Order Establishing Supplementary Rules Respecting the Sale of Natural Health Products Containing Ephedrine or Pseudoephedrine: SOR/2025-93

Canada Gazette, Part II, Volume 159, Number 7

Registration
SOR/2025-93 March 7, 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 Establishing Supplementary Rules Respecting the Sale of Natural Health Products Containing Ephedrine or Pseudoephedrine under section 30.01footnote a of the Food and Drugs Act footnote b.

Ottawa, March 7, 2025

Mark Holland
Minister of Health

Order Establishing Supplementary Rules Respecting the Sale of Natural Health Products Containing Ephedrine or Pseudoephedrine

Definitions

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

combination product
means a natural health product that contains, among its ingredients, ephedrine or any of its salts, pseudoephedrine or any of its salts, or any combination of those ingredients in combination with one or more other substances listed in Schedule 1 of the Regulations. (produit combiné)
non-combination product
means a natural health product that contains, as its only medicinal ingredients, ephedrine or any of its salts, pseudoephedrine or any of its salts, or any combination of those ingredients. (produit non combiné )
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)

Words and expressions

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

Application

2 (1) Subject to subsection (2), this Order applies to the sale of combination products and non-combination products.

Non-application

(2) This Order does not apply to

Application of Regulations

3 For greater certainty, unless otherwise provided for by this Order, the Regulations apply to combination products and non-combination products, except that the reference to “these Regulations” in paragraphs 18(1)(a) and 39(1)(a) and section 92 of the Regulations are to be read as including a reference to this Order.

Prohibition — retail sale

4 (1) Subject to subsections (2) to (4), a person must not sell a combination product or non-combination product at the retail level.

Exception — non-combination products

(2) A pharmacist or a person working under the supervision of a pharmacist may sell, at the retail level, a non-combination product that is not accessible to the public for self-selection.

Exception — combination products offered for self-selection

(3) A pharmacist or any other person working in a retail location serviced by a pharmacist may sell, at the retail level, a combination product that is accessible to the public for self-selection in the case where a pharmacist is available, at the request of a purchaser or consumer, to discuss the product prior to purchase.

Exception — combination products not offered for self-selection

(4) A pharmacist or a person working under the supervision of a pharmacist may sell a combination product at the retail level without making it accessible to the public for self-selection.

Prohibition — further sale

5 A person must not sell a combination product or non-combination product to another person, other than a pharmacist, for further sale at the retail level.

Coming into force

6 This Order comes into force on May 18, 2025, but if it is registered after that day, it comes into force on the day on which it is registered.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Order.)

Issues

Natural heath products (NHPs) containing ephedrine and/or pseudoephedrine are at risk of misuse such as for the purposes of performance enhancement and weight loss, and are at risk of diversion for the illegal production of methamphetamine. To address these issues, Health Canada made the Interim Order Concerning the Sale of Certain Natural Health Products Containing Ephedrine or Pseudoephedrine (the Interim Order) on May 17, 2024. The Interim Order will cease to have effect one year from that date, and action is needed to ensure that there will continue to be consistent condition-of-sale restrictions across Canada for NHPs that contain ephedrine and/or pseudoephedrine and their salts as their only medicinal ingredient(s) (“non-combination” products). In addition, if condition-of-sale restrictions are not introduced for NHPs containing ephedrine and/or pseudoephedrine in combination with other substance(s) set out in Schedule 1 of the Natural Health Products Regulations (NHPR) (“combination” products), these products could be marketed in non-pharmacy settings, increasing their potential misuse and diversion and resulting in significant risks to public health and safety.

Background

The National Association of Pharmacy Regulatory Authorities (NAPRA) began removing all NHPs from its National Drug Schedules (NDS) in 2020 to implement an updated policy on NHPsfootnote 1, which outlines that NHPs approved for sale under the NHPR are not considered products for scheduling within the NDS. This culminated in the removal of ephedrine and pseudoephedrine from the NDS in 2024, which had been in place since April 2006. Since many provinces and territories incorporate by reference NAPRA’s NDS in their respective laws, the removal of non-combination and combination products from the NDS resulted in the removal of the associated condition-of-sale restriction to pharmacy settings. Select provinces such as British Columbia and Quebec have condition-of-sale restrictions in place for these products in their laws, instead of incorporating by reference NAPRA’s NDS, which has resulted in inconsistencies in the oversight of these products across Canada. Furthermore, there is evidence that despite provincial condition-of-sale restrictions for these products, many such products continued to be sold outside of a pharmacy setting. The removal of ephedrine and pseudoephedrine from the NDS has the potential to increase the risk of misuse and diversion. In response to NAPRA’s intent and these identified risks, the Minister of Health (the Minister) made the Interim Order, which introduced condition-of-sale restrictions for NHPs containing ephedrine, pseudoephedrine, or ephedrine and pseudoephedrine as their only medicinal ingredients.

