Question Period Note: Nicotine Replacement Therapy

• Following the authorization of the Zonnic nicotine pouches, there have been serious concerns raised around the availability, use and advertising of the product.
• The Department received correspondence from several health organizations, Canadian Chief Medical Officers of Health, and citizens requesting to take immediate actions to mitigate youth access and appeal.
• This issue has also been the subject of sustained media attention.

• Health Canada shares the concerns expressed by health care professionals about reports of growing popularity and recreational use of nicotine replacement therapies among youth, including access to Zonnic and unauthorized nicotine pouches.
• Health Canada authorized Zonnic as a smoking cessation tool for adults only. The department has expressed concerns and expectations to the manufacturer regarding the labeling and advertising of their product in an effort to limit youth appeal.
• Health Canada has taken steps to verify that Zonnic’s current advertising and product labelling is in compliance with the Food and Drugs Act and its regulations, but we need stronger measures to prevent these products from being marketed or sold to youth.
• Health Canada is taking action to strengthen government controls to prevent youth access and to protect public health. To this end, the department is pursuing legislative and regulatory options for additional measures to protect youth from risks related to use of nicotine replacement therapies for a purpose other than its intended use.
• Health Canada continues to work with federal partners, such as the Canadian Border Services Agency and the Royal Canadian Mounted Police to monitor regulatory compliance and take enforcement action as needed, including the removal of unauthorized products from the market.
IF PRESSED ON … WHAT IS HEALTH CANADA DOING TO ADDRESS THE CONCERNS OF THE HEALTH COMMUNITY?

• The Department has communicated its strong concerns to the manufacturer to underscore the importance of preventing youth access to the product and the expectations regarding labeling and advertising of their products, making it clear that these products are only for use by adults over 18 years who want to quit smoking.
• Health Canada has confirmed that contracts are in place with retailers, with the exception of pharmacies, to place the product behind the counter, with age verification required prior to sale. Health Canada has also received confirmation from an association representing some convenience stores and gas stations that it requires its members to age verify the product
• The Department is taking the concerns very seriously and is taking legislative and regulatory action to prevent youth access and appeal of certain nicotine replacement therapies. The department published a notice of intent on March 21, 2024, to inform the public that Health Canada is taking these actions, and legislative amendments were announced as part of Budget 2024 that would enable the Department to make additional rules to prevent risks associated with unintended access, if the amendments are passed
• The Department is also engaging with international counterparts who are seeing similar issues with nicotine products in their own jurisdictions, including products that haven’t been seen yet in Canada.
IF PRESSED ON … WHY DID HEALTH CANADA AUTHORIZE THESE PRODUCTS IF THERE IS A CONCERN FOR YOUTH ACCESS?
• Health Canada authorizes health products based on the evidence supporting their safety, efficacy and quality when used as directed.
• Health Canada’s current regulations require that labelling for nicotine replacement products state they are only for use by adults over 18 years of age who are trying to quit smoking, but we need stronger measures to help ensure that these products are not being aggressively marketed or sold to youth.
• When Health Canada identifies or is notified of non-compliance, actions are taken based on the risk they may pose to the public. A number of compliance and enforcement actions are available, including seizures, recalls, and public communications.
IF PRESSED ON … WHY HEALTH CANADA IS NOT BANNING FLAVOURS?
• The Department is reviewing its approach to regulating nicotine replacement products and will consult with stakeholders on potential regulatory changes to reduce the risk of youth appeal and access to these products, while maintaining the smoking cessation objective of these products.
IF PRESSED ON … WHY HEALTH CANADA LICENSED A PRODUCT THAT IS OWNED BY THE TOBACCO INDUSTRY?
• Health Canada is committed to protecting the health and safety of Canadians by reviewing the safety, efficacy and quality of all health products before they enter the Canadian market.
• If a company can successfully demonstrate that their health product is safe, efficacious when used according to the recommended conditions for use, and of high quality and that they meet all the requirements in the applicable laws and regulations, they can obtain a licence to sell their health product in Canada.
• Zonnic nicotine pouches were authorized by Health Canada for smoking cessation only for adults 18 years and older, and Health Canada will monitor the advertising to ensure that it is not deceptive and that it is aligned with the intended use; it will take any post-market compliance actions it considers necessary in case of non-compliance.
IF PRESSED ON … LACK OF ENGAGEMENT WITH P/TS AND HEALTH ORGANIZATION
• Health Canada has been engaging with provincial and territorial counterparts, as well as several non-governmental organizations including health advocacy groups on possible options for restricting place-of-sale of this product and ensuring age verification is conducted.
• Health Canada intends to further consult a range of implicated stakeholders as it proceeds with any additional measures to protect against unintended access by youth.
IF PRESSED ON … WHAT IS HEALTH CANADA DOING ABOUT OTHER NICOTINE REPLACEMENT THERAPIES
• Health Canada has written to all licence holders who sell nicotine replacement therapies to remind them of the terms of their licencing and that products should not be advertised to youth and should be labelled according to the terms of the authorization.
• Additional requests on advertising and labelling for nicotine replacement therapies were included in the letter, including clear age restrictions, no lifestyle advertising, and less bright colours.
IF PRESSED ON … WHAT IS HEALTH CANADA DOING ABOUT UNAUTHORIZED NICOTINE REPLACEMENT THERAPIES
• Health Canada does not hesitate to take action when it identifies or is notified of the sale of unauthorized nicotine replacement therapies.
• Health Canada continues to work on identifying and seizing unauthorized products in retail locations across Canada, and disrupting the supply of these products into the country by working closely with the Canada Border Services Agency.
• The Department also issued a public advisory reminding Canadians about the risks of nicotine, especially for youth, as well as stressing the importance of only using authorized nicotine pouches as directed, and not buy or use unauthorized pouches

