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

Canada Gazette, Part II, Volume 158, Number 18

Registration
SOR/2024-169 August 15, 2024

FOOD AND DRUGS ACT

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 30.01^{footnote a} of the Food and Drugs Act ^{footnote b}.

Ottawa, August 9, 2024

Mark Holland
Minister of Health

Supplementary Rules Respecting Nicotine Replacement Therapies Order

Interpretation

Definitions

1 (1) 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

• (a) contains nicotine or its salts; and
• (b) 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

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

Application

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.

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

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.

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

Labelling

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

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

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.

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.

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.

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

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.

Smoking cessation

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

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.

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.

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.

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.

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”.

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).

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).

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.

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.

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

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.

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.

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.

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.

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.

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.

Coming into Force

Publication

31 This Order comes into force on the day on which it is published in the Canada Gazette, Part II.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Order.)

Executive summary

Issues

A nicotine replacement therapy (NRT) is a treatment to help people stop smoking by delivering low doses of nicotine through means other than tobacco, such as through gums, patches, lozenges or sprays. NRTs deliver nicotine to the brain in a slower manner than through cigarettes, providing a means to reduce withdrawal symptoms and cravings for nicotine while quitting smoking. While Health Canada has only authorized NRTs for the specific use of smoking cessation by adults, there is concern that some of these products may be appealing to, and accessed by, people who do not smoke — and particularly by young people (under 18 years of age) in Canada. Nicotine is a toxic and addictive substance that can be harmful to health, particularly when consumed in excessive amounts; young people may be particularly susceptible to its harmful effects, including addiction.

Innovation in the NRT market is evolving both in Canada and internationally, with increasing interest in newer dosage forms such as nicotine pouches, rapid disintegration tablets, and sublingual slow dissolving tablets (e.g. pearls). Some products are available in a variety of flavours and are often labelled in appealing ways using bright colours and graphics. Some products have also been advertised and promoted for uses other than for smoking cessation by adults, in ways that may appeal to young people through different types of media, including social media.

Background

Regulation of NRTs in Canada

In Canada, NRTs are regulated as drugs under the Food and Drugs Act as they do not contain tobacco and are authorized for the purpose of smoking cessation. As such, NRTs are not tobacco or vaping products under the Tobacco and Vaping Products Act, which regulates the manufacture, labelling, sale and promotion of tobacco and vaping products sold in Canada.

NRTs may be authorized in Canada as either a prescription drug under the Food and Drug Regulations, or as a natural health product under the Natural Health Products Regulations, depending on the NRT’s dosage form and the quantity of nicotine per dosage unit. NRTs are required to undergo a premarket review by Health Canada before being made available for sale. Drugs containing nicotine are subject to the Prescription Drug List, with certain exceptions. These exceptions include NRTs in the dosage form of a transdermal patch, chewing gum, and lozenge, as well as other dosage forms administered orally for buccal absorption by a non-active device, provided they contain or deliver less than a certain amount of nicotine per dose. NRTs subject to these exceptions are regulated as natural health products. Even though some vaping products contain nicotine and do not contain tobacco, no vaping product in Canada has undergone premarket review and received a licence to market a vaping product for the purpose of smoking cessation, or any other health claim, as a drug under the Food and Drugs Act.

Nicotine use among young people

In Canada, tobacco and vaping products that contain nicotine cannot be legally accessed by young people. Despite this, a significant number of young people still access and use nicotine products recreationally. The Canadian Tobacco and Nicotine Survey 2022 measured the prevalence of cigarette smoking, vaping, cannabis, and alcohol use among young people aged 15–19 and found that approximately 4.2% of those surveyed currently smoke cigarettes, while 11.6% reported vaping with nicotine within the past 30 days.^{footnote 1} Research has shown a steady increase in nicotine product use among young people in Canada over the past several years, primarily due to the popularity of vaping products.^{footnote 2,footnote 3}

While NRTs that are regulated as natural health products are not licensed for use by young people, there are no age verification requirements for these products that would prevent their sale at the retail level to young people; and they are available for self-selection. The proportion of young people in Canada who use NRTs for uses other than smoking cessation has increased slightly over the past several years.^{footnote 2} There is also research conducted in the United States (U.S.) suggesting that the use of some nicotine products, including nicotine pouches, may be particularly appealing to young people who already use cigarettes or vaping products, resulting in the recreational use of multiple nicotine products concurrently.^{footnote 4} Given the increasing use of nicotine products among young people in Canada and the nature of nicotine addiction and dependence, there is a potential risk for increased recreational use of NRTs among both existing users of nicotine products (e.g. vaping products) and non-users of nicotine products.^{footnote 5}

There are multiple factors that may contribute to the interest in and use of nicotine products by young people, including stress reduction, curiosity, and enjoyment.^{footnote 2,footnote 6} While most young people perceive that nicotine is harmful, one study in the U.S. found that almost three quarters of the young people surveyed perceived the nicotine in vaping products as less harmful than that in cigarettes and the nicotine in NRTs as less harmful than the nicotine in vaping products.^{footnote 7} Young people curious to try a nicotine product may first turn to a form they perceive as less risky, such as NRTs, although the nicotine in these products can still result in nicotine addiction if they are accessed and used inappropriately (i.e. recreationally).

The growing popularity of nicotine pouches within the U.S. may also have a significant impact on the awareness of and interest in using these products among young people in Canada, for example through exposure via social media platforms and other forms of media.^{footnote 8,footnote 9} In the U.S., the 2023 National Youth Tobacco Survey found that nicotine pouches were a popular nicotine product among middle school and high school students, and such products were the most used behind e-cigarettes, cigarettes, and cigars.^{footnote 10}

Harms to the health of young people from exposure to nicotine

Nicotine is a highly addictive substance that may be harmful to health, particularly when consumed in excessive amounts. Excessive amounts of nicotine can cause acute poisoning, resulting in respiratory failure and death.^{footnote 11} Dependence on, and withdrawal from, nicotine can result in important negative impacts on an individual’s mental health. Common side effects of orally administered NRTs include mouth and tongue irritation and an increased risk of developing mouth sores or gingivitis, upset stomach, and headaches. Rare side effects include severe nausea and vomiting, difficulty breathing, dizziness, chest pain, and heart palpitations.^{footnote 12}

Young people are especially susceptible to the harmful effects of nicotine, including addiction, and can become dependent on nicotine at lower levels of exposure than adults.^{footnote 13,footnote 14} Research has also found that nicotine use by young people may change how their brains develop, leading to problems with memory and concentration, impulse control, and behaviour.^{footnote 15,footnote 16} Early exposure to nicotine may lead to mood disorders,^{footnote 17} worsen symptoms of anxiety and depression,^{footnote 18,footnote 19} or cause learning problems.^{footnote 20} Enhanced activation of reward centres in the brain may also lead to behavioural changes and result in increased susceptibility to addiction to other substances. Young people that use multiple nicotine products concurrently may receive excessively high doses of nicotine, resulting in harmful effects that may be more acute and contribute to long-term addiction.^{footnote 21,footnote 14,footnote 22}

Risk of harm associated with certain dosage forms

While NRTs are intended to support smoking cessation by lessening nicotine dependence in addition to replacing cigarettes with a safer nicotine alternative, inappropriate NRT access and use has the potential to create or potentiate nicotine dependence. Moreover, the potential for dependence on a specific NRT may be positively correlated to that NRT’s rate of nicotine delivery.^{footnote 23,footnote 24,footnote 25} NRTs that are administered orally for buccal absorption, including pouches, lozenges, and gums, are usually faster acting than transdermal patches. Transdermal patches are designed to provide a slow, steady dose over 16 to 24 hours; in contrast, orally administered dosage forms are designed to elicit a more rapid response that permits greater user flexibility in self-regulating nicotine withdrawal symptoms. This more rapid absorption of nicotine may result in a head-rush or “buzz,” particularly if multiple doses are taken at once. In the context of vaping, these sensations have been identified by some young people in Canada as a primary appeal of using the product. Similarly, young people seeking these short-term effects from inappropriate NRT use may increase the dose quantity and/or frequency of such products over time, increasing their overall exposure to nicotine and its related harms (e.g. addictiveness, effects on the developing brain).^{footnote 26}

Compared to other NRT dosage forms, orally administered NRTs are more widely available,^{footnote 27} can be manufactured in a variety of flavours, are easy to use, and are advertised broadly. These features may increase the likelihood that these products will appeal to, be accessed by, and be used by young people and people who do not already smoke or vape nicotine, especially in comparison to transdermal dosage forms (i.e. patches). Considering all of these risk factors together, a tailored regulatory approach focusing on orally administered NRTs is warranted to reduce the appeal of, access to, and use of these products by young people, which in turn may reduce the potential for nicotine exposure, dependence, and other health harms for this population.

Over the past decade, some pharmaceutical companies that manufacture NRTs have been acquired by international tobacco conglomerates. This convergence has coincided with a change in how these NRTs are marketed, advertised, and where they are sold.^{footnote 28} Traditionally, NRTs have been sold mainly in pharmacies; however, some NRT manufacturers now sell orally administered NRTs, such as gums and pouches, outside of pharmacies,^{footnote 27} such as in convenience stores and gas stations with prominent advertisements throughout such stores, including behind the cash-register area where tobacco products are sold. Novel tobacco products, vaping products, and NRTs are evolving to become increasingly similar to each other, with more widespread availability through non-medical channels (including online), reduced pricing, and a greater variety of flavour options.^{footnote 28} Blurring the lines between tobacco, vaping products, and NRTs may cause confusion and misuse by consumers, which may result in the initiation of nicotine use by those naïve to nicotine or the concurrent recreational use of NRTs and tobacco or vaping products—behaviors that can potentially lead to an increased risk of harm. This evolving landscape and its resulting risks highlight a need for additional regulatory intervention for orally administered NRTs, especially those with a limited history of appropriate use, such as nicotine pouches and rapid disintegration tablets, in particular these products’ accessibility and availability (i.e. place of sale) and appeal (i.e. flavour), in order to mitigate risks associated with their unintended use, including risks to the health of young people.

Flavours and appeal

Flavouring is used in the manufacture of NRTs to support compliance with dosage forms that remain in the mouth for an extended time. However, the same flavours that make NRTs more palatable to people who are using them to quit smoking are also appealing to young people and adults who are not using these products for their intended purpose.

Research with respect to vaping products in Canada has shown that flavours influence both product perceptions and usage behaviours among young people. Flavours other than tobacco, as well as the presence of sugars and sweeteners, are associated with increased product appeal, decreased perception of product-related harm, and increased intention to try or use such products by those who do not use tobacco or vaping products.^{footnote 29,footnote 30,footnote 31,footnote 32} Research has also shown that the presence of flavours may contribute to a risk of persistent nicotine use and exploration of different nicotine product brands or flavours, and that young people may be at greater risk than adults.^{footnote 33,footnote 34} Studies also suggest that preferences for sweet flavours in vaping products are likely due to increases in perceived smoothness and sweetness as compared to perceived bitterness or harshness, that is most likely from the presence of nicotine.^{footnote 35,footnote 36}

Flavour names and descriptions also play a role in product appeal. Studies have shown that the names of scents and flavours can have significant impacts on perceived pleasantness, intensity, and arousal when exposed to the taste or smell.^{footnote 37} Flavour names and descriptions may be used in a manner that promotes awareness of NRTs to young people and may influence young people’s interest, curiosity and openness to use these products for purposes other than for smoking cessation.