The Interim Order prohibits the sale of non-combination products at the retail level by any person except pharmacists or individuals working under the supervision of a pharmacist. Additionally, these products cannot be readily accessible to the public (e.g. not available in an open self-selection area of a pharmacy). The Interim Order also prohibits any person from selling non-combination products to another person, other than a pharmacist, for further sale at the retail level (e.g. wholesaling, distributing).

Without the Interim Order measures, gaps in oversight could expose people in Canada to significant risk to health and safety.

Potential for misuse and diversion of ephedrine and pseudoephedrine NHPs

While NHPs containing ephedrine or pseudoephedrine have been licensed with approved conditions of use as decongestants, there is evidence that these products have been promoted and sold for unintended uses outside the pharmacy setting, often to consumers wishing to enhance athletic performance and increase weight loss and energyfootnote 2. There has been little research to assess whether these products are safe in the context of weight loss and bodybuilding, and adverse reaction reports in both Canada and the United States have highlighted symptoms ranging from dizziness, tremors, headaches and irregularities in heart rate to seizures, psychosis, heart attacks and stroke. Additionally, these products have the potential to interact with other medications or dietary supplements that a consumer is takingfootnote 3,footnote 4,footnote 5. Misuse of ephedrine products in sport and bodybuilding has been internationally recognized, with ephedrine and ephedrine alkaloids being banned by the World Anti-Doping Agencyfootnote 6, the International Olympics Committeefootnote 7, and the majority of major professional and amateur athletics associations.

NHPs containing ephedrine also have an established history of being diverted to the illegal production of the controlled substance methamphetamine in Canada and internationally. As a neurotoxin, methamphetamine can damage the neural tissue within the brain. Exposure can damage areas of the brain related to both cognition and memory and, in some cases, brain function may never fully recover even years after discontinuation of use. For this reason, methamphetamine addiction places an individual at heightened risk of long-term cognitive and psychological problems, including episodes of violent behaviour, paranoia, anxiety, confusion, and insomniafootnote 8,footnote 9.

The high risk of diversion associated with ephedrine and pseudoephedrine NHPs has long been cited as a concern by Canadian law enforcement and law makers. In the Methamphetamine Report for Federal-Provincial-Territorial Ministers Responsible for Justice, Ministers underscored the need to restrict the sale of products containing ephedrine and pseudoephedrine, given how easily they could be purchased and given the evidence of diversion as these products have been found at drug crime scenes across the countryfootnote 10. Prior to the making of the Interim Order, law enforcement identified the diversion of ephedrine NHPs as a primary driver of clandestine methamphetamine production in Canada. The Royal Canadian Mounted Police (RCMP) and Health Canada’s Drug Analysis Service have recorded instances of clandestine laboratories using ephedrine tablets to synthesize methamphetamine between 2011 and 2020. Both ephedrine and pseudoephedrine are controlled in Canada as precursors under the Controlled Drugs and Substances Act (CDSA).

Ephedrine and pseudoephedrine NHPs that contain other NHPs as medicinal ingredients

Under the Interim Order, combination products are not subject to federal condition-of-sale restrictions. Currently, there are no marketed combination products in Canada. This may be attributed to lack of interest in combination products given the availability of non-combination products prior to the condition-of-sale restrictions imposed by the Interim Order. Following the Interim Order, as availability of non-combination products from non-pharmacy retailers decreased, there are reasonable grounds to believe that combination products are likely to serve as an alternative source of ephedrine and pseudoephedrine that may be misused or divertedfootnote 11,footnote 12. Since the Interim Order was made, Health Canada has received licence applications for combination products, indicating a potential shift towards the sale of combination products in Canada. If these combination products are marketed without condition-of-sale restrictions, they would be widely accessible, increasing their potential misuse or diversion, resulting in significant risks to public health and safety.

