Order Amending the Supplementary Rules Respecting Nicotine Replacement Therapies Order: SOR/2025-9

Canada Gazette, Part II, Volume 159, Number 4

Registration
SOR/2025-9 January 31, 2025

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 Order Amending the Supplementary Rules Respecting Nicotine Replacement Therapies Order under section 30.01footnote a of the Food and Drugs Act footnote b.

Ottawa, January 29, 2025

Mark Holland
Minister of Health

Order Amending the Supplementary Rules Respecting Nicotine Replacement Therapies Order

Amendments

1 Subsection 29(2) of the Supplementary Rules Respecting Nicotine Replacement Therapies Order footnote 1 is repealed.

2 Subsections 30(2) and (3) of the Order are replaced by the following:

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 in accordance with the Regulations on or before November 28, 2025.

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 in accordance with the Regulations on or before November 28, 2025.

Coming into Force

3 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.)

Issues

Certain Nicotine Replacement Therapy (NRT) licence holders who manufacture NRTs subject to the Supplementary Rules Respecting Nicotine Replacement Therapies Order (the Order) raised concerns that the transition period provided in the Order to bring labels into compliance is not sufficient. In addition, as the majority of NRTs sold in Canada are manufactured and labelled outside of Canada, licence holders that import NRTs have raised concerns that a large portion of their supply that was labelled but not imported by August 28, 2024, will not be able to be sold after February 28, 2025. Based on product supply information gathered by Health Canada from certain licence holders who manufacture NRTs, an insufficient supply of NRTs in Canada could occur as early as March 2025, impacting adults who want to access them to quit smoking.

Background

The Order was published and came into force on August 28, 2024. It introduced measures for NRTs that are regulated as natural health products under the Natural Health Products Regulations and that are for administration in the oral cavity. The objectives of establishing the Order were:

The Order included two categories of transitional provisions:

Licence holders who manufacture NRTs for some brands and private label companies in Canada have raised concerns to Health Canada that the transition provisions provided by the Order do not give these licence holders enough time to transition to compliant labelling. This may result in an insufficient supply of certain brands, dosage forms, or flavours of NRTs and as a result, could negatively impact adults who are using them to quit smoking. The majority of NRTs sold in Canada are manufactured and labelled outside of Canada, which adds complexity to the supply chain. Licence holders that import NRTs have raised concerns that a large portion of their supply that was labelled and destined for the Canadian market was not imported by August 28, 2024. As these products do not meet the conditions of the permitted sale provisions provided for by the Order, they would need to be sold before February 28, 2025.

Objective

The objective of the amendments to the Order is to remove unintended barriers to the supply of licensed NRTs for adults who are accessing them to quit smoking.

Description

The amendments to the Order extend the date of the permitted sale provisions in subsections 30(2) and 30(3) of the Order from the date the Order came into force (August 28, 2024) to November 28, 2025. This means that the permitted sale provisions will now allow NRTs that are not labelled in accordance with the requirements in sections 14 to 16 and 20 to 23 of the Order to continue to be sold until their expiry, as long as they are otherwise labelled in accordance with the Natural Health Products Regulations on or before November 28, 2025. This includes NRTs not labelled in accordance with the following rules:

The amendments to the Order also remove the requirement that NRTs that are imported must be both imported and labelled before the specified date in accordance with the Natural Health Products Regulations to qualify for the permitted sale provisions. As such, these amended permitted sale provisions only refer to the date in which the NRT was labelled in accordance with the Natural Health Products Regulations.

These amendments do not impact subsection 30(1) of the Order, which allows a person to sell an NRT that is not in accordance with section 10 if it was labelled before the Order’s coming into force, or in the case that it was imported, it was imported and labelled before that day. As of February 28, 2025, sale of an NRT that was labelled – or if it was imported, imported and labelled – on or after the Order’s coming into force will be prohibited if the statements or graphic design elements, including brand elements, displayed on the product’s label or package could be appealing to young people. This includes any flavour names that are displayed with descriptive or qualifying words that follow or precede the name, if they are appealing to young people.

