Friday 12 July 2024

Recent Parliamentary decisions affecting tobacco

This post reports on the recent progress through Parliament of three pieces of federal tobacco-related legislation -  and the additional steps that are required if they are to benefit public health.

SUPPLEMENTARY RULES ON THERAPEUTIC PRODUCTS
Budget Bill gives Health Minister authority to impose post-market rules

On June 20th, Royal Assent was given to a 668-page law which implemented measures linked to the 2024 Budget. C-69, the Budget Implementation Act 2024 included three short paragraphs which could be the foundation for addressing concerns with BAT/ITL's Zonnic nicotine pouches

Supplementary rules — therapeutic product
30.‍01 (1) Subject to any regulations made under paragraph 30(1)‍(j.‍1) and if the Minister believes on reasonable grounds that the use of a therapeutic product, other than the intended use, may present a risk of injury to health, the Minister may, by order, establish rules in respect of the importation, sale, conditions of sale, advertising, manufacture, preparation, preservation, packaging, labelling, storage or testing of the therapeutic product for the purpose of preventing, managing or controlling the risk of injury to health.

Promotion
(2) For greater certainty, the Minister may, in the order, establish rules for the purpose of preventing the therapeutic product from being promoted for a use, other than the intended use, of a therapeutic product or preventing a use, other than the intended use, of a therapeutic product from being appealing.

Uncertainty
(3) The Minister may make the order despite any uncertainty respecting the risk of injury to health that the use of the therapeutic product, other than the intended use, may present.

In May Health Canada briefed interested parties on the path forward, indicating that the initial use of this new power would be to curtail ways in which nicotine pouches were being marketed and supplied, but that any such order would be preceded by a consultation. They also indicated that a more general guide to these new authorities would be published "shortly" after the law was adopted. 
Although the authority for supplementary rules applies to all therapeutic products -- including the multi-billion dollar market for prescription and over-the-counter drugs - the only public opposition to date has been from Imperial Tobacco (as articulated in its brief to Parliament and news releases), its allies in the convenience store industry, and its supporters in libertarian agencies. How the hundreds of producers of other affected products view this new power is not yet known. 

What does this mean for tobacco control?  

Health Canada should be applauded for its use of an efficient legislative process (the Budget Bill) to respond to concerns about the public health risks of nicotine pouches. For this new legislative authority take effect, however, the department will need to prepare and enforce an 'order' with better rules to direct pouch sales. 

The ball is now in the opposition parties' hands. If they continue to support Bill C-368 (see below), this measure will be undone.


A REGULATORY CARVE-OUT FOR NATURAL HEALTH PRODUCTS
Opposition parties voted to exempt vitamins, homeopathy, herbal cures and nicotine products from post-market controls

On May 29th, the House of Commons voted to approve in principle Bill C-368 An Act to amend the Food and Drugs Act (natural health products)

The sole objective of this short bill is to exclude "Natural Health Products" from the measures that apply to "therapeutic products" in the Foods and Drugs Act. In effect, C-368 will reverse the changes made in the 2023 Budget Implementation Bill, when these products were put under post-market regulation and subject to Vanessa's Law after the Auditor-General criticized the inadequate regulation of these self-care goods. 

Natural Health Products are defined by regulation to include plants, plant extracts, many vitamins, homeopathic and traditional medicines when these are sold for therapeutic use (cannabis is excluded). As a result, NRT are authorized by the same system that decides whether and how products as diverse as Ayurvedic medicine, toothpaste, homeopathic treatments, vitamins and traditional medications ("little dragon pills") can be marketed. 

For decades, public and industry resistance to evidence-based regulations on Natural Health Products has been loud and sustained. Parliamentarians have reportedly been "inundated" with letters from constituents calling for continued exclusion of this category of product from this post-market regulatory oversight. This grass-roots support for often-questionable therapies overshadows support for regulation from the small number of health experts who are willing to speak in favour of regulation. 

At the second reading vote on C-368  all Opposition parties stood in support: the bill was passed by a vote of 171 to 146. It has now been referred to the Standing Committee on Health, which is currently inviting submissions and which is expected to hold hearings in the early fall. 

What does this mean for tobacco control?  

Unless one of the larger opposition parties changes its position on C-386, Health Canada will lose its new authority to curtail the marketing of nicotine pouches.