Exposure of young people to advertisements for nicotine product brands

In the U.S., nicotine pouches have been heavily marketed since the mid 2010s. In 2019, six brands of nicotine pouch products spent $11.2 million (USD) on advertising. The manufacturers of the Velo and Zyn brands generated the greatest number of advertisements. Both brands made lifestyle-related claims such as novelty, modernity, and the ability to use the product in a variety of contexts, such as in workplaces, while taking public transportation, and during leisure activities.^{footnote 8} In addition, celebrities and influencers have featured nicotine pouch brands in their social media content, creating product interest for their followers. Given the global nature of the internet and the increasing usage of social media, young people worldwide are exposed to this content, despite its American origin.^{footnote 38,footnote 9}

Public Opinion Research (POR #077-23) conducted by Health Canada in January 2024 confirmed awareness of Zyn as a brand by young people in Canada. When participants were asked if they had seen any advertising for nicotine pouches, very few identified Zonnic, the brand of pouches authorized by Health Canada, but instead focused on the American brand, Zyn. Participants highlighted that they primarily heard about nicotine pouches through their friends and social media influencers. Some groups identified various athletes as people in the public eye who endorsed or posted online about nicotine pouches, endorsing their use as a focus and energy aid. Further, advertising seemed to be primarily directed towards males, with some male participants highlighting that they had seen nicotine pouches being advertised during sporting events such as hockey games.

A 2017 survey examining the appeal to young persons of vaping product advertisements in the U.S., Canada, and England found that among young people exposed to such advertisements, nearly 40% reported that those advertisements looked appealing to them.^{footnote 39} Other studies have found that the promotion of vaping products through various media such as social media has led to increased positive perceptions of these products by young people and a subsequent increase in those individuals’ likelihood of vaping.^{footnote 40,footnote 41}

Maintaining access to NRTs for smoking cessation

While there is a need to implement measures to limit the appeal of, and access to, NRTs by young people for recreational, exploratory use — to prevent inappropriate nicotine exposure and eventual nicotine dependence in these age groups — there is also a need to maintain access to NRTs for people who are using such products for smoking cessation. It is not easy to quit smoking, and many people are unable to do so without the aid of smoking cessation products. It is also common for people to make multiple attempts before successfully quitting. Measures to reduce NRT access and appeal in respect of unintended uses, including by young people, should be balanced regarding appropriate access and use, to avoid creating hesitation or active resistance to the use of NRTs for smoking cessation.

Tobacco use is not equally spread across the population in Canada, and it is often linked to other health and social inequalities.^{footnote 42} Canada’s Tobacco Strategy notes that giving adults who smoke access to less harmful options than cigarettes will help reduce health risks and possibly save lives. Further, research shows that NRTs make it more likely that a person’s attempt to quit smoking will be successful. Based on available evidence for adults, the chances of stopping smoking can increase by 50% to 60% when NRTs are used.^{footnote 43}

Objective

The objectives of the Supplementary Rules Respecting Nicotine Replacement Therapies Order (the Order) are to:

• mitigate the risk of harm to health associated with the unintended use of NRTs by young people and those who are not using such products for smoking cessation;
• contribute to the prevention of nicotine exposure and dependence among young people through measures that reduce access and appeal of these products; and
• avoid creating significant barriers for the access to safe and effective treatments by adults trying to quit smoking.

Description

Scope

This Order applies to certain NRTs, which are defined for the purposes of the Order as natural health products that contain nicotine or its salts and that are for administration in the oral cavity. These products include, but are not limited to, NRTs such as pouches, gums, sprays, and lozenges that contain or deliver 4 mg or less of nicotine per dosage unit or dose, as the case may be. This Order does not apply to transdermal patches or other nicotine-containing products that are regulated under the Food and Drug Regulations due to their dosage form or nicotine content (i.e. are subject to the Prescription Drug List). Further, the Order does not apply to homeopathic medicines as these products do not have the biochemical composition of other NRTs. In addition, the Order does not apply to the sale or importation of NRTs for the purposes of a clinical trial regulated under Part 4 of the Natural Health Products Regulations, as this Part already imposes adequate rules for these products when sold for the purposes of a clinical trial.

Application requirements

Requiring mock-ups of labels and packages instead of label text

Currently, the Natural Health Products Regulations require that applicants for a natural health product licence submit the text of every label associated with the product; however, label text alone does not allow Health Canada to review what the marketed product labelling will look like prior to licensing or amending a product licence, including the graphic design elements, or the size and placement of the information.

This Order requires that mock-ups of all product labels and packages be submitted as part of the application for a product licence for an NRT. These mock-ups will allow the Department to proactively determine if the NRT is represented properly for use in smoking cessation and will ensure that all warnings are displayed appropriately.

In addition, when a licence holder wishes to amend a product licence, the Order requires that they also submit mock-ups of all product labels and packages to be used in conjunction with the NRT after the change, when the change impacts the product’s label or package [i.e. changes described in paragraphs 11(1)(a) to (h) of the Natural Health Products Regulations]. To note, the submission of mock-ups satisfies the existing requirements in the Natural Health Products Regulations to submit the text of each label as part of an application for a product licence or an application to amend a product licence, as the case may be.

Requiring an amendment application for a brand name change and a change to a non-medicinal ingredient that affects flavour, instead of a notification

Currently, under the Natural Health Products Regulations, if a licence holder changes the brand name of a natural health product, or adds or substitutes a non-medicinal ingredient that does not affect the product’s safety or efficacy (including those that affect the product’s flavour), they must notify the Minister of such a change in accordance with section 12 of those Regulations. Despite this provision, the Order requires that such a licence holder submit, in respect of an NRT, an application to amend the product licence in accordance with subsection 11(2) of the Natural Health Products Regulations if the licence holder changes the brand name or adds or substitutes a non-medicinal ingredient that affects the flavour of an NRT (which does not affect the product’s safety or efficacy, as a change that does affect the product’s safety or efficacy would already require an application to amend the product licence under the Regulations). The licence holder must not sell any lot or batch of the NRT affected by the change unless they submit such an application, and the Minister has amended the licence accordingly. This amendment will allow the Department to review and approve such changes prior to being made by the licence holder and will satisfy the licence holder’s obligation under the Natural Health Products Regulations to notify the Minister.

Submitting an amendment application, rather than a notification, will allow the Department to assess if a brand name may mislead a purchaser or consumer, be appealing to young people, be associated with young people, or if it may be mistaken for cannabis or a food product. It will also allow the Department to assess whether the addition or substitution of a non-medicinal ingredient that affects an NRT’s flavour complies with the restrictions set out in the Order.

In accordance with the Order, an application to amend a product licence regarding a change to the brand name or to a non-medicinal ingredient affecting the flavour of an NRT must also include the submission of mock-ups of labels and packages.

Issuance of and amendments to product licences

The Order ensures that the Minister may only issue or amend a product licence, in respect of an NRT, where the application to issue or amend a product licence is in accordance with the Order’s label and package mock-up requirements.

Place of sale

Certain new and emerging dosage forms of NRTs on the market in Canada have generated greater concerns related to inappropriate access and use by young people in Canada, as opposed to dosage forms that have been on the market for some time.

This Order prohibits the direct public access (i.e. by self-selection) to NRTs that have a limited history of appropriate use in Canada (i.e. new and emerging dosage forms). Such NRTs are those in dosage forms not set out on the List of Nicotine Replacement Therapy Dosage Forms that may be Accessible for Self-selection by Purchasers or Consumers (the List) incorporated by reference in the Order. Over time, the Department may add other NRT dosage forms to this List based on evidence submitted by a licence holder to support such NRT dosage forms’ history of appropriate use. At the time of publication, this List does not include, for example, oral nicotine pouches and rapid disintegration tablets. Dosage forms not on the List will be subject to the place of sale restrictions described below, until such time that a history of appropriate use can be demonstrated and the NRT dosage form is added to the List. Guidance will outline additional information regarding the type of evidence and information that licence holders will need to provide to demonstrate a history of appropriate use to allow the Department to determine whether to add an NRT dosage form to the List.

The Order prohibits persons from selling NRTs in a dosage form that is not on the List, on a retail basis, except by a pharmacist or an individual working under the supervision of a pharmacist. In addition, such NRTs must not be accessible to the public for self-selection. In practice, this means they will be kept behind the pharmacist’s counter when sold at most physical pharmacy locations. For the purposes of this Order, the phrase “selling on a retail basis” captures retail entities who sell such products to consumers or purchasers for end-use, such as members of the general public. This prohibition does not capture individuals or entities who distribute these products through, for example, a patient-provider relationship in accordance with their scope of practice under provincial or territorial law. This includes health care practitioners providing care to their patients, for example, in hospitals or other clinical settings.

This prohibition and exception applies to both physical and online sales. For example, the dosage forms of NRTs not set out on the List may still be sold where:

• they are distributed through a remote dispensing location, where the pharmacist or a person working under the supervision of the pharmacist is physically present in either the remote dispensing location or in the pharmacy that operates the remote dispensing location; or
• a pharmacy sells them online—but only where the pharmacist or a person working under the supervision of the pharmacist intervenes in that sale. For example, a person could put such an NRT into their online shopping cart/basket but would not be able to purchase the product without a secondary verification step by a pharmacist.

Both situations above ensure that these NRTs are otherwise not accessible to the public for self-selection.

In addition, the Order prohibits persons from selling NRTs in a dosage form that is not on the List to a person that is not a pharmacist for further sale on a retail basis by that other person. In other words, this prohibition applies to distributors when selling these products to retailers. Again, this prohibition does not apply in respect of a health care practitioner distributing these products to their patients when providing health care in accordance with their scope of practice under provincial or territorial law, as such a sale would not be on a retail basis. This prohibition closes a gap that would otherwise exist between distributors of these specific NRTs and the types of persons to whom they may sell such products. This rule will complement the Order’s other measures by targeting different points in the supply chain.

Dosage forms of NRTs that are on the List (e.g. gums and lozenges) may continue to be sold from any retail outlet, as they are now.

Prohibitions

Brand names

Concerns have been raised regarding the brand names of certain NRTs in Canada. Clear requirements for NRT brand names are necessary to ensure that brand names are not appealing to young people and do not mislead the purchaser or consumer in respect of the intended use of an NRT (i.e. for smoking cessation). The Order prohibits the sale of an NRT where there are reasonable grounds to believe that its brand name may:

• mislead purchasers or consumers about its intended use;
• be appealing to, or be associated with, young people; or
• be mistaken for a cannabis or food product.

Flavours

For NRT dosage forms that are not on the List, the Order prohibits the sale and manufacture of NRTs in these dosage forms that contain a flavour other than mint, menthol, or a combination of mint and menthol. For NRT dosage forms that are on the List, the Order prohibits the sale and manufacture of NRTs in these dosage forms that contain a dessert, confectionery, energy drink, or soft drink flavour. Flavouring helps to disguise the taste of nicotine and supports a more consistent adherence with dosage regimens of NRTs that remain in the mouth for an extended time. However, some flavours may be particularly appealing to young people.

Labelling and packaging

The Order prohibits a person from selling an NRT unless it is labelled and packaged in accordance with the Order; however, a person is not subject to this prohibition if they sell an NRT that is not labelled and packaged in accordance with the Order if the sale is to a manufacturer or distributor.

Design elements and statements that may appeal to young people

The Order prohibits the sale of an NRT if the statements or graphic design elements, including brand elements, displayed on the product’s label or package could be appealing to young people. Guidance will provide further details and examples as to how certain statements and graphic design elements could be appealing to young people.