Subsection 29(2) of the Order is repealed by these amendments, as the amended subsection 30(2) allows for the sale of an NRT that is not labelled in accordance with sections 14 to 16 of the Order, as long as it is otherwise labelled in accordance with the Natural Health Products Regulations on or before November 28, 2025.

Regulatory development

Consultation

Following the coming into force of the Order on August 28, 2024, licence holders who manufacture NRTs alerted Health Canada that the packaging and labelling provisions in the Order could result in an insufficient supply of NRTs on the Canadian market. On October 11, 2024, Health Canada reached out to 14 companies who manufacture NRTs licensed in Canada to obtain additional information relating to NRT availability. Health Canada received responses from 13 companies. In their responses, they indicated that the transition provisions would not provide enough time for them to come into compliance. One company also noted that NRTs not meeting the conditions of the permitted sale provisions provided by the Order would be destroyed and would result in significant waste. Overall, the information provided by companies demonstrated that there may be an insufficient supply of NRTs at the retail level as early as March 2025.

In November 2024, Health Canada met with three companies who manufacture licensed NRTs and two organizations representing pharmacy distributors that supply NRTs to pharmacies and hospitals. In these meetings, the NRT companies continued to raise concerns about the feasibility of having fully compliant products at the retail level by the end of the transition period. One company noted that there may be adverse impacts on smoking cessation programs and hospitals. The pharmacy distribution organizations expressed similar concerns about their inability to maintain a sufficient supply of NRTs following the end of the transition period in February 2025.

Notice of Intent

Health Canada published a Notice of Intent on December 12, 2024, to signal the Department’s intent to amend the transition provisions provided in the Order to allow for an extension to comply with certain labelling and packaging requirements. Following the publication of the Notice, Health Canada held three targeted engagement sessions on December 16, 2024, to discuss extending the date from which the permitted sale provisions would be applicable. These sessions included participation from provincial and territorial health ministries, pharmacy regulatory authorities, health advocacy associations and healthcare practitioners, NRT licence holders, and key industry associations that represent NRT licence holders. Written feedback following these sessions was received from four stakeholders.

Overall, participants from all stakeholder groups were supportive of taking action to prevent any disruptions in the supply of NRTs for individuals who want to quit smoking, while maintaining key measures to prevent youth appeal of, and access to NRTs.

Provincial and territorial health ministries and pharmacy regulatory authorities raised no concerns with extending the permitted sale provisions, but asked if the extension would apply to NRT dosage forms both on, and not on the List. They also questioned if an extension would be provided for compliance with the place-of-sale restrictions for products not on the List and the prohibition on NRTs containing certain flavours. Health Canada confirmed that these amendments would apply to all NRTs subject to the Order, and that provisions that directly mitigate youth appeal, including those that prohibit the use of certain flavours and the place-of- sale restrictions that came into force upon publication of the Order, would be maintained.

Health advocacy associations and healthcare practitioners raised concerns about the impact that an insufficient supply of NRTs would have for participants who take part in provincial and territorial smoking cessation programs. These concerns were reiterated in a written submission following this session from one of the participating organizations. These stakeholders also voiced concern that reduced availability of NRTs could lead people to turn to smoking or vaping.

Industry participants were supportive of an extension, however, some mentioned that even a 12-month extension to the date of application of the permitted sale provisions would not be enough to maintain product availability at the retail level. Written feedback from two industry stakeholders following this session indicated that licence holders would need an extension to the date of application until November 2025. Participants also signaled the urgency of getting the amendment formalized as soon as possible to allow manufacturers that may have stalled operations pending a regulatory decision to continue to manufacture and label product with their existing labels.

Taking these views into consideration, Health Canada is extending the date of the permitted sale provisions in subsections 30(2) and 30(3) of the Order to November 28, 2025. This would allow companies to continue labelling their NRTs with non-compliant labelling and allow for these NRTs to continue to be sold until their expiry, provided that their labels or packages are not appealing to young people and are otherwise labelled in accordance with the Natural Health Products Regulations. This will provide additional time for all licence holders to produce compliantly labelled products and should prevent disruptions in the availability of NRTs for people who are using them to quit smoking.

