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Proposed risk-based approach for the authorization of infant food for a special dietary purpose

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List of abbreviations

FDA
Food and Drugs Act
FDR
Food and Drug Regulations
EC
European Commission
FRA
Foreign regulatory authority
FSANZ
Food Standards Australia New Zealand
FSDP
Food for a special dietary purpose
FSDU
Food for special dietary use
FSMP
Food for special medical purposes
HMF
Human milk fortifier
IbR
Incorporation by reference
NGO
Non-governmental organization
NIFI
New infant food ingredient
SMPPi
Special medical purpose product for infants
US FDA
United States Food and Drug Administration

1.0 Introduction

Health Canada is advancing the modernization of Divisions 24 and 25 in Part B of the Food and Drug Regulations (FDR), which set out regulations for foods for special dietary use (FSDU)Footnote 1 and infant foods.

To date, Health Canada has undertaken two pre-consultations on the modernization of Divisions 24 and 25. The first consultation, which ran from November 28, 2023 to February 26, 2024, proposed a restructuring of the current regulatory framework, including details on how the modernized framework would remove the term FSDU and create a framework to regulate "food for a special dietary purpose" (FSDP)Footnote 2. The term FSDP was introduced into the Food and Drugs Act (FDA) in 2019 as part of a broader legislative modernization. Its purpose is to enable a more tailored regulatory approach for the higher-risk products that fall within this definition. Of relevance to the present consultation, these include infant formula and medical foods for infants such as human milk fortifiers (HMF). The 2023 pre-consultation paper proposed that most infant FSDP would be subject to pre-market authorization and committed to review its pre-market assessment timelines. The second consultation, which ran from October 23, 2024 to January 22, 2025, set out proposed compositional requirements for many of the foods covered under Divisions 24 and 25, including infant formula.

Health Canada's proposal to amend the regulations to require pre-market authorization for most infant FSDP generated mixed reactions. While this change would simply formalize the current practice and received support from some stakeholders, others stressed the need to align more closely with international jurisdictions and to implement oversight that is risk-based.

To address these concerns and to align with the Government of Canada's recent commitment to modernize outdated regulations and reduce red tape, this proposal sets out a risk-based approach to the oversight of infant FSDP, with requirements scaled according to product complexity and uncertainty. The proposed approach is designed to support access to products and reduce unnecessary regulatory burden, while maintaining rigorous safety standards for the vulnerable populations who use them.

1.1 Purpose

The purpose of this pre-consultation document is to present Health Canada's proposed risk-based approach for the authorization of infant FSDP. Stakeholder comments to this proposal will inform the drafting of regulations to be pre-published in the Canada Gazette, Part I for public comment. Section 5.0 outlines the proposed risk-based authorization approach, while Section 6.0 offers guiding questions for stakeholders.

1.2 Scope and definitions

The scope of this proposal is limited solely to the authorization of infant formula and fortified medical foods for infants.

Infant formula

For the purpose of this proposal, infant formula is defined as "any food that is labelled or advertised for use as a partial or total replacement for human milk and is intended for consumption by infants". In the context of this consultation paper, this includes:

Fortified medical food for infants

For the purpose of this proposal, medical food for infants is defined as "a food, other than infant formula, that has been specially processed or formulated and is intended for the dietary management of infants, to be used under medical supervision. It is intended for the partial feeding of infants:

  1. with a limited or impaired capacity to take, digest, absorb, metabolize, or excrete ordinary food or certain nutrients contained therein, or metabolites, or
  2. with other medically determined nutrient requirements

whose dietary management cannot be reasonably achieved by modification of the normal diet alone".

The term 'fortified' refers to the addition of vitamins, minerals and amino acids to foods to restore or improve their nutritional quality. Therefore, a fortified medical food for infants contains added nutrients. An example of a fortified medical food for infants is an HMF.

Exclusions

This proposal excludes other aspects of the Division 24 and 25 modernization project. Specifically, other food categories - such as medical foods for ages one or more - or elements like product composition and labelling for infant formula and medical foods for infants are scoped out. It also excludes non-fortified medical foods for infants (for example, food thickeners), which, while meeting the definition of medical foods for infants, are not within the scope of this proposal as there are no proposed authorization requirements for these. Unless otherwise specified, references to "medical foods for infants" throughout this document refer to fortified medical foods only. All components of Division 24 and 25 modernization will be addressed in a broad regulatory package to be published in Canada Gazette, Part I.

