Regulations Amending the Tobacco Products Appearance, Packaging and Labelling Regulations: SOR/2024-137

Canada Gazette, Part II, Volume 158, Number 14

Registration
SOR/2024-137 June 17, 2024

TOBACCO AND VAPING PRODUCTS ACT

P.C. 2024-715 June 17, 2024

Her Excellency the Governor General in Council, on the recommendation of the Minister of Mental Health and Addictions and Associate Minister of Health, makes the annexed Regulations Amending the Tobacco Products Appearance, Packaging and Labelling Regulations under section 17footnote a of the Tobacco and Vaping Products Act footnote b.

Regulations Amending the Tobacco Products Appearance, Packaging and Labelling Regulations

Amendments

1 Paragraph 90(1)(g) of the Tobacco Products Appearance, Packaging and Labelling Regulations footnote 1 is replaced by the following:

2 Subparagraph 91(1)(c)(ii) of the Regulations is replaced by the following:

3 Paragraph 102(1)(f) of the Regulations is replaced by the following:

Transitional Provisions

4 (1) The following definitions apply in this section.

former Regulations
means the Tobacco Products Appearance, Packaging and Labelling Regulations as they read immediately before the day on which these Regulations come into force. (règlement antérieur)
new Regulations
means the Tobacco Products Appearance, Packaging and Labelling Regulations as they read on the day on which these Regulations come into force. (nouveau règlement)

(2) Words and expressions used in this section have the same meaning as in the Tobacco Products Appearance, Packaging and Labelling Regulations.

(3) A manufacturer may sell or distribute, until July 31, 2026, a tobacco product contained in a primary package placed in a carton that does not meet the requirements of paragraph 90(1)(g), subparagraph 91(1)(c)(ii) and paragraph 102(1)(f) of the new Regulations if the carton meets the requirements of paragraph 90(1)(g), subparagraph 91(1)(c)(ii) and paragraph 102(1)(f) of the former Regulations.

(4) A retailer may sell, until October 31, 2026, a tobacco product contained in a primary package placed in a carton that does not meet the requirements of paragraph 90(1)(g), subparagraph 91(1)(c)(ii) and paragraph 102(1)(f) of the new Regulations if the carton meets the requirements of paragraph 90(1)(g), subparagraph 91(1)(c)(ii) and paragraph 102(1)(f) of the former Regulations.

Coming into Force

5 These Regulations come into force on the day on which they are registered.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Executive summary

Issues: Tobacco use continues to be the leading preventable cause of illness and premature death in Canada. Approximately 46 000 Canadians die each year from tobacco use. Health-related messages on tobacco products packaging is recognized as one of the best approaches to inform people in Canada of the health hazards of tobacco use. Messages should be large and prominently displayed to maximize their visibility and effectiveness.

The Regulations Amending the Tobacco Products Regulations (Plain and Standardized Appearance), made in 2023, updated and expanded the health-related message requirements for tobacco products packaging. These Regulations consolidated all tobacco product appearance, packaging and labelling requirements under one set of regulations by amending the Tobacco Products Regulations (Plain and Standardized Appearance) [TPR-PSA] and repealing previous tobacco labelling regulations. With these amendments, the TPR-PSA was renamed the Tobacco Products Appearance, Packaging and Labelling Regulations (TPAPLR).

Problematic wording in the TPAPLR was identified with specific provisions related to the placement of health-related messages on certain tobacco product package formats. This problematic wording may cause health warnings (HW) to be displayed in a manner that reduces their visibility and size. As a result, an objective of the TPAPLR which is to enhance public awareness of the health hazards of tobacco use, may not be fully met.

Description: The Regulations Amending the Tobacco Products Appearance, Packaging and Labelling Regulations (the Regulations) strengthen the TPAPLR by clarifying requirements related to the placement of health-related messages on a secondary package that is a carton. Specifically, the Regulations introduce minor technical amendments to provisions related to the placement of HW and toxicity information (TI) on secondary packages that are a carton, to ensure they fully support the objectives of the TPAPLR.

Rationale: The Regulations are expected to enhance public awareness of the health hazards of tobacco use.

