no longer fits the physical reality of the equation:

· I had my first cigarette at 9. At 15 years old I was a pack a day smoker and having what could be described as a 2-year battle of wills with my father (which in hindsight, we both lost). The fact that 33 years later, we still have an adolescent smoking population could indicate that similar parents are still having these battles with similarly strong-willed children. Would my present health have benefited had this technology existed then? What about smoking adolescents now?

· Youth nicotine dependency vs. smoking mortality. One of the previous consultations that was suspended due to concerns over youth product uptake was the consultation which identified pre-approved comparisons vapour technology vendors could use to get the message out to smokers that this product may be of benefit to them. What is an acceptable rate of once a week or 15 out of 30-day vaping “never-smokers”? At what point does Health Canada say “’You’ will have to keep smoking, so that ‘they’ do not become nicotine dependant”?

· Current messaging to youth about vapour technology uses statements about “lung damage” and “impacting brain function”, this message is also picked up by smokers, some of whom, given the absence of an equally strong message about how vapour technology could impact their risk levels, equate the two processes as equivalent in harm and continue smoking.

· How do we tell a vapour technology user that they must stand in a “smoking” area and address the conundrum of the less harmful product being used in an area prone to second hand smoke?

What Do I Think?

As a former smoker:

· I think our public health bodies have lost touch with the means to effectively reach the smoking population. Smokers are not broken. Smokers are not less human than non- smokers. Smokers are, by and large, not cognitively brain damaged; no matter the age they started smoking. One cannot have a productive conversation with a significant portion of the population that through policy, has been alienated.

· I think prohibiting smoking indoors was a measure that resulted in public health benefit. I think prohibiting smoking (and vaping) in playgrounds and on school (K-12) property has logical merit. I think that arguing whether smokers should be 5, 10, or 15 meters from doors, windows, and air intakes, or prohibited from all areas of open air public spaces is based on ideological grounds, not scientific grounds and I think in these cases “PublicHealth” is used as a weak, blanket justification.

· I think over dramatizing potential health effects and focusing on the rare but extreme examples damages public health credibility:

o When the image on my cigarette package was a wilted cigarette and the words said I was going to become sexually dysfunctional, I tucked my four children into bed for the night. After they fell asleep, I had relations with my wife – and public health took a credibility hit.

o Smoking might very well impact fetal development and birthweight, but in 1965 50% of the Canadian population smoked. In 1971, during all three trimesters, my mother smoked. The mothers of many of my playmates smoked. We like to all think of ourselves as relatively normal – and public health took a credibility hit.

o The cancerous tongue used as the example in Health Canada’s presentation on the new plain packaging standards (https://www.cbc.ca/news/health/cigarette- tobacco-plain-packaging-1.5118564)? I’m nearly 48 years old, I’ve been surrounded by smokers all my life through familial relation, social circles, advocacy circles, and now profession. I have never seen a tongue like that. The Canadian Cancer Society states there were 4700 cases of oral cavity cancer in 2017. If every one of those cases was smoking related, that would be an impact to approximately 0.1% of 4.5 million smokers in a year.

“Shock and Awe” tactics only work until the target audience becomes accustomed, and immune to,

shock and awe.

It’s time to start talking to smokers instead of trying to scare the fecal matter out of them. As a smoker, I knew I was going to die. I couldn’t find a way out for over ten years. I accepted what my likely outcome was going to be. Making fun of my willy, making me stand out in the elements, those little fake coughs people would make as they passed me, the public derision, none of it had an impact beyond applying tactics of shame, pressure, and stress…

Which I promptly dealt with by having a cigarette, losing faith, and becoming bitter.

What Do I Think?

As A Parent:

I had occasion to speak with my oldest son (15) this week about adolescent experimentation. There was an incident involving a cell phone video that got out to parents within his peer group. The rule is: I ask a question, he answers honestly, there will be no punishment.

· He has experimented with cannabis twice.

· He has experimented with vaping twice.

· In both cases it was with the same group of friends.

· He has not experimented with cigarettes and at this point does not desire to do so.

We talked openly, about youth experimentation, my experimentation as an adolescent with both cannabis and tobacco and how it impacted my life in matters of education, dependency, and financial impacts. My concern at how my use of tobacco will always have the potential to make me very sick and/or die prematurely even though I have stopped smoking.

We talked about how vaping did not “save my life”, it simply reduced my odds of suffering negative consequences for continuing 33 years of smoking and exposing myself to the related toxicity. We talked about fear and random chest pains. We talked about peer pressure and adolescent bravado. We talked about adolescent risk-taking behaviour and why adolescents, biologically, are prone to take risks.

We talked about harm reduction and abstinence. We talked about moderation, and legal access. We talked about illicit and legitimate supply chains. We talked about contamination of illicit product and risks that my son could be exposed to that were non existent, or of such remote possibility in my region in the 1980’s that they were not a credible threat to me. We talked about the different risk profiles of different substances: nicotine both in smoking and vaping, cannabis, magic mushrooms, cocaine, opioids, amphetamines, and chemical drugs that were not present in my youth.

We talked about adolescent brain development and nicotine. Apparently, he also has issues with

the credibility of Health Canada’s messaging. In typical adolescent irreverent fashion, with regards to “brain damage” in adolescent nicotine users, his response to me was “I’m not a rat, and you aren’t retarded”. I will have to have further discussions with him about how terminology gets refined over time and words that were once acceptable in certain frames of reference do not always remain so.

Do I think that he will never experiment with things again? No, I’m pretty sure he will. He was right

in his assessment of my mental status.

But so long as he knows he can talk to me about these matters, that when I ask questions he can answer honestly, and I maintain my credibility by not over reacting or getting overly dramatic, I can have influence in his decision making that I would not have if those lines of communication were closed.

What Do I Think?

As an advocate and business owner:

· 45,464 deaths attributed to smoking in 2012- One every 11.56 minutes

· I think it is time to re-examine our public health policies and standpoints around smoking, smokers, abstinence, and harm reduction. We made progress with abstinence only models over the last 50 years, but we still have a population level user base of combustion-based products at roughly 15%.

o Abstinence only models in other public health (STI, illicit drug use) matters have not managed to achieve harm elimination either and in most cases harm reduction measures (condoms, safe injection sites, publicly available naloxone kits) are championed and employed to reduce public health impact of less socially acceptable (and in some cases illegal) public habits and behaviours.

o In each case, when harm reduction policies were being discussed and introduced, there was public outcry, debate, resistance, and opposition from abstinence only advocates.

o In each case, while that debate carried on, members of the public who could not, or would not conform to an abstinence only public health model, suffered, and in some cases, died.

· I think youth experimentation is a valid concern, and should be monitored, however I don’t think we should be placing a disproportionate amount of weight on experimentation alone.

o What is the number of youths who are using vaping products weekly? 15 out of 30 days? Daily?

o How many of them were smoking? 10 years ago, all experimentation and use involved the more hazardous product.

o We have an “Exceeds LRDG” level for both chronic and acute alcohol risk. Why not

for smoking and nicotine use?

o In smoking behaviour, the common question asked to determine the level of

dependency is “How long is the time frame after you first wake up, before you have your first cigarette”

· I know the saddest day of my business career was the day I told a distraught mother that I could not sell her a vaping product for her somewhat belligerent and rebellious teenager, who was standing at her side before me in the shop reeking of cigarette smoke. I don’t know that kids name, but I know that kid. I know the battle that mother is going to have. I know that kids’ future as clearly as I know my past. I know I could have had an impact there, and I know it would have put my business at risk and impacted my ability to help a lot of other people. That adolescent is still smoking cigarettes. Similar incidents have occurred both before and after this visit. But for some reason, this particular interaction stays with me.

