Sunday 31 March 2024

Ontario's Chief Medical Officer of Health calls for better controls on tobacco and nicotine.

This post highlights an important report from the senior public health officer in Canada's largest province. 

In "Balancing Act: An All-of-Society Approach to Substance Use and Harms", Ontario's Chief Medical Officer of Health, Dr. Kieran Moore, focuses on Ontario's experience with substance use. He provides specific recommendations on four categories of substances: tobacco-vaping products, cannabis, alcohol and opioids.

The analysis and recommendations in this 81-page report do not reflect the policy of the current Government of Ontario. Ontario's Chief Medical Officer of Health has a duty to provide the legislature with an independent annual "on the state of public health in Ontario." In recent years these reports have focused on specific public health issues - last year's report focused on pandemic preparedness.

Dr. Moore's 2024 report provides a comprehensive review of the impact of both legal drugs (nicotine, cannabis, alcohol) and illicit drugs (opioids), and addresses upstream and downstream factors which influence use and harmful use.

As the title "Balancing Act" suggests, the report identifies the forces and tensions which influence public policy in these areas -- respect for individual autonomy with respect to substance use, community protection, economic benefits and harms, reducing harm without increasing use, etc.

The recommendations which flow from this analysis challenge many current policies and practices of both the Ontario and Federal government. (Not only did the Ontario government quickly distance itself from his recommendations, it chose to release the report on the Friday afternoon of a long weekend.)

With respect to tobacco and nicotine - an area largely abandoned by Ontario's Conservative government after its election in 2019 - Dr. Moore offers little support for federal government's harm reduction approach. Dr. Moore casts doubt on the potential for vaping products to assist with smoking cessation when sold as consumer products: "Studies comparing nicotine e-cigarettes to usual care/no treatment suggest only a small benefit, and the long term (i.e. longer than two years) benefits and harms of e-cigarette use are largely unknown due to short follow-up of current studies. The World Health Organization (WHO) recommends that “any government pursuing a smoking cessation strategy utilizing e-cigarettes should control the conditions under which the products are accessed to ensure appropriate clinical conditions and regulate the products as medicines."

The report's approach to vaping and nicotine do align, however, with that made earlier by Dr. Moore's provincial and federal colleagues, who provided guidance on vaping policies collectively as Canadian Chief Medical Officers of Health. This Ontario report is also consistent with the advice of Canadian health agencies and with the World Health Organization

For example, Dr. Moore's report casts doubt on the potential for vaping products to assist with smoking cessation when sold as consumer products:  "Studies comparing nicotine e-cigarettes to usual care/no treatment suggest only a small benefit, and the long term (i.e. longer than two years) benefits and harms of e-cigarette use are largely unknown due to short follow-up of current studies. The World Health Organization (WHO) recommends that “any government pursuing a smoking cessation strategy utilizing e-cigarettes should control the conditions under which the products are accessed to ensure appropriate clinical conditions and regulate the products as medicines."

Instead, Dr. Moore uses the report to call for stronger controls on nicotine products (including nicotine pouches): "Ontario still falls short of many of the World Health Organization recommendations to protect children, including banning flavours as well as any features that could appeal to youth." His specific recommendations for tobacco-and nicotine policies and programs are listed verbatim below. 

Dr. Moore's advice is good for Ontario, and would be good for the rest of the country too. 

More than 2 decades have passed since Canada had a national vision for tobacco control. The last pan-Canadian strategy (the National Strategy to Reduce Tobacco Use (NSTRTU)) was drafted by a steering committee composed of provincial and federal governments representatives as well as those from civil society.

Canada's national approach to tobacco control was abandoned in 2001 when the federal government stepped away and established its own approach. The Federal Tobacco Control Strategy (FTCS) modified the NSTRTU framework (Prevention, Protection, Cessation, Denormalization) to drop Denormalization and to replace it with the goal of Harm Reduction. Some provincial governments have subsequently adopted their own strategies, but most of these have languished without renewal in recent years. None have formally adopted harm reduction as a tobacco control objective.

Dr. Moore's report offers a sensible plan to protect public health from tobacco industry products. It will however take a major change in approach by either the Ontario and Federal government for these measures to be put in place.

Recommendations from "Balancing Act: An All-of-Society Approach to Substance Use and Harms" related to Tobacco and Nicotine

Reinvigorate the Smoke-Free Ontario Strategy, focusing on populations and regions with high rates of tobacco use. Expand the strategy to create a comprehensive, coherent public health-oriented framework for regulating vaping and all nicotine-containing products. 