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.

Instrument choice

Status quo: Under this option, the transition and permitted sale provisions of the Order would be maintained. This option would allow the market to adjust without amending the Order and would maintain a level playing field for those NRT licence holders that have already invested resources to develop packaging and labelling that are in compliance with the Order by the end of the transition period (February 28, 2025). However, certain NRT licence holders have raised concerns to Health Canada that this approach is likely to result in an insufficient supply of NRTs for administration in the oral cavity as early as March 2025. This may have a negative impact on people in Canada trying to quit smoking if they cannot access their preferred brand, dosage form or flavour of NRT. While some Canadians may choose to stop using NRTs as a result, others may choose to use other nicotine-containing products such as vaping products and cigarettes, or unauthorized products that can be purchased online for personal use.

Amending the Order: Under this option, the Order would be amended to extend the date of the permitted sale provisions of the Order; meaning that the permitted sale provisions would apply to those NRTs that do not contain prohibited flavours or brand names and are labelled on or before November 28, 2025, instead of before August 28, 2024. This amendment would be limited only to allow products not labelled and packaged in accordance with sections 14 to 16, and 20 to 23 of the Order. This option would also remove the requirement for NRTs that are imported, that they must be both imported and labelled in accordance with the Natural Health Products Regulations to qualify for the permitted sale provisions.

Health Canada has assessed that the benefits of amending the Order to maintain a sufficient supply of NRTs for retail outlets and smoking cessation programs would outweigh the risks posed by delaying the benefits provided by sections 14 to 16 and 20 to 23 of the Order that relate to labelling and packaging. Measures to reduce NRT access and appeal in respect of unintended uses, including by young people, were balanced against the objective of avoiding the creation of significant barriers to access for those using NRTs for smoking cessation purposes. Due to the elevated health and safety risk to young people, the Department would not extend the permitted sale provision that prohibits labelling or packaging elements that are appealing to young people and would maintain the six-month transition period to come into compliance with the advertising requirements. As of February 28, 2025, an NRT with statements and graphic design elements, including brand elements, displayed on its label or package that could be appealing to young people would be prohibited from being sold. This would include any flavour names that are displayed with descriptive or qualifying words that follow or precede the name of the flavour. Further, as of this date, NRT advertisements that could be appealing to young people and those for a use other than smoking cessation would be prohibited. As such, young people would be less likely to be exposed to advertising that may feature NRTs for uses other than smoking cessation and in ways that appeal to them. The transition period for all other advertising requirements set out in the Order would also end on this date, including those related to indications and illustrations of flavours and flavour names. In addition, NRT advertisements must be transparent with respect to the NRT’s intended use (i.e., for smoking cessation by adults 18 years or older) and the addictive nature of nicotine throughout the permitted sale period.

These requirements, along with other requirements in the Order that were not provided with a transition period (i.e., the place of sale restriction for NRTs in dosage forms with limited history of appropriate use in Canada and the prohibition on the use of certain flavours), are sufficient to reduce the appeal of, access to, and use of NRTs by young people while industry transitions to compliant labelling. In addition, NRTs that were labelled outside of Canada do not present any more risk than NRTs that were labelled in Canada.

Companies that have already invested resources to come into compliance with the labelling and packaging provisions of the Order may perceive this approach as creating an uneven playing field and providing a competitive advantage to those companies who have not yet invested resources. Health Canada acknowledges this option may have created some competitive disadvantage to those who have fully complied with the labelling and packaging provisions of the Order.

Companies and the Department understand the importance of product availability and choice on the market for adults who are looking to quit smoking. It is important that consumers continue to have access to NRTs to aid them in quitting. Continued access to their preferred brand, dosage form, and flavour will support smoking cessation efforts. An ongoing intent of the Order is to avoid creating significant barriers to access for those using NRTs to quit smoking and the Department is being responsive to the needs of people in Canada.

