Guidance: Transition strategy to prepare for the expiration of Health Canada’s interim policy to mitigate the infant formula shortages

December 18, 2023

Modified November 14, 2024

The 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  has been further extended until December 31, 2025, specifically for products that have completed the steps outlined in the Transition Strategy.  

Table of contents

1.0 Introduction

Health Canada's 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 (hereinafter referred to as "interim policy") has been an essential tool. It strengthened the infant formula supply in Canada in response to important disruptions occurring in the Canadian market since 2022. The interim policy recommends that the Canadian Food Inspection Agency apply its enforcement discretion with respect to certain provisions of the Food and Drug Regulations (FDR) for eligible infant nutrition products imported to Canada on a temporary basis to mitigate shortages.

Many products are currently eligible for temporary importation from countries with high regulatory and manufacturing standards comparable to those in Canada. They include infant formula sold at retail (regular and hypoallergenic formula) as well as products reserved for medical use (hospital and metabolic products). Before adding a product to the interim policy, Health Canada reviewed information provided by the manufacturer to support their request for temporary importation and to ascertain product safety.

The interim policy was recently extended until December 31, 2024. This extension was intended to ensure market stability and continuity of care in the short term, while Health Canada works on a longer-term approach to manage future shortages of infant formula and other foods for a special dietary purpose and modernize related sections of the regulations. Now that the infant formula market is showing signs of recovery, and the need to add new products to the interim policy is subsiding, there is a need to clarify the regulatory pathway for manufacturers who are dedicated to stay in the Canadian market for the continued sale of listed products after the interim policy expires. This is intended to promote long-term product diversity and a Canadian market that is more resilient to global supply chain disruptions and inflation.

2.0 Transition strategy

The transition strategy enables products to move from a temporary status (via the interim policy) to full compliance with the Food and Drug Regulations (FDR) so they can be sold in Canada on a long-term basis. To participate in the transition strategy, manufacturers must commit to submitting a complete pre-market notification package following the steps and timelines described within this document.

If the steps described below are not followed or the information provided is deemed inadequate for review then the importation of the product would not be allowed after December 31, 2024, when the interim policy expires. Products on the interim policy imported before December 31, 2024, will be permitted to be sold until the end of their shelf-life while supplies last. A revised data package submitted at a later date under the standard pre-market notification process would however be considered without prejudice.

3.0 Approach

The transition strategy includes three steps that apply to manufacturers who:

  1. are interested in adding their product(s) to the interim policy (see Figure 1) or
  2. already have at least one product listed under the interim policy (see Figure 2).
Figure 1. overview of transition strategy for manufacturers wanting to add products to the interim policy
Figure 1. Text version below.
Figure 1: Text description

Figure 1 is a diagram describing the three steps of the transition strategy for manufacturers wanting to add products to the interim policy. Three circles identify Step 1 (left), Step 2 (center) and Step 3 (right). A rectangular box below each circle describes the actions to be completed by manufacturers interested in adding new product(s) to the interim policy. Health Canada's responses to each step can be found to the right of the respective rectangular boxes.

The information in the rectangular boxes is as follows for each step:

Step 1: Letter of Intent

  • E-mail (SMIU) with product(s) information and;
  • Intent to submit a full premarket notification package.

A footnote explains that SMIU stands for Submission Management and Information Unit.

Step 2: Data and plan

  • Submit data required in Appendix 2 and;
  • A plan specifying when and how the required data for complete premarket notification submission will be provided and;
  • A separate plan for a new manufacturing facility submission (if applicable).

Step 3: Full data package

  • Send complete data package to support premarket notification and;
  • A separate new manufacturing facility submission (if applicable).

On the right side of the rectangular box for step 1, the corresponding response from Health Canada is as follows:

  • Health Canada acknowledges the receipt of letter of intent.

On the right side of the rectangular box for step 2, the corresponding response from Health Canada is as follows:

  • Health Canada acknowledges the receipt of data and plan and;
  • Prioritize by quality and completeness of data received and;
  • If the data submitted as per Appendix 2 is found acceptable, the product will be added to the interim policy.

On the right side of the rectangular box for step 3, the corresponding response from Health Canada is as follows:

  • Health Canada acknowledges receipt of full data package and;
  • Starts screening submission by end of 2024. A decision is issued.

At the bottom of each of the three boxes is a right-pointing arrow, in which is written the number of days allocated for each of the three steps. A footnote explains that this represents the number of days following the publication of the transition strategy.

  • For step 1: 30 days
  • For step 2: 90 days
  • For step 3: 210 days
Figure 2. overview of transition strategy for manufacturers with existing products listed in the interim policy
Figure 2. Text version below.
Figure 2: Text description

Figure 2 is a diagram describing the three steps of the transition strategy for manufacturers with existing products listed in the interim policy. Three circles identify Step 1 (left), Step 2 (center) and Step 3 (right). A rectangular box below each circle describes the actions to be completed by manufacturers who already have product(s) on the interim policy. Health Canada's responses to each step can be found to the right of the respective rectangular boxes.

