Health Canada's Second Legislative review: a prescription for some small fixes, but no firm plan to make them.

Late Monday afternoon - and after a silence that has extended since her appointment last summer -- the Hon. Ya'ara Saks, the federal Minister of Mental Health and Addictions (and Associate Minister of Health), laid out her vision for tobacco control.

The occasion was the mandatory tabling of the second Tobacco and Vaping Products Act legislative review. Because this federal law requires the Minister to table a report in Parliament by May 23 on every alternate year, the report was 25 days late. This is a marked improvement on the previous minister, who was in breach of the law for almost a half year before tabling the first report in December 2022. 

The timing, it would seem, was related to the appearance by Ms. Saks and her colleague the Minister of Health (the Hon. Mark Holland) before the House of Commons Standing Committee on Health. As a hold-over of ancient parliamentary rights (grievance before supply), federal ministers in Canada face a wide-ranging grilling by elected parliamentarians each spring. 

The Legislative Review was released a few minutes before 5:00 in the evening -- only minutes before the Minister appeared before the committee and could have faced concerns about the tardiness fo the report. As it turns out, tobacco and vaping were not mentioned by either minister or any members of the committee.

The outcome of this report is difficult to discern. Although she provided parliament with a 57 page review, identified areas of weakness and proposed specific action steps to address them, the Minister nevertheless made no commitment to act on any specific issues.

Instead, her report punted meaningful reforms to the future - and likely to a future minister:

"... Amendments at the level of the Act are not proposed at this time. ... The analysis indicates that there are areas that could be considered to further reduce tobacco use in Canada, preserve the gains made, and ensure the legislation remains modern and responsive to emerging issues and products. Additional analysis in the areas for potential action could result in future legislative or regulatory amendments." (emphasis added)

The recommendations in this report are a good starting point conversations on how to improve the federal tobacco law -- when and if the department and the minister are ready to talk. At the end of this post, the "activities for consideration" (aka recommendations) are listed.

A consultation exercise, not a performance audit

As was the case in the first report, this second Legislative Review was prepared by public servants and was developed in the form of a public consultation (our response can be found here). The department received 115 written submissions and held 19 meetings. Similar also to the first report, this one is heavily reliant on the views of those who participated in the consultation and reveals little about any internal analyses conducted by those who administer the law.  

Nonetheless, this is a highly readable report which contains a lot of useful and important information on the Canadian experience with tobacco use, and some usefully-presented statistics. 

• Revenues from tobacco sales are divided among the federal taxes (21.7%), provincial and territorial taxes (31%) and industry revenues (38.4%).
• Canadian smokers are aging -- with 3 in 5 smokers now older than 45 years of age and fewer than 1 in 20 under 25 years of age.  

Other takeaways from the Second Legislative Review of the TVPA 

Engagement with indigenous communities is the department's highest priority

More than half (10 of 19) of the meetings held by the department were with indigenous stakeholders, and seven pages of the report are allocated to detailing the feedback from indigenous agencies which are identified by name. By contrast, the traditional spear-carriers for tobacco control such as the Canadian Cancer Society, the Heart and Stroke Foundation and Lung Association are not mentioned by name.

The report opens with a de facto apology to indigenous communities for lack of extensive consultation and engagement when amending the legislation. The first issued identified is "Prioritizing First nations, Inuit and Métis engagement, cooperation and reconciliation." 

Interest in new products, but not yet in new powers.

The report is a disappointment for those who believe a new nicotine regulatory framework is needed to manage changes to the market that are being driven by tobacco industry innovation. 

As we recommended last fall: "the Legislative Review is an opportunity for Health Canada to present its analysis of developments in the nicotine market, to articulate a public health objective with respect to this market, and to make recommendations for the modernized legislative foundation that would support these objectives."

While this year's legislative review acknowledges that "the nicotine market continues to evolve" and that some respondents sought legislative changes, there was no analysis of the potential or risks of an increasingly heterogenous nicotine market other than the current challenge of nicotine pouches.

De-emphasizing "harm reduction"

In 2018, Health Canada returned to harm reduction as a key element in its tobacco control strategy (previous inclusions had been in the 1970s and in 2001). In recent years, however, this element seems to be more soft-pedalled and there are fewer direct references to the department trying to encourage smokers to switch to alternative nicotine products. 

Yesterday's report continues that trend. In the first Legislative Review, for example, attention was drawn to Canada's Tobacco Strategy including "harm reduction - helping those who cannot or do not wish to quit using nicotine to identify less harmful options". In this Second Review, the characterization of the department's strategy did not include the concept, and most references to harm reduction were reflections of input from participants in the consultation.