(1) Government of Canada website – Smoking and Mortality. https://www.canada.ca/en/health-canada/services/health- concerns/tobacco/legislation/tobacco-product-labelling/smoking-mortality.html

(2) Canadian Cancer Society Press Release. http://www.cancer.ca/en/about-us/for-media/media-releases/national/2017/cost-of- tobacco/?region=on

(3) Alexandru Dobrescu, Abhi Bhandari, Greg Sutherland, Thy Dinh “The Costs of Tobacco Use in Canada, 2012” - The Conference Board of Canada, October 16, 2017 – https://www.conferenceboard.ca/e-library/abstract.aspx?did=9185

(4) Government of Canada website – “Canadian Motor Vehicle Traffic Collision Statistics: 2017” - https://www.tc.gc.ca/eng/motorvehiclesafety/canadian-motor-vehicle-traffic-collision-statistics-2017.html

(5) Government of Canada website – “National Report: Apparent Opioid-related Deaths in Canada (April 2019)” - https://infobase.phac- aspc.gc.ca/datalab/national-surveillance-opioid-mortality.html

(6) Library and Archives Canada – “Service Files of the Second World War – War Dead, 1939-1947” - http://www.bac- lac.gc.ca/eng/discover/military-heritage/second-world-war/second-world-war-dead-1939-1947/pages/files-second-war-dead.aspx

(7) Royal College of Physicians. Nicotine without smoke: Tobacco harm reduction. London: RCP, 2016. https://www.rcplondon.ac.uk/projects/outputs/nicotine-without-smoke-tobacco-harm-reduction-0

(8) Royal College of Physicians. Consultation response – E-cigarettes Enquiry. London: RCP, 2017. https://www.rcplondon.ac.uk/guidelines-policy/e-cigarettes-inquiry

(9) Royal College of Physicians. Policy statement – “What the RCP thinks about tobacco”. London: RCP, 2018 https://www.rcplondon.ac.uk/projects/outputs/what-rcp-thinks-about-tobacco

(10) Government of Canada website – Road Safety in Canada. https://www.tc.gc.ca/eng/motorvehiclesafety/tp-tp15145-1201.htm

(11) Stewart, D.E., Arora, H.R. and Dalmotas, D. (1997). Estimation Methodologies for assessing Effectiveness of Seat Belt Restraint Systems and the National Occupant Restraint Program. Motor Vehicle Safety Directorate, Transport Canada, Ottawa, Canada. Publication No. TP 13110 E.

(12) National Academies of Sciences, Engineering, and Medicine. 2018. Public health consequences of e-cigarettes. Washington, DC: The National Academies Press. doi: https://doi.org/10.17226/24952.

(13) The Guardian December 28, 2018 - https://www.theguardian.com/society/2018/dec/28/vaping-is-95-safer-than-smoking-claims- public-health-england

(14) Ash UK Press Release “Ash Welcomes New Public Health England Report” http://ash.org.uk/media-and-news/press-releases-media- and-news/ash-welcomes-new-public-health-england-report-e-cigarettes/

(15) Cancer Research UK Position statement (In conjunction with the Royal College of General Practitioners) https://www.cancerresearchuk.org/health-professional/awareness-and-prevention/e-cigarette-hub-information-for-health- professionals/e-cigarette-statement?

( (16) NHS Website “Using E-Cigarettes to Stop Smoking” https://www.nhs.uk/live-well/quit-smoking/using-e-cigarettes-to-stop-smoking/

(17) London Fire Brigade Website “STOPTOBER: Firefighters urge smokers to vape to prevent fires” https://www.london- fire.gov.uk/news/2018-news/stoptober-firefighters-urge-smokers-to-vape-to-prevent-fires/

(18) Wilson, S.; Partos, T.; McNeill, A.; Brose, L.S. Harm perceptions of e-cigarettes and other nicotine products in a UK sample. Addiction 2019. Doi: https://doi.org/10.1111/add.14502

( (19) FDA Press Release “Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to address epidemic of youth e-cigarette use” September 12, 2018

(20) The Real Cost (https://therealcost.betobaccofree.hhs.gov/) “There is an Epidemic” advertisement - https://www.youtube.com/watch?v=zYuyS1Oq8gY

(21) The Real Cost (https://therealcost.betobaccofree.hhs.gov/) “There is an Epidemic” advertisement - https://www.youtube.com/watch?v=SskqJ_

(22) Truth (www.thetruth.org) “Am I a Puppet/Inner Monologue” advertisement - https://www.youtube.com/watch?v=oHi_zJR7pq0

(23) Truth (www.thetruth.org) “Mind Blown” advertisement - https://www.youtube.com/watch?v=1OGI4f6IwnM

(24) Hajek et al. “A Randomized Trial of E-Cigarettes versus Nicotine-Replacement Therapy” The New England Journal of Medicine. 30 January 2019. Doi: 10.1056/NEJMoa1808779. https://www.nejm.org/doi/full/10.1056/NEJMoa1808779

(25) Royal College of Physicians. Smoking and Health. London: RCP, 1962. https://www.rcplondon.ac.uk/projects/outputs/smoking-and- health-1962

Flavour and Ingredient Restrictions and Prohibitions

Further restricting promotion, prohibiting specified flavours and ingredients

Should Health Canada consider expanding the list of flavour categories for which promotion is prohibited?

What purpose would be served by this measure? If the concern is minors “vaping” as a category, then promotion of “vaping” as a category should be controlled in venues where minors can reasonably be expected to be present and exposed to such promotion.

· While the quote from the Health Canada consultation document (page 7) states “It is notable that tobacco, mint and menthol flavours were reported by a larger fraction of adults than by youth and young adults, who were more likely to report candy and dessert flavours”:

o It is notable that that ‘fraction of adults’ according to the Environics Report ⁽¹⁾ cited, is 23% for tobacco, and 16% for mint and menthol. This indicates that 61% of adult users prefer flavours outside of those two categories. Further complicating the transfer of information to those combustible tobacco users will impact the ability to transition them to a lower risk product.

o It is also notable that the “Young Adult” category is defined in that report, by age range, as 20-25 years old. This category of respondents can legally purchase combustible tobacco products in every Canadian jurisdiction and therefore are an important population subset as a target audience for harm reduction principles. In fact the potential that this category is less likely to have been smoking for as long as the older “Adult” category (given that common perception, as noted in the consultation is that combustible tobacco users tend to start smoking before the age of 18), may be the basis for a stable argument that they can be impacted quicker and with less intense effort than their older counterparts. In this category, the “fractions” are 7% for tobacco, and 12% for mint and menthol, indicating that 81% of these potential combustible tobacco product users prefer flavours outside of these two categories. Further complicating the transfer of information to those combustible tobacco users will impact the ability to transition them to a lower risk product.

o It is of lesser note that the “Youth” category includes 18 and 19-year-old Canadians. 18- year-olds in some Canadian jurisdictions can legally purchase combustible tobacco products, and 19-year-olds can purchase those products in every Canadian jurisdiction.

· It is important to understand that unlike smoking, in which case every time the user uses the product they are limited to a single flavour profile (in jurisdictions where “menthol” cigarettes are prohibited), vapers can change their flavours on a whim, either on an intermittent basis (day to day) or on a transitional basis (used to prefer one profile but over time changed to another profile entirely), this is one of the properties of vaping that helps many smokers transition to vaping as a substitute delivery system for nicotine. In a 2018 survey ⁽²⁾ that met qualifications for FDA submission by Konstantinos Farsalinos et al. with 69,233 adult American individual respondents (74.6% who identified as former smokers who used e-cigarettes while quitting) who identified as “ever-vapers”:

o Identified that on initiation of e-cigarette use tobacco flavours were used regularly by 20.8% of respondents, menthol by 21.9%, and mint/wintergreen by 13.8%. Fruit was used regularly by 82.8% of respondents, Dessert/Pastry/Bakery by 68.6%, and candy/chocolate sweet by 52.2%

o When asked to identify a single flavour most often used at initiation, eliminating flavour use in rotation, those statistics dropped to Tobacco - 7.7%, Menthol - 6.3%, and Mint/wintergreen - 1.9% respectively. Fruit was 48%, Dessert/pastry/bakery was 25.8%, and candy/chocolate/sweet accounted for 4.1% of responses.

o When asked to identify flavour profiles used regularly at the time of the survey (post initiation); Tobacco – 7.8%, Menthol – 13.3%, Mint/Wintergreen – 9.6%. Fruit came in at 83%, Dessert/Pastry/Bakery profiles rose slightly to 70% and Candy/Chocolate/Sweet was a profile regularly used by 46.3% of respondents

o Single flavour used most often at the time of the survey; Tobacco - 2.1%, Menthol – 2.5%, Mint/wintergreen – 1.2%, Fruit – 49%, Dessert/pastry/bakery – 35.3%, and Candy/chocolate/sweet at 4.4%

As demonstrated, flavours, when it comes to vaping, are a complex, and very important variable with regards to transitioning smokers to a lower risk option ⁽³⁾. This needs to be considered carefully in balancing youth experimentation and initiation vs. the 45,000 smokers who suffer a premature mortality rate in Canada each year, and the $6.5B in direct annual healthcare costs attributable to smoking related death and disease ⁽⁴⁾.

