Regulations Amending the Tobacco Products Regulations (Plain and Standardized Appearance): SOR/2023-97

Canada Gazette, Part II, Volume 157, Number 12

Registration
SOR/2023-97 May 19, 2023

TOBACCO AND VAPING PRODUCTS ACT

P.C. 2023-448 May 18, 2023

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 Regulations (Plain and Standardized Appearance) under sections 7footnote a, 17footnote b and 33footnote c of the Tobacco and Vaping Products Act footnote d.

Regulations Amending the Tobacco Products Regulations (Plain and Standardized Appearance)

Amendments

1 The title of the Tobacco Products Regulations (Plain and Standardized Appearance) footnote 1 is replaced by the following:

Tobacco Products Appearance, Packaging and Labelling Regulations

2 (1) The definitions carton, drab brown, gray and health warning in subsection 1(1) of the Regulations are replaced by the following:

carton
means a secondary package in which two or more primary packages containing the same type of tobacco product are placed. (cartouche)
drab brown
means the colour known as Pantone 448. (brun terne)
gray
means the colour known as Pantone Cool Gray 2. (gris)
health warning,
in respect of a tobacco product, means the applicable health warning
  • (a) referred to in subsection 88(1) and displayed on a tobacco product package; or
  • (b) referred to in subsection 118(1) and displayed directly on a tobacco product. (avertissement sanitaire)

(2) Subsection 1(1) of the Regulations is amended by adding the following in alphabetical order:

cigar
means a roll or tubular construction intended for smoking, other than a little cigar, that contains a filler composed of natural or reconstituted tobacco and has a wrapper, or a wrapper and a binder, composed of natural or reconstituted tobacco. (cigare)
cigarette
includes any roll or tubular construction that contains tobacco and is intended for smoking, other than a cigar, little cigar or tobacco stick. (cigarette)
display area
means the portion of the surface area of a tobacco product package, leaflet or tobacco product on which a labelling element is to be displayed. (zone d’affichage)
manufacturer
does not include an individual or entity that only packages or distributes tobacco products on behalf of a manufacturer. (fabricant)
top edge
means the edge that is in the horizontal plane and forms the upper limit of the package when the package is used in the customary manner to gain access to the tobacco product. (arête supérieure)

3 Subsection 1(5) of the Regulations is repealed.

4 Section 2 of the Regulations is replaced by the following:

Tobacco product and package — retail sale

2 (1) These Regulations 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.

Package that does not contain tobacco products

(2) Part 1 also applies, in accordance with section 60, to a package that does not contain a tobacco product but is furnished by a manufacturer of a tobacco product so that a tobacco product, primary package or secondary package may be placed in it after the tobacco product, primary package or secondary package is sold at retail in Canada.

5 Subsection 5(2) of the Regulations is replaced by the following:

Information — package

(2) For the purposes of section 15.3 of the Act, these Regulations set out the requirements that manufacturers of tobacco products must meet in respect of the manner of displaying information on tobacco product packages and on leaflets, including the form and placement of the information.

6 The Regulations are amended by adding the following after section 6:

Labelling — required information

6.1 For the purposes of sections 15 and 15.2 of the Act, these Regulations set out the labelling requirements that manufacturers of tobacco products must meet in respect of

7 The heading of Part 1 of the Regulations is replaced by the following:

Appearance and Dimensions of Tobacco Product Packages

8 Subsection 10(2) of the Regulations is replaced by the following:

Exception — required or authorized information

(2) Other colours may be used on the interior and exterior surfaces to display a health warning or other information that is required or authorized by or under the Act, any other Act of Parliament or any Act of the legislature of a province, in accordance with the requirements imposed by or under that Act, other Act of Parliament or Act of the legislature of a province.

9 Section 11 of the Regulations is renumbered as subsection 11(1) and is amended by adding :

Exception — pouch or soft package

11 (2) The interior surfaces and exterior surfaces of a primary package that is a pouch or soft package may have a glossy finish if those surfaces include a transparent film.

10 Subsection 15(3) of the Regulations is replaced by the following:

Information — characteristics

(3) The alphanumeric code must not convey any information relating to characteristics of the tobacco product that the primary package or secondary package contains or the tobacco product’s emissions.

11 (1) Subsection 22(2) of the Regulations is replaced by the following:

Exception — required or authorized information

(2) The exterior surfaces of a primary package and of a secondary package may include an irremovable sticker that displays information that is required or authorized by or under the Act, any other Act of Parliament or any Act of the legislature of a province, if the sticker is placed on an exterior surface in such a manner that it does not conceal or obscure any such information on the package.

(2) Paragraph 22(5)(a) of the French version of the Regulations is replaced by the following:

(3) Subsection 22(7) of the French version of the Regulations is replaced by the following:

Autocollants et languettes transparents et incolores

(7) Les autocollants et les languettes qui recouvrent les informations exigées sous le régime de la Loi, de toute autre loi fédérale ou de toute loi provinciale sont transparents et incolores.

12 Paragraph 24(e) of the French version of the Regulations is replaced by the following:

13 (1) Paragraph 25(b) of the Regulations is replaced by the following:

(2) Paragraphs 25(d) and (e) of the French version of the Regulations are replaced by the following:

14 Paragraph 26(e) of the French version of the Regulations is replaced by the following:

15 Subsection 29(4) of the Regulations is replaced by the following:

Other primary package or secondary package

(4) In the case of any other primary package or secondary package, the brand name may be displayed only once on each exterior surface of the package.

16 Subsections 31(1) and (2) of the French version of the Regulations are replaced by the following:

Présentation

31 (1) Le nom de marque qui figure sur une surface extérieure d’un emballage primaire ou d’un emballage secondaire sur laquelle figure également un avertissement sanitaire est disposé parallèlement à l’avertissement et dans le même sens que celui-ci et est centré sur la superficie qui n’est pas occupée par l’avertissement ou par toute autre information exigée ou autorisée sous le régime de la Loi, de toute autre loi fédérale ou de toute loi provinciale.

Autres cas

(2) Le nom de marque qui figure sur une surface extérieure d’un emballage primaire ou d’un emballage secondaire sur laquelle ne figure aucun avertissement sanitaire satisfait aux exigences suivantes :

17 Section 33 of the Regulations is replaced by the following:

Manner of display

33 In the case of any primary package or secondary package, other than a cylindrical package, the manufacturer’s identity and principal place of business must be oriented parallel to and in the same direction as any other information that is displayed on the same exterior surface.

18 Section 35 of the French version of the Regulations is replaced by the following:

Présentation

35 (1) La déclaration de quantité nette du produit du tabac et son nom commun qui figurent sur une surface extérieure d’un emballage primaire ou d’un emballage secondaire sur laquelle figure également un avertissement sanitaire sont disposés parallèlement à l’avertissement et dans le même sens que celui-ci.

Autres cas

(2) Si la déclaration de quantité nette et le nom commun figurent sur une surface extérieure d’un emballage primaire ou d’un emballage secondaire sur laquelle ne figure aucun avertissement sanitaire, ils sont disposés parallèlement aux autres informations figurant sur cette surface et dans le même sens que celles-ci.

19 Section 36 of the Regulations is replaced by the following:

Placement

36 In the case of a primary package or secondary package that has a rectangular cuboid shape when it is closed, the declaration of net quantity and the common name of the tobacco product must be displayed in such a manner that the last letter of that information is 5 mm from the bottom and right edges of the package.

20 Section 40 of the Regulations is replaced by the following:

Primary package — requirement

40 A primary package that contains cigarettes must be a slide and shell package.

21 Paragraph 41(a) of the Regulations is replaced by the following:

22 The Regulations are amended by adding the following after section 42:

Dimensions of upper slide-flap

42.1 (1) The upper slide-flap of a slide and shell package that contains regular size cigarettes must have the following dimensions:

King size cigarettes

(2) The upper slide-flap of a slide and shell package that contains king size cigarettes must have the following dimensions:

Width

(3) The width of the upper slide-flap of a slide and shell package must be equal to the width of the slide.

23 Paragraph 44(a) of the Regulations is replaced by the following:

24 Section 45 of the Regulations is replaced by the following:

Declaration of size of cigarettes

45 (1) The declaration of the size of cigarettes as regular size or king size may be displayed on the exterior surface of the front and back of a primary package and of a secondary package.

Manner of display

(2) The declaration of the size of cigarettes must be identified by the words “Regular Size” or their abbreviation “RS” or the words “King Size”or their abbreviation “KS”, as the case may be, and be printed in alphabetic characters of 10 points, oriented parallel to and in the same direction as the health warning and positioned in such a manner that the first letter of the declaration is 5 mm from the bottom and left edges of the primary package or secondary package.

25 Sections 49 and 50 of the Regulations are replaced by the following:

Interpretation — primary package

49 Despite these Regulations, a package is considered to be a primary package if it is intended for retail sale in Canada and cigars that are individually covered by overwrap are directly placed in it.

Overwrap — cigar

50 (1) An overwrap that covers one cigar and an overwrap in which two or more cigars are placed must mould to the cigars and meet the requirements of paragraphs 24(b) to (d).

Overwrap — two or more cigars

(2) The information and features referred to in section 25 may be displayed on an overwrap in which two or more cigars are placed.

Overwrap — sticker

(3) Subject to subsections (4) and (5), the interior and exterior surfaces of an overwrap in which two or more cigars are placed must not include any sticker.

Exception — required or authorized information

(4) An exterior surface of an overwrap in which two or more cigars are placed may include an irremovable sticker that displays information required or authorized by or under the Act, any other Act of Parliament or any Act of the legislature of a province, if the sticker is placed on the overwrap in such a manner that it does not conceal or obscure any such information on the overwrap.

Sticker — requirements

(5) The requirements of section 9, subsections 10(1) and (2), sections 11 and 12, subsections 13(1) and 14(1), section 17 and subsection 20(1) that are related to interior and exterior surfaces apply to the sticker.

26 Paragraph 57(e) of the French version of the Regulations is replaced by the following:

27 Section 63 of the Regulations is replaced by the following:

Alphanumeric code

63 (1) A tobacco product may display an alphanumeric code described in subsection 15(1), printed in black or gray.

Subsection 5.3(3) of the Act

(2) For the purposes of subsection 5.3(3) of the Act, black and gray colouring agents used to display the alphanumeric code on a tobacco product are prescribed additives.

Other requirements

(3) The alphanumeric code must

Exception — cigars

(4) Despite paragraph (3)(a), instead of being printed on a cigar, the alphanumeric code may be printed on a cigar band that meets the requirements of subsection 71(4) if the code is displayed only once on the band and is printed in characters of no more than 10 points.

Information — characteristics

(5) The alphanumeric code must not convey any information relating to characteristics of the tobacco product or its emissions.

Brand element

(6) The alphanumeric code must not evoke the tobacco product’s brand elements.

28 (1) The portion of subsection 71(1) of the French version of the Regulations before paragraph (a) is replaced by the following:

Informations figurant sur les bagues de cigares

71 (1) Les informations ci-après peuvent figurer sur les cigares si elles figurent sur une bague qui est placée autour de la circonférence du cigare et satisfont aux exigences prévues au présent article :

(2) Subsection 71(2) of the French version of the Regulations is replaced by the following:

Exigences — informations

(2) Ces informations ne figurent qu’une seule fois sur la bague et :

29 Part 3 of the Regulations is replaced by the following:

PART 3
Tobacco Product Labelling — Required Information

Definitions

Definitions

81 The following definitions apply in this Part.

health information message,
in respect of a tobacco product, means the applicable health information message referred to in subsection 94(1). (message d’information sur la santé)
labelling element,
in respect of a tobacco product, means
  • (a) a health warning described in section 87, a health information message described in section 92 or the toxicity information described in section 99 that is displayed on a package or leaflet; and
  • (b) a health warning described in section 117 that is displayed directly on a tobacco product referred to in that section. (élément d’étiquetage)
source document
means the document that sets out labelling elements, as well as the attribution of those labelling elements, entitled Labelling Elements for Tobacco Products, as amended from time to time and published by the Government of Canada in print and electronic form. (document source)
toxicity information,
in respect of a tobacco product, means the applicable toxicity information referred to in subsection 100(1). (information sur la toxicité)
year
means a period of 12 consecutive months beginning on the day on which section 89 comes into force or any subsequent anniversary of that day. (année)

General Provisions

Electronic files

82 (1) A manufacturer must obtain from the Minister, in the form of electronic files, the labelling elements and the attribution of the labelling elements, as set out in the source document, and display the labelling elements on tobacco products, packages or leaflets.

Source document

(2) Subject to the other provisions of this Part, a manufacturer must display labelling elements on tobacco products, packages and leaflets in the same manner as they are presented in the source document published in print form.

Attribution

83 (1) If a manufacturer attributes a labelling element contained in an electronic file, they must do so by displaying the phrase “Health Canada” with the English version of the labelling element and the phrase “Santé Canada” with the French version of the labelling element.

Source document

(2) Subject to the other provisions of this Part, a manufacturer must display the attribution of a labelling element on tobacco products, packages and leaflets in the same manner as it is presented in the source document published in print form.

Legibility and official languages

84 The text of labelling elements and attributions that are displayed on a tobacco product, package or leaflet must be legible and displayed in both official languages in the same manner.

Permanence

85 Labelling elements that are displayed on a tobacco product, package or leaflet must be irremovable.

Printing

86 Labelling elements and attributions that are displayed on a tobacco product, package or leaflet must be printed

Labelling on Packages — Required Information

Health Warnings

Requirement — primary package and secondary package

87 (1) Every primary package and every secondary package that contains a tobacco product, other than papers and filters intended for use with a tobacco product, must display a health warning that consists of three or more of the following components:

Requirement — overwrap

(2) Every overwrap in which two or more cigars are placed must also display a health warning that consists of three or more of the components referred to in subsection (1).

Source document

88 (1) The health warnings that are required for a tobacco product and must be displayed on packages are the health warnings set out for that type of product in the following Sections of the source document:

Health warnings — rotation

(2) The health warnings that are set out in the source document for each type of tobacco product must be used in rotation, beginning on the day on which these Regulations come into force, with each of the rotations set out in the source document being applicable during the following periods:

First rotation

(3) Despite paragraph (2)(a), in the case of cigarettes, little cigars, cigarette tobacco and tubes, the first rotation of health warnings applies during the period that begins on the day on which these Regulations come into force and ends on July 31, 2026.

Rotation — transition

(4) The health warnings set out in a rotation in the source document may be used during the period of 90 days before the day on which that rotation applies in accordance with subsection (2).

Retail sale continued

(5) Despite paragraph (2)(b), if a new rotation of health warnings becomes applicable in respect of a type of tobacco product referred to in that paragraph that is sold, by a retailer, in a package that displays a health warning of the preceding rotation, the preceding rotation continues to apply.

Equal use

89 Every manufacturer must, to the extent possible, use each health warning set out in each applicable rotation of health warnings in the source document in respect of an equal number of each type of package of each brand name of tobacco products that they package in a year.

Placement — display area

90 (1) A health warning must be displayed on the following display areas:

Space occupied

(2) The health warning and any attribution of the health warning must occupy at least the following portions of the display area of a package:

Manner of display — official languages

91 (1) Health warnings must be displayed on packages in both official languages in such a manner that

Alignment

(2) The health warnings must be positioned parallel to and as close as possible to the top edge of the package or to the hinge opening, depending on the type of package.

Specific requirement — cigar tube

(3) Despite subsection (2), in the case of a cigar tube, the health warning must be positioned perpendicular to the edge of the lid of the cigar tube.

