New Health Labelling for Tobacco Packaging

Read the New Health-Related Labelling for Tobacco Products: Consultation Summary.

Document for Consultation
October 2018

Table of contents

• Executive summary
• Introduction
  • The health burden of tobacco use
  • Tobacco control in Canada
  • Health labelling for tobacco products
  • Why now?
  • Key considerations for health labelling on tobacco products
• What we are consulting on
  1. Labelling on cigarettes
  2. Labelling content and design
     1. Health Information Messages
     2. Toxic Statements (includes Toxic Emissions Statements and Toxic Constituents Statements)
     3. Connecting labelling elements
     4. Quitline information
  3. Labelling size and placement
     1. Percentage of coverage of Health Warnings on tobacco products other than cigarettes and little cigars
     2. Minimum size of health warnings on tobacco products other than cigarettes and little cigars
  4. Labelling for all tobacco products that do not currently require labels
  5. Labelling rotation
  6. Other considerations
• We want your feedback
• Appendix A: Overview of the regulatory process for the Tobacco and Vaping Products Act
• Appendix B: Canada's regulatory framework for health labelling of tobacco products
• Appendix C: Selection of current health labelling on tobacco packages in Canada

Executive summary

Tobacco use is the leading preventable cause of premature death in Canada. It causes diseases and serious health outcomes, leading to immeasurable suffering for thousands of Canadians, their friends and family.

Through Canada's Tobacco Strategy, the Government of Canada has committed $330 million over the next 5 years to help Canadians who smoke to quit or reduce in order to minimize the harmful health effects of tobacco. A key initiative under this strategy is the renewal of health messages for tobacco packaging. Health information on tobacco products is recognized as one of the best approaches to tell people about the health risks of tobacco use. The current labelling requirements for cigarettes and little cigars have been in place since 2011. The current requirements for most other tobacco products have been in place since 2000.

This document describes areas Health Canada is exploring for renewed health labelling for tobacco products. For each consultation section, the current approach is outlined and potential issues with that approach are identified. The approach Health Canada is considering is then presented along with specific questions where your input is requested.

The appendices provide additional information related to the federal regulatory process, the Canadian Regulatory Framework for Health Labelling of Tobacco Products, and additional examples of components of tobacco labels in Canada.

Introduction

The health burden of tobacco use

Tobacco use in Canada is a deadly and costly problem. It causes dozens of diseases in tobacco users as well as those exposed to second-hand smoke. In fact, tobacco use is the leading preventable cause of premature death in Canada.^{Refernce 1} Every year, more than 45,000 Canadians die from illnesses caused by smoking; ^{Refernce 2} that is about one Canadian every 12 minutes. In a single year, smoking costs in Canada are over $6.5 billion for direct health care and $16.2 billion in combined health and economic costs.^{Refernce 3} It also impacts families and friends caring for the ill and grieving those who have passed away.

Tobacco control in Canada

In May 2018, the Government of Canada announced Canada's Tobacco Strategy, an enhanced federal strategy to address tobacco use. The Strategy includes $80.5 million in new funding over five years, starting in 2018-19. The Government is committed to reducing tobacco use to less than 5% of Canadians by 2035.

Actions by all levels of government, and many others committed to reducing the burden of smoking, have contributed to reducing tobacco use among Canadians over the last several decades. Despite these efforts, 15% of Canadians still report having used tobacco in the past 30 days. ^{Refernce 4} Smoking rates for youth have not changed since 2013.

Health labelling for tobacco products

Messages on tobacco packages and products have the potential to be seen by millions of people each day and are an important tool in reducing smoking rates to help Canadians live healthy, tobacco-free lives.

Health labels on tobacco products have been put into place all over the world. As of 2016, more than 100 countries, covering 58% of the world's population, require picture-based warnings on cigarette packages. Recent research shows that countries that have implemented the Framework Convention on Tobacco Control labelling requirements have seen smoking rates decrease an average of 1.5% as a result. ^{Refernce 5}

We know that health warning messages on tobacco packages are effective at informing and raising awareness of the health hazards and health effects of using tobacco products.^{Refernce 6},^{Refernce 7}, ^{Refernce 8} We want to build on the achievements of Canada's current labelling system by exploring new ways to maximize the effectiveness of the health-related labels and make them even more impactful. For more information on the regulatory development process under the Tobacco and Vaping Products Act, please see Appendix A. For more information on Canada's Regulatory Framework for Health Labelling of Tobacco Products, please see Appendix B.