Following the expiration of the Interim Order, sales restrictions are needed for all NHPs containing ephedrine and/or pseudoephedrine to continue to help limit their access for purposes other than their intended use. Without such restrictions, both non-combination and combination products would be accessible in retail settings other than pharmacies. Given the evidence outlined above, the Minister has reasonable grounds to believe that the broad accessibility of these products represents a risk to public health and safety for people in Canada. Therefore, restricting their sale to a pharmacy setting should increase the degree of control in their sale and help to prevent misuse and diversion.

Objective

The objective of the Order Establishing Supplementary Rules Respecting the Sale of Natural Health Products Containing Ephedrine or Pseudoephedrine (Ministerial Order) is to address the risk of misuse and diversion of ephedrine and pseudoephedrine natural health products by maintaining the requirements set out in the Interim Order for non-combination products, while introducing new condition-of-sale restrictions for combination products, which align with previous NAPRA restrictions under Schedule III of the NDS.

Description

Scope

The Ministerial Order applies to both non-combination products and combination products regulated under the NHPR.

Non-prescription drugs (NPDs) containing ephedrine and/or pseudoephedrine are not included within the scope of the Ministerial Order as they are generally sold in pharmacies as opposed to non-pharmacy retail settings. As set out in the Notice of Intent: Proposal to Amend the Regulations for Precursors and Designated Devices under the Controlled Drugs and Substances Act published on February 1, 2025, Health Canada is considering whether there is a need for additional condition-of-sale restrictions for health products containing ephedrine and pseudoephedrine. This could include condition-of-sale restrictions for NPDs containing ephedrine and pseudoephedrine.

Non-application

The Ministerial Order does not apply to the sale of non-combination or combination products for the purpose of a clinical trial regulated by Part 4 of the NHPR, and does not apply to the distribution of these products as samples under section 103.4 of the NHPR to practitioners or pharmacists.

Application of the NHPR

The Ministerial Order allows the Minister to suspend, reinstate, or cancel a product licence or site licence issued under the NHPR if the Minister has reasonable grounds to believe the holder of the licence has contravened the Ministerial Order.

Definitions

The Ministerial Order defines the following terms:

Non-combination products

The Ministerial Order maintains the requirements set out in the Interim Order by carrying over the prohibitions on retail sale and sale for further sale of non-combination products, as follows:

Retail sale

The Ministerial Order prohibits a person from selling non-combination products at the retail level, unless that person is a pharmacist or a person working under a pharmacist’s supervision. Additionally, these products cannot be readily accessible to the public, e.g. not available in an open self-selection area of a pharmacy.

Sale for further sale

The Ministerial Order prohibits a person (e.g. wholesaler, distributor) from selling non-combination products to a retail seller other than to a pharmacist, such that sales are limited to a pharmacy.

Combination products

The Ministerial Order introduces prohibitions on retail sale and sale for further sale of combination products. These restrictions are aligned with previous restrictions for these products under NAPRA’s NDS, which were intended to reduce the risk of diversion and misuse and align with restrictions currently in place for combination products in several provinces.

The Ministerial Order introduces two exceptions to the retail sale prohibition of combination products, which enables pharmacists to determine how accessible these products are within the pharmacy for self-selection:

Retail sale – assisted self-selection

The Ministerial Order allows a pharmacist, or a person working in a retail location served by a pharmacist, to sell combination products in a retail setting where these products may be readily accessible to the public, for example, in an open self-selection area of the pharmacy which is operated under the direct supervision of a pharmacist and subject to any local professional discretionary requirements which may increase the degree of control. A pharmacist must be available to potentially assist the purchaser or consumer with making an appropriate self-medication selection prior to purchase.

Retail sale – no self-selection

The Ministerial Order also allows pharmacists to further restrict the retail sale of combination products should they choose to. For example, where there is evidence of misuse or particular concern about misuse, a pharmacist or a person working under the supervision of a pharmacist, may sell combination products at the retail level where these products cannot be readily accessible to the public, e.g. not available in an open self-selection area of a pharmacy.

Sale for further sale

The Ministerial Order prohibits a person (e.g. wholesaler, distributor) from selling combination products to a retail seller other than to a pharmacist, such that sales are limited to a pharmacy.

Retail setting

The Ministerial Order is technologically neutral in that its prohibitions and exceptions apply to both physical and online settings. For example, non-combination products may be sold at the retail level (1) via a remote dispensing location, in which a pharmacist (or a person working under the supervision of a pharmacist) is physically present in the remote dispensing location or in the pharmacy that operates the remote dispensing location; and (2) via online pharmacies – but only where a pharmacist or a person working under the supervision of a pharmacist conducts the sale of the non-combination products.

