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Updated Proposal - Ministerial class exemption order for the exceptional importation and sale of certain foods for a special dietary purpose to mitigate a shortage or risk of a shortage

June 30, 2025

Table of contents

Summary

The purpose of this Notice of Intent (NOI) is to outline revisions made to the proposal originally set out in the NOI published on October 1, 2024, in which the Minister of Health signalled Health Canada's intention to make a ministerial exemption order (hereafter referred to as "the proposed Order") for the exceptional importation of certain foods for a special dietary purpose (FSDP) to mitigate a shortage or the risk of a shortage of these products. The revisions to the proposed Order were made to streamline its requirements, to address targeted feedback from stakeholdersFootnote 1, and to better align the proposed Order with the ministerial class exemption authority set out in section 30.05 of the Food and Drugs Act (FDA).

The proposed Order would now consist of two parts. Part 1 would establish a framework for the exceptional importation and sale of certain classes of FSDP should another shortage or risk of a shortage occur. Products for exceptional importation and sale would include foreign-made FSDP authorized for sale in and imported from designated foreign jurisdictions with acceptable food safety and quality standards. It would also include domestically manufactured FSDP that are authorized for sale in designated foreign jurisdictions. Part 2 aims to ensure the continued market access for the infant formula and human milk fortifiers that form part of Health Canada's Transition strategy to prepare for the expiration of Health Canada's interim policy to mitigate infant formula shortages (hereafter referred to as "Transition Strategy").

As noted in the October 2024 NOI, the proposed Order would replace Health Canada's administrative 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 (hereafter referred to as "the shortages interim policy"). Moreover, it remains the intent that the proposed Order be a temporary measure. It would remain in force until shortage-related regulations for FSDP are made as part of work underway as part of Health Canada's Regulatory modernization of foods for special dietary use and infant foods: Divisions 24 and 25 of the Food and Drug Regulations (FDR).

Background

Foods for a special dietary purpose

Foods for a special dietary purpose (FSDP) are food products that have been specially processed or formulated to meet the particular nutritional requirements of individuals with health conditions or to serve as the sole or primary source of nutrition. Examples include human milk substitutes (commonly known as 'infant formula'), human milk fortifiers, formulated liquid diets, and foods to address special dietary needs for a medical condition, such as metabolic products for the dietary management of inherited metabolic disorders (formerly referred to as inborn errors of metabolism).

FSDP serve as a critical source of energy and essential nutrients for vulnerable people in Canada. A significant disruption in access to these products can have serious, potentially fatal consequences on the health of the individuals who rely on them.

Shortages and risk of shortages

A shortage can arise from a range of circumstances, including manufacturing disruptions, difficulties in accessing raw materials, surges in demand, and unforeseen events affecting the global supply chain. In recent years, shortages of FSDP have become a significant concern due to global supply chain issues and product recalls.

Canada is particularly susceptible to shortages of FSDP due to its small market size and reliance on a limited number of predominantly foreign suppliers. Compounding this vulnerability are the outdated regulations under Divisions 24 and 25 of the FDR, which are not consistent with those of like-minded regulatory authorities and main trading partners. This can exacerbate a shortage because it restricts the importation of FSDP available from other countries with similar food safety standards. Moreover, unlike drugs and medical devices for which shortage regulations exist, there is no regulatory framework under the FDR for the exceptional importation and sale of FSDP in the event of a shortage.

In 2022 and 2023, Canada experienced shortages of certain FSDP, including infant formula, human milk fortifiers, and metabolic products for the dietary management of inherited metabolic disorders. In the absence of a shortages regulatory framework for FSDP, Health Canada has relied on the shortages interim policy to permit the importation and sale in Canada of products that do not fully meet Canadian regulatory requirements with respect to labelling and/or composition. This temporary and administrative mechanism relies on the Canadian Food Inspection Agency (CFIA) to exercise enforcement discretion respecting the application of the FDA and FDR to products from other countries that adhere to standards comparable to those upheld in Canada.