(1) Environics Research. Longitudinal Vaper Panel Survey to Measure Attitudes and Behaviours regarding Vaping Products. April 2018. http://epe.lac-bac.gc.ca/100/200/301/pwgsc-tpsgc/por-ef/health/2018/047-17-e/report.pdf.

(2) Farsalinos et al. “Patterns of flavored e-cigarette use among adults vapers in the United States: an internet survey.” Submitted to: Docket No. FDA-2017-N-6565 for “Regulation of Flavors in Tobacco Products.” https://www.regulations.gov/document?D=FDA- 2017-N-6565-22941

(3) Royal College of Physicians. Nicotine without smoke: Tobacco harm reduction. London: RCP, 2016. https://www.rcplondon.ac.uk/projects/outputs/nicotine-without-smoke-tobacco-harm-reduction-0

(4) Canadian Cancer Society “Smoking causes 1 in 5 of all deaths, costs $6.5 billion in healthcare in Canada each year: study” http://www.cancer.ca/en/about-us/for-media/media-releases/national/2017/cost-of-tobacco/?region=on

Should Health Canada consider prohibitions on the manufacture and sale of vaping products with certain flavours or flavour ingredients?

Any consideration of prohibitions on the manufacture and sale of vaping products with specified flavours needs to be carefully considered against the risk of impacting the uptake of a much lower risk product (vaping) by users of the far more harmful product ⁽¹⁾ (combustible tobacco). Taste buds are not solely a sensory function of youth, nor is nicotine the only substance available that is adulterated to increase its palatability for the end user:

· Coffee, whose habit-forming constituent is caffeine, is bitter; often cream, sugar, artificial sweetener, and/or artificial flavouring agents are added to make it more palatable. Caffeine in more potent concentrations is also widely available in energy drinks of varying flavours. (It can be noted that outside of combustion-based delivery systems, nicotine has been compared directly to caffeine, a claim of ongoing debate, in regards to potential harm by some public health bodies ⁽²⁾). Currently there are no prohibitions on furbishing caffeine-based products to youth despite the risk of caffeine dependency, and in the case of energy drinks, known and demonstrated harms and adverse health effects ⁽³⁾.

· Alcohol (a substance with well known negative health and societal impacts yet a much more prominent level of societal acceptance) is available in a wide variety of flavours that could be considered “appealing to youth” and openly promoted on label and via media platforms. While the sale of alcohol to minors is currently prohibited, it is of note that CTADS 2017 reports that in the 15-19-year-old age range, ‘past 12-month use’ was indicated in 56.8% of respondents. 10.3% of youth surveyed met ‘exceeds LRDG chronic’ status and 6.6% were tallied as ‘exceeds LRDG acute’ ⁽⁴⁾.

Prohibiting specific flavours will not address higher risk tolerance levels and risk-taking behaviours in

youth. They will find another ‘flavour’ and continue with the behaviour.

Then we prohibit that flavour, and they move on to another they find palatable…

Despite the argument that it is “youth appealing flavours” Health Canada is questioning; such a tactic will only be truly effective once the product category is “unpalatable” to the target population (youths). This will have a significant impact on Canada’s 4.6 million smokers ⁽⁵⁾ (who have similar opinions with regards to palatability).

Beyond the FDA submission ⁽⁶⁾ by Dr. Konstantinos Farsalinos et al. referenced in my answer to the question of further promotional restrictions, there are two other published articles I would like to reference regarding the impact of flavour prohibitions and how they would impact Canadian smokers:

· The first is also from Dr. Farsalinos, published in the International Journal of Public Health. In 2013 titled “Impact of Flavour Variability on Electronic Cigarette Use Experience: An Internet Survey” ⁽⁷⁾.

o 4117 respondents, all users of vapour products. 91.2% identified as ‘former smokers’, 8.8% as ‘current smokers’.

o ‘Current smokers’ reported a substantial reduction in cigarette consumption, from 20 to

4 cigarettes per day.

o “The average score for importance of flavours variability in reducing or quitting smoking was 4 (“very important”). Finally, the majority of participants stated that restricting variability of flavours would make the EC experience less enjoyable while almost half of them answered that it would increase craving for tobacco cigarettes and would make reducing or completely substituting smoking less likely.”

· The second was published in 2018 in Harm Reduction Journal; “Changing patterns of first e- cigarette flavor used and current flavors used by 20,836 adult frequent e-cigarette users in the USA” ⁽⁸⁾ by Christopher Russell et al.

o 20,836 frequent e-cigarette users

o 15,807 participants (76.4%) had completely substituted e-cigarettes for combustible tobacco.

o “This study identified an increasing popularity of non-tobacco flavors and declining popularity of tobacco flavors by over 15,000 adult frequent e-cigarette users who formerly smoked cigarettes. The findings suggest that access to a variety of non-tobacco flavored e-liquid may be important for encouraging and assisting adults to use e- cigarettes in place of conventional cigarettes. Restricting the availability of non-tobacco flavors could reduce adult smokers’ interest in switching to e-cigarettes or rationalize a return to cigarette smoking among frequent e-cigarette users whose journey towards smoking abstinence started with, progressed to, and is being sustained by frequent use of e-cigarettes containing non-tobacco flavors.”

(1) Royal College of Physicians. Nicotine without smoke: Tobacco harm reduction. London: RCP, 2016. https://www.rcplondon.ac.uk/projects/outputs/nicotine-without-smoke-tobacco-harm-reduction-0

(2) Royal Society for Public Health (UK) ‘Nicotine “No more harmful than caffeine”’ https://www.rsph.org.uk/about-us/news/nicotine-- no-more-harmful-to-health-than-caffeine-.html

(3) Seifert, Sara M et al. “Health effects of energy drinks on children, adolescents, and young adults.” Pediatrics vol. 127,3 (2011): 511-

28. doi:10.1542/peds.2009-3592 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3065144/

(4) Canadian Tobacco, Alcohol, and Drugs Survey (CTADS) 2017. https://www.canada.ca/en/health-canada/services/canadian-tobacco- alcohol-drugs-survey/2017-summary/2017-detailed-tables.html

(5) Canadian Tobacco, Alcohol, and Drugs Survey (CTADS) 2017. https://www.canada.ca/en/health-canada/services/canadian-tobacco- alcohol-drugs-survey.html

(6) Farsalinos et al. “Patterns of flavored e-cigarette use among adults vapers in the United States: an internet survey.” Submitted to: Docket No. FDA-2017-N-6565 for “Regulation of Flavors in Tobacco Products.” https://www.regulations.gov/document?D=FDA- 2017-N-6565-22941

(7) Farsalinos, Konstantinos E et al. “Impact of flavour variability on electronic cigarette use experience: an internet survey.” International journal of environmental research and public health vol. 10,12 7272-82. 17 Dec. 2013, doi:10.3390/ijerph10127272 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3881166/

(8) Russell et al. “Changing patterns of first e-cigarette flavor used and current flavors used by 20,836 adult frequent e-cigarette users in the USA” Harm Reduction Journal (2018) 15:33 https://harmreductionjournal.biomedcentral.com/articles/10.1186/s12954-018- 0238-6

With regards to flavour ingredients:

There are indeed some flavour ingredients that should be discussed, not in terms of appeal to youth, young adults, or adults (because as noted previously, what appeals to one has a very high likelihood of appealing to the others), but in terms of potential harm to end users of vapour products. They should be discussed not in terms of absolute risk, but in terms of relative risk to other nicotine delivery systems.