Cigarette and little cigar packages in Canada are required to have three health labelling components: Health Warnings (graphic warnings of the health effects of tobacco use, see #1 below), Health Information Messages (messages on the health benefits of quitting smoking, see #2 below), and Toxic Emissions Statements (information on the health effects of toxic substances in cigarettes, see #3 below). Appendix C shows additional examples of current Health Warnings, Health Information Messages, Toxic Emissions Statements, and Toxic Constituents Statements (product-specific toxic constituent information for various products other than cigarettes and little cigars).

#1 Health Warnings

#2 Health Information Messages

#3 Toxic Emissions Statements

Why now?

The current labelling for cigarettes and little cigars has been in place since 2011. The labelling for most other tobacco products has been in place since 2000. Regularly updating the content and styles of tobacco product health labels helps ensure that they are more noticeable, memorable, and engaging.^{Refernce 9},^{Refernce 10} In addition, Health Canada has proposed plain and standardized appearance requirements for tobacco packages and certain tobacco products. Some research shows that the noticeability of Health Warnings increases when they are combined with plain packaging. ^{Refernce 11},^{Refernce 12}, ^{Refernce 13} For these reasons, it is an opportune time for Health Canada to be considering changes to its health labelling requirements.

Key considerations for health labelling on tobacco products

Health Canada is committed to developing new health labelling for tobacco products based on the most effective Canadian and international practices. We are guided by peer-reviewed, published studies as well as ongoing consultations with experts in the field, all of which emphasize the importance of the following considerations:

Messages that appeal to all Canadians

Labelling must be understood by people of every age and by a diverse population. New health labelling for tobacco products would continue to feature a range of messages and images to respect different ages, genders, and backgrounds, as well as those who may be at higher risk for developing an addiction to nicotine or other negative health effects.

Personal stories

Personal testimonials or stories are a useful tool in communicating the health hazards of tobacco use and motivating people to quit smoking. Research has shown that Health Warnings are most effective if the viewer can relate to the person or situation described.^{Refernce 14}, ^{Refernce 15} Current health labelling in Canada includes four personal and true stories from former tobacco users whose health has been harmed by tobacco use. Health Canada will make every effort to continue to feature such testimonials on future health labelling.

Messages that cause emotional reactions

Accurate, shocking depictions of the health conditions caused by tobacco use on warning labels are the most likely to be remembered by tobacco users, while messages that are difficult to look at, such as images of rotting teeth, diseased mouths, throat cancer, and disfigurement are generally rated as most effective.^{Refernce 16},^{Refernce 17}, ^{Refernce 18} Graphic images on warning labels appear to be particularly effective among groups that have been hard to reach, including youth and people with low literacy.^{Refernce 19}, ^{Refernce 20} Other types of messages that cause strong feelings, such as images of children affected by tobacco use, have also been found to be memorable and effective.^{Refernce 21}, ^{Refernce 22} Health Canada will continue to incorporate a mix of images that cause emotion in new Health Warning labels.

What we are consulting on

Today, we are consulting with Canadians on the following issues:

1. Labelling on cigarettes
2. Labelling content and design
   1. Health Information Messages
   2. Toxic Statements (Toxic Emissions Statements and Toxic Constituents Statements)
   3. Connecting labelling elements
   4. Quitline information
3. Labelling size and placement
   1. Percentage of coverage of Health Warnings on tobacco products other than cigarettes and little cigars
   2. Minimum size of Health Warnings on tobacco products other than cigarettes and little cigars
4. Labelling for all tobacco products that do not currently require labels
5. Labelling rotation
6. Other considerations

1) Labelling on cigarettes

Applies to: Cigarettes

Current approach: There is currently no health labelling on cigarettes themselves.

