The Minister of Health launched public consultations for the proposed Vaping Products Labelling and Packaging Regulations on June 21. The proposed regulations strive to increase awareness of the health effects of nicotine, create consistent labelling and packaging standards for vaping products, and fill gaps in the regulation of refillable vaping devices and their parts.
What you need to know
- Currently, regulation of labelling and packaging of vaping products is fragmented and spans various pieces of legislation. The requirements that would apply to a particular vaping product depend on how the product is marketed. The proposed regulations fall under the Tobacco and Vaping Products Act and the Canada Consumer Product Safety Act and create a unified set of requirements for vaping products, which include the following key changes:
- Child-resistant packaging: refillable vaping products, such as devices and their parts must be child-resistant and include labelling instructions for proper use of the closure.
- Labelling requirements: an ingredient list, and, depending on the presence and concentration of nicotine, a nicotine concentration statement, a health warning about nicotine addiction, and a toxicity symbol must be clearly displayed on vaping products.
- The comment period for the proposed regulations ended September 5.
- Although Health Canada has not provided a future timetable for finalizing these regulations, recent US FDA findings associating severe respiratory illness with the use of vaping products may motivate expediting the process.1
- The next step would be for finalized regulations to be published in the Canada Gazette, Part II. The draft regulations currently stipulate a coming-into-force date of 180 days after their publication in the Gazette.
Current labelling and packaging requirements
As set out below, existing regulation of labelling and packaging of vaping products is piecemeal and subject to several pieces of legislation depending on the intended use of a particular vaping product.
- The Canada Consumer Product Safety Act regulates vaping products that are not marketed for therapeutic uses and prohibits the manufacture, importation, advertisement or sale of consumer products that are a danger to human health or safety. The Consumer Chemicals and Container Regulations, 2001 (CCCR, 2001) of the Canada Consumer Product Safety Act (CCPSA) apply to products containing certain nicotine concentrations and mandate child-resistant containers and toxicity warnings for stand-alone containers.
- The Tobacco and Vaping Products Act (TVPA) gives the legislature the ability to prescribe products and packaging and labelling requirements for tobacco-related products.
- The Food and Drugs Act and its regulations apply to vaping products that make a health claim.
- The Cannabis Act and the Cannabis Regulations regulate packaging and labelling of cannabis accessories, which include vaporizers that are represented to be used in the consumption of cannabis. The Cannabis Act and Cannabis Regulations outline specific information that must be included on cannabis product labels, including a health warning and cannabis symbol and require child resistant packaging for cannabis products.
There are gaps in the protection provided in the current regulatory framework, specifically with respect to refillable vaping devices and their parts. These products do not need to meet the requirements of CCCR, 2001 because an exemption was put in place in 2018 to give the industry time to develop or source containers that would meet the child-resistance requirements. Additionally, there is currently no requirement to display information related to the presence or absence of nicotine, nor is it mandatory to include a warning respecting the addictiveness of nicotine on these products.
The proposed regulations, made under the authority of the TVPA and the CCPSA, create a single set of labelling and packaging requirements that apply to vaping products, except for those that make health claims, which are regulated under the Food and Drugs Act. Vaping products represented for cannabis use will be subject to the regulations made under the CCPSA as well as the requirements outlined in the Cannabis Act and Cannabis Regulations.
Part 1 of the proposed regulations applies to every vaping product subject to the TVPA that is intended for sale in Canada. Depending on the presence and concentration of nicotine, a health warning about addictiveness of nicotine, a statement of the nicotine concentration, and a toxicity warning about nicotine ingestion must be displayed on the vaping product. Any information that must be displayed, must be visible, permanent and legible. The regulations also stipulate expressions that may be used to indicate vaping products that do not contain nicotine.
Part 2 of the proposed regulations applies to consumer products under the CCPSA. These draft regulations require child-resistant packaging or containers for refillable vaping devices and their parts, including component tanks or reservoirs, as well as stand-alone containers of vaping substances containing nicotine in a concentration of 0.1 mg/mL. A label must be included on the closure that instructs its proper operation and the closure must maintain its function for the duration of its useful life. Importers and manufacturers must obtain and maintain records to demonstrate that the container meets the applicable standards. Single-use containers must display a statement specifying that the container is not child-resistant and the entire contents should be used upon opening. A list of ingredients is required for every vaping substance, as well as an indication with respect to ingredients that add flavour to allow consumers to make informed choices regarding the products they choose to use. A toxicity warning and hazard symbol must be displayed if the vaping substance has a nicotine concentration of 0.1mg/mL or greater.
It is possible that the proposed regulations outlined above may change in the final regulations.
Timeline for finalization of the proposed regulations
Health Canada discusses vaping in its Forward Regulatory Plan, but has yet to provide a future timetable for these proposed regulations.2 Although it is not possible to predict with certainty when final regulations will be issued, recent findings of negative respiratory health effects associated with vaping may accelerate their finalization.
The 75-day comment period for the proposed regulations, inviting stakeholders to make submissions to the government regarding the draft regulations, ended September 5. The final form of the regulations must be approved, registered, and published in the Canada Gazette, Part II. The draft regulations currently stipulate a coming-into-force date of 180 days after their publication in the Gazette.
To discuss these issues, please contact the author(s).
This publication is a general discussion of certain legal and related developments and should not be relied upon as legal advice. If you require legal advice, we would be pleased to discuss the issues in this publication with you, in the context of your particular circumstances.
For permission to republish this or any other publication, contact Janelle Weed.
© 2019 by Torys LLP.
All rights reserved.