1.3 Guiding principles

Health Canada's proposed risk-based approach for the authorization of infant FSDP is underpinned by the following guiding principles:

  1. Ensuring safety, nutritional adequacy and quality
    • All infant FSDP sold in Canada would continue to meet rigorous regulatory standards to protect the vulnerable population who uses them.
  2. Enhancing access, reducing barriers to importation and supporting innovation
    • Timely access to a diverse range of infant FSDP, including innovative products and/or products available globally, would be facilitated.
  3. Implementing risk-based regulatory oversight
    • Oversight would be tailored to product complexity and uncertainty, so that regulatory review is proportionate to potential risk.
  4. Improving regulatory efficiency
    • Modernized regulatory processes would increase efficiency, reduce administrative burden and support the Government of Canada's commitment to reduce red tape.

To support these guiding principles, the proposed approach incorporates a number of measures, described in Section 5.1.

2.0 Background

2.1 Canada's current approach

Under Division 25 of the FDR, petitioners must notify Health Canada at least 90 days before selling or advertising any new infant formula or one with a major changeFootnote 3. This process requires submitting detailed product information—including composition, labelling, packaging, manufacturing, and nutritional adequacy—as outlined in guidance. The same process applies to both standard and medical infant formula. If the submission is satisfactory, Health Canada issues a Letter of No Further Questions, which petitioners usually await before selling their products, though it's not required by regulations.

For HMF, which were added to Division 25 of the regulations in 2021, pre-market authorization is required for any new or majorly changed products. Other medical foods for infants, including unfortified products, do not have specific requirements set out in the regulations.

For both infant formula and HMF, the performance standard is to issue a decision within 410 days for 90% of submissions.

A submission is also required for any new ingredient that has not been previously used in an infant formula or an HMF in Canada. If the ingredient is determined to be a novel food (as defined under Division 28 of the FDR), then a pre-market assessment is conducted to support its safe use in the general population, including infants. If the ingredient is determined not to be novel for use in the general population, Health Canada's current approach, set out in guidance, requires a pre-market safety review of the new infant food ingredient (NIFI) in the infant population. In either case, the ingredient must be assessed as safe prior to permitting its use in infant formula.

2.2 Canada's 2023 proposed approach

In 2023, Health Canada consulted on a proposal to expand the requirement for pre-market authorization, which is currently in place for HMF, to all new and majorly changed infant formula and fortified medical foods for infants. Health Canada also committed to review the timelines for pre-market assessment with the objective of expediting the process for less complex submissions.

To address concerns about review timelines and the management of proprietary information, the 2023 pre-consultation paper recommended establishing regulations that would require a NIFI to receive a separate pre-market authorization before a submission for an infant formula containing that NIFI could be made. It was also proposed that the onus would lie with the NIFI manufacturer to submit the pre-market request rather than the infant formula manufacturer that uses a NIFI.

3.0 Stakeholder engagement

The 2023 proposal to amend the regulations to require pre-market authorization for all infant formula as opposed to the current pre-market notification requirement generated mixed reactions. While this change aligns with the current approach for HMF and received support from a few stakeholders (two non-governmental organizations (NGOs), one regional public health authority, one industry representative and one consultant), a few industry representatives raised significant concerns, specifically regarding:

In contrast, one NGO emphasized that medical infant formulas should be subject to enhanced scrutiny, particularly regarding the justification for their composition.

Industry stakeholders raising concerns noted that enabling faster market entry for new infant formulas would support trade, foster innovation, and enhance the availability and diversity of products in Canada. Recommendations to expedite timelines included applying a risk-based approach, leveraging decisions from other competent regulatory authorities and considering history of safe use.

Regarding medical foods for infants, one industry stakeholder recommended an expedited pre-market notification process, taking into account approvals and history of safe use in other countries. A different industry stakeholder expressed support for the proposal that unfortified medical foods for infants would not be subject to pre-market authorization requirements.