Regulatory analysis

This section describes the potential impacts of the amended Order on industry stakeholders involved in the manufacturing, importation, distribution, labelling and packaging (collectively referred to as suppliers) and/or retailing of NRTs in Canada; consumers of these products; and Health Canada. All costs and benefits are reported qualitatively as it is expected that the amendments will impose an average annual cost of less than $1 million per year over the 10-year policy period (from 2025 to 2034).

Costs and benefits

Baseline Scenario

The Order exists unamended as it was published in August 2024. It prohibits the advertising of an NRT in a manner, including by means of its label or package, 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. In addition, the Order requires that the label of an NRT, and any advertisement for an NRT, must include a warning and an intended use statement.

The Order further prohibits the advertising and promotion of an NRT for an unintended use, or in a manner that may appeal to young people. 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, any graphic design elements and statements that appear on the NRT’s label or package must not be appealing to young people.

The Order also includes permitted sale provisions that allow for the continued sale of NRTs until their expiry without labels or packaging that are compliant with the Order, provided the NRTs were labelled (or if they were imported, imported and labelled) in accordance with the Natural Health Products Regulations before August 28, 2024.

Policy scenario (Amendments to the Order)

The amendments to the Order extend the date of the permitted sale provisions of the Order, with respect to sections 14 to 16 and 20 to 23 of the Order. This means that the permitted sale provisions will apply to those NRTs that are not labelled in accordance with sections 14 to 16 and 20 to 23, but are labelled in accordance with the Natural Health Products Regulations on or before November 28, 2025, instead of before August 28, 2024. All NRTs that are labelled in accordance with the Natural Health Products Regulations on or before November 28, 2025, can be sold until their expiry without complying with the requirements described hereinabove. Products labelled after November 28, 2025, must be fully compliant with the labelling and packaging requirements of the Order to be sold on the Canadian market.

Current market dynamics since the Order’s publication
NRT suppliers

Since the publication of the Order, suppliers of some NRTs have indicated that, in the short term, they are not able to supply the volume of NRTs compliant with the requirements of the Order by February 2025 to meet the demand of their consumers in Canada. Some suppliers have moved to become compliant, while others have indicated they could become compliant by the first or second quarter of 2025.

A further segment of suppliers with long production runs have indicated they have large volumes of stock in the supply chain that will not be compliant at the time of import.footnote 2 Suppliers importing NRTs to Canada on or after August 28, 2024, may have product that requires relabelling or repackaging to be sold as of February 28, 2025. The limits on the advertising of certain flavour names on the label of an NRT (such as requiring those dosage forms not on the List to be named only “mint”, “menthol” or a combination of the two) and the prohibition on including any descriptive or qualifying words that may accompany the flavour name, result in selected NRTs being required to be relabelled by the end of the transition period (February 28, 2025), if they do not meet the conditions of the permitted sale provisions of the Order. Some suppliers may also have NRTs that are being held in warehouses that will require relabelling to be sold following the end of the transition period. These challenges have the potential to interrupt the supply of specific NRTs on the market, particularly when retailers have sold out of these specific brands and smoking cessation programs have depleted their stock while product suppliers work towards full compliance with the Order.

Health Canada is uncertain when each NRT supplier will come into compliance but acknowledges concerns raised that to fully comply with the Order’s labelling and packaging requirements by February 28, 2025, may result in an insufficient supply of certain NRTs on the Canadian market.

Retailers

The Order allowed NRTs that are not labelled or packaged in accordance with the Order to be sold until expiry, provided they were labelled (or imported and labelled), in accordance with the Natural Health Products Regulations before August 28, 2024.

The Order also outlined that any NRT that was labelled, or imported and labelled, on or after August 28, 2024, must be fully compliant with the labelling and packaging requirements of the Order by February 28, 2025. After February 28, 2025, NRTs that are not compliant with the labelling and packaging requirements of the Order will not be permitted for sale in Canada. These NRTs may be destroyed, redirected for sales in other jurisdictions, or relabelled. Some large retailers may choose not to carry products that are not fully compliant with the latest regulatory requirements, even if the products meet the conditions of the permitted sale provisions when the products were delivered.