The Regulations support Canada’s Tobacco Strategy (CTS), which aims to reduce the burden of disease and death from tobacco use, its consequential impact on the health care system and Canadian society. The long-term benefits of the Regulations, in combination with other interventions under the CTS, include the prevention of long-term dependence on tobacco, reduction of tobacco-related morbidity and premature mortality, and reduction of the burden on Canada’s health care system and society.

The cost of implementing and rotating new health-related messages was accounted for in the Regulations Amending the Tobacco Products Regulations (Plain and Standardized Appearance) Regulatory Impact Analysis Statement published in the Canada Gazette, Part II, on June 7, 2023.

The Regulations may result in incremental costs to some tobacco manufacturers. These manufacturers may need to change the placement of health-related messages printed on certain formats of tobacco product packages. These costs could not be quantified due to a lack of data. Costs are anticipated to be minimal, a small fraction of the costs to implement one rotation of health-related messages.

The small business lens applies, as up to five of the businesses on which the Regulations may impose costs, meet the definition of a small business.

There is no administrative burden on businesses that would result from the Regulations; therefore, the one-for-one rule does not apply.

Issues

Tobacco use continues to be the leading preventable cause of illness and premature death in Canada. While tobacco use has decreased, a significant number of Canadians still use tobacco. Approximately 46 000 Canadians die each year from tobacco use. The health and economic costs associated with tobacco use in Canada were estimated at 11.2 billion in 2020, with direct health care costs of $5.4 billion.footnote 2

Health-related messages on tobacco products packaging is recognized as one of the best approaches of informing Canadians of the health hazards associated with tobacco use. The Regulations Amending the Tobacco Products Regulations (Plain and Standardized Appearance), made in 2023, updated the health-related messages and extended health warnings (HW) and toxicity information (TI) to all tobacco products packaging. These regulations also consolidated all tobacco products appearance, packaging, and labelling requirements into a single set of regulations, by amending the Tobacco Products Regulations (Plain and Standardized Appearance) [TPR-PSA] and repealing previous tobacco labelling regulations. With these amendments, the TPR-PSA was renamed the Tobacco Products Appearance, Packaging and Labelling Regulations (TPAPLR).

The objectives of the TPAPLR directly support three of the four tobacco-related objectives of the Tobacco and Vaping Products Act (TVPA) including enhancing public awareness about the health hazards of tobacco use. The TPAPLR are built on the achievements of the previous tobacco product labelling requirements while aiming to improve their overall effectiveness.

Under the 2011 Tobacco Products Labelling Regulations (Cigarettes and Little Cigars) [TPLR-CLC], tobacco manufacturers were required to display HW on the four largest exterior surfaces of a secondary package that is a carton. This HW placement on cartons aimed to maximize their visibility and effectiveness. The intent during the drafting of the Regulations Amending the Tobacco Products Regulations (Plain and Standardized Appearance) in 2023 was for this requirement to remain the same. However, following the final publication of these regulations, Health Canada was informed the wording of certain provisions regarding the placement of HW on a secondary package that is a carton was problematic as it created a discrepancy between the intent and the HW layouts on certain cartons.

Under the TPAPLR, a carton with a vertical orientation has HW displayed on only two of the four largest exterior surfaces (front and back) of the carton and the two smallest exterior surfaces (top and bottom) of the carton. The placement of HW, in this format, no longer maximizes the visibility of HW, which may lessen their desired impact. As a result, an objective of the TPAPLR, that is to enhance public awareness of the health hazards of tobacco use, may not be fully realized.

Also, under the TPAPLR, TI is displayed on one of the largest exterior surfaces of a carton with a vertical orientation.
This is also a change from the TPLR-CLC and does not meet the intent of the TPAPLR as the HW, and not the TI, are intended to be displayed on the largest exterior surfaces of cartons for greatest visibility and impact.

Additionally, the wording of the official language requirements for the display of HW on a secondary package that is a carton, is also problematic. The wording in the TPAPLR uses two different terms (i.e. exterior surface and side) when describing the display areas for HW and this may be confusing to regulated parties.

The problematic wording in the affected provisions of the TPAPLR was an unintended consequence of merging the previous tobacco labelling requirements with the related tobacco packaging requirements set out in the TPR-PSA. The wording to describe package surfaces differed slightly between the two sets of regulations. As a result, consistency with certain past labelling requirements was lost in the TPAPLR and the objectives of the TPAPLR may not be fully met.