Intended subpopulation statement on the outermost label

The Order requires that the label of an NRT includes a statement in both official languages that conveys the intended use by persons 18 years of age and older on its outer label or, if it does not have an outer label, on its inner label. Further, this statement must be clearly visible to a purchaser or consumer without having to manipulate the label (e.g. it cannot be under a peel-back label). Such a statement provides a way for consumers to easily identify that these products are intended for adults only.

Warning statement on principal display panel

The Order also requires the statements “WARNING: Nicotine is highly addictive.” and “AVERTISSEMENT : La nicotine crée une forte dépendance.” to be shown on the principal display panel of the inner and, if any, outer label of an NRT. Research has shown that front of package warnings have been effective for many years on tobacco products and, more recently, on vaping products.^{footnote 44,footnote 45} Front of package warnings can reach a broad audience of current and potential nicotine users to inform them of the risks of nicotine exposure and discourage unintended use.

Legibility

The intended subpopulation and warning statements described above must adhere to the requirements of the Order relating to type size, font style, colour, and related prominence and discernability requirements, for legibility and consistency across products.

Advertising and promotion

Advertising and recommended use

This Order prohibits a person from advertising or otherwise promoting an NRT for a use other than smoking cessation. Advertising and promotional activities can help bring awareness to adults considering their smoking cessation options; however, they can also play a role in influencing a young person’s desire to access and use certain NRTs. Guidance on advertising will be developed to provide additional details and examples with respect to advertising or promoting an NRT for smoking cessation. Guidance will clarify which aspects and elements ought to be considered when developing advertising, including lifestyle elements,^{footnote 46} to assist industry in developing compliant advertisements.

Appeal to young people

This Order also prohibits a person from advertising or otherwise promoting an NRT if there are reasonable grounds to believe that the advertisement or promotion could be appealing to young people. Concerns have been raised regarding the way certain NRTs are advertised and promoted, particularly regarding their appeal to young people. Guidance will be developed in collaboration with Canadian Advertising Preclearance Agencies and will provide additional detail and examples with respect to what is considered to be appealing to young people in the context of advertising or promoting NRTs.

To note, “advertising or otherwise promoting” in respect of the two requirements above does not include by means of an NRT’s label or package, as similar policy objectives in relation to NRTs’ labels and packages are achieved through the Order’s labelling rules and Health Canada’s pre-market assessment of label and package mock-ups.

Intended use and warning statements conveyed in advertisements

NRT advertisements must be transparent with respect to the intended use (i.e. smoking cessation by adults 18 years or older) and the addictive nature of nicotine. For that reason, the Order also requires that any advertisement for an NRT must convey one of the following statements with respect to its intended use:

• “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 addition, any advertisement for an NRT must also convey the following warning that relates to the addictive nature of nicotine:

• “WARNING: This product contains nicotine. Nicotine is highly addictive.”

Further, these required statements and warnings must be in the same language as the advertisement, whether English or French, or, in the case of an advertisement in both official languages, both English and French. The Order also contains requirements concerning how these intended use and warning statements must be conveyed in visual advertisements, audio advertisements, and advertisements that have both audio and visual elements. For example, in visual advertisements, the intended use and warning statements must be clearly and prominently displayed and readily discernible to a purchaser or consumer. Guidance will provide details on how to ensure the intended use and warning statements are clearly conveyed in all forms of advertising.

To note, “advertisements” in respect of these requirements also does not include by means of an NRT’s label or package.

Flavours — including on its label or package

Similar to the sale and manufacturing-related prohibitions regarding NRT flavours, the Order also prohibits a person from advertising an NRT, including on its label or package, in a manner that could cause a purchaser or consumer to believe that the NRT contains a flavour that a person is prohibited from manufacturing or selling under this Order.

In addition, the Order prohibits the advertising of a flavour name, including on its label or package, that does not reasonably convey the product’s actual flavour. For NRT dosage forms that are not set out in the List, the Order further limits the advertising of such flavours, including on the product’s label or package, to the names “mint” or “menthol,” or a combination of “mint” and “menthol”. Flavour names for all NRTs subject to the Order are also required to be displayed without any other descriptive or qualifying words preceding or following the names. For example, the Order would prohibit “cool mint” and “fresh berry.” Guidance will provide further detail and examples of what the Department considers descriptive or qualifying words concerning flavour names and graphic design element considerations or illustrations.

Unlike the other advertising and promotion requirements that do not include advertising by means of the package or label of the NRT, these advertising requirements with respect to flavours also apply to the NRT’s package and label.

The Natural Health Products Regulations and Enforcement Powers

A person conducting a regulated activity in respect of an NRT must comply with both the Order and the Natural Health Products Regulations, including as modified by the Order.

The Order also ensures that the Minister may suspend a product licence and/or a site licence where the Minister has reasonable grounds to believe that a licence holder has contravened the Order, and may direct a stop sale where the Minister has reasonable grounds to believe that a product is not packaged or labelled in accordance with the Order.

Coming into Force and Transition

This Order comes into force on the day on which it is published in the Canada Gazette, Part II.

The following requirements must be complied with as soon as the Order comes into force:

• Place of sale restrictions: Following the coming into force of the Order, NRTs in dosage forms not on the List must not be sold on a retail basis except by a pharmacist or an individual working under the supervision of a pharmacist. In addition, these NRTs must not be accessible to the public for self-selection.
• Brand name restrictions: Following the coming into force of the Order, NRTs must not be sold if the brand name may mislead purchasers or consumers about its intended use, may be appealing to — or be associated with — young people, or be mistaken for a cannabis or food product.
• Flavour restrictions: Following the coming into force of the Order, NRTs must not be manufactured or sold unless they are compliant with the flavour restrictions set out in the Order.
• Label and package mock-up requirements: Following the coming into force of the Order, mock-ups of labels and packages must be submitted for all new NRT product licence applications and amendment applications, including those arising from a change to an NRT’s brand name or non-medicinal ingredient affecting its flavour. For NRT product licence applications and amendment applications submitted prior to the Order’s coming into force, but for which a product licence or amended product licence has not yet been issued, the applicant must submit mock-ups before the Minister may issue or amend a licence.

Beyond the requirements immediately above, the Order provides a six-month transition period for persons, including NRT companies and licence holders, during which they do not have to comply with the Order’s other requirements that relate to packaging and labelling and the prohibitions on advertising or otherwise promoting an NRT for a use other than smoking cessation, and advertising or otherwise promoting an NRT where the advertisement or promotion could be appealing to young persons. This transition period will also apply in respect of persons’ compliance with the other advertising and promotion requirements set out in the Order, including those related to indications and illustrations of flavours, flavour names, and intended use and warning statements in advertisements. This transition period will provide companies with time to develop new advertising and other promotional materials and allow Health Canada to consult on guidance with the Advertising Preclearance Agencies.

Further, the Order allows a person to sell an NRT that is not labelled or packaged in accordance with the Order after the six-month transition period referred to above if it was labelled prior to the coming into force of the Order, or, if the NRT was imported, it was imported and labelled in accordance with the Natural Health Products Regulations prior to the coming into force of the Order. In other words, only NRTs that are in Canada and labelled prior to the coming into force of the Order fall within the scope of this transitional provision. To be clear, a person who imports an NRT in accordance with section A.01.044 of the Food and Drug Regulations, as incorporated by section 100 of the Natural Health Products Regulations, before the coming into force of the Order still has three months to ensure that the respective product label complies with the Regulations; the Department considers such products “imported and labelled in accordance with the Natural Health Products Regulations prior to the coming into force of the Order,” and within the scope of this transitional provision.

Regulatory development

Consultation

Overview of consultation activities

Consultations to support the Order began in March 2024, when Health Canada met with two academic experts to seek their views on the effects of labelling and advertising on the perception and youth appeal of NRTs. Feedback indicated that labelling and packaging affect the perception of products, and that warning statements can help to align perception with a product’s risks. They also noted some place of sale considerations, including the impact of place of sale on the perception of products and the potential benefits of limiting retail sale settings to reduce access to young people. One expert also shared information on the impacts of digital marketing and social media on a product’s appeal to youth.

Health Canada published a Notice of Intent on March 20, 2024, to signal its intent to take action to address risks associated with youth appeal and access to certain NRTs. The notice indicated the Department’s consideration of introducing new requirements and restrictions for labelling and packaging, flavours, advertising, and place of sale.

Public Opinion Research

Health Canada contracted Public Opinion Research on Youth and Young Adults Vaping Segmentation (POR # 077-23) that was completed between January and March of 2024. Though the focus of this POR was vaping and not NRTs, some questions about knowledge, use, and opinions of nicotine pouches were posed in various focus groups from different regions of Canada. In total, 95 people participated in the focus group discussions. When asked about nicotine pouches, some participants noted that they use these products for smoking cessation, but most noted mainly recreational use. When prompted to discuss certain aspects of nicotine pouches, participants mentioned that packages were colourful and visibly on display. Participants also denoted a wide availability of these products, mentioning access from a variety of stores, friends, online, or strangers. The feedback received during these sessions suggests some general uncertainty and unawareness among the participants regarding the potential risk of harms from nicotine.

Targeted consultation sessions

Health Canada held eight engagement sessions throughout June 2024, with a range of partners and stakeholders, including representatives from provincial and territorial health ministries and pharmacy regulatory authorities, health advocacy associations and healthcare practitioners, academics and researchers, industry associations and NRT manufacturers, and individuals with lived experience in smoking and smoking cessation. During each of the sessions, Health Canada explored several different potential requirements with partners and stakeholders, including requirements for place of sale, flavours, labelling and packaging, and advertising and promotion.

The various targeted consultation sessions were held on:

• June 4, 2024, with provinces and territories, pharmacy regulatory authorities, and pharmacy associations;
• June 5, 2024, with health advocacy associations and healthcare practitioners;
• June 10, 2024, with members of the Scientific Advisory Board on Vaping Products;
• June 18, 2024, with the Tobacco Control Liaison Committee and Council of Chief Medical Officers of Health;
• June 19, 2024, with industry associations and NRT manufacturers;
• June 20, 2024, with Advertising Preclearance Agencies;
• June 25, 2024, with individuals with lived experience in smoking and smoking cessation; and
• June 26, 2024, with the Canadian Pharmacists Association.

Written submissions

Health Canada received nine written submissions regarding the regulation of NRTs prior to direct engagement with stakeholder groups, including submissions from health advocacy associations, healthcare practitioners, the Council of Chief Medical Officers of Health, and industry.

Following the targeted consultation sessions, Health Canada received 27 written submissions from provinces and territories, pharmacy associations, health advocacy associations, healthcare practitioners, scientific experts, individuals with lived experience in smoking cessation, and industry (including their representative associations). Feedback was received from session participants emphasizing or expanding on points raised during the sessions, representatives who attended but did not speak during the sessions, and other individuals who did not attend a session, including member companies of associations that attended the sessions. The majority of written feedback echoed key points that were raised during the sessions. Feedback received during the sessions and in writing was considered in developing the final policy.

Summary of “What Was Heard” on key policy areas

Scope of impacted products

Health Canada sought feedback on the potential scope of products that would be impacted by new requirements, including if there were certain orally administered forms of NRTs that should be included in such measures to reduce access and appeal by young people.

