Thursday 3 October 2024

Mistakes happen

The bad news is that the data from the Canadian Community Health Survey released by Statistics Canada earlier this week were incorrect. The good news is that the growth in vaping rates is lower than indicated by the data published on Wednesday.

Statistics Canada reached out earlier today to inform us that "the numbers cited in your message have actually been revised for the 2022 reference period. When we published yesterday, we had not known that there was an error in the coding of the indicator for past 30 day vaping/e-cigarette use. ... we have released the corrected numbers for 2022 (Health indicator statistics, annual estimates (statcan.gc.ca)), which show 1.7 million vapers or 5.7% of the adult population, rather than the numbers we had mistakenly published yesterday (1.3 million/4.8%)."

The corrected figures are shown below:






The growth in the vaping population as measured by this survey between 2022 and 2023 was thus 168,700. We still do not know whether these individuals are people who used vaping to quit smoking, or whether vaping products are their introduction to nicotine use, or whether they both smoke and vape. Such tabulations are not difficult, but they require access to the data files (not currently available to non-University-based researchers).

Information on smoking status was readily available to the public when the Canadian Tobacco and Nicotine Survey was in the field from late 2019 to early 2013. The last wave of that now-defunct survey found 240,100 more vapers in 2022-23 than in 2021-22. Of those, 206,900 (86%) were never smokers. 




Thursday 5 September 2024

Health Canada needs a new legislated purpose for tobacco

This post discusses the increasing importance of amending the Tobacco and Vaping Products Act to give Health Canada a broader scope for action and clearer instructions from Parliament. This reflection is prompted by two actions recently taken by Health Canada.

The first of these was the release of the department's proposed framework for cost recovery from tobacco companies.  As reported here earlier, the department's capacity to apply the polluter pay principle to this industry is severely limited by the narrowly-constructed purpose of the current law. Only those costs which are linked to the legislative objectives of the Tobacco and Vaping Products Act (TVPA) can be claimed from the industry.

The second action was the Ministerial Order made public and formally published in August which set specific rules for the marketing and distribution of nicotine pouches regulated under the Food and Drugs Act (FDA). The order is a reminder that as tobacco companies morph into other product categories, health authorities need flexible and wrap-around powers to manage this transformation. The 'belt' of this Ministerial Order would be more secure if the department had the 'suspenders' of integrating the use of these products in its tobacco strategy.

The TVPA's purpose is well past its best before date

The TVPA's purpose was conceived in the 1980s and reflects the priorities and limitations of that era. Despite two major legislative overhauls, the intent and purpose of the federal tobacco law has not substantially changed in almost 40 years. 

The evolution in the purpose of the Tobacco Products Control Act (1988), the Tobacco Act (1997) and the Tobacco and Vaping Products Act (2018) is shown below and can be downloaded here. The articulated purpose is limited to (a) preventing people from starting to use vaping or tobacco products and (b) providing information and countering disinformation on health risks of vaping or using tobacco products. 

The tobacco industry has gone through substantial re-invention since that mandate was conceptualized, and Canadian support for stronger laws has steadily grown. Nonetheless, Parliament has not returned to its vision of how to manage tobacco and has yet to give Health Canada stronger powers and clearer directions on how to manage the problems caused by this industry. 

The current law does not authorize Health Canada to adopt strategies to end tobacco use -- or even to promote smoking cessation. It sets no goals to reduce the number of people who smoke, or to reduce the injuries caused by these products. The vagueness of this legislated mandate is reflected in the minimalist documentation for "Canada's Tobacco Strategy". The narrowness of the legislative mandate means that Health Canada will have difficulty demanding that the industry pay for many of the costs that it causes.


Parliament has given Health Canada clear instructions in other laws

The Canadian Environmental Protection Act (CEPA) provides an example of an expanded and robust legislative purpose, and is a model for how the TVPA could re-invigorate the federal strategy. Like the tobacco law, CEPA was first passed by Parliament in 1988. It however, has been the subject of more detailed Parliamentary study. Parliament's instructions to CEPA are outlined in 3 mutually-reinforcing sections:

1) DECLARATION. A 35-word legislative objective that gives the law broad application: "It is hereby declared that the protection of the environment is essential to the well-being of Canadians and that the primary purpose of this Act is to contribute to sustainable development through pollution prevention."

