The ZONNIC Dilemma: Access, Regulation, and Canada’s Quit-Smoking Goals

A federal policy intended to ensure safety is creating hurdles for smokers and added strain for pharmacists, slowing progress on quitting.

In a country where more than 3.5 million people still smoke, Canada’s path to a smoke-free future may have found a surprising ally—ZONNIC, the first nicotine pouch approved by Health Canada as a Natural Health Product (NPN 80125630). Yet, recent regulatory changes have raised questions about how best to balance public health goals with accessibility for adult smokers.

ZONNIC is the first tobacco-free nicotine pouch authorized by Health Canada as a Nicotine Replacement Therapy (NRT), following a rigorous two-year bioavailability and safety assessment. Like gums and lozenges, it delivers controlled doses of nicotine without combustion or tobacco exposure. Each pouch contains less than 4 mg of nicotine and uses pharmacy-grade ingredients. Public health experts note that its nicotine content is comparable to existing NRTs, but the pouch format provides a discreet and portable delivery method that can be used throughout the day.

Supporters argue that tools like ZONNIC can help Canada reach its federal target of reducing smoking rates to below 5 percent by 2035. Critics, however, caution that new products must be carefully regulated to balance harm reduction with youth protection.

Between 2023 and 2024, provinces where ZONNIC was available in convenience stores and gas stations saw cigarette sales decline more rapidly than regions where only cigarettes were sold. During this period, ZONNIC captured 45 percent of Canada’s NRT market, becoming one of the country’s leading products. Analysts suggest that accessibility played a key role. While gums and lozenges have been available for decades, ZONNIC’s innovative format appears to have resonated with smokers seeking alternatives.

In August 2024, a federal ministerial order reclassified ZONNIC, allowing it to be sold only behind the counter at pharmacies. Other NRTs, including gums and lozenges, remained freely available. Health Canada stated the move was intended to ensure safe use and prevent youth access, noting that ZONNIC’s format was new to the Canadian market. However, some observers point out that cigarette sales—which had been declining—began to rise again following the change. Nearly 20 percent of Canadian postal codes lost convenient access, forcing smokers to travel farther to find a pharmacy carrying it.

Another unintended consequence has been the growth of an illicit market for high-dose nicotine pouches. Enforcement officials report that many of these unregulated products exceed Health Canada’s 4 mg limit, with some offering up to 10 times the legal amount. These products are often flavored, inexpensive, and more appealing to youth—raising concerns among health advocates.

Globally, countries like Sweden have demonstrated that embracing harm reduction can yield real progress. With smoking rates now below 5 percent, Sweden is considered “smoke-free,” aided in part by alternative nicotine products. Cancer rates there are 41 percent lower than the European average. New Zealand and Japan have reported similar success stories. By contrast, Canada’s more restrictive approach risks stalling momentum.

Since the ministerial order, pharmacists have become the gatekeepers for ZONNIC, required to dispense it exclusively from behind the counter. Pharmacist groups say this adds workload to already stretched practices, while also creating barriers for smokers in regions with fewer pharmacies. Other pharmacists see it as essential to keep pouches behind the counter in pharmacies to ensure necessary counselling and appropriate use.

Calls are growing among public health experts and retail associations for a review of the ministerial order. Proposals include allowing ZONNIC to be sold over-the-counter like other NRTs, ensuring consistent rules across all products, and addressing the illegal market directly.

The central challenge for policymakers is balancing access, innovation, and safeguards. Evidence from Canada and abroad suggests that when safer alternatives and smoking cessation tools are made convenient and affordable, smokers are more likely to make the switch.

Whether Canada achieves its 2035 smoke-free target may depend on finding that balance and products like ZONNIC will most probably be part of that equation.