Backgrounder: Regulation of vaping products in Canada

December 2019

The Government of Canada has established a strong regulatory framework for vaping products, and continues to take concrete action to reduce and prevent uptake by youth and adults who do not smoke tobacco products. This framework provides information to Canadians on the risks of vaping, including general information on what vaping is.

Federal Legislative Framework for Vaping Products in Canada

Vaping products are regulated differently depending on whether or not they make therapeutic claims or they contain cannabis.

Vaping Products That Do Not Contain Cannabis

The Tobacco and Vaping Products Act (TVPA), which became law on May 23, 2018, regulates the manufacture, sale, labelling and promotion of both tobacco and vaping products (other than those that contain cannabis) regardless of whether the vaping products contain nicotine or make a therapeutic claim.

The TVPA includes significant restrictions to prevent the uptake of vaping products by youth and adults who do not use tobacco products:

• The furnishing of vaping products to young persons (under 18) is prohibited. Sending and delivering these products to young persons is also prohibited.
• The content of vaping product promotions is restricted across all media channels, including social media. For instance:
  • Both advertising that could be appealing to young persons and lifestyle advertising are prohibited.
  • Promotion of vaping products by means of testimonials or endorsements or sponsorship promotion are prohibited.
  • Flavour descriptors that are appealing to youth are prohibited.
• The Act provides regulatory authorities to further restrict vaping product promotions, such as the placement of advertisements and promotion at point of sale.
• The manufacture, sale and promotion of vaping products containing certain ingredients, such as vitamins and minerals, caffeine and colouring agents, are prohibited. Regulatory authorities to further restrict ingredients are also provided for in the Act.

Vaping products, other than those that contain cannabis or to which the Food and Drugs Act (FDA) applies (i.e., those that make therapeutic claims), are consumer products and are subject to the Canada Consumer Product Safety Act (CCPSA). The CCPSA prohibits the manufacture, import, advertisement or sale of any consumer product that is a "danger to human health or safety" and it requires mandatory incident reporting by manufacturers, importers and sellers of consumer products, and mandatory document retention by any person who manufactures, imports, advertises, sells or tests a consumer product for commercial purposes. In addition, the CCPSA provides the authority to order recalls as well as tests or studies on a product, including for products such as vaping devices and their batteries or chargers, as well as vaping substance contents and it prohibits the sale of "very toxic" vaping substances (i.e., those containing 66 mg/g nicotine or more) because they are "a danger to human health or safety".

On December 19, 2019, Health Canada announced new proposed regulations to further restrict the promotion of vaping products, with the aim of reducing youth exposure to such advertising and thereby protect them from inducements to using vaping products. The proposed Vaping Products Promotion Regulations reflect comments received earlier this year in response to the Government's consultation on proposed new regulatory measures to restrict vaping product advertising. These regulations would prohibit advertising that can be seen or heard by youth, and prohibit the display of vaping products at retail locations, including online, that can be seen by youth. The proposed regulations would also require the display of health warnings on permitted vaping advertisements.

On December 19, 2019, Health Canada also announced the final Vaping Products Labelling and Packaging Regulations to create new labelling and packaging requirements for vaping products to increase awareness of the health hazards of using vaping products, help prevent the public from being misled about those hazards and to help protect the health and safety of Canadians, especially young children, by reducing the risk that they will ingest vaping substances containing toxic concentrations of nicotine.

Health Canada consulted Canadians on the Vaping Products Labelling and Packaging Regulations from June to September 2019. The Department considered all feedback in the development of the final regulations. They require that vaping substances display important health and safety information. Vaping products containing nicotine must display a standardized nicotine concentration statement and a health warning about the addictiveness of nicotine. In addition, vaping products containing nicotine must be packaged in child-resistant containers and display a toxicity warning and first-aid treatment statement. A list of ingredients must be displayed on all vaping substances, regardless of nicotine content. These regulations will come into force on July 1, 2020 with one exception. The requirement for refillable vaping devices and their parts to be child-resistant will come into force on January 1, 2021.

The FDA and its regulations apply to vaping products that are marketed for a therapeutic use (for example, products that have a health claim, such as "helps people quit smoking"). This includes products that contain nicotine or any other drugs as defined by the FDA. Products marketed for therapeutic use must receive an authorization from Health Canada before they can be advertised, sold or commercially imported in Canada. To date, no vaping products have received authorization under the FDA.