2) PREAMBLE. An 800 word expansion of the values behind the law, with 24 clauses outlining specific values.

3) DIRECTION. CEPA gives a dozen or more specific instructions to the federal government in how the law should be administered. Examples of these obligations include a mandate to ... "apply the precautionary principle ....", "protect the right of every individual in Canada to a healthy environment...", "take the necessity of protecting the environment into account in making social and economic decisions."

The CEPA approach can be adapted for tobacco control

Adapting the CEPA approach to modify the federal tobacco law would provide a number of benefits and could help:

  • clarify the goals that should guide Health Canada's strategy
  • expand the scope of activities that can be charged to the tobacco and nicotine industry
  • provide instructions, guidance and support to health ministers in managing this long-standing health problem
  • authorize the department to engage in activities to discourage the use of nicotine products other than tobacco- and vaping products.
  • provide the public with transparency about the mandate of Health Canada
An example of a revised purpose section is shown below (and can be downloaded here). This text adds only 200 more words to the law, but greatly expands and clarifies Health Canada's responsibilities. 

In this example, the core purpose of the federal tobacco law is simply stated: "The primary purpose of this Act is to contribute to the elimination of the harms to human and environmental health caused by commercial tobacco and nicotine products."

The suggested text instructs Health Canada on key aspects of addressing the harms caused by the tobacco industry. These include: 

  • Developing a nicotine reduction strategy with measurable objectives 
  • Fully implementing the Framework Convention on Tobacco Control
  • Respecting and supporting traditional non-commercial tobacco use in First Nations
  • Adopting measures to protect the environment with respect to tobacco and nicotine products
  • Reducing health disparities with respect to the use of tobacco and nicotine products
  • Appling the precautionary principle.

Filling a crucial gap

As it is currently written, the TVPA governs tobacco products (those made with tobacco) and vaping products (aerosolized nicotine) but has no power over novel nicotine products. Nicotine pouches are one example of tobacco industry products which are left unaddressed in the law, but there are others on the horizon. 


Over the last year Philip Morris began selling its zero-tobacco LEVIA heat sticks in Czechia, and  Romania and over the past month has launched them in the Netherlands. (They have signalled their intention to market them in Canada by registering the trademark). BAT also sells a tobacco-free heat stick. Both companies also have hybrid products (mixture of vaping and heated tobacco) in development or on the market.

It is not too early to anticipate that these products will be introduced to Canada, whether or not they are legal for sale under federal law. In its public documents (including the Departmental Plan) Health Canada has not made public whether or how it is analyzing the potential benefits or harms of these products being sold in Canada. 

Our organization is among those calling for a fulsome revision and modernization of the federal law, but Health Canada has largely responded to these recommendations by ignoring them. The proposed revisions to the purpose and direction sections would give the department the responsibility and authority to initiate this process.


Thursday 22 August 2024

Canada's Health Minister breaks new ground to regulate nicotine pouches

Physicians for a Smoke-Free Canada joined other health agencies and concerned Canadians in applauding the Health Minister for ordering Imperial Tobacco (British American Tobacco) to change the way it markets nicotine pouches in Canada

"The measures announced today will put these novel nicotine products where they belong: behind the pharmacist's counter," said executive director Cynthia Callard. "The new controls will protect kids by ending advertising, labelling and flavourings which are inappropriate for smoking cessation aids."

"By the time Canadian children are back in the classroom, these products will no longer be displayed and sold in the convenience stores where kids stop to buy snacks or candies."  The Ministerial Order will require Zonnic pouches to be removed from convenience stores and gas stations before Labour Day weekend. 

ZONNIC display at 
Giant Tiger, Wellington St,
Ottawa. Aug 2024

Nicotine pouches are small sachets containing plant fibre, nicotine,  flavourings and sweeteners. In Canada they are not permitted for sale as tobacco products. Instead they are regulated as Natural Health Products and are subject to the same rules as traditional nicotine replacement products like gum and patches. 