TOBACCO COST RECOVERY
Legislative authority is a key milestone, but the finish line is still in the distance.

On June 19, Royal Assent was given to Bill C-59 (Fall Economic Statement Implementation Act 2023). Included in this 546-page law were 3 pages of text which give Health Canada the authority to charge tobacco companies for "the costs incurred by His Majesty in right of Canada in relation to the carrying out of the purpose of this Act, including regulations."

This authority is an important milestone in requiring tobacco companies to carry the financial burden of regulating their products -- but we are still far from the finish line.

The next step for the federal department is to establish the regulations that will be used to collect regulatory fees. Based on information provided by the department, it will be 2027 before these are in place. In its May 2024 Forward Regulatory Plan, Health Canada suggests that consultations will not be held until the spring of 2025. In December 2023, it told tobacco and vaping companies that regulations would take 18 months after consultation period. 

If history is a guide, this timeline is optimistic. Tobacco and vaping regulations adopted by Health Canada over the past decade have taken an average of 4 years to go from appearance on the Forward Regulatory Plan to finalization. One in 5 of these proposals have fallen by the wayside, and have been dropped from the plan.

There are also uncertainties about how much money the department will be able to collect or whether the fee will strengthen the work of the federal government. Although the law permits the recovery of costs related to both tobacco and vaping, the department has told the companies that it has no current plans to recovery costs of managing the vaping market. The department's budget for tobacco and vaping is $66 million per year, and many individuals work on both vaping and tobacco. How the department will conduct a cost-allocation exercise that will survive a tobacco industry-challenge has not been made public. 

What does this mean for tobacco control?  

The passage of C-59 begins the process of imposing a charge on tobacco companies, which may take a few years to be put in place. Although implementing this measure will impose significant staff costs on Health Canada, it will not increase the department's budget for tobacco control or expand its program activities. 

HIGHER TAXES ON TOBACCO AND VAPING PRODUCTS
Despite taxes, companies are keeping prices kid-friendly

Bill C-69 also formalized the increases to federal excise taxes on tobacco products (which took effect on April 17) and on vaping products (which took effect on July 1st). Despite the tax on e-cigarettes more than doubling in the four provinces which also began collecting the tax on July 1st, manufacturers have managed to keep prices low even on their own direct-to-consumer sales: 

* Imperial Tobacco/BAT's VUSE website sells at the same price in Ontario today as it did before the additional $1.24/2ml tax came into effect.

* Philip Morris sells its 2 ml Veev at $7 today - compared with $11 last October. It has introduced a 5 ml version which it now sells for $11. 

As reported here earlier, the cost of using nicotine continues to fall, despite excise tax increases. Health Canada has the authority to impose minimal pricing, but has not yet indicated an interest in doing so.

What does this mean for tobacco control?  

Federal and provincial finance ministries have established a system to coordinate and collect taxes on vaping products. Vaping manufacturers have adjusted their pricing so that these taxes are not being passed on to consumers, and the price of nicotine continues to fall. Until health ministries address the impact of pricing on use, advances in tax policy may not have a health benefit.



Tuesday 2 July 2024

"Tobacco Free Generation" - the best next thing?

This post reflects on the Tobacco Free Generation (TFG) policy - a regulation to ban the sale of tobacco products to people born after a certain year. 

TLDR?: 

Using birthdate-based restrictions to phase in a ban on tobacco sales is currently a popular idea and is under review in two Canadian provinces.

This measure is unlikely to produce public health benefits in the short term. Both short- and long-term risks will result if it only applies to traditional tobacco products and not also to vaping or other modern nicotine products.

For provinces which want to do more to reduce tobacco use, there are more powerful regulatory innovations available, even though these other options may not have the political palatability of a measure which does nothing to disrupt the immediate market or to reduce the tax revenues that flow from it.

AMBIGUOUS: One term, two concepts

The term "tobacco-free generation" is applied two distinct concepts, both of which are used with varying scope.

Some use the terms to describe a public health objective: the point at which smoking or tobacco use is no longer picked up by young people as a result of strong conventional tobacco control policies. Examples of tobacco free generation being discussed in this way by researchers and advocates can be found in Europe (including conference resolutions) and the United States

This post focuses on the term as it is used to describe a phased-in legislated ban on tobacco sales.  An example can be found in a recent draft law for England and Wales"(1) It is an offence to sell any of the following to a person born on or after 1 January 2009."  The term "smoke-free generation" is synonymously used. 

