March 9, 2017
It was more than 50 years ago that the most successful public health campaign in Canada began with the first salvo from Canada’s Health Minister of the time, Judy LaMarsh. On June 17, 1963, she declared in the Other Place: “there is scientific evidence that cigarette smoking is a contributory cause of lung cancer and associated with chronic bronchitis and coronary heart disease”. In a world where smoking was a firmly established culture associated with happiness, relief and leisure, this was a bombshell. But it also prompted the reversal of complete denial, even from the tobacco companies, that there was any evidence of health risks associated with smoking.
It is interesting to note that the day after LaMarsh rose in the Other Place to admit publicly that the evidence had accumulated and could not be denied any longer, one of the largest multinational tobacco companies announced it would no longer air tobacco commercials when children would likely be watching, before 9pm.
And, so began this half century of addressing the public health problem of tobacco use, here in Canada, and around the world. At that time about 50% of Canadians smoked, 61% of men and 38% of women. Today about 13% of Canadians are smokers.
The first legislation, an attempt to ban advertising of cigarettes, was enacted in 1989 only to be struck down by the Supreme Court in 1995.
Currently there are two Federal Acts that address tobacco products and their use at the Federal level: the Tobacco Act administered by Health Canada since 1997, and the Non-smokers’ Health Act administered by HRSDC. In 2001, the Federal Tobacco Control Strategy was introduced in Canada. It focused on smoking prevention for children and youth, smoking cessation, and second-hand smoke prevention. In 2005 Canada became party to the WHO Framework Convention on Tobacco Control.
This history is important to keep in mind today as we try to understand the legislation introduced here in the Senate, Bill S-5, An Act to amend the Tobacco Act and the Non-smokers’ Health Act and to make consequential amendments to other Acts. Essentially, Bill S-5 amends the Tobacco Act to add and regulate vaping products as a separate class of products, and aligns other existing Acts to conform.
Bill S-5 also follows through with additional tightening of certain tobacco regulations. Now, with this legislation, we are faced with the question of how to regulate a new product on the market, the “e-cigarette”.
In fact, there are differing opinions in Canada about what to do at this particular juncture: regulate, ignore and wait for more evidence about the product, or ban the e-cigarette altogether. In order to begin to think about Bill S-5, now before us, we must lay out some of the largest issues we are confronted with. What is vaping and the e-cigarette? What is the prevalence of e-cigarette use in the Canadian population? What is the scientific evidence to-date on vaping and e-cigarette safety? What is the experience in other countries? What is the rationale for legislating in Canada now.
Many of us in this Chamber will be unfamiliar with both the product, electronic cigarettes, and the process of vaping. Developed in 2003 by a pharmacist in China, and first introduced into the US in 2007, the e-cigarette is one of a category of products called electronic nicotine delivery systems. The e-cigarette, a battery-powered device designed with the look and feel of a traditional cigarette, is meant to deliver inhaled doses of a nicotine-containing aerosol to users. It does this by heating a solution (commonly referred to as e-liquid) made up of the carrier compound propylene glycol with or without glycerin, the nicotine, and a wide range of other additives and flavours.
The flavours are many, and include tobacco, coffee, menthol, fruits, candies, alcohols, and some as delicious as watermelon, popcorn, and cherry cheesecake.
The nicotine concentrations are not regulated and users can modify many of the products in the e-liquid as well as using it to deliver other drugs like cannabis.
The e-cigarettes used today reflect significant technological advances and are continually being refined to meet after-market demands. However, there is a wide variability in e-cigarette engineering that results in different mechanisms to heat and convert the nicotine solution to an aerosol. In all cases batteries, some rechargeable and some not; and cartridges, some refillable and some not; are part of the engineering of an e-cigarette. Some also have electronic settings that permit the regulation of length and frequency of puffs, as well as degrees of heat.
There has been rapid market penetration and increasing involvement in the vaping business by the major multinational tobacco companies. Sales are said to have doubled every year in the United States since 2008.