Several recommendations emerged from stakeholder input on the NIFI submission process. It was suggested that NIFI submissions be permitted from either the NIFI manufacturer, the infant formula producer, or jointly by both parties. Additionally, stakeholders advocated for the acceptance of concurrent submissions for both the NIFI and the infant formula that would contain the NIFI, or for the evaluation of the NIFI to be integrated within the infant formula submission process itself. There was also strong support for considering new ingredient approvals granted by other jurisdictions in order to streamline processes.

4.0 International context

US Food and Drug Administration

Under the US Food and Drug Administration's (US FDA's) regulatory frameworkFootnote 4, a pre-market notification approach applies to all infant formula, including medical infant formula and certain medical foods for infants which are regulated as exempt infant formulas. All infant formulas sold in the US must meet regulatory requirements, including compositional standards. However, exempt infant formulas, intended for specific medical conditions, may deviate from standard nutrient specifications for medical purposesFootnote 5. Manufacturers must register with the US FDA and provide notification of new infant formulas or modifications to existing formulas 90 days prior to distribution.

New ingredients that are Generally Recognized as Safe (GRAS) for use in infant formula are not required to undergo pre-market approval by the US FDA. In order to be considered GRAS and acceptable for use in infant formula, the ingredient must meet the GRAS provisions of the Federal Food, Drug and Cosmetic ActFootnote 6. Manufacturers of infant formula are strongly encouraged to notify the US FDA of their self-determination of GRAS before submission of a new infant formula notificationFootnote 7. However, the US FDA recently announced plans to publish a proposed rule that would make the submission of GRAS notices for new food ingredients mandatory. This proposed rule would eliminate self-affirmed GRAS determinations, require all GRAS conclusions to be submitted to FDA for review and expand the public inventory of GRAS notices to increase transparencyFootnote 8.

European Union - European Commission

The EU European Commission (EC) has a post-market notification system for infant formula. Infant formulas sold in EU countries must comply with detailed compositional standardsFootnote 9.

In EU countries, medical infant formulas and medical foods for infants are regulated as food for special medical purposes (FSMP) and are also subject to post-market notification. FSMP are intended for the exclusive or partial feeding of infants whose nutritional requirements cannot be met by normal foods. Products can deviate from prescribed FSMP compositional requirements to achieve their intended medical purposeFootnote 10.

Substances that can be added to infant formula and FSMP are set out in a positive list. Pre-market review is required to permit new substances to be added to the listFootnote 9,Footnote 10.

Food Standards Australia New Zealand

In Australia, infant formula products, including those intended for medical purposes, are permitted to be sold without notification or assessment by Food Standards Australia New Zealand (FSANZ), as long as the product complies with the regulations, including compositional requirementsFootnote 11. Medical infant formulas (regulated as special medical purpose product for infants (SMPPi)) generally follow standard infant formula composition; however, deviations are permitted to meet specific medical needs. The SMPPi category does not include specialised medical products for infants that are not used as the sole or principal source of nutrition (for example, HMF); rather these are regulated as FSMPFootnote 12.

The substances added to infant formula and SMPPi must be on the list of permitted ingredients. Substances not on the list must undergo pre-market assessment by FSANZ, followed by the standard process for making amendments to the regulationsFootnote 11, Footnote 12.

5.0 Overview of the proposed risk-based authorization approach for infant food for a special dietary purpose

In alignment with the Government of Canada's recent commitment to modernize regulations and reduce red tape, a risk-based approach to the oversight of infant FSDP is proposed. The approach is designed to enhance regulatory efficiency and ensure that oversight is calibrated to the level of risk. It facilitates access to products, reduces barriers to importation, and supports innovation and market diversification, all while maintaining rigorous safety standards to protect the vulnerable population who rely on these products.

As shown in Figure 1, the proposal introduces a three-tiered approach, with regulatory oversight increasing with product complexity and uncertainty:

Figure 1: Proposed risk-based three-tiered approach for authorization of infant FSDP
Proposed risk-based three-tiered approach for authorization of infant FSDP
Title: Text description

A pyramid diagram illustrates Health Canada's proposed risk-based three-tiered approach for authorizing infant FSDP. The pyramid is divided into three horizontal tiers, each a different colour and representing a different level of regulatory oversight.

