451-00030 (Health)

Health Canada authorizes nicotine replacement therapies (NRTs) for the specific use of smoking cessation by adults. They are not authorized for recreational use or use by people under 18 years of age; however, there is concern that some of these products, especially emerging formats such as pouches, are becoming popular with youth and may lead them to nicotine dependence. Nicotine is a toxic and addictive substance that can be harmful to health; young people are particularly susceptible to nicotine’s addictive properties.

To address these concerns, the Supplementary Rules Respecting Nicotine Replacement Therapies Order(the Order) was published on August 28, 2024, introducing new measures for orally administered NRTs to reduce the appeal of, access to, and use of these products by youth, including requirements related to place of sale, flavours, packaging and labelling, and advertising.

The List of Nicotine Replacement Therapy Dosage Forms that may be Accessible for Self-selection by Purchasers or Consumers(the List) is a document incorporated by reference into the Order that sets out the NRT dosage forms that can be sold on a retail basis in self-selection areas because they have an established history of appropriate use. The List currently includes gums, lozenges, inhalers and sprays. NRT dosage forms not on the List, including nicotine pouches, are those with a limited history of appropriate use in Canada. This means that these dosage forms may not be sold in self-selection areas in retail settings including convenience stores. Over time, Health Canada may add an NRT dosage form to the List based on evidence submitted by a licence holder to support its history of appropriate use.

Health Canada understands that quitting smoking can be challenging and is committed to maintaining access to NRTs for adults who use these products for smoking cessation. At the same time, the Department is responding to the public health concerns about the availability, use and marketing of certain NRTs and their potential appeal to youth.

Health Canada is actively addressing the distribution and sale of unauthorized nicotine products. We are also working closely with the Canada Border Services Agency to identify and seize unauthorized nicotine products and prevent their entry into the country.