Health Canada Nicotine Cap Regulations

R4V Consumer Submission: David Sweanor.

Comments on
Concentration of Nicotine in Vaping Products Regulation
(Canada Gazette, Part I, Volume 154, Number 51, published Dec. 19, 2020)

March 2, 2011

Submitted by David Sweanor

David is a lawyer and public health advocate who has worked on policies on tobacco and health since 1983. His focus has long been on pragmatic regulatory, financial and litigation interventions that reduce the rate of cigarette-caused diseases while respecting people who use nicotine and empowering them to make better personal health decisions. He is also deeply concerned about maintaining public trust in the institutions of a liberal democracy and of the deleterious effects of regulations that do not adhere to principles consistent with the Cabinet Directive on Regulation.

Janine Timmons
Janine smoked for over 40 years. With every failed quit attempt she felt worse about herself. She thought she’d never succeed in saying good-bye to cigarettes until she purchased an e-cigarette at a local vape shop. Two weeks after her purchase she quit smoking. That was 5 years ago. She is a healthy 63-year-old, able to easily climb stairs and enjoy long walks. She no longer gets colds or flu, feels good about herself and is proud to say she is a non-smoker. She firmly believes vaping saved her life.

Marion Burt
Marion smoked for almost 40 years and tried everything from “cold turkey” to self-help books to patches to quit. Nothing worked. When her doctor warned her that she was in danger of developing COPD, she bought a vape and knew from her first puff that she would never smoke again. She has been smoke-free for 7 years. Her doctor now says that her lungs are “perfect”. When she had hip surgery, the doctors and anaesthesiologists asked if she smoked. She told them that she had quit but now vaped and they congratulated her and marked her as a non-smoker. She is glad that frontline doctors see through the propaganda and pseudo-statistics to the reality.

Dave Jones
Dave (Major Retired RCAF) quit a 40 year smoking habit during his 41 year military career through vaping. He has been smoke free for 8 years. As a heavy smoker he started at 28mg with some cigarettes and quickly transitioned over 2 weeks to no smoking and lower nicotine requirements. Over the past 8 years he has become a passionate vaping advocate. He testified at the 2014 Federal HESA committee, input into Ontario Bill 45 and again testified at the Senate SOCI vaping Bill S5. He was a former volunteer Director and Policy advisor for the Tobacco Harm Reduction Association of Canada and is now coordinating the Ottawa Vaping Advocates group. He feels vaping saved his life and that if there was only 20mg e-liquid when he started his journey to being smoke-free he would still be smoking. ‘Nothing About Us Without Us’.
Introduction

Evaluating proposed health-related regulations is usually a matter of weighing the costs to businesses and consumers against the number of cases of disease averted and of lives saved. In the area of tobacco control, this has historically been a straightforward exercise: cigarettes kill roughly half of long-term smokers, so even a marginal reduction in smoking rates provides a large benefit.

In the case of regulations on vaping products, the calculation must be fundamentally different. Both benefits and costs are measured primarily in numbers of people getting sick or dying from smoking. Measures that reduce youth uptake of vaping might eventually increase deaths from smoking if those who avoid vaping as a result of the measures would instead have ‘graduated’ to long-term smoking and got sick from it.

A rational policy would follow the expressed purposes of the legislation and seek to encourage people who smoke cigarettes to switch to vaping while also addressing concerns about youth vaping. It would acknowledge that the horrendous toll of disease and death from cigarettes is due almost entirely to the inhalation of the products of combustion and weigh the gains that can be achieved through empowering millions of Canadians to get off cigarettes with any unintended consequences, including addressing youth vaping. To take a potential unintended consequence as reason to hold back progress on dealing meaningfully with our leading cause of preventable death would be on equivalent to discouraging approved covid vaccinations due to a potential unintended consequence.

The fact is that all policy measures have the potential for unintended consequences, and an unscientific and irrational campaign to create a moral panic about vaping should be treated by Health Canada in the same way as similar campaigns against vaccinations.

