Exemption Order in Respect of Foods for a Special Dietary Purpose: SOR/2025-248

SUPPLEMENT

Canada Gazette, Part II, Volume 159, Number 26

Registration
SOR/2025-248 December 9, 2025

FOOD AND DRUGS ACT

Whereas the Minister of Health believes on reasonable grounds that the annexed Order is necessary for a health or safety purpose or is otherwise in the public interest;

And whereas the Minister of Health believes on reasonable grounds that, having regard to its benefits and conditions, the annexed Order is unlikely to result in unacceptable health, safety or, if applicable, environmental risks or an unacceptable degree of uncertainty respecting health, safety or, if applicable, environmental risks;

Therefore, the Minister of Health makes the annexed Exemption Order in Respect of Foods for a Special Dietary Purpose under section 30.05footnote a of the Food and Drugs Act footnote b.

Ottawa, November 26, 2025

Marjorie Michel
Minister of Health

Exemption Order in Respect of Foods for a Special Dietary Purpose

Interpretation

Definitions

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

List
means the document entitled List of Human Milk Fortifiers, Infant Formulas and Formulated Liquid Diets for Exceptional Importation and Sale in the Case of a Shortage or Risk of Shortage that is published by the Government of Canada on its website, as amended from time to time. (Liste)
Regulations
means the Food and Drug Regulations. (Règlement)
shortage,
in respect of a human milk fortifier, human milk substitute or formulated liquid diet that is sold in Canada, means a situation in which the supply of a category of that food is insufficient to meet the demand for it. (pénurie)

References to manufacturer

(2) In sections 6 to 10, with the exception of paragraph 7(a), a reference to manufacturer is to be read as a reference to a manufacturer of a human milk fortifier, new human milk substitute or formulated liquid diet to which the exemption under section 3 applies.

Words and expressions

(3) Unless the context otherwise requires, words and expressions used in this Order have the same meaning as in Part A, B or D of the Regulations, as applicable.

PART 1
Shortage or Risk of Shortage

Class Exemptions — Certain Human Milk Fortifiers, New Human Milk Substitutes and Formulated Liquid Diets

Foods manufactured outside Canada — exemption criteria

2 Every human milk fortifier, new human milk substitute and formulated liquid diet that is manufactured outside Canada and meets the following criteria is exempt from the application of the provisions set out in section 4:

Foods manufactured in Canada — exemption criteria

3 Every human milk fortifier, new human milk substitute and formulated liquid diet that is manufactured in Canada for consumption or use outside Canada and meets the following criteria is exempt from the application of the provisions set out in section 4:

Exemptions

4 A human milk fortifier, new human milk substitute or formulated liquid diet to which the exemption under section 2 or 3 applies is exempt from the application of

Conditions

Notification of importation

5 (1) An importer of a human milk fortifier, new human milk substitute or formulated liquid diet to which the exemption under section 2 applies must notify the Minister, in writing, of the importation of each shipment of the food at least five days before the day on which it is imported.

Information — notification

(2) The notification must set out the following information in respect of the food:

Notification of sale

6 (1) A manufacturer of a human milk fortifier, new human milk substitute or formulated liquid diet to which the exemption under section 3 applies must notify the Minister, in writing, of the sale of each lot of the food at least five days before the day on which it is sold.

Information — notification

(2) The notification must set out the following information in respect of the food:

Document

7 If any information shown on the label of a human milk fortifier, new human milk substitute or formulated liquid diet to which the exemption under section 2 or 3 applies does not comply with one or more of the labelling provisions that would otherwise be applicable under Part A, B or D of the Regulations, the importer or manufacturer, as the case may be, must prepare a document that sets out the following information:

Document — copy to Minister

8 (1) The importer or manufacturer, as the case may be, of a human milk fortifier, new human milk substitute or formulated liquid diet to which the exemption under section 2 or 3 applies must provide a copy of the document referred to in section 7 to the Minister prior to the first sale of the food to which the document relates.

Updated document

(2) If the document is updated, the importer or manufacturer, as the case may be, must provide a copy of it to the Minister prior to the first sale of the food to which the updated document relates.

Notification of risk

9 The importer or manufacturer, as the case may be, of a human milk fortifier, new human milk substitute or formulated liquid diet to which the exemption under section 2 or 3 applies must notify the Minister immediately, in writing, of information in respect of any risk of injury to human health that they receive or become aware of in relation to the food.

Notification — foreign regulatory authority

10 If a human milk fortifier, new human milk substitute or formulated liquid diet that belongs to a category of food set out in column 1 of Part A or B of the List is no longer authorized by a corresponding foreign regulatory authority set out in column 2 for sale in a corresponding jurisdiction set out in column 3, the importer or manufacturer, as the case may be, must notify the Minister, in writing, immediately after becoming aware of that fact.

Document — copy to purchaser or consumer

11 Any person that sells a human milk fortifier, new human milk substitute or formulated liquid diet to which the exemption under section 2 or 3 applies must make a paper copy of the document referred to in section 7 available to the purchaser or consumer at the time of sale.

Sale of human milk fortifiers

12 A human milk fortifier to which the exemption under section 2 or 3 applies may only be sold in the following situations:

PART 2
Transition Strategy Products

Class Exemptions — Certain Human Milk Fortifiers and New Human Milk Substitutes

Foods — exemption criteria

13 Every human milk fortifier and new human milk substitute for which the following criteria are met is exempt from the application of the provisions set out in section 14:

Exemptions

14 A human milk fortifier or new human milk substitute to which the exemption under section 13 applies is exempt from the application of

Conditions

Document

15 If any information shown on the label of a human milk fortifier or new human milk substitute to which the exemption under section 13 applies is information that would otherwise be required under the Regulations to be shown in both official languages but that information is shown in only one official language, the importer must prepare a document that sets out that same information in the other official language.

Notification of risk

16 The importer of a human milk fortifier or new human milk substitute to which the exemption under section 13 applies must notify the Minister immediately, in writing, of information in respect of any risk of injury to human health that they receive or become aware of in relation to the food.

Notification — foreign regulatory authority

17 If a human milk fortifier or new human milk substitute to which the exemption under section 13 applies is no longer authorized by a foreign regulatory authority in a jurisdiction referred to in paragraph (a) of that section for sale within that jurisdiction, the importer must notify the Minister, in writing, immediately after becoming aware of that fact.