Similarly, combination products may be sold, by a pharmacist or a person working in the retail location serviced by a pharmacist, at the retail level (1) via a remote dispensing location; or (2) via online pharmacies; however, in both scenarios, a pharmacist must be available (e.g. by telephone, video, text, or other means of communication), to potentially assist the purchaser or consumer with making an appropriate self-medication selection prior to purchase.

Regulatory development

Consultation

On October 17, 2024, representatives from most provincial and territorial ministries of health, from provincial and territorial pharmacy regulatory authorities, and from NAPRA participated in a consultation session on the impact of the Interim Order and plans for a future Ministerial Order, including broadening the scope to combination products. During this consultation, provincial and territorial health officials and pharmacy stakeholders noted that they were appreciative of the Interim Order measures.

Comment: In discussing the scope of the proposal, two provincial pharmacy regulatory authorities indicated that they were not supportive of online sales for non-combination and combination products.

Response: Like the Interim Order, the Ministerial Order is technologically neutral (i.e. its prohibitions and exceptions apply to both physical and online sales). Therefore, online sales will be subject to the same restrictions for non-combination and combination products. That is to say that if non-combination products are sold online, the sale must be conducted by a pharmacist. If combination products are sold online, the sale can either be conducted by a pharmacist or by a person working in a retail location serviced by a pharmacist, although a pharmacist must be available to assist the purchaser or consumer.

Comments: Regarding the policy proposed for combination products, one provincial pharmacy regulatory authority indicated that they would prefer that Health Canada not further restrict the sale of these products beyond current condition-of-sale restrictions in their provincial laws. Otherwise, they were supportive of the proposed scope for combination products. Another province stated that there is no need to consider restrictions for combination products like those for non-combination products imposed under the Interim Order, at this time.

Response: The restrictions on sale outlined in the Ministerial Order align with those previously set out in NAPRA’s NDS for both non-combination and combination products. Since many provinces and territories incorporated NAPRA’s condition-of-sale restrictions in their laws, the requirements introduced under the Ministerial Order do not extend beyond previous requirements for the sale of these products. In addition, although there are currently no marketed combination products in Canada, Health Canada has received licence applications for authorization of these products. If authorized, these products could potentially pose misuse and diversion risks if they are marketed without condition-of-sale restrictions.

No additional concerns were expressed by provinces and territories in regards to the federal measures proposed during this consultation session.

On October 22, 2024, a consultation session was held with industry associations, NHP licence holders and distributors to provide an update and discuss the proposal.

Comment: One industry association indicated that Health Canada should consider the impact of the proposed measures related to combination products in the self-care space, as it could be perceived as reducing access to these products for lawful use.

Response: Health Canada responded to this association by email stating that these products would be restricted to sale in a pharmacy setting similar to the condition-of-sale restrictions currently in place in several provinces, and in line with previous restrictions under NAPRA’s NDS.

Comment: Written feedback received from one industry association indicated that they did not agree with including pseudoephedrine in the Ministerial Order, as they feel its inclusion is unnecessarily restrictive without clear evidence of diversion. Health Canada later met with this association where the association sought clarification as to whether NPDs containing pseudoephedrine (i.e. non-prescription products assigned a Drug Identification Number that also contain pseudoephedrine) would be prohibited from sale to non-pharmacy retailers.

Response: Health Canada responded to this association by email and reiterated later at the meeting, that like ephedrine, pseudoephedrine can be used in the illegal production of methamphetamine and can also be extracted from combination products. In addition, there is evidence that products containing pseudoephedrine have been found in clandestine laboratories. As both ephedrine and pseudoephedrine are regulated as precursors under the CDSA, it is well established that these precursors pose risks to public health and safety when diverted to the illegal market. It is for these reasons that Health Canada has given careful consideration to products containing either ephedrine or pseudoephedrine being marketed in non-pharmacy settings, including when present in combination with other NHP ingredients. This also aligns with the restriction previously set out in NAPRA’s NDS. Health Canada confirmed that NPDs containing ephedrine and/or pseudoephedrine are not under the scope of the Ministerial Order.

Comment: During both consultation sessions, provinces, territories and industry stakeholders asked about data related to the diversion of NHPs containing ephedrine and pseudoephedrine.