Beneath the pyramid, the abbreviations used are clarified. FRA stands for foreign regulatory authority; IF stands for infant formula.

  • Tier 1 (bottom, dark blue):
    • Labeled: "~70% Post-market notification."
    • A text box to the left of Tier 1 is connected by a line and lists the types of products that correspond to this category: "Standard IF* manufactured in Canada or in a comparable FRA's†"
  • Tier 2 (middle, medium blue):
    • Labeled "~25% Pre-market authorization with expedited review."
    • A text box to the left of Tier 2 is connected by a line and lists the types of products that correspond to this category: "Medical IF* and medical foods for infants with an established safe use and manufactured in a comparable FRA's†"
  • Tier 3 (top, light blue):
    • Labeled "<5% Pre-market authorization with full review."
    • Three separate text boxes to the left of Tier 3 are connected by a single line and list the types of products that correspond to this category:
      • "Standard IF* containing new macronutrient sources"
      • "Medical IF* and medical foods for infants with no established safe use and/or not manufactured in a comparable FRA's† jurisdiction"
      • "Standard IF* not manufactured in Canada or in a comparable FRA's† jurisdiction"

To the right of the pyramid, an upward-pointing arrow labeled "Level of uncertainty and complexity" indicates that both increase from Tier 1 to Tier 3.

The proposed approach ensures that regulatory resources are focused where they are most needed, while enabling a more agile pathway for lower-risk products. The proposed approach, along with several supporting measures described below, would improve efficiencies, thereby facilitating entry into the market of new and changed products. An overview of the key elements of the proposed risk-based approach are included in the Appendix.

5.1 Supporting measures to improve efficiencies

5.1.1 Leveraging information and/or decisions of foreign regulatory authorities

To support the post-market regime applicable under Tier 1 and to streamline the pre-market assessment process that is applicable under Tier 2, Health Canada would leverage certain information and decisions from foreign regulatory authorities (FRAs) that have comparable standards and rigorous food safety regulations (for example, good manufacturing practices), similar to Canada's. This means that, rather than independently reviewing all aspects of a product or manufacturing process, Health Canada may choose to accept or reference the approvals, assessments, or other information already established under comparable FRAs. Essentially, this would allow Health Canada to build upon the work of reputable international partners to make informed decisions about product authorization and oversight in Canada.

5.1.2 Use of Incorporation by Reference

The proposed framework will be designed to help ensure future updates could be implemented in a timely manner in response to evolving science. To this end, Health Canada proposes to make use of lists incorporated by reference (IbR). IbR documents can be amended administratively following stakeholder consultations. The regulations would include the IbR lists described below.

  1. IbR list of foreign regulatory authorities

    To support Health Canada's risk-based approach to regulatory oversight, it is proposed that comparable FRAs be established in an IbR list. This list would be used to identify which FRAs could be leveraged for certain information, such as manufacturing standards and establishing safe use. Inclusion on the IbR list would be limited to FRAs whose food safety and quality standards are comparable to Canada's and that largely align their regulatory requirements with the standards of the Codex Alimentarius Commission (Codex).

  2. IbR list(s) for composition of standard infant formula

    The compositional requirements for standard infant formula would be based on the latest scientific evidence and aligned with comparable FRAs to the greatest extent possible. Accordingly, Health Canada will be following the work of comparable FRAs with the intent of having Canadian compositional requirements for standard infant formulas that would accommodate products manufactured in these jurisdictions.

    The IbR list(s) for standard infant formula composition would include:

    • Mandatory and optional nutrients with associated minimum and maximum levels, where applicable
    • Acceptable sources of: macronutrients, vitamins, minerals and other substances, where applicable
    • Other optional ingredients (including those currently referred to as NIFIs) with associated maximum levels and specifications, where applicable

Infant formulas that deviate from the IbR list, apart from medical infant formulas whose formulations address a medical need, would not meet the regulations and could not be sold in Canada. Some examples include infant formulas containing a new optional ingredient that is not on the IbR list, and those that have a nutrient level exceeding the maximum amount or a new source material for a vitamin or mineral. In such cases, manufacturers may opt to reformulate their product to align with requirements. Alternatively, manufacturers could petition Health Canada to amend the IbR list to modify the compositional requirements. If the outcome of Health Canada's assessment supports the proposed change, the proposal for modifying the IbR list would undergo a public consultation. If no new scientific information is provided during the consultation period that would require revisions to the proposal, Health Canada would then proceed with formally modifying the IbR list.

