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Are Nicotine Pouches Legal in Canada?

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Health organizations are upset that youth are not prohibited from purchasing buccal nicotine pouches, which just hit the market for the first time in Canada.

But how did we get here in the first place?

Under the federal Tobacco and Vapour Products Act, it’s an offence to furnish tobacco to youth in public. Additionally, provinces across Canada generally prohibit distribution of tobacco to youth.

But this product is a different beast: It contains nicotine but not tobacco.

That makes it a drug under the Food and Drugs Act (FDA). And because it’s a naturally-occurring substance, nicotine is technically a natural health product under the FDA’s Natural Health Products Regulations.

Substances that would otherwise be NHPs can instead be classified by the feds as ‘prescription’ drugs under the FDA that require DIN numbers and prescription by a healthcare practitioner before it can be dispensed. There’s a list online called the ‘Prescription Drug List’ where you can see such designated substances.

In Canada, we’ve taken a dual approach: Certain, lower-dose nicotine products are considered NHPs, while higher dose are considered prescription drugs.

When it comes to nicotine intended to be absorbed buccally, it is an NHP if each unit contains not more than 4mg and a prescription drug if it contains more than that.

NHPs are generally available to consumers without prescription and have a less onerous pre-approval process versus prescription drugs, which are only available upon prescription.

And, of course, these pouches were produced to have the maximum allowable amount to remain an NHP.

We’re all aware of Nicorette, but this was the first nicotine pouch product to be approved in Canada, with approval in June of this year.

The Natural Health Product Regulations do not contain a provision prohibiting the sale of NHPs to young persons. So lower-dose versions of Nicorette, for example, can be sold freely to youth subject to provincial law. Many stores stock their Nicorette products in their pharmacy and require age verification, although this is a matter of store policy and ass-covering and not due to any particular law.

So what can be done? There’s a few options:

a) This could provide an opportunity for the federal government to amend the Natural Health Product Regulations so that it prohibits the sale of certain NHPs to those under the age of 18.

b) The federal government could move buccal nicotine altogether from NHP classification to the Prescription Drug List. This would mean that ZONNIC would only be available by prescription, and no doubt Imperial Tobacco would launch suit against the government. And this wouldn’t actually prohibit its sale to minors altogether.

c) Do nothing. NHPs are approved for certain recommended uses, and in this case Zonnic is intended to be used only by adults. Therefore, enforcement action could still be taken in respect of any advertising inconsistent with this.

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