Format

(4) The health warnings must be displayed on packages in one of the following formats:

Health Information Messages

Requirement — package

92 (1) Every primary package that contains cigarettes or cigarette tobacco must display a health information message that consists of the following components:

Small primary package — cigarette tobacco

(2) However, in the case of small primary package that contains cigarette tobacco and whose dimensions do not allow the health information message to be displayed on the package, on the applicable display area described in paragraph 96(1)(b) or (c), the health information message must be displayed on a leaflet that is at least 80 mm by 53 mm in size and is inserted in the package.

Little cigars

93 A health information message consisting of the components referred to in subsection 92(1) must be displayed on a leaflet that is at least 65 mm by 43 mm in size and is inserted in every primary package that contains little cigars.

Source document

94 (1) The health information messages that are required for a tobacco product are the health information messages set out for that type of tobacco product in the following Sections of the source document:

Health information messages — rotation

(2) The health information messages that are set out in the source document for each type of tobacco product referred to in subsection (1) must be used in rotation, beginning on the day on which these Regulations come into force, with each of the rotations set out in the source document being applicable during a period of 24 months.

First rotation

(3) Despite subsection (2), the first rotation of health information messages applies during the period that begins on the day on which these Regulations come into force and ends on July 31, 2026.

Rotation — transition

(4) The health information messages set out in a rotation in the source document may be used during the period of 90 days before the day on which that rotation applies in accordance with subsection (2).

Equal use

95 Every manufacturer must, to the extent possible, use each health information message set out in each applicable rotation of health information messages in the source document in respect of an equal number of each type of primary package of each brand name of cigarettes, little cigars and cigarette tobacco that they package in a year.

Placement — display area

96 (1) A health information message must be displayed on a primary package on the following display areas:

Removable leaflet — extension

(2) A portion of the surface of the removable leaflet referred to in subparagraph (1)(b)(ii) may extend beyond the edge of the disc if the extended surface displays the phrases set out in subsection 97(2).

Space occupied

(3) The health information message and any attribution of the health information message must occupy the following portions of the display area:

Manner of display — official languages

97 (1) Health information messages must be displayed on primary packages in both official languages in such a manner that

Removable leaflet — extension

(2) The extended surface of the removable leaflet referred to in subparagraph 96(1)(b)(ii) may display the phrase “FRANÇAIS AU VERSO” in the English version and the phrase “ENGLISH ON OTHER SIDE” in the French version, printed in a regular weight and width Lucida Sans Serif font style, in characters of 9 points, in black upper case letters, without italics and in bold type.

Alignment

(3) A health information message that is displayed on the display area of a primary package that contains cigarette tobacco must be

Alignment with health warning

(4) If a health information message is displayed on a display area of a primary package on which a health warning is also displayed, the health information message must be oriented parallel to and in the same direction as the health warning.

Format

(5) The health information message must be displayed on the primary package, including on a removable leaflet referred to in subparagraph 96(1)(b)(ii) or on the freshness seal referred to in subparagraph 96(1)(b)(iii), in “Landscape” format.

Manner of display — subsection 92(2) and section 93

98 (1) A health information message, and any attribution of the health information message, that is displayed on a leaflet that is referred to in subsection 92(2) or section 93 and inserted in a primary package that contains cigarette tobacco or little cigars must be displayed on a display area that occupies the entire surface area of the leaflet.

Official languages

(2) The English version of a health information message must be displayed on one side of the leaflet and the French version on the other.

Format

(3) The health information message must be displayed in “Portrait” format on the leaflet .

Toxicity Information

Requirement — primary package and secondary package

99 (1) Every primary package and secondary package that contains a tobacco product, other than papers and filters intended for use with a tobacco product, must display toxicity information that consists of the following components:

Requirement — overwrap

(2) Every overwrap in which two or more cigars are placed must also display toxicity information that consists of the components referred to in subsection (1).

Source document

100 (1) The toxicity information that is required for a tobacco product is the toxicity information set out for that type of tobacco product in the following Sections of the source document:

Toxicity information — rotation

(2) The labelling elements related to toxicity information that are set out in the source document for each type of tobacco product must be used in rotation, beginning on the day on which these Regulations come into force, with each of the rotations set out in the source document being applicable during the following periods:

First rotation

(3) Despite paragraph (2)(a), in the case of cigarettes, little cigars, cigarette tobacco and tubes, the first rotation of labelling elements related to toxicity information applies during the period that begins on the day on which these Regulations come into force and ends on July 31, 2026.

Rotation — transition

(4) The labelling elements related to toxicity information that are set out in a rotation in the source document may be used during the period of 90 days before the day on which that rotation applies in accordance with subsection (2).

Retail sale continued

(5) Despite paragraph (2)(b), if a new rotation of labelling elements related to toxicity information becomes applicable in respect of a type of tobacco product referred to in that paragraph that is sold, by a retailer, in a package that displays a labelling element related to toxicity information of the preceding rotation, the preceding rotation continues to apply.

Equal use

101 Every manufacturer must, to the extent possible, use each labelling element related to toxicity information that is set out in each applicable rotation in the source document in respect of an equal number of each type of package of each brand name of tobacco products that they package in a year.

Placement — display area

102 (1) Toxicity information must be displayed on the following display areas:

Space occupied

(2) The toxicity information and any attribution of the toxicity information must occupy the following portions of the display area of a package:

Exception — large display area

(3) The portion of the display area that the toxicity information occupies need not exceed 3 000 mm2, except in the case of a secondary package that is a carton.

Manner of display — official languages

103 (1) Toxicity information must be displayed on packages in both official languages in such a manner that the English and French versions are side by side.

Format

(2) The toxicity information must be displayed on the package in “Landscape” format.

Format — cigar tubes

(3) However, in the case of a cigar tube, the toxicity information must be displayed in “Elongated Landscape” format.

Kits

Definition of kit

104 In sections 105 to 109, kit means a package in which two or more of the following types of tobacco products are placed, if at least two of those types of tobacco products are intended to be assembled together by a consumer for their use:

Requirement

105 (1) Every kit must display a health warning described in section 87 and the toxicity information described in section 99.

One type of tobacco product

(2) A kit that contains papers or filters as well as only one type of tobacco product referred to in any one of paragraphs 104(a) to (m) and (p) must display the health warning and the toxicity information required for that one type of tobacco product under sections 88 and 100, as applicable.

Two or more types

(3) A kit that contains two or more types of tobacco products referred to in any of paragraphs 104(a) to (n) and (p) must display the health warning and the toxicity information required under sections 88 and 100, as applicable,

Portion of display area having same size

(4) In respect of the display areas for two or more types of tobacco products contained in a kit, if the largest portion referred to in subsection (3) is the same size for at least two types of tobacco products among those referred to in any one of paragraphs 3(a), (b) and (c), the kit must display the health warning and toxicity information required under sections 88 and 100, as applicable, for the type of tobacco product whose health warnings are set out in the Section of the source document that appears first in the source document.

Health Warning

Display area

106 (1) A health warning must be displayed on the following display areas on a kit:

Space occupied

(2) The health warning and any attribution of the health warning must occupy at least 75% of the display area.

Manner of display — official languages

107 (1) A health warning must be displayed on a kit in both official languages in such a manner that

Format

(2) The health warning must be displayed on the kit in “Landscape” format.

Toxicity Information

Display area

108 (1) Toxicity information must be displayed on a display area that is one of the exterior surfaces of the kit that remains unoccupied by a health warning.

Space occupied

(2) The toxicity information and any attribution of the toxicity information must occupy at least 50% of the display area.

Manner of display — official languages

109 (1) Toxicity information must be displayed on kits in both official languages in such a manner that the English and French texts are side by side.

Format

(2) The toxicity information must be displayed on kits in “Landscape” format.

Technical Specifications — Manner of Display

Labelling on package — integrity

110 (1) The customary method of opening a package containing a tobacco product must not sever or otherwise damage a labelling element or render it illegible.

Severed package

(2) However, a labelling element may be severed and two lines of text within the labelling element may be separated when the package is opened by the customary method if

Non-application

(3) This section does not apply to a package that is ordinarily torn during or discarded after opening.

Visibility

111 (1) A labelling element, component of a labelling element or attribution of a labelling element must not be obscured, except partially by a tear tape required under provincial legislation.

Coverage

(2) A labelling element, component of a labelling element or attribution of a labelling element must not be concealed, except partially by a tobacco excise stamp and on the following conditions:

Tax stamp

112 A labelling element or attribution of a labelling element must not conceal or obscure a tobacco excise stamp that is affixed to the package in the manner prescribed by the Stamping and Marking of Tobacco, Cannabis and Vaping Products Regulations.

Orientation of text

113 The text of a health warning or health information message must be oriented in such a manner that it is readable from left to right when a package is used in the customary manner to gain access to the tobacco product.

Leaflet — visibility and readability

114 A leaflet on which a labelling element is displayed must be

Adaptation

115 Despite sections 82 and 83, if a labelling element or attribution of a labelling element does not fit the portion of the display area on a package, or the surface area on a leaflet, that it must occupy, the labelling element or attribution must be adapted as follows:

Finish — health warning

116 (1) For greater certainty, the text of a health warning or attribution of a health warning that is displayed on a package must have a glossy finish.

Finish — pouch or soft package

(2) In the case of a primary package that is a pouch or soft package and whose interior and exterior surfaces include a transparent film, the text of a health warning or an attribution of a health warning must have a matte or glossy finish.

Health information message and toxicity information

(3) The text of a health information message, the toxicity information or an attribution of those labelling elements that is displayed on a package or leaflet must have a matte or glossy finish.

Labelling on Tobacco Products — Required Information

Requirement — tobacco products

117 (1) A health warning that consists of the explanatory text of the warning or of a warning pictogram or of both the explanatory text and a warning pictogram must be displayed directly on cigarettes, little cigars and tubes.

Exception — little cigars without tipping paper

(2) Subsection (1) does not apply to little cigars that do not have tipping paper.

Source document

118 (1) The health warnings that are required for a tobacco product and must be displayed directly on the product are the health warnings set out for that type of tobacco product in the following Sections of the source document:

Health warnings — rotation

(2) The health warnings that are set out in the source document for each type of tobacco product referred to in subsection (1) must be used in rotation, beginning on the day on which these Regulations come into force, with each of the rotations set out in the source document being applicable during a period of 24 months.

First rotation

(3) Despite subsection (2), the first rotation of health warnings applies during the period that begins on the day on which these Regulations come into force and ends on July 31, 2026.

Rotation — transition

(4) The health warnings set out in a rotation in the source document may be used during the period of 90 days before the day on which that rotation applies in accordance with subsection (2).

Equal use

119 Every manufacturer must, to the extent possible, use each health warning set out in each applicable rotation of health warnings in the source document in respect of an equal number of each size of each brand name of cigarettes, little cigars and tubes that they package in a year.

Placement — display area

120 (1) A health warning that is displayed on a cigarette, little cigar or tube must be displayed on a display area that consists of the surface of the tobacco product’s tipping paper.

Exception — cigarette without tipping paper

(2) However, in the case of a cigarette that does not have tipping paper, the health warning must be displayed on a display area that consists of the surface of the paper that covers the rolled tobacco.

Display area — length

(3) The display area must be at least 24 mm in length,

Space occupied

(4) The health warning and any attribution of the health warning must occupy the entire length of the display area and at least 80% of the display area around the circumference of the cigarette, little cigar or tube.

Manner of display — official languages

121 (1) The health warning must be displayed on cigarettes, little cigars or tubes in both official languages in such a manner that

Alignment

(2) The health warning must be centered horizontally along the length of the display area of the cigarette, little cigar or tube.

Text

(3) The text of the health warning must be printed on two white backgrounds, with the English version on one and the French version on the other.

Format

(4) The health warning must be displayed on the cigarette, little cigar or tube in “Landscape” format.

Format — length of tipping paper

(5) However, if the tipping paper of the cigarette, little cigar or tube is 30 mm or more in length, the health warning must be displayed in “Elongated Landscape” format.

Subsection 5.3(3) of the Act

122 For the purposes of subsection 5.3(3) of the Act, all colouring agents used to display a health warning or an attribution on a cigarette, little cigar or tube are prescribed additives.

Visibility

123 (1) The entire text of each of the English and French versions of a health warning must be visible under normal conditions of use of a cigarette, little cigar or tube without turning the tobacco product.

Alphanumeric code

(2) The health warning and any attribution of the health warning must be positioned in such a manner that they do not obscure or conceal the alphanumeric code referred to in subsection 63(1), if any.

30 The French version of the Regulations is amended by replacing “renseignement” and “renseignements” with “information” and “informations”, respectively, with any necessary modifications, in the following provisions:

Transitional Provisions

31 (1) The following definitions apply in this section and sections 32 to 36.

former Regulations means

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) All other words and expressions used in this section and sections 32 to 36 have the same meaning as in the new Regulations.

32 (1) If a package of a tobacco product or any leaflet provided with the tobacco product displays information in accordance with the former Regulations and that product is sold or distributed by a manufacturer, the former Regulations continue to apply to the package or the leaflet until January 31, 2024.

(2) If a package of a tobacco product or any leaflet provided with the tobacco product displays information in accordance with the former Regulations and that product is sold by a retailer, the former Regulations continue to apply to the package or the leaflet until April 30, 2024.

33 (1) A manufacturer may sell or distribute, until January 31, 2024, a tobacco product in respect of which the former Regulations do not apply and whose package, or any leaflet provided with the tobacco product, does not display information in accordance with Part 3 of the new Regulations.

(2) A retailer may sell, until April 30, 2024, a tobacco product in respect of which the former Regulations do not apply and whose package, or any leaflet provided with the tobacco product, does not display information in accordance with Part 3 of the new Regulations.

34 (1) A manufacturer may sell or distribute, until July 31, 2026, cigarettes in a slide and shell package that does not meet the requirements of section 42.1 of the new Regulations, if the health information message referred to in paragraph 94(1)(a) of the new Regulations is displayed on both the display area referred to in paragraph 96(1)(a) of the new Regulations and the exterior surface of the slide.

(2) A retailer may sell, until October 31, 2026, cigarettes in a slide and shell package that does not meet the requirements of section 42.1 of the new Regulations, if the health information message referred to in paragraph 94(1)(a) of the new Regulations is displayed on both the display area referred to in paragraph 96(1)(a) of the new Regulations and the exterior surface of the slide.

35 (1) A manufacturer may continue to sell or distribute, until April 30, 2024, king size cigarettes that do not meet the requirements of Part 3 of the new Regulations.

(2) A retailer may continue to sell, until July 31, 2024, king size cigarettes that do not meet the requirements of Part 3 of the new Regulations.

36 (1) A manufacturer may continue to sell or distribute, until January 31, 2025, regular size cigarettes, little cigars and tubes that do not meet the requirements of Part 3 of the new Regulations.

(2) A retailer may continue to sell, until April 30, 2025, regular size cigarettes, little cigars and tubes that do not meet the requirements of Part 3 of the new Regulations.

Repeals

37 The Tobacco Products Information Regulations footnote 2 are repealed.

38 The Tobacco Products Labelling Regulations (Cigarettes and Little Cigars) footnote 3 are repealed.

Coming into Force

39 These Regulations come into force on August 1, 2023.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations or the Order.)

Executive summary

Issues: Tobacco use continues to be the leading preventable cause of illness and premature death in Canada. Approximately 48 000 Canadians die each year from tobacco use. The provision of health-related messages on tobacco products packaging is recognized as one of the best approaches to inform Canadians of the health hazards of tobacco use.

The health-related messages displayed on tobacco product packaging required under both the Tobacco Products Information Regulations (TPIR) and the Tobacco Products Labelling Regulations (Cigarettes and Little Cigars) [TPLR-CLC] have reached their maximum potential and need to be updated to remain impactful. In addition, young persons who usually experiment with single cigarettes obtained from social sources are less exposed to the health warnings displayed on cigarette packaging. Not all tobacco product packaging is currently subject to labelling requirements, including packages for products intended for use with devices, those devices and their parts, water pipe tobacco, blunt wraps, as well as those for any novel tobacco product that may be introduced into the market in the future.