Document — copy to purchaser or consumer

18 Any person that sells a human milk fortifier or new human milk substitute to which the exemption under section 13 applies must make a paper copy of the document referred to in section 15 available to the purchaser or consumer at the time of sale.

Sale of human milk fortifiers

19 A human milk fortifier to which the exemption under section 13 applies may only be sold in the following situations:

Coming into Force

Publication

20 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: Foods for a special dietary purpose (FSDP) such as infant formulas (IFs), human milk fortifiers (HMFs) and formulated liquid diets (FLDs) serve as a critical source of energy and essential nutrients for certain vulnerable people in Canada with specific nutritional needs. A shortage in FSDP can have serious and potentially fatal consequences on the health of individuals who rely on them. Currently, there are no regulations in place under the Food and Drugs Act (FDA) to help mitigate a shortage or risk of shortage of these foods. In the absence of such regulations, Health Canada has had to primarily rely on administrative measures to permit access to critical FSDP during past shortages. However, administrative measures do not provide a predictable and sustainable tool to permit continued and future access to these foods in the event of a shortage or risk of shortage.

Description: The Exemption Order in Respect of Foods for a Special Dietary Purpose (the Order) is a Class Exemption Order that contains two parts:

  • Part 1 enables the exceptional importation and/or sale of certain FSDP in the case of a shortage or risk of shortage, by exempting foods that meet the class criteria from specified provisions of the FDA and Food and Drug Regulations (FDR); and
  • Part 2 permits the continued exceptional importation and sale of IFs and HMFs that are part of Health Canada’s Transition Strategy while the pre-market review for these foods is underway, by exempting them from specified provisions of the FDA and FDR.

To ensure that the Order’s exemptions do not introduce unacceptable health and safety risks, specific conditions relating to the food’s label, notifications to the Minister of Health (the Minister) and restrictions on the sale of HMFs are imposed under this Order.

Rationale: The Order is a regulatory tool that will allow future shortages and risks of shortages of certain FSDP in Canada to be addressed in a responsive and transparent manner. It will also support the continued importation and sale of FSDP that are part of Health Canada’s Transition Strategy. The Order will benefit all people in Canada who rely on these foods, as well as their caretakers, by permitting ongoing access to critical IFs, HMFs and FLDs. In the event of a future shortage or risk of shortage, the Order is expected to generate cost and time savings for industry and Health Canada by exempting products from certain provisions of the FDA and FDR. Some additional administrative and operational costs for industry, Health Canada and the Canadian Food Inspection Agency are also expected as a result of the Order. However, these costs are estimated to be low. Health Canada consulted stakeholders, including on matters related to the cost-benefit analysis, to seek feedback on the development of the Order and to inform its expected impacts. Overall, stakeholders supported the proposal and provided feedback on the proposal’s scope of products, exemptions, labelling conditions and Health Canada’s process to establish that a shortage/risk of shortage exists.

Issues

FSDPfootnote 1 are foods that have been specially processed or formulated to meet the particular requirements of an individual in whom a physical or physiological condition exists as a result of a disease, disorder or abnormal physical state; or to be the sole or primary source of nutrition for an individual. Examples of FSDP include IFs, HMFs and FLDs, the majority of which are imported into Canada from a limited number of manufacturing facilities worldwide. Significant disruptions to FSDP access could have serious, potentially fatal consequences for the health of the individuals who rely on them.

In recent years, Canada experienced shortages of certain FSDP. Given the absence of shortage regulations for these foods under the FDA, Health Canada primarily relied on administrative measures, namely the (ARCHIVED) Interim policy on the importation and sale of infant formulas, human milk fortifiers and dietary products for the treatment of inborn errors of metabolism to mitigate shortages (the shortages interim policy), which was set to expire on December 31, 2025, to maintain a supply of these critically necessary foods on the Canadian market. Unlike regulatory tools, administrative measures do not provide long-term regulatory certainty and predictability for stakeholders, including the general public.

While the shortages recently experienced have largely subsided, the risk of future shortages remains. Therefore, it is in the public interest to maintain access to the foods that were exceptionally imported through the shortages interim policy to continue to stabilize the Canadian market. In addition, continued reliance solely on administrative measures does not provide the government with a formal instrument that could be quickly mobilized to address FSDP shortages in the future. As such, it is critical that a transparent and predictable tool be made to permit continued and future access to certain critical FSDP.

Background

IFs, HMFs and FLDs are FSDP that are considered by Health Canada to present the highest risk to human health if a shortage occurs. They are regulated under the FDA and subject to specific regulatory requirements as outlined in Part B of the FDR. In particular:

Shortages Interim Policy & Transition Strategy

In February 2022, a key foreign supplier of FSDP for the global and North American markets was closed for several months. Powdered IFs and other FSDP products made by the plant were affected, resulting in a shortage of these critical foods in Canada.

To address the immediate crisis, Health Canada published the shortages interim policy in March 2022. It recommended that the Canadian Food Inspection Agency temporarily exercise enforcement discretion with respect to the application of the FDA and FDR for products identified in the policy’s Appendix that was maintained by Health Canada. Operationally, this permitted the temporary importation and sale of IFs, HMFs and other FSDP that did not fully comply with the FDA and FDR, in particular pre-market, labelling and compositional requirements.

For IFs, the shortage initially affected the supply of specialized formulas for infants with medical or special dietary needs. However, as the shortage evolved, regular powdered IFs also became increasingly difficult to access. Families in Canada experienced limited availability of IFs for several months throughout 2022 and into 2023.

As of September 2023, the Canadian supply of regular IFs began to stabilize. However, the prolonged nature of the shortage highlighted the vulnerability of Canada’s FSDP supply chain, which relies heavily on imports from the United States. Furthermore, Canada has limited domestic manufacturing capacity.

In December 2023, Health Canada introduced the (ARCHIVED) Transition strategy to prepare for the expiration of Health Canada’s interim policy to mitigate infant formula shortages (Transition Strategy). The Transition Strategy was published to clarify the regulatory pathway for manufacturers committed to staying on the Canadian market beyond the expiration of the shortages interim policy on December 31, 2025. Its aim was to improve product diversity in Canada and further bolster the country’s resilience to future supply chain disruptions.

The Transition Strategy set out a process to transition the products from a temporary status under the shortages interim policy to full compliance with the FDA and FDR, so that they could be legally imported and sold in Canada on a long-term basis.

