Why prescription status is the best short-term option to manage nicotine pouches in Canada.

A month has now passed since Health Minister Mark Holland expressed his frustrations with the marketing of British American Tobacco (Imperial Tobacco Canada) Zonnic nicotine pouches. 

"I'm mad. I think it is wholly inappropriate," the Minister told CBC reporter Marina von Stackelberg on November 28th. "I am frustrated that yet once again we have to go back and adjust our regulations because the tobacco industry has found some Machiavellian clever way to skirt regulation and try to addict new people.... We are looking at what actions we can take and to take those actions quickly. We want to shut down this loophole."

This post provides a recap of events to date and looks at the actions available to the Minister and Health Canada to "shut down" the loophole that allowed the current marketing of Zonnic-brand nicotine pouches. A subsequent post will report on ways in which other governments are addressing the health risks of these products.

The story so far: Zonnic nicotine pouches in Canada

Zonnic nicotine pouches are manufactured by British American Tobacco (BAT) and distributed in Canada by its subsidiary Imperial Tobacco Canada. They are the same as the 4mg version of the company's Velo-brand nicotine pouches sold in other countries.

Canadian tobacco control laws do not currently allow the sale of nicotine pouches. BAT was able to overcome this barrier by applying for and receiving authority from Health Canada to sell them as a smoking cessation and craving-control medication. This permission was given in late July 2023, shortly before the Hon. Mark Holland was appointed health minister. They are regulated as a Natural Health Product, subject to the same rules as homeopathic medicines, supplements and herbal remedies. More background can be read here.

Imperial Tobacco began shipping these pouches to retailers in October with supportive digital and retail advertising campaigns. The first observed sales in Ottawa were the week of October 9th. 

Soon after the products appeared for sale, health agencies raised concerns about the risks they posed to children and young adults who could be induced to experiment with this addictive drug. Of particular concern was the absence of federal or provincial laws which prohibited selling these pouches to children.

In November, the groups called on the Minister of Health to put these products under prescription control until better controls were in place. The Minister's response - cited above - followed those appeals and was echoed by opposition health critics. 

The problems created by the changes to the Prescription Drug List in 2018.

Health Canada created a loophole for nicotine novelties when it amended the nicotine qualifiers on the Prescription Drug List in 2018.

In Canada, nicotine that is found in tobacco products or vaping products is regulated by the Tobacco and Vaping Products Act. For these categories of products, manufacturers do not need to permission to sell these products -- or even to notify the government before they put them on the market.

Any other kinds of nicotine products are regulated by the federal Food and Drug Act). In these cases, the government must give specific approval to each product before it can be marketed. By default, such products can only be sold under prescription, but there are 5 conditions which allow them to be authorized as natural health products. 

This list of exemptions was last modified in 2018 when vaping products were legalized in Canada. The language used to describe nicotine inhalers was modified to avoid ambiguity about the status of electronic cigarettes. As shown below, the new wording provided a vague exemption for products "in a form to be administered into the oral cavity by means of a non-active device (one that operates on energy generated by the human body or by gravity) that delivers 4 milligrams or less of nicotine per dose for buccal absorption.” 

This wording also allows oral nicotine products that were not marketed in Canada -- or even those that were not yet invented -- to be authorized as medicines. Even if these are manufactured by tobacco and vaping product companies, once approved as a natural health product they can be marketed without the constraints that are placed on these companies other goods -- advertising restrictions, age limits, taxes, reporting requirements, licensed retailers, etc. This is the loophole that needs to be closed.

The Options available to Minister Holland to "close the loophole"

The best short-term action:
Making nicotine pouches a prescription product.

By restoring the qualifier to the Prescription Drug List to its pre-2018 meaning, Minister Holland can put new nicotine products under prescription controls. 

The "d" category of the exemption list could be reworded from: ... "a non-active device (one that operates on energy generated by the human body or by gravity) that delivers 4 mg of less of nicotine per dose for buccal absorption" ... To:  "a form to be administered orally by means of an inhalation device which operates on energy generated by the human body or gravity delivering 4 mg or less of nicotine per dosage unit."

This minor wording adjustment could allow Zonnic to remain on the market but would require a doctor or to prescribe it (provincial governments could allow pharmacist prescriptions). It would take the products off the counters of convenience stores, and would place additional constraints on marketing. Direct-to-consumer advertising for prescription drugs is not banned in Canada, but faces higher constraints than other medications.

This approach would be similar to the one adopted in Australia with respect to vaping products. Although the Australian health department does not formally authorize electronic cigarettes or test them for safety or efficacy, it does restrict access to prescription basis.

The Food and Drug Act, section 29, gives the Minister clear authority to decide which drugs are placed on the Prescription Drug List. The Food and Drug Regulations, section C.01.040.3, list the factors that the Minister must consider in doing so. These include identifying whether practitioner oversight is necessary to monitor the use of the drug and whether the use of the drug can cause "a risk to public health which can be mitigated by a practitioner's supervision."

Putting nicotine pouches under prescription management will allow an assessment of what role these products should play in the management of nicotine addiction. This is consistent with the historic treatment of pharmaceutical NRT products, which were sold by prescription before they were allowed for sale over the counter.  Nicotine Gum was first approved for sale in Canada in 1979 as a prescription medication and only after 1992 did the 2mg dosage not require a prescription. The 4 mg gum was under prescription until 1997. The nicotine patch was sold as a prescription drug in Canada between 1992 and 1998, when it became available over-the-counter.

The less-good short-term action: 
Enforcing the Natural Health Product Regulations

If Health Canada tries to crack down on Imperial Tobacco using regulations designed for vitamin pill companies, it will soon find that this toothpaste will not easily go back in the tube.  The enforcement approach is too slow and too unwieldy, and does not address the structural problems within the regulations.