Potential for the tobacco industry to pick up the tab for some cessation services?

For decades, government reports have included hand-wringing statements about the challenge of supporting, encouraging and achieving successful quitting by Canadian smokers. This report similarly identifies the lack of general progress as well as specific health inequities in quitting - but also includes a new thought.

A month ago, Parliament approved changes to the Tobacco and Vaping Products Act to authorize the collection of cost recovery fees "in relation to the carrying out of the purpose of that Act."   This Legislative Review suggests charging the industry costs related to cessation programming and public education "for equity-deserving groups" and singles out indigenous communities as recipients.  

Long-promised work is still being promised.

Since at least 2016, Health Canada has made public statements that it intends to introduce guidelines to assist decision-makers in implementing Article 5.3 guidelines of the Framework Convention on Tobacco Control. (These are the suggestions for how governments should address tobacco industry interference, including by shutting down PR campaigns like #UNSMOKE). 

Other long-stated  intentions repeated in the Second review include:

• facilitating public disclosure of information reported to the government by industry. This was the subject of a parliamentary recommendation almost 20 years ago, to which the government said it would try to do more. 
• addressing weaknesses of age-verification in online sales. Three years have elapsed since the department included this in its Forward  Regulatory Plan. 
•  supporting FCTC discussions on potential new tobacco control measures. Earlier this year the Treaty members agreed to Canada's suggestion to move forward in this area.  

Second Legislative Review on the TVPA: "Activities for Consideration"

Prioritizing First Nations, Inuit and Métis engagement, cooperation and reconciliation

• Recognizing the Government of Canada's obligations to take, in consultation and cooperation with First Nations, Inuit and Métis Peoples, all measures necessary to ensure that existing and new federal laws are consistent with the UNDRIP, an assessment of the impact of the TVPA on First Nations, Inuit and Métis Peoples to better understand their unique needs, priorities and recommendations related to the regulation of tobacco and vaping products in their respective communities is necessary. This assessment should be distinctions-based and ensure that the distinct rights, interests and circumstances of the First Nations, Inuit and Métis are acknowledged, affirmed and implemented.
• Continue to support interventions led by First Nations, Inuit and Métis to address the high rates of commercial tobacco use in their respective communities.

Addressing Barriers to Cessation

• Develop an equity-informed cessation plan by examining barriers to quitting and engaging partners, including: people with lived and living experience, particularly from equity-deserving groups; First Nations, Inuit and Métis Peoples; provinces and territories, and health care professionals.
• Information about existing cessation supports and programs delivered by health care professionals could be shared to promote best practices and expand reach. National smoking cessation standards could be implemented to establish consistent practices across the health care system.
• Work with provinces and territories to enhance awareness of the availability of and access to cessation medications and services, particularly for equity-deserving groups.
• Recover costs from industry related to cessation programming and public education for equity-deserving groups, including funding provided to First Nations, Inuit, and the Métis Nation to develop and implement their own self-determined, culturally appropriate and distinct approaches to reducing commercial tobacco use based on their own needs and priorities.

Strengthening enforcement, increasing transparency and addressing industry interference

• Develop additional tools to respond to non-compliance with a progressive enforcement approach and continue to work closely with provinces and territories to identify, monitor and address issues of non-compliance. Legislative and regulatory options should be explored when considering additional tools to address issues related to compliance and enforcement issues.
• Expand efforts to make compliance and enforcement more transparent by regularly publishing information about actions resulting from compliance and enforcement activities.
• Proactively disclose information on tobacco products from industry, that can be made publicly available, to increase transparency, accountability and the use of data by other orders of government, academics, and citizens.
• Disseminate guidance to Canada's policy and decision-makers to raise awareness of the World Health Organization Framework Convention on Tobacco Control Article 5.3 obligations.
• Examine remaining promotional activities by tobacco product manufacturers and importers, including intra-industry promotional activities and activities related to price promotion, discrimination and segmentation, to better understand the impact of these activities on tobacco use in Canada.

Preserving gains and ensuring legislative framework is responsive to modern realities

• Enhance Health Canada's understanding of how the market is changing by collecting new information about technical innovations.
• As Health Canada takes action to address risks associated with the access and apparent appeal to youth and people who do not smoke of certain nicotine replacement therapies approved under the Food and Drugs Act, it will be important to ensure the appropriate oversight is in place to protect youth, while maintaining the smoking cessation objective of authorized nicotine replacement therapies to meet Canada's Tobacco Strategy. 
• Enhance compliance and enforcement actions under existing authorities to prevent youth from accessing tobacco products online.
• Continue examining retail environment with provinces and territories with a view to assessing the current provisions and practices, identifying collaborative opportunities and considering all possible regulatory, policy, program and research activities to ensure that youth are and remain adequately protected.
• Consider developing guidance or regulatory requirements to set out in greater detail the actions that regulated parties involved in online and distance sales may take to verify age and identity.