Tobacco and Vapes Bill, 2024


VAGUE: One term, variable scope

In some jurisdictions (i.e. the United States) tobacco is defined to include e-cigarettes, and TFG would (unless otherwise specified) apply also to e-cigarettes. The Brookline Bylaw, for example, takes this approach.  

In other jurisdictions (i.e. Canadian federal law) the term "tobacco" applies strictly to products containing tobacco leaf. The U.K. and New Zealand proposals discussed below did not impose any restrictions on the sale of e-cigarettes or other modern nicotine products, but focused restrictions on traditional combustible tobacco (in both countries traditional oral tobacco has long been banned).

NASCENT: an untested proposition  

The idea of phasing in a ban on tobacco sales was first proposed in 2010 and campaigned for by medical professionals based in Singapore. Since then the concept has been discussed around the world, with an increased level of interest in the past few years. No country has yet implemented it, although a small number of cities in the United States have.

The first legislature to consider TFG was the Australian state of Tasmania. Hearings on a proposed bill were held in 2015, but the measure died on the order paper. 

In July 2021, the town of Brookline, Massachusetts received state approval for a by-law that banned the sale of cigarettes to anyone born after January 1, 2000. Brookline is a satellite city of Boston, and four neighbouring communities have also adopted this measure. A legal challenge which delayed the initial implementation of the law was resolved earlier this year when the bylaw was upheld by the state's upper court. It is now due to come into effect on January 1, 2025. These laws apply equally to tobacco and vaping products.  

In December 2022, revisions to New Zealand's Smokefree Environments and Regulated Products Act were made which included a ban on the sale of tobacco products to anyone born after January 1, 2009.  After a general election the following year and a change of government, the NZ legislature reversed these amendments and removed them from the law. 

TFG had a second false start in a national legislature in 2024. In March 2024, the U.K. government introduced the concept as part of its Tobacco and Vapes Bill, received submissions from the public and debated the issue in Committee. The House of Commons had not finished its study of the bill before a general election was called on May 30. Similar to the New Zealand proposal, the U.K. government intended to ban the sale of tobacco products to people born after January 1, 2009 but not to impose such constraints on non-tobacco nicotine products (such as vaping or pouches). 

The Hong Kong government included TFG measures in its 2023 consultation on future tobacco control initiatives. A year later, however, this was not included among the 10 measures the government chose to implement. 

TOPICAL: under review in 2 Canadian jurisdictions

This spring two Canadian provinces have launched public consultations about TFG measures. 

On May 14, 2024, Canada's smallest province issued a "Consultation Paper on Wellness in Prince Edward Island" which included TFG among 4 proposals to help the province "Breathe Well". "No one born after Jan. 1, 2009 would be able to legally purchase cigarettes. The effect of a TFG approach is to stop the next generation of youth from purchasing tobacco products." 

Prince Edward Island already has in place Canada's most advanced restrictions to protect young people from nicotine use. Four years ago it increased the minimum age to buy tobacco or vaping products from 19 to 21 and to only permit the sale of vaping products in specialty stores. A year later it banned flavourings in e-cigarettes. 

The other proposals included in this consultation are to permit tobacco to be sold only in tobacconist shops, to increase public education investments to prevent youth initiation of tobacco and vaping and to expand supports for smoking cessation. Public comments on these proposals are due by July 5, 2024, and a survey tool is available to PEI residents to respond


On May 30, 2024, Newfoundland and Labrador announced that it would consult on changes to its tobacco law. The on-line consultation will be open until July 8, 2024. Our answers to the Newfoundland consultation are pasted at the end of this post.

NON-DISRUPTIVE: minimal impact in the short term

A recent article written by tobacco control leaders identified some benefits and risks of "birthdate-based commercial tobacco sales." (Malone RE, McAfee T. Birthdate-based commercial tobacco sales restrictions: will ‘tobacco-free generation’ policies advance or delay the endgame? Tobacco Control Published Online First: 19 June 2024. doi: 10.1136/tc-2024-058716). 