Objective

The objective of the Order is to permit access to certain FSDP by enabling the:

Specific conditions are imposed under the Order to ensure that the exemptions do not introduce unacceptable health and safety risks.

Description

The Order is organized in two parts:

Both parts of the Order only exempt from the application of specified provisions of the FDA and FDR.

Importers and domestic manufacturers would still be required to have a Safe Food for Canadians licence to import or manufacture FSDP products and would continue to be subject to the applicable provisions of the Safe Food for Canadians Act and Safe Food for Canadians Regulations.

Part 1 (Shortage or Risk of Shortage)

Scope

Part 1 of the Order applies to IFs,footnote 3 HMFs and FLDs. These products may be either foreign or domestically manufactured and must meet the class criteria described below on an ongoing basis. These FSDP may be exceptionally imported and/or sold in Canada to help mitigate a shortage or risk of shortage of these foods even though these foods do not fully meet all applicable requirements of the FDA and FDR.

Class criteria for foreign-manufactured FSDP

To be exceptionally imported and sold under Part 1, a foreign-manufactured IF, HMF or FLD must:

Class criteria for domestically-manufactured FSDP

To be exceptionally sold under Part 1, an IF, HMF or FLD that was domestically-manufactured for consumption or use outside of Canada must:

Only the quantities of the food that are redirected for sale in Canada are captured under the Order.

The List

The List is incorporated by reference in the Order and will be amended from time to time as needed in accordance with the guiding principles outlined in Health Canada’s Incorporation by Reference Policy. The List provides a mechanism for Health Canada to respond in a timely and flexible manner to a future shortage or risk of shortage of certain FSDP.

For the purposes of Part 1 of the Order, a shortage is defined as a situation in which the supply of a category of IF, HMF or FLD sold in Canada is insufficient to meet the demand for it. A risk of shortage is a situation where it is anticipated that the Canadian supply of a category of IF, HMF or FLD will be insufficient to meet the demand for it.

Part A of the List will set out the categories of foreign-manufactured foods that are permitted for exceptional importation and sale, if the applicable criteria set out in the Order are met. Part B of the List will set out the categories of domestically-manufactured foods that are permitted for exceptional sale, if the applicable criteria set out in the Order are met.

Column 1: A category of food will be added to Part A or B of the List on the basis of evidence of a shortage or risk of shortage in the supply of that category of food and where enabling the exceptional importation and/or sale of the FSDP is considered necessary to help mitigate the shortage or risk of shortage in question.

Evidence of a shortage or risk of shortage may be brought to Health Canada’s attention from sources such as an FSDP manufacturer, importer, distributor, and/or the health care community. Health Canada may also identify a shortage or risk of shortage through the Department’s own monitoring and intelligence gathering activities.

Columns 2 and 3: Both the food safety standards and the quality standards of an FRA will be taken into consideration before column 2 of the List is populated. These factors are considered to ensure that the exceptional importation and/or sale of foods authorized for sale in these jurisdictions are unlikely to result in unacceptable risks to the health and safety of people in Canada.

Exemptions

Part 1 of the Order exempts an IF, HMF or FLD belonging to the designated class from specified provisions of the FDA and FDR. These exemptions are necessary to permit the exceptional importation and/or sale of these foods despite them not being fully compliant with all applicable requirements of the FDA and FDR.

For labelling requirements, Part 1 of the Order broadly exempts the foods from all labelling provisions in Parts B and D of the FDR, including bilingual labelling requirements and product specific requirements under Divisions 24 (FLDs) and 25 (IFs, HMFs). In the case of HMFs, Part 1 of the Order also broadly exempts these foods from all labelling provisions in Part A of the FDR.

For compositional requirements, Part 1 of the Order exempts the foods from the application of the following compositional requirements of the FDA and FDR:

In addition, Part 1 of the Order exempts the foods from the application of pre-market requirements under Division 25 (infant foods) and Division 28 (novel foods) of the FDR.

Conditions

To ensure that the Order’s exemptions do not introduce unacceptable health and safety risks, the following conditions apply to the exceptional importation and/or sale of foods under the Order:

Labelling

Under Part 1 of the Order, if the label of the food does not comply with existing labelling requirements under the FDR, the following labelling conditions must be met:

These labelling conditions ensure that the purchasers and consumers of foods sold under this Order have access in both official languages to the critical information necessary for their safe preparation, use and storage.

Notification of importation

This condition requires Canadian importers of IFs, HMFs or FLDs captured under Part 1 of the Order to notify the Minister of each incoming shipment of food at least five days before its arrival in Canada. The written notification must include certain information about the food:

Notification of sale

This condition requires the Canadian manufacturer of domestically-manufactured IFs, HMFs or FLDs captured under Part 1 of the Order to notify the Minister at least five days before the sale of each lot of the food. The written notification must include certain information about the food:

For both the Notification of importation and the Notification of sale, the information will support Health Canada’s ability to effectively manage the shortage or risk of shortage as it unfolds. In addition, these conditions will support the Department’s communications with federal, provincial and territorial governments and health care partners who look to Health Canada for information and updates during emergency situations.

Notification of risk

The Order includes a condition that requires Canadian importers and Canadian manufacturers of an IF, HMF or FLD that is being exceptionally imported and/or sold in Canada to immediately notify the Minister, in writing, of any information related to any risk of injury to human health that they receive or become aware of in relation to the food. This condition helps to ensure that appropriate action can be taken by the Government of Canada to protect the health and safety of people in Canada should a potential risk to health be identified.

Notification regarding FRA

This condition requires Canadian importers and Canadian manufacturers to immediately notify the Minister, in writing, if they become aware that the food that is being exceptionally imported and/or sold in Canada is no longer authorized by the FRA for sale in a corresponding jurisdiction. If a food is no longer authorized for sale by the FRA, it will cease to be included in the class of foods that benefit from the exemptions under Part 1 of the Order and will therefore no longer be permitted for exceptional importation and/or sale in Canada.