Innovative international best practices

• Work with international counterparts to identify measures beyond those required by the World Health Organization Framework Convention on Tobacco Control and assess the feasibility and effectiveness of implementing these measures within Canada.

Young Canadian vapers are as likely to report breathing problems as their smoker peers

This post draws attention to a recent study reporting on the potential impact of vaping and smoking on the respiratory health of young Canadians. 

The paper "Associations between vaping and self-reported respiratory symptoms in young people in Canada, England and the US" was published in BMC Med on May 29. It draws on data from the ITC Youth Tobacco and Vaping Survey and was authored by members of that project team, including two Canadians based in Waterloo (Jessica Reid and David Hammond).

The ITC Youth survey is a (usually) annual web-based survey of older teenagers (aged 16 to 19 years) who live in England, Canada and the United States. These young people are asked a series of questions about their opinions and behaviours concerning nicotine products (tobacco and non-tobacco), with some additional questions also about cannabis and alcohol use and about their life circumstances. 

In 2020 and 2021 the survey included questions about recent experience of certain respiratory problems: shortness of breath, wheezing, chest pain, phlegm and cough. This BMC paper reports on the analysis of the responses to those questions.

Both vaping and smoking increase the likelihood of respiratory symptoms and by about the same amount

Overall, they found that those who vaped or smoked in the past 30 days were about 50% more likely to experience these respiratory problems, and those who did both or who vaped intensively were twice as likely. (The odds ratios shown above are extracted from the paper and the authors adjusted them to reflect a number of personal characteristics as well as for the use of other substances.)

Salt nicotine and some flavourings are associated with higher rates of respiratory symptoms (with caveats), but the type of vaping device does not seem to matter.

Those who reported using salt nicotine were more likely to report respiratory symptoms than were those who reported using non-salt. However, about half of the survey respondents were not aware of the nicotine type they used, and these uncertain respondents were included with the non-salt reference group. For this reason, the authors urged caution in relying on self-reported data on nicotine type in all studies. 

Those who used sweet flavours and mint-menthol flavours were as likely as the (much smaller) number who used tobacco or tobacco-menthol flavourings to report respiratory symptoms. Those who used fruit, multiple and other flavours were more likely to do so.

The results were not entirely what the researchers had predicted.

Before the study began, the authors registered their five hypotheses. They anticipated that those who vaped would be less likely to report respiratory symptoms than those who smoked, and that flavourings would make no difference to likelihood of experiencing these respiratory issues. The results did not support these hypotheses.

They did find evidence for their other hypotheses -- that more intense vaping would be associated with more symptoms, that types of nicotine devices did not make a difference, and the experiences in the three countries would be similar.

Not the first paper to support concerns about vaping and respiratory health among Canadian youth

This is not the first study involving young Canadians which has found an increased risk of respiratory problems among those who vape. A study led by Michael Chaiton and colleagues also found that among 16 to 25 year-olds the "use of e-cigarettes was associated with increased rate of respiratory symptoms, and that the greater the frequency of vaping the higher the number of symptoms." (Smoking, e-cigarettes and the effect on respiratory symptoms among a population sample of youth: Retrospective cohort study. 2023, was published in January 2023)

More reasons for Minister Saks to act

Some of the data reported in this study was gathered after a former Minister of Health issued draft regulations to restrict flavourings in vaping products.

This study underscores the urgency of this seemingly-abandoned proposal. It suggests that vaping flavours hurt the lungs of young Canadians not only because they are an inducement to use vaping products, but also because some flavourings themselves are linked to harm.

This week health organizations published an advertisement in Parliament Hill's local newspaper (the Hill Times) reminding the Health Ministers of the importance of banning these flavours. Banning flavours in vaping products falls under the responsibility of addictions minister Ya'ara Saks, while measures to address flavours in nicotine pouches falls under the responsibility of Minister of Health Mark Holland. While Minister Holland has publicly stated his intention to take action, Minister Saks has remained largely silent on the subject since her appointment last July.

The new VUSE 8000 and what should be done about it

The launch last month of (yet another) VUSE disposable vaping device is a reminder of how favourable marketing opportunities are for vaping manufacturers in Canada, and how important it is for provincial and federal regulators to better control this market. This post identifies three key measures governments should take to better protect youth from the marketing activities displayed in this VUSE launch.