Unintended consequences are something that risk-proportionate regulation can address. However, these proposed regulations get it backwards by focusing on measures that make low-risk vaping products a less viable alternative to cigarettes. This perpetuates the acknowledged 48,000 annual deaths from cigarette smoking in Canada, without any realistic analysis of the horrendous public health toll that entails. In addition, there is a failure to adequately consider the health advantages of preventing young people from going straight to smoking by having made a far less hazardous alternative more viable.

These constitute some of many fundamental biases in favour of an absolutist, abstinence-focused approach to vaping in these regulations. This approach is, in turn, at odds with the adoption of a harm reduction strategy to other drugs by Health Canada and the Government of Canada. The potential of unintended consequences from restricting the viability of risk reduction products and services for people who use drugs is not just real, but abundantly clear, entirely foreseeable, and a horrendous attack on the autonomy, health and rights of millions of Canadians.

Vaping products are clearly substitutes for cigarettes. This has been well documented in the academic literature, and Professor Michael Pesko at the Department of Economics at Georgia State University has recently compiled an excellent review that is appended to this submission. This was also the basis for the New England Journal of Medicine commentary Professors Frank Chaloupka, David Sweanor and Kenneth Warner published in 2015. It is noteworthy that Health Canada has chosen to ignore such a paper, along with a significant number of additional academic and popular media work by these and other experts that are germane to this regulatory proposal in its Regulatory Impact Analysis Statement (RIAS).

The evidence on the substitution effect of vaping and other non-combustible products in place of cigarettes is also shown in available market monitoring data from such firms as Nielsen, and reported by publicly listed tobacco companies and witnessed constantly in Canadian retailers of vaping products, none of which Health Canada appears to have consulted in producing this RIAS.

The unavoidable fact is that any measure that makes vaping products comparatively less attractive will therefore cost lives amongst people who smoke but who might otherwise have switched.

To make this concrete, let us compare a 50-year-old smoker (who started at 15) with a youth of 15 who is on the verge of starting to vape. The adult has accumulated about half the risk of a life-long smoker and is at imminent high risk of fatal smoking-caused disease. Even if the youth, upon starting to vape, were guaranteed to switch over to smoking, they are still several decades behind the adult smoker in terms of mortality risk. In the heartless language of cost-benefit analyses, at the discount rate of 7% per year used by Health Canada for these proposed regulations, it would take six such youths starting to vape (and all progressing to life-long smoking) to balance out the cost of a single 50-year-old smoker who switches to vaping.

The RIAS avoids the key question of whether this use of such discount rates actually reflects the principles of our Charter of Rights and the protection of an individual’s right to life. Most policy experts, ethicists and citizens would weigh the pros and cons of vaping regulations rather than cherry-picked data to support a pre-existing bias, and Canadians deserve better from Health Canada. There are some other very good reasons to give higher priority to the health of long-time smokers:

1. By the time today’s youth are old enough to get sick from smoking, cigarettes may be obsolete.

Cigarettes have long been the dominant form of nicotine use in Canada, but there is no reason this should be the case even in two decades’ time. To the extent vaping products offer all the perceived advantages of smoking (in terms of nicotine delivery etc.) with few of the health risks, why shouldn’t cigarettes go the way of previous dominant but now obsolete technologies? (Horse-drawn carriages, unsanitary foods, deadly industrial machinery, snake-oil medicines, unsafe-at-any-speed automobiles, telegrams, electric typewriters etc.)

2. Health scares are significant motivators to quit smoking, so prospective adult switchers (to vaping) are likely to be disproportionately at risk of serious disease.

Adults who have smoked for several decades are likely to have made several (or even numerous) unsuccessful quit attempts in the past. They are likely to be more addicted than the average 25- or 30-year-old smoker, and therefore have relapsed despite various social pressures to quit. A heart attack or a cancer or COPD diagnosis may well trigger further attempts. If people in this group see vaping as a less difficult but still effective way to quit smoking, the benefits in terms of increased life expectancy are likely to be large.

