Guidance on Vaping Products not Marketed for a Therapeutic Use

Table of Contents

1. Introduction

This document provides information to industry on the health and safety requirements for vaping products without therapeutic claims under the authority of the Canada Consumer Product Safety Act (CCPSA). For the purpose of this document, ‘vaping products’ refers to a vaping product without therapeutic claims.

Vaping productsFootnote 1 include the vaping device (commonly referred to as an e-cigarette, vape pen, vaporizer or vape mod), as well as the vaping liquid (commonly referred to as e-liquid or e-juice) and its container. 

More specifically, this document provides information about the legislative requirements under the CCPSA, including the requirement for child-resistant containers, and health or safety considerations, such as those to address certain electrical and mechanical hazards, for vaping products that are manufactured, imported, advertised, or sold in Canada.  

In addition to the CCPSA, vaping products are also legislated under the Tobacco and Vaping Products Act (TVPA), Food and Drugs Act (for vaping products with therapeutic claims) and the Non-smokers’ Health Act. For more information on specific requirements, please consult the relevant legislation.

This document is not intended to substitute for, supersede, or limit the requirements under the applicable legislation. In case of any discrepancy, the legislation will prevail.

For further information, refer to Appendix A - Information Resources, or contact a Health Canada Consumer Product Safety Office via email (hc.cps-spc.sc@canada.ca) or telephone at 1-866-662-0666 (toll-free within Canada and the United States).

Health Canada will be assessing other potential dangers associated with vaping products, including but not limited to those outlined in this guidance document. This guidance may be further revised.

For the most recent version of this document, consult Reports and Publications – Consumer Product Safety.

2. Legislation – Canada Consumer Product Safety Act (CCPSA)

Vaping products that are manufactured, imported, advertised, or sold in Canada are subject to the CCPSA, which includes, for example:

Under the CCPSA, Health Canada has the power to:

  • order recalls and other measures (see sections 31 and 32); and
  • order tests or studies on a product (see section 12(a)).

Further information is available in the CCPSA Quick Reference Guide.Footnote 3

The Consumer Product Safety Program administers and enforces the CCPSA and its regulations. Enforcement actions taken by Health Canada on non-compliant products depend on the degree of risk associated with non-compliance. For example, these actions may include:

  • commitment to product correction by industry;
  • negotiation with industry for the voluntary removal of these products from the market;
  • orders by Health Canada to take specified actions;
  • product seizure by Health Canada, and/or:
  • prosecution under the CCPSA.

3. Requirements for Vaping Liquids and Containers under the Consumer Chemicals and Containers Regulations, 2001 (CCCR, 2001)

At this time, no product-specific regulations under the CCPSA exist for vaping products.  While provisions of the CCPSA will always apply to vaping products, Health Canada intends to introduce regulations under the CCPSA to address health or safety risks posed by these products. Until specific regulatory requirements are in place, the Consumer Chemicals and Containers Regulations, 2001 (CCCR, 2001) will be applied to address these risks.

One of the 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 detected in some vaping liquids labelled as “nicotine-free”. Nicotine can adversely affect the cardiovascular and central nervous systems at very low doses. Flavours are widely utilized in vaping liquids in order to make them pleasant to smell or taste and provide a variety of choices to users. These flavours also may make vaping liquids more appealing to children and increase the risk of ingestion and poisoning.  A number of cases of acute nicotine poisoning have occurred when vaping liquids containing nicotine were ingested. A child may experience serious and potentially life-threatening health effects following ingestion of even a small amount of vaping liquid that contains nicotine.

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 manufactured, imported, advertised, or sold as consumer products:

  1. Vaping liquids containing equal to or more than 66 mg/g nicotine meet the classification of "very toxic" under the CCCR, 2001 and are prohibited from being manufactured, imported, advertised, or sold under section 38 of the CCCR, 2001.
  2. Vaping liquids containing between 10 mg/g and less than 66 mg/g nicotine meet the classification of "toxic" under the CCCR, 2001. Stand-alone containers of these liquids must meet the CCCR, 2001 requirements for “toxic” chemicals, including child-resistant containers and hazard labelling.
  3. While the CCCR, 2001 excludes ingredients present between 0.1 mg/g and 10 mg/g when calculating a chemical product's toxicity, Health Canada has determined that nicotine is potentially toxic via oral exposure in this concentration range. Therefore, vaping liquids containing nicotine between 0.1 mg/g and 10 mg/g or under 1% (m/m)Footnote 4 that do not meet the requirements for the “toxic” classification under the CCCR, 2001 are a violation of the general prohibition set out in paragraphs 7(a) or 8(a) of the CCPSA and are subject to enforcement action.