NRT consumers

The Order also outlined that NRTs being supplied to the Canadian market on or after August 28, 2024, are required to be fully compliant with the labelling and packaging requirements of the Order by February 28, 2025. Consumers who cannot get their preferred brand, dosage form, or flavour of NRT due to insufficient supply, may stop using smoking cessation aids altogether, switch to other NRTs available on the market, begin vaping, or revert back to smoking.

Cost Analysis

This analysis focuses on the group of stakeholders that will be impacted by the amendments of the Order. It includes impacts to NRT suppliers and retailers, consumers, and Health Canada. This section outlines the cost and benefit analysis qualitatively.

Costs to businesses

The amendments to the Order extend the date of the permitted sale provisions of the Order, with respect to sections 14 to 16 and 20 to 23 of the Order. This means that the permitted sale provisions will apply to those NRTs that are not labelled in accordance with sections 14 to 16 and 20 to 23, but are labelled in accordance with the Natural Health Products Regulations on or before November 28, 2025, instead of before August 28, 2024. This provides additional time for NRT suppliers to supply, to the Canadian market, products that do not comply with the labelling and packaging requirements of the Order referenced in the amendments. It is anticipated that permitting these NRTs to continue to be supplied to the Canadian market, if they were labelled on or before November 28, 2025 (instead of before August 28, 2024, in the baseline scenario), will result in cost savings to most NRT suppliers, specifically those with products not fully compliant with the labelling and packaging requirements of the Order referenced in these amendments. In addition, these amendments will also reduce losses (of profit and/or market share) due to reduced production that is anticipated in the baseline scenario. Some suppliers may have already relabelled or repackaged their products to comply with the Order. The relabelling or repackaging costs spent before this amendment is believed to have been up to three times more costly due to a shorter turnaround time, as compared to having an extended period to comply with the requirements of the Order.

These amendments also result in an uneven playing field among NRT suppliers, particularly for suppliers who have complied with the Order earlier than others (i.e. prior to the publication of these amendments). Consumers of their products can no longer access product labelling or packaging, and flavour names that they are familiar with, while other suppliers can continue supplying products with flavour names that have accompanying descriptive or qualifying words. As a result, this may cause suppliers who have changed their product labels or packages sooner to suffer a loss of market share due to the labelling and packaging requirements specified in the Order. Following the amendments to the Order, it is assumed that NRT suppliers will choose to comply with the labelling and packaging requirements based on profit maximization, by considering the trade-off between the higher compliance costs, market share, and management of logistics and inventories. It is also assumed that NRT suppliers will exhaust all product labels or packages already ordered prior to the publication of the Order.

Costs to NRT consumers

The amendments to the Order will delay compliance with the labelling and packaging requirements of the Order referenced in these amendments, which could delay the added benefit of the warning statement displayed on NRT labels. Further, it would also delay the benefit of the minimum age of intended use statement being displayed on certain NRT labels. There is also a possibility that flavour names may be accompanied by the use of descriptive or qualifying words, which may lead to the NRT’s appeal, and its unintended use by young people until all NRTs are fully compliant with the Order. Some consumers may be inconvenienced if retailers will not carry NRTs that are not fully compliant with the Order’s regulatory requirements, even if they meet the amended conditions of the permitted sale provisions. It is unclear how long it may take to see full compliance at the retail level, making it difficult to fully assess the cost to consumers.

However, if consumers do not have reliable access to their preferred NRT brand, dosage form, or flavour, they may be required to spend more resources on finding their preferred NRT at different retail locations or seeking alternative brands, dosage forms, or flavours, which could cost them time and more money if they are paying higher prices. For those consumers who do not find a satisfactory NRT alternative, they may eventually switch to vaping or smoking as a substitute, which would impede their initial intention to quit smoking. The amendments to the Order will, to some extent, delay the original intent of the Order which maximizes the protection of young people while continuing to encourage smokers to quit smoking by using NRTs in combination with other available tools and supports. This may slow down the progress made by some health promotion organizations which aim to help young people avoid nicotine use.