3. Treatments and technologies for smoking-caused disease and for nicotine addiction will inevitably improve.

Vaping technology can continue to improve markedly in coming years if health-promoting innovation can be facilitated rather than stymied. Lessening the scope for innovation by reducing the range of acceptable product parameters can cause harm measured by the number of Canadians who will be expected to continue smoking, sickening and consequently dying.

Restrictions on vaping technologies need to be based on much more narrowly targeted concerns that are rationally addressed and that weigh consequences.

In addition, the technology for treating cancers with quite low survival rates, improved early diagnosis and treatment have markedly increased survival rates in Canada over the last two decades. In the three, four or even five decades between the time that today’s 15-year-olds risk smoking-caused disease, rates will inevitably improve. The costs of reduced acceptability of vaping is measured in the deaths over the next 20 years of potentially hundreds of thousands of Canadian who smoke cigarettes. The risks to a much smaller number of young Canadians based on a theoretical transition from vaping to smoking, which can in any event be addressed through risk-proportionate regulation, should have been put into context. So, too, the non-negligible prospect of breakthrough innovations in treatment or prevention over the next 20-30 years.

Similarly, the depressingly low success rate of most treatments for addiction may well rise – and again, today’s youth can mostly avoid disease if innovations are rolled out even two decades from now.

The JUUL scare and the 20 mg/mL nicotine limit

The proposed regulations are a response to widespread media reports and concern about the impact of the launch of nicotine salt-based JUUL pods (and by now, a number of imitators) in the Canadian market in 2018. This concern was substantially fuelled by data from the International Tobacco Control (ITC) study, which appeared to show a simultaneous rise in Canada of youth vaping and youth smoking – a pattern not noted in any other country. The finding with respect to youth smoking appears to have resulted from sampling issues and the authors have since issued a correction which the RIAS evidently ignores.

According to the manufacturer, increasing the proportion of nicotine salts (as opposed to freebase nicotine) results in more rapid absorption of nicotine, with a spike in blood nicotine levels that is similar to that of cigarettes. This also appears to make such e-liquids substantially more attractive to youth than conventional e-liquids with higher pH levels.

It is important to note that the 20 mg/mL nicotine limit, first imposed by the European Union in 2014, pre-dates JUUL and the concern about nicotine salts. The stated rationale for the limit, as per the EU Tobacco Products directive, is that “[t]his concentration allows for a delivery of nicotine that is comparable to the permitted dose of nicotine derived from a standard cigarette during the time needed to smoke such a cigarette.” Canada has not followed the EU example of imposing limits on machine-measured yields from cigarettes, and with very good reason: there is little relationship between machine-measured yield and actual human intake. Smokers (and presumably vapers) adjust their behaviour to achieve their usual levels of nicotine.

As it happens, most JUUL pod sales in Canada are for higher-concentration products. (At latest report, the company sells 5%, 3% and 1.5% strengths.) Copying the EU rule therefore provides an apparently easy albeit indirect way of ‘fixing’ a misidentified problem. Has Health Canada even looked at which strength products young people are using? Has there been consideration of the fact that the high dosage of nicotine that many smokers need in order to replace their cigarettes, and that these proposed regulations would kill (along with those smokers), would be a vomit-inducing situation for a nicotine-naïve young person? Health Canada should also be aware of the fact that higher levels of nicotine were provided to heavy smokers in dedicated vape stores for years without any corresponding youth uptake.

Problems with the proposed regulations and the Regulatory Impact Analysis

The RIAS contends that, even in the most pessimistic scenario with respect to implementation costs and increased smoking amongst adult smokers because of the prohibition of higher-concentration vaping products, a 4.11% reduction in the annual vaping initiation rate would be sufficient to ensure benefits would equal costs.

This analysis is based on some highly questionable assumptions that are simply in the realm of fantasy. Basic data for critical aspects of the calculations is not provided, which makes it impossible for an outsider to check whether the calculations have even been done correctly. That violates key principles of administrative law.