Alpha-Diketones

Diacetyl (2,3-butanedione), an alpha-diketone, is a flavouring agent attributed with a buttery taste and has been identified as a suspect ⁽¹⁾ cause in a 2000 incident report regarding 8 workers/former workers at a popcorn factory in Missouri who were diagnosed with Bronchiolitis Obliterans. Acetyl propionyl (2,3- pentanedione) is another alpha-diketone with similar molecular characteristics that may cause it to similarly be suspect in potential damage if inhaled.

There are two primary means for Diacetyl to make its way into e-liquid; It can be added as a direct constituent, or it can be present in some quantity in flavourings used in the manufacture of e-liquids (often in quantities below reporting requirements for commercial ingredient lists),.

In 2014, partially in response to concerns from within the vaping end user community, Dr. Konstantinos Farsalinos performed an investigation and portions of his abstract published in Oxford Journals’ Nicotine and Tobacco Research ⁽³⁾ are quoted as:

· “In total, 159 samples were purchased from 36 manufacturers and retailers in 7 countries. Additionally, 3 liquids were prepared by dissolving a concentrated flavor sample of known DA and AP levels at 5%, 10%, and 20% concentration in a mixture of propylene glycol and glycerol. Aerosol produced by an EC was analyzed to determine the concentration of DA and AP.”

· “DA and AP were found in 74.2% of the samples, with more samples containing DA. Similar concentrations were found in liquid and aerosol for both chemicals. The median daily exposure levels were 56 μg/day (IQR: 26–278 μg/day) for DA and 91 μg/day (IQR: 20–432 μg/day) for AP. They were slightly lower than the strict NIOSH-defined safety limits for occupational exposure and 100 and 10 times lower compared with smoking respectively; however, 47.3% of DA and 41.5% of AP-containing samples exposed consumers to levels higher than the safety limits.”

· “DA and AP were found in a large proportion of sweet-flavored EC liquids, with many of them exposing users to higher than safety levels. Their presence in EC liquids represents an avoidable risk. Proper measures should be taken by EC liquid manufacturers and flavoring suppliers to eliminate these hazards from the products without necessarily limiting the availability of sweet flavors.”

As a result of this study and its findings the industry for the most part responded internally. The Electronic Cigarette Trade Association (ECTA) of Canada published a policy regarding Diacetyl and Acetyl Propionyl with a goal of Non Detect for both substances, a tolerance of 22 µg/ml for DA and 45 µg/ml for AP, a mandated notification to the consumer of it’s presence between 22.1 µg/ml (DA) and 45.1 µg/ml (AP) and 99.9 µg/ml, and a product stop sale order at 100 µg/ml or more for either compound⁽⁴⁾.

It is of note that these levels are significantly (orders of magnitude) lower than the demonstrated levels of Diacetyl found in the emissions of a combustible cigarette which were identified in 2006 by Fujioka et al. to be between 301-433 µg/cigarette ⁽⁵⁾. To date I am aware of no known reports of Bronchiolitis Obliterans as a result of cigarette use.

Diacetyl is prohibited as an e-liquid ingredient under the Tobacco Products Directive in the European Union ⁽⁶⁾.

A valid argument could be made to prohibit the use of Diacetyl and Acetyl Propionyl as “Ingredients”.

Manufacturers should be encouraged to monitor their flavour formulations to ensure that constituent- based contamination remains at minimum, no greater than the levels currently found in the combustible cigarette.

I would recommend the adoption of the ECTA guidelines ⁽⁴⁾.

· Target of ND (Non-Detectible)

· Diacetyl < 22 µg/ml in the e-liquid - constituent or reaction-based contamination levels (No action)

· Diacetyl levels between 22 µg/ml and 99.9 µg/ml (liquid testing) – Consumers must be notified of the presence of diacetyl.

· Acetyl Propionyl < 45 µg/ml in the e-liquid - constituent or reaction-based contamination levels (No action)

· Acetyl Propionyl levels between 45 µg/ml and 99.9 µg/ml (liquid testing) – Consumers must be notified of the presence of acetyl propionyl.

· At 100 µg/ml liquid concentration of either constituent the product should be prohibited from sale.

(1) CDC, The National Institute for Occupational Safety and Health (NIOSH) “Flavourings-related Lung Disease” https://www.cdc.gov/niosh/topics/flavorings/exposure.html

(2) CDC, Fixed Obstructive Lung Disease in Workers at a Microwave Popcorn Factory --- Missouri, 2000--2002 https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5116a2.htm

(3) Farsalinos, Konstantinos E et al. “Evaluation of electronic cigarette liquids and aerosol for the presence of selected inhalation toxins.” Nicotine & tobacco research: official journal of the Society for Research on Nicotine and Tobacco vol. 17,2 (2014): 168-74. doi:10.1093/ntr/ntu176 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4892705 /

( (4) ECTA of Canada Testing Protocols http://ectaofcanada.com/testing/

(5) Fujioka, K et al. “Determination of Toxic Carbonyl Compounds in Cigarette Smoke” Environ Toxicol. 2006 Feb;21(1):47-54. https://www.ncbi.nlm.nih.gov/pubmed/16463255

(6) EU Tobacco Products Directive https://ec.europa.eu/health/sites/health/files/tobacco/docs/dir_201440_en.pdf

What evidence exists to support the role that flavours play in youth inducements to use vaping products?

There is all kinds of evidence that youth like various flavours in many things, from cereal, to soda, to candy bars. Both reports commissioned by Health Canada, and referenced in the consultation document (Environics⁽¹⁾, and Phoenix⁽²⁾) attest to the fact that all user groups show a preference towards flavours that best match their individual palates. However, that does not necessarily indicate flavours being either solely, or even primarily, responsible for inducement or initiation.

· Question 11 is the primary example I will use for a response from the Environics report, as it was the one question that asked the direct question “Why did you try an e-cigarette?”. Although this question was only asked of one-time users, and allowed multiple responses, this was the one question I could find that specifically spoke to initiation of use.

o 64% identified social circle influenced triggers. “It was offered to me” (36%) and “My friends were vaping” (28%). These answers are reflective of both wave 1 and wave 2 participants.

o 20% of wave one participants indicated “I liked the flavours and/or smell”. There could be some argument that the wording of that answer could lean towards a social circle influence, but I am willing for the sake of expediency to accept it as a trigger on its own. In wave 2 the percentage dropped to 16%.

o While most of the responses to the Environics report are broken down into the three age categories (Youth 15-19, Young Adult 20-25, and Adult 25+), this question was not. That is unfortunate.

o It is similarly unfortunate that this question was not asked of the other participants.

“Why did you try?”, and “Why did you start”, are very different questions than “Why do you use?”.

· The Phoenix report had somewhat similar numbers for the most part, and similar concerns with the ability to choose multiple answers (2) and wording around flavours that could be interpreted as social sphere of influence as opposed to a stand-alone trigger.

o 64% of respondents identified social circle influence. “Friends were vaping” (44%), and “It was offered” at 20%.

o “Liked the flavours and smell” registered at 39%. This is higher than the Environics report, however, unlike the Environics report, the Phoenix report focused on youth and young adult categories (15-19, and 20-25) so some variability can reasonably be expected.

(2) Phoenix Strategic Perspectives Inc. Peer Crowd Analysis and Segmentation for Vaping and Tobacco. Internal Analysis of raw data. November 2018. http://epe.lac-bac.gc.ca/100/200/301/pwgsc-tpsgc/por-ef/health/2018/074-17-e/report.pdf

What are the potential public health risks of expanding the prohibition of flavour promotions or the prohibition of the manufacture and sale of certain attributable flavours?

· 45,464 deaths attributable to smoking in 2012, an average of 1 every 11.56 minutes. ⁽¹⁾

· $6.5 Billion in direct health care costs. ⁽¹⁾

· $9.5 Billion in indirect costs. ⁽¹⁾

The primary public health risk in over regulating vapour technology is in limiting the impact that vapour technology can have on existing rates of disease and death in the smoking population.