Provinces and territories and pharmacy regulatory authorities were mainly concerned with new and emerging NRT dosage forms, but some suggested that the scope be kept broad to capture potential future dosage forms. The Council of Chief Medical Officers of Health recommended to include all orally administered dosage forms. However, health advocacy associations and scientific experts were supportive of applying different requirements for different dosage forms, for example having more stringent requirements for new and emerging NRTs.

Taking these views into consideration, the requirements in this Order apply to all NRTs for administration in the oral cavity, with additional requirements for new and emerging NRTs (i.e. dosage forms not on the List). The NRTs dosage forms not on the List will be subject to additional place of sale and flavour restrictions to minimize access by and appeal to young people.

Place of sale

During consultations, Health Canada requested feedback on a variety of potential place of sale restrictions, including the value and impacts of limiting sale to and within certain settings such as pharmacies. Considerations for online sales were also discussed.

While the Tobacco Control Liaison Committee and Council of Chief Medical Officers of Health were supportive of restricting sales to behind the counter in pharmacies, representatives from provinces and territories and pharmacy associations expressed concerns with the resulting increase in pharmacists’ workload. Health advocacy associations and a few pharmacists voiced support for having certain NRTs behind the counter, while keeping traditional NRTs (e.g. nicotine gums and lozenges) in areas of self-selection. Scientific experts supported restricting the sale of NRTs to pharmacies, but individuals with experience in smoking cessation raised concerns that this would create barriers for adults who smoke. Feedback received from industry associations advocated against place of sale restrictions for all NRTs, suggesting they should remain accessible by adults who smoke in places where cigarettes are sold.

In terms of online sales, some health advocacy associations opposed online sales of NRTs, while provinces and territories noted access considerations for remote and rural communities who rely on online sales. Scientific experts and individuals with experience in smoking cessation also expressed support for online sales to help maintain access.

Taking these views into consideration, the Department is restricting the place of sale of NRTs that have a limited history of appropriate use in Canada (i.e. new and emerging dosage forms) to behind the counter in pharmacies, to help minimize direct access of these products by young people. Although adults will also experience reduced access to these products, the overall impact is expected to be minimal. Products in this category represent only a small portion of the NRT market, with only four products currently licensed. As many NRTs will remain widely available in a variety of retail settings, including online, it is expected that adults trying to quit smoking will continue to have adequate access to NRTs.

Age restriction and verification

During consultations, Health Canada explored restricting the sale of NRTs to those aged 18 years and over and requiring age verification to prevent direct access to NRTs by young people. Through verbal and written feedback, a few stakeholders expressed support for age restriction and verification, including the Tobacco Control Liaison Committee, individuals with experience in smoking cessation, and some health advocacy associations; however, other health advocacy associations indicated that age restriction/verification may not be very effective due to its history of limited success in preventing young people from accessing age-restricted products. In addition, scientific experts emphasized the significant challenges that would likely arise in enforcing this measure given the range of retail outlets selling NRTs.

Given these comments and considerations, the Department is not establishing explicit age restriction or age verification requirements for NRTs. NRT dosage forms not on the List will only be available to purchase from a pharmacist or someone under their supervision (e.g. from behind the counter), who would ensure that the product is appropriate for the consumer (i.e. adults trying to quit smoking).

Flavours

Health Canada consulted broadly on flavour restrictions and sought feedback on a variety of topics, including the effectiveness of different flavour restrictions on appeal to young people, the potential impact of flavour restrictions on adults who smoke, and the additional value of introducing standardized flavour names.

Overall, many partners and stakeholders were supportive of restricting certain flavours that may be appealing to young people, including provinces and territories, health advocacy associations, healthcare practitioners, and scientific experts. However, there were varied opinions on the extent of flavour restrictions needed; some stakeholders demonstrated support for mint and menthol flavours only, while some stakeholders were in favour of restricting all flavours. Several other partners and stakeholders, including provinces and territories, health advocacy associations, and individuals with experience in smoking cessation, advocated that flavour options are needed for adults trying to quit smoking. There was also broad support for standardizing flavour names.

Taking these views into account, the Department is continuing to allow a variety of flavours for NRTs in dosage forms that will be on the List, to ensure that adults have flavour options to support smoking cessation. However, flavours that are particularly appealing to young people (dessert, confectionery, soft drink or energy drink flavours) will be prohibited, as will the use of descriptors and qualifiers as part of the flavour name on the label, and the use of a flavour name that is not representative of the actual flavour. Moreover, NRT dosage forms that do not have a history of appropriate use, which are not on the List, will be limited to mint/menthol flavour to help reduce appeal to young people, while still providing adults with a flavour option.

Labelling and packaging

During consultation, feedback was requested on potential labelling and packaging requirements, including the effectiveness of prohibiting elements that are appealing to young people or which imply that the product is a food product, confection, or tobacco, and the effectiveness of front-of-pack labelling requirements such as an age statement (e.g. “Adults 18+”) and a warning similar to that required for vaping products (e.g. “Nicotine is highly addictive”).

Considering the broad support for requirements that labelling and packaging elements do not appeal to young people, including from scientific experts, health advocacy associations, and the Tobacco Control Liaison Committee, the Department is introducing labelling and packaging requirements.

Some health advocacy associations and scientific experts noted that a label statement such as “Adults 18+” would likely not be effective in dissuading young people from accessing these products and may inadvertently make them more appealing. Given this consideration, and that subpopulation information is already required on the label as part of the recommended conditions for use, the Department is not requiring an “Adults 18+” statement for NRTs on the principal display panel. Despite not requiring this statement, the Order does require that the intended subpopulation be clearly and prominently displayed and readily discernible on the product’s outermost label, without having to manipulate the label.

Although individuals with experience in smoking cessation expressed some hesitation concerning a health warning (e.g. “nicotine is highly addictive”) and its potential to confuse consumers and incorrectly portray NRTs as similarly harmful to cigarettes, there was general support for a front-of-pack warning among other stakeholders, including pharmacy regulatory authorities, scientific experts, healthcare practitioners, and health advocacy associations. As such, the Department is requiring a statement indicating that nicotine is highly addictive on the principal display panel of NRTs.

Advertising and promotion

Health Canada requested feedback on potential advertising and promotion restrictions, including the effectiveness of explicitly conveying the intended use and intended audience of NRTs in advertisements, including promotions, as well as the effectiveness of warning statements like those used for vaping products. There was broad support for introducing advertising restrictions for NRTs to ensure that they do not appeal to young people. Scientific experts, healthcare practitioners and health advocacy associations also noted that NRT advertisements should only convey the product as a smoking cessation aid. There were also many suggestions to limit social media marketing.

Considering the evidence and this broad support, the Order prohibits all forms of NRT advertisements, including promotions, that convey a product purpose other than smoking cessation and that do not explicitly convey the smoking cessation purpose, as well as those that appeal to young people. While individuals with experience in smoking cessation raised concerns regarding potential confusion for consumers caused by warning statements in advertisements, other stakeholders did not express concerns. As such, the Department is requiring that advertisements contain a statement regarding the intended audience and intended use of the product, as well as a health warning statement.

Advertising Preclearance Agencies indicated that the proposed NRT advertising measures could result in notable increases in requests for advertisement reviews, which in turn may lead to delays in their advertisement approvals. They also anticipated potential difficulties with industry compliance, as the onus is on industry to resubmit their advertisements for a new preclearance approval.

The Advertising Preclearance Agencies shared their potential role in supporting industry compliance with new advertising measures as well as considerations to support this compliance. A key consideration was the need for clear guidance from Health Canada to be developed first, in order to support the development of their internal guidelines. Advertising Preclearance Agencies requested early collaboration with Health Canada on its guidance development, which, among other benefits, would bring efficiencies through concurrent development of their internal guidelines, their review of officer training, and expedited implementation of their review and preclearance services.

Implementation timelines

During the session with industry representatives, Health Canada sought feedback on the feasibility of transition timelines. Industry associations and specific NRT companies shared concerns that a short transition timeline for labelling and packaging changes would lead to product waste and environmental impacts. They also noted that there should be consideration for transition timelines at both the manufacturing level and retail level.

Due to the elevated health and safety risk to young people, the Department is limiting the transition period to six months for impacted persons, including NRT licence holders and businesses, to come into compliance with the labelling, packaging, and advertising and promotion requirements. However, NRTs that do not contain prohibited flavours or brand names can continue to be sold despite not being packaged and labelled in accordance with the Order after this six-month period, provided they were labelled — or if they were imported, imported and labelled in accordance with the Natural Health Products Regulations — prior to the coming into force of the Order. To be clear, for NRTs in dosage forms that are not on the List, this sale must occur in accordance with the new place of sale rules.

Modern treaty obligations and Indigenous engagement and consultation

As required by the Cabinet Directive on the Federal Approach to Modern Treaty Implementation, an assessment of modern treaty implications was conducted. The assessment did not identify any modern treaty implications or obligations.

The Initial Assessment examined the geographical scope and subject matter of the initiative in relation to modern treaties in effect and did not identify any potential modern treaty implications. This initiative is product-specific and intended to prevent NRTs from being appealing to and used by young people and other unintended users, such as individuals who do not smoke. While health services are delivered to some modern treaty partners, such services will not be impacted by this Order.

During the development of the Order, Health Canada provided information on NRTs — including the concerns related to new and emerging products such as nicotine pouches — and the Department’s related work to Indigenous organizations, including the Assembly of First Nations, Métis National Council, Inuit Tapiriit Kanatami, the Congress of Aboriginal Peoples, the Native Women’s Association of Canada, Les Femmes Michif Otipemisiwak, Pauktuutit, the Council of Yukon First Nations, and Dene Nation.

Instrument choice

1. Regulatory amendments to the Natural Health Products Regulations

A legislative amendment to the Food and Drugs Act in 2023 extended the authorities introduced through Vanessa’s Law for therapeutic products to natural health products, including NRTs. Since that time, the Governor in Council has the authority to make regulations related to imposing terms and conditions on natural health product authorizations, including NRTs, for the purposes of managing risks to health. Terms and conditions could be applied to authorizations in a flexible and controlled manner to address the specific issues at hand (e.g. place of sale and advertising) and could be tailored to the specific product in question (e.g. nicotine pouches or other emerging products). They would allow the Department to manage uncertainties and risks and could be tailored in a case-by-case manner. Terms and conditions have already been used in relation to opioids regulated under the Food and Drug Regulations and the Department intends to make them available for use in relation to other drugs and medical devices through regulatory amendments in the future. As a regulatory amendment would be required to make the terms and conditions authority operational for natural health products, the Department also considered proposing targeted amendments to the Natural Health Products Regulations at the same time. These additional regulatory measures could address elements associated with NRTs and risks to health, such as restricting the use of certain flavours if they were found to be appealing to young persons.

This option was not pursued as it would not permit the Department to address the health and safety concerns associated with NRTs, as a class of products, in a timely and efficient manner. This option would require a regulatory amendment followed by the development of appropriate terms and conditions.

2. Amending the Tobacco and Vaping Products Act to introduce new regulations for NRTs

Innovation is taking place at a rapid pace, which is expanding the availability, appeal, and unintended use of nicotine-containing products in Canada. Legislative amendments could be considered to broaden the scope of the Tobacco and Vaping Products Act to provide the Department with the authority to impose rules to address emerging risks of new and emerging dosage forms of NRTs. This option would provide a pathway to market for nicotine products that do not make health claims relating to smoking cessation. This is the current approach for authorizing vaping products that contain nicotine. Many of the legislative and regulatory measures that were considered for NRTs already exist in the Tobacco and Vaping Products Act and their associated regulations (i.e. restrictions for advertising, sale, labelling and promotion, including certain flavours). Moreover, the Tobacco and Vaping Products Act prohibits the use of promotional activities that are appealing to young persons. However, given the time needed for more substantive legislative changes, expanding the Tobacco and Vaping Products Act to include NRTs was not pursued at this time.