Canada is not yet fully compliant with its tobacco labelling obligations under the World Health Organization Framework Convention on Tobacco Control (FCTC), as not all tobacco product packaging is currently subject to labelling requirements.

Description: The Regulations Amending the Tobacco Products Regulations (Plain and Standardized Appearance) [TPR-PSA or the Regulations] bring Canada into full compliance with its international tobacco labelling requirements under Article 11 of the FCTC by extending the display of health warnings and toxicity information to all tobacco product packages. They also introduce a rotation scheme for all health-related messages. The Regulations introduce a mandatory display of health warnings directly on individual cigarettes, little cigars that have tipping paper, and tubes, which is consistent with the Guidelines for implementation of Article 11 of the FCTC.

The Regulations introduce additional enhanced measures, such as renewed health-related messages that are memorable, noticeable and impactful, a minimum size for health warnings on most tobacco product packages covering at least 75% of the main display area, a new location for health information messages for cigarette packages and an ambulatory incorporation by reference of the document entitled Labelling Elements for Tobacco Products (Source Document), to allow for the update of the content and images featured in health-related messages as required from time to time.

The Regulations also allow the use of “RS” or “KS” on cigarette packages as alternatives to “regular size” or “king size” as a declaration of cigarette size on the package.

The Regulations consolidate all tobacco product appearance, packaging and labelling requirements in a single set of regulations, entitled the Tobacco Products Appearance, Packaging and Labelling Regulations (TPAPLR), by amending the TPR-PSA and repealing the TPIR and TPLR-CLC.

In addition, the Order Amending Schedule 1 to the Tobacco and Vaping Products Act (the Order) permits the use of colouring agents to whiten the tipping paper of cigarettes, of little cigars where present and of tubes, where a white background for the health warning is required.

Rationale: New and amended measures introduced in the Regulations are expected to enhance public awareness, particularly among young persons, of the health hazards of tobacco use, and help prevent the public from being misled or deceived about those hazards. In addition, the health warnings to be displayed on cigarettes, on little cigars that have tipping paper and on tubes, support the objective of protecting young persons and others from inducements to use these products.

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 Regulations will result in total incremental costs estimated at $214 million present value (TPV) over 10 years (or about $30.4 million in annualized value). The monetized costs to the tobacco industry are primarily associated with the introduction and rotation of new sets of messages and new placement requirements for health information messages on cigarette packages. Implementation of the Regulations will result in incremental costs to Health Canada from performing compliance and enforcement activities; these costs will be absorbed through existing budget allocations.

A break-even analysis indicates that a relatively small effect on cigarette smoking initiation and cessation — in the order of a 0.21% increase in annual cessation rates or a 1.04% reduction in annual initiation rates — would be sufficient to produce health benefits to the public equivalent to or greater than the estimated monetized costs. The relatively small effects on these rates would be equivalent to either 11 100 fewer people who start smoking or 2 400 additional people who quit over the next 10 years. In 2021, there were 3.8 million persons who smoked in Canada.

Small business lens and one-for-one rule: The small business lens applies as some of the businesses on which the Regulations impose costs meet the definition of “small business.” Analysis has determined that 28 domestic small business manufacturers will face annualized compliance costs equivalent to $920,000, or $33,000 on average per business.

The one-for-one rule applies since the Regulations repeal two existing regulatory titles and amend another one. The regulations merge the TPIR, the TPLR-CLC and the TPR-PSA into a single set of regulations. As a result, a net of two titles out is counted under the rule.

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 48 000 Canadians die each year from tobacco use.footnote 4 The health and economic costs associated with tobacco use in Canada were estimated at $12.3 billion in 2017,footnote 4 with direct health care costs of $6.1 billion.

Health-related messages on tobacco products packaging is recognized as one of the best approaches to inform Canadians of the health hazards associated with tobacco use. Health-related messages for cigarettes and little cigars have been in place since 2011 through the TPLR-CLC, while those for cigarette tobacco, cigars, pipe tobacco, leaf tobacco, tobacco sticks, chewing tobacco and snuff have remained unchanged since their introduction in 2000 through the TPIR. These messages have reached their maximum potential.footnote 5 Further, they no longer reflect the most up-to-date information, research and science available.

Young persons experimenting with cigarette smoking often obtain individual cigarettes through social sources and are not exposed to the health-related messaging on cigarette packaging. This significantly reduces the ability of the health warnings to reach and inform youth of the health hazards and health effects of tobacco use.

Other tobacco products, such as those intended for use with devices (better known as heated tobacco products), the devices themselves and their parts, water pipe tobacco, blunt wraps, as well as any novel tobacco product that may be introduced in the market in the future, are currently not subject to package labelling requirements. Users of these products are not informed of the health hazards of tobacco use via the packaging and may be misled about the harm these products may pose to their health. Further, Canada is not fully compliant with its tobacco labelling obligations under Article 11 of the FCTC with respect to the following:

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 6 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 7

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 8

Decades of coordinated efforts have resulted in smoking prevalence in Canada decreasing from 26% in 2001footnote 9 to 13% in 2020.footnote 10 Despite these advances, 1 in 10 Canadians report smoking on a regular basis. Adults (aged 25 and older) are almost three and a half times more likely to report being someone who uses tobacco than youth (aged 15 to 19).footnote 11

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.

Legislative framework and regulatory landscape

Parliament adopted the Tobacco Products Control Act (TPCA) in 1988, which provided the authority to mandate health warnings on tobacco product packages, among other requirements. The Tobacco Act replaced the TPCA in 1997, which also included the authority to mandate health warnings on tobacco product packages. In 2018, the Tobacco Act was amended by Parliament and renamed as the Tobacco and Vaping Products Act (TVPA). The TVPA regulates the manufacture, sale, labelling and promotion of tobacco and vaping products. With respect to tobacco products, the TVPA provides a legislative response to tobacco use, a national public health problem of substantial and pressing concern. Specifically, it aims to

Currently, tobacco products package labelling requirements are found in the TPIR and the TPLR-CLC. These regulations specify that health-related messages must be displayed on tobacco product packaging and leaflets and how they must be displayed. Additionally, the TPR-PSA set out the requirements for manufacturersfootnote 12 of tobacco products regarding the plain and standardized appearance, shape and content of tobacco product packages. Combined, these regulations directly support the TVPA objectives of enhancing public awareness of the health hazards of using tobacco products, preventing the public from being misled about the health hazards of using tobacco products, and protecting young persons and others from inducements to use tobacco products.

The TPIR and TPLR-CLC apply to packages of tobacco products intended for retail sale within Canada, while the TPR-PSA apply to both tobacco products and their packaging.

As per requirements of the TPIR and the TPLR-CLC, tobacco products packages must display the following labelling elements.

Health warnings

Health warnings (HW) are messages, usually combining text with illustrations, 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.

Health information messages

Health information messages (HIM) are messages that combine text with illustrations. They are found either inside tobacco packages, on a leaflet inserted into tobacco packages, or on the exterior of cylindrical packages of cigarette tobacco. In contrast to HW, they focus primarily on the benefits of quitting and provide tips on smoking cessation and complement HW.

Toxic emissions and toxic constituents information

As per both the TPIR and the TPLR-CLC, toxic emissions and toxic constituents statements displayed on the side of most tobacco product packages are either in the form of short statements about the health impacts of toxic chemicals found in tobacco smoke, or as a list of some of the toxic emissions. Toxic constituent statements display a range of value for selected constituents in chewing tobacco and snuff.

The TPIR were introduced in 2000, and apply to cigars, pipe tobacco, cigarette tobacco, bidis, kreteks,footnote 13 leaf tobacco, tobacco sticks,footnote 14 chewing tobacco and snuff. These regulations require HW to cover at least 50% of the principal display area of packages of most of these tobacco products. The HW for packages of kreteks, tobacco sticks, cigarette tobacco, leaf tobacco, pipe tobacco and cigars contain both graphics and text, while those for chewing tobacco, snuff and bidis are text only. The TPIR also require text-based HIM to be placed on cigarette packages or on a leaflet inserted in little cigar and cigarette tobacco packages. Additionally, the TPIR set out requirements for toxic emission and toxic constituent statements to be displayed on the package. With the implementation of the TPIR, Canada became the first country to require pictorial HW on tobacco packages and continues to be the only country where HIM are required to be displayed inside cigarette, little cigars and cigarette tobacco packages.footnote 15

In 2011, the TPLR-CLC replaced the requirements of the TPIR for cigarettes and little cigars. The TPLR-CLC currently require pictorial HW covering 75% of the front and back panels of cigarette and little cigar packages. They also require HIM, enhanced with colours and graphics, be displayed inside packages, and the display of easy-to-understand toxic emissions and toxic constituent information on the exterior packaging. HW include a pan-Canadian toll-free quit line number and web portal address to inform tobacco users about the availability of cessation services.

Additionally, the TPR-PSA, introduced in 2019, set out requirements that standardize the appearance and shape of packages and certain tobacco products. These regulations were introduced to reduce inducements to use tobacco products by limiting the appeal of tobacco packages and the products they contain, and to prevent the public from being deceived or misled with respect to the health hazards of using tobacco products. Under the TPR-PSA, no distinctive or attractive features can be displayed on tobacco products or their packages. The TPR-PSA mandate the size, shape, and colour of tobacco product packaging, as well as the location, font size and colour of permitted text to be displayed. All tobacco product packages are required to be the same drab brown colour, bearing only the permitted text displayed in a standard location, font style, colour and size.

Effectiveness of health-related messages

Evidence 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 16 on tobacco product packages and products have the potential of being seen daily by millions of people to help Canadians live healthy, tobacco-free lives.

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. However, these messages need to be regularly updated and rotated to maintain impact and effectiveness.footnote 17 The current health-related messages have been displayed on tobacco product packages for the past decade for cigarettes and little cigars, and the past two decades for cigarette tobacco, cigars (other than little cigars), pipe tobacco, tobacco sticks, kreteks, bidis, leaf tobacco, chewing tobacco and snuff. These messages have reached their maximum potential and no longer have the same impact as when they were first implemented.

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 18 HW with large text and pictures on tobacco packages have been shown to increase the motivation to quit,footnote 19,footnote 20 and are more effective and generally perceived as more credible for both youth and adults who smoke.footnote 21,footnote 22,footnote 23,footnote 24 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 25

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 was more visible and legible and had a greater overall impact when integrated into a larger warning.footnote 26,footnote 27,footnote 28,footnote 29. 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 30,footnote 31,footnote 15

Research indicates combining positive (HIM) and negative (HW) elements is important in motivating behaviour change.footnote 32,footnote 33,footnote 34 It suggests pictorial health warnings that elicit strong emotional reactions are significantly more effective.footnote 20

Young persons’ exposure to package warnings

Young persons experimenting with cigarette smoking often obtain single cigarettes from social sources, such as friends, peers or family. In these situations, they are not exposed to HW on cigarettes packages. Recent data shows that 84% of students in grades 7 to 12 in Canada (secondary I through V in Quebec) who smoked in the past 30 days obtained their cigarettes from social sources, including 94% of students in grades 7 to 9.footnote 35 For individuals who do not see the package, and are consequently not exposed to the HW displayed on the package, the effectiveness of the HW to raise or enhance awareness of the health hazards and health effects of tobacco use with this segment of the population would either be absent or significantly reduced.

Appeal of cigarettes

Studies from a number of countries have explored the potential of reducing the appeal of cigarettes. These studies show that cigarettes with HW displayed directly on them can further reduce the appeal of the product, in particular among young persons,footnote 36,footnote 37,footnote 38,footnote 39,footnote 39,footnote 40,footnote 41 and may have the potential to influence tobacco users in their decision not to smoke.

Health Canada conducted three public opinion research (POR) studies between 2018 and 2020 regarding the appeal and attractiveness of cigarettes with a health warning printed directly on the product.footnote 42,footnote 43,footnote 44 Participants, particularly youth who smoke, as well as youth and adults who do not smoke, felt that health warnings on products made cigarettes less appealing than those without warnings, and complemented the health-related messaging on the product packages.

In 2018, Australian researchers published a review of nine studies that evaluated participants aged 11 and over on their perceptions of visual cigarette stick attributes to investigate how people who smoke, people who used to smoke and people who do not smoke identify cigarettes as being attractive or unattractive.footnote 45 The review found that the inclusion of HW on cigarettes was particularly effective in changing the perceptions of participants.

HIM placement on cigarette packages

Canada remains the only country to mandate that HIM be displayed inside cigarette, little cigar and cigarette tobacco packages.

While HW focus on the health hazards of smoking, HIM focus on positive cessation messages, including motivational life experiences and testimonials from people who formerly used tobacco and tips about quitting. POR studies conducted by Health Canada with people who smoke suggest that more frequent reading of HIM is associated with an increase in self-efficacy to quit, quit attempts and sustaining quitting.footnote 46

However, POR results showed that the current placement of the HIM on the back of cigarette slide-and-shell packages does not maximize its visibility and effectiveness in communicating with people who use tobacco.footnote 47

Rotation

Health-related messages have the greatest impact shortly after implementation and lose their novelty effect over time. Research indicates the absence of a rotation scheme for health-related messages reduces their effectiveness, and that periodically updating health-related messages can help increase noticeability of these messages.footnote 48,footnote 49

Static incorporation by reference of the Source Document

The health-related messages required to be displayed on tobacco product packages or leaflets under the TPIR and TPLR-CLC are found in Source Documents published by Health Canada. These Source Documents show the different health-related messages that must be used based on package shape and related display surface (e.g. portrait, landscape). The Source Documents indicate the types of health-related messages required for each tobacco product subject to the TPIR and TPLR-CLC, and illustrate the standard expected for the display of messages on packages or leaflets. These Source Documents are incorporated by reference into the TPIR and TPLR-CLC. As such, they are integral parts of each respective set of regulations and serve as a compliance-monitoring tool for Health Canada.

Currently, updates to these Source Documents can only be implemented through amendments to the regulations. This hinders Health Canada’s ability to update health-related messages in a timely manner when new scientific information and research emerge about the link between tobacco use and certain medical conditions, or to maintain the effectiveness of these messages.

International obligations

Article 11 of the FCTC requires Parties to adopt measures including requirements for the display of large, rotating health warnings, and measures to prevent false, misleading, or deceptive packaging and labelling. As a Party to the FCTC, Canada has implemented and complies with most of its obligations under Article 11. However, Canada is not fully compliant with respect to the following tobacco labelling obligations:

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.footnote 50 The Guidelines suggest Parties specify the number of HW and other messages to appear concurrently on tobacco products packages, and establish two or more sets of HW and other messages to alternate after a specified period between 12 to 36 months with a transition period during which two sets are used concurrently. The Guidelines also call for Parties to consider the introduction of innovative measures such as requiring HW to be printed directly on cigarettes.

Objective

The objectives of the Regulations and Order directly support three of the four tobacco-related objectives of the TVPA, namely: enhance public awareness about the health hazards of tobacco use; help prevent the public from being deceived or misled about these hazards; and help protect young persons and others from inducements to use tobacco products and the consequent dependence on them.

The Regulations build on the achievements of the current tobacco product labelling requirements while aiming to improve their overall effectiveness. They continue efforts to inform Canadians through the balanced use of information about the health hazards and health effects of using tobacco, and the health benefits of quitting and contribute to preventing the public from being deceived or misled with respect to those hazards. The Regulations continue efforts to reduce the appeal of tobacco products in proposing further measures to protect youth and others from inducements to use tobacco.

The Regulations are an integral part of CTS and, in association with other tobacco control measures under the CTS, will contribute to addressing the public health problems associated with tobacco use and nicotine addiction among Canadians.