Current estimates are for global sales of vaping products to reach ten billion dollars this year, and they are expected to surpass conventional cigarette sales over the next decade.
Unlike conventional cigarettes, e-cigarettes have been marketed through television, the Internet, and print advertisements to promote a lifestyle as well as their use as a healthier alternative to tobacco smoking, for smoking cessation, and to reduce cigarette consumption. However, there is insufficient evidence to support such premises, and even less evidence about the risks of exposure in long-term use.
There are important questions yet to be answered about the safety of e-cigarettes to both the user and the second-hand bystander, the efficacy of e-cigarettes in harm reduction and cessation for smokers, the role of e-cigarettes as a gateway for youth to move on to the “real thing”, and the total impact of e-cigarettes on public health. Today, there is a high level of concurrent dual use of both e-cigarettes and conventional cigarettes among adults and youth. The toxins users are exposed to and their health effects are yet to be assessed in their particular contexts.
I will try to present a concise overview of the evidence around these large questions, with the knowledge that when S-5 is studied in Committee, expert witnesses will address the scientific evidence that will guide us in our legislative decision-making.
One of the first considerations must be how extensive is this new phenomenon – vaping?, In other words: what is the prevalence of e-cigarette use?
Understanding e-cigarette use, especially among young people, is critical because previous research suggests that nine in ten adult smokers first try conventional cigarette use during adolescence. Epidemiologic population-based studies indicate that, across countries, e-cigarettes are most commonly being used concurrently with conventional tobacco cigarettes. Among young adults – about 25% of current smokers, 12% of former smokers, and 3% of nonsmokers use e-cigarettes. Dual use with conventional combustible cigarettes is the predominant pattern in US high school students where 80% of smokers are dual users.
In Canada, in 2015, one in four Canadian youth aged 15 to 19 years reported ever having tried an e-cigarette; and one in three young adults aged 20 to 24 years.
The Canadian Student Tobacco, Alcohol and Drug Survey 2014–15 showed that 18% of students in grades 6 to 12 have ever used an e-cigarette.
The same proportion, 18%, had ever tried smoking a traditional cigarette. In Canada, the smoking rate overall has fallen from 22% in 2001 to 13% in 2015, but the rate of decline is said to be slowing in recent years.
To respond to what is now considered a growing need because of the increased use of e-cigarettes over the last decade, more scientific research has been, and is being conducted, to assess the safety of e-cigarettes. Analysis of numbers of published articles has shown a database that has grown exponentially since 2012 from less than 100 studies to more than 1500 in 2016. However, most do not report a study sample or a sample of significant size, nor do they address some of the most important issues.
There have been at least two significant reviews of published e-cigarette studies over the last 2 years. There are 3 completed, small, randomized clinical trials, the gold standard in clinical studies, reported to date.
And, important to note, is that 14 trials are now in progress. These will provide some compelling data and evidence on the use and safety of e-cigarettes.
The 3 completed small trials do not provide strong evidence that using e-cigarettes to aid in smoking cessation is effective nor that serious adverse events are associated with e-cigarettes use in the short term. Long term safety of these devices remains unknown.
There are four large issues to be considered when examining the scientific evidence on vaping and e-cigarette safety, and these I have already alluded to: as an aid in smoking cessation; as a gateway for youth to tobacco use; the toxicity of the emissions in the inhaled vapour; and potential risks from second-hand exposure to vapour.
The limited number of studies to-date do not provide sufficient evidence that e-cigarette use is effective in smoking cessation. Despite the limited evidence base, it is generally agreed that e-cigarettes are safer than combustible tobacco cigarettes.
In 2016, a total of 24 studies including three randomized clinical trials were reviewed. Two of the trials with a total of 662 participants showed that people using e-cigarettes with nicotine were more likely to stop smoking for at least 6 months compared with those who received placebo e-cigarettes without nicotine. One other trial compared e-cigarettes with nicotine patches and found similar effectiveness in 6-month smoking cessation rates. As for safety, none of the trials showed a difference in adverse events between e-cigarettes and placebo. Some suggest that e-cigarettes are less harmful as they reduce exposure to combustible tobacco.