Issue: There is recent but limited research showing that Health Warnings placed directly on a product, such as cigarettes, could be effective in making the product less appealing to users.^{Refernce 23},^{Refernce 24}, ^{Refernce 25} Please see below for potential examples of how this may look.

Draft potential examples of Health Warnings directly on cigarettes

Approach under consideration: Health Canada is considering introducing requirements for Health Warnings directly on cigarettes. All elements of design, such as size, wording, font and colour are being considered.

1. Do you believe that displaying information directly on cigarettes would be effective in informing Canadians of the health hazards and effects of cigarettes?
2. Do you have suggestions for types of messages on cigarettes that would be effective in informing Canadians of the health hazards and effects of cigarettes?
3. Do you have specific suggestions about the size, font or colour for Health Warnings on cigarettes that would be effective in informing Canadians of the health hazards and effects of cigarettes?
4. Are there any studies that would support the measures that you are suggesting? If so, please list the studies.

2) Labelling content and design

2a) Health Information Messages

Applies to: Cigarettes, little cigars, kreteks, cigarette tobacco, leaf tobacco and tobacco sticks

Current approach: Current Health Information Messages focus mainly on the benefits of quitting and provide tips to help people quit. They are either printed on the package or on a leaflet inserted into the package. Examples of current Health Information Messages are shown below.

Issue: Health Information Messages should be as noticeable as possible to maximize their effectiveness in communicating with tobacco users.

Approach under consideration: Several options are being explored for maximizing the noticeability of Health Information Messages, including increasing the size of leaflets inserted into packages, requiring them to be stuck onto packages so that they cannot be thrown away, and changing where Health Information Messages are printed on the inside of packages. In recent public opinion research run by Health Canada, participants noted that Health Information Messages on cigarette packs are most likely to be noticed and read when they included new or unusual design features such as vibrant colours, thought bubbles, or cartoons. ^{Refernce 26} An example of a potential new Health Information Message is shown below.

1. Do you have specific suggestions related to the size, colour and design of new Health Information Messages that would maximize the noticeability of the information?
2. Do you have specific suggestions related to the placement of new Health Information Messages that would maximize the noticeability of the information?
3. Do you have suggestions for topics for future Health Information Messages?
4. Are there any studies that would support the measures that you are suggesting? If so, please list the studies.

2b) Toxic Statements (includes Toxic Emissions Statements and Toxic Constituents Statements)

Applies to: All tobacco products

Current approach: Toxic Emissions Statements are required on packages of cigarettes and little cigars. Certain other tobacco products display a list of some of the toxic emissions or the amount of toxic constituents found in the product. Examples of Toxic Emissions Statements for packages of cigarettes and little cigars are shown below.

Issue: Toxic Statements on products that currently have them should be updated to maximize their effectiveness.

Approach under consideration: Health Canada is considering updating requirements related to current Toxic Statements. This includes considering changes to the messages, design and location of the Toxic Statements.

In recent public opinion research run by Health Canada, participants found Toxic Emissions Statements on cigarette packages most eye-catching and easiest to read when: English and French texts were presented side-by-side; black text was on a yellow background and white text was on a red background; and a red "WARNING" banner was placed above the text. ^{Refernce 27} Please refer to the potential example below.

1. Do you have specific suggestions related to the size, colour and design of new Toxic Statements that would serve to make them even easier to notice and read?
2. Do you have specific suggestions related to the placement of new Toxic Statements that would serve to make them even easier to notice and read?
3. Do you have specific suggestions regarding the content of future Toxic Statements?
4. Are there any studies that would support the measures that you are suggesting? If so, please list the studies.

2c) Connecting labelling elements

Applies to: All tobacco products

Current approach: There is currently no requirement for the various health messages on tobacco products and packages to relate to one another.

Issue: There may be benefits to thematically linking the labelling elements on tobacco packages in order to provide more information about a particular health condition, increasing understanding of the health effect and its causes.

