Why does Health Canada think Zyn is a sin? The official reasons simply do not add up…

Nicotine is found in cigarettes and chewing tobacco sold in Canada, and a Canadian consumer can get a prescription for nicotine, so why not allow for over-the-counter sales of Zyn?

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When it comes to the world of tobacco and nicotine, it is downright bizarre which products Health Canada is fine with and which products it bans. Cigarettes, cigars, chewing tobacco – these products are all readily available for over-the-counter sale. But alas, those who are fans of Zyn must cross the border if they want to get their nicotine fix.

Zyn is a tobacco-free nicotine pouch and comes in a variety of flavours. The product is placed between the cheek and the gum. Other brands include the likes of On! and Velo. These products have a growing fan base, but Canadians cannot freely purchase Zyn in Canada.

We reached out to Health Canada to find out why. Our queries were as follows:

  1. What is the ostensible policy reason for the prohibition of Zyn in Canada given that other products containing nicotine (i.e., cigarettes) are available for sale in Canada?
  2. I understand that nicotine is being used successfully for the treatment of Parkinson’s Disease. Zyn is comprised of nicotine, and I understand Canadians can get prescriptions for nicotine. If that is indeed the case, again, what is the logic behind a Zyn ban?

And here was the response from Health Canada:

In Canada, tobacco-free nicotine pouches are regulated as a drug under the Food and Drugs Act (FDA). They are classified either as a Natural Health Product or a prescription drug based on the quantity of nicotine they contain. More specifically, if a nicotine pouch delivers 4 mg of nicotine or less, it is regulated as a Natural Health Product (NHP) under the Natural Health Products Regulations (NHPR).

If the pouch delivers more than 4 mg of nicotine, it is regulated as a prescription drug under the (FDR). Excessive amounts of nicotine can have serious health risks, and as such, ‘nicotine or its salts’ has been listed on the Prescription Drug List (PDL) since 2013 with certain exclusions, depending on the dosage and route of administration. In this case, the licensed nicotine pouch contains 4 mg of nicotine per dose which meets the exclusion criteria.

These products are not subject to the Tobacco and Vaping Products Act (TVPA) as they do not contain tobacco and do not meet the Act’s definition of a vaping product.

On July 18, 2023, Health Canada authorized the tobacco-free nicotine pouch product ZONNIC as a nicotine replacement therapy product for adults 18 years of age and older. The buccal pouch contains 4 mg of nicotine per dose and is considered a natural health product.

As with other nicotine replacement therapies, Health Canada thoroughly assessed evidence to support the safety and efficacy of ZONNIC before authorizing its use in Canada.

In 2020, Health Canada advised Canadians that no nicotine buccal pouches (also known as tobacco-free nicotine pouches and oral nicotine pouches) had been authorized in Canada, and warned against the use of unauthorized health products. Since the publication of this advisory, a public advisory update has been published indicating that Health Canada has authorized ZONNIC.

Authorized products have been evaluated by Health Canada for safety, efficacy and quality, to make sure that their benefits as a nicotine replacement therapy outweigh their potential risks.

To date, Health Canada has only licensed one nicotine pouch; however, other submissions are currently under review. When a NHP obtains a product license, it is authorized to be sold in Canada.

You will notice that Health Canada did not weigh in on the Parkinson’s Disease issue. Yet even so, we don’t think the rationale for a ban makes any sense. Nicotine is found in cigarettes and chewing tobacco; meanwhile, a Canadian consumer can get a prescription for nicotine. If that is the case, why not allow for over-the-counter sales of Zyn — or is this yet again another example of a health bureaucracy bending the knee to big pharma?

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