• The Zonnic nicotine pouch was authorized by Health Canada on July 18, 2023, as a smoking cessation aid for adults 18 years and older, similar to other nicotine replacement therapy products (NRTs) such as gums or lozenges.

• Health Canada has authorized close to 100 NRT products for sale in Canada, including lozenges, gums, patches, liquids, sprays, and vaporizers. The health claims approved for the Zonnic pouch, the rules around access to these products, and the flavours are similar to those approved for other licensed NRTs.

• Nicotine pouches are subject to a variety of regulatory approaches around the world, from outright bans to partial or selective regulation, depending on how they are defined and classified by governments to no regulation. For example, in Belgium these products were freely available on the market and unregulated prior to being banned. In United States, nicotine pouches without health claims are regulated as Tobacco products.

• In November and December 2023, the Department received correspondence from a coalition of six health organizations, which was also published online, the Canadian Chief Medical Officers of Health from across Canada, and citizens regarding concerns about youth access and appeal of nicotine pouches. Since then, other public health leaders have continued to raised similar concerns.

• The coalition of health organizations (Action on Smoking and Health, Canadian Cancer Society, Canadian Lung Association, Coalition québécoise pour le contrôle du tabac, Heart & Stroke, and Physicians for a Smoke-Free Canada) has met with Health Canada to share its concerns about the risks of youth using nicotine pouches.

• The Department recognizes that nicotine is a powerfully addictive substance, and children and teenagers are especially susceptible to its addictive properties as brain development continues throughout adolescence and into early adulthood. Given this, Health Canada has taken immediate action regarding concerns about youth access and appeal of nicotine pouches.

• As part of the proactive surveillance of nicotine pouches, Health Canada has requested the manufacturer of Zonnic nicotine pouch to submit annual safety reports in order to proactively monitor for adverse reactions and other post-market data on benefits and risks. In addition, Health Canada is also proactively investigating other data sources for surveillance (i.e., Canadian Poison Centres) related to all nicotine replacement therapies, with a focus on intentional and unintentional use in individuals under 18 years of age. Should there be new safety issues identified, Health Canada will take action, as appropriate.

• Furthermore, Health Canada has written to all NRT licence holders to remind them of the terms of their licence and that products should not be advertised to youth and should be labelled according to requirements under the NHPR. Additional specific guidelines for NRTs were included in the letter, including clear age restrictions, no lifestyle advertising, and less bright colours. These guidelines will be posted online.

• Health Canada is holding ongoing engagement with P/Ts to remind them that they have the authority to restrict place of sale or require age verification, if they deem appropriate. Federal and P/T officials have agreed to work together to prevent youth access to these products. Outreach will continue between the Health Canada and P/T officials and detailed information on the regulations available in each PT will be collected to better inform the discussion.

• On February 7, 2024, BC announced that it amended its Drug Schedules Regulation to require buccal nicotine pouch products, like the ones sold under the brand name Zonnic, to be kept behind the counter at pharmacies. Individuals wishing to purchase these products will need to consult a pharmacist, who can inform those purchasing the pouches about the health risks associated with nicotine dependency.

• In Quebec, regulations already existed for nicotine replacement therapy products to be sold only in pharmacies. However, the Quebec Order of Pharmacists further encouraged pharmacists to keep these products behind the counter to ensure that use is safe and consistent with the intended use of these products.

• On March 21, 2024, the department published a notice of intent to inform the public that Health Canada is planning to take action to address risks associated with the access and apparent youth appeal of certain nicotine replacement therapies (NRTs), such as nicotine pouches.

• In Canada, nicotine pouches are regulated under the Food and Drugs Act (FDA). They are classified either as a natural health product (NHP) or a prescription drug based on the quantity of nicotine. More specifically, if a nicotine pouch delivers 4 mg of nicotine or less per dose, it is regulated as a NHP under the Natural Health Products Regulations (NHPR).
• The Zonnic nicotine pouch was authorized by Health Canada on July 18, 2023, as a smoking cessation aid for adults 18 years and older, similar to other nicotine replacement therapy products (NRTs) such as gums or lozenges.
• While NRTs are approved federally for use by adults 18 years and older, the place-of-sale and age-related restrictions for sale fall under provincial and territorial regulatory authority.
• Advertising rules under the FDA stipulate that advertisements may not be false or misleading and must comply with the conditions of the authorization. As such, any product authorized for sale in Canada cannot make false and misleading claims that target youth.