Response: Health Canada explained that because there are currently no marketed combination products in Canada, there can be no evidence of diversion of these products. Both ephedrine and pseudoephedrine are regulated as precursors under the CDSA because of their use in the illegal production of methamphetamine. However, Health Canada highlighted that the RCMP and Health Canada’s Drug Analysis Service have recorded evidence related to the diversion of 8 milligram ephedrine non-combination products. Health Canada also shared that law enforcement had been calling on the Department to address the diversion of 8 milligram ephedrine NHPs for a number of years, and that the RCMP was supportive of the Interim Order. Since the introduction of the Interim Order, Health Canada has received licence applications for combination products, which would otherwise be widely available for retail sale in non-pharmacy settings unless their sale is restricted by regulation.

Questions related to costing were introduced by Health Canada at the industry stakeholder session to inform the Cost-Benefit Analysis (CBA). The questions were formally distributed by email to stakeholders for their response by November 8, 2024.

Comments: Impacted industry stakeholders stated that limiting the sale of non-combination and combination products to pharmacy retailers would impact their sales revenue. One stakeholder suggested that allowing the sale of combination products to non-pharmacy retailers could help offset revenue losses. However, another stakeholder indicated that, based on past experience, there is no market or consumer interest in these combination products.

Response: Recognizing that there may have been little consumer interest in combination products prior to the Interim Order, the receipt of licence applications for combination products indicates a shift towards the sale of combination products in Canada as a substitute revenue stream to non-combination products. As ephedrine and pseudoephedrine can be extracted from combination products, limiting the sale of combination products to pharmacy settings will protect people in Canada, as the misuse and diversion of these products pose a risk of injury to their health. This will also align with the restriction previously set out in NAPRA’s NDS.

Health Canada acknowledged comments and concerns from stakeholders during these two consultation sessions and through written feedback, and took them into consideration during the development of the Ministerial Order.

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 on the proposal. The assessment did not identify any modern treaty implications or obligations.

In addition, a UN Declaration Consistency Analysis was conducted on the proposal. The assessment did not identify potential intersections between the proposal and the rights and interests of First Nations, Inuit and Métis, and no inconsistencies with the United Nations Declaration on the Rights of Indigenous Peoples (UN Declaration) are apparent.

Instrument choice

Health Canada considered the following regulatory and non-regulatory options:

1. Take no action after the Interim Order ceases to have effect

If additional regulatory measures on condition-of-sale restrictions for non-combination and combination products are not put in place after the Interim Order ceases to have effect, any person could sell these products at the retail level and in non-pharmacy settings. This lack of oversight could expose people in Canada to significant health and safety risks resulting from misuse of these products, or diversion for use as precursors in the illegal production of methamphetamine.

For these reasons, this option was not deemed adequate to address the health and safety risks associated with these products.

2. Amendments to the Natural Health Products Regulations and/or the Precursor Control Regulations

The NHPR, made under the Food and Drugs Act (FDA), and the Precursor Control Regulations (PCR), made under the CDSA, could be amended to incorporate condition-of-sale restrictions for non-combination and combination products.

Currently, the Department is considering future amendments to the PCR to introduce condition-of-sale restrictions for products containing ephedrine and pseudoephedrine. A Notice of Intent was published on February 1, 2025, to this effect.

Relying on regulatory amendments at this time would risk not having sale restrictions in place when the Interim Order expires as it would not permit the Department to develop Governor in Council (GiC) regulations in time to address the risk of misuse and diversion associated with these products. Therefore, this option was not pursued.

3. Recommended option - Establish supplementary rules for certain NHPs through a ministerial order

The supplementary rules authority, under section 30.01 of the FDA, provides the Minister with the ability to make an order that establishes rules addressing, among other things, condition-of-sale restrictions for a therapeutic product (including NHPs) for the purpose of preventing, managing or controlling a risk of injury to health that the use of that product, other than its intended use, may pose.

This authority permits the Minister to make an order in situations where there may be uncertainty respecting the risks to health that the unintended use of a therapeutic product (in this case NHPs containing ephedrine and/or pseudoephedrine) may present. In addition, unlike the interim order authority that exists under the FDA, the supplementary measures ministerial order authority is not time-limited and therefore provides certainty to stakeholders.

A supplementary rules ministerial order addresses the risks associated with these products, and allows product specific rules to be made and therefore was the preferred option.