While the shortages experienced in 2022 and 2023 have largely subsided and the market has stabilized, the risk of future shortages remains given the market's heavy reliance on a limited number of foreign suppliers. Given this, a regulatory instrument is needed until the necessary amendments to the FDR can be made. A ministerial class exemption order is a new regulatory tool that provides Health Canada with a way to implement appropriate, responsive, and enforceable solutions within the framework of the FDA.

Ministerial class exemption authority

Under subsection 30.05(2) of the Food and Drugs Act, the Minister of Health may, on any conditions that the Minister considers necessary, make a ministerial class exemption order only if the Minister believes on reasonable grounds that

Proposed ministerial class exemption order

Objectives

Part 1 – Shortages and risk of shortages

Proposed scope

Part 1 of the proposed Order would apply to the following classes of FSDP:

IF, HMF and FLD are the classes of FSDP considered to pose the highest risk to human health should a shortage occur.

Note – the transition strategy products are out of scope of Part 1 of the proposed Order. Their importation and sale is covered under Part 2.

Metabolic products

Metabolic products for the dietary management of inherited metabolic disorders are excluded from the scope of Part 1 of the proposed Order. They will continue to be managed through the Interim policy statement on foods for special dietary use for inherited metabolic disorders. Health Canada considered incorporating these products within the scope of Part 1. However, the decision was made to continue to manage them through the interim policy given the unique circumstances and conditions needed to access these specialty products.

Definition of a shortage

For the purposes of Part 1 of the proposed Order, a 'shortage' would be defined as a situation where the supply in Canada of IF, HMF, or FLD that complies with the Food and Drugs Act is insufficient to meet the demand for that food. A 'risk of a shortage' would refer to a situation where it is anticipated that the supply in Canada of IF, HMF, or FLD that complies with the Food and Drugs Act will be insufficient to meet the demand for that food.

Evidence of a shortage

The exceptional importation and sale of a category of IF, HMF or FLD (e.g., hypoallergenic infant formula) is only intended to be triggered when there is credible evidence of a shortage or risk of a shortage in the supply of FDA compliant products, and where enabling the exceptional importation and sale of products authorized for sale in other markets is, in the view of the Minister of Health, necessary to help mitigate the shortage or risk of a shortage.

Determining whether there is a shortage or a risk of a shortage will be assessed on a case-by-case basis by the Minister of Health. Evidence of a shortage or risk of a shortage may be brought to Health Canada's attention from any number of sources, such as an FSDP manufacturer, importer, distributor, and/or the healthcare community. Health Canada may also identify a shortage or risk of a shortage through the Department's own monitoring and intelligence gathering activities.

Example:

If there is a shortage in Canada of FDR-compliant formula A, but sufficient alternatives (i.e., FDR-compliant formulas B, C, D and E) are available to make up the demand normally met by formula A, the Minister may determine that triggering the exceptional importation and sale of infant formula is not necessary. Conversely, if the available supply of FDR-compliant alternatives is insufficient, permitting the exceptional importation and sale of products authorized for sale in other jurisdictions may be necessary to meet demand.

Triggering the exceptional importation and sale of products

Where a shortage or risk of a shortage has been established by the Minister of Health, it is proposed that a two-part incorporated by reference (IbR) list be used to trigger the exceptional importation and sale of products. The IbR list would specify the category of IF, HMF or FLD for which there is a shortage or a risk thereof, as well the foreign regulatory authorities (FRAs)Footnote 2 and markets where products for exceptional importation and sale must be authorized for sale.

In both cases, only those products corresponding to the identified category set out in column 1 of the IbR list and authorized for sale by a corresponding FRA set out in column 2, whether imported from or manufactured for that FRA's jurisdiction, could be exceptionally imported and sold in Canada.