In July 2023, Imperial Tobacco became the first company to receive authorization from Health Canada to sell nicotine pouches as smoking cessation products. When the products entered the market in the early fall, Canadians were alarmed to see the company was using lifestyle imagery and marketing strategies similar to those they used to sell cigarettes, and at the absence of regulations which would prevent this from happening. 

"We are deeply appreciative of the urgency with which Minister Holland responded to these concerns, and of the measure he is taking to ensure that the marketing of nicotine pouches is appropriate for their authorized use," said Ms. Callard. 

"We also want to acknowledge the speedy contribution of departmental officials who designed flexible and tailored regulatory tools to protect vulnerable citizens, and to thank the parliamentarians who gave the Minister the authority to use these new powers in late June. We also value the initiative of governments like British Columbia which initiated some of these restrictions."

Ms. Callard noted that health departments in other countries are also grappling with the recent introduction of nicotine pouches and their growing popularity among youth. "By making Canada the first country where nicotine pouches are dispensed by pharmacists and where flavours are restricted,  Minister Holland is setting an important regulatory precedent." (Australia allows e-cigarettes (vaping products) to be sold only through pharmacies.)

"We can expect tobacco companies and their retail allies to use their their extensive legal and public relations resources to try to defeat these measures." cautioned Ms. Callard. "Canadians should apply the 'scream test' to their response: the more the industry objects to a measure, the more important it is to implement it."

"This fall Canadian children will be better protected from nicotine addiction, but much more needs to be done," said Ms. Callard. "Minister Saks has not finalized the federal regulations to restrict e-cigarette flavours. As a result, this back-to-school season will see even more kids experiment with and become addicted to these fun flavoured products." 

Nicotine pouches are regulated under the Food and Drugs Act (which is the responsibility of Health Minister Mark Holland) and tobacco and vaping products are regulated under the Tobacco and Vaping Products Act (which is the responsibility of Minister of Addictions Ya'ara Saks). 








Saturday 3 August 2024

Health Canada's Tobacco Cost Recovery Fee: no new money, but more administration

Responses to consultation on the
tobacco cost recovery
framework are
due by October 10
This week Health Canada formally articulated how it intends to collect and spend the tobacco cost-recovery fee which was mandated by the Prime Ministers office some 31 months ago.  The details are provided in the Consultation document: Proposed tobacco cost recovery framework, with public comments being invited until October 10th.

This document confirms that Health Canada's budget for tobacco control will not increase as a result of tobacco companies being charged for a sub-set of its tobacco control activities. 

What will significantly increase is the administrative burden on the tobacco control directorate. Some staff will be redirected from health-oriented activities to financial administration.

This post identifies eight concerns about the proposed framework. A subsequent post will suggest ways to overcome some of these challenges.

Health Canada's proposal in brief:

As described in the consultation document, the federal government proposes that:

1. The budget for Canada's Tobacco Strategy will be continued at the levels set in 2018, with $66.2 million allocated to cover the activities of the six federal departments involved. There has been no inflationary increase and none is forecast, meaning the budget is worth 17% less than when set in 2018 and continues to devalue.

2. Three of the departments involved (Health Canada, Public Health Agency and Indigenous Services) will monitor how much they spend in a given fiscal year on eligible expenses. Eligible expenses are for activities (a) connected to conventional tobacco products and (b) related to the purpose of the Tobacco and Vaping Products Act. 

4. Health Canada will require tobacco manufacturers to provide a statement at the end of each April saying how much revenue they received from sales in Canada in the previous fiscal period (April 1 to March 31).

5. On October 1st of each year, Health Canada will issue an invoice to each manufacturer (unless their market share is under 0.001%). The amount of each company's invoice will be the total eligible expenses times that company's share of tobacco revenues. The companies will be given one month to submit payment.