Sale of an HMF

Consistent with existing requirements under B.25.019 of the FDR, the Order restricts the sale of foreign-manufactured and domestically-manufactured HMFs to ensure that they are only used when a medical professional has determined that they are required. The sale of an HMF is only permitted from:

Part 2 (Transition Strategy Products)

Scope

Part 2 of the Order only applies to a closed list of IFs and HMFs. These products form part of the Transition Strategy through which foreign manufacturers indicated their intention to come into compliance with the FDA and FDR and to continue to sell their products in Canada after the expiration of the shortages interim policy. This class of IFs and HMFs in scope of Part 2 must meet the following criteria:

Once a final decision is made (whether favourable or unfavourable), the IF or HMF will no longer be subject to the Order.

IFs and HMFs that are captured under Part 2 of the Order are excluded from Part 1 of the Order.

Exemptions

Part 2 of the Order exempts Transition Strategy products from the application of certain provisions of the FDA and certain pre-market, labelling and compositional provisions applicable to IFs and HMFs under Parts A, B and D of the FDR.

As Part 2 relates to the closed list of Transition Strategy products for which Health Canada already has information for labels and composition, certain exemptions are either not required or are more targeted in Part 2 as compared to Part 1.

The exempted labelling provisions include:

Similar to Part 1 of the Order, Part 2 exempts Transition Strategy products from the application of the following compositional provisions of the FDA and FDR:

Part 2 of the Order also exempts Transition Strategy products from the pre-market requirements under Division 25 (infant foods) and Division 28 (novel foods) of the FDR.

Conditions

As with Part 1, to ensure that the exemptions under Part 2 of the Order do not introduce unacceptable health and safety risks, the following conditions apply:

Labelling

Most Transition Strategy products currently imported for sale have FDR compliant bilingual labels. However, a small number of these products are being imported and sold with unilingual labels. In these latter cases, Part 2 of the Order requires that Canadian importers prepare a document that sets out the same information as found on the unilingual label in the other official language.

A paper copy of this document must be made available to the purchaser or consumer when the food is sold.

These conditions ensure that purchasers and consumers of the Transition Strategy products have access to the same labelling information in both official languages.

Notification of risk

As with Part 1, Part 2 of the Order requires Canadian importers of Transition Strategy products to immediately notify the Minister, in writing, of any information related to any risk of injury to human health that they receive or become aware of in relation to the food.

Notification regarding FRA

This condition, consistent with Part 1 of the Order, requires Canadian importers to immediately notify the Minister, in writing, if they become aware that the food is no longer authorized by the FRA for sale in that jurisdiction. A change in a Transition Strategy product’s authorization status will result in the food no longer meeting the class criteria for products permitted for exceptional importation and sale in Canada under Part 2 of the Order.

Sale of an HMF

Like Part 1, Part 2 of the Order also restricts the sale of HMFs in accordance with B.25.019 of the FDR. The sale of an HMF is only permitted from:

Regulatory development

Consultation

Health Canada published two notices of intent to seek stakeholder feedback on the development of the Order. To assess potential costs and benefits of the Order, the Department also sought responses from stakeholders on two cost-benefit analysis (CBA) surveys.

Notice of Intent #1: October 1, 2024 to November 15, 2024

A total of four submissions were received from interested parties in response to the first Notice of Intent. Respondents provided suggestions and adjustments to specific components of the 2024 proposal, such as its scope, the labelling condition and notification requirements. The feedback was considered as part of the revisions made to the proposal in 2025.

Notice of Intent #2: June 30, 2025 to August 14, 2025

In 2025, Health Canada further revised the proposal for the Order to better align with the authority under section 30.05 of the FDA. The updated proposal also took into consideration the feedback received from stakeholders as part of the first Notice of Intent.

A total of eight submissions were received from industry, health professional organizations and consumers. Stakeholders were generally supportive of the proposal and provided feedback mainly related to Part 1 of the Order. Feedback pertaining to the components of the Order was considered by Health Canada and key highlights are summarized below.

Establishing shortages and risks of shortages

Comments: Two respondents called for greater transparency and ongoing information sharing from Health Canada regarding the factors and process to be used to determine whether there is a shortage or risk of shortage. Specifically, the respondents suggested that consideration should be given to the availability of ’equivalent’ or ’suitable’ alternative products, not simply alternatives. In addition, stakeholders suggested that the availability of Transition Strategy products be considered. One of the respondents was also opposed to mandatory reporting of supply chain disruptions for the Order.

Response: Every potential shortage or risk of shortage situation will be considered on a case-by-case basis. To establish a shortage or risk of shortage for a given category of IF, HMF or FLD, Health Canada would rely on evidence from a variety of sources, including discussions with implicated stakeholders, such as the FSDP industry, retailers, provincial and territorial governments, FRAs, and public health professionals and organizations. The Department would also rely on its own proactive monitoring and intelligence gathering activities.

As part of the process, factors to be considered would include the availability of suitable alternative products in Canada, including Transition Strategy products, where applicable.

The provision of information from sources to Health Canada is voluntary. The Order does not require mandatory reporting of supply chain disruptions to Health Canada.

Scope

Comments: Several respondents commented that the proposed scope of Part 1 of the Order was too narrow and should be expanded to include other FSDP such as sole source nutrition formulas and oral nutrition supplements, as well as metabolic products and other specialized products captured under Division 24 of the FDR. Two respondents also recommended that the closed list of Transition Strategy products in Part 2 of the Order be included in the scope for Part 1.

Response: IFs, HMFs and FLDs were selected for the scope of the Order as they are considered to pose the highest risk to human health should a shortage occur. They are also recognized under the FDR as specific categories of food and are subject to a distinct set of requirements. Furthermore, they were amongst the most impacted products during the FSDP shortage in 2022 and 2023.

Metabolic products, while also impacted by past shortages, require unique circumstances for access and therefore are not included in the scope of the Order. Their access will continue to be managed through the Interim policy statement on foods for special dietary use for inherited metabolic disorders. Other terms for FSDP used in foreign jurisdictions, such as sole source nutrition formulas and oral nutrition supplements are not defined under the FDR. However, these products may fall within the scope of Part 1 of the Order if they are considered an IF, HMF or FLD under the FDR.

Through the proposed regulatory modernization initiative to update Divisions 24 and 25 of the FDR, Health Canada plans to establish a shortages framework for all FSDP.

In terms of Part 2 of the Order, it supports the continued importation and sale of the Transition Strategy products until Health Canada completes its review of the pre-market submissions. If a disruption in the supply of a Transition Strategy product results in a shortage or risk of shortage of a category of food, that category of food could be added to the List to permit the exceptional importation and sale of foods under Part 1 of the Order.