The Natural Health Product Regulations (s. 17 to 19) give the Minister the power to instruct a manufacturer to stop selling a product, and also the power to suspend a license -- BUT there are very narrow conditions under which this can be done. These conditions include problematic packaging and labelling, but do not include unintended use or impact on public health. 

Health Canada's internal rules for enforcing these regulations as laid out in a compliance and enforcement policy are not well designed for dealing with tobacco companies. The policy is based on principles which include to "work collaboratively with regulated parties ... to achieve compliance and to mitigate risks."  

Other departmental rules also weigh down immediate action. The framework to risk management gives little encouragement for "precautionary approaches" and generally directs officials to find evidence of harm before the department intervenes in the market. Addiction is not one of the risks identified in this operational manual. 

These operating rules will make it harder for the Minister to "take actions quickly" or "close the loophole".

They do, however, allow the department to put pressure on Imperial Tobacco to change its marketing, and there are signs that these communications are taking place. Imperial Tobacco has now modified its Zonnic.ca website, reducing the lifestyle imagery and animations on it. It is reasonable to speculate that changes to labelling have been requested, following reports from retailers that they have ceased receiving shipments of the product and have been told that the company is "fixing a problem before bringing it back." 

Imperial Tobacco has toned down
but not stopped showing lifestyle
promotions on its revised Zonnic.ca website 

Meanwhile, Imperial Tobacco has increased the youth-facing advertisements in thousands of convenience stores across Canada. 

Circle K promotions for Zonnic behind the cash
register are visible to all customers 

Fundamentally, the Natural Health Product Regulations are the wrong tool for the job. They lack the provisions necessary to protect children from experimenting with nicotine. They do not ban sales to  youth, they do not ban advertising.  Re-writing these regulations to make them strong enough to protect children will take months or years.

The necessary short-term fix and long-term plan: 
Tweak the Tobacco and Vaping Products Act (TVPA) and prepare for a new Nicotine Control Act. 

Canada's tobacco laws lag behind the marketing ingenuity of tobacco companies. Nicotine pouches are not the only nicotine innovation the companies have started selling since the law was last amended in 2018. Others on the horizon are products such as heated nicotine sticks (e.g. Philip Morris' Levia and BAT's VEO), and hybrid heated tobacco/vaping devices (e.g. Philip Morris lil HYBRID). Start-up companies have recently launched other novelties, such as newly-patented sublingual nicotine pearls

Nicopop patent  was filed
in Canada in 2020

In many cases these products do not fit comfortably under a law that was designed with cigarettes, pipe tobacco, chewing tobacco and vaping products in mind. Although Health Canada adopted “harm reduction” language in 2018, no formal strategy (and no legislative basis) has accompanied this change. There is no federal legislative or programmatic objective with respect to vaping or other forms of nicotine use by individuals over 18 years of age. In short, Health Canada has no parliamentary direction on how it should manage the market for new nicotine products.

As discussed here earlier, Health Canada is currently engaged in a review of the administration of this law, and is required by table a report on this legislative review by May 23, 2024. Ideally, this report will include proposals for substantial revisions to the law and expand it to address all tobacco- and nicotine-industry products.

In the meantime, however, the law can be adjusted to meet short-term needs to put Zonnic and other similar products under appropriate controls. 

Relatively minor adjustments could be made to the law to ensure that some important protective measures are put in place. These include banning the non-prescription sale of any nicotine product to a minor, banning advertisements in places where young people have access, requiring regular reporting on marketing activities and health warning labels. 

One way or another, this issue will likely end up in court

Health Canada is no stranger to lawsuits filed by tobacco companies and other regulated industries. Each of the paths identified above carries the likelihood of being challenged in court by Imperial Tobacco and possibly requiring the government to expose its policy response to outside scrutiny. 

Imperial Tobacco may claim that putting Zonnic under prescription status is a regulatory taking, and seek compensation under investment or trade agreements. It may go to Federal Court to challenge enforcement actions or other administrative decisions of the department. 

Failing to address the nicotine pouch loophole will, however, expose the department to litigation by other stakeholders. Imperial Tobacco was only one of many companies seeking permission to sell nicotine pouches, and a refusal to issue further licenses can also be challenged in court. (A timely and relevant example is the department's experience defnding its decision to deny authorization to the Resolve stop smoking aid). 

Some legal battles need to be fought. 

The World Health Organization's Call to Action on E-cigarettes

Today the World Health Organization issued a press release calling on governments to take "strong decisive action" to protect children from the uptake of e-cigarettes. The release was accompanied by a "Call to Action" with specific recommendations and a readable Technical Note providing background on these recommendations.

WHO's statement today is consistent with the concerns it has previously raised about the threat to public health raised by permissive marketing of these addictive products. WHO reminds governments that "The tobacco industry profits from destroying health and is using these newer products to get a seat at the policy-making table" and that it "funds and promotes false evidence to argue that these products reduce harm."

WHO's review of the evidence does not lead it to believe that e-cigarettes when sold as consumer products are effective as cessation support. Instead, the health authority advises "Cessation strategies should be based on the best available evidence of efficacy, to go with other tobacco control measures and subject to monitoring and evaluation. Based on the current evidence, it is not recommended that governments permit sale of e-cigarettes as consumer products in pursuit of a cessation objective."