Approach under consideration: Since 2012, Australia has connected labelling elements on tobacco packages so that they have messages that relate to one another.^{Refernce 28} An example of the Australian theme "Smoking Causes Blindness" is shown here.^{Refernce 29}

Similar measures to those in Australia could be implemented for future labelling in Canada. One example could be a Health Warning showing lung cancer, a Toxic Statement about chemicals in tobacco smoke that damage lungs, and a Health Information Message that explains how quitting smoking reduces the risk of developing lung cancer.

1. Do you feel that linking the information on tobacco packages by theme would improve understanding of the information presented?
2. Do you have any suggestions related to linking this information by theme on tobacco packages that would improve understanding of the information presented?
3. Are there any studies that would support the measures that you are suggesting? If so, please list the studies.

2d) Quitline information

Applies to: All tobacco products

Current approach: Toll-free quitline and web site information is currently on Health Warnings for cigarettes and little cigars, as well as on some Health Information Messages. Other products do not require quitline information. Please refer to the example below.

Issue: Quitline information should appear on all tobacco products and be as noticeable as possible to maximize their effectiveness in communicating with tobacco users.

Approach under consideration: Health Canada is considering changes to the size, colour, and placement of quitline and website information on labelling to maximize its noticeability. It is also considering adding quitline and website information to other tobacco products, such as smokeless, heated tobacco, and fine cut tobacco products.

1. Do you have specific suggestions related to the size, colour, and placement of quitline and website information on new labelling that would maximize the noticeability of the information on various types of tobacco product packaging?
2. Do you have suggestions for improving how tobacco packages show information about available quitline and web-based cessation services to tobacco users beyond simply displaying the telephone number and website (i.e. smartphone application, #tag, QR code, @symbol, or other methods)?
3. Are there any studies that would support the measures that you are suggesting? If so, please list the studies.

3) Labelling size and placement

3a) Percentage of coverage of Health Warnings on tobacco products other than cigarettes and little cigars

Applies to: Tobacco products other than cigarettes and little cigars

Current approach: Health Warnings on cigarette and little cigar packages must cover at least 75% of the two largest sides of the package or primary display area. For certain other tobacco products, Health Warnings must either cover up to 50% of the main surface or meet size requirements (that are less than 50%), depending on the type of product. Only toxic constituent amounts are required on packages of smokeless tobacco. Examples of these requirements are shown below using proposed Plain and Standardized Appearance* requirements.

*At the time of publication, the Tobacco Products Regulations (Plain and Standardized Appearance) have not yet been published in Canada Gazette Part II. Please refer to Appendix A for information on the regulatory process. For more information on Plain and Standardized Appearance please visit www.canada.ca/en/health-canada/news/2018/06/plain-and-standardized-appearance-for-tobacco-packaging.html

Issue: There is a great deal of research that larger Health Warnings are more effective and generally seen as more believable for both youth and adult cigarette smokers.^{Refernce 30},^{Refernce 31}, ^{Refernce 32}

Approach under consideration: Health Canada is considering expanding the 75% Health Warning requirements for cigarettes and little cigars to other tobacco products.

1. Should the amount of space required for Health Warnings be the same for all tobacco products?
2. If not, what should the exceptions be? What is the rationale for these exceptions?
3. Are there any studies that would support the measures that you are suggesting? If so, please list the studies.

3b) Minimum size of health warnings on tobacco products other than cigarettes and little cigars

Applies to: Tobacco products other than cigarettes and little cigars

Current approach: Labelling requirements for tobacco products other than cigarettes and little cigars are varied, with minimum size requirements (in cm²) applying only to a small number of package types.

Issue: In Canada, tobacco products are sold in a variety of package sizes and formats, including pouches, cans, tins, and kits, among others. New tobacco products with novel package designs continue to emerge on a regular basis. Health Warnings should be large enough to be clear, visible, easy to read, and effective at informing users of the health hazards and effects of tobacco product use.

Approach under consideration: Health Canada is considering establishing a minimum size for Health Warnings on tobacco products other than cigarettes and little cigars. Minimum sizes for Health Warnings for products other than cigarettes and little cigars have also been adopted in Australia^{Refernce 33} and the European Union.^{Refernce 34}

1. Should we require tobacco products other than cigarettes and little cigars to have minimum sizes for Health Warnings?
2. Do you have specific suggestions regarding minimum size requirements for Health Warnings on tobacco products other than cigarettes and little cigars in Canada in the context of plain and standardized appearance measures?
3. Are there any studies that would support the measures that you are suggesting? If so, please list the studies.