Of note, deviations from macronutrient sources would not be addressed through the IbR amendment process. Instead, products containing sources not identified on the IbR list would be subject to pre-market authorization under the Tier 3 stream. Once there is sufficient evidence to allow the use of a new macronutrient source in all infant formulas, the IbR list could be amended to add the source.

For medical foods for infants, no compositional requirements are proposed as these products are specifically formulated to meet the needs of the intended consumer. However, products must be made with acceptable sources of vitamins and minerals identified on the IbR list for composition of standard infant formula. Alternatively, manufacturers could reformulate or petition Health Canada to amend the IbR list.

5.1.3 Approach for optional ingredients (that is, those currently referred to as NIFIs)

Currently, optional ingredients are not included in the FDR's compositional requirements for infant formula but Health Canada conducts a manufacturer-specific pre-market safety review prior to permitting their use in infant formula. The proposed approach would replace manufacturer-specific approvals with generic approvals of ingredients, adopting a model similar to the EU and FSANZ. The standard infant formula composition IbR would list all ingredients previously reviewed and approved by Health Canada for use in infant formula along with relevant specifications.

To address stakeholder concerns regarding the approval process for new optional ingredients, it is proposed not to restrict who may petition Health Canada to amend the IbR list; for example, this would include - but would not be limited to - the infant formula manufacturer or the ingredient manufacturer.

5.1.4 Use of exemptions for medical infant FSDP

  1. Exemptions to allow deviations from compositional requirements

    As conveyed in previous consultations, medical infant formulas would be required to meet the standard infant formula compositional requirements. However, exemptions would be permitted when deviations are necessary to achieve the product's intended medical purpose.

  2. Exemptions to reduce barriers to importation

    Given that medical infant formula and medical foods for infants are vital for vulnerable infants and largely imported into Canada, Health Canada is exploring the possibility of targeted exemptions to certain regulatory requirements, such as deviations in product composition that are not intended to address a specific medical purpose. The purpose of such exemptions would be to reduce barriers to the importation into Canada of products complying with the requirements of the exporting country – provided that the exporting country is represented by an FRA included on the IbR list. Australia, who similarly depends on imports, has a framework that allows for such specific exemptions for SMPPi to help ensure the supply of these essential products for the vulnerable infants who depend on them. Health Canada plans to conduct additional analysis to determine if similar exemptions could be included in the proposed regulatory framework.

5.2 Tier descriptions

5.2.1 Tier 1 ─ Post-market notification

5.2.1.1 Scope

It is proposed that products captured under Tier 1 would be:

Products in Tier 1 must meet the compositional requirements for standard infant formula.

Examples of products captured under Tier 1 include:

5.2.1.2 Rationale

Products captured in Tier 1 carry the lowest level of uncertainty and complexity. Products were assigned to Tier 1 based on the following considerations:

5.2.1.3 Notification requirements

Tier 1 products would be sold without pre-market approval; however, manufacturers/importers would need to submit supporting information to Health Canada via post-market notification no later than the first day of sale in Canada. The notification requirements are still under consideration, but it is anticipated that they would not be onerous (for example it could include a copy of the label, name of importer/manufacturer). This information would support monitoring of products on the Canadian market and assist in ensuring an appropriate response should a shortage or potential shortage arise.

Importantly, the onus would be on manufacturers/importers to ensure that they comply with the regulations. In addition to regulations specific to infant formula, including regulations for the use of food additives in infant foods, manufacturers/importers are responsible for ensuring that their product complies with all applicable legislative and regulatory requirements under the Food and Drugs Act and Regulations and the Safe Food for Canadians Act and Regulations including licensing, traceability, food packaging, labelling and safety. This means that a regulatory amendment request would be necessary for any deviations from the regulations and the request would require approval prior to selling the product.