In the introduction of this report, the Hajek et al. blind clinical trial published in the New England Journal of Medicine ⁽²⁾ was referenced. This trial provided evidence that vapour technology, in controlled conditions, provided a 1-year abstinence rate at nearly twice the value of nicotine replacement therapy. Non scientific (anecdotal) evidence was mentioned that a vapour technology shop, financially could not be successful at even the increased conversion rates demonstrated by the clinical trial. It is highly likely that specialty vapour technology shops have a higher conversion rate than was demonstrated scientifically by Hajek et al. if for no other reason than those shops are not restricted by the limitations of clinical trials.

It is important to remember that the target consumer is currently using a product engineered to be extremely effective at delivering nicotine, with a complexity of operation that does not exceed the following procedure:

1. Open the box.

2. Remove stick from box.

3. Ignite one end of the stick.

4. Inhale from the other end.

And a 1 step trouble-shooting guide of “If you set the wrong end on fire, turn the stick around and set

the opposite end on fire”.

Vapour technology responds to the simplicity and efficacy of cigarettes by offering a more palatable and pleasant experience for the user. The availability of flavours is a key component of that experience.

Given the federal restrictions on the consumer product (no cessation claims, no comparisons of emissions between vapour technology and combustible tobacco products, and other promotional restrictions), the media focus on the dramatics of remote absolute risks, the moral panic on the issue of youth uptake, and smokers confusing messages intended for adolescents as being directed towards them, vendors of vapour technology are already facing an up hill battle trying to market the product to it’s intended target user base. Further restricting what few means those shops currently have to reach smokers, directly impacts the vendors’ ability to get the smoking population transitioned to the less harmful product, the mortality rate remains high, and public health benefit goes unrealized.

(1) Alexandru Dobrescu, Abhi Bhandari, Greg Sutherland, Thy Dinh “The Costs of Tobacco Use in Canada, 2012” - The Conference Board of Canada, October 16, 2017 – https://www.conferenceboard.ca/e-library/abstract.aspx?did=9185

(2) Hajek et al. “A Randomized Trial of E-Cigarettes versus Nicotine-Replacement Therapy” The New England Journal of Medicine. 30 January 2019. Doi: 10.1056/NEJMoa1808779.

What Do I Think?

As a former smoker:

· I think that the availability of a wide range and variety of flavours was important in helping me accept the complexity of vapour technology and choose that technology over the simplicity, and efficacy of nicotine delivery, of combustion-based products.

· Neither of the two e-liquids I used in my transition could be referenced as a tobacco flavour.

o The primary e-liquid I used was called “Beaver Drops” – A maple cinnamon pastry flavour akin to that of a bakery item referred to as a “Beaver Tail”.

o The second flavour was called “Iceberry Tots” and was very reminiscent of a “Jelly Tots” candy with mint.

o I was in my early 40’s during my transition and those two flavour profiles were important to my success.

· The fact that vapour technology “tasted” better than combustion-based delivery was enough justification for me to put up with the much more complex operating requirements (Fiddling around with bottles of e-liquid, changing coils, device user interfaces, etc.) and somewhat less efficient nicotine delivery (I transitioned prior to the availability of nicotine salts being available in vapour products. Free-base nicotine does not have as rapid an uptake.).

· I think that when Public Health Bodies issue blanket statements such as “flavours appeal to youth”. They are deliberately oversimplifying the response based on puritanical and prohibitionist policies and procedures that have previously been applied in an effort to reduce public health harms (morbidity and mortality) from smoking.

o Those same flavours are appealing to me as an adult.

o Statistically there is a significant likelihood that the leaders and employees of these public health bodies do not drink their coffee unadulterated.

o They do not have a single bottle of “unflavoured” grain alcohol in the cabinet.

o The cough syrup they use when under the weather is likely fruit flavoured.

o Their retirement cake will likely be vanilla or chocolate.

o I think that they understand that taste buds do not whither and disappear at the completion of puberty, no matter how politically correct, or expedient it is, to allude that it is otherwise.

· I thought I was going to smoke cigarettes for a very long time to come. I used to say I’d butt my last cigarette out on the earthen side of the trench as my casket was being lowered. I said this not so much as an act of rebellion, but more as an act of morbid resignation.

o Vapour technology changed that.

o Flavours played their part in that change.

What Do I Think?

As a parent:

· I don’t believe it is appropriate to see the amount of promotion currently in use at convenience stores and gas stations. (This would be addressed with the implementation of the measures put forth in the February 2019 request for consultation).

· I think adolescent risk-taking behaviour is well studied in the research community and has been communally understood amongst parents for as long as there have been adolescents and parents.

· I don’t think my son tried vaping because of the flavour of the product. If that were the case then the odds are higher that he would have nicked one of my vapourizers and gone through my liquids on his own, very quietly, in his room. My son tried vaping because he was with a group of his peers, which is well known academically to increase risk tolerance levels in adolescent males, and one of his mates pulled out a vapourizer and offered it around the group.

· I think that had my response to this been overly dramatic and emphatic, two things would have happened:

o I would not have been able to leverage the available opportunity to talk about risk as an absolute, risk in comparisons to other risks, and other (and in some cases far more dangerous) things he is likely to be exposed to within his peer group in this new phase of his life where he is pushing to assert his growing individuality and independence.

o The next time I inquire about things he is exposed to, interested in, or actively experimenting with, I would be met with furtive resistance, dishonesty, or denial. I can’t influence his decision-making process at all if he chooses to keep it from me entirely.

· We would do well to remember that ten years ago, all youth experimentation with nicotine was done with combustion-based products. While 50 years of abstinence only policy did reduce the number of youths performing the experimentation, it certainly and demonstrably did not eliminate it.

· If my son were smoking cigarettes and I was having the difficulties my father had with me in this matter over 30 years ago. I would put the vapour product in his hand in whatever flavour it took to keep him from smoking.

o No, I don’t think vaping is the brightest decision he could make, nor was I thrilled that he was experimenting with it, and I don’t condone what he did. However, this won’t be the last time in history that a teenager (including one of mine) does something I think of as dumb and risky. My primary responsibility, biologically, is to make sure he survives these dumb, risky decisions.

o In 30 years, I don’t particularly want any of my children to be one of the 45000, waiting to see if it’s their turn because the minute hand moved a little over 1/6^th of the circumference of the clock on the wall. I would happily keep that life experience to myself.

What Do I Think?

As an advocate and business owner:

· My businesses are age restricted and have been since well before the TVPA received royal assent, and we specifically target smokers. My average customer is more represented by soccer moms and grandparents than millennials and hipsters. As of the time of this writing here are the top 5 flavour profiles my customers purchased in the last month (out of an available 100 or so potential profiles):

o Grape soda.

o Watermelon hard candy.

o Hazelnut ice-cream and cheesecake.

o Strawberry coconut.

o RY4 Tobacco.

o The tobacco flavour constituted 11.56% of the top 5 products, by volume sold.

· I spend a good portion of my day currently trying to figure out how to reach the adult smokers of the communities in which I operate without running afoul of the promotion prohibitions of the TVPA. In some cases, I can’t openly respond to consumer questions, or media reports making statements that misrepresent the risks of vapour technology to smokers. I am constantly concerned that if I am misquoted or misunderstood that I can be found in violation of the TVPA, and the repercussions of a violation can quickly elevate to the point of being an existential threat to my business.

o This greatly impacts my ability to help adult smokers transition to vapour technology.

o Further instances of regulatory muzzling will not make reaching adult smokers any easier.

· The first round of promotional restrictions based on flavour profiles only came into effect on November 19^th of 2018, roughly 5 months before the consultation request. I do not think enough time has passed to assess the impacts of those restrictions on youth uptake for effectiveness. This leads me to believe that expanding this measure would not be based on data, but emotional reaction. Emotionally based regulation is seldom “good” regulation.

· I do believe that the ability to relay accurate flavour profiles to adult consumers within an age restricted venue is important. This information does not have to necessarily be “on label” where it would pass through the door into youth accessible, public domain, but it does need to be conveyed to adult users in an effective and clear manner within the age restricted venue.

· Given that my business only deals with adult consumers. Flavour bans will only impact adults when it comes to my consumer reach.