3. Amending the Prescription Drug List to require that certain NRTs be sold as prescription drugs

The Food and Drug Regulations require that a drug or class of drugs listed on the Prescription Drug List be sold to the general public pursuant to a prescription. The Prescription Drug List includes a listing for nicotine and its salts. However, the nicotine listing contains qualifiers that except certain dosage forms (e.g. gums, lozenges, other orally administered products) that contain or deliver 4 mg or less of nicotine per dose from prescription status.

The Department considered amending the Prescription Drug List to remove exceptions in respect of dosage forms that do not have a history of appropriate use for smoking cessation by adults, such as nicotine pouches. This approach would then have required such NRTs to be sold pursuant to a prescription. In other words, a person would have to have obtained a prescription from a health care practitioner to be able to access such NRTs.

This approach would have effectively restricted access to these NRTs by young people (unless prescribed to them by a health care practitioner); however, it would also unreasonably restrict access by the intended users (i.e. adults who wish to quit smoking). In addition, further regulatory changes would be required to manage other risks associated with these products, such as advertising and labelling.

Due to these limitations, this option was not pursued in favour of an option that would allow for a more timely and targeted approach. This latter option, as expressed in the Order, balances the need to maintain appropriate access to NRTs to support smoking cessation in the intended patient population (i.e. adults trying to quit smoking), while addressing specific risks of NRT access by and appeal to youth (i.e. packaging/labelling, advertising/promotion and flavours).

4. Status quo — Encourage provincial and territorial governments to take further measures as necessary and work with licence holders to reduce the appeal of NRTs to young people through voluntary measures.

Health Canada worked closely with provincial and territorial counterparts to explore potential complementary measures, particularly in light of steps that have already been taken in British Columbia and in some pharmacies in Quebec, where certain NRTs such as nicotine pouches are now sold behind the counter in pharmacies to reduce access by young people. While these measures protect young people from health and safety risks in these provinces, the unintended use of NRTs, including by young people, is a nationwide issue that impacts all provinces and territories. This option does not achieve the objective of effectively reducing the risks of access to, appeal of, and unintended use of these NRT products by young people in Canada as a whole.

Health Canada worked with licence holders of certain NRTs to revise labels and advertisements for the purposes of reducing their appeal to young people and to better communicate the health and safety risks of these products. As these discussions took place with individual licence holders as concerns arose, this option was not recommended as it would lead to inconsistency in labelling and advertising for NRTs. Furthermore, this option would not provide a level playing field for current NRT licence holders, and it would not provide transparent and consistent expectations for new NRT applicants regarding product licences in Canada.

In the absence of further legislative or regulatory amendments, the Minister of Health has the authority to order the holder of a product licence to recall the product or to change the product’s label or package. However, these authorities may not allow the Minister to effectively prevent or mitigate emerging risks relating to the unintended use of NRTs, including by young people.

5. Recommended option — Establish supplementary rules for certain NRTs through a ministerial order

The supplementary rules authority, under section 30.01 of the Food and Drugs Act, provides the Minister of Health with the ability to impose additional rules by means of a ministerial order. This authority enables precise, tailored regulatory rules to address potential harms from therapeutic products in respect of uses other than those authorized. The authority also clarifies that the Minister may establish such rules for the purpose of preventing the promotion of a therapeutic product for uses other than its intended use, or for preventing the appeal of the product’s unintended use.

In addition, unlike the interim order authority that exists under the Food and Drugs Act, the supplementary measures ministerial order authority is not time-limited, and it may be used to make broader, tailored regulatory requirements for therapeutic products, provided such requirements are for the purposes of managing risks associated with the unintended use of the products. In addition, this authority permits the Minister to make an order to address emerging risks where there may be uncertainty respecting the risks to health that the unintended use of the therapeutic product may present.

For the purposes of the NRTs subject to this Order, this authority provides the ability to better manage the emerging risks associated with the access to, appeal of, and use of these products by young people and those who are using them for purposes other than smoking cessation, while balancing the need to maintain reasonable access to these products by adults trying to quit smoking.

Regulatory analysis

Benefits and costs

This section provides a description of the potential impacts of the Order on industry stakeholders involved in the manufacturing, importation and/or retailing of NRTs in Canada; consumers of these products; and Health Canada. All costs and benefits in this section are estimated in 2024 dollars over a 10-year policy period (from 2024 to 2033) and discounted at a rate of 7% as recommended by the Treasury Board Secretary of Canada. The full cost-benefit analysis report is available upon request.

Sector profile of NRT products

The global market of nicotine replacement therapy products

Compared to the other health product sectors, the NRT sector does not have a long-established history. The sector exists due to increasing awareness by smokers of the importance of quitting smoking for health reasons. Despite the availability of numerous market intelligence reports in open sources, the data reported varies widely. For example, the reported global sector revenue ranges from $3 billion^{footnote 47} to $29 billion^{footnote 48} (USD) between 2022 and 2024; and the compound annual growth rate reported by different agencies varies between 4.8%^{footnote 49} and 10.2%,^{footnote 50} although consultations with industry stakeholders provided a lower growth rate for the sector development in Canada. However, market research reports consistently indicated that North America is the largest market for these products, ranging between 35.7% and 48%, with more than half the market share comprised of nicotine gum.

Industry players of NRT products in Canada

Health Canada has issued 89 NRT product licences between 1992 and 2023.^{footnote 51} Among the licensed NRTs, 19 (approximately 21%) are transdermal patches, which are out of the scope of this Order. It is assumed in this analysis that the Order impacts 67 NRT product licences (each with an identifiable number, also known as Natural Product Number or NPN), held by 17 companies. However, internal analysis by Health Canada suggests that approximately 39 of these 67 NRT product licenses are active on the Canadian market.^{footnote 52}

Product Type	Number of products authorized (in %)	Estimated number of products in the market (in %)	Estimated maximum number of SKUs table b1 note *
lozenge	29 (43%)	16 (41%)	231 (43%)
gum	22 (33%)	14 (36%)	195 (36%)
spray/mist/inhaler	12 (18%)	6 (15%)	95 (18%)
pouch/tablet	4 (6%)	3 (8%)	21 (4%)
Total	67 (100%)	39 (100%)	542 (100%)
Table b1 note(s) Table b1 note * SKU denotes stock keeping unit Return to table b1 note * referrer

Distributions of NRT suppliers in Canada

Three quarters of the 67 licensed products are owned by Canadian enterprises, while 13% are owned by American enterprises, and 9% and 2% are owned by European Union and Indian enterprises, respectively. Based on information available from open access sources, almost 60% of the NRT product licence holders in Canada are medium or large enterprises, with only 29% believed to be small businesses.^{footnote 53}

Retail outlets in Canada

Consumers of NRTs in Canada can purchase these products through different retail channels. It has been reported that brick-and-mortar sales dominate the market segment in Canada.^{footnote 54} However, it has also been reported that transactions of NRTs via online retail channels will grow at a faster rate than those via storefronts in the coming years.^{footnote 50} Licensed NRTs sold offline (i.e. in person) occur in large retailers (mass merchandisers), pharmacies, convenience stores, and retail kiosks located in gas stations across Canada. However, the distribution of NRTs available for sale in these different retail outlets across the country varies greatly. Among 7 611 convenience retailers and pharmacies in Canada^{footnote 55} (excluding British Columbia and Quebec),^{footnote 56} one branded NRT was available in over 7 000 stores (convenience stores and pharmacies), while another product was available in less than 2 300 stores, as indicated by the locator maps for these products (accessed on June 6, 2024). Such data suggests that the distribution networks of NRTs in Canada varies greatly.

It was also reported that unauthorized NRTs are being sold on the Canadian market. This was highlighted during consultations with industry stakeholders, who said that there are both legal and illegal NRTs being used by Canadians available on both domestic and international websites.^{footnote 57}

Consumers of NRT products in Canada

The entire consumer profile for NRTs in Canada is not known, given possible recreational use.^{footnote 58} The 2022 Canadian Tobacco and Nicotine Survey^{footnote 1} revealed that 6.14% of nicotine users in Canada were 15 to 19 years old (0.32 million out of 5.22 million).^{footnote 59} The survey findings also indicated that 375 000 (26.3%) smokers used NRT products as a smoking cessation aid (whether successfully or not). NRT products are licensed with the specific recommended use or purpose of smoking cessation by adults; however, there is a growing concern that some NRTs are being purchased by, or purchased for, young people for recreational use.^{footnote 60} In such cases, these products would be used outside of the recommended use or purpose for which they are licensed by Health Canada.

Baseline scenario

Under the Baseline scenario for this analysis, NRTs on the Canadian market are sold over the counter and are available in retail outlets such as convenience stores and pharmacies in addition to online sales on domestic and international websites.^{footnote 61} All NRTs lawfully on the market are licensed under the Natural Health Products Regulations and there is no requirement to submit mock-ups of labels and packages as part of a product licence application. There are also no restrictions on the manufacturing or selling of NRTs that contain certain flavours, the use of descriptive terms that could be appealing to young people, or the use of flavour names to promote product sales. There are limited restrictions on brand names, labelling and packaging elements, and advertising elements that could be appealing to young people, in respect of both digital advertising and printed materials.

One NRT product licence can be used to market the respective product under multiple brand names in Canada. As of March 31, 2024, there are 39 product licences (or NPNs) for NRTs, which are actively sold on the Canadian market under various brand names, that are assumed to be within the scope of the Order.^{footnote 62} These licences could result in up to 542 SKUs being available for sale on the Canadian market.^{footnote 63}

Policy scenario

The policy scenario prohibits direct public access to dosage forms of NRTs that are not on the List, such as nicotine pouches and rapid disintegration tablets by requiring that they be sold by a pharmacist or someone under their supervision. In physical stores, these products will be kept behind the pharmacist’s counter. For online sales, a pharmacist or person working under their supervision must intervene prior to a purchase. Licence holders of NRTs in dosage forms not on the List can no longer sell them in non-pharmacy retail outlets such as convenience stores. This place of sale restriction comes into force immediately upon the publication of the Order.

Applications for new or amended NRT product licences must contain mock-ups of the labels and packages associated with the NRT to ensure such products comply with the new requirements for brand names, flavour names, and labelling and packaging. In addition, NRT licence holders making post-market changes to a brand name or non-medicinal ingredient affecting flavour are required to submit an application to amend their product licence instead of a notifying Health Canada.

It is prohibited to manufacture or sell an NRT that is in a dosage form that is not on the List, if it contains a flavour other than mint, menthol, or a combination of mint and menthol; and for products in a dosage form on the List, the Order prohibits dessert, confectionary, soft drink, and energy drink flavours. This restriction comes into force immediately upon publication of the Order. In addition, it is prohibited to advertise an NRT in a manner, including by means of its package or label, that could cause a person to believe that the NRT contains a prohibited flavour. Flavour names associated with NRTs must also reasonably convey the NRT’s flavour and not be preceded or followed by any descriptive or qualifying words. These restrictions that impact the NRT’s advertising, including the package and label, have a six-month transition period.

It is prohibited for an NRT’s brand name to be appealing to, or associated with, young people, or to mislead the consumer about the NRT’s intended use. Further, the NRT’s packaging and labelling graphic design elements and statements must not be appealing to young people. In addition, the Order requires that warning and intended use statements are included on the label. These requirements that impact the packaging and labelling of NRTs have a six-month transition period.

