Notice of Intent to address risks of youth appeal and access to nicotine replacement therapies
Notice of intent to explore legislative and regulatory options for additional measures to protect youth from new and emerging risks related to nicotine replacement therapies
Purpose
The purpose of this Notice of Intent is 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.
Background
NRTs are classified as a drug under the Food and Drugs Act (FDA) as they are intended for use by adults aged 18 years and older who smoke regularly and wish to quit. Health Canada regulates NRTs under the FDA to ensure regulatory requirements for safety, efficacy and quality are met, and reduce health risks to Canadians. Drug products are subject to pre-market review and approval by Health Canada. Evidence behind health claims is reviewed to make sure that the product does what it claims to do, and the benefits outweigh the risks.
Depending on the amount of nicotine contained or delivered by the product, an NRT would be considered a prescription drug or a natural health product. All NRTs need market authorization from Health Canada and must carry an approved health claim for smoking cessation to be legally sold in Canada. NRTs that are regulated as natural health products are presently available for sale at retail, including in pharmacies, in a range of formats and with certain flavours.
Strong concerns have been raised regarding the access and potential appeal to youth of certain new and emerging NRTs, such as nicotine pouches, and the way they are marketed. Youth smoking rates are at an all-time low in Canada and advertising of NRTs should not be appealing to youth. NRTs should only be promoted for use in smoking cessation. The representation of NRTs through labelling, packaging, and advertising among other things should reflect the intended audience of adults who smoke and the public health objective of these products. As nicotine is addictive and toxic, nicotine products should be kept out of the reach of children and youth at all times.
Children and teenagers are especially susceptible to the addictive properties of nicotine as brain development continues throughout adolescence and into early adulthood. Youth access and appeal to youth, as well as place of sale, are not typically managed as part of the regulations under the FDA.
The Tobacco and Vaping Products Act (TVPA) regulates the manufacture, labelling, sale and promotion of tobacco and vaping products. Youth access and appeal are restricted through prohibiting sales to people under the age of 18, certain promotional activities (e.g., lifestyle advertising), and limiting certain flavours appealing to youth. However, the TVPA does not apply to NRTs, other than vaping products, as they are classified as drugs when authorized for smoking cessation purposes and do not contain tobacco.
Proposal
Given the concerns about the potential access and appeal to youth of certain NRTs, and the scope and design of the current legislative and regulatory frameworks, Health Canada is considering additional legislative and regulatory mechanisms to enhance controls and public health protections. New requirements to reduce youth access and appeal, such as, but not limited to, specific requirements for labelling and packaging, as well as restrictions related to colours, flavours, advertising, and place of sale, are being considered.
Rationale
Protecting the health of young persons from exposure to and dependence on nicotine is an important objective for Health Canada and a priority under Canada's Tobacco Strategy. Health Canada is committed to ensuring the appropriate oversight is in place to protect youth, while maintaining the smoking cessation objective of authorized NRT products.
Contact Information
Natural and Non-prescription Health Products Directorate
Health Products and Food Branch
Health Canada
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