· Given that my target audience is smokers and looking at the statistical representations of flavour preference amongst my consumer base, flavour bans will directly impact my ability to effectively reach the adult smokers in my region.

Nicotine Concentration and Delivery Restrictions

What are the potential public health benefits and consequences of placing restrictions on the concentration and/or delivery of nicotine in vaping products?

Restricting nicotine concentrations has the potential to impact far more than just youth initiation and uptake.

Nicotine users do not smoke or use vapour technology for the nicotine in a cigarette or the concentration of nicotine in a vapour device. The trigger to use either product has to do with the nicotine in their blood and its impact on their nervous system. A device that delivers a higher concentration of nicotine in a lower vapour volume can create the same effect as a high-volume, lower concentration, solution.

Given the fact that the consultation document identifies “Evidence in the role of nicotine in youth appeal of vaping products is very limited and may not reflect current trends. However, available data suggest that youth are not specifically seeking nicotine when making a decision to try a vaping product.”, then restricting nicotine concentration and delivery with the intent of reducing youth appeal and initiation is not likely to be overly effective. In the cases where those youth are currently regular users of combustion-based tobacco products, if nicotine is restricted in delivery and concentration, we may push them back to illicit tobacco use. An argument could reasonably be made that for those specific young individuals that by restricting nicotine levels, we have done them a public health harm.

Public health impacts amongst adult smokers resulting from restrictions on concentration and delivery of nicotine would largely be the morbidity and mortality rates that would continue to affect those who do not switch to the cleaner delivery system because they cannot meet their dependency requirements for nicotine.

Public health impacts among vapers would largely be associated with the “unknown” long term effects of vaping and how those effects would be magnified by lowered nicotine concentrations. Let’s use the Juul device for an example, given that that’s where the current focus is in the media with regards to nicotine:

· A recently transitioned pack a day smoker is using a Juul device at a rate of one 0.7ml, 59mg/ml pod a day. Daily nicotine intake is 41.3 mg in relation to liquid consumed.

Regulation imposes a 20mg/ml limit similar, to EU TPD regulation.

· Because the trigger to use the product is based on the dependency of the user, and the trigger for putting the device down is based on meeting the needs of that dependency, reducing the nicotine content means the user needs to use the device more often and/or for longer time periods of time to feel satisfied. This results in increased exposure to carrying agents (Propylene Glycol, Vegetable Glycerine) and flavouring constituents in the vapour product.

Regulation impacting the formulation of nicotine (freebase nicotine versus nicotine salt) will similarly be of limited impact in a youth’s decision to try vaping; as mentioned in the consultation document. It does however have a very real potential to impact conversion rates for Canadian adult smokers to vapour technology.

Freebase nicotine causes throat irritation. Amongst vapers it is referred to as “throat hit” and for smokers, within a limited range of freebase nicotine concentration, it can be reminiscent of the throat irritation they were subjected to when they smoked a cigarette. Simple logic would dictate that throat irritation would be a negative trait in vapour technology, however, many transitioning smokers often notice a lack of throat hit as “something missing”, and has been noticed by vendors to be enough of a differentiation to cause some smokers to reject the technology and return to the delivery system they are intimately familiar and comfortable with.

Conversely, with heavier smokers who require higher concentrations of freebase nicotine (18mg/mL, 24mg/mL, etc.) to successfully replace the nicotine they were getting from combustion-based delivery systems, the throat hit can exceed that of a cigarette. In some cases, it is “too harsh”, and the consumer also returns to the more familiar and comfortable product that is readily available at many locations within their immediate vicinity.

The introduction of nicotine salts to vapour technology was a significant change to the industry - a

“disruptive” technology internal to the vapour technology market. Nicotine salt formulations allowed for lower powered, lower volume delivery devices to more effectively reach smokers, and often in a form factor that more closely matched the combustion-based systems in ease of use. This made for a relatively effective convenience store solution that required little to no instruction, and placed vapour technology in the same location where smokers purchased cigarettes. These systems, like all vapour technology are not perfect, and they have limitations, but they are an effective and well-placed introductory tool for smokers.

Specialty vapour technology shops that adopted nicotine salts to their existing tool kits are very likely to anecdotally report an increase of conversion rates amongst their smoking customers and a reduction in liquid volume sold per vaper who adopted the new liquid formulation. If our Canadian research and regulatory bodies were to have studied ‘real world’ conversion rates both before and after the introduction and uptake of nicotine salt product this would have been very likely validated.

Again, it is important to recognize that vapour technology is competing with a delivery system that has been around for centuries, if not millennia; depending on how one would like to define “smoking”. In its modern form of the cigarette, this delivery system has been highly studied, engineered, and perfected, as the most effective delivery system for nicotine in existence; and consequently, because it is combustion based, it is also the most dangerous.

The proper amount of nicotine in either freebase, or nicotine salt formulation, to be delivered to a smoker can only truly be defined as “as much as it takes to stop setting a cigarette on fire” within the toxicological limits of nicotine as a substance in it’s own right. This is as specific to the individual consumer as individuality itself is specific to the consumer.

The more tools in a specialty vapour technology shop’s toolbox, the higher the conversion rate.

The higher the conversion rate, the greater the impact of the disruptive technology on the morbidity and mortality rates amongst the existing Canadian smoking population.

What Do I Think?

As a former smoker:

· My first bottle of e-liquid was a freebase 24mg/mL formulation and was used in a moderate volume (vapour) delivery device. It had far more throat hit than a cigarette did. It was uncomfortable, almost uncomfortable enough for me to write the technology off and go back to using the product I had 3+ decades of experience and comfort with. 24 mg/mL was enough nicotine to replace my 35-40 cigarette a day habit. I was vaping as often, and for as much time, as I had been smoking cigarettes.

· My second bottle of e-liquid was a freebase 18 mg/mL formulation used in the same device. While it’s throat hit was more tolerable (still more than a cigarette but not overly unpleasant) I found I was using it constantly throughout the day for the first 2 weeks. I continued to use 18 mg/mL for a further 8 months, by which time I again found the throat hit too irritating and I stepped down to 12 mg/mL solution.

· Currently, depending on the device I am using, my nicotine concentration in solution varies;

o In a low resistance, high volume (Vapour) device, I use a 3mg/mL solution.

o In a moderate resistance, moderate volume device, I use a 6mg/mL solution.

o In a high resistance, variable power, low volume device, I use either a 6mg/mL freebase solution or a 10mg/ml nicotine salt solution.

o In a high resistance, low power, very low volume sealed pod system, I use a 35 mg/mL nicotine salt solution.

· In each of the above cases my usage pattern is unchanged from that as a smoker. I get a trigger, I use the device until I am satisfied, I put the device down. Using the higher levels of nicotine does not lead to more nicotine use over all. If one were to test my cotinine levels on a regular basis, I am confident they would remain relatively constant regardless of the device, or nicotine concentration used.

· Had nicotine salt solutions been available on the market when I made my transition, it is highly likely the transition would have been easier to make due to the lower level of throat irritation.

· I have no interest in stopping my use of nicotine as a stimulant anymore than I intend to stop having coffee in the morning. I find it helps with my focus and attention to detail, lowers agitation when I am stressed, and yes, I have a dependency. I’m ok with that on a personal level – What I would like to do however is lower my risk of emphysema, lung cancer, heart disease, stroke, etc. that has impacted, and continues to wreak havoc with, many lifelong smokers.

· In a “quit or die”, abstinence only based approach to nicotine use and smoking, I had accepted and come to peace with the fact that my future had a 50% chance of disease and premature death, and I understand that as a former smoker of 33 years, that this still may be my future, but for a good portion of Canada’s 4.5 million or so smokers, it does not necessarily have to be “their future”. Their future very much depends on whether Health Canada continues to be concerned with nicotine related dependency more than smoking related disease and death.

What Do I Think?

As a Parent:

· My son didn’t try vaping for “nicotine” any more than the tried it for “flavours”. My son tried vaping because he was with a group of his peers, which is well known academically to increase risk tolerance levels in adolescent males, and one of his mates pulled out a vapourizer and offered it around the group.