In addition, the Order requires that any advertisement for an NRT must include a warning and an intended use statement. The Order further prohibits advertising or otherwise promoting an NRT for a use that is not its intended use, or in a manner that may appeal to young people. These requirements, which impact the advertising of NRTs, have a six-month transition period.

To Health Canada’s knowledge, not all brand names are being actively sold on the market. It is assumed in this cost-benefit analysis that all 542 SKUs exist in the market to account for the most inclusive estimate of the impact to the industry due to this Order.

Costs

Cost impacts due to the Order are organized by stakeholder group and each quantification of cost is estimated based on assumption(s) made using information gathered from a review of available literature.

Cost to businesses

It is assumed that businesses involved in the NRT supply chain (including manufacturers, importers, and retailers; and referred to collectively as “suppliers” in this section) will be impacted by the Order’s requirements. The Order will result in incremental compliance costs concerning (i) labelling and packaging; (ii) the submission of mock-up labels; (iii) the reformulation of non-mint and non-menthol NRTs in a dosage form not on the List; (iv) changes in the place of sale for existing NRTs in a dosage form not on the List; and (v) pharmacists’ time due to place of sale restrictions for NRTs in a dosage form not on the List.

As almost all compliance costs have been estimated based on the unit cost of a SKU. This analysis also estimates compliance costs using the highest possible number of SKUs of 542. As mentioned in the Baseline scenario, this total number of SKUs is estimated using the number of product licences and authorized brand names in respect of each licence that are being actively sold (as listed by product categories in the table in the Sector profile section and described in footnote 58).

It is believed that the NRT market in Canada is highly competitive. Therefore, Health Canada does not anticipate that the Order will cause any product discontinuation.^{footnote 64} For example, in cases where NRTs containing certain flavours will no longer be permitted (i.e. NRTs in dosage forms not on the List containing prohibited flavours, it is assumed that NRT manufacturers will maintain products containing permitted flavours and develop new NRTs containing permitted flavours (i.e. reformulate). It is also assumed in this analysis that the compound annual growth rate of the NRT sector will be 4% in the policy period (2024–2033).

(i) Labelling and packaging

Certain requirements of the Order will require businesses to redesign their product labels to comply with the Order. These requirements include (i) the nicotine warning statement on the product label, (ii) a statement to ensure the intended subpopulation (i.e. adults) is clearly discernable on the label under the customary conditions of purchase, without having to manipulate the label, (iii) flavour name restrictions concerning the product label (i.e. flavour names must reasonably convey the product’s flavour, and flavour names cannot include descriptive or qualifying words), and (iv) restrictions on graphic design elements or statements that may appeal to young people.

With only a six-month transition period, it is assumed that NRT licence holders would incur a higher than usual product labelling or packaging redesign cost. As stated in the Regulations Amending the Food and Drug Regulations (Nutrition Symbols, Other Labelling Provisions, Vitamin D and Hydrogenated Fats or Oils),^{footnote 65} the costs to conduct a label change with a front of package indication could range from $13,473 to $23,146 (in 2021 constant dollars).^{footnote 65} This analysis uses the upper bound of $23,146 per SKU (with 3-year transition period) and applies a multiplier^{footnote 66} of three to account for a shorter than one-year transition period for licence holders to fully comply with the new requirements.^{footnote 67} Therefore, this analysis assumes the compliance cost to redesign and relabel the principal display panel equates to $79,486 per SKU when providing a six-month transition period. Using $79,486 per SKU for redesigning the product label or packaging of 542 SKUs, the compliance cost is estimated at $43.1 million, present value, for NRTs currently on the market. It is assumed that new products that will enter the Canadian market after this Order comes into force will fully comply with the labelling and packaging requirements in the Order.

(ii) Mock-ups of labels and packages

The Order requires all new NRT applicants to submit product mock-ups of labels and packages to Health Canada for all new NRT product licence applications, as well as amendment applications. Assuming the NRT sector will have a compound annual growth rate of 4%, the average cost to submit mock-ups is $20,000 per SKU (in current dollars), and 13 SKUs^{footnote 68} of existing product licences will be amended, in addition to all future new NRT submissions, the total incremental cost to comply with the mock-up requirement is estimated at $3.5 million, present value, over the 10-year policy period.

(iii) Cost to reformulate non-mint or non-menthol NRTs

The Order only prohibits NRTs in dosage forms not on the List from being sold or manufactured if they contain a flavour other than mint, menthol, or a combination of mint and menthol. Licence holders of NRTs in dosage forms not on the List, and future applicants, must ensure their products’ formulations comply with this new requirement. As mint, menthol, and the combination of these two flavors are the most used by NRT product suppliers, and as Health Canada does not anticipate any product discontinuation, it is assumed in this analysis that only 50% of pouches^{footnote 69} and 60% of rapid disintegration tablets^{footnote 70} (a total of 13 SKUs) of the existing NRTs will need to be reformulated to comply with this requirement. Although a product reformulation cost could range from tens to hundreds of thousands of dollars, any reformulation to comply with the Order would only involve flavours, which are considered non-medicinal ingredients, which is assumed to be a lower cost change. Therefore, this analysis uses the product reformulation cost of $88,673 (or $75,000 in 2019 constant dollars) per SKU for pouches, and $56,157 (or $47,500 in 2019 constant dollars) per SKU for rapid disintegration tablets, as used in the estimation of costs to reformulate flavours in vaping products.^{footnote 71} Assuming that this reformulation cost (at $88,673 per SKU) will also apply to 60% of NRT dosage forms not on the List that plan to enter the Canadian market in next three years (which were formulated using non-mint or non-menthol flavours and will require reformulation), the estimated cost due to reformulation of product ingredients and flavors is $4.0 million, present value. If these NRTs suppliers are already supplying NRTs in mint and menthol flavours, they may choose to discontinue their licences associated with prohibited flavours or they may reformulate such products with permissible flavours.

(iv) Place of sale for dosage forms of NRTs without a history of appropriate use

The Order requires that NRT dosage forms that are not on the List be inaccessible for self-selection by consumers and that they may only be sold by a pharmacist or a person working under their supervision, immediately upon the coming into force of the Order. Licence holders of these NRTs may incur a delisting cost in some retail outlets (such as convenience stores)^{footnote 72} to comply with this requirement. A delisting fee represents compensation for losses incurred by retailers when suppliers clear stocks of a product on the shelf. On average, the listing cost is $1,500 per store per SKU.^{footnote 73} It is assumed in this analysis that the delisting cost is equal to this listing cost. It is also assumed in this analysis that if a product is moved from the self-selection area to behind the counter in the same pharmacy, this fee does not apply. The locator map (accessed on June 6, 2024) of a large enterprise supplying nicotine pouches to the Canadian market indicates that there are over 7 000 stores selling the enterprise’s products. Considering that some stores will no longer hold stock, it is assumed that 4 251 stores^{footnote 74} will not be permitted to sell the pouches that they have on hand when this Order comes into force.

Conversely, the locator map of a small enterprise supplying rapid disintegration nicotine tablets (accessed on June 6, 2024) shows that, the product is sold in less than 10% of the convenience stores and pharmacies in Canada.^{footnote 75} Consultation with industry stakeholders also revealed that more than 90% of sales of NRTs occur in pharmacies or retail outlets (such as grocery stores) with pharmacies.^{footnote 69} It is assumed in this analysis that all 16 SKUs of nicotine rapid disintegration tablets are sold in up to 10% of retail outlets (which equates to 469 stores).^{footnote 76} By requiring NRTs in dosage forms not on the List to be sold behind the counter, suppliers of these NRTs may incur delisting fees up to $40.3 million, present value.

Licence holders of NRTs in dosage forms that are not on the List and which, prior to the coming into force of the Order, were sold in non-pharmacy retail outlets, are required to move their products to pharmacies upon the Order’s coming into force, to continue to sell such products. It is assumed that there are eight SKUs of NRTs in dosage forms not on the List that could be sold behind the counter in pharmacies until their expiration.

It is assumed there is a total of 13 SKUs of non-mint and non-menthol NRTs in dosage forms that are not on the List, which are no longer permitted to be sold on the Canadian market after the Order comes into force. The unsold units of these NRTs are assumed to be destroyed immediately. Assuming the loss of unsold units by retailers are covered by delisting fees applicable for non-pharmacy retail outlets, and on average, that each retail outlet will require an employee to be paid at a minimum wage rate (at $17.30) to spend an hour to clear these NRTs from the shelves, this requirement will result in total costs due to additional wages of $81,656.

(v) Extra time required by pharmacists to confirm the suitability of NRTs

Requiring a pharmacist or person working under their supervision to oversee the sale of NRTs in dosage forms not on the List will also result in incremental costs to pharmacists or, for example, pharmacy technicians. The pharmacist may also advise or answer questions related to the use of these NRTs. In general, pharmacists would follow a standard practice of confirming information on allergies, current use of prescribed medications, etc., before advising a purchaser on an appropriate NRT and potential side effects of the NRT, and/or creating a personal record of the purchaser in their IT systems prior to selling NRT by prescription. On average, assuming that these NRTs will be kept behind the counter for two years, that it will take a pharmacist 30 seconds to hand over a product to a customer by request, and that it will take a pharmacist up to five minutes to advise or to answer questions by these product users, while assuming that only 1.7%^{footnote 77} of the NRT units will be sold to consumers where pharmacist oversight is required, the estimated incremental cost equals $1.7 million, present value, over the 10-year policy period.^{footnote 78,footnote 79,footnote 80}

(vi) Other costs

There are other costs not monetized in this analysis. For example, the new requirements for advertising and promotion are expected to create wastage from materials that are no longer needed or that may need to be changed before the next planned promotional campaign. While the Order provides industry with a six-month transition period to comply with new requirements regarding advertising and promotion, if this period does not overlap with the usual business cycle for industry stakeholders to produce new advertising or promotional materials, some NRT suppliers may incur incremental costs to comply with these new requirements, to produce compliant advertising materials on a more advanced timeline. Advertising businesses may experience losses due to the new prohibitions imposed by the Order, such as a loss of transactions in advertisements or other promotional activities, or a loss of profit to be generated from events. On the other hand, some NRT suppliers may be required to generate new promotion or advertising materials sooner than their usual business cycle. This may result in an incremental cost to NRT suppliers, but which may increase sales and profits of advertising firms for work that would otherwise happen later (i.e. in the next business cycle).

Retail outlets, other than pharmacies, will also be affected by the requirement that NRTs in dosage forms not on the List, such as nicotine pouches and rapid disintegration nicotine tablets, are not accessible for self-selection by consumers and may only be sold under the supervision of a pharmacist or person working under their supervision. This requirement will result in a loss in sales in respect of these NRTs at convenience stores. However, this loss in sales may be mitigated by sales of other NRT products to some extent, or by sales of these affected NRTs from pharmacies (rather than convenience stores), or by sales in the tobacco or vaping sector if smokers stop attempting to quit smoking. Another possible outcome is a shift in NRT sales from retail outlets to legal and/or illegal online NRT vendors.

In summary, the total quantified cost for the NRT industry sector, pharmacies, and retail outlets to comply with the Order is estimated at $92.66 million, present value, over the 10-year policy period. This total cost includes costs related to the labelling and packaging, the reformulation of flavours, the submission of label and package mock-ups, the delisting fees, and the extra effort required by pharmacists before selling NRTs behind-the-counter.

