Canada’s approach to nicotine pouch regulation has created a system that puts pharmacists at the centre of access to authorised products — while unauthorised pouches remain widely available. Has the policy achieved its intended goals, or has it created new problems?
In this GFN Science Lab presentation from GFN 2026 in Warsaw, pharmacist Todd Prochnau examines Canada’s pharmacy-centric regulatory model and its implications for public health, smoking cessation and tobacco harm reduction.
Transcription:
GFN Science Lab 4 — Todd Prochnau
2026-06-05 · 11:30-13:00 (Europe/Warsaw) · Global Forum on Nicotine 2026
Barnaby Page 0:00:11
We'll move on now. We'll move from Poland to Canada, look at a rather different approach to nicotine pouch regulation. And with us, we have a pharmacist, Todd Prochnau from the Independent Republic of Alberta.
Video 0:00:25
Welcome to Canada's pharmacy-centric and very unique nicotine pouch regulation. In Canada, tobacco products and vaping products are regulated under the Tobacco and Vaping Products Act. Oral nicotine products, however, are regulated differently, and these would be products that do not contain tobacco.
Anything that has more than four milligrams of nicotine is considered a schedule one prescription drug. Oral nicotine products, though, that have four milligrams or less of nicotine are regulated as natural health products. And other examples of natural health products include vitamins, minerals, herbal remedies and probiotics.
and importantly natural health products are not typically restricted to pharmacy only this means that they can be sold over the counter both in a pharmacy and in other retail locations now prior to 2023 the available authorized oral nicotine products in canada were the gum the spray the inhaler and the lozenge and all of these non-prescription nicotine products are authorized as smoking cessation aids also known as nicotine replacement therapies.
Things changed in 2023 though. Health Canada approved the first nicotine pouch in Canada, a four milligram nicotine pouch, and it was approved based on a pharmacokinetic study that showed the four milligram pouch had similar bioavailability to the four milligram lozenge.
So this four milligram pouch was the first approved and it is approved and regulated as a nicotine replacement therapy. However, in August of 2024 the Canadian health Minister enacted a ministerial order that restricted the sale of any authorized nicotine pouches to behind the counter in pharmacies only, and this was with the goal to reduce youth access.
this ministerial order further mandated that pouches only be available in a mint or mental flavour that lifestyle advertising be strictly prohibited and that front of package nicotine addiction warnings be required now this is only applicable to the authorized nicotine pouches so the ministerial order does not restrict unauthorized pouches because they're not authorized And so, these unauthorized pouches remain readily available in Canada, both online and in many retail locations.
In fact, Canadians are actually permitted to import a maximum 90 day supply of unauthorized nicotine pouches as long as it's for personal use, and this can mean up to 90 tins depending on the border services agent.
pouches that have more than four milligrams of nicotine would be considered prescription drugs and they may result in seizure by a border official we have to pay attention to this nicotine addiction warning because in canada our largest public health crisis is unintentional death due to opioid overdose we have a very potent and lethal illicit opioid supply and we have seen thousands of Canadians dying from opioid overdose year after year.
Health Canada, in response to this, requires that pharmacists place a sticker on all opioid prescriptions that says opioids can cause dependence, addiction, and overdose.
When we contrast this to the warning that has to be placed on authorized nicotine pouches that say nicotine is highly addictive, it's really applying that implying that nicotine is more of a public health concern than opioids. Opioids are killing thousands of Canadians each year. Now, what data do we have to actually look at youth uptake?
It's limited, but the most recent is from August of 2024, and it looks at past 30-day use of various nicotine products by youth. And so the youth reported in August of 2024 that 2.5% had used the nicotine pouch in the last 30 days. Compare this to 3.3%, which is for other types of nicotine replacement therapies.
And when we look at smoking, 6% of youth reported smoking and 14% reported vaping. So there really is not any data to support that youth use of nicotine pouches is a major concern at the present time in Canada. More youth are vaping, smoking, or even using other forms of nicotine replacement therapy. So what pharmacy implications does this ministerial order have?
There have been several, and several have resulted in challenges to pharmacists, but some of the key ones are pressures on pharmacists' time, which takes us away from clinical work. In Canada, pharmacists have the most expanded scope of practice for pharmacists versus anywhere in the world.