So, for example, cardiovascular risks associated with smoke are dose dependent. To reduce the number of cigarettes smoked from a pack a day to 10 a day would reduce risk.
One fear is that e-cigarette use will serve as a gateway to tobacco addiction for a new generation of users. The evidence is not yet in, but a recent review by the University of Victoria suggests that tobacco use in the US, Canada, and other countries is declining significantly among 12-19 year olds as vapour device use is increasing. The US Surgeon General released a report in 2016 indicating that 25% of students in grades 6 to 12 had tried e-cigarettes. According to the same US Surgeon General Report, exposure to nicotine during adolescence may adversely affect cognitive function and development. The critical issue that remains is that nicotine is a very addictive substance. E-cigarettes may stop tobacco use but not nicotine use, and may ultimately lead to the use of conventional tobacco products.
A larger public health question is whether e-cigarettes will contribute to the renewed normalization of smoking and of tobacco-containing products.
There are serious concerns about the health effects associated with vapour devices and their emissions, the compounds found in the vapour mist. Vapour devices do not deliver tar, and emissions do not contain 61 of the 79 cigarette toxins.
However, vapour products on the market are unregulated; standards and measurement of vapour device emissions are yet to be fully addressed. A recent 2016 study published in the journal Environmental Science and Technology identifies more than 31 compounds generated with vaporizers, and states there are many more yet to be identified.
According to the University of Victoria study just published, Clearing the Air: A systematic review, no independent research has measured vapour device emissions of BDE, the highest source of cancer risk in cigarettes. The vapour device itself depending on its design, voltage, number of coils, build-up of byproducts from the vapour liquid that degrades upon heating, produces harmful emissions that are expected to be ubiquitous when e-cigarette vapour is present. So the risks from the emissions differ among products but also can be conditioned by user behaviour such as the number and depth of puffs.
Second-hand exposure to the vapour from e-cigarettes has been tested to some extent, and is found to be less toxic than cigarette smoke as it does not contain carbon monoxide or volatile organic compounds. However, the vapour does produce a measurable absorption of nicotine in bystanders and how to measure that risk is not yet clear.
All reviews of second hand exposure have called for more testing to clarify the conflicting findings on the emissions of particulate matter, metals and other substances.
Bill S-5 amends the Tobacco Act, the Non-Smokers Health Act, the Food and Drugs Act and the Canada Consumer Product Safety Act. The intent is to make these existing pieces of legislation coherent with the primary purpose of S-5: that is to regulate vaping products as a separate class of products under the Tobacco Act. As such, the Tobacco Act would be renamed the Tobacco and Vaping Products Act. Bill S-5 states in its long title that it is “An Act to regulate the manufacture, sale, labeling, and promotion of tobacco products and vaping products”. Of course it introduces new definitions necessary to vaping and e-cigarettes.
S-5, is a complex piece of legislation that also implements plain packaging for tobacco products. I plan to focus today on the more contentious issues in S-5 as identified by the many stakeholders I have met with over the past couple of months.
They include associations, societies and charities in the health field who represent patients, consumers, researchers and health professionals; as well as manufacturers, retailers, factory workers, and law enforcement.
First of all, it is important to know that because nicotine is a drug, it is subject to the requirements of the Food and Drugs Act, and must be authorized by Health Canada prior to sale based on evidence of safety, efficacy, and quality. It was quite a surprise for me to discover that no vaping product has been authorized to-date in Canada and all nicotine-containing vaping products are being sold illegally.
Vaping products not intended for use with nicotine and without therapeutic claims are legally available without authorization, and are subject to an after-market regime under the Canada Consumer Product Safety Act, not under the Tobacco Act. This is the current state of affairs around vaping and e-cigarettes in Canada. Clearly we have a situation that does not address the increasing use of e-cigarettes by young people as well as by current adult smokers. The consensus among all stakeholders is that federal leadership on vaping products is required.