Cost to consumers

The NRT market in Canada is highly competitive; therefore, it is assumed that new requirements imposed by the Order will not create significant inconvenience to users of NRTs who intend to use them for smoking cessation. Due to the competitiveness, it is also assumed that the Order will not result in the discontinuation of existing products. It is further assumed that NRT suppliers will not transfer any costs to consumers if they choose to maintain the competitiveness of their products in the market. The Order may not affect the anticipated sector growth of NRTs in Canada, but it may change the market share for NRTs in dosage forms not on the List that will be subject to the more stringent place of sale and flavour rules. However, due to the short transition period provided by this Order, these affected NRT suppliers may encounter supply chain bottlenecks with third party graphic designers, labellers, and packagers, in particular, because Health Canada has also recently published regulations that contain labelling and packaging measures that impact other health products such as foods, biocides, and natural health products. This may lead to short-term supply challenges for NRTs on the Canadian market. Another potential consequence could be growth in the use of unlicensed NRTs among current users if they are not able to purchase their preferred licensed brand of NRT.

A limited subset of consumers who use nicotine pouches or rapid disintegration tablets as their preferred NRT are expected to experience some inconvenience as these NRTs, which were previously available in many convenience stores (outside of British Columbia and Quebec) and pharmacies across Canada, will now only be able to be sold under the supervision of a pharmacist or person working under their supervision. This new requirement is anticipated to reduce access by these consumers, particularly those located in remote areas which may, in some cases, negatively affect these specific consumers’ attempts to stop smoking using these products.

Cost to provincial and territorial governments

Health Canada does not anticipate that the provincial or territorial governments will incur any costs due to the Order.

Cost to the Government of Canada

The Order will require Health Canada officials to spend more time reviewing product licence amendment applications and product licence applications, including by reviewing mock-ups of labels and packages, which is not currently required under the Natural Health Products Regulations. Assuming that it will take approximately one hour to screen an application to amend a product licence, and four hours in total to review and approve a label mock-up, and the compound annual growth rate of NRTs to be 4%, this average incremental cost is estimated to be approximately $7,517 per year, which equates to $52,795, present value, over the 10-year policy period. Health Canada will also expend incremental resources in advertising compliance assessments and monitoring impacts of NRTs with a limited history of appropriate use to be introduced to the Canadian market.

It is anticipated that Health Canada will initiate more compliance and enforcement verification cases related to NRTs. Compliance and enforcement actions to enforce the requirements of the Order are expected, and the level of effort could vary greatly depending on a number of factors including the nature of the non-compliance, risk to health, level of cooperation by the regulated party. Recent analysis of cases related to NRTs shows that few cases were initiated in 2022–2023, over 100 cases were initiated in 2023–2024, and, based on the first quarter of 2024–2025, it is estimated that there could be over 400 cases initiated. The Ministerial Order establishes additional requirements for NRTs related to place of sale, labelling and packaging, flavours, and advertising and promotion, which should increase the number of cases related to NRTs. Since the number of cases is increasing rapidly, it is difficult to determine if a future case were the result of the Ministerial Order or simply the growth in NRT cases in general.

Environmental impacts

The Order prohibits NRT labels and packages that may be appealing to young people. Due to the urgency to reduce the appeal to and unintended use of these products by young people, the Order provides a transition period of six months for NRTs to have labels and packages that comply with the new requirements (including flavour names and warning statements). However, NRTs in dosage forms not on the List which contain mint or menthol flavours, or a combination of these flavours, must be moved to pharmacies upon the coming into force of the Order, in order to be sold. NRTs in dosage forms that are not on the List and contain prohibited flavours will no longer be permitted to be sold on the Canadian market upon the coming into force of the Order. This could lead to unavoidable wastage of unsold products that need to be removed from the shelves. Health Canada anticipates there will be up to 21 SKUs of NRTs that will not be permitted to be sold via self-selection when the Order comes into force. Of the 21 SKUs of NRTs, it is anticipated that eight SKUs would be in mint or menthol flavours, which could be sold in pharmacies, while the other 13 SKUs will need to be removed from the shelves of all retail outlets in Canada, which may be redirected to international markets that permit the sales of these products or they may be destroyed.

In this analysis, it is assumed that the financial loss of unsold units of the affected NRTs would be covered by the delisting fees applicable to non-pharmacy retail outlets, which would be paid by product suppliers. Suppliers of NRTs will need to either transfer all affected non-mint or non-menthol NRTs in dosage forms not on the List to international markets to minimize loss or to destroy all these products, whichever option is more cost effective. This analysis assumes that the proxy of the logistic cost to redirect the products to other international markets outside Canada is equal to the environmental impact, if these products are destroyed. In this analysis, the environmental impact only estimates the equivalents of packaging materials, assuming to be cardboard, used in these SKUs, excluding the environmental impact due to the destruction of the NRTs. The environmental impacts due to the destruction of the 13 SKUs of NRTs of non-mint and non-menthol NRTs in dosage forms not on the List that are no longer permitted to be sold on the Canadian market is estimated at 3 219 tons of CO₂ equivalent, which equates to $257,504, present value.^{footnote 81}

Benefits

This section provides a qualitative description of potential benefits of the Order.

Qualitative impacts

Positive impacts on health of young people

Young people who use or are likely to start using NRTs recreationally will be the population that benefits most from the Order. As a result of the Order, it will be less likely that young people are exposed to advertising or other promotional activities that may feature these products for uses other than smoking cessation and in ways that appeal to young people, and therefore they are expected to be less likely to use these products recreationally, which will protect their health. However, these benefits only arise from restrictions to advertising in domestic media such as domestic printed newspapers or magazines, and domestic digital media. Young people may still be exposed to NRT advertising through non-domestic media that would otherwise not comply with the Order, both in digital and printed forms.

The Order also requires that NRTs in dosage forms not on the List, including pouches and rapid disintegration tablets, only be sold by pharmacists or those working under their supervision, and that such products are not accessible for self-selection, which will reduce the accessibility of these products by young people. The restrictions imposed on the use of flavours other than mint, menthol, or the combinations of these flavours for NRTs in dosage forms not on the List may reduce the attractiveness of these NRTs to young people, thereby reducing the likelihood of recreational use by this population.

In addition, NRT use has many known physiological impacts on young people. Common side effects listed on the label of orally administered NRTs on the market in Canada include mouth and tongue irritation and an increased risk of developing mouth sores or gingivitis, upset stomach, and headaches. Rare side effects include severe nausea and vomiting, difficulty breathing, dizziness, chest pain and heart palpitations.

Research has also found that nicotine use by young people may change how their brains develop, leading to problems with memory and concentration, impulse control, and behaviour.^{footnote 15,footnote 16} Early exposure to nicotine may lead to mood disorders,^{footnote 17} worsen symptoms of anxiety and depression,^{footnote 18,footnote 19} or cause learning problems.^{footnote 20} The Order is expected to minimize the likelihood that non-smoking young people are exposed to NRTs, thereby reducing their risk of harm associated with the use of products containing nicotine.

Positive impacts on healthcare systems

Nicotine is known to be a highly addictive substance. The use of NRTs recreationally by young people may lead to addiction to nicotine at an early age. The potential health and social impacts may lead to indirect demand on the healthcare system. Therefore, the new requirements in this Order are expected to help reduce demand in the healthcare system associated with addiction to nicotine among young people. It will also reduce resources that may be required to address challenges faced by adults caused by early exposure to nicotine and nicotine dependence.

Cost-benefit statement

• Number of years: 10 (2024 to 2033)
• Price year: 2024
• Present value base year: 2024
• Discount rate: 7%
• All values are in million Canadian dollars.

Monetized costs

Impacted stakeholder	Description of cost	Base year	Other relevant years	Final year	Total (present value)	Annualized value
Government	Review and approval of label and package mock-ups, and licence amendment applications	$0.009	$0.053	$0.009	$0.053	$0.008
NRT suppliers	Compliance costs including labelling/ packaging, mock-up labels, point of sale, reformulation of flavours	$44.25	$50.72	$0.60	$90.97	$12.95
Environmental impacts	Destruction/ disposal of non-mint and non-menthol NRTs	$0.26	$0.00	$0.00	$0.26	$0.037
Pharmacies	Provide advice and counselling to young people using NRTs with prescription	$0.10	$1.93	$0.29	$1.68	$0.24
All stakeholders	Total costs	$44.62	$52.70	$0.90	$92.97	$13.24

Summary of monetized benefits and costs

Impact	Base year	Other relevant years	Final year	Total (present value)	Annualized value
Total benefits	$-	$-	$-	$-	$-
Total costs	$44.62	$52.70	$0.90	$92.97	$13.24
Net impact	- $44.62	- $52.70	- $0.90	- $92.97	- $13.24

Qualitative impacts

Positive impacts

• Young people who are at risk of using NRTs recreationally will be the population that benefits most from the Order. As a result of the Order, it will be less likely that young people are exposed to advertising or other promotional activities that may feature these products for uses other than smoking cessation and in ways that appeal to them.

Negative impacts

• Retail outlets such as convenience stores will lose some sales revenue and profit due to the Order as certain NRTs will be removed from their shelves.
• Consumers using dosage forms of NRTs that are not on the List may need to find an alternate source to buy NRTs, which they could previously purchase in their own neighbourhood in the Baseline scenario.
• The Order places additional requirements on pharmacists and persons supervised by them to manage the sales of NRTs at pharmacy outlets, which may take away time from those individuals’ other priorities.

Small business lens

The small business lens applies as there are small businesses that are subject to the requirements of the Order. Among the licence holders that have indicated they are currently supplying NRTs to Canadian retail outlets, more than half are large businesses collectively supplying more than 71% of brand names on the Canadian market. It is assumed that these suppliers have the capacity to comply with the requirements of the Order. The six small businesses that have NRT product licences supply almost 29% of NRT brand names in Canada. One was incorporated in Canada in 2022, that supplies rapid disintegration tablets on the Canadian market, while the other five licence holders supply other dosage forms of NRT products on the Canadian market, namely nicotine gums, lozenges, sprays and mists. In this analysis, these small businesses will be required to replace product labels or packaging, reformulate their products to comply with flavour restrictions, submit package and label mock-ups for approval by Health Canada if they amend their product licence, and incur expenses to dispose of excess or unused product labels that are no longer in compliance with the Order.

The requirement that NRTs in dosage forms not on the List be inaccessible for self-selection by consumers and only be sold by a pharmacist or person working under their supervision will affect only one small business that is currently supplying up to 16 SKUs of rapid disintegration tablets on the Canadian market. It is assumed that customers interested in buying NRTs that are no longer available in retail settings outside of pharmacies could substitute NRT pouches and rapid disintegration tablets with NRTs in other dosage forms. It is also assumed that only limited customers will decide to travel a further distance to purchase products that are required to be sold by a pharmacist or a person working under their supervision. Most customers will either use other NRTs available in their preferred stores as substitutes, purchase the products online (legally or illegally), or stop using NRTs. Some product suppliers may be required to pay a product delisting fee to remove products from their stores. The six small businesses that supply NRTs are estimated to incur costs of $23.60 million, present value, to comply with the Order, which equates to $3.36 million, present value, per business over the 10-year policy period or $0.56 million, present value, per business per year.