Vaping Products That Contain Cannabis

Vaping products containing cannabis are regulated under the Cannabis Act and its regulations. The Cannabis Act came into force on October 17, 2018, and establishes the framework for controlling the production, sale and possession of cannabis across Canada. The purpose of the Act is to protect public health and public safety, by, among other things, restricting youth access to cannabis, protecting young persons and others from inducements to using cannabis, and deterring illicit activities in relation to cannabis through appropriate sanctions and enforcement measures.

Following the coming into force of amendments to the Cannabis Regulations on October 17, 2019, cannabis extracts, such as vaping products, are legal for sale in Canada and are expected to gradually enter the Canadian market. Vaping products containing cannabis that are available through the illegal market in Canada are not subject to any controls or oversight and may pose additional risks to health and safety. Canadians should not purchase these products, and should immediately stop using any that may be in their possession.

In developing the regulations governing the production and sale of new cannabis products, including vaping products, Health Canada took into consideration risks associated with various routes of exposure to cannabis. Inhalation poses potential health risks because of the greater sensitivity and vulnerability of lung tissue to certain chemicals. For this reason, some of the regulatory requirements pertaining to inhalable cannabis extracts, such as vaping products, are even more stringent than those for other non-inhaled cannabis products. Licence holders must comply with all the provisions of the Cannabis Act and its regulations.

Under the amended regulations, ingredients that can be used in cannabis extracts, including vaping products, are restricted. It is prohibited for cannabis extracts to contain anything that may cause injury to the health of the user when the product is used as intended or in a reasonably foreseeable way. Further, cannabis extracts, including vaping products, are not permitted to contain anything other than carrier substances, flavouring agents, and substances that are necessary to maintain the quality or stability of the product. The use of sugars, sweeteners or sweetening agents as ingredients in cannabis extracts, including vaping products, is not allowed. Nicotine, caffeine and ethyl alcohol are prohibited in cannabis vaping products.

Similar to the rules for nicotine vaping products, the use of any ingredient listed in column 1 of Schedule 2 to the TVPA is not permitted in cannabis extracts, including vaping products. This includes prohibiting the addition of colouring agents, mineral nutrients and vitamins, including vitamin E acetate (although small amounts of vitamins are permitted to be used when necessary to preserve product quality or stability or to be present in carrier substances or flavouring agents at naturally occurring levels). In addition, to reduce the risks associated with vaping cannabis, the ingredients used in cannabis vaping products, other than flavouring agents, must be of pharmaceutical quality.

Licence holders are required to retain records related to cannabis extracts, such as vaping products, that they produce, and these records need to contain information on the ingredients used, their purpose and the results of analytical tests that must be conducted (e.g., microbial and chemical contaminant testing, THC and CBD concentration).

The Cannabis Act and itsregulations also include packaging and labelling controls to protect young persons and others from inducements to using cannabis and to promote informed consumer decisions. Cannabis extracts, including vaping products, need to be in plain, child-resistant packaging. Each package needs to be labelled with the standardized cannabis symbol if it contains THC, a health warning message developed by Health Canada, the product's THC and CBD concentration, and a list of ingredients, among other required elements. In addition, the amended Cannabis Regulations require the display of the standardized cannabis symbol on any cannabis accessory that contains inhalable cannabis extracts, such as vaping products, and that contains more than 10 μg/g of THC (e.g., the device or cartridge containing the cannabis extract).

These packaging and labelling requirements complement the strict controls on promotion established in the Cannabis Act, which are designed to protect young persons and others from inducements to using cannabis. In general, it is prohibited to promote cannabis, including cannabis vaping products. Limited promotion of cannabis, cannabis accessories and services related to cannabis is permitted under the Cannabis Act. For example, informational or brand-preference promotion is permitted in limited circumstances, such as if the promotion is in a place where young persons are not permitted by law or if it is in a communication that is addressed and sent to an adult who is identified by name.

Licence holders are required to provide Health Canada with 60 days' notice in advance of selling a cannabis product for the first time in Canada. This requirement applies to all products, including cannabis vaping products. This notice does not constitute approval for sale by Health Canada, nor does it mean that the product complies with legislative or regulatory requirements. This notice period may provide Health Canada an opportunity to intervene before a product enters the market if the Department has concerns or questions. Licence holders are responsible for ensuring that all their products meet the requirements set out in the Act and Regulations.

As with vaping products containing nicotine, the safety of cannabis vaping devices (such as the batteries) is regulated under the CCPSA.