We prescribe medication, we help to manage chronic disease, largely due to the physician shortage in Canada. And so these pressures on pharmacists' time have a big impact on the Canadian health system. There's also many conflicting feelings about providing a smoking cessation product to a patient that might use it recreationally.
And then confusion about the actual safety and efficacy of nicotine pouches because there's been a lot of mixed messaging from leading Canadian experts. Here are some real opinions about nicotine pouches from Canadian pharmacists. I am worried that youth are misusing and abusing nicotine pouches.
I think nicotine pouches are another tool in our toolbox to get people off cigarettes. Nicotine pouches are just a new way to get young people hooked on nicotine for life. I know some people are going to use nicotine. Having access to products like pouches that are less harmful than smoking is a win for my patients.
Big tobacco is replacing lost revenues now that less people are smoking with new addictive products like nicotine pouches. I admit I was sceptical at first, but some of my patients have had success quitting smoking using a nicotine pouch. Nicotine pouches are not credible as a nicotine replacement therapy. I barely have time to care for my regular patients.
We are stretched thin in my pharmacy and there is a pharmacist shortage in Canada. We don't have time to check ID, so my pharmacy doesn't even carry nicotine pouches. Nicotine is not the enemy. Tobacco is the enemy. Patients who smoke should have access to products like nicotine pouches wherever they buy cigarettes. I found nicotine pouches in my teenager's room.
We need to get rid of these products to protect our kids. It is crazy that it is easier to buy cigarettes than a nicotine replacement therapy. Providing nicotine pouches to my patients feels like an ethical dilemma. I don't know if I should sell it to them if they aren't using it to quit smoking.
Todd Prochnau 0:07:37
So yeah, those were real opinions from Canadian pharmacists, but I used AI to protect their identities because this is such a polarizing topic. But you can see that there's a lot of different opinions from Canadian pharmacists about these products. And unfortunately, the ministerial order kind of overnight put them in the hands of pharmacists and pharmacists only.
So a lot of pharmacists were not even really aware that pouches existed at this time. And there's a lot of confusion because you have to remember that the authorized nicotine pouch says it's for adults who are wanting to quit smoking, right?
So pharmacists that aren't as well maybe versed in nicotine really feel conflicted because this product is saying it's to help quit smoking. So if somebody is wanting to purchase it for another reason, they're unsure. And of course, we understand that the risk of a nicotine pouch is very low, and why would we restrict that?
But for the average pharmacist that's in the field, they may not know that.
And it might be surprising for those of you from other countries too, that four milligrams is our maximum, because it probably seems like a very low amount of nicotine, but that is just how the term, there needs to be some change to the Tobacco and Vaping Products Act to maybe include a new category for oral nicotine pouches.
Because these pouches can be found anywhere in Canada. You can order them very easily online. You can buy them in many retail stores. And of course, the only thing that was actually restricted was the authorized nicotine pouch. We currently have two different authorized nicotine pouches, only one of which is marketed.
So it's a very small market that the ministerial order targeted. So yeah, happy to take any questions.
Fiona Patten 0:09:42
We have a pharmacy-based system there. And I'm wondering if there's any comparisons you could make with what we're doing in Australia compared to what you're doing in Canada.
Todd Prochnau 0:09:56
Yeah, I mean, I think, because originally in Australia... vaping required prescription, but am I correct in understanding now it's only, it's sold in pharmacy, but you can obtain it without a prescription?
Fiona Patten 0:10:08
You can buy it over the counter or it's behind, I guess your term, the behind the counter and the patient has to attest that they're using it to quit smoking and there has to be a conversation with the pharmacist. And that product I think is two milligrams.
Todd Prochnau 0:10:28
um yes it's a very low very low yeah so i mean i feel like it's basically um they copied the australian model for implementing this um and so i think it's it's quite similar and and not a lot of patients are are you know i shouldn't say not a lot there are patients that will access the nicotine pouch through the pharmacy but i think one of the the problems with making things um not accessible, like Australia and Canada is that there's a lot of people that won't access those products in a pharmacy, right?
So even not even looking at the strength limitations, and people might not get enough nicotine. But that's why accessibility is so important, because it's not a one size fits all thing, right? Some people will go to their pharmacist for something like this, and some just won't, they'll never do that. So
Fiona Patten 0:11:22
Can I just ask a quick follow-up? So in Australia, very few pharmacies will stock nicotine vapes. Obviously, we don't have pouches. They'll stock gums and patches. But the Pharmacy Guild itself has been very negative about... about vaping, and I'm wondering, is the Guild positive about these harm reduction tools, or do they take a negative approach as well?