Illustrative example of the proposed IbR list
Item

Column 1

Category of product

Column 2

Foreign regulatory authority (jurisdiction)

 Notes
Part A – Foreign manufactured products for exceptional importation and sale
1 hypoallergenic infant formula
  • Foreign Regulatory Authority A (jurisdiction A);
  • Foreign Regulatory Authority B (jurisdiction B);
  • Foreign Regulatory Authority C (jurisdiction C);
 Item added on 10-06-2028. Ref: M-MOS-28-01
Part B – Domestically manufactured products for exceptional sale
1 hypoallergenic infant formula
  • Foreign Regulatory Authority A (jurisdiction A);
 Item added on 10-06-2028. Ref: M-MOS-28-01

The use of an IbR list would provide the Minister with the flexibility to tailor the exceptional importation and sale as needed to address the particulars of a shortage or risk of a shortage, both at its outset and as it evolves. When a shortage or risk of a shortage for an identified category of product is resolved, the IbR list would be revised to remove the category of product in question, at which point the exceptional importation and sale would no longer be permitted.

The FRAs and jurisdictions added to column 2 of the IbR list would be those where, in the view of the Minister of Health, acceptable food safety and quality standards exist. This would help ensure that permitting the exceptional importation and sale of products from designated jurisdictions is unlikely to result in unacceptable risks to the health and safety of people in Canada.

The IbR list would only specify the categories of IF, HMF or FLD that may be exceptionally imported and sold pursuant to the Order. It would not list individual products. In the event of a shortage or risk of a shortage, supporting communications produced by Health Canada would include an administrative list of individual products being exceptionally imported and sold. This approach would help ensure transparency for consumers and health care providers regarding the products being imported and sold under exceptional circumstances.

Proposed exemptions

Part 1 of the proposed Order would exempt products from specified provisions of the FDA and FDR pertaining to composition, labelling and pre-market review. These exemptions would be necessary to permit the exceptional importation and sale of IF, HMFs and FLDs that do not comply with one or more of these provisions.

Note – The proposed Order would only exempt from the application of specified provisions of the FDA and FDR. Importers and manufactures would still be required to have a Safe Food for Canadians licence (SFC licence) to import or manufacture FSDP products and would continue to be subject to the applicable provisions of the Safe Food for Canadians Act (SFCA) and Safe Food for Canadians Regulations (SFCR).

Proposed labelling exemptions

Part 1 of the proposed Order would exempt from the following labelling requirements of the FDR:

Proposed compositional exemptions

Part 1 of the proposed Order would exempt from the following compositional requirements of the FDA and FDR:

Proposed pre-market review exemptions

Part 1 of the proposed Order would exempt from the following pre-market review requirements of the FDR:

Proposed conditions

Products exceptionally imported and sold pursuant to the proposed Order would be required to meet the following conditions.

1. A document with core labelling information in both English and French must be made available to the purchaser or consumer when the product is sold in Canada.

Products exceptionally imported and sold pursuant to Part 1 of the proposed Order would not, in most cases, carry bilingual labels nor would labels present all the mandatory information in a manner that fully aligns with the applicable requirements in the FDR. To ensure consumers, parents, and caregivers (including health practitioners) have access to the information needed to prepare, consume, administer and store these foods safely and properly, Part 1 of the proposed Order would require that a hard copy document that clearly sets out the following 'core' labelling information be made available to the purchaser or consumer when the product is sold in Canada:

In English or French:

  1. the name of the food's manufacturer and their contact information

In English and French:

  1. the brand name and product name under which the food will be sold or advertised for sale in Canada;
  2. a description of the special dietary purpose for which the food is represented, including an indication of its class (e.g., infant formula, human milk fortifier or formulated liquid diet) and its indication(s) for use;
  3. a list of the food's ingredients;
  4. a statement concerning the presence of food allergen sources, gluten sources and added sulphites in the food;
  5. if aspartame is present, a statement to the effect that the food contains phenylalanine or that aspartame contains phenylalanine;
  6. a statement, expressed in a standardized unit of measure per stated serving, of the following:
    1. the food's energy value;
    2. the quantity of protein, fat, carbohydrate, and, if present, fibre;
    3. the quantity of vitamins, mineral nutrients, and amino acids; and
      1. for infant formula, any other added nutritive substances normally found in human milk;
      2. for human milk fortifiers, any other nutritive substances present in the food
  7. directions for the preparation, use and storage of the food;
    1. for infant formula, directions as per B.25.057(1)(e) of the FDR;
    2. for human milk fortifiers, directions as per B.25.020(1)(e) of the FDR;
    3. for formulated liquid diets, directions as per B.24.103(f) of the FDR
  8. for formulated liquid diets, a statement that the food is intended to be consumed orally or by tube feeding;
  9. the food's expiration date or if the expiration date is located on the packaged product, a statement to the effect that the expiration date is on the food's package, its location, and the format of the expiration date; and
  10. the lot number for the food or if the lot number is located on the packaged product, a statement to the effect that the lot number is on the food's package and its location