Foreign jurisdictions

Comments: One stakeholder recommended that Health Canada pre-approve foreign jurisdictions so that products can be rapidly imported for sale in response to a shortage or risk of shortage. The respondent also suggested that Health Canada communicate regulatory differences on its website.

Response: The choice of which FRAs and jurisdictions to add to the List will be based on the circumstances of the particular shortage or risk of shortage. It will also depend on the Department’s familiarity with and confidence in the food safety and quality standards of a given FRA. Additional information on the departmental considerations when adding an FRA and jurisdiction to the List is detailed further in the Regulatory cooperation and alignment section of this document.

Labelling conditions

Comments: Five respondents, including industry and health stakeholders, expressed concerns with the proposed labelling conditions for Part 1 of the Order. Respondents highlighted the time, human and financial resources needed to prepare and affix paper copies of the core labelling document or to distribute copies to retail locations. They noted that this could delay the delivery of products to address a shortage. Some respondents also noted that making the documents available in self-selection areas (e.g., on store shelves) could create challenges for retailers to manage document access and availability. As an alternative to the paper copy document, stakeholders recommended that Health Canada permit the use of digital options, such as QR codes on labels, to make the labelling information available to consumers.

Two respondents recommended that Health Canada permit a direct translation of the existing label found on the product instead of requiring the use of a standardized template.

One respondent was supportive of the option to have the paper copy document affixed to products.

Response: The labelling conditions under Part 1 of the Order aim to ensure that all consumers and purchasers have timely and equal access to the core information needed to safely and correctly use exceptionally sold FSDP in the official language of their choice.

Health Canada acknowledges the benefits of digital labelling, such as QR codes, and supports its use as a complementary measure, but not as a replacement to the paper copy document. While many caregivers are digitally literate, not all consumers can or wish to access critical product information digitally. Reliance on digital labelling formats alone may inadvertently exclude vulnerable populations during a shortage. Requiring that a physical copy of the core labelling information be made available to consumers in both official languages at the time of purchase helps to ensure fair and equal treatment, and is consistent with Canada’s official language obligations.

The core information required under Part 1 aligns generally with international labelling standards for these products. As such, Health Canada expects that most product labels already include the required information in at least one official language. Therefore, the associated costs/efforts may relate mainly to making the information available in the other official language. Labelling costs are discussed further in the Regulatory Analysis section. In addition, under the second Notice of Intent, Health Canada had proposed to require the use of a standardized template. However, upon further consideration and based on stakeholder feedback, the use of the standardized template will not be required. The template will be published online as a guide to help manufacturers and importers.

Food contamination standards

Comments: One stakeholder recommended that products remain subject to Canadian food contamination standards.

Response: FSDP that are exceptionally imported and/or sold under the Order will remain subject to the contaminant standards applicable under the FDA and FDR. The Order does not exempt foods from Division 15 of Part B of the FDR. Furthermore, the exemption in relation to paragraphs 4(1)(a) or (d) of the FDA is limited to the specific types of substances set out in the Order, which do not include toxins, chemical contaminants, pathogens, and other poisonous or harmful substances or adulterating substances.

Cost-Benefit Analysis Survey #1: October 3, 2024 to December 20, 2024

Two responses were received from stakeholders on this first CBA survey. These two individual businesses provided input on the economic impacts to their business related to the various components of the first Notice of Intent proposal.

Cost-Benefit Analysis Survey #2: June 30, 2025 to August 14, 2025

Health Canada sent a follow-up CBA survey to stakeholders on the revised proposal for the Order. A total of one response was received.

Indigenous engagement, consultation and Modern Treaty obligations

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.

In addition, a United Nations Declaration Consistency Analysis was conducted. 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 Declaration on the Rights of Indigenous Peoples (UN Declaration) are apparent.

Instrument choice

The following non-regulatory and regulatory options were considered.

Option 1: Continue to rely on the shortages interim policy (status quo)

Administrative measures, such as interim policies, serve as short-to-medium term solutions to allow Health Canada to rapidly address specific public health incidents or needs. While the shortages interim policy was an effective tool for managing the shortages experienced in 2022 and 2023, it is not an appropriate long-term solution. Extending the shortages interim policy past its December 31st, 2025, expiration date was considered but deemed inappropriate as the practice of relying on enforcement discretion lacks regulatory certainty and transparency.

Option 2: Propose regulatory amendments to the FDR

While shortage regulations exist for drugs and medical devices, the FDR does not currently include a regulatory framework for the exceptional importation and/or sale of foods, including FSDP, during a shortage or risk of shortage. Health Canada is proposing a regulatory modernization initiative to update Divisions 24 and 25 of the FDR which includes a framework for FSDP shortages; however, additional time is required to complete and implement that regulatory proposal. During this additional time, Health Canada would have needed to extend the expiration date of the shortages interim policy and continue to rely on enforcement discretion for the Transition Strategy products and in the event of another shortage or risk of shortage.

Option 3: Bring forward a class exemption order (chosen option)

The exemption authority under subsection 30.05 of the FDA authorizes the Minister to exempt by order, on any conditions that they consider necessary, a class of foods, therapeutic products, persons or activities from the application of all or any of the provisions of Part I, section 37 of the FDA or the regulations. It is intended, in part, to help address market gaps, disruptions or vulnerabilities, such as shortages for therapeutic products and foods that pose a risk to the health or safety of Canadians. The class exemption order made under this authority provides a mechanism by which future shortages and risks of shortages of certain FSDP can be quickly addressed as they arise. In addition, the Order provides a framework to enable the continued importation and sale of Transition Strategy products until Health Canada completes its review of pre-market submissions under the FDR.

Health Canada proceeded with Option 3 after determining it to be the most appropriate instrument choice until future regulatory amendments can be made to formalize a framework for FSDP shortages under the FDR.

Regulatory analysis

Benefits and costs

The CBA aims to inform stakeholders of the impacts of the Order. It applies exclusively to Part 1 of the Order based on the assumptions outlined below. To analyze the benefits and costs associated with the exemptions and conditions, Health Canada considered input from industry experts, public health and health care professionals, subject-matter experts at Health Canada and the Canadian Food Inspection Agency, the shortages interim policy and other internal data. It is anticipated that the total cost as a result of the Order would be $231,249 present value, discounted at 7%. This translates to an annual cost of $63,593, undiscounted. As per the Cabinet Directive on Regulation: Policy on Cost-Benefit Analysis, regulatory proposals expected to impose less than $1 million nationally in average annual costs are considered low-cost impact proposals.footnote 5 The total estimated net savings from the Order is $5.5 million present value, discounted at 7%.