For governments -- like that in Canada, the United Kingdom and New Zealand - which encourage the use of e-cigarettes as a cessation strategy, WHO recommends that the market be strongly regulated to protect the unintended use of e-cigarettes by children: "Any government pursuing a smoking cessation strategy using e-cigarettes should control the conditions under which the products are accessed to ensure appropriate clinical conditions and regulate the products as medicines (including requiring marketing authorization as medicines). The decision to pursue a smoking cessation objective, even in such a controlled form, should be made only after considering national circumstances, along with the risk of uptake and after exhausting other proven cessation strategies."

Among the Eight recommendations for e-cigarette regulation identified in WHO's Call to Action, only one is currently in place in Canada.

The recommendation currently in place across Canada is:

– Limiting the concentration and quantity of nicotine, to reduce the risk of dependence

The recommended regulations that have not been adopted by Health Canada are:

– Banning all flavouring agents, including menthol and synthetic menthol analogues
– Prohibiting attractive and/or promotional features related to the presentation and packaging of the products, such as colours or colouring properties, attractive descriptors, including names
– Regulating features that enable the user to manipulate the product, post-sale
– Setting a maximum volume for e-cigarette cartridges, to limit toxicants exposure and use
– Setting a maximum battery power, to limit the influence of power on nicotine and toxicant delivery
– Prohibiting device features that permit transmission of information to and from third parties (including manufacturers), such as connections to smartphone apps, that could be used to collect personal information, details of use topography, or to remotely control the product
– Prohibiting additives that have carcinogenic, mutagenic and reprotoxic properties.

Three important regulations have dropped from view

Health Canada's lack of progress in restricting flavours in e-cigarettes has been much discussed., but there are two other regulatory reforms that have also dropped from view. These are

Access Regulations (Age Verification for Online/Distance Sales). These regulations to require more than a box-tick to access on-line sales were identified on the Forward Regulatory Plan almost three years ago (February 2021), but no apparent action has been taken on them since.

Vaping Products Promotion Regulations (Package and Design Features). This regulation was intended to "place certain limits on what promotional elements can appear on vaping product packages. They would also impose restrictions on design features that are appealing to youth to prevent their use in the manufacture of vaping products." It was identified in the Forward Regulatory Plan in early 2021, but dropped in the revision to the list the following year.

Australia's new tobacco law and what Canada can learn from it

 Last week both houses of Australia's Parliament gave approval to an updated tobacco law. The Public Health (Tobacco and Other Products) Bill 2023 was introduced in mid-September 2023, and was approved by both the lower and upper chambers on December 7th. 

Australia has long been considered a fore-runner of tobacco regulation. In modernizing its tobacco law, it has set an example for countries (including Canada!) on raising the bar for health protection. This post identifies 5 measures adopted in Australia that Canadian governments might want to copy.

1) A modernized and broad purpose.

The new Australian law has 3 objectives and identifies 12 means of obtaining them. 

The objectives are (1) to improve public health by discouraging smoking and the use of regulated tobacco items, and encouraging people to give up smoking and to stop using regulated tobacco items; (2) to give effect to certain obligations that Australia has as a party to the WHO FCTC; and (3) to address public health risks posed by vaping and e-cigarette products. The 13 means include discouraging people who have given up smoking or vaping from relapsing, preventing and reducing nicotine addiction, reducing exposure to second hand smoke, reducing environmental risks of tobacco products, limiting innovations by tobacco manufacturers and increasing public knowledge about the tobacco industry.  

By contrast, the purpose of the Canadian Tobacco and Vaping Products Act is vague and the specific objectives (similar to the 'means' in Australia) are narrow. The overall purpose of the law is "to provide a legislative response to a national public health problem of substantial and pressing concern and to protect the health of Canadians in light of conclusive evidence implicating tobacco use in the incidence of numerous debilitating and fatal diseases."  The four specific objectives are removing inducements to initiate use, restricting access to young people, preventing misleading or deceptive messaging, and enhancing knowledge of health risks. These objectives were drafted in the mid-1980s (and mapped onto vaping products in 2018), but have not been substantially revisited in 35 years. 

Adopting a broader scope, as Australia has done, would permit warnings about environmental damage, and would give Health Canada cover for more ambitious programming. Until then, there is no statutory obligation for the department to actually prevent youth uptake, or to facilitate or achieve cessation, and no mandate to reduce addiction to nicotine. Without legislation to back it up, the goal of "less than 5% by 2035" is more of a campaign slogan than an accountability framework. 

Australia's example is particularly relevant to Canada given the recent introduction of a cost-recovery system for tobacco regulation. The legislation which proposes this regulatory charge limits the use of these funds to those "in relation to the carrying out of the purpose of this Act, including regulations." If a purpose similar to that of Australia's were in place, tobacco companies could be assessed for the costs of media campaigns to encourage quitting, for research, for environmental clean-up.

2) A belt and suspenders approach to regulating nicotine 

In Australia, vaping products are not permitted as consumer goods, although they are available as prescription cessation aids for smokers. Their Therapeutic Goods Administration regulates the supply of electronic cigarettes through a system that does not require the same type of review and approval or licensing that is applied to some other medications. 

In the revisions to its tobacco law, Australia's health regulators recognized that the drug-regulatory system permitted more advertising than was appropriate for e-cigarettes. As the legislative proposal explained: "In order to limit the risk of e-cigarette products becoming a gateway into smoking, and to address the health risks of vaping, this Act includes similar prohibitions [for advertising and sponsorships] in relation to e-cigarette products." 

If Canada followed Australia's example, restrictions on marketing of nicotine pouches or e-cigarettes could be imposed (including minimum age for sale) independent of their authorization as cessation products. This would, for example, address many of the concerns with Zonnic. 