Background

Tobacco use is a known or probable cause of more than 40 debilitating and often fatal diseases of the lungs, heart, and other organs.footnote 3 Tobacco products contain nicotine, a highly addictive substance responsible for tobacco dependence and consequent repeated long-term use resulting in chronic exposure to harmful chemicals. Young persons are particularly susceptible to the risk of dependence and report symptoms of dependence even at low levels of cigarette use.footnote 4

The health care costs associated with tobacco use represent 47% of health care costs associated with substance use in Canada. Beyond the economic costs of tobacco use, is the burden in terms of human suffering. A 2021 report on Smoking and Tobacco Use by the Centers for Disease Control and Prevention (CDC) in the United States found that for every person who dies of smoking-related causes, at least 30 people live with a smoking-related illness.footnote 5

Decades of coordinated efforts have resulted in smoking prevalence in Canada decreasing from 26% in 2001footnote 6 to 12% in 2022.footnote 7 Despite these advances, 1 in 10 people in Canada report smoking on a regular basis. Adults (aged 25 and older) are almost three times more likely to report being someone who uses tobacco than youth (aged 15 to 19).footnote 8

Canada’s Tobacco Strategy (CTS), introduced in 2018, focuses on helping Canadians quit using tobacco, protecting youth and people who do not use tobacco from nicotine addiction, strengthening the foundations in science, surveillance and partnerships, and working with national and regional Indigenous organizations. The CTS aims to achieve the ambitious target of less than 5% tobacco use prevalence by 2035, with targeted approaches focused on specific populations associated with high levels of tobacco use. CTS includes $66M in annual funding.

Legislative framework and regulatory landscape

The TVPA regulates the manufacture, sale, labelling and promotion of tobacco and vaping products. The overall purpose of the TVPA is to provide a legislative response to a national public health problem of substantial and pressing concern and to protect the health of Canadians in light of the conclusive evidence implicating tobacco use in the incidence of numerous debilitating and fatal diseases. With respect to tobacco products, the purpose of the Act is to support the overall tobacco control objectives, and in particular, it aims to

Currently, tobacco products package labelling requirements are found in the TPAPLR.footnote 9 These regulations specify the form and manner the labelling elements must be displayed, meaning which health-related messages must be displayed on tobacco product packaging, leaflets, and tobacco products, as well as where and how they are to be placed.

The TPAPLR apply to every tobacco product that is intended for retail sale in Canada, as well as to any package that contains such a tobacco product.

Primary Packages, Secondary Packages and Cartons

The TPAPLR require HW and TI to be displayed on all primary and secondary packages.

A primary package is any package that is intended for retail sale in Canada and in which a tobacco product is directly placed. A primary package that contains cigarettes must be made of rigid cardboard.

A secondary package is any package that is intended for retail sale in Canada and in which a primary package is placed. A secondary package that contains cigarettes or little cigars must be made of rigid cardboard.

These packages do not include a package that is an overwrap (i.e. a transparent colourless wrap) that covers a primary or secondary package.

A carton is a secondary package in which two or more primary packages containing the same type of tobacco product are placed. Examples of tobacco products sold in cartons include, but are not limited to cigarettes, little cigars and tobacco products made in whole or in part of tobacco intended for use with devices that are necessary for their use (better known as heated tobacco products). Most cartons sold in Canada have a rectangular cuboid shape consisting of six exterior surfaces, including four long exterior surfaces and two small exterior surfaces, and contain 8 to 10 packages of cigarettes or little cigars. A carton that contains packages of cigarettes or little cigars may be made of paper also called a carton wrap.

Some manufacturers sell cartons in a format displaying HW in a vertical orientation while others display HW in a horizontal orientation. Both formats are permitted.

Health warnings

Health Warnings (HW) are health-related messages, usually combining text with images, prominently displayed on the front and back of most tobacco product packages. These messages focus primarily on the health hazards and negative health effects associated with tobacco use. They include the toll-free, pan-Canadian quit line number and Government of Canada web address relating to tobacco cessation linking people who smoke to services in their province or territory.

HW must be displayed on tobacco product packages in both official languages and in the same manner. Sets of HW are rotated on a predetermined schedule, either every 24 or 36 months depending on the tobacco product type, to help maintain relevance and impact of the messages.footnote 10

Paragraph 90(1)(g) of the TPAPLR requires a HW to be displayed on the exterior surface of the “front, back, top and bottom” of a secondary package that is a carton.