Baseline versus Regulatory Scenario

Under the baseline scenario, regulated parties would continue to conduct activities outlined as part of the shortages interim policy. However, the administrative mechanisms would no longer be in place when the shortages interim policy expires. Therefore, in the event of a future shortage or risk of shortage, regulated parties would be required to comply with the existing FDA and FDR requirements. Pre-market review for products that form part of the Transition Strategy and are captured under Part 2 of the Order, are assumed to be completed prior to another shortage or risk of shortage. Transition Strategy products that are not fully compliant with the FDA and FDR would no longer have access to the Canadian market. Therefore, for the purpose of the CBA, it was assumed that the Transition Strategy products would be included in the baseline as they would no longer be subject to this Order.

Under the regulatory scenario, Part 1 of the Order enables the exceptional importation and/or sale of certain FSDP that meet the class criteria, in the case of a shortage or risk of shortage, by exempting them from specified provisions of the FDA and FDR. It will apply to foreign-manufactured IFs, HMFs and FLDs authorized for sale in and imported from designated foreign jurisdictions. It will also apply to domestically-manufactured IFs, HMFs and FLDs that are authorized for sale in designated foreign jurisdictions and no longer intended for export. To ensure that the Order’s exemptions do not introduce unacceptable health and safety risks and to support Health Canada’s ability to effectively manage a future shortage or risk of shortage situation as it unfolds, the Order will impose specific conditions relating to the food label, notifications to the Minister, and restrictions on the sale of HMFs.

It is difficult to predict at what future point a category of IF, HMF or FLD, as well as an FRA and its jurisdiction may be added to the List to address a shortage or risk of shortage. While short-term FSDP-related supply disruptions in Canada have occurred in the past, these events have been rare and temporary.footnote 6 Taking into account the historically limited occurrences of FSDP-related shortages, it is assumed that the probability and potential impact of a future shortage of IFs, HMFs and FLDs in Canada is low. For the purposes of the CBA, Health Canada can assume that there may be one FSDP-related shortage every 10 years.

Costs

I. Industry
Labelling Conditions

In most cases, IFs, HMFs and FLDs that are exceptionally imported and/or sold under the Order will not carry bilingual labels nor have all the information required by the FDR for these foods on their labels. For products that do not comply with existing FDR requirements, Part 1 of the Order will require either the importer or the manufacturer, as the case may be, to prepare a paper copy document that clearly sets out the core labelling information in both official languages and require anyone who sells the food in Canada to provide the paper copy document to the purchaser or consumer. This will help ensure that consumers, parents, health care practitioners and caregivers have access to the core information needed to safely prepare, use and store any products that are exceptionally imported and/or sold under the Order, in the official language of their choice. These labelling conditions are expected to result in additional operational costs for industry. These costs may include professional translation services, printing, procurement, staff resources and/or training to ensure accurate distribution of the required labelling information. This would likely require a one-time cost to translate their product labels and a cost per paper copy of said label to be provided to the consumer or purchaser. Health Canada distributed a CBA survey to industry stakeholders seeking information to estimate how much this condition could cost, with only one qualitative response provided. Due to limited data, this cost could not be quantified at the time of the analysis.

Notification Conditions

Under the Order, regulated parties will be required to provide notifications relating to importation, sale, health and safety, and changes in FRA authorizations of their products. Though relatively low, it is expected that industry may incur additional costs related to the preparation and submission of these required notifications. This could include compiling the necessary information, verifying its accuracy, and submitting it to Health Canada through the appropriate channel. There may also be costs associated to staff coordination, and ensuring consistency across notifications. Based on feedback received from the initial CBA survey, it is estimated that industry could incur a cost of $334 to provide notifications per year. The resources required to prepare and submit these required notifications would be considered administrative burden and are therefore also included in the one-for-one rule section below.

II. Government
Establishing shortages or risks of shortages

Determining whether there is a shortage or risk of shortage will be established on a case-by-case basis by Health Canada. Evidence of a shortage or risk of shortage may be brought to the Department’s attention from any number of sources, such as an FSDP manufacturer, importer, distributor, FRAs and/or the health care community. Health Canada may also identify a shortage or risk of shortage through the Department’s own monitoring and intelligence gathering activities. As the shortage interim policy was set to expire on December 31, 2025 (and was excluded from the regulatory scenario), activities related to establishing a shortage or risk of shortage will be conducted under the Order. Additional costs associated with assessing evidence could require staff time, involving specialized efforts to analyze data based on clinical relevance and supply conditions, and anticipating the emerging risks of a shortage. These additional costs may also include increased ongoing engagement and coordination efforts with industry stakeholders, public health and health care professionals and other relevant parties on the evidence of a shortage or risk of shortage. It is estimated that Health Canada could incur a cost of $46,028 to assess evidence per year based on recent experience with the shortages in 2022 and 2023.

Compliance and Enforcement

Under the Order, in the event of a future shortage or risk of shortage, it is estimated that the Canadian Food Inspection Agency could incur a cost of up to $17,231 per year for compliance and enforcement related activities including implementation efforts, additional staff coordination and support, and operational delivery facilitation. It is expected that the frequency of planned compliance and enforcement activities may not increase nor have an impact on the Canadian Food Inspection Agency’s Inspectorate resources as a result of the Order. However, if food safety incidents occur involving FSDP that have been imported and/or sold under the Order, the Canadian Food Inspection Agency could incur additional costs to conduct food safety investigations which will be dependent on the number, context and level of risk to public health of these incidents.

Benefits

I. Industry
Pre-market Review Exemptions

For IFs and HMFs that belong to a category identified on the List, they will not need to meet the Division 25 requirements of the FDR for pre-market notification (IF) or pre-market authorization (HMF). These products will benefit from reduced burden of market entry while on the List and can expect some savings. They will be exempt from the pre-market standard review time of 410 calendar days, permitting their expedited access to the Canadian market.footnote 7 It is expected that the exemptions under the Order would enable a broader range of products to be imported and sold, increasing flexibility and market opportunities. The Order is anticipated to improve operational efficiency for industry stakeholders by helping them maintain supply continuity during a future shortage or risk of shortage.