6. The costs of administering this program will be taken from the existing tobacco control budget.

Concern #1: The cost-recovery fee will recover only a fraction of the federal costs related to tobacco industry products

The cost-recovery fee will apply only to activities which are related to the use of traditional tobacco products and which are carried out by Health Canada, the Public Health Agency and Indigenous Services Canada. The current tobacco-control budget for those three agencies is $55.3 million - but much less than that will be recoverable. 

Even though the youth vaping and pouch-use crisis is arguably the most pressing issue facing the health department and even though tobacco companies contribute largely to this problem, none of the federal costs for nicotine use outside of conventional tobacco will be charged to the companies.

The activities of half of the federal departments involved will not be included in the program. These represent 15% of the budget for Canada's Tobacco Strategy. Similarly, federal costs by other departments which do not participate in the strategy will not be recovered. Examples of such activities include developing strategies to address plastic filter waste, managing smoking in federally-regulated workplaces, or addressing the tobacco-related health costs of prisoners, the military, etc.

Concern #2: The objectives of the Tobacco and Vaping Product Act are so narrow that the department will face challenges in assessing fees for many activities.

There are further restrictions in applying the fee to federal activities related to traditional tobacco products. As stipulated in the law that permits the fee, the department can only use the fee to recoup "costs incurred by His Majesty in right of Canada in relation to the carrying out of the purpose of this [Tobacco and Vaping Products] Act, including regulations." 

The purpose of the Tobacco and Vaping Products Act (TVPA) is narrow and arguably antiquated. This section of the law was drafted in the mid 1980s as part of the Canada's first efforts to impose regulatory controls on the industry and at a time when the priorities and challenges were very different than today. 

The law is silent about encouraging cessation, preventing addiction, protecting people from second-hand smoke, or reducing environmental and economic harm caused by this industry.

The TVPA has 4 specific objectives with respect to tobacco:

  • "To protect young persons and others from inducements to use tobacco products and the consequent dependence on them"
  • To protect the health of young persons by restricting access to tobacco products
  • To prevent the public from being deceived or misled with respect to the health hazards of using tobacco products
  • To enhance public awareness of the health hazards of using tobacco products."

Health Canada recognizes this limitation in the Consultation document, and provides a list of the costs which it considers can and cannot be recovered

However, many of the activities which the department says will be eligible are unlikely to be recovered without a fight from the companies. These are the activities which go beyond the explicit purpose of the Act and regulations - such as "resources to help people quit smoking" and providing "access to less harmful sources of nicotine."  

Given this industry's litigious past, such disputes are likely to land in court. The department's chariness about defending its policies in court will put pressure on staff to use a much narrower scope when recovering the costs than it is proposing in this consultation paper.

Concern #3: This framework creates an incentive for the department to de-fund non-eligible activities

Cost-cutting exercises are common place in Ottawa, especially following changes in governments. The proposed tobacco cost recovery framework provides a mechanism for ongoing reimbursement, but does not insure public health from decisions to 'de-prioritize' tobacco control. (The approaches used in other countries are better for this purpose, as discussed below). 

The limitations on which activities can be covered, combined with pressure to avoid disputes over eligible costs will create an incentive for departmental planners to focus expenditures on activities tightly aligned with the TVPA. 

The following hypothetical scenario describes this potential vulnerability: Health Canada focuses half its tobacco control activities on activities eligible for reimbursement, and recoups $23 million annually from tobacco companies. A government decision to cut programming costs by 15% across the board prompts the deputy minister to instruct that 80% of the work be on reimbursable activities in order that $13 million in departmental funding can be saved. Programs directed at researching and regulating vaping products are disproportionately cut.

Concern #4: The framework imposes a significant administrative burden 

The design of this cost recovery fee requires the department to calculate how much it spends on eligible activities before requesting reimbursement from manufacturers. 

Because only a subset of current activities are eligible, cost-accounting will be required to establish the eligible tobacco-share of all costs. This will impose a significant new burden on staff, and establishing criteria for eligibility will be a major management undertaking.

All of this will have to be done at an auditable standard. As the Consultation Document makes clear, the regulatory fee comes with requirements for transparency in recording costs. "There are also a number of legislative and government policy requirements to ensure proper accountability and transparency when fees and charges are introduced through ministerial regulations."