Toxicity information

Toxicity information (TI) is health-related messaging in the form of text-only messages that provide clear, concise, and easy-to-understand information about the toxic substances found in tobacco smoke or the product. TI is displayed on the side of most tobacco products packages. Sets of TI are rotated on a predetermined schedule, either every 24 or 36 months depending on the tobacco product type, to maintain relevance and impact of the messages.

Paragraph 102(1)(f) of the TPAPLR requires TI be displayed on the exterior surface of one of the sides of the carton.

Effectiveness of health-related messages

Research indicates displaying health-related messages on tobacco packaging is one of the most effective approaches to inform users of the health hazards of tobacco use.footnote 11 Messages on tobacco product packages and products have the potential of being seen daily by millions of people.

The effectiveness of health-related messages on tobacco product packages in Canada was measured as part of the Evaluation of the Federal Tobacco Control Strategy 2012-2013 to 2015-2016. The evaluation showed HW are effective in informing those who smoke about the health risks and health hazards associated with tobacco use.

Research has shown that youth and adults strongly support HW on tobacco packaging and view the messages on cigarette packages as good and reliable sources of information.footnote 12 HW with large text and pictures on tobacco packages have been shown to increase the motivation to quit,footnote 13,footnote 14 and are more effective and generally perceived as more credible for both youth and adults who smoke.footnote 15,footnote 16,footnote 17,footnote 18 Research has also shown that people who use tobacco products are more likely to recall larger warnings, and have been found to equate the size of the warning with the magnitude of the risk.footnote 19 The coverage of 75% of the front and back of the package was deemed an appropriate size to include all the necessary information, and retain the overall effectiveness of the message communicating with tobacco users. Research also indicated cessation services information were more visible and legible and have a greater overall impact when integrated into a larger warning.footnote 20,footnote 21,footnote 22,footnote 23 The inclusion of the quit line on health-related messages led to an increased call volume to cessation services, and an increase in efforts to attempt to quit.footnote 24,footnote 25,footnote 26

International obligations

Canada has been a Party to the World Health Organization Framework Convention on Tobacco Control (FCTC) since 2004. The TPAPLR brought Canada into full compliance with its labelling obligations set out in Article 11 of the FCTC and included measures that are consistent with the Guidelines for implementing Article 11. Article 11 requires Parties to adopt measures including requirements for the display of large, rotating HW, and measures to prevent false, misleading, or deceptive packaging and labelling.

The Guidelines for implementation of Article 11 of the FCTC, adopted in 2008, do not create obligations on the Parties, but rather propose measures that can be used to increase the effectiveness of tobacco packaging and labelling measures. The Guidelines for implementation of Article 11 of the FCTC recommend the location and layout of HW on a package should ensure maximum visibility and be positioned on all main exterior surfaces if there are more than two.

Objective

The Regulations directly support one of the four tobacco-related objectives of the TVPA, namely, to enhance public awareness about the health hazards of tobacco use.

The Regulations address problematic wording in the TPAPLR by making minor technical amendments to clarify requirements related to the placement of HW and TI on secondary packages that are a carton. They continue efforts to inform Canadians about the health hazards and health effects of using tobacco, and contribute to preventing the public from being deceived or misled with respect to those hazards.

In association with other tobacco control measures under the CTS, the Regulations will contribute to addressing the public health problems associated with tobacco use and nicotine addiction among people in Canada and contribute to Canada’s goal to reduce the prevalence of tobacco use to less than 5% by 2035.

Description

The TVPA prohibits manufacturers and retailers from selling a tobacco product unless the product and its packaging displays health-related information in the manner required by the Regulations. The Regulations apply to tobacco products packages intended for retail sale in Canada. Entities that only package or distribute tobacco products to retailers on behalf of a manufacturer, will not be affected by the Regulations.

The Regulations will improve the effectiveness of the TPAPLR by clarifying requirements for the placement of HW and TI on a secondary package that is a carton.

Health warnings and toxicity information on cartons

The Regulations strengthen tobacco labelling requirements by clarifying HW must be displayed on the four largest exterior surfaces of a secondary package that is a carton, regardless of package orientation. It ensures HW are large and prominently displayed on cartons making them more effective at communicating health hazards of tobacco use.