They identify that such "have intuitive appeal, largely because they do not appreciably disrupt the status quo of retail sales, which continue unchanged for all those born before the designated cut-off date." This, combined with the minimal impact on short-term tax revenues, enhances their "political palatability" 

These authors conclude that birthdate-based restrictions will not greatly accelerate reductions in tobacco use and does not satisfy the need for more profound change. "[Birthdate-based Sales Restriction] makes only gradual changes to the structural, political and social dynamics that sustain the epidemic, as the population to whom the products may be legally sold grows older and the use of the products perhaps appears less appealing to young adults."

These authors - who were among the first to promote a tobacco Endgame - do not rate this as a sufficiently powerful public policy. "Overall, as an endgame policy, compared with other proposed policies BSR is the temporally weakest and least disruptive to the status quo, allowing the tobacco industry to continue promoting lethal products, retailers to continue selling them and permitting the tobacco epidemic to continue for decades as the eligible to-buy population gradually declines." 

SUB-OPTIMAL: stronger new interventions are available

Better endgame measures are available, these authors suggest. Among the alternatives they propose are:

* A shorter phase-out of retail sales of tobacco [including vaping and modern oral] products (1–5 years), ideally combined with transition funding and education for retailers as well as education and cessation support for tobacco users....

* A rapid ban on sales of combustible tobacco products, coupled with additional restrictions on non-combustible sales but without an immediate ban...

* Major restrictions on retail outlet density, number and types of stores... 

* ..Bans on sales of flavoured products, allowing sales only of products with nicotine at non-addictive levels and/ or marketing/advertising bans.

These American researchers based their analysis on U.S. circumstances, where tobacco is legally defined to include vaping and other nicotine products. Consequently, they did not profile the inherent problems of banning one form of nicotine sales while allowing another. 

For governments like Newfoundland and Prince Edward Island, this is a crucial consideration. Banning sale of tobacco products to come individuals, while allowing the sale of other addictive and harmful products made by the same manufacturers sends a signal. Consumers will interpret that alternative nicotine products are not very harmful (or else they would be embraced by the restriction). The industry will encourage the distinction to be interpreted as an endorsement of its plans to recruit new generations to its newer products.

------------------------

Response of Physicians for a Smoke-Free Canada to Newfoundland's consultations on Amendments to Tobacco and Vaping-related Statutes

1. Should individuals born after a certain year (e.g., born after 2008) be prohibited from purchasing tobacco and related products?

Our answer is a conditional yes.

We recommend that such a prohibition should only be implemented if it is accompanied by a similar prohibition on the sale of vaping and other current or future recreational nicotine products.

Such a prohibition should not apply to nicotine used in a therapeutic context (e.g. supplied through therapeutic channels like pharmacies and used for the purpose of treating addiction or other disease).

The benefits of a tobacco free generation measure that does not include vaping products is likely to be small. Cigarette smoking is passé among newer generations, just as pipe smoking became passé among their grandparents. This means that a prohibition on tobacco use among people born after 2008 may not result in lower use of tobacco products than if no such measure were in place. For example, the Canadian Tobacco and Nicotine Survey showed that 8% of Canadians born between 1998 and 2003 smoked cigarettes, but 20% used vaping products.

The risks of a tobacco-free generation measure that does not include vaping products are significant. They include:
* young people perceiving that there is government approval for the use of these products after the age of 19 (or 21)
* the industry being able to point to government as a validator of its position that the widespread sale of vaping products should be tolerated or encouraged and that rules that apply to tobacco products should not apply to vaping, pouches or other nicotine 'starter' products.

The province should explore alternative ways to accelerate reductions in tobacco use, including mandatory phase-outs of combustible tobacco and other nicotine products (potentially in different time-frames), retail restrictions including tobacco- or nicotine-only stores, strict liability for tobacco or nicotine manufacturers when young people use their products, etc.

2. Should the legal age for the purchase of tobacco and related products be increased to 21?

This measure should be implemented as soon as possible and should apply to all products for which youth use is a concern.

3. Should non-tobacco flavoured vaping products, such as candy, fruit, and mint flavours, be prohibited?

Yes.

The failure of the federal government to fulfill its obligations by implementing flavour restrictions has unreasonably placed the burden of protecting youth on provincial governments. Newfoundland should adopt this measure while also calling for federal measures. Without a federal ban, provincial bans are easily undermined by cross-border internet sales.

A ban on flavourings should also include restrictions on the types of ingredients than can be used, including mint-menthol additives and sweeteners.

4. Should the sale of nicotine pouches be restricted, such as by only allowing sales at pharmacies?

Yes.

