Thursday 28 December 2023

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 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 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. 

Thursday 14 December 2023

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.

Wednesday 13 December 2023

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."

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.