Nicotine Replacement Therapies

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The “Supplementary Rules Respecting Nicotine Replacement Therapies Order” (SOR/2024-169) was issued by the Canadian Minister of Health under the Food and Drugs Act. The order introduces new regulatory measures regarding nicotine replacement therapies (NRTs), which are used to help individuals quit smoking by delivering nicotine through gums, patches, lozenges, and sprays. The primary concern behind the order is the potential appeal of these products to non-smokers, particularly young people under 18 years old, who may be susceptible to nicotine addiction and other health risks. The objective of the order is to reduce nicotine exposure, dependence, and health harms among young people.

NRTs are classified as natural health products and regulated under the Natural Health Products Regulations if they are orally administered. This order specifically applies to such orally administered NRTs, excluding transdermal patches and prescription-only products. The order addresses several key concerns about the accessibility, flavoring, marketing, and labeling of NRTs in order to mitigate risks associated with their misuse, especially among youth.

One of the main features of the order is the creation of a list of approved NRT dosage forms that are available for self-selection by consumers. NRT products that are not on this list must be sold by a pharmacist or under their supervision, restricting their availability to reduce the risk of inappropriate use. Furthermore, the order restricts the flavors that can be used in NRTs. Only mint, menthol, or combinations of these flavors are permitted in NRTs sold over the counter. Other flavors, especially dessert, confectionery, soft drink, and energy drink flavors, are prohibited, as they may appeal to young people.

The order also imposes new rules regarding the advertising, packaging, and labeling of NRTs. Advertising that could be appealing to young people or that suggests any use other than smoking cessation is prohibited. Additionally, NRTs with misleading brand names or packaging that could appeal to young people, resemble cannabis products, or look like food products are also banned.

Health Canada’s rationale behind these measures is grounded in the growing popularity of nicotine products among youth. Nicotine is a highly addictive and harmful substance, particularly for young people whose developing brains are more vulnerable to addiction. Research has shown a significant increase in nicotine product use among Canadian youth, driven by the popularity of vaping products, and there are concerns that NRTs could become part of this trend. Although NRTs are intended for smoking cessation, young people may perceive them as less harmful and could misuse them for recreational purposes, increasing the risk of nicotine dependence.

The order reflects concerns that the marketing and sale of NRTs are becoming increasingly similar to those of tobacco and vaping products, which can create confusion among consumers. This overlap in marketing and product availability could lead to unintended or concurrent use of NRTs, tobacco, and vaping products, further exacerbating health risks, particularly for youth.

Canada (SOR/2024-169) August 28, 2024