Exclusion for Vaping Devices that Hold or May Hold Vaping Liquids Containing Nicotine

Vaping devices with refillable tanks and other vaping device parts that hold or may hold vaping liquids with nicotine have been excluded from the scope of the CCCR, 2001 by subsection 4(4) of the CCPSA.

This is an interim measure, intended to provide time for industry members to manufacture or source vaping devices with refillable tanks that meet the requirements of the CCCR, 2001 (which include child-resistant containers and toxicity labelling). Health Canada plans to introduce specific vaping product (health or safety) regulations which may include child-resistant container and toxicity labelling requirements for all containers of vaping substances, including refillable vaping device tanks. Industry should begin to source vaping devices with refillable tanks that could meet the requirements of the CCCR, 2001 now.  In the meantime, vaping devices are still subject to the CCPSA, including sections 7 and 8 of the Act.

Current regulatory requirements for text that must be present on the label of a stand-alone vaping liquid container do not preclude manufacturers from placing other information on the label, including expiry dates, lot numbers and contact information.

4. Additional Health or Safety Considerations

As per the general prohibition in sections 7 and 8 of the CCPSA, vaping products that are manufactured, imported, advertised, or sold in Canada must not pose a danger to human health or safety.

4.1 General Considerations

Manufacturers are encouraged to have quality control plans for their vaping products. These plans should define procedures for the inspection, validation, and quality of all materials and components used in the manufacturing process. It is Health Canada’s expectation that manufacturers thoroughly understand their manufacturing process and implement all the necessary controls required for product safety. In addition, manufacturers should consider relevant health and safety standards, guidelines, and other safety-related guidance in the manufacture of their products.

4.2 Electrical and Mechanical Considerations

Most vaping devices consist of a battery, a heating element, a reservoir, and a mouthpiece. The following provides a summary of the health or safety considerations related to certain electrical and mechanical hazards of vaping devices. Many of the considerations outlined below are dealt with in Standard ANSI/CAN/UL 8139, and manufacturers are strongly encouraged to certify their products to this standard.

4.2.1 Devices

Consideration should be given to the electrical and mechanical integrity of vaping devices. Vaping devices should be manufactured to withstand the maximum anticipated current, voltage and temperature specifications of the product. The mechanical integrity of internal connections should be sufficient to withstand conditions of reasonably foreseeable misuse. Accessories for the vaping device and replacements should specify their operating characteristics and compatibility to avoid the risk of rupture, fire, or explosion.

Vaping devices should not be susceptible to external short circuits, and should incorporate a pressure-relief mechanism so that they will discharge excessive internal pressure in a direction where the harm is minimized, and at a rate that will preclude rupture, explosion, or self-ignition.

4.2.2 Batteries

Manufacturers should consider battery quality and performance. While Lithium-ion battery failures are uncommon, they do occur – in fact, battery failures are responsible for the majority of hardware incidents with vaping devices. The problem is primarily due to the Lithium-ion battery chemistry and construction and is not unique to vaping device applications. Within a vaping device, these batteries are often confined in an enclosure that can allow pressure to build up. Failures often occur when a consumer is holding the device at or near their face, further increasing the severity of the injury.

Integrated Lithium-ion batteries should meet the requirements of Standard CAN/CSA-E62133 or equivalent, and manufacturers should ensure these batteries are not overstressed during intended use. A battery management system should be incorporated into a vaping device so that integrated cells cannot be over charged or discharged. When a vaping device allows consumers to replace batteries, the vaping device manufacturer should clearly identify the battery capacity and peak current requirements of their device. This will allow the consumer to choose replacement batteries compatible with the device.

4.2.3 Chargers

The manufacturer’s charging specifications and instructions should clearly identify appropriate voltage, current, and temperature limits, and should be provided with each charger. Any charger provided with the product should be certified to the applicable Canadian national standard by a certification body accredited by the Standards Council of Canada.

4.3 Vaping Liquid Considerations

The following subsections provide a summary of the health or safety considerations related to vaping liquids.

4.3.1 Nicotine

Nicotine is a highly potent toxicant that can adversely affect the cardiovascular and central nervous systems at very low doses. Nicotine may also contain various impurities and, as such the nicotine used in vaping liquids should be within the specifications of an accepted pharmacopoeia, such as is outlined in Schedule B of the Food and Drugs Act. The nicotine content of all vaping liquids should be accurately described on the label.

For information on the permissible levels of nicotine in vaping liquids and corresponding regulatory requirements under the CCPSA, please refer to section 3 of this document. 