5.2.2 Tier 2 ─ Pre-market authorization with an expedited review

5.2.2.1 Scope

Two types of products, listed below, are proposed for inclusion under Tier 2. For both categories, products must be manufactured and have an established safe use in a comparable FRA's jurisdiction. Criteria for demonstrating an established safe use are outlined in Section 5.2.2.3.

Recognizing the importance of international alignment and Canada's reliance on imported medical infant FSDP to meet the needs of vulnerable infants, Health Canada is exploring the possibility of targeted exemptions for Tier 2 products as described in Section 5.1.4(ii).

Examples of products captured under Tier 2 are listed in Table 1.

Table 1 - Types of products captured under Tier 2

Product types

Medical infant formulas

Fortified medical foods for infants
  • Pre-term infant formulas
  • Metabolic infant formulas
  • Amino acid-based infant formulas
  • Extensively hydrolyzed protein infant formulas
  • Infant formulas with no added carbohydrates
  • Infant formulas intended for infants with failure to thrive
  • Human milk fortifiers
  • Fortified modulars
  • Semi-solid foods/mixes for ages 6 months and up for the dietary management of medical conditions
5.2.2.2 Rationale

Compared to other products categorized under the 3-tiered system, these products carry a moderate level of uncertainty and complexity. Much like the current framework for HMF, pre-market authorization ensures oversight for these medically necessary products. However, the proposed expedited review leverages information from comparable FRAs to gain efficiencies, enabling quicker access while maintaining safety and quality standards. Products were assigned to Tier 2 based on the following considerations:

5.2.2.3 Submission requirements

As is the case with Tier 1 products, manufacturers/importers are responsible for ensuring that their product complies with all applicable legislative and regulatory requirements under the Food and Drugs Act and Regulations and the Safe Food for Canadians Act and Regulations including licensing, traceability, food packaging, use of food additives, labelling and safety. This means that a regulatory amendment request would be necessary for any deviations from the regulations for a non-medical purpose and the request would require approval prior to Health Canada's review of the infant formula submission. This applies regardless of the exemptions being considered under Section 5.1.4(ii) to reduce barriers to importation.

A full description of submission requirements for Tier 2 products is still under consideration. However, at this time, the following requirements are proposed:

  1. Data to demonstrate an established safe use in a comparable FRA's jurisdiction:
    • Evidence that the product:
      • was reviewed and authorized for use by a comparable FRA, for example, the most recently approved foreign label and a letter of approval from the authorizing FRA

      or

      • has been sold and safely used in the comparable FRA's jurisdiction for a minimum period of two years, for example, expert reports from clinicians who have overseen the product's safe use or FRA reports such as post-marketing surveillance records.

Note that under the latter scenario, a two year period is proposed to allow time for reporting any safety concerns, including adverse reactions, following twelve months of use.

  1. Data to support product composition:
    • For medical infant formulas that differ from standard compositional requirements due to a specific medical purpose, a brief rationale and supporting evidence to justify the variation would be needed.
    • For medical foods for infants, even though there are no prescribed compositional requirements, a concise justification and supporting evidence would be needed to support the product formulation.
5.2.2.4 Expedited pre-market authorization process

It is proposed that manufacturers/importers be required to send a written request to Health Canada to market their product. Upon receipt of the submission, an initial screening would be conducted and an acknowledgement letter would be sent to the petitioner.

It is proposed that the expedited review will focus on verifying safety and nutritional adequacy. For example:

Authority to market the product would occur when the manufacturer/importer receives a written authorization from Health Canada.

5.2.3 Tier 3 – Pre-market authorization with a full review

5.2.3.1 Scope

It is proposed that products captured under Tier 3 would include the same categories of products captured under Tiers 1 and 2, except:

5.2.3.2 Rationale

Compared to other products categorized under the 3-tiered system, these products carry the highest level of uncertainty and complexity. The proposed pre-market authorization approach with full review would mitigate the higher risk of these products associated with the three issues described below.