Costs to government

The amendments to the Order to extend the date of the permitted sale provisions for NRTs may result in cases of unintended use of NRTs during this period due to the lack of the nicotine warning on the principal display panel, potential lack of the minimum age of intended use statement being visible to the consumer at the time of purchase, or the use of descriptive words accompanying the flavour name. Although consumers’ decisions to switch or revert to vaping and smoking may not result in an incremental cost to the health care system in the short term, in the long-term it could result in an incremental cost to the health care system in managing an increase in vaping and smoking in the population.

Benefit analysis
Benefits to Businesses

Extending the date of the permitted sale provisions for NRTs, from August 28, 2024, to November 28, 2025, allows NRT suppliers to label and package products that are not in compliance with certain labelling and packaging requirements of the Order referenced in the amendments, until this date. These NRTs can then continue to be sold until their expiry. These amendments permit NRT suppliers to continue packaging and labelling their products for sale on the Canadian market, as prior to the Order’s publication, thus minimizing potential disruption in the supply chain.

It is anticipated that the extension of application of the permitted sale provisions will result in cost savings to the suppliers who will have more time to redesign, approve, and print new labels or packaging, lessening the mark up in costs due to “urgent” service requests related to these compliance activities. In addition, suppliers of NRTs do not need to relabel or repackage products for full compliance with all labelling and packaging requirements as outlined in the Order by February 28, 2025. This will result in less wastage or destruction of labelling or packaging, and in some cases, the product itself. There will also be less redirection of NRTs that are not in full compliance with the labelling and packaging requirements of the Order, which are in their production facilities, or in transit to other markets.

It is anticipated that these amendments will minimize loss of market share and sales (therefore profit margin) during the period prior to full compliance with the Order since businesses can continue supplying NRTs as they were before August 28, 2024, as long as labelling or packaging elements are not appealing to youth. It is assumed that unless they have already taken action, NRT suppliers will decide when to comply with the Order based on the principle of profit maximization, by trading off the potential gain in meeting preferences of consumers of their products and the compliance costs with relabelling or repackaging requirements. It is also anticipated that with these amendments, retailers of NRTs will be less likely to hold clearance sales to dispose of NRTs with labels or packages that are not in full compliance with the Order as the extended permitted sale period will allow NRTs labelled up until November 28, 2025 to be sold until their expiry.

Benefits to NRT consumers

It is anticipated that extending the date of the permitted sale provisions for NRTs, from August 28, 2024, to November 28, 2025, should mitigate any potential for insufficient supply of NRTs on the Canadian market. Consumers who rely on NRTs to quit smoking will continue to have access to their preferred NRT brand, dosage form, and flavour, and would avoid potentially paying higher prices for NRTs or spending resources to seek and purchase alternatives. This will increase the likelihood of success for consumers whose initial intention to use NRTs to quit smoking. This will also reduce the possibility for them using vaping products or returning to cigarettes if they were not able to access their preferred NRTs as in the baseline scenario.

Benefits to government

The amendments to the Order to extend the date of the permitted sale provisions for NRTs are expected to have a negligible impact on compliance and enforcement costs.

Environmental impacts

It is anticipated that the amendments to the Order will result in limited destruction of NRTs, including labels, packages, or product itself, or redirected sales of NRTs which are likely to be seen in the baseline scenario. For an extended period of time, NRT suppliers will be permitted to supply their products to retail outlets and smoking cessation programs in Canada with labels and packages that are not compliant with certain requirements of the Order referenced in the amendments, and retailers and programs will have more time to deplete their stocks until their expiry. This in turn is anticipated to minimize or eliminate negative environmental impacts that would have resulted from the destruction (including destruction of product labelling and packaging), and/or redirection of product to other markets.