4.3.2 Diluents

Vaping liquids typically utilize propylene glycol, glycerol, or a combination of both as a ‘base’, alternatively referred to as a ‘carrier solvent’ or ‘vehicle’. The available data suggest that propylene glycol is likely to have low systemic toxicity, but may have irritant effects on the respiratory tract. Although widely used in food, cosmetics, and pharmaceuticals, there are few publicly available inhalation studies on glycerol and the long-term health consequences associated with heating and inhaling this substance are unknown. The diluents used in vaping liquids should be within the specifications of an accepted pharmacopoeia, such as is outlined in Schedule B of the Food and Drugs Act. When selecting a diluent, solvents of known human toxicity, such as ethylene glycol or diethylene glycolFootnote 5, should not be added.

4.3.3 Flavourants and Other Additives

Flavours are widely utilized in vaping liquids in order to make them palatable and to provide variety and choice to users. However, to date, limited information exists on the inhalation safety of the majority of flavourings used in vaping liquids, and certain flavourings have been associated with pulmonary diseaseFootnote 6. All flavourants added to vaping liquids should be of food grade or higher purity, and those substances with known inhalation risks (e.g., diacetyl and 2,3-pentanedione) should not be used in flavourings. Substances intentionally added to vaping liquids, including flavourings, preservatives, and fragrances, should be evaluated for their potential to cause adverse health effects via inhalation.

4.3.4 Impurities

Published research studies Footnote 7 Footnote 8 Footnote 9 have shown that commercially available vaping liquids may contain a wide range of potentially harmful impurities, including heavy metals, polycyclic aromatic hydrocarbons (PAHs), benzene, toluene, naphthalene, 1,3-butadiene, propylene oxide and various tobacco-specific nitrosamines. Manufacturers should source ingredients of suitable quality/purity from reliable suppliers and take steps to minimize the presence of impurities in vaping liquids through manufacturing specifications. For more information on the legislative requirements for tests, studies, and the compilation of information, see paragraph 12(a) of the CCPSA. 

4.3.5 Thermal Degradation of Products

Under intended conditions of use, users of vaping products are exposed to the emissions that are formed from vapourization of vaping liquids, and not to the vaping liquid itself. For a typical vaping product, the vaping liquid is heated to form a vapour, which is drawn through the device and condenses into an aerosol that is then inhaled. The heat used to vapourize the vaping liquid may alter the proportion of different ingredients, and may also result in thermal decomposition of the carrier solvent or other constituents. For example, it is known that the thermal degradation of propylene glycol and glycerol during vaping can lead to the emission of significant amounts of formaldehyde, acetaldehyde, and acrolein, among other potential toxicants.

Studies have demonstrated that these thermal degradants are produced as a result of the so-called ‘dry hit’ or ‘dry puff’ phenomenaFootnote 10 as well as under other conditions that are still pleasant to the user. Through device design and limits on operating parameters, the generation of harmful emissions due to thermal decomposition should be as low as reasonably achievable.

4.3.6 Microbial Contamination

Vaping liquids should be manufactured, prepared, preserved, packaged, and stored for sale under sanitary conditions in order to prevent microbial contamination.

Appendix A – Information Resources

NOTICE: For further information visit the resources below or contact a Health Canada Consumer Product Safety Office via email (hc.cps-spc.sc@canada.ca) or telephone at 1-866-662-0666 (toll-free within Canada and the United States).

Footnotes

Footnote 1

A vaping product is defined under the Tobacco and Vaping Products Act 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; and (d) a substance or mixture of substances, whether or not it contains nicotine, that is intended for use with those devices to produce emissions.

Return to footnote 1 referrer

Footnote 2

“Danger to human health or safety” means any unreasonable hazard — existing or potential — that is posed by a consumer product during or as a result of its normal or foreseeable use and that may reasonably be expected to cause the death of an individual exposed to it or have an adverse effect on that individual’s health — including an injury — whether or not the death or adverse effect occurs immediately after the exposure to the hazard, and includes any exposure to a consumer product that may reasonably be expected to have a chronic adverse effect on human health.

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Footnote 3

Health Canada. Canada Consumer Product Safety Act Quick Reference Guide
http://www.hc-sc.gc.ca/cps-spc/pubs/indust/ccpsa_ref-lcspc/index-eng.php

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Footnote 4

Representations of nicotine concentration in mg/mL and mg/g are not necessarily interchangeable as mass varies with the density of the vaping liquid.

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Footnote 5

http://pubs.acs.org/doi/pdf/10.1021/acs.est.6b01741

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Footnote 6

https://www.cdc.gov/niosh/docs/2016-111/?s_cid=3ni7d2DiacetylPressRel102016

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Footnote 7

http://www.fda.gov/downloads/drugs/scienceresearch/ucm173250.pdf

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Footnote 8

http://www.mdpi.com/1660-4601/12/5/4796

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Footnote 9

http://www.atsdr.cdc.gov/toxprofiles/tp96.pdf

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A dry hit occurs when there is insufficient supply of liquid to the wick, which results in high operating temperatures that overheat the liquid and produce a strong, unpleasant taste.

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