In the case of a foreign manufactured food that is being exceptionally imported for sale, the Canadian importer of the food would be responsible for producing the document containing the core labelling information described above. In the case of a domestically manufactured food that was produced for a foreign market but is being redirected for exceptional sale in Canada, the Canadian manufacturer would be responsible for producing the document. To ensure that the information set out in the document is presented to purchasers and consumers in a consistent manner, the proposed Order would prescribe the use of a standardized template prepared by Health Canada.

All core label information would be required to be provided in the hard copy document. For instance, it would not be acceptable for the document to simply include a QR code or web address indicating where the core label information may be found.

The proposed Order would require the person who sells the product to ensure that a hard copy of the document is made available when the product is sold. Here are examples of acceptable means by which the document could be made available:

  1. the document accompanies the food (e.g., is attached to the food's package).
  2. the document is provided to the purchaser or consumer at the time of sale.
  3. where the food is available for sale in an open self-selection area, copies of the document are placed adjacent to the food in a manner that permits the purchaser or consumer to take one (e.g., the document is made available at the point of purchase on the shelf or in a nearby display case).
2. A copy of the document with the core labelling information must be provided to the Minister prior to the food's first sale in Canada. Moreover, if revisions are made to that document, the Minister must be notified and provided with a copy of the revised document.

The proposed Order would not require importers or manufacturers to seek Health Canada's review and approval of the document with the core labelling information. The aim of this condition is to ensure that Health Canada has on record a copy of the information that is being made available to purchasers and consumers.

3. The Minister of Health must be notified in writing of incoming shipments of a product subject to the Order at least five days ahead of the product's arrival in Canada. In the case of a domestically manufactured product, a notification of sale would be required at least five days before the sale of each lot of the product in Canada.

This condition would ensure that Health Canada has access to the information needed to effectively manage a shortage as it unfolds. The notification would be required to provide the following information:

Notification of importation – foreign manufactured products for exceptional importation and sale

  1. the brand name and product name of the food that is being imported for sale in Canada;
  2. the category of food set out in the IbR list under which the imported food is captured as well as the Foreign Regulatory Authority (FRA) and jurisdiction where the food is authorized for sale and from which the food is being imported;
  3. the Canadian importer's name and contact information;
  4. the name and contact information of the manufacturer of the food;
  5. the intended port of entry into Canada;
  6. the estimated date of arrival into Canada of the shipment of the food; and
  7. the estimated number of units of the food (e.g. five hundred 250 ml bottles) in the shipment.

Notification of sale – domestically manufactured products for exceptional sale

  1. the brand name and product name of the food that is for exceptional sale in Canada;
  2. the category of food set out in the IbR list under which the food is captured as well as the Foreign Regulatory Authority (FRA) where the food is authorized for sale;
  3. the Canadian manufacturer's name and contact information;
  4. the estimated number of units of the food (e.g. five hundred 250 ml bottles) for exceptional sale.
4. The Minister of Health must be immediately notified, in writing, if a product that is being exceptionally imported and/or sold pursuant to the Order is no longer authorized for sale by the designated foreign regulatory authority.

To benefit from the proposed Order, a product must remain at all times authorized for sale by the foreign regulatory authority (FRA) set out in column 2 of the IbR list. A change in the product's authorization status would result in the product no longer being within scope of the Order, and thus no longer permitted for exceptional importation and/or sale in Canada. The Canadian importer or Canadian manufacturer would be responsible for notifying the Minister.

5. The Minister of Health must be immediately notified, in writing, of any health and/or safety issues that arise with a product that is being exceptionally imported and/or sold pursuant to the Order.