First, some Tier 3 products are not manufactured in Canada or a comparable FRA's jurisdiction. Conducting a full pre-market review will allow Health Canada to verify that the product complies with key applicable regulatory requirements. It will also permit an assessment of the manufacturing process and quality control procedures to ensure products are produced according to internationally recognized food safety and quality standards.

Second, medical infant formula and medical foods for infants captured under Tier 3 would not have an established safe use in Canada or a comparable FRA's jurisdiction. A full pre-market review would allow Health Canada to assess the nutritional adequacy and safety of the formulation based on clinical evidence.

Finally, for infant formulas using new macronutrient sources, there is limited evidence regarding their role in supporting growth and development in healthy term infants. The Tier 3 pre-market authorization stream would enable Health Canada to evaluate the nutritional adequacy and safety of a product containing a new macronutrient source by reviewing clinical evidence.

5.2.3.3 Submission requirements

As is the case with Tier 1 and 2 products, manufacturers/importers of Tier 3 products are responsible for ensuring that their product complies with all applicable legislative and regulatory requirements under the Food and Drugs Act and Regulations and the Safe Food for Canadians Act and Regulations including licensing, traceability, food packaging, use of food additives, labelling and safety. This means that a regulatory amendment request would be necessary for any deviations from the regulations for a non-medical purpose and the request would require approval prior to Health Canada's review of the infant formula submission.

For products that are not manufactured in Canada or a comparable FRA's jurisdiction, it is proposed that manufacturers/importers be required to submit evidence demonstrating that they are in compliance with regulatory requirements as well as complete details related to the manufacturing process and quality control procedures (for example, data to demonstrate the product was manufactured following good manufacturing practices).

For medical infant formula and medical foods for infants without an established safe use as well as any infant formula containing a new macronutrient source, it is proposed that the manufacturer/importer be required to submit clinical evidence to support the nutritional adequacy and safety of the formulation under the recommended conditions of use. In addition, a rationale to justify the product composition of medical infant formula and medical foods for infants would also be required.

5.2.3.4 Pre-market authorization process

It is proposed that manufacturers/importers be required to send a written request to Health Canada to market their product. Upon receipt of the submission, an initial screening would be conducted and an acknowledgement letter would be sent to the petitioner. Next, Health Canada would conduct an assessment of the required information to determine whether the safety, quality and/or nutritional adequacy of the product have been demonstrated. Components of Health Canada's review are included in the overview table in the Appendix.

Authority to market the product would occur when the manufacturer/importer receives a written authorization from Health Canada.

5.3 Anticipated efficiencies

By shifting the majority of products to a post-market notification regime and expediting pre-market reviews through leveraging information and/or decisions of comparable FRAs, the proposed approach would create significant efficiencies without compromising safety.

Timelines for pre-market review for Tier 2 and Tier 3 products will be proposed in conjunction with the draft regulations and will consider comments to this consultation. However, it is anticipated that review timelines for Tier 2 products would be shorter than those for Tier 3 products.

5.4 Changes to marketed products

Currently, any major change to a marketed infant formula or HMF requires a pre-market submission. Under the modernized regulatory framework, updates to this approach, are proposed.

5.4.1 Changes that maintain compliance with FDR requirements

Changes to marketed infant FSDP – whether standard infant formulas, medical infant formulas or fortified medical foods for infants – would be permitted without notification, provided that the revised product maintains compliance with existing regulations. For example, a change to:

For medical foods for infants, since nutrient levels would not be set out under the FDR, any changes to these levels would necessitate a pre-market authorization request as outlined below.

5.4.2 Changes that require regulatory action

If a change does not comply with the regulations, two pathways apply:

  1. Regulatory amendment request

    A regulatory amendment request would be necessary if the change involves a deviation from the FDR and is not intended for a medical purpose. For example, the revised product contains an ingredient or level not permitted under the FDR, such as an unapproved food additive or a nutrient level exceeding a maximum amount.

    It is anticipated that most regulatory amendment requests would be updates to IbR documents where changes could be made administratively.