Industry stakeholders indicated through consultation that more than 90% of NRTs sales in Canada happened in pharmacies and retail outlets with pharmacies, though this may not apply to all NRTs. Other small businesses affected by the Order may include independent or franchise retail outlets such as those located at gas stations, convenience stores, and other similar locations. Such small businesses selling pouches and rapid disintegration tablets will lose the business revenue generated from selling these NRTs and other new and emerging NRTs as they will no longer be permitted to carry such products in their stores after the Order comes into force.

Small pharmacies are estimated to incur costs of $49,567, present value, to advise consumers who may have questions on NRTs required to be sold by a pharmacist or a person working under their supervision, which equates to $17.42 per business, or $2.48 per year per small business.

Small business lens summary

• Number of small NRTs suppliers impacted: 6
• Number of small drug stores impacted: 2 845
• Number of years: 10
• Price year: 2024
• Present value base year: 2024
• Discount rate: 7%

Costs

Administrative or compliance	Description of cost	Present value	Annualized value
Administrative	N/A	-	-
Compliance	Small NRTs suppliers to comply with requirements of the Order including delisting fee	$23,601,499	$3,360,322
	Extra time incurred by pharmacists or technicians under their supervision to advise on appropriate choice and use of NRTs	$49,567	$7,057
Total	Total costs	$23,651,066	$3,367,380

Net impacts

Amount	Present value	Annualized value
Net impact on all NRT small businesses [Total benefits minus total costs]	- $23,601,499	- $3,360,322
Net impact on all pharmacy small businesses [Total benefits minus total costs]	- $49,567	- $7,057
Average net impact per small NRTs supplier	- $3,933,583	- $560,054
Average net impact per small pharmacy	- $17.42	- $2.48

One-for-one rule

The one-for-one rule applies, as this Order creates a new title. However, the Order will not result in any administrative burden to any NRT licence holders and businesses that supply or sell NRTs in Canada.

Sensitivity analysis

This section notes a few sensitivity tests on the compliance costs to industry if different assumptions were applied in this analysis. Assuming industry stakeholders were given a longer transition period of three years, the compliance cost to change NRT labels and packages would decrease greatly by up to $26,500. This decrease in compliance cost would reduce the labelling and packaging costs from $43.1 million, present value, to $7.2 million, present value, if assuming there are seven SKUs per marketed NPN (as opposed to all authorized brand names), that is, the Order would impact 273 SKUs of NRTs on the Canadian market. Using $79,486 per SKU to comply with the labelling and packaging requirements, this total compliance cost would decrease from $43.1 million, present value, to $21.7 million, present value.

Regulatory cooperation and alignment

Provinces and territories

Health Canada has worked closely with provincial and territorial counterparts to explore complementary measures to help limit the access and appeal to young people of certain NRTs, such as nicotine pouches. As of February 2024, British Columbia requires nicotine pouches to be sold behind the counter in pharmacies to reduce access by young people. While the sale of NRTs are restricted to pharmacies only in Quebec, some pharmacies have voluntarily moved nicotine pouches to behind the counter due to concerns raised regarding their appeal to young people.

International

Countries have diverse approaches to regulating products that contain nicotine. Some countries rely on existing tobacco control policies to regulate synthetic nicotine and generally classify synthetic nicotine contained in products, such as oral nicotine pouches, as tobacco products. These regulations focus on the plant from which nicotine was historically derived (tobacco). Other countries regulate synthetic nicotine as a drug, focusing on the chemical compound (nicotine) itself in the legislation, including Australia and Japan; both countries regulate synthetic nicotine differently from tobacco-derived nicotine.

In Australia, nicotine is regulated as a tobacco product when it is derived from the tobacco plant. This includes loose tobacco, cigarettes, and cigars. NRTs that are licensed for use in smoking cessation that are included in the Australian Register of Therapeutic Goods (such as patches, lozenges, chews and gums) do not require a prescription and are available from pharmacies and some retail outlets. All other products containing synthetic nicotine, including vaping products, are available only by prescription. No nicotine pouches have currently been approved in Australia for use in smoking cessation; however, nicotine pouches can be imported for personal use if users have a prescription from a medical professional who can assess if the product is appropriate for individual use.

As of March 2022, the U.S. regulates synthetic nicotine-containing products for recreational use as tobacco products. This approach provides additional authorities, for example, to restrict the sale of these products to persons 21 years of age or older (both in-person and online) and to prohibit the distribution of free samples of these products. Unlike in Canada, tobacco products, including those containing synthetic nicotine, can only be legally marketed in the U.S. if they receive premarket authorization by providing sufficient evidence to demonstrate that the product meets the necessary public health standard required by law. In addition to regulating recreational use products, the U.S. also has approved NRTs that are regulated as drug products for smoking cessation, including patches, gums, inhalers, and lozenges. As of April 2024, the U.S. has not yet authorized any nicotine pouch brands for recreational use or for smoking cessation.

In the United Kingdom, the Tobacco and Related Products Regulations apply to tobacco products such as cigarettes and cigars, as well as vaping products. NRTs such as oral nicotine pouches, transdermal patches, and gums are considered consumer products and fall under the General Product Safety Regulations. These products are not required to be reviewed or licensed prior to marketing, and they are permitted to be marketed with claims for smoking cessation. In addition, there are no limits to the content of nicotine that is contained in or delivered by each dose.

Certain countries, such as Belgium, Germany, and the Netherlands, have banned the sale of nicotine pouches. In Germany and the Netherlands, synthetically derived nicotine pouches are considered foods that contain the unauthorized novel food ingredient nicotine, meaning they cannot be legally sold. In these countries, NRTs that are marketed with claims for smoking cessation remain available for sale without a prescription but must be sold in a pharmacy setting.

Canada’s approach to the regulation of NRTs is in line with that of most other countries, which acknowledges the importance of maintaining access to these products for use in smoking cessation and aligns with global initiatives to promote tobacco cessation. The measures introduced through this Order also align with recent recommendations by the WHO to reduce nicotine products’ appeal to and access by young people.^{footnote 82} The measures included in this Order provide a pathway for the legal sale of new and emerging NRTs in Canada for adults who wish to use them for smoking cessation, while reducing the risks of unintended use by limiting their access by and appeal to young people.

Strategic environmental assessment

The environmental costs associated with these rules will depend on the extent of changes to labelling and advertising materials needed, as well as the lifespan of product labels/materials. Feedback from industry indicated that a short transition timeline may result in product waste. However, the Order’s six-month transition period (in respect of labelling, packaging, and advertising) and related “sell-through” transitional rules will minimize these environmental impacts.

Further, while flavour restrictions apply upon the coming into force of the Order, without a transition period, these restrictions would not impact any NRT dosage forms on the List as there are currently none on the market that have a restricted flavour. As for NRTs not on the List, the flavour restrictions would impact only a relatively small number of products and are not expected to have substantial environmental impacts.

Gender-based analysis plus

There is evidence that large disparities in rates of cigarette smoking exist between different subpopulations, including, but not limited to, individuals of lower socioeconomic status or with lower education levels, Indigenous communities, and individuals with a mental health disorder.^{footnote 83} A review of the literature also suggests that certain populations may be more likely to use certain smoking cessation aids, including individuals with higher income or education levels, and women.^{footnote 84,footnote 85,footnote 86,footnote 87} Despite existing disparities between people who smoke, the Order was designed to reduce any further disproportionate impacts in access to NRTs overall.

During consultations, concerns were raised regarding access to NRTs by remote and rural communities should place of sale restrictions be put into effect. Individuals living in remote and rural communities, where there may be limited access to pharmacies, may be more likely to experience reduced access to new and emerging NRTs that are required to be sold by pharmacists or individuals under their supervision. However, these products may also be available online on pharmacy websites, when sold by a pharmacist or person working under their supervision, and NRT dosage forms on the List (e.g. gums and lozenges, etc.) will continue to be available through current retail settings. This approach is expected to maintain overall access to NRTs by all intended populations.

Other distributional impacts are based on age. Although young people are not the intended users of NRTs, some may already use these products. Some feedback received during consultation expressed concerns for legitimate access to NRTs by young people (i.e. via a prescription). However, young people will continue to have access to these products as needed through healthcare professionals. Young people who use or are considering using NRTs recreationally are expected to benefit the most from the Order, as the rules are intended to reduce the likelihood of unintended use (i.e. recreationally) of these products and is therefore expected to reduce the likelihood of experiencing the harmful effects of nicotine for this population.

Implementation, compliance and enforcement, and service standards

Implementation

The Order will come into force immediately upon publication, with a six-month transition period and ’sell-through’ transitional rule in respect of some requirements. The impact of this Order on a given product will depend on the status of the product licence and whether the product is in a dosage form on the List.

For NRT applications in queue at Health Canada: For NRTs that are the subject of a product licence application (i.e. in respect of which Health Canada has not yet issued a licence), as well as all new product licence applications, applicants must submit mock-ups of their labels and packages before the Minister may issue or amend a product licence.

For all marketed NRTs: A six-month transition period is being provided for labelling and packaging and advertising and promotion requirements (including those related to flavour names). Guidance will provide greater detail on compliance with this Order including the new labelling and packaging requirements.

For NRT dosage forms on the List: The Order allows a person to sell an NRT that is not labelled or packaged in accordance with the Order after the six-month transition period referred to above if it was labelled prior to the coming into force of the Order, or, if the NRT was imported, it was imported and labelled in accordance with the Natural Health Products Regulations prior to the coming into force of the Order.

For NRT dosage forms not on the List: The Order allows a person to sell an NRT that is not labelled or packaged in accordance with the Order after the six-month transition period referred to above if it was labelled prior to the coming into force of the Order, or, if the NRT was imported, it was imported and labelled in accordance with the Natural Health Products Regulations prior to the coming into force of the Order. Following the coming into force of the Order, these products must be sold by a pharmacist or an individual working under the supervision of a pharmacist and only if the NRT flavour is mint, menthol, or a combination of mint and menthol, and the brand name is not prohibited by the Order.

Health Canada will work with stakeholders to support them during the transition period.

Health Canada will consider updating the List once a history of appropriate use has been demonstrated for an NRT dosage form that is not on the List. Guidance will provide information on the type of evidence and information required for an NRT dosage form to be included on the List. Any amendments to the List would be made in accordance with Health Canada’s Incorporation by Reference Policy.

Compliance and enforcement

Compliance and enforcement of the Order will be in accordance with a risk-based approach, aligned with existing departmental policies, including Health Canada’s Compliance and enforcement policy for health products (POL-0001). Health Canada employs a wide range of compliance and enforcement actions and tools. Some actions and tools are designed to help regulated parties understand their responsibilities under the law (e.g. compliance promotion), while other actions and tools are designed to induce compliance with the law. For example, failure to comply with the requirements of the Order could result in the Department taking compliance and enforcement action in accordance with POL-0001, including suspending the product licence or site licence.

When necessary, enforcement actions are used to address non-compliance with the law. The actions, tools, and level of intervention used are dependent on the situation, context, and risk to health. For example, Health Canada continues to work on identifying and seizing unauthorized nicotine products in retail locations across Canada. Unauthorized nicotine products have not been assessed by Health Canada for safety, efficacy and quality, and they should not be used. Further, Health Canada continues to work with the Canada Border Services Agency to stop non-compliant health products from entering Canada. Packages that contain non-compliant health products are seized or refused entry.

Contact

Bruno Rodrigue
Executive Director
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Health Canada
Holland Cross, Suite P2108
11 Holland Avenue
Ottawa, Ontario
K1A 0K9
Address locator: 3000A
Email: lrm.consultations-mlr@hc-sc.gc.ca