3) Accelerated work on regulations

In Canada, the Tobacco and Vaping Products Act was before Parliament for 18 months before it was adopted in May 2018. Despite this long gestation, very few regulations under the act were ready to be put in place when the law was proclaimed. It took more than a year for warnings on vaping products to be regulated (December 2019) and two years before promotional restrictions on vaping products were in place (July 2020). A maximum level of nicotine in vaping liquids was not imposed for three years after the law was changed (June 2021), and basic reporting requirements on vaping manufacturers were not finalized for 5 years (June 2023). 

Australia has avoided some of these delays by releasing draft regulations for consultation only days after its new law was passed by parliament and before it is in force. 

4) Greater transparency and protection from tobacco industry interference

Australia is among the many countries which have included proactive disclosure of regulatory submissions part of their transparency initiative, enhancing this principle by invoking Article 5.3 of the Framework Convention on Tobacco Control. 

Submission made to government during the consultation process on new regulations will generally be made public proactively (with exceptions for those submissions considered to "contain offensive or defamatory comments").

Unlike Canada, the Australian government considers that its obligation to protect public health from tobacco industry interference  "also extends to the e-cigarette industry." It will impose a conflict of interest screen on submissions from those associated with either. "Written submissions received from individuals or organisations associated with the tobacco or e-cigarette industry will be deemed to have a conflict of interest (whether actual or perceived)."

 

5) Stronger controls on product names

Australia has introduced new restrictions on the words that can be used by tobacco manufacturers. No longer will they be able to use words that suggest reduced harm or other positive qualities, use the names of colours or filter terms, or use terms like "additive-free."

Australia 
Public Health (Tobacco and Other Products) Bill 2023

Canada also imposes restrictions on brand names. In 2011 the terms "light" and "mild" were prohibited and in 2019 as part of plain packaging regulations a ban was placed on brand names that "evoke a colour or a characteristic of a filter."   Terms that imply positive health effects - like "organic" - and terms which convoke positive qualities - like "smooth", are still permitted. 

Australia's new law provides an example of an approach which anticipates new marketing tactics and implements preventive measures against them.

The Hon. Mark Holland on Zonnic (And an update on developments elsewhere)

This post provides updates on recent developments in tobacco control in Canada and elsewhere.

Minister Holland expresses anger over the marketing of Zonnic.

Parliament was not sitting last week, when health groups called on Minister of Health Mark Holland to suspend the sale of Zonnic, the nicotine pouch authorized by his department this summer as a smoking-cessation aid.

With the House back in session, journalists were able to question the Minister about his response. The full scrum is available on CPAC (starting at 54:32) -- with some highlights from Minister Holland's comments pasted below.

Well, first of all, I am appalled by the actions of the tobacco industry. Yet again they have tried to seek a loophole to find a new way to peddle nicotine.

It is very clear in my view that there are very serious questions about what the tobacco industry is doing here and what their intention is. It would seem that their intention is to addict new young people to nicotine - which is disgusting. I think that we have to take this seriously and are.

I'm mad. I think it is wholly inappropriate. I am frustrated that yet once again we have to go back and adjust our regulations because the tobacco industry has found some Machiavellian clever way to skirt regulation and try to addict new people.

We are looking at what actions we can take and to take those actions quickly. We want to shut down this loophole.

We are going to have to review our processes. I don't want anything going out there that is going to target new users and particularly young people. We are going to have to take a rigorous look at our processes.

The way that this [product] was presented was that it was for the purposes of cessation. We were duped.

The true intent appears to have been concealed. Obviously if we knew their intention, we would never have allowed the product.

The fact that we could have allowed this to get across the line and not seen this eventuality and not seen what they are going to do, I am deeply apologetic for. I do not want this out in the world and we are going to do everything we can to remediate it.

Minister Holland responds to questions about Zonnic
(54:32 - 103:40)

Updates on smoking behaviours from the Canadian Community Health Survey 2022

This post provides information on data collected by the Canadian Community Health Survey (CCHS) during 2022. The 5 figures presented below use data made public on Statistics Canada web-site (Health Characteristics annual estimates), Health Canada's website and the Data Dictionary for the survey which was provided to us by Statistics Canada. A downloadable data sheet  which relates to some of the figures is available.

Background: Canada's national surveys on smoking behaviour

With 65,300 participants, the Canadian Community Health Survey is the largest health survey in Canada, but it is not the only one. 

The Canadian Community Health Survey has been conducted for over 20 years, although several changes have been made over those years. The questions on smoking behaviour were redrafted in 2022 and questions on vaping behaviour were added. Major changes to the way information is collected were made in 2015 (when in-person interviews were reduced), in 2020 (when they were abandoned) and in 2022 (when on-line interviews were added to telephone interviews). As reported here earlier, the method by which data is collected seems connected to peoples' willingness to self-identify as a smoker: people who responded face-to-face were more likely to say they smoked. 

On behalf of Health Canada, since late 2019 Statistics Canada also conducts the Canadian Tobacco and Nicotine Survey, (CTNS) which now also includes questions on cannabis and alcohol use. 12,100 Canadians participated in that survey in 2022, and data from that wave were released by Health Canada this past September. The CTNS was preceded by the Canadian Tobacco Use Monitoring Survey (CTUMS, 1999-2012) and the Canadian Tobacco Alcohol and Drug Survey (2013-2017).  The CTNS collects information on-line, and the previous surveys used telephone interviews.

Figure 1: the gaps between survey estimates are closing

For many years there was a sizeable gap in the estimates of smoking rates produced by the CCHS and CTUMS/CTADS, with the larger survey identifying a million more smokers than the smaller telephone surveys. 

There was very little difference in the estimates for 2022. The CTNS collected in winter 2022-23 found 10.9% of Canadians over 15 years of age smoked daily or on occasion (10.9%), close to the CCHS estimate of 11.6% for Canadians over 12 years of age. 