S-5 does not merely amend the Tobacco Act and apply all existing tobacco restrictions and requirements to vaping products. Rather, S-5 makes exceptions or offers alternatives for e-cigarettes.
So, what differentiation does S-5 make between tobacco cigarettes and e-cigarettes? This is the area where some controversies exist.
Important is that all restrictions of access and sale of tobacco cigarettes to those under 18 years would also apply to vaping products. These include the ban of sale of all vaping products to youth under the age of 18 years, no vending machine sales, and age verification with postal delivery for online purchases. In addition, flavor ingredients that appeal to youth are prohibited such as confectionary, dessert, cannabis, soft drink and energy drink. Also manufacture, promotion and sale of vaping products with ingredients that give the impression that they have positive health effects are prohibited – such as amino acids, probiotics, caffeine and vitamins. However, as of yet, no standards for maximum levels of nicotine contained in the vaping liquid have been established.
Perhaps the aspect that has created the most controversy in S-5 is in the area of marketing and promotion. While virtually all marketing has been banned for tobacco cigarette products, that will not be the case for e-cigarettes. So-called “information advertising” will be permitted with no restrictions: that is, brands, logos, ingredients and pricing, will be available on internet, television, billboards and other places. Whatever health warnings there will be on vaping products would focus solely on the nicotine content and addictiveness. Thus, it is important to note that packaging restrictions will not be the same as they currently are for tobacco products. Lifestyle advertising will be permitted only for adults through mailouts, coupons, and in adult environments.
Much discussion has focused on whether there should be the right to advertise “harm reduction” or what is often referred to as a “continuum of risk”.
The argument has been made that health claims should be made in a comparative way among all tobacco and vaping products. For example:
To advertise that an e-cigarette reduces your risk of cancer and cardiovascular disease when compared with the tobacco cigarette; or ,that chewing tobacco is less harmful than smoking combustible cigarettes. With S-5 protection, health claims such as these must be tested in the very same way as for pharmaceuticals in Canada – with the requirement for the usual scientific evidence based on clinical trials and final approval by Health Canada. Regulations in S-5 do additionally build in the authorities for the flexibility of a pathway to market based on emerging evidence. So, as the science improves, and the studies demonstrate more conclusiveness, regulations can be amended to become either more restrictive narrowing the scope of use, or less so, and broadening it.
As the legislation is written, no claims can be made even to adults regarding cessation, toxins or secondhand smoke exposure unless the scientific evidence demonstrates enough certainty in this regard. Products would have to meet existing pre- and after-market requirements for safety, quality and efficacy as in the case of all new pharmaceuticals covered by the Food and Drugs Act.
Also written into S-5 are regulatory authorities that will require industry to report to Health Canada on product sales and research, as well as maintain ongoing data collection and surveillance that includes incident reporting and recalls, in order to provide transparency for Canadians.
In addition, use of vaping products would be subject to the very same prohibitions as tobacco in federally-regulated workplaces.
The Summary statement on the very first page of Bill S-5 states that these amendments to the Tobacco Act are in response to the Report of the House of Commons Standing Committee on Health entitled, Vaping: Towards a Regulatory Framework for E-Cigarettes. Indeed, most of the recommendations of the Committee have been implemented in Bill S-5.
Specifically, the Committee noted that the current regulatory regime for electronic cigarettes in Canada has been in place since 2009 when Health Canada issued a notice cautioning consumers that e-cigarettes may pose health risks but none were regulated through safety standards.
The Committee in the Other Place did recognize the serious confusion about nicotine contents in e-cigarettes that has persisted, and makes it clear that there is some urgency for legislation.