1. Lack of evidence that vaping uptake actually leads to long-term smoking.

The key benefit claimed for these regulations is their putative impact on smoking rates. That is, despite a very high estimate on the relative harms of vaping and smoking (i.e. that vaping is 20% as harmful as cigarette smoking), more than 90% of the benefits in the analysis come from reduced smoking by young people who start their nicotine career with high-nicotine vaping products and later ‘graduate’ to smoking. But the RIAS fails to cite the Department’s own data showing youth smoking has been declining as vaping became more prevalent.

To support this claim, the RIAS relies on a 2018 review of the evidence by the U.S. National Academy of Sciences, Engineering and Medicine (NASEM), and in particular that review’s conclusion that “there is substantial evidence that e-cigarette use increases the risk of ever using combustible tobacco cigarettes among youth and young adults”. The wording here is crucial: “ever using” cigarettes is not the same as the long-term habitual use that actually leads to disease. As the same report also points out, US data provide no indication of a negative impact of e-cigarettes on trends in youth and young adult smoking, both of which are at record lows, and have fallen more rapidly as vaping products became available.

The apparent wilful twisting of evidence, and exclusion of evidence that does not fit the (irrational) goal of capping nicotine levels raises serious questions about the Department’s adherence to the government’s own Scientific Integrity Policy.

As the saying goes, absence of proof is not proof of absence: we have no direct way of measuring the impact of youth vaping initiation on smoking rates at 40 or 50 years of age as vaping products have not been on the market for long enough. But if the RIAS is based on the assumption that “ever use” of cigarettes will convert into habitual, long-term use at the same rate as it did in the pre-vaping past, this would be highly questionable. Unfortunately, no information on the assumed conversion rate is provided.

The NASEM report also examines the hypothesis that vaping products have a diversion effect on youth, that is that some who would otherwise have become smokers instead become vapers. It concluded at the time that there was not enough evidence to support this hypothesis – which of course does not mean it is necessarily false. A plausible guess is that there are both gateway and diversion effects, depending on the individual. But also, crucially, on policy measures. If the goal is to prevent consumers moving from vaping to lethal cigarettes, measures that make vaping a less viable alternative, which is what this RAIS seeks to achieve, are counterproductive.

2. Unstated but apparently unrealistic assumptions on conversion of youth vapers to long-term smoking.

As mentioned, the main benefits of limiting nicotine concentration claimed in the RIAS are from reduced smoking. If smoking is “only” five times as dangerous as vaping, as the RIAS claims (but which is at odds with far more authoritative estimates from Public Health England and the Royal College of Physicians that the RAIS ignores), the breakdown of stated benefits from reduced smoking vs. reduced vaping appears to require heroic assumptions with respect to the percentage of youth vapers who go on to lengthy smoking careers. Roughly twice as many vapers of high-nicotine liquid would need to switch to smoking as continue vaping to get the breakdown of benefits cited in Table 2.

No evidence is provided for this assumption and it is difficult to imagine conclusive evidence on this point emerging before several decades have passed. But it is peculiar for regulations under the Tobacco and Vaping Products Act to assume that smoking will remain the dominant form of nicotine consumption in Canada in several decades’ time. Among other things, this is diametrically opposed to the view of Health Canada itself on the importance of measures to encourage a move from smoking to vaping. To quote: ‘Help Canadians quit tobacco . . . This will be achieved by . . . giving information on and access to less harmful sources of nicotine.’

2. Failure to consider misperceptions on nicotine and relative harm of cigarette and vaping products and the signal effect of the measure.

The RIAS helpfully includes reference to public opinion research on tobacco and nicotine products by Earnscliffe Strategy Group. This research indicates a severe problem of public misperceptions which these regulations have the potential to make even worse.

According to the research, only 4% of smokers aged 25 and over are aware that vaping products that contain nicotine are “much less harmful than smoking cigarettes” (n=694). In this group, 22% believe nicotine-containing vaping products are more harmful, while 44% say they are “equally harmful. In the case of vaping products without nicotine or cannabis, only 13% correctly note they are much less harmful than smoking cigarettes, while 15% believe they are more harmful.