Small business lens

The small business lens applies as there are small businesses that are implicated by the amendments to the Order as they pertain to packaging and labelling. It is anticipated that extending the date in which the permitted sale provisions for NRTs are applicable, from August 28, 2024, to November 28, 2025, will benefit large and small businesses alike. Small businesses are not specifically restricted by these provisions in the Order, and could supply their products to the Canadian market until that date, even if they are not fully compliant with the labelling and packaging provisions of the Order. It is anticipated that they could avoid any destruction of NRTs, including its packaging, labelling, or the product itself, or the need to redirect sales of products outside Canada. These amendments to the Order would reduce the compliance cost for these small NRT suppliers who have not yet taken action to comply with the requirements.

However, small NRT suppliers who have acted quickly to be in full compliance with the Order, may have incurred higher costs due to urgent service fees to redesign their labels and packages in an expedited manner. In addition, these businesses may lose some market share if their customers choose a different brand due to the more appealing labels or packages of a competitor (i.e., due to the presence of flavour names with descriptive or qualifying words, or the lack of a warning on the principal display panel).

It is also anticipated that some NRT suppliers and retailers, including small businesses may have become less viable due to having quickly responded to the publication of the Order. These small businesses may have already relabelled or repackaged their products so that these products could be sold in Canada. In addition, some small retailers may also have conducted clearance sales to dispose or redirect their product inventories in the baseline scenario. It depends on the resilience and financial health of these small businesses if they could withstand these losses.

Small retailers may also benefit from these amendments as there is a lower risk of insufficient supply to meet market demands for consumers preferred brands, dosage forms, or flavours of NRTs. In addition, more NRTs that do not comply with certain labelling and packaging requirements of the Order can continue to be sold until their expiry. This is expected to minimize their losses from sales as compared to prior to the publication of the Order in August 2024.

One-for-one rule

The “one-for-one” rule does not apply as the amendments to the Order will not result in any administrative burden to any NRT licence holders and businesses that supply or sell NRTs in Canada.

Effects on the environment

In accordance with the Cabinet Directive on Strategic Environmental and Economic Assessment, this proposal has been exempted from the requirement to complete a Climate, Nature and Economic Lens (CNEL).

The amendments to the Order extend the date from which the permitted sale provisions of the Order, for certain provisions, are applicable. This allows NRT licence holders more time to change their labels to comply with certain packaging and labelling requirements outlined in the Order, as such, these amendments should minimize the environmental impacts of the Order. This change is administrative in nature; therefore, it is exempt from the CNEL process on the grounds that it is an administrative procedure with low likelihood of important environmental effects.

Gender-based analysis plus

During consultations, concerns were raised regarding the impact of a lack of availability of NRTs for those who access these products through smoking cessation programs. These smoking cessation programs often serve many individuals that typically face barriers to health equity, for example those from lower socioeconomic status, living in rural areas, Indigenous peoples, and women. Individuals who are underserved and have less access to healthcare would be most adversely affected. However, the amendments to the Order will help to ensure continued supply of NRTs, including for provincial and territorial smoking cessation programs.

Implementation, compliance and enforcement

Implementation

The amendments to the Order will come into force immediately upon publication.

The amendments to the Order extend the date of the permitted sale provisions of the Order, with respect to sections 14 to 16 and 20 to 23 of the Order. This means that the permitted sale provisions will apply to those NRTs that are not labelled in accordance with sections 14 to16 and 20 to 23 of the Order but are otherwise labelled in accordance with the Natural Health Products Regulations on or prior to November 28, 2025, instead of August 28, 2024.

The amendments to the Order do not impact the transition period outlined in the Order for section 10, with respect to an NRT’s label or package, and sections 18 to 28 for any advertisements or promotions, except for those on an NRT’s label or package. This means that any NRT that is labelled after August 28, 2024, must be in full compliance with section 10 of the Order to be sold and any advertisements or promotions, except for those on a NRT’s label or package, must be in compliance with sections 18 to 28 after February 28, 2025.

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 compel or 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