Supplementary Rules Respecting Nicotine Replacement Therapies Order (SOR/2024-169)

Whereas the Minister of Health believes on reasonable grounds that the use of a therapeutic product, other than the intended use, may present a risk of injury to health;

Therefore, the Minister of Health makes the annexed Supplementary Rules Respecting Nicotine Replacement Therapies Order under section 30.01Footnote ^a of the Food and Drugs ActFootnote ^b.

• Return to footnote ^aS.C. 2024, c. 17, s. 326

• Return to footnote ^bR.S., c. F-27

Ottawa, August 9, 2024

Le ministre de la Santé, Mark Holland Minister of Health

Interpretation

Marginal note:Definitions

• 1 (1) The following definitions apply in this Order.

  brand element

  brand element includes a brand name, trademark, trade name, logo, distinguishing guise, graphic arrangement, design or slogan that is reasonably associated with, or that evokes, a product, a service or a brand of product or service. (élément de marque)

  List

  List means the document entitled List of Nicotine Replacement Therapy Dosage Forms that may be Accessible for Self-selection by Purchasers or Consumers, as amended from time to time and published by the Government of Canada on its website. (Liste)

  nicotine replacement therapy

  nicotine replacement therapy means a natural health product, other than a homeopathic medicine, that

  • (a) contains nicotine or its salts; and

  • (b) is for administration in the oral cavity. (thérapie de remplacement de la nicotine)

  pharmacist

  pharmacist has the same meaning as in subsection C.01.001(1) of the Food and Drug Regulations. (pharmacien)

  Regulations

  Regulations means the Natural Health Products Regulations. (Règlement)

  young person

  young person means an individual who is under 18 years of age. (jeune)

• Marginal note:Words and expressions

  (2) Unless the context otherwise requires, words and expressions used in this Order have the same meaning as in the Regulations.

Application

Marginal note:Application of Regulations

• 2 (1) For greater certainty, unless otherwise provided by this Order, the Regulations apply to a nicotine replacement therapy referred to in this Order, with the following modifications:

  • (a) in paragraphs 18(1)(a) and 39(1)(a), section 92 and subsection 103.4(1) of the Regulations, the reference to “these Regulations” is to be read as including a reference to this Order; and

  • (b) in paragraphs 17(1)(e) and (2)(d) of the Regulations, the reference to “Part 5” is to be read as including a reference to this Order.

• Marginal note:Non-application — clinical trials

  (2) This Order does not apply to the sale or importation of a nicotine replacement therapy for the purposes of a clinical trial regulated by Part 4 of the Regulations.

Product Licences

Marginal note:Application for product licence

3 An application for a product licence, in respect of a nicotine replacement therapy, that is submitted under section 5 of the Regulations must contain, in addition to the information and documents required under that section, mock-ups of every label to be used in connection with the nicotine replacement therapy — including any leaflet, any package insert and any information that appears on a website — and mock-ups of its packages.

Marginal note:Application for amendment

4 An application to amend a product licence, in respect of a nicotine replacement therapy, that is submitted under subsection 11(2) of the Regulations must contain, in addition to the information and documents required under that subsection, mock-ups of every label to be used in connection with the nicotine replacement therapy — including any leaflet, any package insert and any information that appears on a website — and mock-ups of its packages, to be used in conjunction with it after the change, if the change is any of those described in paragraphs 11(1)(a) to (h) of the Regulations or in section 5.

Marginal note:Changes — brand name or non-medicinal ingredient

5 Despite section 12 of the Regulations, if a licensee makes any of the following changes in respect of a nicotine replacement therapy, the licensee must not sell any lot or batch of the nicotine replacement therapy affected by the change unless an application to amend the product licence is submitted in accordance with subsection 11(2) of the Regulations and the licence is amended accordingly:

• (a) a change to a brand name that was submitted under paragraph 5(e) of the Regulations; or

• (b) an addition or substitution of a non-medicinal ingredient that affects the flavour of the nicotine replacement therapy but that does not affect its safety or efficacy.

Marginal note:Issuance and amendment

6 For the purposes of sections 7 and 10 of the Regulations, in respect of a nicotine replacement therapy, the application for a product licence or the application to amend a product licence must also be in accordance with section 3 or 4, as the case may be.