The information in the rectangular boxes is as follows for each step:

Step 1: Letter of Intent

  • E-mail (SMIU) with product(s) information and;
  • Intent to submit a full premarket notification package.

A footnote explains that SMIU stands for Submission Management and Information Unit.

Step 2: Plan

  • A plan specifying when and how the required data for complete premarket notification submission will be provided and;
  • A separate plan for a new manufacturing facility submission (if applicable).

Step 3: Full data package

  • Send complete data package to support premarket notification and;
  • A separate new manufacturing facility submission (if applicable).

On the right side of the rectangular box for step 1, the corresponding response from Health Canada is as follows:

  • Health Canada acknowledges the receipt of letter of intent.

On the right side of the rectangular box for step 2, the corresponding response from Health Canada is as follows:

  • Health Canada acknowledges the receipt of data plan and;
  • Prioritize by quality and completeness of data received.

On the right side of the rectangular box for step 3, the corresponding response from Health Canada is as follows:

  • Health Canada acknowledges receipt of full data package and;
  • Starts screening submission by end of 2024. A decision is issued.

At the bottom of each of the three boxes is a right-pointing arrow, in which is written the number of days allocated for each of the three steps. A footnote explains that this represents the number of days following the publication of the transition strategy.

  • For step 1: 30 days
  • For step 2: 90 days
  • For step 3: 210 days

3.1 Step 1: letter of intent

Deadline: January 17th, 2024

All manufacturers interested in participating in this transition strategy must provide a letter of intent to Health Canada by January 17th, 2024.

  1. Manufacturers interested in adding their product(s) to the interim policy must signal their intention to provide a full premarket notification package* to support the long-term sale of their product(s) in Canada beyond December 31, 2024. The letter must clearly identify the products to be added to the interim policy within the scope of the transition strategy.
  2. Manufacturers with one or more products listed on the interim policy must confirm in writing their intention to provide a full premarket notification package* to support the long-term sale of their product(s) in Canada beyond December 31, 2024. The letter must clearly identify the products to be considered within the scope of the transition strategy. The information provided should be for the identical product (s)reviewed for the interim policy.

Step 1 notes:

3.2 Step 2 – plan to address data requirements

Deadline: March 18th, 2024

A detailed plan describing how and when data requirements for a full premarket notification will be addressed must be submitted by March 18th, 2024.

  1. Manufacturers interested in adding their product(s) to the interim policy must submit the necessary information to satisfy the requirements (see Appendix 2 for details). A detailed plan is also required in this case. If additional time is needed to provide specific requirements (e.g., if a clinical trial is to be completed), please include a rationale for the need for this extension and the expected timeline.
  2. Manufacturers with one or more products listed on the interim policy must provide the detailed plan.

Appendix 1 contains a list of all data requirements for a full premarket notification submission with useful links to various Government of Canada websites as well as other useful resources. This information will help manufacturers prepare a complete premarket submission.

Appendix 2 contains a list of data requirements for manufacturers wanting to add a product to the interim policy. It is an abbreviated version of the full premarket notification.

If the manufacturing facility is new to the Canadian market, then the manufacturer will have to prepare a separate submission for a new manufacturing facility in addition to the infant formula full premarket notification submission package. Please refer to the guidance document titled New manufacturing facility requirements - infant formulas and human milk fortifiers about data submission requirements for a new manufacturing facility.

For additional support, manufacturers are strongly encouraged to request a pre-submission consultation with Health Canada to further guide the development of their plan and subsequent data package.

Step 2 notes:

3.3 Step 3 – submission of full data package

Deadline: July 15th, 2024

All data required to support a full premarket notification should be submitted by July 15th, 2024, unless a rationale was provided at Step 2 to justify the need for additional time.

Step 3 notes:

For additional information, Appendix 3 lists frequently asked questions about the transition strategy.

4.0 Contact us

Health Canada will engage with stakeholders who are affected by the transition strategy. If you have any questions related to the transition strategy, please contact the Bureau of Nutritional Sciences via email: bns-bsn@hc-sc.gc.ca.

Appendix 1: summary of data requirements for a premarket notification submission

Category Description Reference Documents

Details

  • Include the product name and format (powder, concentrate, ready-to-feed, size).

Guide for preparing infant formula and human milk fortifier premarket submissions

Guide on the sale of human milk fortifiers

Good manufacturing practices for infant formula

(for food additives and composition of infant formula)

Health Canada List of Permitted Food Additives (use Infant Formula as keyword to search each list for cleared food additives)

Type

  • Specify the product type and intended population, e.g., regular (for term infants 0-12 months) or specialty (hypoallergenic, for hospital use only, other types of products are indicated in the Guide for preparing infant formula and human milk fortifier premarket submissions).

Composition

Include:

*Note: A NIFI is an optional food ingredient not used before in infant formula.