Concern #5: The transparency required by this framework may not be achievable for Indigenous Services, which will reduce the amount that can be recovered

Fifteen percent of the funds for Canada's Tobacco Strategy are transferred by Indigenous Services Canada to First Nations agencies. To date, that department has elected to not make the details of how --- or indeed if -- the money provided for tobacco control is spent as intended. 

When asked by parliamentarians for details on components of tobacco control funding, for example, Indigenous Services Canada has dodged giving any specific information and has instead said only that it was used "according to the priorities" of the recipient communities. (An example of such a response can be seen here and is pictured below).

There is little incentive for Indigenous Services Canada to force the issue with recipient agencies. Transparency is required to recover the costs, but cost recovery is not required for the department to receive its share of the CTS allocation. How Health Canada will address this issue is not spelled out in the Consultation Document.

Government reply to Order Paper Question
asked by Don Davies, MP, 2018

Concern #6: This framework does not borrow from good examples in other countries.

Health Canada has taken a different approach than that in the United States, France or other countries which have implemented regulatory fees on tobacco companies. These countries do not bill the industry for past expenses, but instead impose an up-front contribution based on sales revenue. This has had the effect of increasing their resources and expanding their range of activities.

United States: Since 2009, U.S. law has imposed a user fee on tobacco product manufacturers which is provided to the Food and Drug Authority for use at its discretion. Current revenues are USD $712 million (equivalent to CAD $985 million). No fee is imposed on the manufacturers of e-cigarettes. 

The FDA currently invests these fees in a wide range of activities, including in campaigns aimed at discouraging youth vaping.  If Canada adopted the U.S. approach, it could engage in additional work to reduce the onset of nicotine use as well as increasing cessation.

France: Since 2016, France has demanded a "social contribution" from tobacco companies, originally assessed at 5.6% of the wholesale revenues and providing about 120 million euros per year.  The revenue was assigned to a new tobacco control fund, whose purpose was later expanded to include all addictions. (Fonds de lutte contre les addictions). The funds are used to support a wide range of activities managed by government and non-government agencies

Unlike Canada, France chose to use a cost recovery system to expand the resources available. Instead of restricting activities to those by national government, it divides resources among regions and has appointed stakeholders to the oversight board which allocates funds.

Concern # 7: More efficient ways to recover costs are available

Unless the constraints identified above are addressed, the approach proposed by Health Canada is unlikely to generate more than $25 million in revenues. This estimate is calculated as the departmental tobacco control budget less 45% for expenses on vaping-related activities or other ineligible expenses.

While it is not possible at this point to quantify the cost of administering the cost recovery fee, it is likely to be non-trivial. Estimating the cost base, allocating the charge across different manufacturers, providing transparency about the process and defending the system in courts will take time and money. This time and money will be provided from the existing budget for federal tobacco control, which will impact other activities of the branch.

Other frameworks for cost recovery are available,  including options which generate more money with fewer strings and less administrative overhead.

Concern # 8: The recovery fee does not reflect the industry's capacity to pay 

The amount being proposed for recovery is less than a rounding error on any of these companies budgets. Because the companies are currently sheltered by insolvency protection, they have been required to provide semi-annual financial statements. From these, we know that a typical annual net revenue of the three large companies is about 2 billion per year.

The smallest of the three companies (JTI-Macdonald, whose revenues are about 17% of the industry total) reports that it spends $150 million a year on promotional activities. (Monitor's Report, page 12). Based on its recent revenue share, its contribution to a $30 million annual regulatory fee would only be $5 million.





Monday 22 July 2024

Fact checking the "Swedish Experience"

This post responds to recurring efforts by tobacco companies and their allies to promote the "Swedish Experience" as template for harm reduction based on oral nicotine delivery. 

Data from reliable sources are used fact check the industry's claims. They show that for most indicators Sweden has not out-performed Canada with respect to reducing smoking prevalence or reducing tobacco-related disease. The Swedish experience is one where twice as many people use nicotine... and smoking is not being phased out more quickly.