Todd Prochnau 0:11:51
Yeah, I wouldn't necessarily... Like, we have the Canadian Pharmacists Association, but then there's also 10 provincial associations, the beauty of our model, but... So... Canadian Association has, they've released a little bit of information and I wouldn't say it's overly positive, but it's not a hard negative stance. But some provinces have instituted additional measures.
So Saskatchewan, for example, they have scheduled the product as a Schedule 2 drug, which means that, yeah, you could still get it without a prescription, but there's more that the pharmacist actually has to do. They need to you know, assess the patient, they need to document that assessment. And so that's a huge barrier because patients really don't like that.
And, uh, pharmacists, obviously it's a big time constraint. So yeah, it's a, it's a bit of a mixed bag when it comes to how it's been approached and viewed, but I wouldn't say it's overly positive. Um, and, uh, You know, the other thing I'd like to add, too, is the ministerial order that restricted it in this way is extremely unusual.
It's not the Canadian health minister doesn't schedule drugs. Right. And so they actually had to they kind of hit it in the budget bill to give the federal health minister the power to do this. But it's concerning even outside of nicotine.
Like if you think about a very conservative health minister might say, you know, we're going to restrict Plan B or we're going to restrict the abortion pill or something like that. So it's concerning for that reason as well.
Pascal Michel 0:13:44
Pascal Michel, PMI Canada. Todd, you spoke about the health reaction of pharmacists, pharmacy also business. What's the reaction of pharmacists in terms of now they have the chance of being the only points of sale for those products? How did they react about this? Would they be willing to bring it back in front of the counter or at other points of sales?
Todd Prochnau 0:14:10
Yeah, great question. So I think one thing to note is before the ministerial order, pharmacies could carry the nicotine pouch. Because it's regulated as a natural health product, it didn't mean that it wasn't in pharmacy. So it could be both. I would say that you wouldn't get a lot of pushback from pharmacists to move it to other retail locations as well.
Even from a business perspective, it's taking more time pharmacists time is valuable and it's expensive so it's not really worth it just to sell like one retail skew.
Barnaby Page 0:14:54
Great, thank you. I'll just follow up with a couple of really quick things for you, though, may I, Todd? First of all, a kind of general question. I mean, you spoke about the polarisation among pharmacists there. It struck me there were also some slightly mixed signals coming from the government, at least suggested by the legislation.
Do you get the sense that government thinking about reduced-risk products and pouches in particular is joined up, or is it a situation like... The one we heard about in Poland, for example, where the ministries aren't talking to each other. So that was one question. The second question, completely different.
With the higher strength nicotine pouches, and given the restricted availability in pharmacies, are you seeing a large illicit market developing there?
Todd Prochnau 0:15:39
Yeah, for sure. So to answer your first question, I think Canada is kind of interesting because Health Canada, When you actually go to their website and you look at, you know, what they say about vaping, for example, it's very much a harm reduction message. But that's not broadcast widely. And I think it's because of the political concerns.
Because politicians don't want to advocate for it because they're worried about, you know, their own standing with their constituents. And so in the case of the nicotine pouch, it was really, I think, the personal vendetta of the health minister at the time.
He, you know, was saying kind of some crazy things in the media, like these pouches are, you know, the tobacco companies are targeting our kids. They found a loophole to get it authorized, which wasn't the case. I mean, they went through the Health Canada approval process. You know, I think he even said pouches are good. going to kill people or something like that, right?
So I think that Health Canada is, in a way, is fairly pro-harm reduction, but they're not kind of been, haven't been given the political power to, I think, actually widely broadcast that. And then your second question, oh yes, illicit markets. So there's a, yeah, a massive illicit market. Like, you can find many different types of products.
And of course, we know all the concerns with that, right? Might not be age-gated and things like that. So in a way, the ministerial order probably has had the opposite effect and made it maybe more accessible for youth. So that's a concern. But even before the pouch was authorized in Canada, they were there. Like we've had nicotine pouches in Canada.
So even before it was authorized, there was already a listen market.