If a NIFI or new FA is added to the infant formula for the Canadian market, the infant formula manufacturers must provide evidence that the said NIFI or FA is cleared by Health Canada for use in infant formula. Please note, as mentioned under step 3, the assessment of any NIFI or new FA that Health Canada has not yet cleared for use in infant formula will lead to a lengthier review time.

Label

Include:

Labelling requirements for infant formula and human milk fortifier (the Canadian Food Inspection Agency)

Guide for preparing infant formula and human milk fortifier premarket submissions

International Code of Marketing of Breastmilk Substitutes

Packaging material

Include:

  • Description and diagram(s) of the packaging.
  • Decision documents if available (i.e., Letters of No Objection) from Health Canada related to packaging materials (including all layers), as applicable.

Refer to Section 4.11 of the Guide for preparing infant formula and human milk fortifier premarket submissions

Food Packaging Regulations

Evidence

Include:

  • History of safe use (and state which jurisdiction).
  • Details on nutritional adequacy.
  • Growth and tolerance clinical trial when required. Submit either:
    1. Completed trial or trial in progress (with end date). Include the complete study report (with individual raw data) OR
    2. Evidence-based rationale to explain why and how the data provided (instead of using a full clinical trial) demonstrates how the product supports the normal physical growth and development of infants. Include complete list of references.

Note: In either case above, Health Canada will determine if the proposed data is acceptable. If an evidence-based rationale is provided in lieu of a full clinical trial, Health Canada will determine if there is sufficient evidence to warrant an exception.

Scientific evidence requirements for nutritional adequacy of preterm infant formulas and human milk fortifiers

Scientific evidence requirements for nutritional adequacy of term infant formulas

Growth and tolerance clinical trial protocol - preterm infants

Growth and tolerance clinical trial protocol - healthy term newborn infants

Manufacturing of the product

Include details of the manufacturing process and quality control procedures used throughout processing.

Guide for preparing infant formula and human milk fortifier premarket submissions (see sections on manufacturing)

Good manufacturing practices (GMP) for infant formula

For a new manufacturing facility

A new manufacturing facility means a new or an existing facility that has not yet produced infant formula or human milk fortifiers in Canada before.

If a product is made in that new facility, then the company must submit:

  1. data for the infant formula product (as presented above) AND
  2. a separate submission for the new facility.

New manufacturing facility requirements for infant formulas and human milk fortifiers

Appendix 1A: list of new infant formula ingredients cleared for use in infant formula available for sale in Canada (as of November 5, 2024)

Bioactives - Oligosaccharides Bioactives - Other (Nutrients) Microbes
  • NutraFlora®scFOS (Ingredion)
  • 2'-FL manufactured using genetically modified E. coli BL21 (DE3) strain #1540 or strain #1242 (Chr. Hansen, formerly Jennewein Biotechnologie GmbH)
  • 2′-Fucosyllactose (2′-FL) produced via fermentation using a genetically modified E. coli K12 MG1655 strain (DuPont Nutrition & Biosciences)
  • 2′-Fucosyllactose (2′-FL) produced via fermentation using a genetically modified E. coli K-12 (DH1) MDO MAP1001d strain [Glycom A/S (affiliated with DSM Nutritional Products Inc.)]
  • Vivinal®GOS Syrup (Friesland Campina Ingredients)
  • Dairy Crest GOS (Saputo Dairy UK)
  • Orafti® HP (Beneo GmbH), a long-chain inulin or long-chain fructo-oligosaccharide (lcFOS) in combination with Vivinal® GOS Syrup (Friesland Campina Ingredients) in a 1:9 ratio
  • VITAGOSTM (Vitalus Nutrition Inc.)
  • Vivinal®GOS Syrup LE (Friesland Campina Ingredients)
  • VITAGOSTM IF (Vitalus Nutrition Inc.)
  • DHASCO-B (DSM, formerly Martek)
  • DHA from Schizochytrium sp. T18 (Mara Renewables)
  • DHA550 from Schizochytrium sp. FCC-3204 (Fermentalg)
  • YK docosahexaenoic acid (DHA)-rich Algal Oil (LinYi YouKang Biology Co. Ltd.)
  • YK DHA-rich Algal Powder (LinYi YouKang Biology Co. Ltd.)
  • Lacprodan milk fat globule membrane (MFGM)-10 (Arla Foods)
  • Vivinal Milk Fat - Anhydrous Milk Fat (AMF) (Friesland Campina Ingredients)
  • InFat (Frutarom, formerly Enzymotec)
  • Lactobacillus helveticus R0052 (Lallemand): only for FUF (6 months and older)
  • Bifidobacterium bifidum R0071 (Lallemand): only for FUF (6 months and older)
  • Lactobacillus reuteri DSM17938 (BioGaia)
  • Lactobacillus casei ssp. rhamnosus GG/LGG (Chr. Hansen, originally by Valio Ltd.)
  • Bifidobacterium lactis Bb. 12

Appendix 2: summary of data requirements for adding products to the interim policy

For more information, see the Guide for the preparation of infant formula and human milk fortifier premarket submissions and other relevant hyperlinked references provided below.

Appendix 3: frequently asked questions

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