· 10 years ago, they would have offered him a cigarette.

· If my son were smoking cigarettes and I was having the difficulties my father had with me in this matter over 30 years ago. I would put the vapour product in his hand in whatever nicotine strength it took to keep him from smoking.

· I would be ecstatic if my children made it through their lives avoiding every mistake I ever made. Making the right decision the first time; every time. However, that’s not an overly realistic standpoint to have as a parent, or as an adult who understands human nature.

· On the list of “Things My Kids Could Get Messed Up With” that keeps me up at night;

o Risk taking behaviour that could be classified as IDLH (Immediately Dangerous to Life and Health) is in the top three.

o Unprotected sex/Premature parenthood is in the top five.

o Smoking is in the top five.

o Binge Drinking is in the top ten.

o Experimentation/Exposure to opioid’s is in the top ten.

o The only reason cannabis experimentation is on the list at all within the top 25 is due to illicit supply chains used by minors and potential for contamination with far more harmful substances.

o Nicotine use outside of a combustion-based delivery system? It’s a concern, and not

an invalid concern, but It’s on the same level as caffeine use on my list.

What Do I Think?

As an advocate and business owner:

· The primary reason vapour technology is so disruptive to combustion-based delivery systems is largely due to its variability in application. The ability to adjust nicotine levels up and down to meet the consumer’s individual needs is critical to transition success rates. Limiting that nicotine delivery by concentration (beyond limitations attributed to toxicological impact levels) or by formulation will limit that transition rate for smoking Canadians.

· My business succeeds or fails based on conversion rates of adult smokers to vapour technology. After the introduction of nicotine salts, we realised both an increase in conversion rates overall, and a positive impact in the ease of conversion (fewer dual users, and a shorter time frame in dual use before complete transition).

· Reducing nicotine concentrations and formulations beyond what is required for consumer safety will reduce the viability of the product for certain segments of the Canadian adult smoking population. Those smokers will continue to suffer the 50% premature mortality rate that they always have, along with the pre-mortality disease that precedes it.

· Youth uptake should be addressed through youth access, and youth accountability. While adolescent nicotine use is a valid concern, the root of most youth abuse of adult oriented consumer products is adolescent risk-taking behaviour. This can only be effectively be addressed by first recognizing its existence and tailoring our messaging to account for it.

· Uptake of vapour technology by youth nicotine dependent smokers should be weighed for public health impact.

· The nicotine Health Canada is concerned that youth and non-smokers will become dependent upon is the very same nicotine that smokers require to reduce the morbidity and mortality of combustion-based systems.

· Nicotine dependency is not a greater public health threat than smoking mortality. Nicotine dependency is not the enemy here. Smoking related death and disease is, and should be, the focus.

Device Restrictions based on “Youth Appeal”

In the same fashion as was noted with both flavouring and with nicotine, the consultation paper notes that device features are not a primary consideration in youth experimentation and uptake.

As with both flavouring and nicotine strength, trying to limit youth uptake of vapour technology by addressing the appeal of the technology to youths is confounded by the fact that this same variability in configuration is what makes it appealing to the smoking population. In restricting the attributes of the

technology to the point where it is no longer “appealing” to the youth population, it will, by default become unappealing to a significant portion of the intended target smoking population as often both groups share common opinions when it comes to what makes a product appealing.

Vapour technology to date, has yet to perfectly replicate the intuitiveness, the ease of operation, the speed of nicotine delivery, or the comfort of use, of current combustion-based delivery systems.

With the technology’s limitations in mind, and because legislation severely restricts vapour technology businesses from promoting the product based on comparative harms and prohibits cessation statements. The industry is left with only one primary means of reaching those combustion-based product users; variability. In palate, strength, form factor, and price point. That variability, the potential to access and adjust a wide variety of attributes to the personal preference of the individual consumer, is a foundation of vapour technology’s success in reaching adult smokers.

Device attributes in a consumer driven economy are driven by the consumer purchasing decisions. These attributes were not designed with the intent of appealing to minors, but to better appeal to adult smokers and increase the penetration of the vapour technology market into the combustion-based delivery consumer base.

When we remove the variability from consumer-based technology, we need to understand that we are removing options for Canadian smokers with opinions on appeal as individual as the smokers themselves. In some cases, this will induce them to continue using the more harmful product.

No matter how much we reduce appeal for smokers we cannot hit the primary source of appeal for youth; the appeal of accessing an adult product that they have been told they may not access at this point in their lives.

Again, we are left with adolescent risk-taking behaviour, which will not be addressed effectively by making the vapour technology product so drab, that it appeals to no-one.

Restricting Online Access

It is again of note that the “Youth” category includes individuals who are of legal age to purchase vaping products in some (18) or all (19) Canadian jurisdictions. In order to clarify legal vs. illicit access, one would need to create a delineation in the study formats used by the federal government agencies to identify which “youth” are acting within those legal limitations as opposed to those who are not.

The consultation document identifies youth accessibility as: social access in excess of 75%, specialty vape shops and convenience stores coming in at 10% a piece, and online purchase data as “too low to count”. Applying restrictions on the least prevalent source of youth access would likely have limited impact on youth experimentation and uptake.

Social access may be the most difficult means of access to control, but it is where the biggest gains can be made. Age verification at physical point of sale and enforcement of existing regulation around age of access would be the second largest impact (although still dwarfed by social access).

Applying regulation to online access would be the least costly as far as implementation and enforcement are concerned (no need for boots on the ground outside of a central enforcement office), but aside from raising public perception that the government “takes youth nicotine use very seriously” and “is actively regulating the market in response to youth vaping”, it is unlikely to have a significant impact on youth experimentation and uptake. It will have no impact where those online retailers are outside of Canadian jurisdictional and enforcement boundaries.

That said, some of the proposals are already being implemented by the vapour technology industry. Most Canadian online retailers already have statements regarding age restrictions for on-line purchase and many business owners already require age verification at point of delivery and signatures from recipients. There are already couriers (Canada Post and perhaps some others) who have procedures in place and can provide this service.

Two points should be brought up about the implied messaging in the proposals;

· Requiring two stage verification for vaping purchases when it is not required for either alcohol or cannabis, as noted in the consultation document, implies that nicotine, outside of combustion-based delivery systems, carries a larger risk profile than either alcohol or cannabis. This does not align with current availability of nicotine in lozenge, gum, or other approved cessation devices, nor does it align with known public health harms attributed to the other two adult products.

· In the wording of the section on restricting online access there are multiple instances where reference is made to ordering “tobacco or vaping products” online, while the two products are covered under the same act, they are differentiated within that act. Currently cigarettes cannot be ordered online. Unless it is Health Canada’s intent to start a debate as to whether they should be sold online, the wording around that proposal should be reviewed.

Increasing Regulatory Transparency and Openness

Regulation should be formulated upon logic, scientific principle, and data accessible to all parties, not emotion, misrepresentation, and rhetoric.

Consultation Request – Citation 3

It is of concern that one of the drivers for this consultation paper is what shall be referred to as “The Report”. The report is found in the consultation request document as citation number 3 in the references and was presented to the Scientific Advisory Board on Vaping Products in Toronto, Ontario on November 19^th, 2018.

This submission cannot directly reference the report, its contents, or its findings, because the report has not been published yet. This submission does not have the permissions required from either the lead author or the originating university.

The report has however been shared with the scientific advisory board, it has been referenced in

broadcast media by its co-author, and it was referenced within the consultation document.

· "All signs are very worrisome." – “Teen vaping in Canada has taken a ‘worrisome’ turn” CBC News Dec 8th, 2018 - https://www.cbc.ca/news/health/health-canada-youth-teenage-vaping-smoking-hammond-1.4937593

· “Is it enough to be worried about? You’re damned right.” - “Canada’s ‘wicked’ debate over vaping” CBC News February 2nd, 2019 - https://www.cbc.ca/news/health/vaping-juul-vype-health-canada-cigarette-smoking- nicotine-addiction-1.5003164

· “More recent evidence presented to Health Canada suggests that there has been a sizeable increase in vaping among 16 – 19-year-old Canadians” – “Reducing Youth Access and Appeal of Vaping Products: Consultation on Potential Regulatory Measures” – Health Canada, April 2019

There are many reasons why academic literature has such a thorough and rigorous, review and publishing structure. Some of those reasons are to ensure that the data can be validated as accurately attained and formulated, to question the conclusions in a manner that either affirms their validity or identifies their limitations, and to ensure that regulators and others who will go on to use that literature are working with the best possible data they have access to. That review process also allows those who are impacted by any such regulation to either grasp the logic behind the regulatory measures proposed or speak to their own interpretations of the data set within their means. Emotion and fear tend to be poor reasoning for regulation as they tend to override logic and reason.