  2. Pre-market authorization request

    A pre-market authorization request would be necessary in the following circumstances:

    • The product is no longer manufactured in Canada or within a comparable FRA's jurisdiction
    • A change in manufacturing site or process for a product not manufactured in Canada or within a comparable FRA's jurisdiction
    • The change involves a deviation from the FDR to address a specific medical purpose (for example, based on new clinical evidence), such as, changes to the composition of a medical infant formula
    • The change affects nutrient levels in fortified medical foods for infants.
      • Since fortification levels would not be prescribed under the FDR, a pre-market review would be necessary to support safety.

Of note, pre-market authorization requests could be streamlined for products with an established safe use and/or manufactured in Canada or a comparable FRA's jurisdiction.

6.0 Questions for stakeholders

Health Canada encourages respondents to provide their feedback by responding to the following questions. Please elaborate in your responses where appropriate. For example, if you do not agree with a proposal, please explain why.

  1. Do you support the proposed 3 tiered risk-based approach to infant FSDP authorization?
  2. Do you support the proposed scope of products captured under each tier?
  3. Do you support the proposal to leverage certain information and decisions from comparable FRAs to expedite certain aspects of the pre-market review process?
  4. Do you support the proposed approach to include compositional requirements, including optional ingredients (that is, those currently referred to as NIFIs), through a document that is incorporated by reference to the regulations?
  5. Do you have thoughts regarding whether Health Canada should consider exemptions for medical infant FSDP (that is, Tier 2 products) that comply with the requirements of a comparable FRA to reduce barriers to importation for products complying with the requirements of the exporting country?
  6. Do you support the proposed approach to addressing changes to marketed products?
  7. Do you support the proposal regarding submission requirements proposed under Tiers 2 and 3?
  8. Do you have any additional feedback on aspects that may not have been addressed?

7.0 Conclusion

Health Canada's proposed risk-based approach to the authorization of infant FSDP aligns with the Government of Canada's initiative to modernize outdated regulations and reduce red tape by balancing regulatory oversight with the need to support product innovation, facilitate access to a diverse range of products, and align with FRAs. By scaling requirements according to product complexity and uncertainty, the approach aims to maintain rigorous safety standards for products intended for vulnerable populations while reducing unnecessary regulatory burden and supporting trade. Importantly, these goals are achieved by shifting the majority of products (that is, those with lower risk) to a post-market notification regime and expediting pre-market reviews for moderate-risk products by leveraging information and/or decisions of comparable FRAs, creating significant efficiencies without compromising safety.

Stakeholder feedback is essential to ensure that the regulations are effective and responsive to the needs of consumers, healthcare professionals and industry. Comments received during this pre-consultation will inform the drafting of regulations to be pre-published in the Canada Gazette, Part I for further public input.

Appendix

Overview of key elements of proposed risk-based approach to infant FSDP authorization
Categories Origin of manufacture Must meet compositional & other applicable FDR requirements Deviations from standard composition for medical purposes Review component (i): Compliance with FDR requirements Review component (ii): Manufacturing (safety & quality) Review component (iii): Justification for medical deviation/ composition Review component (iv): Data to demonstrate an established safe use Review component (v): Clinical evidence for medical deviation/ composition Review component (vi): Clinical evidence for new macronutrient source
Tier 1: Post-market notification
IF for healthy term infants Canada or a cFRA's jurisdiction Yes N/A NR NR N/A N/A N/A N/A
Tier 2: Pre-market authorization with expedited review
Medical IF & medical food for infantsTable 2 Footnote a A cFRA's jurisdiction Yes YesTable 2 Footnote b NR NR Yes Yes NR NR
Tier 3: Pre-market authorization with full review
IF for healthy term infants Any jurisdiction other than Canada or a cFRA's Yes N/A Yes Yes N/A N/A N/A N/A
IF for healthy term infants containing a new macronutrient source Any jurisdiction Yes N/A YesTable 2 Footnote c YesTable 2 Footnote c N/A N/A N/A Yes
Medical IF & medical food for infants Canada or any jurisdiction other than a cFRA's Yes YesTable 2 Footnote b YesTable 2 Footnote d YesTable 2 Footnote d Yes N/A Yes YesTable 2 Footnote e

FDR – Food and Drug Regulations; IF – infant formula; cFRA – comparable foreign regulatory authority; N/A – not applicable; NR – not reviewed

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2025-11-26