• Adopt Health Canada’s target of less than 5% tobacco use by 2035 
• Develop aggressive targets to prevent the use of vaping products by youth and people who do not smoke 

Health Promotion 
• Continue to raise awareness among Ontarians, particularly youth, of the risks associated with tobacco and vaping products 

Regulatory Measures 

Minimum legal age of purchase 
• Increase the minimum legal age to purchase tobacco and vaping products from 19 to 21 years old 
• Consider progressively increasing the minimum legal age to purchase these products over time as a way to ban the purchase of these products by future generations 

Product Controls 
• Ban flavours for all tobacco and vaping products 
• Expand restrictions on where people can smoke or vape (i.e. not in social housing, near building entrances, exits and air intakes, in all outdoor spectator stands, beaches, and specified parts of provincial parks) 
• Require apartment landlords and condominium boards to have a smoking/vaping policy 
• Ban the use of water pipes in all places where smoking is banned 
• Expand the current regulatory framework to include specified non-tobacco nicotine products, such as nicotine pouches, and prevent their sale and promotion to youth and people who do not smoke 
• Ban the sale of disposable vaping products 
• Establish product controls to prevent the evolving risk of vaping devices being used to deliver other drugs, such as cannabis, fentanyl, and crystal methamphetamine.

• Restrict physical store locations where tobacco and vaping products can be sold, including prohibiting any new stores within 200 metres of an elementary or secondary school or an existing tobacco/vaping retail outlet, and capping the total number of retail locations in a municipality/region (i.e. retail density)
• Impose a licensing fee for retailers of tobacco and vaping products 
• Explore measures to reduce illegal, untaxed tobacco sales outside of First Nations communities 
• Work with the federal government to ban online retail sales of tobacco and vaping products without in person age verification at delivery 

Pricing and Taxation 
• Increase the provincial sales tax on tobacco products and increase the tax each year to keep pace with inflation 
• Maintain provincial sales tax on vaping, and increase annually to keep pace with inflation 

• Work with the federal government to restrict:
   o online and social media advertising of tobacco and vaping products 
   o the design, appearance, and branding of e-cigarettes to reduce their appeal to youth 
• Reduce or eliminate the number of price signs allowed in tobacco and vaping retail settings visible to youth 
• Prohibit manufacturers from offering incentives to retailers (e.g. bonuses for reaching sales volume targets, chances to win vacations or entertainment tickets, lower prices based on volumes purchased), and prohibit retailers from passing incentives on to consumers 

• Issue time-limited suspensions for retail outlets that repeatedly sell vaping products to minors, as is done for tobacco 
• Enforce the current limitations on nicotine concentration in vaping products (20 mg/ml), determine whether companies are using product strategies to undermine the 20 mg/ml standard, and restrict the capacity of tanks, pods and refill containers 

• Increase access, including free products, to evidence-based smoking cessation therapies and supports, such as the Ottawa Model for Smoking Cessation 
• Increase research and training on vaping cessation therapies and supports for youth and adults

Monitoring and Reporting 
• Establish key performance indicators for public health inspectors and others involved in enforcing tobacco and vaping policies designed to protect minors and non-smokers 
• Work with Public Health Ontario and with federal, provincial, territorial and Indigenous partners to continue to: 
   o Monitor the impact of tobacco and vaping on health 
   o Review new evidence on vaping and other non-tobacco nicotine use 
   o Assess the impact/effectiveness of tobacco and vaping policies 
   o Issue regular public reports on Ontario’s progress (key performance indicators) in reducing harms associated with tobacco and vaping use

Wednesday 27 March 2024

More countries move to ban flavours and disposable vapes

This post provides an update on recent actions taken by health authorities outside Canada to address nicotine use by youth.

Flavour bans

The number of countries which have banned all flavours (other than tobacco flavour) in vaping products grew to 7 in January, when Latvia finalized its law to that effect. As with the Netherlands and China, Latvia restricts tobacco flavourings to a "white list" of permitted ingredients. The Latvian restriction comes into effect on August 1, 2024. 

Australia, which does not permit the sale of vaping products except under prescription, placed restrictions on the flavours for which prescriptions can be issued: only tobacco-flavour, mint and menthol are permitted. This measure took effect at the beginning of March. (Australia does not currently ban menthol in cigarettes).

A description of international flavour restrictions can be downloaded here. 

A list of health organizations calling for flavour restrictions can be downloaded here


Banning disposable vapes

At the beginning of 2024 only two countries which otherwise permitted e-cigarette sales banned the sale of disposable vaping products: New Caledonia and Australia

Over the past two weeks it has become clear that the number of countries in which disposable e-cigarettes will not be permitted will grow.  

These new announcements are in addition to proposals earlier this year by authorities in Scotland (draft regulations) and England (announced but not specified in subsequently-tabled legislation)

In early March 2024, seven European organizations with responsibility for waste management called for a ban on disposable cigarettes "by the end of 2024 at the very least."

A chronology of recent regulatory actions on vaping products can be downloaded here

Wednesday 6 March 2024

Stop Smoking medications authorized in Canada include 4 manufactured by tobacco-nicotine companies

Three months have now passed since federal Health Minister Mark Holland told reporters that he wanted to "shut down the loophole" that resulted in Imperial Tobacco being granted authorization by the department to market Zonnic nicotine pouches. 

CBC reporter Marina von Stackelberg reported on November 30th that "When asked how Health Canada failed to anticipate that risk, Holland said he takes 'responsibility for that' and vowed to take a "rigorous look" at the processes for approving nicotine products."