Nicotine pouches may (or may not) prove to be a much safer form of nicotine use than vaping, chewing tobacco or smoked tobacco. However, it now appears that the most likely users of these products are young people who are not currently smokers, including young adults who are being targeted with messages encouraging nicotine use as a way to improve concentration, mood or to reduce weight. Restricting sales to pharmacies is one way to ensure that they are used in ways which promote health, and do not serve as a on-ramp to nicotine addiction.

5. Should the sale of tobacco and related products through vending machines be prohibited?

Yes.

This measure is long overdue and should be implemented as soon as possible. On-line sale of tobacco and vaping products should also not be permitted, except in exceptional circumstances regarding remote communities.

6. Should vapour product retailers be licensed?

Yes.

The licensing requirements on vapour product retailers should include an obligation to report sales volumes to the province. This will permit the province to assess the impact of unrestricted number of retail outlets on nicotine use at a neighbourhood level.

7. Should there be stricter enforcement measures and/or penalties in legislation governing the sale of tobacco and related products?

Yes.

Tobacco and nicotine companies should also bear responsibility for the sale to and use by underage users. A suitably adapted strict liability system should be in place to penalize those who sell products in ways that facilitate youth use. For example, the websites of British American Tobacco (VUSE) and Philip Morris (VEEBA) offer volume discounts in on-line sales, which provides an economic incentive for social sales. Strict liability for underage use would encourage these companies to adopt measures to ensure no spillage of their supply into social or illicit sales.


Tuesday 18 June 2024

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:


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.

Sunday 9 June 2024

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.







Monday 3 June 2024

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.

Wednesday 1 May 2024

Budget Bill gives Minister new powers to address nicotine pouches (and other therapeutic products)

In late March, Health Minister Mark Holland cautioned Imperial Tobacco to "stay the hell away from our kids" while marketing their Zonnic brand nicotine pouches.  Yesterday, Parliament was notified about the specific changes to the law the Minister is seeing which will provide the power to make this happen. 

This post provides an update on this important development in thee nine-month saga of Canada's experience with nicotine pouches. 


The proposed power

Among the measures contained in the 650-plus pages of the Notice of Ways and Means Motion to introduce an Act to implement certain provisions of the budget tabled in Parliament on April 16, 2024  were three paragraphs of legislative text that expand the power of the Minister to issue Interim Orders. In cases where the Minister perceived a risk to health - even if it was not proven - he or she would be authorized to lay down the rules by which therapeutic products could be sold or promoted: 

Supplementary rules — therapeutic product
30.01. Subject to any regulations made under paragraph 30(1)(j.1) and if the Minister believes that the use of a therapeutic product, other than the intended use, may present a risk of injury to health, the Minister may, by order, establish rules in respect of the importation, sale, conditions of sale, advertising, manufacture, preparation, preservation, packaging, labelling, storage or testing of the therapeutic product for the purpose of preventing, managing or controlling the risk of injury to health.

Promotion
(2) For greater certainty, the Minister may, in the order, establish rules for the purpose of preventing the therapeutic product from being promoted for a use, other than the intended use, of a therapeutic product or preventing a use, other than the intended use, of a therapeutic product from being appealing.

Uncertainty
(3) The Minister may make the order despite any uncertainty respecting the risk of injury to health that the use of the therapeutic product, other than the intended use, may present.

The potential scope 

It seems clear from the budget document that this section was introduced to address nicotine pouches, but the powers given to the Minister would extend to other therapeutic products regulated by the Food and Drugs Act. Nicotine pouches and other NRT are the only nicotine products regulated under this act. 

The potential speed

Unlike regulations, Interim Orders can be issued without pre-notification and without the administrative burden of developing regulatory impact assessments, cost-benefit analyses and other time-consuming background. The Interim Order mechanism is designed to provide an urgent response, and such orders are time-limited, as these new "Supplementary Rules" may be.  The Minister cannot make these orders without the support of cabinet colleagues through the Order in Council process.

There is no authority for Interim Orders in the Tobacco and Vaping Products Act. Regulations under that Act generally take more than two years to put in place. 

The Budget Bill is one of the government's highest priorities and  -- despite its enormous size and complex set of laws being adjusted - is usually passed more quickly than other government legislation. It is possible that with the Budget Bill passed by the beginning of summer, new rules for marketing pouches could be in place this summer. 

