Nicotine Health Products
When it comes to quitting smoking there are several products available to assist smokers such as nicotine replacement products and e-cigarettes also known as vaping products. Health Canada has introduced and amended relevant Acts and Regulations to control the manufacturing, sale, and promotion of tobacco products, vaping products and nicotine replacement therapy products sold in Canada.
In response to the rising prevalence of vaping Health Canada has replaced the Tobacco Act with the Tobacco and Vaping Products Act (TVPA) to support the Government of Canada’s tobacco control objectives and prevent the use of vaping products from leading to tobacco product use by young persons and non-users of tobacco. The TVPA creates a legal framework to regulate vaping products by prohibiting their sale to persons under 18 years of age, restricting how vaping products are advertised and limiting which ingredients can be included in these products.
The definition of a “vaping product” is set out in Item 2 of the TBVA as:
- (a) a device that produces emissions in the form of an aerosol and is intended to be brought to the mouth for inhalation of the aerosol
- (b ) a device that is designated to be a vaping product by the regulations
- (c) a part that may be used with those devices
- (d) a substance or mixture of substances, whether or not it contains nicotine, that is intended for use with those devices to produce emissions
Substances or liquid mixtures intended for use with a vaping device are covered under Item 2(d), therefore these liquids are subject to the labelling requirements set out in the TVPA.
Nicotine replacement therapy (NRT) products, unlike vaping products, are exempt from the requirements of the Tobacco and Vaping Products Act based on the newly created regulations excluding certain health products from the TVPA if they are already regulated under the Food and Drugs Act. Nicotine gum and nicotine patches sold in Canada are two such examples of exempt health products, and they are sold and regulated in Canada as natural health products (NHPs). Health Canada approved NHPs for smoking cessation are permitted to carry statements regarding their ability to reduce nicotine cravings and withdrawal symptoms. These NHPs are permitted to be promoted as having less medical risk associated with their use than cigarettes; statements such as these may be used as long as they align with (and don’t extend beyond) their market authorization. In order to sell or import NRT into Canada manufacturers must first provide evidence to Health Canada to support the safety and efficacy of products including health claims support.
A nicotine-containing health product can only be classified as an NHP if the format of the contained nicotine matches one of the formats provided in the relevant listing in the NNHPD ingredient database. If nicotine is provided in a form other than gum, lozenges or patches, the nicotine must be administered into the oral cavity by means of a non-active device (one that operates on energy generated by the human body or by gravity). Vaping substances, based on the mechanism of their administration are not covered by the nicotine listing under the NHP regulations.
Nicotine snus (pouches) recently approved by the US Food & Drug Administration would be classified as natural health products in Canada according to the above classification criteria. Health claims and promotional material would need to be consistent with those listed on the product license issued by Health Canada’s Natural and Non-prescription Health Products Directorate.
Health Canada’s acceptance of exemptions for certain products from the TPVA demonstrates their confidence with the current framework for oversight of modified risk nicotine products. For new nicotine product formats there may be some advantages to leveraging existing regulations that allow for health claims so that consumers receive as much information as possible to support their choices of suitable smoking cessation products.