This post post presents information on stop-smoking products which have been authorized for sale by Health Canada. 

The loophole the Minister is trying to close and the process for approving nicotine products is not limited to Zonnic, manufactured by a subsidiary of British American Tobacco.  

Health Canada has also given permission to other tobacco-nicotine companies to sell nicotine products as stop smoking medication, allowing them to avoid the more restrictive rules placed on their other nicotine products. These authorizations include:
* Rogue nicotine gum manufactured by a subsidiary of the cigar-manufacturer Swisher.
* Sesh+/Lucy nicotine gum manufactured by nicotine gum and pouch company Lucy Goods
* Quit (TM) gum manufactured by Fertin Pharma, a subsidiary of Philip Morris International.

A list of stop-smoking products authorized by Health Canada can be downloaded here.

Canada's two-track system for stop-smoking medicines

Health Canada's regulation of drug products is managed under the authority of the Food and Drugs Act, with specific reliance on the regulations under that act. In the case of stop-smoking medications, two distinct regulatory systems are involved.

Track 1: Pharmaceutical and Over the Counter Drugs. 

The Food and Drug Regulations set the parameters for the sale of prescription and non-prescription drugs, including the issuance of Drug Identification Numbers (DIN) to authorized products, the licensing of manufacturers, and restrictions on advertising. Medications containing nicotine are considered prescription drugs, unless they meet certain criteria for dosage levels and modes of delivery, in which case they are regulated as  Natural Health Products. 

The stop-smoking medications that are regulated as Drugs and managed under the Food and Drug regulations are Varenicline and Bupropion. Five manufacturers are authorized to sell varenicline in Canada, one of which (Pfizer's Champix) is currently not for sale. Health Canada identifies that 5 authorized manufacturers currently sell bupropion.

Track 2: Natural Health Products

The Natural Health Products (NHP) Regulations set the parameters for the sale of health products made from plant or plant material or extracts other than those in categories which are excluded (cannabis, opioids). These products cannot be sold unless than have been authorized and assigned a Natural Health Product Number (NPN). The regulations governing application for authorization, advertisements and manufacture are different (and have been found less stringent) for Natural Health Products than they are for Drugs. 

There are currently almost 100 authorizations issued by Health Canada for Natural Health Products sold as a way to help smokers quit. 

- Stop smoking products made by Consumer healthcare companies

The NHP regulations were adopted in 2003. Before they were in place, nicotine gum and nicotine patch were regulated as drugs, and were initially sold on a prescription basis. Many mainstream consumer healthcare companies (e.g. Kenvue, Haleon) are authorized to sell NRT in Canada, as are generic drug companies (e.g. Teva, CellChem).    

Health Canada has authorized many pharmaceutical
companies to sell nicotine replacement products

Beginning in 2016, Health Canada has authorized 5 manufacturers to sell Cytisine (Baptitoxine), of which at least 2 are currently for sale in Canada (CRAVV and Tobalief)

Two authorized cytisine products
are now marketed in Canada

- Stop smoking products made by Alternative medicine suppliers

Health Canada has authorized the sale of stop-smoking aids for which the evidence of effectiveness is quite small. These include include a homeopathic remedy and herbal medications made from Lobelia plants or from other combinations.

Herbal remedies authorized by Health Canada 
for sale as stop-smoking aids. 

- Stop smoking products made by Tobacco and nicotine manufacturers

Health Canada has also authorized companies which normally sell nicotine as a consumer/recreational drug to also sell it as a medication to address the addiction caused by their primary business activity.

In addition to authorizing Zonnic (sold by Imperial Tobacco Canada / British American Tobacco), Health Canada has also given permission to three other recreational drug manufacturers to sell nicotine as Natural Health Products. 

The first of these was the 2021 authorization to Lucy Goods for the sale of Lucy and Sesh+ nicotine gum in Canada. Just over a year ago, Lucy gum was introduced to the Canadian market, quickly raising concerns about the manner in which it was being sold.

Since then authorization to sell NRT has also been given to ReCreation Marketing, a subsidiary of Turning Point Brands whose mainline business is smoking accessories like Zig Zag papers and cannabis pipes. Its Solace and Fre brands are not yet for sale in Canada, although they are currently sold in the United States.

Rogue Holdings is another company that has been given permission to sell nicotine lozenge and gum. Rogue is a subsidiary of Swisher Brands, whose main activity is the manufacture of cigars. Rogue nicotine gum and lozenge are currently for sale in the USA, but do not seem to be yet sold in Canada. 

Another company authorized to sell NRT in Canada is Philip Morris International (PMI). In 2021, PMI acquired Fertin Pharma, which had previously been authorized to sell nicotine gum in Canada.

Rogue and Solace are not yet sold in Canada
(product illustrations from USA)


Health Canada makes available the list of substances for which a prescription is required, the drugs that have been authorized for sale in Canada and also authorized natural health products. A consolidated list of these products is available here.