Compositional Exemptions

The Order exempts IFs, HMFs and FLDs from certain compositional requirements of the FDA and FDR to permit their accelerated access to the Canadian market during a future shortage or risk of shortage. Industry is expected to save time and costs related to reformulation of their products to meet Canadian specific standards. Based on feedback received from the initial CBA survey, it is estimated that the savings from the compositional exemptions could be up to $712,601.

Labelling Exemptions

Part 1 of the Order would exempt from applicable labelling provisions in Parts A, B and D of the FDR, including bilingual labelling requirements. This may generate savings for industry stakeholders compared to the baseline, where they would incur additional costs and time to relabel their products to carry a bilingual label that includes all the necessary information required by the FDR in the event of future shortage or risk of shortage. Due to limited evidence, estimated savings could not be quantified at the time of the analysis.

II. Government
Response Capabilities

The Order would support Health Canada’s capacity to respond in a timely manner to future shortages or risk of shortages by exempting classes of FSDP from the application of certain provisions of the FDA and FDR. The categories of foods identified in the List for exceptional importation and/or sale can be adjusted as the situation evolves.

The Order would also contribute to improved transparency and accountability in regulatory processes. Clearly defined exemptions and conditions in the event of a future shortage or risk of shortage are expected to promote consistency in requirements across stakeholder groups while also reinforcing public trust in Health Canada as a regulatory authority. This clarity would help facilitate enforcement and compliance activities by the Canadian Food Inspection Agency and improve operational efficiency across departments. It would also reduce the burden associated with case-by-case decision-making for individual products during a future shortage and support better coordination between Health Canada, the Canadian Food Inspection Agency and relevant stakeholders.

Pre-market Reviews

Pre-market reviews involve detailed evaluations of a product’s safety, quality, labelling and compositional aspects, which are subject to a service standard of 410 calendar days with costs incurred by Health Canada. Under the Order, IFs and HMFs are exempt from the application of pre-market review requirements of the FDR. Health Canada is instead relying on the authorization by a designated FRA for sale of the product in their jurisdiction to permit access to critical IFs, HMFs and FLDs during a future shortage or risk of shortage. The estimated savings from the pre-market review requirement exemptions are $883,249 per year. The savings may vary based on the complexity and volume of the pre-market review submissions.

III. Public systems and People in Canada

A shortage or risk of a shortage of IFs, HMFs and FLDs can place a significant burden on public health and social systems, as well as individuals and families that rely on them. These products are essential for some vulnerable people in Canada, often serving as a sole or primary source of nutrition. The Order would reduce the risk of adverse health outcomes by helping to stabilize supply during a future shortage or risk of shortage, which would ease pressure on public health systems, support timely and reliable access to these critical products, and support better health outcomes. The Order is expected to reduce stress on individuals and families who rely on these products by introducing greater transparency and predictability in the availability of IFs, HMFs and FLDs during a future shortage or risk of shortage. It is anticipated that individuals and families will feel more reassured and supported during these challenging times knowing that suitable alternatives of IFs, HMFs and FLDs more likely remain accessible for their medical and dietary needs.footnote 8

The Order supports continuity of care and would help mitigate the impacts of future product shortages within the public health care system. When access to medically necessary nutrition products is compromised, there is a heightened risk of increased hospital visits, longer hospital stays, and potential long-term health complications. The Order would proactively mitigate these risks through a structured regulatory approach and contribute to the overall resilience and efficiency of the health care system.

Requiring that a paper copy of the core labelling information be made available to purchasers and consumers in both official languages at the time of purchase helps ensure fair and equal access to product information and is consistent with Canada’s official language obligations, including during emergency situations such as a shortage. It is expected to also enhance clarity on the required labelling content, prevent errors in understanding, promote consistency and support comparability by enabling alignment on the type of labelling information across the different products to help consumers make informed decisions in the official language of their choice.

Small business lens

The Department does not anticipate any impact on small businesses. Based on the experience under the shortages interim policy, all businesses that entered the Canadian market appeared to be well established and large-scale with significant international operations. Consequently, it is assumed, similar to previous experiences with FSDP-related shortages, that the Order will not impact small businesses during a future shortage or risk of shortage.

One-for-one rule

The one-for-one rule applies since there is a potential incremental increase in administrative burden on business, and the Order is considered burden “IN” under the rule. No regulatory titles are repealed or introduced. Under the Order, regulated parties will be required to provide notifications relating to importation, sale, health and safety, and changes in FRA authorizations of their products. The resources required by businesses to prepare and submit these required notifications would be considered administrative burden. It is assumed that these activities would require businesses to spend 30 minutes for each notification at a rate of $31.04 an hour,footnote 9 and there would be two notifications per year. The annualized increase in administrative burden to businesses is estimated at $55 ($2012) or $5 ($2012) per business.

Regulatory cooperation and alignment

The Order is not part of a formal regulatory cooperation plan. However, relying on conditional exemptions from regulatory requirements to facilitate rapid access to products in urgent or special situations is not unique to Canada and is a common practice among regulators globally. For example, the United States implemented the Access to Baby Formula Act in 2022 to enable families to have continued access to IFs during emergencies by providing temporary waivers for certain regulations and restrictions that could limit formula availability during emergencies.footnote 10 In other instances, as in the United Kingdom and Australia/New Zealand, mechanisms exist within their respective food legislation and/or regulations to address market disruptions and ensure continued access to specialized products, including IFs. Though these measures do not necessarily mirror the mechanics of this Order, nor are they limited to shortages, they operate under the same principle of providing measured and calculated flexibilities from domestic requirements that would otherwise prevent access to necessary products.

As well, the food safety and quality standards of an FRA and their jurisdictions will be taken into consideration before they are included on the List. This approach was also used to enable the temporary importation and sale of products under Canada’s shortages interim policy.

For Part 1 of the Order, a key factor in determining whether to add an FRA to the List is the alignment of its regulatory requirements with the standards of the Codex Alimentarius Commission (Codex). Codex is an international organization established by the Food and Agriculture Organization and the World Health Organization, which develops international food standards, guidelines, and codes of practice to help facilitate international trade and maintain consistent quality and safety across borders.footnote 11 The four jurisdictions set out in Part 2 of the Order (the United States, United Kingdom, European Union and Australia) are also members of Codex and have FSDP regulatory frameworks that generally align with Codex standards.