The Regulations clarify that TI must be displayed on one of the remaining exterior surfaces of a secondary package that is a carton that does not contain a HW. It ensures that HW, and not TI, are displayed on the largest exterior surfaces of a secondary package that is a carton. This thereby maximizes the desired impact of HW.

The Regulations also clarify the wording of official languages requirements for the display of HW and TI on a secondary package that is a carton. It ensures that placement requirements for HW and TI are clear and consistent.

These amendments ensure that the wording of all provisions related to the display of HW and TI on a secondary package that is a carton is clear and consistent. This aligns with the intent during the drafting of the Regulations Amending the Tobacco Products Regulations (Plain and Standardized Appearance) and fully supports the objectives of health-related messages under the TPAPLR.

Regulatory development

Consultation

Health Canada conducted a targeted consultation to inform and seek feedback from public health stakeholders, academics and researchers, and the tobacco industry on issues with the TPAPLR concerning the placement of health-related messages on a secondary package that is a carton. A consultation document, Consultation on the Tobacco Products Appearance, Packaging and Labelling Regulations, was electronically mailed to interested stakeholders on November 16, 2023. The consultation was open for comments for a 30-day period ending December 16, 2023.

The consultation document explained that Health Canada was reviewing certain provisions of the TPAPLR and considering potential approaches to clarifying the requirements for the placement of health-related messages on a secondary package.

Health Canada received a total of seven submissions from public health stakeholders, academics, researchers, and the tobacco industry. Overall, public health stakeholders and the tobacco industry supported making amendments to the affected provisions of the TPAPLR and recommended the amendments align with previous tobacco labelling requirements for secondary packages that are a carton. Suggestions included requiring HW be displayed on the four largest exterior surfaces of a secondary package that is a carton, and for TI to be displayed on one of the remaining exterior surfaces that does not display a HW.

One public health stakeholder suggested future regulatory amendments should standardize the dimensions of cigarette cartons.

Responses from the tobacco industry also suggested a portrait format of TI be added to the Rotation 2 health-related messages found in the TPAPLR Source Document (Labelling Elements for Tobacco Products)footnote 27 which would better fit the display area for TI on a secondary package that is a carton. Currently, the Source Document only provides TI in a landscape format.

Health Canada carefully considered the comments received. The Regulations will introduce amendments to clarify requirements for the placement of HW and TI on a secondary package that is a carton. However, no changes will be made to standardize the dimensions of cigarette cartons at this time. Health Canada may consider providing additional TI layout formats at the time of future updates to the Source Document.

As the amendments are considered minor and technical in nature, an exemption from prepublication in the Canada Gazette, Part I, was granted. It is anticipated that the Regulations will be supported by most stakeholders.

Modern treaty obligations and Indigenous engagement and consultation

In accordance with the Cabinet Directive on the Federal Approach to Modern Treaty Implementation, an assessment of the proposal did not identify any modern treaty implications or obligations.

Instrument choice

Health Canada considered the following two options in developing the Regulations.

Option 1: Baseline scenario (no change in TPAPLR)

This option would maintain the existing problematic wording under the TPAPLR related to the placement of HW and TI on a secondary package that is a carton. Manufacturers displaying HW on a secondary package that is a carton in a vertical orientation would continue to be required to display HW on only two of the four largest exterior surfaces and the two small exterior surfaces of a carton. Additionally, TI, and not HW, would be displayed on one of the largest exterior surfaces of a carton in a vertical orientation which was not the intent during the drafting of the Regulations Amending the Tobacco Products Regulations (Plain and Standardized Appearance).

This option was rejected for several reasons. The placement of HW on tobacco packages should be done in a manner to ensure maximum visibility and impact. In this option, the placement of HW on a carton with a vertical orientation would not be as large and prominent as they could be. This placement may lessen their desired impact to enhance public awareness of the health hazards associated with tobacco use. As a result, the objectives of these health-related messages may not be fully met.

This option would maintain a change from previous labelling requirements for these packages which was not the intent when the previous tobacco labelling requirements were merged with tobacco packaging requirements set out in the TPR-PSA. This change in wording does not fully support the objectives of the TPAPLR.

Option 2 (recommended): Update labelling requirements for the placement of health-related messages on a carton to ensure they fully support the objectives of the TPAPLR.

