On Tuesday this week, Health Canada made public its decision to issue a natural health food license to a subsidiary of British American Tobacco. As a result, British American Tobacco has become the first manufacturer to be authorized to market nicotine pouches in Canada.
This federal license, issued on July 18, 2023, allows BAT/Nicoventures authority to market five flavours of a 4mg nicotine pouch. It also allows the company to advertise these pouches as a way to quit smoking ("help you quit smoking by delivering nicotine to your body, temporarily relieving cravings and nicotine withdrawal symptoms") and a way for smokers to cope where smoking is banned ("used when you need to temporarily refrain from smoking, for example, around others, in smoke-free areas, airplanes, or in other situations when you wish to avoid smoking.") It permits the pouches to be sold to children (although it advises people under 18 not to use it).
This post highlights how this development reveals vulnerabilities in Canada's health regulatory approach, and how BAT has been able to use regulatory pathways intended for health products as a route to market for its addictive consumer products. Although Health Canada has adopted a harm reduction approach to tobacco, it has failed to established a legal framework for this strategy or to be transparent about how nicotine pouches fit into this strategy. Whatever benefits nicotine pouches might offer for public health, allowing British American Tobacco free rein on advertising them is unlikely to achieve a public benefit.
Canadian law does not currently allow for the sale of nicotine pouches, other than as regulated medicines. Over the past five years, BAT and other tobacco companies have launched "modern oral" products as a way to expand their range of nicotine products to overcome reduced cigarette use. Their nicotine pouch is sold under the brand name VELO and is currently available in at least 22 countries. BAT is hoping to expand the market for modern oral tobacco beyond the Nordic countries, including in North America.
BAT can use its ownership of NRT companies to gain access to therapeutic channels to sell nicotine. BAT acquired Niconovum, which pioneered nicotine pouches for sale as a form of NRT, branded as ZONNIC. Scandinavian countries have authorized ZONNIC as NRT. However, the product authorization issued by Health Canada shows that the ingredients and flavourings in the Scandinavian ZONNIC are different from the product that BAT will sell in Canada. Based on the ingredient list and flavourings, the product approved by Health Canada this week is almost certainly the 4 mg version of their VELO nicotine pouch.
BAT will face very few restrictions on how it can market ZONNIC nicotine pouches in Canada, other than with respect to how it represents the therapeutic benefits of the product. Under federal law, advertisements will be allowed in all media, and there are no restrictions on the use of lifestyle imagery. Based on historical marketing practices of BAT, we can expect that the product and promotional material will be available in convenience store outlets in most provinces. Provincial governments have the authority to set restrictions on where the product can be sold and how it can be promoted, but few have such measures currently in place.
Other companies are positioned to start selling nicotine pouches in Canada, and the approval of BAT's application may facilitate their doing so. This development raises questions about the adequacy of Canadian law to protect the public from the marketing strategies of tobacco companies, about Canada's application of Article 5.3 of the Framework Convention on Tobacco Control, and about the need for an integrated nicotine strategy.
Canadian law does not currently allow for the sale of nicotine pouches, other than as regulated medicines.
Three federal regulatory systems are in place which control the sale of nicotine products:
1. By default, nicotine is a prescription drug
Under the Food and Drugs Act, Health Canada establishes which drugs are only available by prescription. Nicotine is currently included on this list, which means nicotine-bearing products can only be sold under prescription unless they are specifically exempted under other laws or regulations. The two current exemptions are tobacco and vaping products (which are exempted in the legislation) and NRT (which is exempted in the Prescription Drug List). The Prescription Drug List is set by Health Canada at an administrative level.
2. NRT is regulated as a Natural Health Product
Certain NRT delivery-systems qualify as natural health products and are regulated under the Natural Health Products Regulations. These include gums, patches, lozenges and NRT 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)." The maximum allowable nicotine per dose is 4 mg, except for patches which can deliver 22 mg per day. These criteria can be changed by Health Canada.
Manufacturers may not sell NRT products unless they receive authorization from Health Canada. Authorization is given for each product and is contingent on Health Canada being provided with evidence to support safety and efficacy as well as support for health claims. Those products which are authorized are given a Natural Product Number (NPN) which is linked with a specific recommended use and specific risk information and contra-indications. (The NPN for Zonnic pouches is 80125630).
|BAT Instagram promotions for VELO
Although Many governments permit the sale of nicotine pouches, in only a few are they sold with medical claims or as a form of NRT.Niconovum reports that Zonnic pouches are currently sold as NRT in the Nordic countries of Sweden, Norway, Finland and Iceland. In these countries it is available in only one flavour (Mint)
The ingredient lists on the Scandinavian package leaflets and the Health Canada authorization show that the ZONNIC product licensed for sale in Canada is not the same as the one licensed for sale in Nordic Countries. Instead, BAT's Canadian natural health product nicotine pouches are made with the same ingredients that they use for the VELO recreational nicotine they sell in other countries.