There was also no difference in the estimates of past-month vaping use between both surveys. Both estimated past-month e-cigarette use at 5.8%. 

Figure 2 : More provincial variation in smoking rates than in vaping rates

With five times as many Canadians participating, the CCHS is better able to provide comparisons of substance use among Canada's smaller provinces than is the smaller CTNS. 

As tested by Statistics Canada, smoking rates are statistically higher than the rest of the country in Newfoundland, Nova Scotia, Saskatchewan and lower in Ontario and British Columbia. Vaping rates are statistically higher in Alberta and lower in Ontario. 

Figures 3a and 3b: Prevention can take the credit for driving smoking rates down.

From 2001 to 2022, the CCHS survey population grew by 7.2 million, the number of smokers fell by 2.8 million, the number of former smokers grew by 1.14 million,  (to on to 33 million), the number of experimenters grew by 0.7 million and the number of Canadians who reported they had never smoked a whole cigarette grew by 8.6 million.

The population growth in Canada during that period reflects the net impact of 1.8 million births, 1.5 million deaths, the net arrival of 1.6 million immigrants and 0.6 million non-permanent residents and the net departure of 0.16 million emigrants. 

The survey results suggest the key role that population turnover is playing in estimates of smoking prevalence. Since 2018, there was a decline both in the number of smokers and the number of former smokers, with a growth in lifetime abstainers that was more than twice as large as the loss of ever smokers.

Figure 4: Cannabis now rivals tobacco for number of users

When considering the total population, the CCHS estimates that many more Canadians have used cannabis in the past month than have smoked cigarettes (4.6 million vs. 3.8 million), with a somewhat smaller difference reported by the CTNS (3.4 million vs. 2.6 million). 

When it comes to daily use, however, cigarettes are more commonly used than cannabis (3 million vs. 2 million Canadians) or vaping (3 million vs. 1 million Canadians).

 

Figure 5: January is a key month for quitting.

In previous years, the CCHS only asked recent quitters about the month in which they quit smoking. In 2022 the information was asked of all former smokers. 

January was most frequently cited as the month in which a smoker quit (19%) followed by June (11%) and September (9%).

The urgent need for a new nicotine regulatory framework

 

Today (November 17th) is the deadline for contributions to Health Canada's legislative review of the federal tobacco law. The Minister is required by law to table a biennial report on the “provisions and operations” of the law no later than May 23, 2024.

This post reports on the key recommendations contained in the PSC response to the discussion paper. Our submission includes 49 additional recommendations aligned with their 19 consultation questions.

Key Recommendation A:

Health Canada should seize this opportunity to modernize its tobacco/nicotine strategy

• The Canadian federal approach to the tobacco industry reflects a 20th century focus on reducing consumer demand for cigarettes, particularly among young people. The objectives of the federal tobacco law (which were mapped onto vaping products in 2018) have not been revisited in 35 years.

• Although Health Canada has adopted the goal of reducing tobacco use to “under 5% prevalence by 2035” this objective is not legislated, and is not supported by an accountability framework for government or industry.

• Although Health Canada adopted “harm reduction” language in 2018, no formal strategy (and no legislative basis) has accompanied this change. There is no federal legislative or programmatic objective with respect to vaping or other forms of nicotine use by individuals over 18 years of age.

• In recent years the tobacco industry has re-invented its marketing strategies and is expanding its range of nicotine products (e.g., heat-not-burn, nicotine pouches, hybrid products) and other psycho-active products (e.g. CBD, functional food and beverages).There is currently no federal programmatic or legislative response to these market developments.

• 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.

This Hallowe'en, Quebec kids get better protection from candy-flavoured nicotine.

Flavoured and Toy-shaped
vapes are now illegal in Quebec,
although they remain offered
for sale on e-stores.

On October 31, 2023 new measures to restrict e-cigarette sales come into effect in Quebec. On this day the revisions to the province's Regulation under the Tobacco Control Act come into force - ninety days after they were published in the province's Gazette.  

From this day on, e-cigarettes are included under the law's prohibition on the sale (s. 29.2) of "a tobacco product that has a flavour or aroma other than that of tobacco, including a menthol, fruit, chocolate, vanilla, honey, candy or cocoa flavour or aroma, or whose packaging suggests it is such a product." (The Quebec law includes e-cigarettes in the definition of tobacco product, but had exempted them from this provision until the regulatory change this year).

Quebec's new regulation also sets new labelling requirements for e-cigarette packaging and:

• prohibits the sale of disposable or capsule products with more than 2 ml of liquid (30 ml for refill containers)
• prohibits the sale of devices that resemble toys or for which the use can be concealed.

This post looks at the challenges for Quebec and other provinces to protect young people from flavours and other youth-oriented marketing without the support from the federal government.

In the absence of federal measures, six Canadian provinces have banned vaping flavours 

As of today, six eastern Canadian jurisdictions have banned all flavours in e-cigarettes. In order of implementation, they are Nova Scotia (April 2020), Prince Edward Island (March 2021), New Brunswick (Sept 2021), Northwest Territories (March 2022), Nunavut (May 2023) and Quebec (October 2023). 

These provinces join six other countries (Finland, Hungary, Netherlands, Ukraine, Lithuania, China) and five U.S. states (Massachussets, New Jersey, New York, Rhode Island and California) which have also banned all flavours other than tobacco. Australia has banned flavourings in its prescription-based system for e-cigarettes and many other countries (shown in black in the figure below) ban all e-cigarettes.

Three other Canadian provinces have adopted regulations to restrict the sale of flavoured vaping liquids to specialty vape shops where children are not permitted to enter. British Columbia (September 2021), Ontario (July 2020) and Saskatchewan (September 2021). Ontario and Saskatchewan also allow menthol and mint to be sold outside of these specialty shops.