Further, the Regulations bring Canada into full compliance with its tobacco labelling obligations under Article 11 of the FCTC by extending HW and Toxicity Information (TI) requirements to all tobacco product packages.

Description

The TVPA prohibits manufacturers and retailers from selling a tobacco product unless its packaging, or the product itself, displays the health-related information required by these Regulations. These Regulations 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. Entities that only package or distribute tobacco products to retailers on behalf of a manufacturer, will not be affected by the Regulations.

Building on the existing TPIR and TPLR-CLC, the Regulations strengthen and expand health warning and toxicity information labelling requirements to all tobacco product packages. The Regulations also set out all requirements related to tobacco products’ plain and standardized appearance, packaging and labelling in a single set of regulations. Consequently, the TPIR and TPLR-CLC are repealed upon the coming into force of the Regulations.

New health-related messages

The Regulations introduce renewed health-related messages and extend HW and TI statements to all tobacco product packages. As in the TPIR and the TPLR-CLC, the Regulations use a combination of HW, HIM, and TI statements to inform users of the health hazards and health effects associated with tobacco use.

The document entitled Labelling Elements for Tobacco Products (the Source Document) sets out two series of HW, of HIM and of TI, to be used in rotation, and applicable for a predetermined period through the Regulations. Each HW,footnote 51 HIM and TI set out in an applicable seriesfootnote 52 must be displayed equally for each type of package of each brand of tobacco product packaged throughout a one-year period.footnote 53

Health warnings

The Regulations strengthen and update the previous HW for the packages of cigarettes, little cigars, cigarette tobacco, cigars, pipe tobacco, leaf tobacco, tobacco sticks, chewing tobacco and snuff. These renewed HW feature a number of new themes, including health conditions not included in current messages mandated by the TPIR or TPLR-CLC.

Other tobacco product packages (e.g. those for water pipe tobacco, blunt wraps, tobacco products intended for use with a device, the devices themselves and their parts, and any new tobacco products to enter the Canadian market in the future) that hadn’t been subject to labelling requirements will be required to display HW under the Regulations. The requirement for HW to be displayed on at least 75% of the front and back of cigarette and little cigar packages will remain and is extended to most tobacco product packages. Pictorial HW will be required for chewing tobacco and snuff, replacing the text-only health warnings that had been previously required.

The Regulations also clarify that HW displayed on tobacco product packages will have a glossy finish, with the exception of tobacco products sold in pouches or soft packages where the exterior and interior of the package is covered in a clear and transparent poly layer which must have either a matte or glossy finish.

Pan-Canadian toll-free cessation service number and web portal

The Regulations expand the display requirement to include a pan-Canadian toll-free quit line number and cessation web portal address on HW to all tobacco product packages and HIM for packages of cigarettes, little cigars, and cigarette tobacco. Previously, this feature was only required on HW and some HIM for packages of cigarettes and little cigars under the TPLR-CLC.

Callers to the pan-Canadian toll-free quit line number will continue to be redirected to existing cessation services offered to tobacco users provided by the provinces and territories. These services provide one-on-one counselling, self-help materials, referrals to community services, and online cessation support. By placing the toll-free phone number and cessation web portal address prominently on tobacco packages, users would be reminded of cessation services every time they look at the package. The information would also be readily available when they are thinking about quitting.

Health information messages

The Regulations mandate a new placement for HIM on an extended upper slide flap of slide-and-shell cigarette packages, improving their noticeability by making it difficult to avoid or discard them. Other changes to the design of the HIM are intended to make them more noticeable, memorable, and impactful.

For packages of little cigars, the Regulations require the inclusion of a leaflet displaying a HIM. For cigarette tobacco, the HIM will be displayed on the package or inside the package, either on the freshness seal or on a leaflet inserted into the package on the inside of the lid.

Manufacturers have the option to print HIM with a glossy or matte finish.

Toxicity information

TI provides clear, concise and easy-to-understand information about the toxic substances found in tobacco smoke.

Other tobacco product packages, including those currently not subject to labelling requirements (e.g. those for water pipe tobacco, blunt wraps, tobacco products intended for use with a device, the devices themselves and their parts, and any new tobacco products to enter the Canadian market in the future), are also required to display TI statements. These TI statements provide information about toxic substances found in either the tobacco smoke or in the product and are required to be displayed on the product packaging.

TI statements use plain language to be accessible to a wider audience. They will be displayed on the side of cigarette, and little cigar packages and on any exterior surface of the package that remains unoccupied by a HW or HIM for other tobacco product packages. Manufacturers have the option to print TI with a glossy or matte finish.

Warnings on individual cigarettes, little cigars with tipping paper, and tubes

The Regulations also introduce a new requirement to display HW on individual cigarettes, little cigars that have tipping paper, and tubes. Messages will be displayed on the tipping paper, with the tipping paper having a length of at least 24 mm. In the case of cigarettes that do not have tipping paper, the HW is to be displayed on the cigarette paper at a length of at least 24 mm that starts from one end of the cigarette. The Regulations do not prevent manufacturers of cigarettes that do not currently have tipping paper from adding that feature.

These warnings will feature information about the health hazards of using these products and will have to be printed in both English and French on two white backgrounds.

Health warning size and minimum health warning size

The minimum relative size of HW for tobacco product packages will be standardized to at least 75% of the display area for most products to maximize visibility and legibility of health-related messages on all types and sizes of tobacco packages.

A HW is required to cover at least

Rotation scheme

The Regulations introduce a rotation scheme that aims to enhance the novelty and relevance of the messages on tobacco packages and the HW on individual cigarettes, little cigars that have tipping paper, and tubes by changing the information on a predetermined schedule. The rotation scheme includes requirements for the periodic rotation of unique sets of HW and TI for all tobacco product packages, and unique sets of HIM for cigarettes, little cigars, and cigarette tobacco packages. The first message rotation will be for a period of 36 months for all products to harmonize with the Regulations’ implementation scheme. Subsequently, unique sets of HW, HIM and TI will rotate every 24 months for cigarettes, little cigars, and cigarette tobacco packages. Unique sets of HW and TI will rotate every 24 months for tube packages. Unique sets of HW for individual cigarettes, little cigars that have tipping paper, and tubes will rotate every 24 months. Unique sets of HW and TI will rotate every 36 months for all other tobacco product packages.

Ambulatory incorporation by reference — Source Document

As with the current TPIR and TPLR-CLC, the Regulations incorporate by reference a Source Document. This document shows the number of health-related messages for each applicable series by type of product and package that must be used by manufacturers based on product type, package shape and related display orientation (e.g. portrait, landscape).

As well, it illustrates the standard expected for the display of messages on packages, leaflets and products. HW on tobacco product packages have to be displayed in a glossy finish, as shown in the printed version of the Source Document.

The Source Document can be amended from time to time without amending the Regulations. This approach gives Health Canada more flexibility to update, edit or replace the images and text in health-related messages to reflect the latest science or new health information. These modifications will be limited to the contents of the health-related messages. The requirements for the packaging, minimum size, rotation scheme and manner of display of the health-related messages cannot be amended, as these are prescribed through the Regulations.

Any changes to the Source Document will be implemented to coincide with a scheduled rotation and will be communicated to interested parties at least eight months ahead of time. The Source Document is available from Health Canada in electronic and print versions free of charge. Information on how to order the Source Document is available on Health Canada’s website.

New terminology

The Regulations introduce new terminology for some tobacco labelling elements and simplify the display of toxicity information on tobacco products. The Regulations unify toxic emissions and toxic constituent information under the term “toxicity information,” which encompasses both types of statements. TI statements will apply to all tobacco products; information will be specific to the type of tobacco product and will consist of short statements about the health impacts of specific toxic substances found in tobacco products or their smoke.

Additionally, the Regulations will use the term “avertissement sanitaire” as a replacement for “mise en garde” when referring to HW in French to better align with international practice.

Other amendment to the TPR-PSA

To accommodate current tobacco industry practices, the Regulations also allow for the display of “RS” or “KS” on cigarette packages, as the case may be, as alternatives to “regular size” or “king size,” respectively, as a declaration of size.

Order amending Schedule 1 to the TVPA

The Order provides manufacturers with the possibility of using a colouring agent to create a white background for the display of a health warning printed directly on cigarettes, little cigars that have tipping paper, and tubes.

Schedule 1 to the TVPA prohibits certain additives (column 1) in the manufacture of a tobacco product (column 2). The tobacco products listed in column 2 exclude products that are manufactured or sold for export. Item 4 (for cigarettes and tubes) of Schedule 1 to the TVPA excludes from the prohibition of colouring agents whitening agents used to whiten the paper or filter and colouring agents used to imitate a cork pattern on the tipping paper of cigarettes or tubes. It is being amended to also exclude whitening agents used to whiten tipping paper.

Item 4.3 (for little cigars with tipping paper) of Schedule I to the TVPA excludes from the prohibition of colouring agents those agents used to render tipping paper drab brown or to imitate a cork pattern. It is being amended to also exclude whitening agents used to whiten tipping paper.

The amendments to these two items enable the display of a HW on a white background on the tipping paper of cigarettes, little cigars that have tipping paper, and tubes.

The colouring agents used to display the HW and any attribution on a tobacco product are not covered by the Order as they are considered prescribed additives for the purposes of subsection 5.3(3) of the TVPA.

Future considerations

Health Canada may consider extending the HW labelling requirement to individual little cigars that do not have tipping paper, and to little cigars that have a plastic mouthpiece or tip through a future regulatory amendment. Health Canada may also consider mandating HW to be displayed on cigar bands for cigars that do not have packaging in the future.

Regulatory development

Consultation

The Department of Health consulted widely on the proposal between 2017 and 2021. Consultations were held with the general public; provincial and territorial, Indigenous and municipal governments; stakeholders, including non-governmental organizations (NGOs), health professionals, academics and researchers; and the tobacco industry. The consultations focused on the format and content of the health-related messages and on specific requirements of the proposal.

New health-related labelling for tobacco products consultation document

Health Canada published New Health-Related Labelling for Tobacco Products: Document for Consultation on October 26, 2018. This document set out proposals on new health-related labelling for products containing tobacco. It was open for comments from the general public and other interested stakeholders for a 75-day period ending January 8, 2019. The consultation asked participants for input on options for renewed health labelling for tobacco products, including labelling content and design, labelling size and placement, labelling for tobacco products that do not currently require labels, labelling rotation, and on-cigarette labelling. The document was also distributed to NGOs, provincial and territorial governments, Indigenous governments, academics and researchers, health professionals, and members of the tobacco industry.

Health Canada received 141 submissions from the general public, national and regional NGOs, public health authorities, associations of health professionals, provincial and territorial governments, academics and researchers, and the tobacco industry. Overall, there was considerable support for the approaches put forward in the consultation document. The majority of these comments were from the general public, but support also came from NGOs, public health authorities, government, academics and researchers.

Respondents indicated strong support for extending labelling requirements to all tobacco products. There was also support for extending the current 75% HW coverage on cigarette and little cigar packages to other tobacco product packages, for establishing minimum size requirements for HW for those products, and for implementing a rotation scheme. Additional support was expressed for displaying health information messages more prominently on the inside of cigarette and cigarette tobacco packages (either printed directly on or affixed to packaging, to prevent removal), and for printing health warning messages directly on individual cigarettes.

Suggestions were received for the placement and appearance of HIM and TI, as well as for the quit line and website information to maximize their noticeability.

As part of the feedback from the consultation document, a number of respondents offered support for provisions that would allow Health Canada to make changes to the contents of the messages administratively, without the need for regulatory changes.

Responses from the tobacco industry were largely in opposition to the approaches put forward in the consultation document. Concerns were primarily about a perceived lack of evidence to support the approaches as well as anticipated technical and logistical difficulties in implementing the proposed labelling changes.

Submissions from the cigar industry suggested the cigar segment of the market should not be grouped with other tobacco products. They argued there should be a distinction made between different sizes of cigars and that, since the retail market for cigars is small, changing HW is unsuitable and not required.

Respondents representing the tobacco industry indicated some support for refreshing health warning contents and for continuing to require information be displayed on packages. However, there was some opposition to the inclusion of quit line information on the grounds that there is not adequate space on smaller packages. A submission from the chewing tobacco and snuff industry opposed the inclusion of quit line information until cessation services tailored for chewing tobacco and snuff product users were available.

A summary of the comments received is available on Health Canada’s website.

Message development

The health-related messages were developed using the best available information, research and scientific evidence. The process of message development was guided by a set of principlesfootnote 54 based on international practices. Foremost among these principles is that all tobacco products are harmful to health, and that people who use tobacco products deserve to be made aware of the health hazards and health effects associated with such use.

To inform the development of messages on specific health conditions and outcomes associated with tobacco use, Health Canada monitored and assessed scientific evidence from well-respected agencies and organizations, including reports developed on behalf of the United States Surgeon General. The health conditions and outcomes featured on the messages were selected based on a process using objective scientific criteria to ensure that the available evidence supports the development of a message. The health conditions and outcomes already featured on messages mandated pursuant to the TPIR and TPLR-CLC were also considered throughout the message development process.

Health Canada reached out to Canadian health organizations, hospitals and universities, as well as international sources, to help source medical images for possible use on tobacco packages.

With assistance from creative design agencies, extensive work was undertaken to create various concepts and content for the renewed messages.

In developing the HW and the HIM, significant emphasis was placed on how to maximize effective communication with tobacco users, while using a variety of approaches to reach different segments of the target audience. To achieve this, the HW and the HIM include

Scientific expert panel

A scientific expert panel of 20 researchers, academics, and practitioners reviewed the draft messages (text and images) for scientific and medical accuracy. This expert review was conducted from February to July 2020 and included HW for cigarettes, cigars, pipe tobacco, chewing tobacco and snuff, as well as HIM and TI statements. Feedback from the panel was used to modify the messages, in particular about specific claims regarding diseases caused by tobacco use, and to add detail about how tobacco use affects the body.

Literacy review

A literacy review of the draft messages was conducted to assess their accessibility to a wide audience. The benchmark reading level for messages is set at a grade 5/6 or lower level. In addition, design elements such as font size, colour, capitalization, and contrast with background were evaluated for their effects on readability. The literacy review provided recommendations on the language and design elements of the messages. Specifically, it recommended shortening sentences, minimizing medical and technical language, removing redundant information, and refraining from using contractions. Design suggestions included using selective capitalization of words for emphasis, increasing font size, improving text readability when compared with the background, and occasionally using bold font for emphasis.

Public opinion research

The principal objective of the Regulations is to enhance public awareness of the health hazards of using tobacco so Canadians can make informed choices regarding their health. Therefore, POR with users and non-users of tobacco products was extensively employed in the development of messages.

Between November 2017 and November 2020, eight POR studies were conducted with youth and adults who use tobacco and youth who do not smoke to solicit opinions on draft HW, HIM, and TI.footnote 55,footnote 56,footnote 57,footnote 43,footnote 58,footnote 59,footnote 60,footnote 61 Focus group sessions were held with more than 4 400 English- and French-speaking people who use tobacco in nine locations across Canada. Five of the studies were conducted in-person, while three of the studies were conducted online with participants from different locations across Canada. One study was an online survey conducted with people who smoke either daily or occasionally from various age groups across Canada.

