Notice to Industry Regarding Vaping Products not marketed for a Therapeutic Use

The Issue

The term “vaping products”^{Footnote 1} refers to both vaping devices (including individual parts such as atomizers, etc.) and vaping liquids.

Vaping devices, also known as e-cigarettes and electronic nicotine delivery systems, vary in design and appearance. Most vaping devices consist of a battery, a heating element, a tank or reservoir, and a mouthpiece. They work by heating vaping liquid to form an aerosol that is inhaled by the user.

Vaping products marketed for a therapeutic use and those that contain nicotine or may be used with nicotine are currently considered health products by Health Canada. These products require market authorization under the Food and Drugs Act (F&DA) before being offered for sale.

Under the Government of Canada’s proposed regulatory framework as described in Bill S-5 (an Act to amend the Tobacco Act and the Non-smokers’ Health Act and to make consequential amendments to other Acts), vaping products not marketed for a therapeutic use, including those that contain nicotine or may be used with nicotine, would be considered consumer products. Therefore, these products would be subject to the requirements of the Canada Consumer Product Safety Act (CCPSA). Vaping products marketed for a therapeutic use will continue to be subject to the requirements of the F&DA.

Health Canada intends to develop additional regulations under the authority of the CCPSA to address health or safety risks posed by vaping products. These may include safety requirements for hardware components, such as the vaping device, batteries and chargers.

The Canada Consumer Product Safety Act

The purpose of the CCPSA is to help protect the public by addressing or preventing dangers to human health or safety posed by consumer products in Canada. The Consumer Product Safety Program of Health Canada administers and enforces the CCPSA and its associated regulations.

Paragraphs 7(a) and 8(a) of the CCPSA prohibit the manufacture, import, advertising, or sale of a consumer product that is a “danger to human health or safety”, commonly referred to as the general prohibition. Such dangers include unreasonable hazards, existing or potential, which may reasonably be expected to cause death or injury.

Description of the Risk

One of the potential risks associated with vaping products is poisoning through ingestion of the vaping liquid. Nicotine is a highly potent toxicant found in many vaping liquids and has also been measured in some vaping liquids labelled as “nicotine-free”. Nicotine can adversely affect the cardiovascular and central nervous systems at very low doses. A number of cases of acute nicotine poisoning have occurred when vaping liquids containing nicotine were ingested. Three of these reported incidents were fatalities. A child may experience serious and potentially life-threatening health effects following ingestion of even a small amount of vaping liquid that contains nicotine.

Flavours are widely utilized in e-liquids in order to make them pleasant to smell or taste and provide a variety of choices to users. These flavours also may make e-liquids more appealing to children and increase the risk of ingestion and poisoning.

Consumer Chemicals and Containers Regulations, 2001 (CCCR, 2001)

The CCCR, 2001 set out a classification-based approach to establishing rules for consumer chemicals, including a prohibition against the sale of very toxic substances and requirements for labelling and child-resistant containers for toxic substances.

Health Canada has reviewed the toxicity of nicotine, and has determined the following classifications for vaping liquids to be sold as consumer products under the Toxic Products category of the CCCR, 2001:

1. Vaping liquids containing equal to or more than 66 mg/ml (6.6%) nicotine meet the classification of "very toxic" under the CCCR, 2001 and will be prohibited from import, advertising or sale under section 38 of the CCCR, 2001.
2. Vaping liquids containing between 10 mg/ml (1.0%) and less than 66 mg/ml (6.6%) nicotine meet the classification of "toxic". These will be required to be sold in child-resistant containers and labelled in accordance with the CCCR, 2001.

When nicotine is present in vaping liquids at concentrations below 10 mg/ml (1.0%), there is no toxic classification under the CCCR, 2001. Notwithstanding, nicotine is potentially toxic via oral exposure at concentrations below 1%. Health Canada has determined that any vaping liquid containing nicotine between 0.1 mg/ml (0.01%) and 10 mg/ml (1.0%) that does not adhere to all requirements of the CCCR, 2001 for “toxic” products, including the requirement for a child-resistant container^{Footnote 2}, is a likely contravention of the CCPSA’s general prohibition. Under sections 7 and 8 of the CCPSA, it is prohibited to manufacture, import, advertise or sell a consumer product that is a danger to human health or safety.

What is Health Canada doing?

Enforcement of the CCPSA on vaping products will begin immediately upon Royal Assent of Bill S-5. Health Canada will use the parameters outlined in the previous section to determine whether products may be subject to compliance and enforcement action.

As Health Canada works towards development of regulations, the department will continue to assess other potential risks associated with vaping products and may take additional actions as needed.

Other Information

If you would like additional information regarding this notice, please contact the Consumer Product Safety Directorate by email at cps-spc@hc-sc.gc.ca or telephone (1-866-662-0666 Canada and U.S. only).

Health Canada is considering introducing regulations on vaping products pursuant to the proposed Tobacco and Vaping Products Act (TVPA). The proposed TVPA is part of Bill S-5, an Act to amend the Tobacco Act and the Non-smokers’ Health Act and to make consequential amendments to other Acts, which was presented to Parliament in November 2016.

The consultation document contains 10 proposed measures for vaping product regulations under the proposed TVPA. These proposed measures range from specifying which information is to be displayed on labels and which information is to be reported to the department, to imposing further restrictions on permitted advertising and to authorizing statements on relative health risks. All interested organizations and individuals are invited to review the measures being considered, and to provide their feedback by October 27, 2017.

The consultation is available online and can be accessed here.