This option clarifies wording in the TPAPLR to require manufacturers display HW on the four largest exterior surfaces of a secondary package that is a carton, for all package orientations; require manufacturers display a TI on one of the remaining exterior surfaces that does not contain a HW; and, make official language requirements for the display of health-related messages on a secondary package clear and consistent.

This option will ensure all HW displayed on cartons are large and prominently displayed and thus more effective at communicating the health hazards associated with tobacco use. TI will be displayed on one of the remaining exterior surfaces which aligns with the intent during the drafting of the Regulations Amending the Tobacco Products Regulations (Plain and Standardized Appearance).

This option will ensure all health-related message requirements for secondary packages that are a carton are clear, consistent, and fully support the objectives of health-related messages under the TPAPLR. This option is recommended as it better helps support the objective of the TVPA to enhance public awareness of the health hazards of using tobacco products.

Regulatory analysis

Benefits and costs

Summary of cost-benefit analysis
Baseline scenario and regulatory scenario

The baseline scenario for manufacturers that display health-related messages on a carton in a vertical orientation is that they will be required to place the HW on only two of the four largest exterior surfaces and the two small exterior surfaces. In this case, TI will be displayed on one of the largest exterior surfaces of the vertical carton.

The regulatory scenario requires manufacturers of cartons in a vertical orientation (vertical cartons) to display HW on the four largest exterior surfaces of those packages by July 31, 2026. This date aligns with the next or second rotation of health-related messages required under the TPAPLR. In addition, TI will be displayed on one of the remaining exterior surfaces that does not contain a HW. Manufacturers displaying health-related messages on cartons with a vertical orientation in compliance with the TPAPLR for the first rotation may incur additional costs when the first rotation of messages is brought back into circulation for the subsequent third rotation. Incremental compliance costs for these manufacturers may include vertical HW and TI print layout changes in advance of the third rotation, and additional ink to print HW on the four largest exterior surfaces instead of only two.

Assessment of costs and benefits

Costs

It should be noted that the manner in which manufacturers display health-related messages (i.e. either in a vertical or horizontal orientation) on a secondary package that is a carton is not a driver of the estimated costs. The orientation of HW and TI displayed on a secondary package that is a carton is essentially included, or absorbed, in the estimated costs for each rotation of health-related messages. These costs are driven by the number of stock keeping units (SKUs) and brands.

The cost of implementing and rotating new health-related messages is accounted for in the Regulations Amending the Tobacco Products Regulations (Plain and Standardized Appearance) Regulatory Impact Analysis Statement, published in the Canada Gazette, Part II. The total compliance costs for all manufacturers to implement one rotation of health-related messages for all cigarettes and little cigars was estimated to be $47.2 million. Potential incremental costs of these Regulations are a minimal, unquantifiable fraction of these costs and would only occur in Year 6 (2028-29) Three tobacco manufacturers, accounting for an estimated 92% of the market for cigarettes and little cigars and over 80% of these costs, notified Health Canada they will continue to comply with the previous HW and TI placement requirements for cartons, as per the repealed TPLR-CLC, and therefore would incur no incremental costs. The remaining manufacturers, accounting for an estimated 8% of the market for cigarettes and little cigars and less than 20% of these costs, may incur incremental costs. However, costs for these remaining manufacturers would be limited to their brands or SKUs that display HW and TI on cartons in a vertical orientation.

Data on the number of cigarette and little cigar brands or SKUs that display HW and TI on a carton in a vertical orientation is not available. Furthermore, it is not known how many of the manufacturers who may be impacted would have noticed the change in wording with the affected TPAPLR provisions, and complied with the change in placement requirements for HW and TI on a carton in a vertical orientation. Some of these manufacturers may have continued following the previous placement requirements under the TPLR-CLC (as the three manufacturers referenced above have indicated) and thus would similarly incur no incremental costs as a result of these Regulations.

Compliance cost estimates for a HW and TI layout change for cartons in a vertical orientation (i.e. to display the HW on the four largest exterior surfaces) is not available, but is not expected to be significant.