Five of the studies surveyed cigarette and little cigar users while one study focused on people who use cigars, pipe tobacco, chewing tobacco or snuff. During in-person and online focus group sessions, participants were shown mock-ups of possible HW, HIM, and/or TI. Participants were asked a series of questions about the noticeability and readability of messages, images, and designs, and their effectiveness at conveying health information related to tobacco use. They were also asked to provide feedback in more open-forum discussions. The views expressed by tobacco users and non-users in these studies were highly influential in informing subsequent revisions to the messages, which were modified based on comments received from each round of research.footnote 57,footnote 56,footnote 59,footnote 58,footnote 60

Three studies explored the concept of HW displayed on individual cigarettes with people who smoke and youth who do not smoke. In the most comprehensive of these studies, involving 188 participants across Canada, the appeal and attractiveness of cigarettes with health warnings was explored and showed these cigarettes were seen as less appealing than cigarettes without health warnings. Cigarettes without health warnings were also perceived as less harmful than those with warnings. Overall, participants felt this new labelling element made the health messaging on cigarette packages more complete and impactful, particularly among youth who do not smoke, smoke occasionally, or wish to quit. Youth participants noted they are not usually exposed to the package HW when obtaining single cigarettes in social situations and that a warning directly on the cigarette would be unavoidable.

Reputable research firms using Government of Canada guidelines conducted all research. These firms ensured an unbiased, fair process and results by leading each session, from recruiting candidates to facilitating the presentation of the messages and subsequent discussions. Health Canada representatives viewed all sessions either through one-way glass (in-person sessions) so as not to influence the outcomes, or online through a web-based platform. A report on each study is available on the Library and Archives Canada website.

Engagement with and feedback from stakeholders

In general, tobacco control stakeholders were supportive of efforts to renew health-related messages. They were also in agreement with more stringent requirements, such as extending labelling requirements and increasing the size of HW for all tobacco products. Stakeholders supported the approach of displaying HW directly on individual cigarettes, with suggestions for the messages to be short and concise.

The target audience of adults and youth who smoke, as represented by the participants in various POR studies, has also been largely supportive of increased measures to help them quit tobacco. This includes mandating HW on individual cigarettes. This measure was seen as complementary to the package warnings and effective at making the product less appealing while providing useful health-related information in support of quitting. Warnings on individual cigarettes were considered particularly impactful at possibly discouraging youth from taking up smoking and developing a long-term nicotine addiction. Youth explained they usually acquired individual cigarettes from friends and family members and were not exposed to HW on packages.

Some dissenting opinions from adults who regularly smoke were heard during focus groups testing the concept of HW on individual cigarettes. These individuals tended to feel the measure was excessive, noting that they already feel sufficiently informed of the health hazards of smoking.

Considering the gamut of recommendations, Health Canada has strived to choose options that best achieve the objectives of the Regulations and result in the greatest health benefit for Canadians, while minimizing burden.

Between 2017 and 2021, the Department of Health also held approximately 20 face-to-face meetings and teleconferences with key stakeholders. Ten of these meetings were held with NGOs, including health organizations, academics and experts. In total, more than 30 organizations and individuals were consulted through these meetings.

The purpose of the meetings varied. Some focused on specific elements of the proposal, while others presented the results of POR undertaken with people who use tobacco. Many of the meetings resulted in recommendations from stakeholders on the features of the proposed Regulations or on the content of the health-related messages. Tobacco control NGOs recommended strengthening the language of the HW to convey the magnitude of the health hazards of tobacco use. They suggested including additional topics, such as diabetes, cervical cancer, breast cancer, and other women-centric health outcomes related to tobacco use. NGOs also recommended using a wider variety of images to better appeal to Canada’s diverse population. The entire suite of HW and HIM was modified as a result of this feedback.

Through consultations with the tobacco industry and Health Canada inspectors, Health Canada has determined that over one in three packages of cigarettes surveyed in 2020 indicated either “RS” or “KS” rather than “regular size” or “king size” as a declaration of size of the product. The tobacco industry has also expressed, both through exchanges during compliance monitoring activities and through correspondence, that the abbreviations “RS” or “KS” are commonly known as declarations of size to the consumers.

Consultations with government agencies

Under the CTS, Health Canada collaborates with the Canada Revenue Agency, the Canada Border Services Agency, the Royal Canadian Mounted Police, the Public Health Agency of Canada, Indigenous Services Canada and Public Safety Canada on tobacco control measures. Health Canada consulted with its partners early in the regulatory development process.

Ongoing considerations

A number of respondents to the consultation document requested Health Canada include a HW on the link between smoking and breast cancer. Tobacco control NGOs have also advocated for such a warning. This recommendation was extensively considered, and a potential warning was tested in the POR. However, Health Canada is not recommending such a message at this time because the scientific evidence is not sufficient to establish a causal effect between smoking and breast cancer. Health Canada will continue to monitor the medical literature for evidence of a causal link between tobacco use and breast cancer.

In recognition of a well-documented causal link to cigarette smoking,footnote 62 Health Canada is including cervical cancer as a health condition that could be prevented by quitting smoking.

Coordination and cooperation

Health Canada has worked with the Canada Revenue Agency to align the Regulations with the Stamping and Marking of Tobacco and Cannabis Products Regulations (SOR/2003-288) and avoid conflicts between the new labelling requirements and current excise stamp requirements.

Prepublication in the Canada Gazette, Part I

The proposed Regulations were prepublished in the Canada Gazette, Part I, on June 11, 2022, for a 75-day consultation period that ended on August 25, 2022. A total of 585 responses were received during the consultation period, including 417 from four letter-writing campaigns and 168 individual responses. Health Canada also held meetings with tobacco manufacturers and importers to gain a better understanding of the technical challenges reported by the tobacco industry regarding implementation of the proposal. Summaries of these meetings are available on Health Canada’s website.

The responses from the letter-writing campaigns were supportive of the proposed measures. They expressed support for health warnings on individual cigarettes, stating that the measure will help to ensure that youth and young adults who are not exposed to health warnings on the packaging will see the warning on the product itself.

Through individual submissions, NGOs, the public health community, academics, and members of the public voiced their support for the full range of proposed measures, with certain suggestions raised.

The tobacco industry (tobacco manufacturers, and their suppliers, business associations, retailers), and some members of the public opposed the proposed regulations, including their application to specific tobacco products. The tobacco industry indicated that the proposed implementation period of 180 days for manufacturers would not be sufficient to comply with the proposed requirements. They argued that there is insufficient evidence supporting the effectiveness of health warnings printed directly on products, and that the new placement of HIMs on cigarette packs may have a negative environmental impact. In addition, the tobacco industry noted the proposed regulations may increase the demand for contraband cigarettes and suggested that additional effort be placed into stopping contraband production.

Several comments received during the consultation were of a technical nature or consisted of suggestions that are outside the scope of the Regulations.

Health Canada has noted the comments received during consultation. Consideration of comments and suggestions received is included below.

Health Canada’s response to key stakeholder suggestions and concerns

Health warnings on tobacco product packaging

NGOs and public health organizations recommended additional language be added to indicate that HW be positioned parallel along the top edge of the package in addition to occupying at least 75% of the display area. It was also recommended the language be modified to specify that, in the case of a secondary package that is a carton a HW be displayed on the two largest sides of the package. Suggestions were also received to require at least 50% of HW found on the front of packaging be available in the official language of the province or territory in which it is sold; HW be developed in various Indigenous languages; and to introduce a HW that links breast cancer to smoking.

The tobacco industry requested that cigarette pouches with a glossy poly layer be exempted from the glossy finish requirement for HW on tobacco product packaging. These products already have a glossy layer on the exterior of the package. The additional glossy finish may make the HW difficult to read. The tobacco industry also expressed concerns over its ability to display a HW of at least 4 000 mm2 on existing packages of blunt wraps, waterpipe tobacco, snuff, tobacco products intended for use with a device, those devices and their parts.

Response: Health Canada has amended the Regulations to require HW must be positioned parallel to, and as close as possible to the top edge of packaging, and to specify that secondary packages that are a carton must have HW displayed on the exterior surface of the front, back, top and bottom. It has also provided the option to not print HW with glossy finish on cigarette tobacco packages that have a clear and transparent poly film. The minimum size for HW to be displayed on blunt wraps, waterpipe tobacco, tobacco products intended for use with a device, and the devices necessary to use these products as well as their parts has been amended to 2 500 mm2.

Health Canada has not amended the Regulations to require 50% of HW found on the front of packaging be available in the official language of the province or territory in which it is sold or to develop HW in various Indigenous languages. With existing requirements for messages to be available in both official languages, Health Canada fulfills its Official Language obligations. With respect to offering health-related messages in Indigenous languages, it is Health Canada’s intention to collaborate with interested Indigenous organizations and groups, and with Provincial and Territorial agencies to leverage the new messages for public education campaigns. Further, at this time, there is insufficient scientific evidence indicating a causal relationship between smoking and breast cancer. As a result, this suggestion was not incorporated.

Health warnings on individual cigarettes, little cigars with tipping paper, and tubes

NGOs and public health organizations suggested specific requirements regarding HW for individual tobacco products, such as font size, type and colour, be removed from the regulatory text to allow for future changes to these HW to be made by amending the Source Document. It was also suggested that HW be extended to other tobacco products with or without a filter, and to increase the font size on those messages.

Some comments from the public pointed to the potential stigmatization of individuals who use these products. Concerns were expressed regarding potential health hazards from exposure to the ink used to print HW. Comments were also received regarding whether this proposed measure would result in an increased demand for contraband tobacco products.

Manufacturers indicated they would be unable to comply with the proposed implementation period of 180 days. They pointed out that several cigarette brands currently on the market, mainly regular size ones, and accounting for approximately 30% of products, are made with tipping paper that is shorter than the proposed minimum length of 24 mm. Necessary adjustments to machinery would impact their ability to comply with the measure within the proposed timelines. They also expressed concerns regarding their ability to consistently adhere to the 1 mm margin for alignment of the HW from the edge of the display area and requested that a greater variance be allowed given the limitations of the tipping paper printing and cutting processes.

Response: Health Canada has made certain modifications to the Regulations in response to the technical concerns expressed by tobacco product manufacturers. For HW on king size cigarettes, manufacturers will be required to implement the changes by April 30, 2024, and retailers will have an additional three months (i.e. until July 31, 2024) to comply. For HW on regular size cigarettes, little cigars with tipping paper, and tubes, manufacturers will be required to implement the changes by January 31, 2025, and retailers will have an additional three months (i.e. until April 30, 2025) to comply. HW specifics, such as font size and colour, have been removed from the regulatory text and HW are required to be printed as shown in the Source Document, following the same approach used for other labelling elements. In regards to health warnings on the tipping paper, the warnings aim to focus on the harmful effects of the product, and are not meant to stigmatize individuals who smoke.

Health warnings and toxicity information statements

The cigar and pipe tobacco industry indicated challenges with the implementation of the proposed minimum 75% health warning size and 60% toxicity information labelling requirements for certain product and package types. The pipe tobacco industry expressed concern over their ability to implement toxicity information labels on the sides of certain cylindrical packages due to an indentation. The tobacco industry also indicated that a HW warning that is at least 4 000 mm2 would require a redesign of packages for blunt wraps, water pipe tobacco, snuff, tobacco products intended for use with a device, those devices and their parts. One manufacturer of smokeless tobacco noted the 4 000 mm2 minimum size originally proposed for the health warning would not fit on the current packaging for this product, and would require the product to be sold in larger package sizes.

Response: Health Canada agrees with some of these requests. The minimum package size has been amended to be 4 000 mm2 for cigar (other than those sold in a cigar tube), snuff, chewing tobacco and pipe tobacco, and 2 500 mm2 for packages of blunt wraps, water pipe tobacco, tobacco products intended for use with a device, those devices and their parts. The Regulations were also modified to allow TI to be displayed on the bottom of cylindrical packages except for cigarette tobacco. For packages of two or more cigars sold in an overwrap, the minimum size for HW has been amended to a range of 50% to 75% of the display area, according to a range of package sizes. The minimum size for TI has been amended to an area of at least 1 800 mm2.

Health information messages

The tobacco industry recommended a number of changes to the proposed HIM requirements and highlighted some technical concerns. It suggested that cigarette tobacco pouches could display the HIM on the lower portion of the pouch, underneath the flap. The industry also indicated the proposed dimensions of the new extended upper slide flap for slide and shell cigarette packages would require significant modifications to existing machinery. Those necessary machine adjustments would negatively impact its ability to comply with the new HIM placement within the implementation period originally proposed.

The industry flagged the proposed leaflet size for HIM in packages of little cigars was too large to fit inside the packaging without being folded and requested that the current size for leaflets for packages of little cigars under the TPLR-CLC be maintained.

Response: Regarding the extended upper slide flap on slide and shell cigarette packs, Health Canada has amended the required dimensions and extended the implementation period to give sufficient time to manufacturers to update their packing machines. Manufacturers will now have to comply with the new measure by July 31, 2026, and retailers will have until October 31, 2026, to comply with the related requirements. Health Canada also agrees with maintaining the leaflet dimensions for HIM in packages of little cigars as set out in the TPLR-CLC. Further, in the case of cigarette pouches, manufacturers will have the option of displaying HIM centred on the interior surface of the flap.

Printing requirements, implementation, and Source Document

NGOs recommended a minimum resolution of 300 dots per inch (DPI) on the printing requirements for labelling elements displayed on a tobacco product, package, or leaflet.

The tobacco industry has requested further clarity regarding whether all tobacco products are included in the 90-day transition period for the introduction of the next series of labelling elements on the retail market. It also expressed some concern over a lack of opportunity for stakeholders to submit input to the development of HW, arguing that it is not within the powers delegated by Parliament to include an ambulatory incorporation by reference of the Source Document.

Response: Health Canada has carefully considered the comments received and has added additional language in the Regulations to clarify that all tobacco products are included in the 90-day transition period. However, at this time, the minimum resolution on printing requirements for labelling elements displayed on a tobacco product, package, or leaflet has not been amended to reflect a minimum resolution of 300 dpi, as this option presents compliance monitoring challenges. Additionally, Health Canada has kept the ambulatory incorporation by reference of the Source Document in the Regulations. The TVPA permits documents developed by the regulation-making authority to be referenced in regulations in a version that can be amended from time to time.

Other amendments to the Regulations

The tobacco industry suggested amending the Regulations to allow for either silver foil or one sheet of silver coloured paper to be used as lining for cigarette packages. In the industry’s opinion, the inclusion of silver colour paper as an alternative would allow for a lining made entirely of a material that is widely accepted for recycling across Canada. Additionally, the industry suggested the removal of the requirement for the interior surface of packaging to have drab brown colouring.

Response: Health Canada has amended language in the Regulations to allow for either silver foil or silver coloured paper to be used as lining for cigarette packages. However, the drab brown colour requirement for interior of packaging remains unchanged.

Outside the scope of the Regulations

Several comments were received from the public that were outside the scope of the proposed Regulations. These suggestions included, but were not limited to, raising the minimum legal age to access tobacco products, increase taxes on tobacco products, lower nicotine contents in cigarettes, amend existing regulations on alcohol products to align with tobacco product regulations, and ban all tobacco products. Responses received from the public also included suggestions to increase funding towards cessation services and provide additional cessation resources for individuals looking for assistance to quit using tobacco products. Suggestions were received to improve educational campaigns and provide additional cessation resources.

Health Canada will consider these suggestions in its future tobacco control activities, including on proposals to meet the Canada Tobacco Strategy’s goal of achieving less than 5% of tobacco use by 2035.

Modern treaty obligations and Indigenous engagement and consultation

Health Canada distributed New Health-Related Labelling for Tobacco Products: Documents for Consultation to various Indigenous organizations and to groups providing services to Indigenous populations. Responses from regional health authorities working with Indigenous populations supported HW being displayed on the packaging of all tobacco products and covering at least 75% of the display surface. There was also support for displaying health messages directly on cigarettes. It was suggested that tobacco health labelling be culturally appropriate for First Nations populations and not reinforce existing stigmas and stereotypes. Feedback called for the recognition of the traditions of tobacco use in First Nations cultural practices and the high rates of commercial tobacco use among this population.