Sale

Marginal note:Sale on retail basis

• 7 (1) A person must not sell a nicotine replacement therapy on a retail basis unless it is in a dosage form set out in the List.

• Marginal note:Exception

  (2) Subsection (1) does not apply to a pharmacist or a person working under their supervision who sells a nicotine replacement therapy on a retail basis if the nicotine replacement therapy is not otherwise accessible to the public for self-selection.

Marginal note:Sale for further sale

8 A person must not sell a nicotine replacement therapy that is in a dosage form not set out in the List to another person, other than a pharmacist, for further sale on a retail basis by that other person.

Marginal note:Brand name

9 A person must not sell a nicotine replacement therapy under a brand name for which there are reasonable grounds to believe may

• (a) mislead a purchaser or consumer in respect of the intended use of the nicotine replacement therapy;

• (b) be appealing to young persons;

• (c) be associated with young persons; or

• (d) be mistaken for cannabis as defined in subsection 2(1) of the Cannabis Act or for a food.

Marginal note:Appealing to young persons

10 A person must not sell a nicotine replacement therapy if its label or package displays statements or graphic design elements, including brand elements, for which there are reasonable grounds to believe that they could be appealing to young persons.

Marginal note:Flavours

11 A person must not manufacture or sell a nicotine replacement therapy that is in a dosage form set out in the List if it contains the flavour of a confectionery, dessert, soft drink or energy drink.

Marginal note:Flavours — mint or menthol

12 A person must not manufacture or sell a nicotine replacement therapy that is in a dosage form not set out in the List if it contains a flavour other than mint, menthol or a combination of mint and menthol.

Marginal note:Labelling

• 13 (1) A person must not sell a nicotine replacement therapy unless it is labelled in accordance with this Order.

• Marginal note:Exception

  (2) Despite subsection (1), a person may sell a nicotine replacement therapy that is not labelled in accordance with this Order if the sale is to a manufacturer or distributor.

Labelling

Marginal note:Statement

14 A statement, in both official languages, indicating an intended use by individuals 18 years of age or older must be shown on the outer label of a nicotine replacement therapy or, if there is no outer label, on the inner label.

Marginal note:Warnings

15 The warnings “WARNING: Nicotine is highly addictive.” and “AVERTISSEMENT : La nicotine crée une forte dépendance.” must be shown on the principal display panel of the inner label of a nicotine replacement therapy and, if there is an outer label, on the principal display panel of the outer label.

Marginal note:Presentation — statements and warnings

• 16 (1) The statements and warnings required under sections 14 and 15 must be

  • (a) clearly and prominently displayed; and

  • (b) readily discernible to a purchaser or consumer under the customary conditions of purchase and use, without having to manipulate the label.

• Marginal note:Presentation — warnings

  (2) The warnings required under section 15 must be

  • (a) in characters of a single colour of type that is a visual equivalent of 100% solid black type on a white background or a uniform neutral background with maximum 5% tint of colour;

  • (b) in characters of a standard sans serif font that is not decorative; and

  • (c) in characters of a type size of at least 6 points.

Advertising

Marginal note:Interpretation — advertisement

17 For the purposes of sections 18, 19, 24 and 25, advertisement as defined in section 2 of the Food and Drugs Act, does not include advertising by means of the label or package of the nicotine replacement therapy.

Marginal note:Smoking cessation

18 A person must not advertise or otherwise promote a nicotine replacement therapy for a use that is other than smoking cessation.

Marginal note:Appealing to young persons

19 A person must not advertise or otherwise promote a nicotine replacement therapy if there are reasonable grounds to believe that the advertisement or promotion could be appealing to young persons.

Marginal note:Flavours

20 A person must not advertise a nicotine replacement therapy, including by means of its label or package, in a manner that could cause a purchaser or consumer to believe that it contains

• (a) if the nicotine replacement therapy is in a dosage form set out in the List, the flavour of a confectionery, dessert, soft drink or energy drink; or

• (b) if the nicotine replacement therapy is in a dosage form not set out in the List, a flavour other than mint, menthol or a combination of mint and menthol.

Marginal note:Flavour name — descriptive or qualifying words

21 A person must not advertise a nicotine replacement therapy, including by means of its label or package, by displaying a flavour name that is preceded or followed by any descriptive or qualifying words.