But the federal government has stalled at the starting gate.

Federal regulation currently prohibits the use of some non-flavouring ingredients in vaping liquids, and does not allow for labels to suggest that the aerosols taste like confectionary, deserts, soft drinks, energy drinks or cannabis. 

In May 2021, Health Canada initiated regulations to restrict vaping flavours, but has not moved forward on these since then. The government will neither confirm nor deny that the proposal has been suspended. 

Questions raised in parliament this fall received the same non-response that had been given in the spring. When Senator Judith Seidman asked earlier this month "When does the federal government plan to ban flavours in vaping products?" - the response from the government representative was a telling "I do not know, and I am not in a position to predict what the government’s plan is." 

The Prime Ministers' office has not endorsed the measure.

In 2019, Prime Minister Trudeau directed incoming Health Minister Patty Hajdu to "address the rapid rise in youth vaping. This should start with regulations to reduce the promotion and appeal of vaping products to young people and public education to create awareness of health risks. You are encouraged to explore additional measures." It was under Minister Hajdu that draft regulations to restrict flavours were formally published in June 2021.

This minister was not reappointed to the  health portfolio after the 2021 general election. A new cabinet position was created, under which tobacco regulation was placed. In his instructions to the inaugural Minister of Mental Health and Addictions, the Prime Minister's mandate letter contained no reference to the flavour restrictions that had been proposed only six months earlier.

New mandate letters have not been issued since the July 2023 cabinet shuffle. The newly-appointed Minister of Addictions and Mental Health (Ya'ara Saks) has not said anything about flavours in her new role. There are indications that she has not yet discussed this topic with departmental staff.

A national approach is needed to make provincial laws enforceable.

Provincial governments which have banned flavours are limited in their ability to control the import of products from web-sites which operate from other provinces, and are not able to lay charges against businesses which ship flavoured products across provincial borders. (Some vape stores located in these provinces also continue to offer illegal flavours, without apparent provincial capacity to shut these sales down).

Without effective enforcement, provincial governments have not been able to fully protect children from these products being available. This is reflected in the results of the 2021-2022 Canadian Student Tobacco, Alcohol and Drug Survey (currently pulled off of Health Canada's website), which show continued use of flavours by youth in the  three provinces where flavour bans were in place at the time of the survey. 

Tobacco companies are assisting the informal market and social sources through which young people acquire flavoured vaping products. They offer deep discounts for volume sales, allowing an individual to purchase products at a wholesale price. Philip Morris on-line stores sells the disposable Veev-Now for $11 each, but cuts the price to only $6 per unit when purchased in quantities of 9 or more, and occasionally offers even deeper discounts. This rewards re-sellers who wish to import products into markets where flavoured products are not legal for sale.

By reducing the price of VEEV-NOW to $6 from $11,
PMI creates an incentive for re-sellers.

National health recommendations are being ignored.

Almost four years have elapsed since Canada's provincial and federal chief medical officers of health recommended that governments "Ban all flavoured vaping products and then provide regulatory exemptions or market authorizations for a minimum set of flavours to support smokers who choose to use vaping to end or reduce their use of nicotine-containing products."

Canada's major health organizations have all called for a ban on flavours - as have their international counterparts. (A list or such organizations is available here). 

Six of Canada's fourteen jurisdictions have taken steps towards implementing that recommendation -- but their efforts are being undermined by the failure of other governments to do so. National action -- preferably headed by the federal government -- is needed.

Trends in overall nicotine use in Canada.

For many decades, health regulators have focused on cigarette smoking as their indicator of tobacco and nicotine use. Around the world, statistical agencies ask variations of the questions "do you smoke cigarettes?" "when did you start smoking cigarettes?" "how many cigarettes do you smoke?" and use the answers to assess the success or failure of their tobacco control efforts.

This same approach has been grafted onto monitoring of vaping behaviour. Soon after these products appeared on the market (and long before they were legalized for sale), Health Canada included questions on e-cigarette use on its tobacco surveys. 

Information on the use of many other nicotine products - like cigarillos, cigars, chewing tobacco/snuff, pipes and waterpipes - is also collected in Canada. For some other products - notably heated tobacco sticks - there is still no monitoring instrument in effect.

This post (and the accompanying data sheet) use data from recent tobacco surveys to show how including information on any form of tobacco or nicotine use provides additional insights on the health behaviour of Canadians.

Measuring the use of any nicotine product in Canada.

Over the past decade, the Canadian Tobacco, Alcohol and Drug Survey (2013, 2015 and 2017) and its replacement, the Canadian Tobacco and Nicotine Survey (annually in the late winters of 2019, 2020, 2021 and 2022) have produced estimates of the number of Canadians who report past-month use of 7 categories of nicotine products: cigarettes, little cigars, cigars, traditional pipe, oral tobacco/snuff, water-pipe, and electronic cigarettes. In addition to the tables provided on government web-sites, the survey results are also available in Public Use Microdata Files (PUMF).

These PUMF files allow the identification of survey respondents who reported using any of the 7 products identified above during the month before they were surveyed. (It also identifies those who use pharmaceutical nicotine, such as patches or gum and those who used tobacco when they were smoking cannabis, but these were not included in the results shown below).

The survey is not currently constructed to establish a measure of how many people use a nicotine-bearing product every day, although they do ask about daily use of cigarettes, e-cigarettes and some other products. Someone who uses either e-cigarettes or traditional cigarettes every day but who does not use either product on each day could not be identified as a "daily" user from the survey as it is now designed.

Ten years of changed nicotine use, but not much progress against it.