Instrument choice

Option 1: Baseline scenario (no change in tobacco labelling regulations)

This option would have maintained the existing TPIR and TPLR-CLC and the health-related messages currently displayed on all tobacco products subject to these two sets of regulations. Tobacco products that are not subject to any labelling requirements (e.g. tobacco products made in whole or on part of tobacco intended to be used with devices, these devices and their parts, water pipe tobacco, blunts, and any novel tobacco products introduced on the market) would have continued to be legally sold to consumers without any health-related messages.

This option was rejected for several reasons. It would have kept existing health-related messages on tobacco products, packages or leaflets. These messages, having been on display for a long time, are no longer effective and do not include the latest scientific evidence. Messages on some tobacco product packages would also have remained comparatively small, which research has shown results in less effective messages. This option would have been unlikely to continue enhancing awareness about the health hazards of using tobacco products, or enable tobacco users to make informed choices regarding tobacco use and their health. Therefore, these messages would have not yielded incremental health benefits.

This option would have not supported the objective of protecting young persons and others from inducements to use tobacco products and the consequent dependence on them, as it would have not required the display of HW on individual cigarettes, little cigars that have tipping paper, and tubes. Youth would have also continued to be less exposed than adult tobacco users to information on the health hazards of using these products, as they are not usually exposed to HW on tobacco packages. When first experimenting with tobacco use young persons often accessing individual cigarettes from social sources without handling the package itself.

This option would have not further contributed to supporting the CTS goal of reducing the prevalence of tobacco use to less than 5% by 2035, nor the objectives of the TVPA of enhancing public awareness of the health hazards of tobacco; preventing the public from being deceived or misled with respect to these hazards; and protecting young persons and others from the inducement to use tobacco products and the subsequent dependence on them.

Finally, by not extending HW and TI labelling requirements to all tobacco product packages, Canada would have remained not fully compliant with its tobacco labelling obligations under Article 11 of the FCTC.

Therefore, the status quo was not considered an appropriate option.

Option 2: Update and standardize labelling requirements for all tobacco products

This option would have updated existing health-related messages on tobacco products packages; expanded labelling requirements for HW and TI to all tobacco product packages; and standardized the size of HW across all tobacco products.

This option would have helped to adequately meet the objective of enhancing public awareness about the health hazards of tobacco use by requiring the display of new messages to replace those that have reached their maximum potential and extending labelling requirements to all packages of tobacco products, including tobacco products not currently covered by existing labelling requirements.

In addition, as tobacco products packages without health-related messages could be seen as safe, this option would have helped support the objective of preventing the public from being deceived or misled about the health hazards of tobacco use.

This option would have brought Canada into greater compliance with its tobacco labelling obligations under the FCTC by extending HW and TI labelling requirements to all tobacco product packages. In addition, by standardizing the minimum size for HW to 75% of the package across most tobacco products, Canada would have exceeded another obligation set out in Article 11 of the FCTC.

This option would not have fully explored the avenues available to increase the effectiveness of labelling requirements. It would have represented a missed opportunity to introduce additional measures to further the objectives of enhancing public awareness in order to better inform Canadians, especially tobacco users and potential users, about the health hazards of using tobacco products; preventing the public from being deceived or misled about these hazards; and protecting young persons and others from inducements to use tobacco products and the consequent dependence on them.

This option would not have introduced a rotation scheme for health-related messages on tobacco product packages and would not have included HW on individual cigarettes, little cigars that have tipping paper, and tubes. It would have maintained the current placement of HIM on the inside back of cigarette packages, which would have failed to maximize visibility and effectiveness in conveying information to tobacco users.

Therefore, this option was not considered to be optimal and was not recommended.

Option 3 (recommended): Update and standardize labelling requirements for all tobacco products, and introduce new measures to enhance and maximize impact

In addition to the elements contained in Option 2, this option will introduce a rotation scheme with multiple sets of messages; allow the incorporation by reference of the Source Document into the Regulations in a version that can be amended from time to time; mandate a new HIM placement for cigarette packages; and, include HW displayed directly on the tipping paper of individual cigarettes, little cigars that have tipping paper, and tubes. In the case of cigarettes that do not have tipping paper, the HW will be displayed on an area that is at least 24 mm in length that starts from one end of the cigarette.

The introduction of a rotation scheme with multiple sets of labels will aim to enhance novelty and relevance of the health-related information by changing the messages periodically. This will allow for a greater variety of messages to heighten awareness of the health hazards of tobacco use and help maintain relevance and impact of the messages. Incorporation by reference of the Source Document will give Health Canada more flexibility to amend the document as new scientific evidence emerges on the health effects or health hazards of using tobacco products without amending the regulations. This approach will also assist Health Canada in renewing the messages on a predetermined schedule in a timely manner.

The requirement to display HW on individual cigarettes, little cigars that have tipping paper, and tubes will help increase awareness among youth of the health hazards associated with using tobacco products, as youth often access individual products from social sources without seeing the HW on the package. It will also help prevent inducements to use tobacco products by making these products less attractive to users and potential users.

The introduction of a new placement for HIM on the inside front of cigarette packages will enhance its visibility and effectiveness in communicating with tobacco users.

This option is recommended. It will more fully support the objectives of the TVPA to enhance public awareness of the health hazards of using tobacco products, prevent the public from being deceived or misled with respect to those hazards and help protect young persons and others from inducements to use tobacco products and the consequent dependence on them.

Collectively, these measures will meet or exceed Canada’s tobacco labelling obligations under Article 11 of the FCTC and include measures that are consistent with the Guidelines for the implementation of Article 11.

Regulatory analysis

Benefits and costs

Summary of cost-benefit analysis

The Regulations and Order will directly support three of the four tobacco-related objectives of the TVPA, namely: enhance public awareness about the health hazards of tobacco use; help prevent the public from being deceived or misled about these hazards; and, help protect young persons and others from inducements to use tobacco products and the consequent dependence on them.

They will result in total incremental costs estimated at $214 million (2020 $Can) expressed as total present value (TPV) over 10 years or about $30.4 million in annualized value. The most significant monetized costs (roughly 50% of the total estimated costs) to the tobacco industry are associated with the introduction and rotation of renewed health-related messages for tobacco product packaging. The estimated cost of complying with the new placement for HIM on the extended upper slide flap of cigarette packages represents roughly 40% of industry compliance costs. Implementation of the Regulations will result in incremental costs to Health Canada from performing compliance and enforcement activities.

The Regulations support the CTS, which aims to reduce the burden of disease and death caused by tobacco use and its consequential impact on the public health care system and on society. Long-term economic benefits of the Regulations, in combination with other interventions under the CTS, would be realized in terms of avoided tobacco-related morbidity and premature mortality, including exposure to second-hand smoke. The break-even analysis indicates that a relatively small effect on cigarette initiation and cessation rates relative to the baseline ratesfootnote 63 — the order of a 0.21% increase applied to annual cessation rates or a 1.04% reduction applied to annual initiation rates — would be sufficient to produce public health benefits equivalent to or greater than the estimated monetized costs. The relatively small effects on these rates would be equivalent to either 11 100 fewer people who start smoking or 2 400 more smokers who quit over the next 10 years. In 2021, there were 3.8 million current smokers in Canada.footnote 64 Offset of estimated incremental costs of the Regulations equates to roughly an additional 1 in 1 600 current smokers deciding to quit over the next 10 years as a result of these regulations working in combination with other interventions under the CTS.

Analytical approach

The Cabinet Directive on Regulation requires departments to analyze the costs and benefits of federal regulations. To measure these impacts, the benefits and costs are estimated by comparing the incremental change from what is anticipated to occur under the current regulatory framework (i.e. the “baseline scenario”) to the new regulatory approach (i.e. the “regulatory scenario”). Following review of feedback from stakeholders and pending the Governor in Council decision to make the Regulations, registration and publication of the Regulations in the Canada Gazette, Part II, could take place in 2023, with a coming-into-force date of August 1, 2023, and transitional provisions from 2024 to 2026 for specific requirements.

This cost-benefit analysis (CBA) covers the 10-year period from 2023 to 2032footnote 65 (inclusive). A 7% discount rate is used to estimate the present value of the incremental costs and incremental offsetting benefits. All values reported for the 10-year period are expressed in 2020 constant Canadian dollars. Cost estimates are typically based on upper and lower variables ranges. The deterministic CBA estimates reported are based on the midpoint value of each of these cost categories, which is assumed to be the most likely outcome. Cost estimates do not incorporate costs to industry associated with potential changes to the content of the Source Document made during the 10-year period, pursuant to the ambulatory incorporation by reference measure. This issue is described in the “Qualitative costs” section.

As noted in the “Consultation” section, the tobacco industry provided feedback following prepublication of the proposed Regulations in the Canada Gazette, Part I. Health Canada requested further information from industry to better understand their feedback. The transitional provisions put in place in response to the consultation, and the additional information received from industry, resulted in changes to the CBA. These adjustments arise from changes to the timing of costs of the first rotation of health warnings, changes to timing and machinery costs for the new placement of the HIMs on the extended upper slide flap of slide-and-shell cigarette packages, and additional machinery and materials costs for the HW to be displayed on individual cigarettes, little cigars that have a tipping paper, and tubes. New information received is subject to significant uncertainty, and therefore is only used to supplement information already included in the CBA. For example, where costs were already accounted for, new information on compliance costs has been incorporated into the range of estimates, resulting in a change to the midpoint value.

The impacts of the Regulations have been estimated using three approaches: quantitative/monetized analysis, where possible; qualitative analysis; and break-even analysis. The cost analysis incorporates information from multiple sources, including tobacco product manufacturers, suppliers, various trade associations, the U.S. Food and Drug Administration (FDA)footnote 66 and information submitted to Health Canada pursuant to the Tobacco Reporting Regulations (TRR).footnote 67 A summary of the CBA is provided herein. A copy of the CBA report is available upon request from pregs@hc-sc.gc.ca.

Overview of the tobacco products market

The overall tobacco products market in Canada — including federal excise duties imposed under the Excise Act, 2001 — was estimated at $7.5 billion (inflated to 2020 dollars using consumer price index for all products in Canada). This wholesale value is driven primarily by sales of cigarettes, which in 2019 accounted for approximately 94.3% of the total value. The remainder of the wholesale market is made up of cigars at 2.7%, cigarette tobacco at 1.7%, smokeless tobacco at 1.2%, and pipe tobacco at 0.1%. In 2019, 34 manufacturers reported wholesale tobacco product sales in Canada.

Tobacco products are sold at convenience stores, gas stations, supermarkets and tobacconists, including stores on First Nations Reserves. Most tobacco product sales occurred at food and beverage stores and gas stations, with cigarette sales accounting for nearly all tobacco product sales by value. It is likely that retail sales of other tobacco products, such as premium cigars or pipe tobacco, occur more often at other types of stores, such as tobacconists. It is estimated smaller retailers include approximately 26 519 gas and convenience stores in addition to 1 900 other small tobacco retailers selling tobacco products in Canada.

Overview of the number of tobacco products in Canada

The CBA uses Health Canada’s Tobacco Products Wholesale Database (the HC Wholesale Database), which stores information reported under the (TRR), to determine the number of products on the Canadian market. The data is organized into stock keeping units (SKUs), assumed to be unique combinations of brand, size, and pack type. The wholesale data is based on 2019 sales, prior to the implementation of the TPR-PSA.

Manufacturers are expected to have begun consolidation of their product lines in response to the TPR-PSA introduced in 2019, resulting in fewer brands and SKUs on the Canadian market. The CBA therefore uses estimates of the number of brands and SKUs that would remain after applying brand consolidation assumptions in the cost-benefit analysis of the TPR-PSA, as listed below in Table 1.

Data on water pipe tobacco, blunt wraps, and tobacco products intended for use with devices (better known as heated tobacco products), the devices and their parts are not available in the HC Wholesale Database. The number of brands and SKUs for these products was therefore estimated using a combination of third-party data sources and desktop research.

Table 1: Estimated number of product brands and SKUs subject to new labelling requirements
Sources: (1) Health Canada, 2019. HC Wholesale Database; (2) Euromonitor International. Market and Packaging Study of Shisha in Canada. A custom report for Health Canada; (3) IEc Research.
Product Number of brands Number of SKUs Consolidation factor Adjusted number of brands Adjusted number of SKUs
Cigarettes 447 1 712 10% 402 1 541
Large non-premium cigars 367 404 10% 330 364
Little cigars 36 46 10% 32 41
Cigarette tobacco 47 132 50% 24 66
Pipe tobacco 381 440 80% 76 88
Smokeless 87 92 50% 44 46
Waterpipe/shisha tobacco 5 7 0% 5 7
Blunt wraps 6 11 0% 6 11
Heated tobacco devices 2 8 0% 2 8
Heated tobacco sticks 2 8 0% 2 8
Assessment of costs and benefits

It is anticipated that the Regulations will result in incremental compliance costs for tobacco manufacturers. The Regulations, in combination with other interventions under the CTS, are expected to lead to long-term benefits realized in terms of avoided tobacco-related morbidity and premature mortality, including from exposure to second-hand smoke. Furthermore, implementation of the Regulations will also require incremental costs to Health Canada for compliance, enforcement and updates to health-related messages. Health Canada commissioned a comprehensive analysis of costs and benefits to support development of a CBA on the impact of the proposed Regulations.

Baseline and regulatory scenario

Under the baseline scenario, the TPIR, TPLR-CLC and the health-related messages displayed on all tobacco products subject to these two sets of regulations would be maintained. Therefore, tobacco products not subject to any labelling requirements (e.g. tobacco products made in whole or on part of tobacco intended for use with devices, those devices and their parts, water pipe tobacco, blunt wraps, any novel tobacco product introduced on the market) would continue to be legally sold to consumers without any health-related messages. Messages on some tobacco product packages would also remain comparatively small. HW would not be required to be displayed on individual cigarettes, little cigars that have tipping paper, or tubes. Canada would remain non-compliant with its tobacco labelling obligations under Article 11 of the FCTC by not extending HW requirements to all tobacco product packages; and by not requiring the display of information about tobacco products emissions and constituents on all packages of tobacco products.

Under the regulatory scenario, existing health-related messages would be updated, labelling requirements would be standardized for all tobacco products, and measures to enhance and maximize impact would be introduced. Specifically, HW would be standardized to at least 75% of the display area of the package for most tobacco products.

A rotation scheme with multiple sets of health-related messages would be introduced, along with incorporation by reference of the Source Document allowing the document to be amended from time to time without amendments to the regulations. A new placement for HIM will be required for cigarette packages, and HW would be required to be displayed directly on individual cigarettes, little cigars that have tipping paper, and tubes. Collectively, these measures will meet or exceed Canada’s labelling obligations under Article 11 of the FCTC and include measures that are consistent with the Guidelines for the implementation of Article 11.

Costs of the Regulations
Quantitative costs

1. Costs associated with implementing and rotating new health-related messages, and requiring a glossy finish on the HW portion of tobacco product packages

The Regulations will require sets of messages to be rotated on a predetermined schedule, the cost of which is partially a function of the rotation frequency. The duration of the first rotation of health-related messages will be for a period of 36 months. Subsequently, unique sets of HW, HIM and TI will rotate every 24 months for cigarettes, little cigars and cigarette tobacco packages. Unique sets of HW and TI will rotate every 24 months for tube packages. Unique sets of HW and TI will rotate every 36 months for all other tobacco product packages. Unique sets of HW on cigarettes, little cigars that have a tipping paper, and tubes will rotate every 24 months. The Regulations will also require tobacco manufacturers to apply a glossy finish on the HW portion of tobacco product packages. The remainder of the package will continue to have a matte finish, as required under the 2019 TPR-PSA (renamed the TPAPLR with the amendments), with manufacturers having the option to print HIM and TI with a glossy finish.