4) Labelling for all tobacco products that do not currently require labels

Applies to: Tobacco products not currently required to have health labels

Current approach: Some tobacco products, such as heated tobacco products, water pipe tobacco and blunt wraps, are not currently covered by health labelling requirements.

Issue: Tobacco products packaged without health labelling could be seen as safe.

Approach under consideration: Health Canada is considering extending health labelling requirements to all packages of products containing tobacco, including products not currently subject to existing labelling requirements.

1. Should health labelling be required on the packaging of all tobacco products?
2. Which types of labelling (Health Warnings, Health Information Messages, Toxic Statements) should be required?
3. Should different messages be considered for different types of tobacco products?
4. Are there additional requirements related to extending health labelling to all tobacco products you would suggest?
5. Are there any studies that would support the measures that you are suggesting? If so, please list the studies.

5) Labelling rotation

Applies to: All tobacco products

Current approach: Health messages on tobacco products are not currently required to rotate after a specified period of time.

Issue: Smokers and non-smokers get used to the health information they see on tobacco product packages even when many different labels are displayed equally on tobacco packages sold across Canada.^{Refernce 35}, ^{Refernce 36} As a result, many countries have rotation periods for their messages on tobacco product packages.

Approach under consideration: Heath Canada is considering implementing several rotating suites of health labelling for tobacco products. Some research suggests that the ideal rotation time between sets of labels is 12-18 months, ^{Refernce 37} and the most common rotation period for countries appears to be 12 months per set.

1. What would be the ideal period of time for the rotation of health labelling on tobacco products?
2. Are there any different considerations for rotation of different labelling elements or for different products?
3. How many labels should be included in each set for rotation?
4. Are there any other measures you would suggest related to the rotation of health labelling for tobacco products?
5. Are there any studies that would support the measures that you are suggesting? If so, please list the studies.

6) Other considerations

In addition to the feedback on the specific elements above, we encourage you to provide any other comments and suggestions. We are open to all ideas that would improve labelling for tobacco products.

More generally,

1. Do you feel that there are other significant measures to regulate the health labelling for tobacco products in Canada that we have not addressed?
2. Do you generally support Health Canada's considerations and approach to changing health labelling for tobacco products?
3. Are there any studies that would support the measures that you are suggesting? If so, please list the studies.

We want your feedback

We are seeking input from interested Canadians on the considerations put forward in this document. All feedback received on or before January 4, 2019 will be considered.

The Department will not retain your email address or contact information when receiving your feedback, and will only retain the comments you provide.

You can provide your input using the contact information below.

Health Canada will summarize the results of this consultation which will be published online. No identifying information will be used in the summary without your explicit permission.

Thank you for taking the time to consider this document and for contributing to helping Canadians to lead healthier, tobacco-free lives.

Mailing Address:

Labelling and Plain Packaging Office
Tobacco Control Directorate
Address Locator 0301A, 150 Tunney's Pasture Driveway
Ottawa, ON K1A 0K9

Email: hc.pregs.sc@canada.ca

Note:

Canada is a Party to the World Health Organization Framework Convention on Tobacco Control (FCTC). Article 5.3 of the FCTC 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. You must declare any perceived or actual conflicts of interest with the tobacco industry when providing input to this consultation.

The personal information you provide is protected in accordance with the Privacy Act and collected under the authority of the Department of Health Act, section 4. The information is being collected to allow you to provide your opinions regarding new health labelling for tobacco products in Canada. Your comments, without identifying information such as your name or email address, may be used to brief senior management and inform policy decisions. A summary of comments will also be posted online. To further safeguard privacy, you should ensure that any written comments you may provide are sufficiently general that you cannot be identified as the author and that individual identities are not disclosed. For more information about the use of your personal information please contact the Labelling and Plain Packaging Office at hc.pregs.sc@canada.ca or the Privacy Management Division at hc.privacy-vie.privee.sc@canada.ca. You also have the right to file a complaint with the Privacy Commissioner of Canada if you think your personal information has been handled improperly.

