20 mg/mL Nicotine Limit for Vapes
Canada Gazette, Part I, Volume 154, Number 51: Concentration of Nicotine in Vaping Products Regulations
Health Canada proposed regulations to limit the nicotine concentration in most vaping products sold in Canada to 20 mg/mL, prohibit packaging or sale that displays a higher concentration, and align the Vaping Products Labelling and Packaging Regulations with this limit while keeping an export ban at 66 mg/mL. The proposal (published 2020-12-19) opened a 75-day comment period and would come into force 15 days after publication of the final regulations in Canada Gazette, Part II. It would apply to manufacturers, importers and retailers (excluding products authorized under the Food and Drugs Act) and is aimed at reducing youth vaping.
- Published
- December 19, 2020
- Department
- Unavailable
- Section
- REGULATORY IMPACT ANALYSIS STATEMENT
- Comment deadline
- March 4, 2021
- Effective date
- Unavailable
- Publication part
- Part I
Summary
Summary#
The federal government, through Health Canada, published a proposal called the Concentration of Nicotine in Vaping Products Regulations that would limit the nicotine level in most vaping products sold in Canada to 20 mg/mL. The proposal says it aims to reduce youth vaping; it is a proposal (not yet law) and includes a 75 days comment period and a planned start point of 15 days after publication in Canada Gazette, Part II.
What it does#
- Sets a maximum nicotine concentration of 20 mg/mL for vaping products manufactured or imported for sale in Canada.
- Prohibits packaging or selling a vaping product if the package shows a nicotine concentration higher than 20 mg/mL.
- Amends the Vaping Products Labelling and Packaging Regulations so domestic product rules match the new 20 mg/mL limit, while keeping the export ban on very high concentrations at 66 mg/mL or more.
- Prescribes the laboratory method (ISO 20714) for measuring nicotine concentration and explains how to convert results into mg/mL.
- Excludes vaping products that are already authorized under the Food and Drugs Act from this rule.
- The proposal was published for comment (a 75 days consultation) and would come into force 15 days after the Canada Gazette, Part II publication of the final regulations.
Who's affected#
- Youth: the rule is aimed at reducing the appeal of vaping to young people.
- Adult vapers and people who smoke: some adults who now use higher-strength products may need to switch to lower-strength products; Health Canada notes this could affect quitting or switching patterns.
- Vaping industry: manufacturers, importers, distributors and retailers would be directly affected. Health Canada estimates total incremental industry costs at $452.0 million (present value over 30 years), or about $36.4 million annually. That includes an estimated $58,254,497 one-time cost to dispose of high-strength stock and profit-loss estimates totalling about $393,737,977 PV.
- Small businesses: the proposal estimates about 8,428 small vaping-related businesses would face costs (disposal, lost profits).
- Provinces/territories: provinces already with similar limits — British Columbia and Nova Scotia — would be largely unaffected; Ontario already restricts sales of >20 mg/mL to specialty vape shops.
Why it matters#
- The proposal is intended to reduce youth exposure to nicotine and the likelihood that experimenting with vaping leads to nicotine dependence or later smoking. Health Canada points to a sharp rise in youth vaping as the main reason for the change.
- There are trade-offs: regulators estimate significant industry costs and recognize some adults who use high-strength products might not find lower-strength options satisfying and could return to or continue smoking.
- Health Canada’s break-even analysis says relatively small reductions in vaping initiation would be enough for health benefits to balance costs (examples in the analysis include reductions in initiation in the low single digits — e.g. 1.03%, 2.56%, or a range of 2.58% to 4.11% under different scenarios).
- This is a federal proposal open for comment — it is not yet law. If finalized, it would change what vaping products can be legally sold in most of Canada.
Key topics
Source: Canada Gazette