The following key assumptions were used in estimating these costs:

Table 2: Parameters used to estimate labelling costs
Sources: IEc Research. FDA text-center for Food Safety and Applied Nutrition, 2014 FDA Labelling Cost Model, prepared by RTI International, August 2015.
Category Print technology Parameter Lower Upper
Materials Rotogravure Cylinders per SKU

9 for cigarettes;

5 for other products

11 for cigarettes;

6 for other products
Rotogravure Cost per cylinder $2,000 $4,000
Offset Full materials cost per SKU $862 $862
Flexography Full materials cost per SKU $4,481 $4,481
Compliance All Compliance cost $4,545 per brand $8,972 per SKU

Estimated costs are calculated as follows:

where, for each share of print technology:

The total present value of the cost of compliance for this measure, including the addition of a gloss finish on HW, is estimated to be $107.9 million TPV over 10 years (or about $15.4 million in annualized value). The costs associated with cigarette packaging account for approximately 80% of these costs.

2. Costs associated with implementing a new placement for HIM on the extended upper slide flap of slide-and-shell cigarette packages

The Regulations will require HIM to be displayed on an extended upper slide flap of slide-and-shell cigarette packages.

The following key assumptions were used in estimating these costs:

Estimated costs are calculated as follows:

The total present value of the cost of compliance for this measure is estimated to be $83.8 million TPV over 10 years (or about $11.9 million in annualized value).

3. Costs associated with implementing a requirement for HW to be displayed on individual cigarettes, little cigars that have tipping paper, and tubes

The Regulations also introduce a new requirement to display HW on individual cigarettes, little cigars that have tipping paper, and tubes. Messages will be displayed on the tipping paper, with the tipping paper having a length of at least 24 mm. In the case of cigarettes that do not have tipping paper, the HW is to be displayed on the cigarette paper at a length of at least 24 mm that starts from one end of the cigarette.

Tipping paper is produced and shipped to cigarette manufacturers in large, double-wide rolls (or bobbins). Interviews were conducted with experts at a major tipping paper supplier to estimate the potential costs associated with applying short messages to tipping papers.

Manufacturers would likely apply the messaging using rotogravure methods, so the cost is largely a function of the number of cylinders used and the quantity of ink applied. Both inputs are themselves a function of the features of the messaging, i.e. the amount of text, text size, and colour specifications. The design involves black text on a white background (rather than colour).

Machinery modifications (“conversion kits”) are necessary for certain tobacco products to facilitate the printing of HW of at least 24 mm in length.

The following key assumptions were used in estimating these costs:

Estimated costs are calculated as follows:

where:

The total present value of the cost of compliance for this measure is estimated to be approximately $18.2 million TPV over 10 years (or about $2.6 million in annualized value).

4. Costs associated with implementing health-related messages for premium cigars

The Regulations will require packages of premium cigars to display a new larger HW and a TI.

Most non-premium cigars are sold in paperboard type packs and package labels are printed using the rotogravure printing process, as in cost item 1. However, premium cigars are primarily imported, and are in packages that vary in size and composition, from paperboard to wood, leather or metal. Due to the wide range of packaging, as well as the relatively low numbers of premium cigars sold in Canada, current regulations allow flexible labelling practices.

Under the 2019 TPR-PSA, importers are allowed to apply adhesive stickers that display an HW to comply with labelling requirements. It is anticipated that importers would use this compliance approach rather than having suppliers redesign all premium cigar boxes. Importers would redesign the sticker sets to comply with new requirements for an enlarged HW and addition of a TI.

The following key assumptions were used in estimating these costs:

Estimated costs are calculated as follows:

where:

The total present value of the cost of compliance for this measure is estimated to be $0.42 million TPV over 10 years (or about $60,000 in annualized value).

Government costs — Health Canada

5. Implementation, compliance and enforcement costs

The implementation of the Regulations will require a modest investment of public sector resources. Specifically, Health Canada would incur modest incremental costs for performing compliance and enforcement activities. It would also incur costs for managing eventual updates to health-related messages. These costs would be absorbed through existing budget allocations.

Implementation activities in the year following the introduction of the Regulations will include the development of a compliance promotion plan, publication of a notice to inform impacted stakeholders of the new regulations and Order, review of compliance and enforcement policies and procedures, development of compliance and enforcement documents (including assessment tools, warning letter templates, external fact sheets and internal guidelines), development of staff training programs and materials, and subsequent training of inspectors.

Compliance monitoring activities include inspections and oversight and coordination of regional enforcement staff. Enforcement activities include seizure of non-compliant products, implementation of enforcement actions and coordination of federal and provincial enforcement activities.

Monitoring compliance with the Regulations will involve activities such as compliance monitoring inspections, seizures of non-compliant products, and implementation of enforcement actions. Health Canada already conducted these activities to monitor compliance with the TPIR and TPLR-CLC. As Health Canada is already conducting compliance and enforcement activities related to tobacco packaging and labelling in a consolidated fashion, the Regulations will result in minimal incremental costs to the Department. Health Canada will continue to utilize existing resources dedicated to tobacco control regulatory activities to facilitate eventual updates to health-related messages and the Source Document. These activities will therefore not result in incremental costs for the Department.

The total government costs are estimated at $3.5 million TPV over 10 years (or about $0.5 million in annualized value).

Qualitative costs

6. Ambulatory incorporation by reference of the Source Document

The Regulations will allow Health Canada to amend the Source Document from time to time.

This is an administrative change in how the source document is incorporated in the regulations. This approach would allow Health Canada to update health-related messages under faster time frames than previous labelling renewals requiring amendments to the regulations. With the continued aim of supporting the objectives of the TVPA, this mechanism would allow for Health Canada to be more responsive to new scientific research on the health effects or health hazards of using tobacco products by updating, editing or replacing content in the Source Document.

Any changes to the Source Document will be implemented to coincide with a scheduled rotation and will be communicated to interested parties at least eight months ahead of time. The costs associated with full-scale changes to the Source Document may be significant and comparable to the costs of implementing new messages and rotations, as discussed in monetized cost item 1. However, it is difficult to predict whether or how often Health Canada might implement a change in label content. Future compliance costs are therefore difficult to predict, as they are associated with the scope of eventual changes.

While ambulatory incorporation by reference will allow Health Canada to propose future changes to the Source Document over the 10-year period analyzed, it cannot be assumed that changes will be undertaken and to what extent. For this reason, future costs associated with making use of this measure are not incorporated in the estimates.

Health Canada will continue to utilize existing resources dedicated to tobacco control regulatory activities to facilitate eventual updates to health-related messages and the Source Document. These activities will therefore not result in incremental costs for the Department as they do not differ from Health Canada’s activities under the baseline scenario.

7. Increased packaging sizes for smokeless tobacco to meet the 4 000 mm2 minimum size for health warnings

As noted in the “Regulatory development” section, in the responses to prepublication in the Canada Gazette, Part I, a manufacturer of one type of smokeless tobacco, indicated that the 4 000 mm2 minimum size for the health warning would not fit on current packaging for this product, and would need to be sold in larger package sizes. This manufacturer did not provide an estimate of the costs associated with a change to the packaging size, nor did they suggest that such costs would be substantial.

Based on the review of publicly available supplier packaging costs, the incremental costs of larger packaging would be approximately $0.03 per container sold. Based on 2019 HC Wholesale data, there are 7.2 million packages of smokeless tobacco sold annually, and some proportion would require an increased package size. If all packaging for smokeless tobacco needed to increase their size, this would imply a $216 000 cost per year. While some consumers may prefer the smaller size packaging for carrying convenience, there is also the potential for manufacturers to increase the amount of product in these larger containers, reducing total cost per kilogram sold making the overall impact ambiguous. Given the uncertainty and relatively small impact their inclusion would have on the total cost of the regulations, these impacts have not been included in the quantified analysis.

Potential economic impacts

8. Profit loss to manufacturers

The introduction of new health-related labelling requirements could have a variety of market impacts that would affect the sales, profitability, and operations of tobacco products manufacturers and their suppliers.

The costs of complying with revised labelling requirements could be passed through to consumers in the form of higher prices, resulting in a reduction in unit sales, and further consolidation of the brands. The impact of a reduction in unit sales on manufacturers’ profits depends on the profit earned on each unit. In general, information on profit margins is closely held by the industry, and the information that is available is largely limited to cigarettes. In addition, if the new messages and presentation of messages, in combination with other measures as part of the overall CTS, result in an overall lower percentage of Canadians using tobacco products, this would be expected to result in an overall lower profitability to the industry.

9. Profit loss to retailers

An increase in tobacco product prices stemming from the implementation of the labelling requirements would also be expected to affect sales of tobacco products and associated profits in the retail sector.

For tobacco products other than cigarettes, little cigars and cigarette tobacco, the Regulations allow retailers to keep products featuring a previous series of health-related messages in stock when a second series in rotation is introduced onto the market as a means to minimize the economic impact.

10. Costs to adults who smoke

As evidence suggests that addictive products negate the self-control that is essential in the model of rational consumer behaviour, the rational choice framework of economics is inappropriate for assessing consumer surplus impacts of the Regulations.footnote 68 Still, manufacturers of tobacco products may pass their compliance costs through to consumers in the form of higher prices and further consolidation in the number of brands; those who continue to purchase these products would realize a loss in consumer surplus either through increased prices and/or loss of access to a preferred product or product packaging format. The potential impact on the price of most tobacco products is expected to be relatively modest.

11. Loss of tax revenue

The Regulations are expected to result in minor tax revenue losses to governments given that demand for tobacco is expected to decrease. Reduced sales of tobacco products reduce provincial sales tax collections, while manufacturer and retailer profit losses reduce corporate income tax revenue.

Sensitivity analysis

The CBA relies on projections that use various assumptions and parameters to determine these cost estimates. Sensitivity analysis has been conducted by analysis of high and low range values derived from the CBA.

Sensitivity analysis has been implicitly built into each cost estimate based on upper and lower bounds for each cost category based on changes to variables that have a range of estimates. The CBA estimates are based on the midpoint value of each cost category in the Regulations. Aggregate sensitivity using this method results in cost benefits ranging from a low of $134 million total present value ($19.1 million annualized value) to a high of $294 million total present value ($41.8 million annualized value). These high and low values result in a midpoint cost estimate of $214 million total present value, as provided in the detail of monetized costs in Table 6.

Benefits of the Regulations

The Regulations will support the CTS, which aims to reduce the burden of disease and death from tobacco use and its consequential impact on the public health care system and society. The success of the CTS, a federal initiative, will be a result of a multifaceted and coordinated approach and the tobacco control efforts of many partners, such as provinces and territories, municipalities, non-governmental organizations, community agencies and the private sector. Given the variety and number of tobacco control interventions at play, quantifying the benefits of an individual tobacco control measure is very challenging.

The Regulations are expected to enhance public awareness about the health hazards associated with the use of tobacco products, supporting informed decisions about not using them. This, in combination with other interventions under the CTS, will lead to long-term benefits realized in terms of avoided tobacco-related morbidity and premature mortality, including from exposure to second-hand smoke. Given the significant uncertainties associated with the expected impact of the Regulations on tobacco use as a single element of a broader strategy, the direct health benefits attributable to the Regulations were not monetized. Instead, a model was developed to examine the implications of changes in cigarette initiation and cessation rates on fatal and non-fatal health effects of tobacco use. Three benefits resulting from changes in the initiation rates and cessation were considered:

Model description

Given the difficulties in establishing a direct impact of the Regulations on initiation and cessation rates, this analysis does not attempt to quantify the direct public health benefits attributable to the Regulations. Instead, the analysis uses the Tobacco Control Health Benefits Model (HBM) to conduct a break-even analysis that specifies the reductions to cigarette initiation and cessation rates over the next 10 years that would be necessary to produce public health benefits commensurate with the costs of the Regulations.

The model was used to conduct a break-even analysis to determine the percentage change in the annual rate of cigarette initiation from 2024 to 2033 and the percentage change in the annual rate of cigarette cessation that would be needed to generate health benefits commensurate with the estimated costs of the Regulations. To reflect cost adjustments to the prepublication of the CBA in Canada Gazette, Part I, a pro-rata adjustment to the HBM breakeven estimates was made.

The HBM focuses on cigarettes, which account for approximately 94% of tobacco sales in Canada and cause the vast majority of tobacco-related health impacts. Data on the adverse health effects of cigarette use are more readily available than similar data available on the use of other tobacco products.

Mortality impacts from smoking

To estimate the mortality risk of current and former smokers, data from Taylor et al.footnote 69 on mortality risks as a function of sex, age, and time since quitting was relied upon. The estimates were adjusted so that the model’s aggregate age- and sex-specific mortality rates match corresponding rates reported by Statistics Canada (average rates from 2014 to 2018.footnote 70 The model estimates annual deaths due to smoking by multiplying the stock of current smokers (and former smokers) by the difference in mortality risk between a current smoker (and former smoker) and a never smoker of the same sex and age.

To value changes in mortality risks, estimates of the value per statistical life (VSL) are used. The VSL is an aggregated estimate of the value of small annual mortality risk changes in a population, based on estimates of individual willingness-to-pay (WTP) to reduce one’s own mortality risk by a small amount. These WTP estimates are derived primarily from wage-risk studies of workers across jobs of varying risk levels. Importantly, the VSL represents the value of one “statistical life,” not the value of saving a specific individual’s life. Consistent with the Treasury Board of Canada Secretariat Policy on Cost Benefit Analysis,footnote 71 the model uses a VSL estimate of $7.99 million (2020 dollars).

In addition to estimating the mortality risks of smoking for current and former smokers, the model also estimates non-smoker deaths attributable to exposure to second-hand smoke (SHS). For this parameter, data on SHS-attributable mortality in 2012 from the Conference Board of Canadafootnote 72 is used. These mortality estimates were divided by smoking prevalence in 2012 to generate SHS mortality per 1 000 smokers. The model then multiplies these mortality rates by the smoking population in each modelled year to generate estimates of SHS-attributable mortality.

Smoking-related morbidity

To estimate the economic costs associated with tobacco-related morbidity, the model relies on 2017 data on tobacco-attributable direct health care costs and short-term disability from the Canadian Substance Use Costs and Harms Scientific Working Group.footnote 73 To estimate these costs, the annual cost of short-term disability and the direct health care costs are divided by the estimated number of people who smoke aged 27 and older. As tobacco-related illnesses generally take several years to manifest, a latency period of 10 years between smoking initiation and the onset of nonfatal health effects is assumed. Available data indicates the average age of cigarette smoking initiation is 17; thus, health costs associated with smoking are assumed to be incurred primarily by adults aged 27 and above who smoke and people who are exposed to SHS. The estimated annual morbidity cost is $2,620 (2020 dollars) for an adult aged 27 and older who smokes.

Results of break-even analysis

The estimated incremental costs of the Regulations lead to a present value of $214 million over 10 years (2020 constant dollars, 7% discount rate). To offset these costs, either a reduction to the annual rate of cigarette initiation by 1.04% relative to the baseline initiation rate, or an increase to annual cigarette cessation rates of 0.21% relative to the baseline cessation rate would be needed. While a more likely result would be a combination of reduced initiation and increased cessation rates, in order to solve the model for a break-even result, one or the other needed to be held constant.

It is important to note that these percentage changes (1.04% and 0.21%) are not the absolute changes to initiation and cessation, rather they are percentage changes that would be multiplied by existing initiation and cessation rates.