This would ensure that appropriate action can be taken to protect the health and safety of Canadians should a potential risk to health be identified with an FSDP that is being exceptionally imported and/or sold in Canada. The Canadian importer or Canadian manufacturer would be responsible for notifying the Minister.

6. For human milk fortifiers specifically, the sale of these products remains subject to the conditions set out in B.25.019 of the Food and Drug Regulations.

To ensure HMFs are only used under appropriate medical supervision, B.25.019 sets out restrictions on the sale of these products. Per these restrictions, the sale of HMF is only permitted from:

The intent of this condition is to ensure that these restrictions apply to HMFs exceptionally imported and sold pursuant to Part 1 of the proposed Order.

Part 2 – Transition strategy products

Proposed scope

Part 2 of the proposed Order would only apply to the closed list of IFs and HMFs that form part of Health Canada's Transition Strategy. These transition strategy products are presently set out in Appendix A of the shortages interim policy.

To be in scope of Part 2, the Order would require the following:

  1. The IF or HMF must be authorized for sale by a foreign regulatory authorityFootnote 3 (FRA) in the United States, United Kingdom, European Union, or Australia and must be directly imported from that jurisdiction;
  2. The IF or HMF must be part of Health Canada's Transition Strategy, i.e., it must be a product for which the manufacturer provided a letter of intent by January 1, 2024, and presented a full pre-market submission by July 15, 2024; and
  3. The IF or HMF must be one for which Health Canada has not yet provided a final decision respecting the pre-market submission. Once a final decision is made (whether favourable or unfavourable), the IF or HMF would no longer be within scope of the Order. Transition strategy products for which a favourable decision is rendered can be legally sold in Canada. Where an unfavourable decision is delivered, the product cannot be legally sold. In this latter situation, a new pre-market submission that addresses the reason(s) for the unfavourable decision can be filed with Health Canada, without prejudice, at which time it will be processed as a new submission. However, the new submission would not form part of the Transition Strategy and would therefore not be in scope of Part 2 of the proposed Order.

Note: The list of jurisdictions captures those where the transition strategy products are presently authorized for sale and are being directly imported from.

'Authorized' includes products authorized for sale pursuant to either pre-market or post-market regimes.

Proposed exemptions

Part 2 of the proposed Order would exempt transition strategy products from certain provisions of the FDA and the FDR. These exemptions are necessary to permit the continued importation and sale of these products which do not comply in full with the FDA and FDR.

The proposed exemptions for Part 2, in some respects, mirror those proposed for Part 1. However, because Part 2 of the proposed Order concerns itself with the closed list of transition strategy products for which Health Canada has access to labels and composition, certain exemptions were either not required or are more targeted in nature.

Note – The proposed Order would only exempt from the application of specified provisions of the FDA and FDR. Importers of transition strategy products would still be required to have a Safe Food for Canadians licence (SFC licence) to import and would continue to be subject to the applicable provisions of the Safe Food for Canadians Act (SFCA) and Safe Food for Canadians Regulations (SFCR).

Proposed labelling exemptions

For the most part, the labels of transition strategy products comply with the applicable labelling requirements of the FDR, with a few minor exceptions. The proposed labelling exemptions described below are targeted to accommodate these exceptions.

Part 2 of the proposed Order would exempt transition strategy products from the following labelling requirements of the FDR:

Proposed compositional exemptions

Part 2 of the proposed Order would exempt transition strategy products from the following compositional requirements of the FDA and FDR:

Proposed pre-market review exemptions

Part 2 of the proposed Order would exempt transition strategy products from the following pre-market review requirements of the FDR:

Proposed conditions

The proposed conditions for Part 2 are, in some respects, identical to those proposed for Part 1. However, because Part 2 concerns itself with transition strategy products that are currently being imported for sale in Canada and for which Health Canada has access to labels and composition, certain conditions were either deemed unnecessary (such as import notification requirements) or were slightly adjusted.

1. In the absence of a bilingual (French and English) label on a transition strategy product, a document with the label information in the other official language must be made available to the purchaser or consumer.

As noted in the previous section on proposed exemptions, the majority of the transition strategy products are currently being sold in Canada with bilingual labels. In the few cases where bilingual labels for transition strategy products are still in the process of being developed, the proposed Order would require that a hard copy of the label information in the other official language be made available to the purchaser or consumer when the product is sold.