Speaking to the “sizeable increase in vaping among 16-19 year old Canadians” from the consultation

document that was attributed to the study;

· What was the percentage of youth that classified as “ever-users” (1 puff)?

· What was the percentage that classified as past 30-day use?

· What was the percentage that demonstrated daily use?

· How many of those youth previously were smoking cigarettes?

· How many of those youth had risk tolerance profiles that would have made them potential smokers?

The answers to these questions can have a significant impact to the “appropriate” level of concern that

should be applied.

· Experimentation is not dependency. One youth with a vapourizer at a party can create 10 “ever- users” in less than 5 minutes, that does not mean any of them are going to become dependent on the product.

· Once a week usage also does not equate to nicotine dependency as measured currently, however it certainly would demonstrate a risk profile and existing pattern of behavior that could reasonably progress to dependency.

· Among youth who “regularly vape” (every day, 15 of 30-day usage) it is important to identify those who previously identified as regular smokers. The mechanics of harm reduction are not age dependent. A consistent and valid argument can be made that a youth who is currently using the more harmful product and refuses to stop usage, would benefit from the less harmful delivery system.

· Never-smoking-regular-vaping youth. This is an indicator that should be monitored closely, and consistently compared to regular-smoking youth. If vapour technology is interrupting youth smoking then as one goes up, the other should come down. This could be argued as an “unpopular” public health benefit. We would all prefer that youth do neither, however we have 50 years of anti-smoking campaign results that demonstrate that what we would prefer is not always represented in actuality.

· It is important to avoid emotionalizing the data set. A shift from 0.5% to 0.75% could certainly be stated as a 50% increase, but then so could a shift from 20% to 30%. Care should be used to make sure the data is provided so that relative comprehension is maintained in the broad perspective. Emotionalizing a data set results in an emotional response. This does not make for good regulatory principle, nor does it generally bring about good regulation.

· Scientific data and academic studies that have not completed review and publication, and therefore are not available to all parties for review, should not form the foundation of regulation.

Equivalent Messaging and Target Audience Identification

As mentioned in the introduction, vapour technology is disruptive to far more than just the combustion- based delivery system. It has also provided reason to re-assess official messaging protocol around nicotine use. In many ways the message prior to an effective harm reduced option was simpler, and after 50 years there will be significant comfort in “the norm” and resistance to change. This comfort and resistance however does not mean this change is not warranted.

Multiple messages now need to be put forward;

· Non-smokers need messaging that reflects inhaling any product aside from fresh air increases your exposure to constituents that may at some point in the future cause some level of harm and that this would include vapour technology.

· Youth, due to the fact that their nervous system has not completed development need to understand that beyond the harms associated with smoking, they are more susceptible to the dependency forming properties of nicotine.

· Smokers (of all age groups) need to understand clearly and without question that vapour technology is significantly less harmful than combustion-based delivery systems.

While the ultimate public health benefit is realized by no Canadian using either product, that goal will be unattainable while tobacco is available in legal form at every corner store and gas station, and highly unlikely to be attainable so long as tobacco is available at all, in either legal, or illicit fashion.

Current messaging around vaping by Health Canada, in its most publicly visible form, is focussed on youth and non-smokers. West Edmonton Mall has laminates on entrance doors for the “Think of the consequences” campaign, and banners for that campaign have been photographed at multiple public events. However, the messaging does not clearly differentiate to the public at large that its target audience is youth. Smokers read the message and view the images of cloudy lungs and concerns about neurological impacts that should be targeted to youth and assume this messaging also applies to them. There is anecdotal evidence of adult vapers asking vape shop owners about this messaging, which then stymies those business owners who are unsure as to how they can legally respond without running afoul of TVPA regulation.

There is no matching highly visible campaign from Health Canada telling smokers that switching to vapour technology can benefit them. TVPA regulation currently prohibits business owners from applying any messaging campaign that would help smokers understand the difference in risk profiles, and the media to this point has been more interested in youth experimentation and dramatics than harm reduction for 15% of the Canadian population.

The bodies that should be telling smokers there is a better choice, aren’t, and the bodies that want to tell them, legally can’t. If we consistently amp up the negative aspects of the technology and downplay the positives, it should come as no surprise when the potential public health benefit goes unrealized.

Concluding Remarks

None of the proposed measures will address youth risk taking behaviour, which is the root of most decisions youth make that we think of as being “poor”.

One cannot attack the “Youth” palatability of a product without attacking the “Adult Smoker” palatability, as functionally there is no clear delineation between the two. One cannot attack the efficacy of the product with regards to nicotine delivery without impacting it’s (now demonstrated by clinical trial) increased success rate in cessation.

One should not allow “Dependency” to have priority over “Morbidity” and or “Death”.

At its heart, that is the fundamental point of these 32 pages, that have taken me a little over a month to write.

· While governments are “gravely concerned” about youth uptake and approaching it from an “at all costs” standpoint…

· While we read a consultation request full of pictures of perfect, healthy, smiling teenagers and formulate a response…

· While the media reports on formaldehyde and popcorn lung without providing the data to place those items in a relative risk context, followed by reports of bathroom doors being removed from high school washrooms…

· While academics selectively share unpublished data and feed fearful and ominous quotes to the press…

· While business owners, many of whom are former smokers who got into this with the legitimate intent of helping others, gnash their teeth, bite their tongues as they watch information get selectively released out of context, or not released at all; unable to respond by law…

· While those business owners spend time developing phrasing around the words “transition”, “switch”, “replace” and my personal phrase “Stop setting things on fire” because for some reason “quit” is determined to be a medical intervention…

While all these things are happening, 4.5 million Canadians, of all ages, are having a cigarette and waiting for eleven and a half minutes to see if it’s “their turn”.

· 45,464 had their turn in 2012. 10’s of thousands a year in the years both before and after.

· Somewhere between 100 and 125 smokers a day. Allowing for the variability of time.

· Over 3000 in the time it took me to research and draft this report.

Youth dependency is a tragedy, and a very valid concern. Smoking morbidity and mortality is a well researched statistic. 45,464 is not an ‘epidemic’, because we have come to expect that number of deaths in a year. We have come to accept it, and it is in that acceptance that we have lost our way.

I think statistics are important. I think we need to re-assess our approach to nicotine.

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Shop Talk with Thomas Kirsop

Report submitted to Health Canada in May of 2019

Declaration of Competing Interests

Introduction

What Do I Think?

As a former smoker:

What Do I Think?

As A Parent:

What Do I Think?

As an advocate and business owner:

· 45,464 deaths attributed to smoking in 2012- One every 11.56 minutes

Flavour and Ingredient Restrictions and Prohibitions

Further restricting promotion, prohibiting specified flavours and ingredients

What evidence exists to support the role that flavours play in youth inducements to use vaping products?

What are the potential public health risks of expanding the prohibition of flavour promotions or the prohibition of the manufacture and sale of certain attributable flavours?

As a former smoker:

What Do I Think?

As a parent:

What Do I Think?

As an advocate and business owner:

Nicotine Concentration and Delivery Restrictions

What are the potential public health benefits and consequences of placing restrictions on the concentration and/or delivery of nicotine in vaping products?

As a former smoker:

What Do I Think?

As a Parent:

What Do I Think?

As an advocate and business owner:

Device Restrictions based on “Youth Appeal”

Restricting Online Access

Increasing Regulatory Transparency and Openness

Consultation Request – Citation 3

Equivalent Messaging and Target Audience Identification

Concluding Remarks

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