Table 3: Break-even results for the primary analysis
Note: Figures may not add up to totals due to rounding.
Cost scenario Break-even point (present value, 10 years, 7% discount rate) Reduction in annual cigarette initiation rate required for benefits to equal costs Increase in annual cigarette cessation rate required for benefits to equal costs
Reduction in consumer demand for cigarettes /
Increase in number of people who have quit cigarettes		 $213,748,199 1.04% 0.21%

To put the analysis of public health benefits for the above break-even scenario into perspective, Table 4 and Table 5 provide additional information. The numbers in these tables are not a prediction of what the Regulations will accomplish. Rather, they illustrate the public health benefits that would be accrued in the event of a 1.04% decrease in the cigarette initiation rate or a 0.21% increase in the annual cigarette cessation rate for the cost scenario. The relatively small effects on these rates would be equivalent to approximately 11 100 more people who do not start smoking or 2 400 more people who stop smoking at the end of year 10. Since the estimated costs for the Regulations have been calculated, the benefits for the break-even scenario must equal or exceed these costs. Note, the break-even analysis does not account for how a reduction in demand for cigarettes would impact the estimated costs of the Regulations.

Table 4: Public health benefits from the Regulations (reduced initiation rate) — Break-even analysis
Note: Figures may not add up to totals due to rounding.
Benefits (avoided cost) Current best estimate cost scenario
Total avoided premature deaths PV of benefits
(in millions of dollars)		 Percentage of total benefits
Deaths due to cigarette use 28 $148 69%
Deaths attributable to second-hand smoke exposure 11 $60 28%
Morbidity costs of cigarette use N/A $6 3%
Total 39 $214 100%
Table 5: Public health benefits from the Regulations (increased cessation rate) — Break-even analysis
Note: Figures may not add up to totals due to rounding.
Benefits (avoided cost) Current best estimate cost scenario
Total avoided premature deaths Present value of benefits (in millions of dollars) Percentage of total benefits
Deaths due to cigarette use 36 $180 84%
Deaths attributable to second-hand smoke exposure 3 $15 7%
Morbidity costs of cigarette use N/A $19 9%
Total 39 $214 100%
Sensitivity analysis

Given the uncertainty in regard to the degree to which the regulations would contribute, with other measures, to aid people in making the choice to quit smoking versus aiding people who do not smoke from not starting smoking, a break-even analysis was used to determine estimates of two metrics: decreases to smoking initiation rates (i.e. fewer people taking up smoking) and increases to cessation rates (i.e. more people who smoke quitting smoking). Initiation rates are held constant in the HBM, while offsetting benefits associated with increases to cessation rates are estimated. Cessation rates are then held constant in the HBM, while offsetting benefits associated with decreases to initiation rates are estimated. Specifics of the health benefits from each metric are provided in Table 4 and Table 5.

Results of decreased initiation rates and increased cessation rates at break-even provide different distributions of reduced health impacts. Break-even increased cessation results in relatively higher reductions of risk of premature mortality due to cigarette use (84% of benefits, 36 avoided premature deaths) compared to break-even reduced initiation (69% of TPV, 28 avoided premature deaths). Break-even reduced initiation yields relatively higher reductions in risk of premature mortality from second-hand smoke exposure (28% of TPV, 11 avoided premature deaths) compared to break-even increased cessation (7% of TPV, 3 avoided premature deaths). Avoided morbidity costs of cigarette use are relatively higher for break-even increased cessation (9% of TPV) compared to those for break-even reduced initiation (3% of TPV). These differences demonstrate how the estimated reduction in health impacts would be distributed if a break-even of estimated costs were to be achieved, depending on how cessation or initiation rates change.

Distributional analysis

Monetized incremental costs to tobacco product manufacturers account for 98% of the total estimated costs, the remaining costs are borne by the Government. Based on Canadian Industry Statistics for the tobacco industry, approximately half of tobacco products manufacturers are located in Ontario, followed by almost a third in the province of Quebec, and the remainder in other provinces.

The small business lens applies, as there are impacts on small businesses associated with the Regulations. As noted in the “Small business lens” section, of the estimated 34 manufacturers, approximately 80% (28) are small businesses.

As described in the “Gender-based analysis plus” section, the Regulations are not expected to negatively impact any particular groups of Canadians. However, some groups may disproportionately benefit. This includes youth experimenting with tobacco use who often access individual cigarettes from social sources and are not usually exposed to health warnings on packages. Also, a given overall reduction in initiation or increase in cessation rate may yield different benefits for women compared to men. For example, women experience more adverse health effects at lower consumption, greater difficulty quitting, higher susceptibility to chronic obstructive pulmonary disease, and higher risk for heart disease, while men are more likely to develop bladder and oral cancers. Additionally, smoking is more prevalent in lower income groups and is therefore a source of health inequality.footnote 74

Health benefits resulting from the Regulations may disproportionately benefit populations disproportionately impacted by tobacco use population groups identified in the “Gender-based analysis plus” section with higher rates of tobacco use, resulting in positive distributive effects.

Cost-benefit statement
Summary

The Regulations are estimated to result in total incremental costs of $214 million TPV over the 10-year period (or about $30.4 million in annualized value). A break-even analysis indicates that a relatively small effect on cigarette smoking initiation and cessation would be sufficient to produce health benefits to the public equivalent to or greater than the estimated costs of the Regulations.

Table 6: Monetized costs
Note: Figures may not add up to totals due to rounding.
Impacted stakeholders Description of cost Base year
(2023)		 Year 5
(2027)		 Final year (2032) Total (present value) Annualized value
Government Total government costs $610,941 $442,446 $442,446 $3,493,579 $497,407
Tobacco industry Implementing and rotating new health-related messages $59,394,536 $0 $0 $107,878,169 $15,359,424
Implementing new HIM placement on the extended upper slide-flap of slide-and-shell cigarette packages $25,076,784 $3,938,662 $3,938,662 $83,802,509 $11,931,592
Implementing HW on individual cigarettes, little cigars that have tipping paper, and tubes $9,799,509 $1,282,186 $1,282,186 $18,153,248 $2,584,614
Health-related messages for premium cigars $139,000 $0 $139,000 $420,694 $59,897
All stakeholders Total costs $95,020,769 $5,663,294 $5,802,294 $213,748,199 $30,432,935
Table 7: Quantified Break-Even Benefits (millions of Canadian dollars)
Note: Figures may not add up to totals due to rounding.
Benefits needed to break-even with the estimated costs Current best estimate cost scenario assuming reduction of 1.04% in the cigarette initiation rate Current best estimate cost scenario assuming 0.21% increase in the annual cigarette cessation rate
Reduced risk of death due to cigarette use $148 $180
Reduced risk of death attributable to second-hand cigarette smoke exposure $60 $15
Reduced risk of morbidity related to cigarette use $6 $19
Total $214 $214
Table 8: Summary of monetized costs and benefits
Impacts Base year
(2023)		 Year 5
(2027)		 Final year
(2032)		 Total
(present value)		 Annualized value
Total costs $95,020,769 $5,663,294 $5,802,294 $213,748,199 $30,432,935
Qualitative positive impacts
Qualitative negative impacts

Small business lens

Based on data on the wholesale tobacco products market, there are an estimated 34 manufacturers and/or importers of tobacco products, concentrated mostly in Ontario and Quebec. Of these, approximately 80% (28) have fewer than 100 employees based on Canadian Industry Statistics for the tobacco industry, and are therefore small businesses pursuant to the Treasury Board of Canada Secretariat definition.

The small business lens applies, as there are impacts on small businesses associated with the Regulations. Small businesses impacted by the Regulations account for approximately 1% of total industry revenues. The market share of small businesses (%) by tobacco product category was used to estimate the industry cost to small businesses.

The total incremental costs to all impacted small businesses are estimated at $6.46 million TPV over 10 years (or $0.92 million in annualized value). The estimated incremental cost of the Regulations per impacted small business is estimated at $231,000 TPV and $33,000 in annualized value per impacted small business. The costs apportioned to these small businesses are not large relative to small business revenues.

Incremental costs to all small businesses in the tobacco industry

The 28 small businesses in the manufacturer category would bear the same compliance costs related to tobacco products as all 34 manufacturers. In the absence of specific estimates on costs to these small businesses, market share by product category cost is used to allocate cost. These include the following cost categories, as summarized in Table 9.

Costs associated with implementing and rotating new health-related messages were allocated to the manufacturers based on the product category and market share. These costs to small businesses were estimated at $6.11 million TPV, or $0.87 million annualized value.

Compliance costs to small businesses for premium cigars were allocated to small businesses based on market share. Total costs to small business for premium cigars were estimated at $143,000 TPV or $20,300 annualized value. Continued allowance of stickers to be used for health-related messages for premium cigars packages reduces costs for businesses impacted, which are likely to be smaller businesses.

HIM placement costs on the upper slide flap of slide-and-shell cigarette packages were allocated to small businesses based on cigarette market share. These costs were estimated at $161,000 TPV or $22,900 annualized value.

The Regulations require HW to be displayed directly on individual cigarettes, little cigars that have tipping paper, and tubes. The costs to small businesses were allocated based on market share for impacted products, resulting in an estimated cost of $50,000 TPV or $7,100 in annualized value.

Additional flexibility considered

The 28 small businesses affected by the Regulations and Order are all manufacturers domiciled in Canada. Modified compliance requirements would limit the public health benefits of the Regulations. Therefore, a flexible option was not developed.

The Regulations provide flexibility for retailers of tobacco products. Specifically, the transition period means that inventory obsolescence for tobacco product retailers is expected to be negligible, as it allows sufficient time for inventory to be depleted through sales.

Small business lens analysis — Costs to all impacted small businesses in tobacco industry
Small business lens summary
Table 9: Compliance costs
Note: Figures may not add up to totals due to rounding.
Activity Annualized value Total (present value)
Implementing and rotating new health-related messages $869,551 $6,107,363
Implementing new HIM placement on the extended upper slide-flap of slide-and-shell cigarette packages $22,949 $161,187
Implementing HW on individual cigarettes, little cigars that have tipping paper, and tubes $7,112 $49,954
Health-related messages for premium cigars $20,301 $142,586
Total compliance costs $919,914 $6,461,089
Cost per impacted small business $32,854 $230,753
Table 10: Administrative costs
Activity Annualized value Total (present value)
None 0 0
Total administrative cost 0 0
Table 11: Total compliance and administrative costs
Total Annualized value Total (present value)
Total cost (all impacted small businesses) $919,914 $6,461,089
Cost per impacted small business $32,854 $230,753

One-for-one rule

The one-for-one rule applies. It is an “out” under the rule for regulatory titles. The Regulations repeal two existing regulatory titles and amend another one: they merge the TPIR, the TPLR-CLC and the TPR-PSA into a single set of regulations. As a result, a net of two titles out is counted under the rule.

In accordance with Treasury Board of Canada Secretariat policy guidance, all costs relating to labelling are deemed to be compliance costs. There will be no administrative burden on businesses as a result of the Regulations.

Regulatory cooperation and alignment

Canada is a Party to the FCTC. The Regulations meet or exceed Canada’s tobacco labelling obligations under Article 11 of the FCTC and include measures that are consistent with the Guidelines for implementing Article 11.

International stakeholders were notified through the World Trade Organization notification process and provided with the same access to documents and opportunities to comment as domestic stakeholders. The Regulations and Order were subject to a 75-day comment period at the Canada Gazette, Part I, stage.

Strategic environmental assessment

In accordance with the Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a preliminary scan concluded that a strategic environmental assessment is not required.

Gender-based analysis plus

A gender-based analysis plus (GBA+) was conducted on draft HW for cigarettes, cigars, pipe tobacco, chewing tobacco and snuff, draft HIM for cigarettes, and draft TI for cigarettes, chewing tobacco and snuff packages. The GBA+ assessed the labels on sex-specific effects of tobacco use, and how sex may affect tobacco-related diseases or conditions. It also assessed the impact of certain factors such as gender norms or gender roles on tobacco use. Equity factors such as low socioeconomic status, impact on Indigenous populations, and on sexual or gender minorities were assessed. Strategies to avoid gender stereotyping in text or images were also reviewed. Recommendations from the GBA+ report included revisiting HW content to support gender equity and using diverse imagery to portray populations disproportionately impacted by tobacco use. The analysis also pointed out to ways to avoid stigmatization in the depiction of women. These recommendations were taken into consideration in the development of messages and imagery.

The Regulations are not expected to negatively impact any particular groups of Canadians based on gender, race, or ethnicity. However, it is likely that some population groups could be differentially impacted as exposure to the new features will vary with tobacco use. For example, youth experimenting with tobacco use often access single cigarettes from social sources and are not usually exposed to warnings on packages. The display of text health warnings on the tipping paper of individual cigarettes, little cigars that have tipping paper, and tubes would help to more effectively reach and inform youth — a population particularly susceptible to nicotine addiction — of the health hazards of tobacco use. The warnings are expected to also reduce the appeal of the product, making it less desirable to consume in social situations, as demonstrated by research studies.

There are gender differences in smoking prevalence among men and women in Canada. In 2020, the prevalence of current cigarette smoking was higher among men (12%) than women (9%).footnote 77 Smoking prevalence is high among LGBTQ+ persons and ranges between 24% to 45% across different groups.footnote 78 LGBTQ+ individuals are more likely to start smoking earlier.footnote 79 There are sex differences associated with tobacco use and certain health conditions. For instance, women experience more adverse health effects of tobacco use at lower consumption levels and experience greater difficulty in quitting. In terms of specific health effects, men who smoke are more likely to develop bladder cancer and oral cancers while women are more susceptible to develop chronic obstructive pulmonary disease with less exposure to tobacco as well as a higher risk for heart disease.

Additionally, there are health inequalities in lower income groups where smoking is more prevalent.footnote 74

Populations disproportionately impacted by tobacco use

Canada’s Tobacco Strategy recognizes certain groups of Canadians face smoking rates that are considerably higher than the general population. These groups require more targeted action to ensure no one is left behind in Canada’s efforts to reach less than 5% tobacco use by 2035. In particular, smoking prevalence among Indigenous peoples is approximately two to five times higher than among non-Indigenous Canadians. Prevalence is higher in certain trades. For example, in 2011, more than one third of construction workers smoked (34%), followed by mining and oil and gas extraction workers (29%) and transportation and warehousing workers (29%).

Health Canada will continue to monitor the health inequalities impacts of tobacco use across the population. Efforts by Health Canada, the Public Health Agency of Canada and Indigenous Services Canada to reach groups with higher rates of smoking will continue through increased resources in tobacco programs.

Implementation, compliance and enforcement, and service standards

Implementation

The Regulations and Order are made pursuant to the powers of the TVPA. They come into force on August 1, 2023.

A transition period is provided for manufacturers until January 31, 2024, for implementation of the labelling requirements. During this transition period manufacturers will be allowed to continue to provide retailers with tobacco packages or leaflets regulated by the TPIR or TPLR-CLC in accordance with their rules. Manufacturers will be able to continue to provide retailers with packages of tobacco products that are not regulated by the TPIR or TPLR-CLC.

In addition, a transition period is provided until

A transition period is provided for retailers until April 30, 2024, for implementation of the labelling requirements. During this transition period, retailers will be able to sell through inventoried tobacco products regulated by the TPIR or TPLR-CLC in accordance with their rules or continue to provide consumers with packages of other tobacco products not regulated by the TPIR or TPLR-CLC.

In addition, a transition period is provided until

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 and Order 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 public consultations on the proposal, 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.

Although the scope of the FCTC only covers tobacco products, members of the vaping and pharmaceutical industries or an affiliated organization, or an individual acting on their behalf, were asked to clearly indicate this 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

Anne Gabriel
Manager
Tobacco Products Labelling Division
Tobacco Products Regulatory Office
Tobacco Control Directorate
Controlled Substances and Cannabis Branch
Health Canada
Address locator: 0301A
150 Tunney’s Pasture Driveway
Ottawa, Ontario
K1A 0K9
Email: pregs@hc-sc.gc.ca