Introducing VUSE 8000

VUSE GO 8000 is the fifth variant of BAT-ITL's disposable vapes to be introduced in less than 24 months. The first (VUSE GO) was launched in Canada in October 2022, followed by successively larger versions. It has been less than a year since BAT launched  VUSE GO 5000 . 

According to the trade news agency 2Firsts, Canada is the first and currently the only country in which this format is for sale. Other countries have imposed speed restrictions on the entry of new products - in the EU, for example, governments must be given 6 months notification of new product launches.

#1: Flavours are used to recruit young users. A federal flavour ban is needed.

In June 2021, Health Canada proposed a ban on all e-liquid flavourings other than tobacco and mint-menthol. Thirty-five months and two ministers later -- despite a tentative 're-consultation' - the final regulation remains in limbo. Associate Minister of Health and Minister for Addictions and Mental Health, (Ya'ara Saks) has largely said  nothing about this (or any other nicotine-related issue) since assuming responsibility for these files in July 2023. 

Not surprisingly, tobacco and nicotine companies are continuing to flood the market with youth-friendly flavours. As shown below, the VUSE 8000 is offered in 10 flavours: 1 tobacco flavour, 2 mint-menthol flavours and 7 other flavours that would have been banned had Health Canada not backed down from flavour restrictions.

The World Health Organization has recently repeated its call for restrictions on flavours as part of its World No Tobacco Day messaging. The decision by the federal health ministers to ignore this issue in their World No Tobacco Day messaging has deepened concerns has deepened concerns that there is no intention to finalize the flavour regulations.

Among Canada’s 13 provincial and territorial governments, 6 have adopted legislation or regulations to ban the sale of any e-cigarette liquid other than tobacco flavour. The absence of a nation-wide restriction has greatly reduced the efficacy of these provincial measures because there are no mechanisms in place to prevent shipments from provinces which permit flavours to those which don't.

#2. Nicotine is increasingly cheaper. Price controls and smarter tax systems are needed.

The price of a mg of deliverable nicotine as delivered by VUSE 8000 ($0.10) is less than half of the price of BAT-ITL's older EPOD system ($0.023), and two-thirds the price of nicotine in the VUSE XL disposable e-cigarette introduced last year ($0.16). 

Federal taxes on vaping liquids have been in effect since October 2022, and will be subject to an inflationary increase on July 1. Some provincial governments have already imposed their own vaping taxes, and others will be joining the federal system at the beginning of next month.   In Ontario, for example, vaping taxes will increase on July 1 from $1 (federal) to $2.24 (joint federal-provincial) per unit taxed. The tax unit is 2 ml or less for the first 10 ml and 10 ml after that.

VUSE 8000 shows how this tax planning can be undermined even before it is put in place, and how low vaping taxes mean the companies can continue to use technical improvements to lower the cost of nicotine. The federal intention that taxes would be  "an effective means to help curtail harmful consumption of these products" has been undermined.

 

The figure below shows how taxes make up a much smaller proportion of the purchase price for vaping products than they do for cigarettes - even after the upcoming price increase. With no minimum price for nicotine (as there is for alcohol), the companies have been able to use design innovations to continually lower the cost of nicotine use, as shown in the figure below. 

This calculation of price and tax per milligram of nicotine delivered (using the methods which produce the highest yields for cigarette emissions) illustrate that it is taxes which are the main reason that e-cigarettes are so much cheaper than conventional cigarettes. Through finance ministries, governments can raise taxes on e-cigarettes significantly without being concerned about making smoking cheaper than vaping. Through health ministries, they can impose minimum pricing or other price controls on nicotine (in cigarettes or e-cigarettes).

#3. Manufacturers have created economic incentives for social supply. Price regulation would stop this practice.

The e-cigarette prices stated above are the sales price charged by BAT-ITL on its own website for the purchase of individual products. For those who buy regularly and in quantity, however, the company reduces prices by 35%.

The purchase of a single 5000 puff disposable product is $25.99 on the BAT-ITL website (and $29.99 in convenience stores), but for those who purchase between 15 and 30 such products online in a month, the price is only $16.89. With 200 mg of nicotine per device, this brings the cost per mg of deliverable nicotine on this devices from $0.13 to $0.08. 

A dangerous consequence of allowing this price discounting is the opportunity it creates for retail distribution through social sources.  A young entrepreneur selling into high schools who is able to purchase 15 to 30 such products in a month will pay only $16.89 per unit, but can compete with corner stores with a 78% mark-up. 

In other words, a 19 year old who can finance a $507 initial purchase of 30 VUSE 5000 vapes can sell them to under-age friends at the convenience store price and make almost $400 per month.