Regulatory analysis

Benefits and costs

The CBA seeks to explain the qualitative and quantitative costs and benefits of this Ministerial Order. The information used to complete the analysis was collected through consultations with industry stakeholders, Health Canada internal data, and publicly available information. All costs and benefits are reported qualitatively and quantitatively, where possible, as per the Cabinet Directive on Regulation: Policy on Cost-Benefit Analysis, when a regulation is expected to impose an average annual direct cost of less than $1 million per year.

Baseline scenario versus regulatory scenario

In the baseline scenario, non-combination products continue to have condition-of-sale requirements through the Interim Order after NAPRA removed them from the NDS. However, they would have no condition-of-sale restrictions in place when the Interim Order expires. In the regulatory scenario, these products will continue to have condition-of-sale restrictions, restricting them to pharmacy areas where they are not available for self-selection.

In the baseline scenario, combination products would have no condition-of-sale restrictions in place, which poses a risk to the health and safety of people in Canada. In the regulatory scenario, these products will have condition-of-sale restrictions, limiting their sales to pharmacy settings only.

In the baseline scenario, a regulatory gap for the wholesale and distribution of non-combination and combination products would continue to exist when the Interim Order expires, allowing for the sale of these products to non-pharmacy retailers, which if diverted, pose risks to the health and safety of people in Canada. In the regulatory scenario, the wholesale and distribution of these products will be limited to pharmacies only.

Benefits

Benefits to people in Canada

The Ministerial Order is expected to enhance safeguards for the health and safety of people in Canada by establishing rules respecting their sale to prevent the misuse of non-combination products and combination products and reducing the risk of their diversion to the illegal production of the controlled substance methamphetamine. Health Canada has restricted the retail sale of these products to pharmacy settings only and has maintained NAPRA’s NDS condition-of-sale requirements within pharmacy settings. However, a distributor and a licence holder of a non-combination product reported that pharmacies showed limited interest in stocking these products, which may impact some consumer access to them for their intended use. The Ministerial Order is expected to support consumers’ informed purchase of these products from pharmacies for their intended use, ensuring they understand the risks and potential adverse reactions, particularly if used outside their intended use.

Direct Costs

Costs to industry

Health Canada’s Interim Order, published in May 2024, introduced a restriction prohibiting distributors from selling non-combination products to non-pharmacy retailers. This restriction is now being incorporated into this Ministerial Order.

Maintaining the condition-of-sale restrictions for non-combination products will incur no additional costs to industry, as it maintains the same restrictions that had been in place under NAPRA and outlined in the Interim Order before the removal of these products from the NDS. However, the restriction prohibiting distributors from selling non-combination products to non-pharmacy retailers is expected to result in net losses to industry.

Products Containing Pseudoephedrine as the only medicinal ingredient

Industry stakeholders have confirmed that the only licensed product containing pseudoephedrine as the only medicinal ingredient is exclusively sold in pharmacies. Therefore, businesses associated with this product are not expected to be impacted by the Ministerial Order.

Products Containing Ephedrine as the only medicinal ingredient - Distributors

There are three products containing ephedrine as the only medicinal ingredient that are expected to continue to be impacted by the new wholesale and distribution restrictions, each distributed by one of three distributors who are also the licence holders of these authorizationsfootnote 13. Feedback from industry consultations was used to estimate their net losses. Canadian distributors, who previously sold non-combination products, indicated that they were unable to redirect sales to pharmacies to mitigate revenue losses, citing limited interest in stocking these products, which may be due to low consumer demand for their intended use.

As a result, the total direct net loss for the three distributors resulting from the sales prohibition is estimated to be $481,012 annuallyfootnote 14.

Costs to Government

Health Canada is expected to incur ongoing costs to enforce the Ministerial Order. More specifically, these costs will be related to verifying compliance and conducting enforcement activities such as stop sales, suspensions, licence cancellations, or product seizures. The costs are estimated at approximately $30,000 annually, which will be absorbed by Health Canada using existing resources.

Net Direct Impact

The total net direct cost to both industry and to the Government of Canada is estimated to be $511,012 annually.

Indirect Costs

Costs to industry

The Ministerial Order will introduce condition-of-sale restrictions for these products. While some provinces and territories already have similar restrictions in place, most provinces and territories had incorporated by reference condition-of-sale restrictions previously outlined in NAPRA’s requirements for NHPs containing ephedrine and/or pseudoephedrine. Health Canada will also expand the wholesale and distribution restrictions to include combination products, restricting wholesale of these products to pharmacy retailers only.