Pouch promoters say Sweden is a tobacco control success story

Tobacco companies promote Sweden's permissive approach to snus as a way to keep smokers happy (with nicotine), keep investors happy (with high sales and profits) and keep health regulators happy (with low levels of disease).  

From BAT Presentation, 2024

Examples of this sales pitch can be found in investor presentations (such as those earlier this spring by British American Tobacco and Philip Morris International), in messaging from allied agencies (such as Smokefree Sweden), in industry-friendly media and on social media.

These pro-pouch arguments boil down to two claims:
* Widespread snus use in Sweden has led to lower smoking rates
* Widespread snus use in Sweden has led to low rates of tobacco-caused disease 

This is not the first time that the Swedish Experience has been trotted out by industry and others to encourage a permissive approach for oral nicotine. The current reprise is being delivered in the context of concerns in the US about the rapid increase in the sales of Zyn, and among European initiatives to regulate the introduction of nicotine pouches and Canada's Health Minister's plans to restrict how these products are marketed. 

(Nor is it the first time that tobacco control agencies have pushed back against these efforts. The data provided below is an update to our 2007 analysis.)

FACT CHECK: IN RECENT DECADES, THE "SWEDISH EXPERIENCE" HAS PRODUCED WORSE OUTCOMES THAN CANADIAN TOBACCO CONTROL. 
(Although the situation in Sweden was better in the last century).

As detailed below:

Widespread snus use in Sweden has NOT led to lower smoking rates
  • Estimates of smoking rates in Sweden are generally not lower than those in Canada. 
  • Smoking rates in Sweden have fallen, but not at a faster rate than in Canada 
  • Twice as many Swedes use tobacco-industry nicotine products as do Canadians (30% vs 15%).
Widespread snus use in Sweden has NOT led to low rates of tobacco-caused disease 
  • Lung cancer death rates among men are lower in Sweden than Canada, but the situation for other major tobacco-related diseases is not better.
  • Tobacco-related deaths have fallen faster in Canada than in Sweden
  • Sweden's lower lung cancer rates are rooted in lower tobacco use in the last century (not an outcome of current snus use)
Smoking rates in Sweden are not lower than in Canada

For decades, the OECD has tracked daily smoking rates among men and women in its high-income member states. The OCED provides access to this data, and also presents it in  data visualizations.  

OECD Countries identified as having lower daily cigarette smoking rates in 2021 than Sweden (9.7%) include New Zealand (9.4%), the United States (8.8%), Canada (8.7%), Mexico (8.6%), Norway (8%), Costa Rica (7.8%) and Iceland (7%). The World Health Organizations' report on tobacco smoking rates similarly shows Sweden behind Canada (12.6% vs 12%, Table A1.2), although rates of smoking manufactured cigarettes are slightly higher in Canada (where roll-your-own tobacco is no longer common).

Smoking rates in Sweden have fallen, but not at a faster rate than in Canada 

The Global Burden of Disease group and the Institute for Health Metrics and Evaluation provide historic smoking prevalence data which has been age-standardized to allow comparisons among countries and across time periods.(The data are available here). 

Their data shows that Sweden has done well (ranking 12th among 204 countries)  - but that other countries, including Canada (ranked 9th) and Australia (ranked 7th) have done better. The country with the greatest progress was Brazil, where the rate of oral tobacco use is very low and e-cigarettes are not legal for sale.  



Twice as many Swedes use tobacco-industry nicotine products as do Canadians 

There are 4 main categories of nicotine products sold by tobacco companies:  cigarettes and cigarette tobacco, electronic cigarettes/vaping products, heated tobacco products and nicotine pouches. 

There are currently  no global databases with information on the overall use of nicotine through these products, but national surveys can be used for this purpose. 

Results from these two surveys show similar rates for past month use of cigarettes (12% in Sweden, 11% in Canada), and not very different rates for vaping (4% in Sweden to 6% in Canada). One in 5 Swedes used either snus or non-tobacco nicotine pouches (20%) compared with fewer than 1% of Canadians. Because of snus use, twice as many Swedes use nicotine as do Canadians (30% vs. 15%).