Appendix A: Overview of the regulatory process for the Tobacco and Vaping Products Act

Establishing regulations under the Tobacco and Vaping Products Act typically follows these steps:

1. Public consultation, where the proposal is made public and comments are invited from interested parties
2. Pre-publication of the proposed regulations, and their accompanying Regulatory Impact Analysis Statement, in the Canada Gazette, Part I, followed by a comment period of 30 or 75 days (the latter where the proposed regulations may affect international trade)
3. Consideration of comments received from the public and adjustments of the proposed regulations where appropriate
4. Final approval by the Governor in Council
5. Registration of the regulations and final publication in the Canada Gazette, Part II
6. Coming Into Force of the regulations on the day of registration, unless otherwise specified. For instance, the Coming Into Force may happen six months after their registration, where a delay is necessary to meet Canada's trade obligations

Appendix B: Canada's regulatory framework for health labelling of tobacco products

In 2000, Canada became the first country in the world to have graphic Health Warnings on tobacco packages. The Tobacco Products Information Regulations (TPIR) currently apply to cigars, pipe tobacco, fine cut tobacco, bidis, kreteks and smokeless tobacco. These regulations require picture-based Health Warnings to be displayed on at least 50% of most tobacco packages, including cigarette tobacco, pipe tobacco, and chewing tobacco. The TPIR also requires text-based Health Information Messages on packages, which tell tobacco users about the health effects and health hazards of tobacco use and the benefits of quitting. It also sets out requirements for toxic emissions information and toxic constituents information.

In 2011, the Tobacco Products Labelling Regulations (Cigarettes and Little Cigars) (TPLR) replaced the requirements of the TPIR for cigarettes and little cigars. The TPLR required Health Warnings to cover at least 75% of the main panels. New images were also introduced. These larger Health Warnings include testimonials and information about available smoking cessation resources (a toll-free, pan-Canadian quitline number and web address). Under the TPLR, numerical values of toxic emissions information, which were generally not well understood, were replaced with text-based Toxic Emissions Statements on the sides of most packages. These new Toxic Emissions Statements were designed to provide clear, concise and easy-to-understand information in a plain-language format. Coloured, pictorial Health Information Messages emphasizing the benefits of quitting replaced text-based Health Information Messages, either as leaflets or printed on the inside of packages. These new Health Information Messages were re-designed to be more engaging and encourage users to read the information, including "teasers" displayed on the upper slide flap to draw attention to the inside of the package or the leaflets through the use of colour and images.

The Tobacco Act was recently amended to create, among other things, new rules for vaping products in Canada and to change its title to the Tobacco and Vaping Products Act. The Act will also allow Health Canada to enhance the public awareness of the health hazards of using tobacco products by requiring that the tobacco product and package display information about the product and its emissions, and about the health hazards and health effects arising from the use of the product and from its emissions. The Act also allows Health Canada to put in place regulations to make sure all tobacco packaging looks the same, reducing their appeal to youth and others. These measures would apply to all tobacco products. The Tobacco and Vaping Products Act also provides the authority to make regulations for information to appear directly on tobacco products such as cigarettes.

Appendix C: Selection of current health labelling on tobacco packages in Canada

Health Warnings - cigarettes:

Health Warnings - little cigars:

Health Information Messages - cigarettes and little cigars:

Toxic Emissions Statements - cigarettes and little cigars:

Toxic Constituents Statements* - Kreteks, Cigarette Tobacco, Leaf Tobacco, Tobacco Sticks, Chewing Tobacco and Snuff:

*Toxic constituents information is provided by the manufacturer and is product -specific.

Health Warnings - cigars and pipe tobacco:

Health Warnings - kreteks, cigarette tobacco, leaf tobacco and tobacco sticks:

Health Information Messages - kreteks, cigarette tobacco, leaf tobacco and tobacco sticks:

To view all labelling visit:

https://www.canada.ca/en/health-canada/services/publications/healthy-living/health-labels-cigarettes-little-cigars.html