There are two other important reports to consider while thinking about our own situation in Canada. Since 2015 both the WHO and the US Surgeon General have issued recommendations to legislate standards for the manufacturing, distribution, marketing and sales of e-cigarettes. The US Surgeon General concluded that e-cigarettes are a rapidly emerging and diversified market class to deliver nicotine and flavourings, and presently surpass conventional cigarette use among youth. The most recent 2016 US Surgeon General’s report laid out policy and practice implications for evidence-based strategy to specifically address e-cigarette use among youth and young adults.
These recommendations include extending FDA authority to all tobacco products including e-cigarettes, the incorporation of e-cigarettes into smoke-free policies, prevention of sales to youth, significant increases in taxes and price, regulation of marketing to youth, ongoing research and surveillance that will maintain and update e-cigarette regulations at the Federal level to protect public health.
A WHO report on e-cigarettes, both nicotine and non-nicotine systems, was prepared for a meeting late last year (November 2016) in Delhi, India, of the 180 countries that had signed the “Framework Convention on Tobacco Control”. The Report attempted to cover updates on the evidence of the health impact of e-cigarettes, their potential role in tobacco cessation, consider methods to measure contents and emissions of these products, and assess policy options.
Essentially WHO’s Report finds inconclusive scientific evidence on e-cigarettes in tobacco control, health risks, second hand risks, cessation, or as a gateway or precursor to smoking. However, WHO does suggest policy options to achieve objectives that especially protect youth and prevent unproven health claims. The public health community is not unanimous over the WHO Report. Some say WHO attempts should be to combat tobacco use not regulate nicotine use. Some say it is already clear that the health risks of using e-cigarettes are much lower than for combustible tobacco. And, overall there is a clear understanding that e-cigarettes should be regulated, should not be promoted among youth, and should be subject to ongoing monitoring and surveillance of health effects, risks and benefits.
At this time in Canada, all regulation of e-cigarettes takes place at the provincial or municipal level. Newfoundland, Prince Edward Island, Northwest Territories, and Yukon have no regulation at all. Nova Scotia, one of the first provinces to implement significant restrictions on e-cigarette sales in Canada passed legislation that treated e-cigarettes as conventional tobacco cigarettes in May 2015. New Brunswick passed similar legislation to Nova Scotia.
Saskatchewan, Manitoba, British Columbia, Alberta and Ontario have very basic restrictions that relate solely to the location of use of e-cigarettes and restrict them as in conventional tobacco cigarettes.
My home province of Quebec adopted the strictest e-cigarette legislation in North America, in 2015. Bill 44 amends the Quebec Tobacco Act and makes e-cigarettes and any other similar devices, including their components and accessories, subject to the very same regulations as tobacco products. The display and sale of e-cigarettes is restricted to specialized retail outlets. In the attempt to protect youth, sales by internet, phone or other means are prohibited, as are online advertisements or window display posters for promotional purposes. Quebec’s Bill 44 has been highly criticized by the Tobacco Industry, and vaping shops have filed a legal challenge in Quebec Superior Court.
I must address another major change to the current Tobacco Act proposed in S-5. According to Health Canada, tobacco packages, and the products they contain, have remained powerful promotional vehicles for the industry to communicate positive brand imagery and attract new tobacco users, especially youth. To combat this, the proposed “Tobacco and Vaping Products Act” would provide the flexibility to support implementation of a range of options such as standardized color, font and finish, and prohibitions on promotional information and brand elements, such as logos. The cigarette pack is said to be a valuable marketing tool especially for youth.
There have been many studies, using focus groups and even randomized trials, to try and learn whether package distinctions impact youth and adult smokers; specifically whether their perceptions of the health risks of smoking, the perceived appeal of tobacco products, and attitudes toward smoking, are influenced.
As of this writing consultations on the future of tobacco control in Canada are underway, and will not be complete until mid-April. The actual standard for plain packaging is yet to be determined.
It is also unclear whether S-5 will require the trademark removal from the actual cigarette tube. If so, if all distinctive markings are to be removed from both the outside package and the inside, including on the actual cigarette, fears are that there will be no way to ensure the authenticity of the product.