The following ingredients are listed for ZONNIC in the package leaflet authorized in Sweden and other Scandinavian countries: Active substance: nicotine - 4 mg; Other ingredients: cellulose (microcrystalline), ascorbyl palmitate (E304), trisodium phosphate, acesulfame potassium (E950), aspartame (E951); Flavourings: mint flavour
The following ingredients for ZONNIC are identified in Health Canada's natural health product database: Medicinal ingredient: 1-Methyl-2-(3-pyridyl)pyrrolidine [nicotine] - 4 mg; Non-medicinal ingredient: Microcrystalline cellulose; Propylene glycol; Sodium alginate; Sodium bicarbonate; Sodium chloride; Sucralose; Water; Xylitol; Flavourings: Berry flavour; Cranberry flavour; Mint flavour; Spearmint flavour, Topical citrus flavour
An ingredient list is provided for VELO pouches on some retail websites (although BAT's information is less specific). Nicotine; Microcrystalline cellulose fibers (E460 (i)), propylene glycol (E1520), sodium alginate (E401); sodium bicarbonate (E500), salt (sodium chloride), sucralose (E955), water, Xylitol (E967); Flavors
Based on the ingredient list and flavourings, the product approved by Health Canada this week is almost certainly a 4mg version of their VELO product.
Health Canada has authorized BAT/Nicoventures to sell Zonnic in the following five flavours: Polar Mint; Berry Frost; Chill Mint; Cranberry Fizz; Tropic Breeze.
Some of these flavours - tropic breeze, polar mint - are identical to those sold with VELO in other markets.
There are currently very few restrictions on how BAT can market these nicotine pouches in Canada, other than with respect to how it represents the therapeutic benefits of the product.
In Canada, federal law puts severe limits on most direct-to-consumer advertising of prescription drugs, as it does for tobacco and vaping products. There are fewer restrictions on advertising for non-prescription or health products.
As a result, advertisements for BAT's nicotine pouches will be allowed on television, in video-games, in corner stores, on social media and in other places where young people have access.
Provincial governments have the authority to set restrictions on where the product can be sold and how it can be promoted, but few have such measures currently in place.Provincial governments have coordinated their regulations on non-prescription pharmaceutical products, but do not have a coordinated system for natural health products. They do retain authority over retailing, and can impose restrictions on if, how and where nicotine pouches can be sold or promoted.
Health Canada has indicated that the results of a clinical trial were submitted with BAT/Nicoventure's application, but further information is not known at this time.
There has been one published Randomized Clinical Trial of Zonnic as a stop-smoking aid, which was conducted in New Zealand and published in Nicotine and Tobacco Research over 14 years ago. The study was paid for by Niconovum,
This study provides a very slender evidence base on which to permit a new category of nicotine products on the market. It involved only 28 people who agreed to abstain from smoking for three days on each of three occasions: one time using a placebo pouch, another using NRT gum and a third time using Zonnic nicotine pouches. Twenty-one of 28 people abstained from smoking for 3 days using 4 mg Zonnic - a better result than was obtained with 4 mg NRT gum.
There are no other published clinical trials of ZONNIC or other non-tobacco nicotine pouches as smoking cessation aids currently identified on Pubmed, although there are studies which compare the way the body receives nicotine from pouches with other NRT. The inventor of Zonnic (Karl Fagerstrom) promotes pouches (NP) as a harm reduction product, but recently acknowledged that "The NP have so far not been well researched and there are only a few papers published."
This decision raises questions about Canada's application of Article 5.3 of the Framework Convention on Tobacco Control .
Like the recent Medicago debacle, Health Canada is again caught in the position of licensing medical products manufactured by tobacco companies. As these companies expand into medically-regulated products, so does the potential for governments to breach their obligations to protect public health from tobacco industry interference. This is especially relevant with respect to stop-smoking medications, which could permit tobacco companies to engage in public relations efforts to forestall tobacco regulations.
This development is a reminder that Canada needs an integrated nicotine strategy.As with SESH+ nicotine gum, this stop-smoking product is a sharp reminder that Canada needs an integrated nicotine policy. Health Canada has not yet acknowledged the need for such reforms.
In the meantime, provincial governments can help by imposing restrictions on the sale and promotion of nicotine pouches that are equivalent to those in place for tobacco and vaping products. Urgently needed are promotional restrictions and bans on sales to minors.