As a member of Codex, Canada works with other members, including its major trading partners, on the development and maintenance of Codex standards and strives to harmonize Canadian regulatory requirements for IFs, HMFs and FLDs with international norms to facilitate trade and protect consumer health.

While Codex standards are technically voluntary, they act as the internationally recognized benchmarks for food safety and quality, particularly under the World Trade Organization’s (WTO) Agreement on Technical Barriers to Trade (TBT Agreement) and Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement). Per these agreements, if an FRA chooses not to align its national food regulations with a Codex standard, it must notify the WTO and provide a scientific rationale for the decision. These notifications permit Health Canada to review the nature and rationale for the deviation and whether it would ultimately impact an FRA’s inclusion for the purposes of the Order.

Effects on the environment

In accordance with the Cabinet Directive on Strategic Environmental and Economic Assessment (SEEA Directive), a preliminary scan concluded that a strategic environmental and economic assessment is not required.

Gender-based Analysis Plus

FSDP are a critical source of energy and essential nutrients for individuals who rely on these foods. Therefore, shortages of these products are a pan-Canadian issue with the potential to affect a broad range of demographic groups in Canada, including infants who may depend on IFs as their sole source of nutrition as an alternative to breastmilk. Evidence from Canadian and American sources suggests that certain subpopulations, such as families with lower incomes, families residing in remote and rural areas, and Black and Indigenous communities may be disproportionately impacted by an FSDP shortage.footnote 12 Overall, Health Canada’s improved capacity to alleviate such shortages will directly benefit all impacted groups by permitting access to certain essential IFs, HMFs and FLDs.

The Order is not expected to disadvantage people in Canada based on their age, sex, gender, race, culture, or other socioeconomic or demographic characteristics.

During the shortages experienced in 2022 and 2023, the limited supply of FSDP on the Canadian market led some families to source IFs outside of their home province or directly from foreign jurisdictions like the United States.footnote 13 Families with lower incomes were at a greater disadvantage as they were less likely to have the time and resources to find and purchase suitable alternatives. Families residing in remote and rural areas also reported being less likely to have access to IF products in their local communities given the variable distribution and availability of FSDP across Canada.footnote 14 Similar challenges were also reported in the United States.footnote 12footnote 15

A United States study published in 2023 that investigated mothers’ experiences during the 2022 IF shortage and its perceived impacts on infants’ diet and health, showed disproportionate adverse impacts on Black mothers and mothers from low-income households.footnote 16 Racial and ethnic disparities still exist in breastfeeding initiation.footnote 17 Furthermore, Black mothers are twice as likely to receive in-hospital formula introduction compared to Caucasian mothers.footnote 18 This suggests that Black and racialized populations may be at a higher reliance on formula and would be more affected when there is a shortage of IFs.

Indigenous women have some of the lowest breastfeeding initiation and duration rates of all women in Canada. According to 2009-2010 data from Statistics Canada, breastfeeding initiation rates for Indigenous women are 77.8%, compared with 88% for non-Indigenous women.footnote 19 Though overall rates appear to have improved since then (average of 81.5% for First Nations, Métis and Inuit women according to 2022 data), this still remains below the 91.4% rate for non-Indigenous women.footnote 20 These statistics suggest a potentially greater reliance on IFs by Indigenous women, and therefore, certain Indigenous communities may be more negatively affected than other communities during an IF shortage. The potential greater impact of shortages on Indigenous communities may be further exacerbated by the fact that roughly 60% of Indigenous Peoples in Canada live in predominantly rural and remote areas, which generally experience a lower socioeconomic status.footnote 21 These factors can create unique challenges in accessing goods and services, including IFs and other FSDP, especially during times of scarcity.

Implementation and compliance and enforcement

Implementation

This Order comes into force upon publication in the Canada Gazette, Part II.

The Order allows Transition Strategy products captured under Part 2 to continue to be exceptionally imported and sold in Canada to permit continued access for people who rely on these foods. Once Health Canada has reviewed the pre-market submissions for these products and delivered final decisions, the Transition Strategy products will no longer be subject to the Order and will instead be subject to all applicable provisions and requirements of the FDA and FDR.

As previously mentioned, the exceptional importation and/or sale of IFs, HMFs or FLDs is only intended to be triggered when there is evidence of a shortage or risk of shortage in the supply of products in Canada. If a shortage or risk of shortage is established, the List will be revised to specify the relevant food category as well as the FRAs and their corresponding jurisdictions where products for exceptional importation and/or sale must be authorized for sale. When a shortage or risk of shortage for an identified category is resolved, Health Canada will amend the List to remove that category. At that time, the exceptional importation and/or sale of the identified category of food will no longer be permitted under the Order.

To support the implementation of the Order, Health Canada will publish a guidance document following the publication of the Order in Canada Gazette, Part II. This guidance document will aid Canadian importers and manufacturers, involved in the exceptional importation and/or sale of FSDP, in understanding and complying with the conditions of the Order.

For greater transparency, Health Canada will also publish administrative lists of individual products being exceptionally imported and/or sold under Part 1 and Part 2 of the Order. This approach will help ensure people in Canada are aware of the products being imported and sold under exceptional circumstances. An administrative list linked to a shortage or risk of shortage under Part 1 of the Order will be updated by Health Canada based on notifications received from importers and manufacturers. Once the shortage or risk of shortage is resolved, any associated administrative list will be revised accordingly. For Part 2 of the Order, the administrative list of Transition Strategy products will be revised to remove individual products as Health Canada completes its reviews of the pre-market submissions and makes final decisions.

Compliance and enforcement

The Canadian Food Inspection Agency is responsible for the enforcement of the FDA and FDR as they relate to food. They will apply existing policies and practices to the enforcement of this Order. This includes taking a risk-based approach to the conduct of inspection activities and the determination of appropriate measures in the case of non-compliance. Such measures, which are based on the risk and the severity of non-compliance, can include: verbal and/or written notifications, product detention, product recall and/or prosecution. The Canadian Food Inspection Agency will engage Health Canada as needed, to contribute to risk assessment or risk communication decisions.

Contact

Debra Haltrecht
Acting 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: 3001
Email: lrm.consultations-mlr@hc-sc.gc.ca