(A data sheet with the information presented below as well as for men and women can be downloaded here).

Lung cancer rates among men are lower in Sweden than in Canada, but the situation for other major tobacco-related diseases is no better.

The World Health Organization provides information on the number and rate of deaths from specific diseases, and also provides data files which make age-adjustments to this data to allow for comparison between countries. 

Using only countries for which WHO signals the data is robust enough for comparison, Sweden is in the second-best quintile for overall deaths from lung cancer and Canada is in the worst. 

For lung cancer rates among men, Sweden is in the second-best quintile for men, but in the second-worst for women. Canada is in the middle quintile for men but the worst for women. 

The 20 countries for which comparable data is available and which have lower age-standardized lung-cancer rates than Sweden for the whole population are (in decreasing order):  Jamaica,  Venezuela, Kyrgyzstan, Philippines, Brazil, Chile, Trinidad-Tobacco, Belize, Grenada, Mauritius, Colombia, Saint Lucia, Barbados, Kuwait, Panama, Mexico, Antigua-Barbuda, Nicaragua, St Vincent and the Grenadines and Costa Rica.

(A data sheet with lung cancer rates extracted from WHO's files can be downloaded here). 

For deaths from other major tobacco-related diseases (e.g. Ischaemic Heart Disease and COPD), Sweden does worse or not much better than Canada. 

The same age-standardized World Health Organization data allow for comparisons with the number of deaths from other tobacco-caused diseases in Sweden and other countries.

With respect to heart disease, Swedish men and women both experience higher death rates than in Canada. In 2019, there were an estimated 6 more deaths from heart disease in Sweden for every 100,000 people than there were in Canada. For Chronic Obstructive Pulmonary Disease, Canada's rates for men are slightly higher than those for Sweden, and those for women are slightly lower: overall Canada had one more death from COPD for 100,000 people than Sweden. Public health agencies in Sweden have also pointed out that tobacco mortality in Sweden is not the lowest in Europe.

The data shown below is available on a downloadable data sheet; Data visualizations are available on Our World in Data. 


Tobacco-related deaths have fallen faster in Canada than in Sweden


Their estimates for Canada and Sweden (downloadable here) show similar results: 1 in 5.6 deaths in Canada is due tobacco, compared with 1 in 6.6 deaths in Sweden. When comparing progress in age-standardized deaths from tobacco between 1990 and 2021, Canada was in a somewhat better condition than Sweden:  the overall rate of deaths from tobacco-caused deaths fell by 15.6% in Canada, compared with 12.3% in Sweden. 
 

Sweden's lower lung cancer rates are rooted in lower tobacco use in the 20th century - not today's nicotine pouches


Lung cancer can occur many decades after tobacco use, and current lung-cancer rates are an indicator of tobacco use in previous periods. One likely reason that Sweden has lower rates of lung cancer now than Canada does is because much less tobacco was smoked in the last century.

Reports on historic tobacco sales produced by PN Lee and colleagues show that over the past century per capita tobacco sales (including cigarettes, cigars, pipe and snus) remained constant in Sweden. By contrasts, per capita consumption in Canada rose dramatically in the middle of the past century (to more than double the rate in Sweden) before falling.

Grams of tobacco consumed per day per adult.
From P.N. Lee, International Smoking Statistics
for Sweden and Canada 


In living memory, most of the tobacco consumed in Canada has been in the form of manufactured or roll-your-own cigarettes. By contrast, snus has been the predominant product in Sweden for 30 years. 


There are many reasons other than the presence of snus that may explain why cigarette smoking never emerged with the ferocity in Sweden as it did in Canada and other European countries. Among these are differing experiences with returning soldiers (Sweden was a neutral country during World War Two), control of the tobacco market by a government-owned company,  and the absence of television advertising in Sweden. Although Sweden is not now looked on as a leader in tobacco control, during the 1970s and 1980s it pioneered several tobacco control measures, including advertising restrictions (1979) and rotating health warnings (1987). 









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.

(A subsequent post by Stan Glantz with additional concerns can be read here.)

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.