Manufacturers will be permitted to use either layout format for the first rotation of health-related messages, in place until July 31, 2026. This again is expected to limit cost impacts. Furthermore, the transition period for this change further provides a flexible implementation for manufacturers. Any costs, if applicable, would not be incurred until after the third rotation of health-related messages is in effect, in Year 6, providing sufficient time for manufacturers to be aware of the new requirements and to make manufacturing adjustments, if necessary.

Benefits

The Regulations will directly support one of the four tobacco-related objectives of the TVPA, namely to enhance public awareness about the health hazards of tobacco use. They will ensure HW on cartons are large and prominently displayed, which can help them be more effective at communicating these health hazards.

Small business lens

Analysis under the small business lens concluded that the proposed Regulations will impact small businesses subject to the Regulations. Based on data on the wholesale tobacco products market, five of the estimated nine manufacturers that may incur incremental costs are small businesses pursuant to the Treasury Board of Canada Secretariat definition.

It is anticipated that these small businesses would incur the same incremental compliance costs as the other businesses. As described in the summary of costs and benefits, these costs are expected to be minimal.

Either manner of displaying HW and TI on a secondary package that is a carton is permitted for the first rotation, which is expected to limit cost impacts on all businesses, including small businesses. Furthermore, costs would not be incurred until Year 6, providing time for manufacturers to make the necessary adjustments, if applicable.

One-for-one rule

The one-for-one rule does not apply. There will be no administrative burden on businesses as a result of the Regulations. In accordance with Treasury Board of Canada Secretariat policy guidance, all costs relating to labelling are deemed to be compliance costs.

Regulatory cooperation and alignment

Canada is a Party to the FCTC. The TPAPLR brought Canada into full compliance with its international labelling obligations under Article 11 of the FCTC and included measures that are consistent with the Guidelines for implementing Article 11.

Strategic environmental assessment

In accordance with the Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals and Health Canada’s Strategic Environmental Policy (2018), this proposal is excluded from conducting a strategic environmental assessment.

Gender-based analysis plus

No gender-based analysis plus (GBA+) impacts have been identified for the Regulations.

Implementation, compliance and enforcement, and service standards

Implementation

The Regulations are made pursuant to the powers of the TVPA. They come into force on the day they are registered.

Manufacturers have a transition period for implementing the labelling requirements until July 31, 2026, while retailers have until October 31, 2026. During their respective transition period manufacturers are allowed to continue to sell or distribute tobacco products in cartons and retailers, to sell these products to consumers, in accordance with the requirements of paragraph 90(1)(g), subparagraph 91(1)(c)(ii), and paragraph 102 (1)(f) of the TPAPLR in the version in force on August 1, 2023.

Compliance promotion and outreach activities (including notices) aimed at informing manufacturers, distributors and retailers of tobacco products will increase awareness of the measures set out in the Regulations to assist parties in achieving compliance.

Compliance and enforcement

The Government of Canada will actively monitor compliance throughout the supply chain, including manufacturers, distributors, and retailers. If Health Canada inspectors have reasonable grounds to believe the Regulations have been contravened, appropriate measures will be taken. These could include warning letters, compliance plans, seizures, and recommendations for prosecutions. Compliance and enforcement strategies are consistent with the overall approach regarding the TVPA and its regulations.

The penalties for not complying with the Regulations are set out under Part VI of the TVPA. For example,

Service standards

These Regulations do not relate to the provision of service to the public or to industry; therefore, there are no service standards associated with them.

Transparency and international obligations

Canada is a Party to the FCTC. Article 5.3 of the Convention obliges Parties, in setting and implementing their public health policies with respect to tobacco control, to protect these policies from commercial and other vested interests of the tobacco industry in accordance with national law. During the targeted consultations that followed the coming into force of the TPAPLR, Health Canada asked interested parties to declare any perceived or actual conflicts of interest with the tobacco industry when providing input. Individuals who are part of the tobacco industry or an affiliated organization, or an individual acting on their behalf, were also asked to clearly state so in their submission.

Finally, for transparency purposes, Health Canada has posted on its website a summary of each meeting held with representatives of the tobacco industry.

Contact

Sunita Gingras
Manager
Vaping and Labelling Regulations Division
Tobacco Products Regulatory Office
Tobacco Control Directorate
Controlled Substances and Cannabis Branch
Health Canada
Address locator: 0302A
150 Tunney’s Pasture Driveway
Ottawa, Ontario
K1A 0K9
Email: pregs@hc-sc.gc.ca