Combination Products

There are no impacts expected for combination products, as none of these products are currently marketed. However, new licence applications for such products have been received by Health Canada since the Interim Order was established. If these products are approved and marketed, licence holders will be able to sell them in pharmacy retailers under the Ministerial Order.

Applicants may not be able to recover the costs already incurred in preparing the applications. However, these costs will be treated as indirect, since the Ministerial Order does not prohibit sales outright and applicants retain the option to sell their products in pharmacies.

Products Containing Ephedrine as the only medicinal ingredient – Contract Manufacturers

Distributors (i.e. licence holders of these products) rely on contract manufacturers for production. The impact on contract manufacturers is determined to be indirect, as regulatory changes are directed to licence holders. At the time of the Interim Order, only one manufacturer was producing these products. Since Health Canada received no feedback from impacted manufacturers, net losses were estimated using average retail prices and pharmaceutical profit margins as proxiesfootnote 15. The net loss is estimated to be $371,767 annuallyfootnote 16.

Small business lens

The Policy on Limiting Regulatory Burden on Business defines a small business as any business, including its affiliates, that has fewer than 100 employees or less than $5 million in annual gross revenues. Based on feedback received from industry, it is assumed that distributors of non-combination products are small businesses. These small businesses are estimated to incur net losses of $481,012 annually as a result of the sales prohibition to non-pharmacy retailers, approximately $160,337 per business.

One-for-one rule

The one-for-one rule does not apply, as there is no incremental change in administrative burden on business.

Regulatory cooperation and alignment

The Ministerial Order is not related to a work plan or commitment under a formal regulatory cooperation forum. However, the Ministerial Order ensures consistent regulatory oversight of non-combination and combination products across Canada.

Condition-of-sale restrictions for non-combination and combination products under federal legislation would align with those that are currently in place in provinces such as British Columbia and Quebec, ensuring consistent oversight of these products across Canada and aligning with rules previously in place under NAPRA’s NDS.

In addition, condition-of-sale restrictions for non-combination products under the Ministerial Order would better align with those that are currently in place under the United States Food & Drug Administration, which require sellers to place these products where they cannot be directly accessed by the public, i.e. behind the counter or in a locked cabinetfootnote 17.

Strategic environmental assessment

In accordance with the Cabinet Directive on Strategic Environmental and Economic Assessment, a Climate, Nature and Economy Lens analysis was conducted, and it was concluded that there will be no expected important environmental effects, either positive or negative; therefore, a detailed environmental assessment is not required, and an economic assessment was not required as the proposal is subject to the Cabinet Directive on Regulation.

Gender-based analysis plus

Health Canada expects that the Ministerial Order will have a positive impact on people living in Canada by enhancing safeguards for health and safety and addressing the risks of misuse and diversion from ephedrine and pseudoephedrine NHPs. The proposed restrictions imposed by the Ministerial Order are intended to regulate the availability of non-combination and combination products, and will potentially help to mitigate the risks to public health and public safety associated with the illegal production and sale of methamphetamine and their unintended use on a long-term basis. Reducing the risks associated with misuse and diversion is expected to potentially benefit individuals who are most at risk from their use, particularly in the production and availability of illegal methamphetamine.

Actions to prevent the diversion of ephedrine and pseudoephedrine to the illegal production of methamphetamine are expected to benefit groups affected by illegal methamphetamine production. These benefits are expected to be experienced by all potentially impacted groups or subgroups. Although there are sex/gender differences in adverse health outcomes associated with the consumption of methamphetamine, there is no evidence indicating that the Ministerial Order will result in any potential for disproportionate impacts to any affected groups or subgroups based on sex/gender, socioeconomic, or any other such characteristics.

Implementation, compliance and enforcement, and service standards

Implementation

Coming into force

The coming into force of the Ministerial Order will be aligned with the expiration of the Interim Order on May 17, 2025, to ensure that there will continue to be consistent condition-of-sale restrictions across Canada for non-combination products.

Compliance and enforcement

Compliance and enforcement will focus on compliance promotion to help regulated parties understand their responsibilities under law. Enforcement of the Ministerial 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). The actions, tools, and level of intervention used are dependent on the situation, context, and risk to health or safety.

Service standards

There are no service standards associated with this proposal.

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, ON
K1A 0K9
Address Locator: 3000A
Email: lrm.consultations-mlr@hc-sc.gc.ca