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.
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
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."
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| 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.
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| 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.
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
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| Nicopop patent was filed in Canada in 2020 |
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
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.