The number of Canadians using nicotine is as high in 2023 as it was in 2013. A decade ago, 5.18 million Canadians reported that the used either cigarettes, other tobacco products or vaping products in the past month. In 2023, the estimate was slightly higher (5.22 million Canadians). 

Overall patterns of use have changed.  In 2013, four in five (82%) of nicotine users reported using cigarettes, but this past winter only two-thirds did (67%). (In both cases, they may also have used other products). The number of nicotine users who were identified as never smokers (they had smoked fewer than 100 cigarettes in their lifetime) more than doubled - from 478,800 to 1,001,100 Canadians. 

(click to enlarge, or download data sheet)

Young people make up the same proportion of nicotine users today as they did a decade ago. In 2013, about 1 in 5 nicotine users (18%) was under 25 years of age. In 2023 the proportion was almost the same (17%).

(click to enlarge, or download data sheet)

Because of population growth, there has been a slight decrease in the percentage of Canadians who use nicotine.  The prevalence of Canadians using nicotine products in the past month dropped from 18% in 2013 to 16% in 2023. (No statistical test has been performed on these estimates).

• The lowest estimates in the number and percentage of Canadians using any nicotine product coincided with the first winter of COVID (December 2020 to January 2021).
• Many more men than women used these nicotine products in 2013 (21% vs 15%), and the gender gap remained a decade later (20% vs 13%).
• The decrease in cigarette use in younger age groups has been largely offsets by increased use of other nicotine products. 
• In comparison with 2013, there was a small drop in the percentage of teenagers (aged 15 to 19) who used nicotine in 2023 (15% in 2023 vs 17% in 2023) 
• Roughly one-quarter of young adults (aged 20 to 24) used in nicotine in 2013 (24%), as do their younger cousins a decade later (24% in 2023). 

(click to enlarge, or download data sheet)

Implications for public health

Tobacco companies are steadily expanding the range of nicotine products they market. Over the past month alone, BAT began selling tobacco-less nicotine pouches in convenience stores in all provinces but Quebec. In other countries both BAT and Philip Morris have launched tobacco-less nicotine sticks intended for use in their heated tobacco devices.  

Using cigarette smoking as a measure of tobacco use is out-dated. Using tobacco use as a measure of nicotine addiction is also out-dated. 

It's time for health authorities to establish an indicator for nicotine use that can be used as a yardstick to measure the impact of changes in the nicotine market and also progress against nicotine use (a precursor to nicotine addiction, for which a separate indicator is likely also needed). 

Tobacco surveys should collect information on the complete range of nicotine products on the market, and the summary tables produced from these surveys should provide information on the emerging patterns of use and co-use of products. 

Data Sheet: Nicotine Users in Canada 2013 – 2023

Heads up! A peek at new nicotine products on the horizon ....

This post reports on recent actions by tobacco companies which signal new products or activities in Canada.

Philip Morris International plans to sell "tobacco free" heat not burn 

On Thursday, September 28 one of the world's two largest tobacco companies made a series of presentations to investors, the slides from which are available on their website. Within this series of presentations was an explanation of their new "LEVIA" heat sticks.

This heat stick is designed to work with the fourth generation of IQOS heat-not-burn electronic devices, ILUMA. This device uses a somewhat different heating system which does not pierce the heat stick and the tobacco (TEREA) or tobacco-free (LEVIA) sticks sold for it are not compatible with other sticks. ILUMA is not yet sold in Canada, but is intended to be present in 50 markets by the end of this year. (slide 8) (Lat month it became available for sale in the UK).

Conceptually, the LEVIA sticks are similar to those developed in Canada by PODA before the intellectual property for the novel nicotine delivery system was sold to ALTRIA last year. (Altria is a partner with PMI in IQOS distribution in the United States). 

Earlier this year, PMI advanced the registration of trademarks for ILUMA, TEREA and LEVIA in Canada. There is no requirement for the company to provide regulators of advance notice of their intention to sell these products. Because they are made with tobacco, the TEREA sticks would be taxed federally as manufactured tobacco sticks, at a per unit rate lower than cigarettes and would be subject to provincial restrictions on tobacco flavourings. Because LEVIA produces a nicotine aerosol, it would likely be regulated as a vaping product in Canada, taxed accordingly, and subject to provincial flavour restrictions.  

"POP TUCK FEEL"

In late September, the auditing firm engaged in Imperial Tobacco Canada Ltd insolvency proceedings reported to an Ontario court that "Imperial anticipates launching Zonnic in Canada in the fourth quarter of 2023." 

Zonnic is the brand name for the first nicotine pouches to be authorized for sale in Canada by Health Canada. A sneak-peek at the packaging is available on the Zonnic Website, which encourages visitors to "stay tuned".

As described here earlier, there will be few regulatory restrictions on the 5 permitted flavours of the 4 mg pouches. These products do not fall under laws which establish minimum age for sales, taxes, mandatory warnings, restrictions on television, billboard advertising or in-store displays.

A marketing slogan filed with the trademark office last spring: "POP, TUCK, FEEL" seems likely to be intended for these nicotine pouches -  it is the same slogan BAT uses to sell its VELO brand nicotine pouches in the UK. 

Noting the way BAT markets Velo and PMI markets Zyn, other countries have moved to tighten laws and prevent nicotine pouches from becoming a starter product for nicotine addiction. The Netherlands government responded to the sale of these products by commissioning research from its public health researchers, following which it banned the sale of pouches with 0,035 milligrams or more nicotine per pouch in November 2021. Belgium similarly imposed regulations which ban their sale (in March 2023).

Renewed "contraband" campaigns on the way?