From a public health perspective, what should a smoker know about health risks? Essentially that it is urgent they quit smoking as quickly as possible – and quit entirely. And do so by any means that work, including if need be vaping high-concentration products for the rest of their life. They also need to know that relapse is frequent and that they should not stop use of nicotine substitutes too early if that leads to relapse.

A reminder of the two relevant purposes of the Tobacco and Vaping Products Act:

1) “to prevent the public from being deceived or misled with respect to the health hazards of using tobacco products” and
2) “to prevent the public from being deceived or misled with respect to the health hazards of using vaping products”.

It is difficult to read the Earnscliffe data and not conclude that adult smokers are either hugely underestimating the risk of smoking cigarettes or hugely overestimating the risk of vaping, and are thus “deceived” or “misled”. (Or more likely: some combination of both.)

Now, what is the likely impact of overestimating the inherent harmfulness of nicotine or the relative risk of vaping products compared to cigarettes? First, avoidance of vaping products, in particular by smokers with health concerns (i.e. those who would most benefit from switching to them). Second, under-dosing among those who do try to quit smoking with vaping products, including rapid taper-off of nicotine levels and a higher risk of relapse.

We don’t know the magnitude of these effects, but they are clearly highly relevant to the success of the Tobacco and Vaping Products Act. And in the case of these regulations, it is entirely plausible that publicly announcing a cap on nicotine concentrations will be understood by many smokers as confirmation that nicotine is inherently harmful and vaping products are comparable in risk to cigarettes or even riskier.

A prudent regulator would attempt to evaluate this potentially large and immediate impact on human health before adopting new measures. This RIAS fails to even mention the problem.

3. Failure to provide basic data.

The analysis of costs and benefits, including the sensitivity analysis, hinges on how many youth and how many adults use high-concentration products and how many smokers per year use vaping products to quit smoking. The RIAS fails to provide actual numbers, which makes it impossible to check whether the quantitative analysis has been performed properly.

4. Failure to seriously consider alternative approaches.

The RIAS briefly considers and rejects the option of directly regulating the form of nicotine used in vaping products, on the basis that “Health Canada is not aware of reliable laboratory methods to directly measure the form of nicotine used in a given vaping substance.”

This is surprising, given that JUUL has a Canadian patent for “[a] nicotine salt liquid formulation for generating an inhalable aerosol in an electronic cigarette comprising nicotine salt that forms about 0.5% to about 20% nicotine”. More generally, simply measuring the pH of e-liquid of known nicotine concentration should provide information on the proportion of the nicotine that it contains which is in freebase or salt form.

A pH-based approach, or one focused on directly measuring the freebase/salt ratio would still require a thorough evaluation, as many of the concerns about the 20 mg/mL limit would still apply. But in this case, it appears the option was not seriously explored.

5. Failure to seriously examine the use of high-concentration liquids by adults.

The RIAS implies that use of high-nicotine liquids is concentrated amongst youth, but the evidence provided is hardly overwhelming. The RIAS mentions that 45% of youth vapers reported using vaping products with concentrations of 20 mg/mL or higher, against 33% of adult vapers over 25, but does not mention the small sample size this is derived from: 171 youth vapers and 115 older adult vapers. It also quotes self-reported numbers from postcards sent in by vapers to Health Canada to oppose additional restrictions on vaping – hardly a random sample. These were from Canadians vapers who frequent vape shops, where the power of the devices sold can compensate for lower nicotine levels. It is hardly relevant to the higher nicotine, smaller products such as Juul. It is also simply unethical to twist many thousands of personal testimonials as to why Health Canada should not be placing irrational limitations on vaping products into a basis to justify such restrictions. Canadians should expect better from Health Canada and Health Canada should show more respect to the principles of public consultation.