The importer of the food would be responsible for producing the document containing the label information in the other official language. All the label information in the other official language must be provided in the hard copy document. For instance, it would not be acceptable for the document to only include a QR code or web address where the label information may be found. The format of this document would be left to the importer's discretion.

The importer would not be required to use the standardized template described in Part 1 as the document would only be required to set out the label information in the other (missing) official language.

The proposed Order would require any person who sells the product for which a document has been prepared to ensure that a hard copy of the document is made available when the product is sold. Here are examples of acceptable means by which the document could be made available:

  1. the document accompanies the food (e.g., is attached to the food's package).
  2. the document is provided to the purchaser or consumer at the time of sale.
  3. where the food is available for sale in an open self-selection area, copies of the document are placed adjacent to the food in a manner that permits the purchaser or consumer to take one (e.g., brochures, tear-aways or other handouts made available at the point of purchase on the shelf or in a nearby display case).
2. The importer must immediately notify the Minister of Health, in writing, if a transition strategy product is no longer authorized for sale in the jurisdiction from where it is being imported.

To benefit from the proposed Order, a transition strategy product must remain at all times, authorized for sale in the jurisdiction from which it is being imported. A change in the product's authorization status would result in the product no longer being within scope of the Order, and thus no longer permitted for exceptional importation and sale in Canada.

3. The importer must immediately notify the Minister of Health, in writing, of any health and/or safety issues that arise with a transition strategy product.

This would ensure that appropriate action may be taken to protect the health and safety of people in Canada should a potential risk to health be identified with a transition strategy product that is being exceptionally imported and sold in Canada.

4. For human milk fortifiers specifically, the sale of these products remains subject to the conditions set out in B.25.019 of the Food and Drug Regulations.

To ensure HMFs are only used under appropriate medical supervision, B.25.019 sets out restrictions on the sale of these products. Per these restrictions, the sale of HMFs is only permitted from:

The intent of this condition is to ensure that these restrictions apply to HMFs exceptionally imported and sold pursuant to Part 2 of the proposed Order.

Proposed coming into force

Health Canada's intent is that the proposed Order would come into force before the planned expiration of the shortages interim policy on December 31, 2025. At the time the Order is made, the transition strategy products listed in Appendix A of the shortages interim policy would be subject to Part 2 of the Order. Health Canada would rely on Part 1 of the Order to address any future shortage or risk of a shortage of IF, HMFs or FLDs should one occur.

Public comments

Interested persons may submit their feedback on the Minister of Health's updated proposal as described in this notice within 45 calendar days after the date of publication of this notice (by August 14, 2025).

Feedback may be submitted by email or in paper format to Health Canada's Bureau of Policy, Intergovernmental and International Affairs (BPIIA) at the contact information provided below. Please specify 'NOI_ FSDP Order/AI_Arrêté AFDS' in the subject line of your correspondence.

Contact information

Bureau of Policy, Intergovernmental and International Affairs
Food and Nutrition Directorate
Health Canada
251 Sir Frederick Banting Driveway
Tunney's Pasture, PL: 2204C
Ottawa, Ontario (Canada) K1A 0K9

E-mail: bpiia-bpaii@hc-sc.gc.ca

Footnotes

Footnote 1

Four responses were received from interested parties relating to the October 1, 2024, Notice of Intent. Respondents provided suggestions for adjustments to specific components of the proposal, such as its scope, the labelling condition, and notification requirements for Health Canada's consideration.

Return to footnote 1 referrer

Footnote 2

Per section 2 of the Food and Drugs Act, a foreign regulatory authority means a government agency or other entity outside Canada that controls the manufacture, use or sale of therapeutic products or foods within its jurisdiction.

Return to footnote 2 referrer

Footnote 3

Per section 2 of the Food and Drugs Act, a foreign regulatory authority means a government agency or other entity outside Canada that controls the manufacture, use or sale of therapeutic products or foods within its jurisdiction.

Return to footnote 3 referrer

Page details

2025-06-30