Supplementary Rules Respecting Nicotine Replacement Therapies Order

Supplementary Rules Respecting Nicotine Replacement Therapies Order 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 30.01a of the Food and Drugs Actb. S.C. 2024, c. 17, s. 326 R.S., c. F-27 Ottawa, August 9, 2024 Definitions The following definitions apply in this Order. 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 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 means a natural health product, other than a homeopathic medicine, that contains nicotine or its salts; and is for administration in the oral cavity. (thérapie de remplacement de la nicotine) pharmacist has the same meaning as in subsection C.01.001(1) of the Food and Drug Regulations. (pharmacien) Regulations means the Natural Health Products Regulations. (Règlement) young person means an individual who is under 18 years of age. (jeune) Words and expressions Unless the context otherwise requires, words and expressions used in this Order have the same meaning as in the Regulations. Application of Regulations 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: 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 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. Non-application — clinical trials 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. Application for product licence 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. Application for amendment 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. Changes — brand name or non-medicinal ingredient 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 change to a brand name that was submitted under paragraph 5(e) of the Regulations; or 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. Issuance and amendment 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 on retail basis 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. Exception 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. Sale for further sale 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. Brand name A person must not sell a nicotine replacement therapy under a brand name for which there are reasonable grounds to believe may mislead a purchaser or consumer in respect of the intended use of the nicotine replacement therapy; be appealing to young persons; be associated with young persons; or be mistaken for cannabis as defined in subsection 2(1) of the Cannabis Act or for a food. Appealing to young persons 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. Flavours 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. Flavours — mint or menthol 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. Labelling A person must not sell a nicotine replacement therapy unless it is labelled in accordance with this Order. 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. Statement 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. Warnings 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. Presentation — statements and warnings The statements and warnings required under sections 14 and 15 must be clearly and prominently displayed; and readily discernible to a purchaser or consumer under the customary conditions of purchase and use, without having to manipulate the label. Presentation — warnings The warnings required under section 15 must be 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; in characters of a standard sans serif font that is not decorative; and in characters of a type size of at least 6 points. Interpretation — advertisement 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. Smoking cessation A person must not advertise or otherwise promote a nicotine replacement therapy for a use that is other than smoking cessation. 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. 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 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 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. Flavour name — descriptive or qualifying words 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. Flavour name — reasonably conveyed 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. Flavour name — mint or menthol 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”. Statements Any advertisement for a nicotine replacement therapy must contain in the case of an advertisement in English, the statement “This product is intended for smoking cessation only. Do not use if you are under 18 years of age.”, or “Only to be used by adults who are trying to quit smoking.”; in the case of an advertisement in French, the statement “Ce produit est uniquement destiné à vous aider à cesser de fumer. Ne pas utiliser si vous avez moins de 18 ans.”, or “À utiliser uniquement par des adultes qui désirent cesser de fumer.”; in the case of an advertisement in both official languages, the statements set out in subparagraphs (a)(i) and (b)(i), or subparagraphs (a)(ii) and (b)(ii); and in any other case, the statement set out in subparagraph (a)(i) or (ii) or (b)(i) or (ii). in the case of an advertisement in English, the warning “WARNING: This product contains nicotine. Nicotine is highly addictive.”; in the case of an advertisement in French, the warning “AVERTISSEMENT : Ce produit contient de la nicotine. La nicotine crée une forte dépendance.”; in the case of an advertisement in both official languages, the warnings set out in paragraphs (a) and (b); and in any other case, the warning set out in paragraph (a) or (b). Audio advertising 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 in their entirety at the same speed, volume and tone as the main message, without any word being emphasized more than any other; and without any music or background sound. Visual advertising The statements and warnings required under sections 24 and 25 that are contained in a visual advertisement for a nicotine replacement therapy must be readily discernible to a purchaser or consumer. Audio-visual advertising Sections 26 and 27 apply to an advertisement for a nicotine replacement therapy that consists of both audio and visual components. Six month transition — appealing to young persons 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. [Repealed, SOR/2025-9, s. 1] Six month transition — advertising 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. Permitted sale — appealing to young persons 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. Permitted sale — labelling A person may sell a nicotine replacement therapy that is not labelled in accordance with sections 14 to 16 if it was labelled in accordance with the Regulations on or before November 28, 2025. Permitted sale — advertising 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 in accordance with the Regulations on or before November 28, 2025. Publication This Order comes into force on the day on which it is published in the Canada Gazette, Part II.