Prior Regulatory Gap

Generally speaking the manufacturing, sale, labelling and promotion of tobacco products are governed by the Tobacco and Vaping Products Act (the “TVPA”).  The TVPA regulates (read: limits) advertising of tobacco and vaping products, and requires clear health warnings, while also limiting nicotine content.

Depending on one’s view of things, a regulatory gap existed for Nicotine Pouches, which are generally tobacco-free, but did not contain nicotine.  These potentially fell into a gray area, and potentially escaped the same degree of regulation that existed for traditional tobacco products or for newer vaping products.

Ministerial Order Closing the Regulatory Gap?

Bill C-69, which received Royal Assent on June 20, 2024, contained amendments to the Food and Drugs Act which granted the Minister of Health the power to issue Ministerial Orders to “establish rules in respect of the importation, sale, conditions of sale, advertising, manufacture, preparation, preservation, packaging, labelling, storage or testing of the therapeutic product for the purpose of preventing, managing or controlling the risk of injury to health”.

The Minister has apparently acted on this new power, to target non-tobacco nicotine products, issuing a Ministerial Order on August 22, 2024.  Among other things, the Order prohibits NRTs “in new and emerging formats, such as nicotine pouches, from being sold with flavours other than mint or menthol”.  The Order also requires these products “to be sold only by a pharmacist or an individual working under the supervision of a pharmacist, and to be kept behind the pharmacy counter”.

Other measures introduced in the Ministerial Order affect NRTs as a whole include:

• Prohibiting advertising or promotion, including labelling and packaging, which could be appealing to youth;
• Requiring front-of-package nicotine addiction warnings, as well as clear indications of the intended use as a smoking cessation aid; and
• Requiring manufacturers to submit mock-ups of labels and packages for all new or amended NRT licenses, to ensure “no youth appeal”.

Commentary

While Nicotine Pouches had previously enjoyed a bit of a regulatory gap in Canada (at least relative to traditional nicotine-containing tobacco and vaping products) a new Canadian regulatory rule appears to have changed that.  Legal advice may be required in order to determine what sort of marketing and sale activities will be permitted going forward – as these products have now joined tobacco and vaping products in an increasingly complex regulatory environment.

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