In order to ensure safety and standards – that the ingredients are what the law and regulations proscribe and what the tobacco companies report to Health Canada – some state that authenticity of the cigarette product must be readily visible to the purchaser.
According to some sources, contraband cigarettes are manufactured in more than 50 illegal factories throughout Canada, and operate outside of any government regulation or oversight. They are sold to Canadians via more than 300 illegal smoke shacks and a criminal distribution network. More than 1 in 3 cigarettes purchased in 2014 were said to be illegal and more than 2 billion dollars claimed to be uncollected due to contraband tobacco.
Contraband tobacco’s low price and easy accessibility make it a prime source for youth smoking, and evidence suggests that schoolyards are used as a location for sale of contraband. More than any other characteristic, price point seems to be the single most important feature that sells a cigarette to youth.
It is said that this proposal, for plain and standardized packaging of tobacco products, has the potential for serious and harmful “unintended consequences” in several domains. It may:
- Increase the likelihood of contraband and counterfeit products;
- Increase youth gangs and violence around the schools where contraband is often made available;
- Increase economic hardship for small grocery store owners who already conform with all the existing restrictions on cigarettes;
- Reduce consumer assurance of certain standards and even the safety of a product whose ingredients are transparently reported by the tobacco company.
- And, create hardship for Canadian workers who are employed in the industry
In addition, tobacco companies have argued and challenged such plain packaging on the grounds that it violates international trade and trademark laws.
Australia is the first country that legislated plain packaging for cigarettes, enacted in 2012. Two more countries, France and the UK, will have fully legislated plain packaging for tobacco cigarettes by mid-2017. Both New Zealand and Ireland are in the process of the final stages of their particular legislation, as well.
In March of last year, the World Health Organization released an executive summary of Australia’s measures concerning tobacco products and packaging. Stated was that, indeed, Australia had witnessed a decline in smoking prevalence rates between the years 2010 and 2013. Rates of daily smokers had declined from 16 to 13 percent among those 18 years and older; however there was some debate as to whether smoking had increased among those aged 12 – 17 years. And, according to a 2014 Australian National University study evaluation using Australian Bureau of Statistics data, plain packaging regulations had not affected tobacco use as measured by tobacco expenditures.
A media debate erupted as to the efficacy of plain packaging policies. Tobacco industry sources suggested that tobacco consumption had increased as well as the illicit trade of contraband tobacco products.
Anti-tobacco activists pointed to the Australian Bureau of Statistics data indicating that while household expenditures on tobacco products had increased over 2013, it had dramatically fallen in the first quarter of 2014. A full recounting and analysis of the Australian situation was published in the journal Agenda- A Journal of Policy Analysis and Reform. The authors were clear that ideally the impact of policy change would be tested examining the change in tobacco consumption controlled for changes in price, income, population, etc. To-date, the success of the plain packaging policy rests on very imperfect indicators.
The question that must be asked is will the introduction of standardized packaging in Canada achieve its stated objectives – to make tobacco cigarettes less appealing to youth and reduce their consumption?
In conclusion, Bill S-5 amends the Tobacco Act to regulate vaping products as a separate class of products, and aligns other existing Acts to conform. It also delivers on a commitment to implement standard plain packaging for tobacco products. As the opposition critic for this Bill, S-5, I have met with many stakeholders representing industry, retailers, consumer groups, the unions, law enforcement, the Charities, Health Associations and health professionals. Although their argumentation has been quite different, they all offer the same opinion as to the pressing need for legislation on e-cigarettes and vaping. Legislation and the ensuing regulations will allow for a rigorous monitoring system, implement safeguards, and ensure standards across the country.
In my meeting with the Canadian Cancer Society, Canadian Medical Association, and Heart and Stroke Association, they expressed the opinion that this could be one of the most important amendments we make to the Tobacco Act in decades. But they are also clear when they say – “we must get it right”! So, I hope that, when this Bill reaches the committee stage, expert witness testimony will help us do exactly that, “get it right”, especially to protect our youth from return to an era of normalized smoking.