The Tobacco Industry

BAT-Imperial Tobacco has launched an aggressive campaign against the Health Minister. Its public-facing PR initiatives include newspaper advertisements and a website. History suggests they will only ramp-up these efforts with intensive behind-the-scenes lobbying.  Health Canada's failure to implement guidance for politicians and public servants on respecting FCTC Article 5.3 (on tobacco industry interference) makes this important legislative step more vulnerable than it should be.

Notably, similar industry advertorials were recently identified as illegal promotions in the United Kingdom.


The hanging threads

Although Zonnic is the only nicotine pouch currently authorized for sale in Canada, other companies are known to have submitted their products for approval. New rules on the nicotine pouch market are likely to be followed with expanded competition in this new market. 

The Hon. Mark Holland has authority over the Food and Drugs Act, but is not the Minister responsible for the Tobacco and Vaping Products Act.  Tobacco legislation is the responsibility of his colleague, the Hon. Ya'ara Saks, who is the Minister of Mental Health and Addictions. In the 9 months since she was appointed to this position, she has been largely silent on questions related to tobacco control. 

This silence may be broken later this month -- on May 23rd -- when she faces a deadline to present Parliament with her review of the Tobacco and Vaping Products Act.  (The law requires the Minister to file such a report every two years, but her predecessor, Dr. Carolyn Bennett, ignored the deadline on this statutory duty ). 

This review is an opportunity for the two Ministers to move forward in developing an integrated regulatory framework for nicotine, as we and others have recommended. 




Thursday 4 April 2024

Public Use Micro File of the Canadian Student Tobacco, Alcohol and Drug Survey (CSTADS) is now available

This post provides information on the release of the Public Use Micro File (PUMF) for the Canadian Student Tobacco, Alcohol and Drug (CSTADS), 2020-2021.

CSTADS is a periodic survey funded by Health Canada on the substance use of Canadian middle and high school students. It has been conducted four times over the past decade - during the school years 2014-2015, 2015-2017, 2018-2019 and then 2021-22. The first 3 waves were conducted by the University of Waterloo, after which the work was was contracted to CCI research

The results of the 2021-22 wave - reported in an earlier blog post - were first made public in May, but were withdrawn from Health Canada's website soon afterwards for unspecified technical reasons. They were recently re-uploaded and updated

CSTADS (now CSADS) is the largest youth health survey in Canada. Information from more than 61,000 students in grades 7 to 12 was provided during class time from most parts of the country. (New Brunswick declined to participate in 3 of the waves, including the most recent one). 

Last week the data files for the 2020-2021 wave of the survey were made public on the federal Open Government Portal. These allow exploration of information not provided on the tables presented by Health Canada, and for more in-depth analysis. 

The charts shown below are derived from the PUMF file, but are presented without the benefit of statistical tests.

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By the time they leave high school, almost 1 in 5 Canadian students use vaping products at least once a week (and 1 in 8 uses them every day).

Health Canada generally groups results into two age groups, but the PUMF file allows for a review of substance use in each grade. Because substance use progresses over time and because younger children are less likely to use substances, grouping produces underestimates of the drug use by students at the end of their school years. The PUMF file, however, allows this estimate to be shown. 


High school students living in rural areas are heavier vapers.

Most students surveyed (82%) were identified as attending a school in an urban area, using Statistics Canada's definitions. Proportionately more students in rural schools reported using e-cigarettes daily. 

According to this survey, although only one-fifth (18%) of students are in rural schools, one-third (34%) of youth who vape daily attend rural schools. Although a similar pattern was seen with respect to cigarette smoking, the very low rates of daily smoking (1.5% overall) make the presentation of data without statistical tests less appropriate. 



"White" and "Aboriginal" high schoolers are heavier vapers.

The survey asked students "How would you describe yourself?" The results were grouped into 8 categories: "white", "black", "West Asian/Arab", "South Asian/Indian", East/Southeast Asian (Chinese ...)", "Latin American/Hispanic", "Aboriginal (First Nations, Métis, Inuit..)" and "Another race/Multiple."

More than half (57%) of students identified themselves as "white", with no other ethnic category composing more than 7% of responses. Three percent of students identified themselves as aboriginal.  

"White" and "Aboriginal" students were disproportionately represented among those who vaped on a daily or weekly basis (70% and 5% respectively).