Last week a series of press releases were issued to raise alarm about contraband cigarette sales. Tehse included the release of a report prepared by EY and commissioned by the Convenience Industry Council of Canada.  "Canadians losing billions to organized crime". This was soon followed by a  report from Imperial Tobacco on contraband in the prairies. 

This activity echoes previous collaborations between the convenience industry and tobacco companies to amplify concerns about contraband in order to pre-empt tax increases or regulation. And recent trademark registrations suggest a new campaign is on its way.

This summer Philip Morris International tried to registered not one but two designs for "Fight Contraband. Fight Together" in connection with proposed "Illicit Trade awareness programmes". The last record on the trademark office's database is that the trademark regulators considered this "Goods or Services Not Acceptable" 

Cheap cigarettes - whether they result from contraband sales, low tax rates or discount pricing - undermine public health because affordability is a major driver of continued smoking. 

In contrast to the cries of alarm from tobacco companies, Revenue Canada has produced its own estimates of the underground economy, with the most recent update for the 2014-2018 period. The CRA report attributes illegal and untaxed tobacco to be responsible for a tax loss of about $400 million, representing 4% of the excise tax revenue. By contrast, personal under-reporting of income (i.e. construction jobs done "under the table") and under-reporting and under-payment of corporate income tax is estimated to cost $5.1 billion to $8.3 billion in lost tax revenue.

Delays and missing details from the 4th wave of the Canadian Tobacco and Nicotine Survey.

 Today Statistics Canada released a few results of the fourth wave of the Canadian Tobacco and Nicotine Survey. This release confirms that without any new constraints on vaping marketing the youth vaping problem continues. 

What we know

The patterns of nicotine use are stable over the past 4 years. As shown in Statistics Canada's Infographic from the release, over the past 4 years, nicotine continues to capture new cohorts of teenagers. As these teenagers age into their twenties, young adult vaping continues to climb while smoking rates fall. Once blended into the larger population of Canadians, however, the use both products has not diminished. 

Overall, an additional 1% of Canadians are using vaping products in early 2023 than in late 2019 and 1% fewer Canadians reported smoking over the same period. 

The impact of policy change is imposed on youth. This survey was implemented after the federal government legalized the vaping market with the intention of providing adult smokers with access to vaping products while protecting youth from vaping.

When compared with data from the period before the change of law in May 2018, the failure to achieve those goals is made clearer. Over the 5 years period, adult use of vaping products has changed little, but youth use rose quickly and has stabilized at a high level.

More than 1 in 5 teenagers who tries a vaping product ends up using them every day. The probability of becoming a daily user of vaping products is high. One fifth of young people who had ever tried vaping products were doing so daily at the time of survey. Even among adults over 25, one-seventh of ever-vapers were vaping daily. 

Sexual orientation is associated with higher vaping rates. Vaping rates are twice as high among non-heterosexual Canadians as among those who identify as heterosexual (11.5% vs 5.5%). The pattern for cigarettes is less pronounced (12.4% vs 10.8%). 

What we still don't know

Frustratingly, very few results from the CTNS were released today. The survey questionnaire covers a wide range of issues related to tobacco and nicotine use. 

Among the data from the survey which is not yet available is that which will allow us to know:

• the smoking status of Canadian vapers (e.g. how many are former smokers?)
• rates of use of other tobacco products (e.g. chewing tobacco) and cannabis
• patterns of co-use of tobacco, vaping and cannabis, and progression of use (e.g. which products are used first?)
• relationship of indigeneity and other racial identity to the use of these products (e.g. which groups appear more vulnerable?).
• use of flavourings in vaping products (e.g. who is using candy and fruit flavourings and why?)
• source of supply of vaping and tobacco products (e.g. where do young people get their nicotine products from?)
• the reasons that Canadians say they use vaping products (e.g. are these to help stop smoking, to reduce stress or to satisfy curiosity?)  
• changes in the use of these substances in different regions of Canada. (e.g. are people in provinces with taxes or flavour restrictions or retail constraints less likely to use these products?)
• the use of stop-smoking aids (e.g. what products are smokers using in their quit attempts - and which are associated with success?)
• beliefs about the  harmfulness of e-cigarettes (e.g. do these beliefs seem to influence use?)

This information will only be available once results of an analysis are made available by federal government agencies, or once the data is made available to independent researchers.

Delaying data release

An important story from today's release is that it took so long to receive so little information. This survey should and could have been released in the spring, as it was in previous years.  By arranging for a delay of the data release, Health Canada was able to defer this bad news story. 

In 2020 and 2021 - despite the pressures of COVID - Statistics Canada released the data in March and made the PUMF file available at the same time. In 2022, the data was released in May, with the PUMF made available August. 

In each of those years, Health Canada made its analysis available many months later.  But because the raw data was available to researchers and other levels of government, the impact of this delay was lessened.

The Health Ministry appears to have objected to Statistics Canada's decision to make the data available to the public in advance of that department. In a memo to the Minister in July 2020, Health Canada officials complained "The Tobacco Control Directorate (TCD) was not aware that the data set was being made available to the public by Statistics Canada until after the fact." 

It appears that this year the intention was for both government departments to release information on the same date. In response to inquiries on the release, Statistics Canada officials informed us this summer that: "The CTNS master file release date for the 2022 reference year is currently planned for September 11, 2023. This is when the data become available to the public. This differs from previous cycles of CTNS, whose master files were released in the spring. Additionally, Health Canada will be releasing web summary tables on September 11. The PUMF for CTNS 2022 is tentatively planned to be released later in October." (emphasis added)

As it turns out, Health Canada does not seem have met this deadline. The last line in today's release notes that "Health Canada will also be releasing a detailed report from the latest cycle of the CTNS in September 2023."