Question Period Note: Nicotine Replacement Therapies

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KEY MESSAGES
• Health Canada shares the strong concerns expressed by health care professionals about youth using new nicotine replacement therapies like pouches recreationally.
• In August 2024, Health Canada published a Ministerial Order which introduced new measures for nicotine replacement therapies to reduce the appeal of, access to, and use of these products by young people for recreational purposes.
• Health Canada is committed to ensuring that appropriate oversight is in place to protect youth. With these rules, nicotine pouches can only be accessed through a pharmacist or someone working under the supervision of a pharmacist.
IF PRESSED
Q1 : If pressed on evidence used to justify the need for a Ministerial Order
A1 :
• Health Canada considered many sources of evidence to inform the new rules, including data on vaping and flavour appeal to youth as well as feedback during consultations from a range of stakeholders.
• Considering the risk factors, a tailored precautionary approach was needed to prevent or mitigate harm to youth while maintaining access to smoking cessation tools for those who need them to quit smoking.
Q2 : If pressed on the measures in the Ministerial Order
A2 :The Order is a regulation that introduces new measures for orally administered nicotine replacement therapies that:
• Prohibit advertising or promotion that could be appealing to youth;
• Require that they be sold only by a pharmacist and kept behind the pharmacy counter;
• Prohibit flavours other than mint or menthol;
• Require a front of package nicotine addiction warning and a clear indication of the intended use as a smoking cessation aid;
• Require manufacturers to submit mock-ups of labels and packages for all new or amended product licenses to ensure no youth appeal.
Q3 : If pressed on industry concerns regarding Ministerial Order measures limiting access to nicotine pouches
A3 :
• Nicotine pouches and emerging nicotine replacement dosage forms with a limited history of appropriate use present risks of unintended use given their potential appeal to youth.
• In an effort to limit access by young people, new and emerging dosage forms may only be sold by a pharmacist or an individual working under the supervision of a pharmacist, who can assess before purchase whether the product will be used for its intended therapeutic purpose by a consumer.
• In addition, such nicotine replacement therapies must not be accessible to the public for self-selection (i.e., they must be kept behind the counter).
• There are other nicotine replacement therapies, including gums, lozenges, inhalers and sprays, that can be sold in areas with direct public access for self-selection including convenience stores to ensure access to these products for people who are using them for smoking cessation.
Q4 : If pressed on why Health Canada authorized these products if there is a concern for youth access
A4 :
• After authorizing the first nicotine pouch product in 2023 for use in adults, concerns were raised over the unintended access, appeal and use by youth and the associated risks.
• While the evidence submitted to obtain a license met all the regulatory requirements, given nicotine’s harmful effects on youth the Department considered different approaches to quickly protect their health and increase oversight of these products.
• Health Canada also continues to work on identifying and seizing unauthorized nicotine products in retail locations and works closely with the Canada Border Services Agency to disrupt the supply of these illegal products into the country.
Q5 : If pressed on the nicotine pouch recently approved by Health Canada as a nicotine replacement therapy
A5 :
• Health Canada remains committed to maintaining access to nicotine replacement therapies for people who are using them for smoking cessation.
• Two nicotine pouches are currently authorized, with more applications being assessed by the Department.
• Health Canada reviewed all product packaging and labels to ensure they meet the regulatory requirements, to reduce the appeal of, access to, and use of these products by youth, while still maintaining access for adults who need them to quit smoking.
Q6 : If pressed on federal vs provincial/territorial jurisdiction over place of sale
A6 :
• Provincial and territorial governments were engaged in the development of the new rules and while they do oversee place of sale restrictions for many types of products, the federal government can also establish place of sale restrictions when there are concerns over risks to health.
• The provincial and territorial governments have the authority to implement additional place of sale restrictions for nicotine replacement therapies should they deem it necessary.
Q7 : If pressed on lack of age restrictions/verification for nicotine replacement therapy sales
A7 :
• The Department considered age restriction as part of the new rules, however, through consultation, Health Canada determined that age verification would not be very effective overall, and was not considered necessary for new and emerging nicotine replacement therapy formats that will only be accessed through pharmacists, or their staff.

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• Tobacco use is responsible for over 45,000 preventable deaths in Canada each year.
• The proportion of young people in Canada who use nicotine products, including nicotine replacement therapies recreationally, has increased over the past several years.
• In the U.S., the 2023 National Youth Tobacco Survey found that nicotine pouches were popular among middle school and high school students, and were the most used behind e-cigarettes, cigarettes, and cigars.