Marginal note:Flavour name — reasonably conveyed

22 A person must not advertise a nicotine replacement therapy that is in a dosage form set out in the List, including by means of its label or package, by displaying a flavour name that does not reasonably convey its flavour.

Marginal note:Flavour name — mint or menthol

23 A person must not advertise a nicotine replacement therapy that is in a dosage form not set out in the List, including by means of its label or package, by displaying a flavour name that is other than “mint”, “menthol” or a combination of “mint” and “menthol”.

Marginal note:Statements

24 Any advertisement for a nicotine replacement therapy must contain

• (a) in the case of an advertisement in English, the statement

  • (i) “This product is intended for smoking cessation only. Do not use if you are under 18 years of age.”, or

  • (ii) “Only to be used by adults who are trying to quit smoking.”;

• (b) in the case of an advertisement in French, the statement

  • (i) “Ce produit est uniquement destiné à vous aider à cesser de fumer. Ne pas utiliser si vous avez moins de 18 ans.”, or

  • (ii) “À utiliser uniquement par des adultes qui désirent cesser de fumer.”;

• (c) in the case of an advertisement in both official languages, the statements set out in

  • (i) subparagraphs (a)(i) and (b)(i), or

  • (ii) subparagraphs (a)(ii) and (b)(ii); and

• (d) in any other case, the statement set out in subparagraph (a)(i) or (ii) or (b)(i) or (ii).

Marginal note:Warnings

25 Any advertisement for a nicotine replacement therapy must contain

• (a) in the case of an advertisement in English, the warning “WARNING: This product contains nicotine. Nicotine is highly addictive.”;

• (b) in the case of an advertisement in French, the warning “AVERTISSEMENT : Ce produit contient de la nicotine. La nicotine crée une forte dépendance.”;

• (c) in the case of an advertisement in both official languages, the warnings set out in paragraphs (a) and (b); and

• (d) in any other case, the warning set out in paragraph (a) or (b).

Marginal note:Audio advertising

26 The statements and warnings required under sections 24 and 25 that are contained in an audio advertisement for a nicotine replacement therapy must be communicated

• (a) in their entirety at the same speed, volume and tone as the main message, without any word being emphasized more than any other; and

• (b) without any music or background sound.

Marginal note:Visual advertising

27 The statements and warnings required under sections 24 and 25 that are contained in a visual advertisement for a nicotine replacement therapy must be

• (a) clearly and prominently displayed; and

• (b) readily discernible to a purchaser or consumer.

Marginal note:Audio-visual advertising

28 Sections 26 and 27 apply to an advertisement for a nicotine replacement therapy that consists of both audio and visual components.

Transitional Provisions

Marginal note:Six month transition — appealing to young persons

• 29 (1) A person may sell a nicotine replacement therapy that is not in accordance with section 10 during the period of six months after the day on which this Order comes into force.

• Marginal note:Six month transition — labelling

  (2) A person may sell a nicotine replacement therapy that is not labelled in accordance with sections 14 to 16 during the period of six months after the day on which this Order comes into force.

• Marginal note:Six month transition — advertising

  (3) A person may advertise a nicotine replacement therapy in a manner that is not in accordance with sections 18 to 28 during the period of six months after the day on which this Order comes into force.

Marginal note:Permitted sale — appealing to young persons

• 30 (1) A person may sell a nicotine replacement therapy that is not in accordance with section 10 if it was labelled before the day on which this Order comes into force or, in the case of a nicotine replacement therapy that was imported, it was imported and labelled in accordance with the Regulations before that day.

• Marginal note:Permitted sale — labelling

  (2) A person may sell a nicotine replacement therapy that is not labelled in accordance with sections 14 to 16 if it was labelled before the day on which this Order comes into force or, in the case of a nicotine replacement therapy that was imported, it was imported and labelled in accordance with the Regulations before that day.

• Marginal note:Permitted sale — advertising

  (3) A person may sell a nicotine replacement therapy that, by means of its label or package, is not advertised in accordance with sections 20 to 23 if it was labelled before the day on which this Order comes into force or, in the case of a nicotine replacement therapy that was imported, it was imported and labelled in accordance with the Regulations before that day.