Moreover, even if the survey numbers were accurate, they do not actually demonstrate that high-concentration liquids are inherently more attractive to young people. A substantial portion of long-time vapers will have started when nicotine salt-based products were not available and may simply have stuck with older products from inertia.

An obvious question of interest is whether smokers who use vaping products to quit start with high-nicotine products and then taper off over time. If Health Canada has explored this question, it is not obvious in the RIAS. Health Canada, even with that non-representative sample, saw only what Canadians were using when the postcard was sent, and not the level of nicotine that was used to make the transition off smoking. We would not condone building standards that made doorways only six feet tall because a large majority of Canadians need nothing taller, and it makes no more sense to seek to restrict nicotine levels in that way.

6. Lack of clarity about trade-offs.

It is clear that nicotine salt-based products with high concentrations have achieved a substantial share of the vaping market in countries where they are widely available (including Canada). The manufacturers’ own explanation of this is because they more closely approximate the speed and quantity of nicotine provided by smoking a cigarette.

If this explanation is accurate, it should not be particularly surprising that young people looking for a buzz favour it. But it should also mean it is a more serious competitor to cigarettes for adult smokers and should thus tend to increase smoking cessation in this group.

In a hypothetical universe where the only nicotine-containing products available had the risk profile of coffee or tea, it is reasonable to expect that more people would use nicotine than in a universe where nicotine was only available in obviously risky form (e.g. intravenous injection with dirty needles – or cigarettes, in a world where smokers were truly aware of the full risk). And the former universe looks like one plausible outcome of successful implementation of the Tobacco and Vaping Products Act.

It is possible to imagine vaping control measures that really would have a massively different impact on vaping product attractiveness to different age groups, and such things are already addressed in existing regulations; further evidence-based measures should be considered. But regulation of product characteristics is a blunt instrument that affects use by all age groups.

In short, the product characteristics that make vaping products more effective in attracting smokers away from smoking are generally likely to be the same characteristics that are appealing to drug-curious young people. Hence any potential measures in this area need be evaluated seriously for their impacts on both groups.

7. Moral panic rather than thoughtful ethics.

As the RIAS makes clear, Health Canada is responding to multiple representations by provincial health authorities, non-governmental organizations and the general public that ‘something needs to be done’ about youth vaping.

To be crass, there is a substantial risk that this reflects the tendency to prioritize the protection of ‘innocent’ teenagers (read: my middle-class children) over that of older smokers, many of whom are members of marginalized groups, who have not been able to quit despite decades of information campaigns about the health hazards of smoking and access to treatments.

Like moral panics of past decades – whether about drugs, pre-marital sex, alcohol, rock ‘n’ roll or rap music – this one is based on unrealistic beliefs about what causes the behaviour parents object to and what its long-term consequences will be.

In past decades, users of cannabis were jailed because of fears they would infect ‘innocent’ teenagers with reefer madness. Canada has grown up in this regard and now has a cannabis policy that seeks to balance competing interests and not put people in jail for their tastes in recreational drugs.

For a series of historical reasons, we appear to still be unable to view the drug nicotine and its most hazardous delivery system, the cigarette, through the same thoughtful ethical analysis. This is deeply regrettable given that smoking continues to kill far more people than all illicit drugs combined.

Conclusion

The proposal to limit the concentration of nicotine in vaping products to 20 mg/mL has not been shown to have a net benefit and indeed has a reasonable probability of doing substantially more harm than good by killing older smokers who would otherwise have quit smoking with the help of vaping products. Essential data is missing from the RIAS, assumptions used are deeply concerning, and the document appears to violate Health Canada’s own Scientific Integrity Policy and is at odds with Canada’s Tobacco Strategy.

The Regulatory Impact Analysis failed to consider foreseeable negative impacts of the proposal, such as its potential to increase already substantial misperceptions about the inherent harmfulness of nicotine and hence to keep people smoking longer than they otherwise might.

Accordingly, these proposed regulations do not meet the standards of Canadian federal regulatory policy, as set out in the Cabinet Directive on Regulation.

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