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
- 2.0 Transition strategy
- 3.0 Approach
- 4.0 Contact us
- Appendix 1: summary of data requirements for a premarket notification submission
- Appendix 1A: list of new infant formula ingredients cleared for use in infant formula available for sale in Canada (as of November 5, 2024)
- Appendix 2: summary of data requirements for adding products to the interim policy
- Appendix 3: frequently asked questions
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:
- are interested in adding their product(s) to the interim policy (see Figure 1) or
- already have at least one product listed under the interim policy (see Figure 2).

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: 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.
- 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.
- 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:
- The letter should be sent via email with the subject line "Transition strategy: Letter of Intent" to the Food Directorate's Submission Management and Information Unit (SMIU) at smiu-ugdi@hc-sc.gc.ca.
- Health Canada will acknowledge receipt of the letter of intent.
- Letters of intent received past January 17th, 2024 will not be considered.
- * Full premarket notification package requirements are described in Appendix 1.
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.
- 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.
- 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:
- The information requested at this step must be submitted via the Transport Form for submitting additional documents to Health Canada.
- Health Canada will acknowledge receipt of the plan to address data requirements. Plans received past the deadline will not be given further consideration within the scope of the transition strategy.
- For manufacturers wanting to add new products to the interim policy, if Health Canada determines the data submitted (Appendix 2) is acceptable, the product will be added to the interim policy list by July 15th, 2024. Should a high volume of requests be submitted, then these will be reviewed in the order they were received by Health Canada, taking into account the quality of the submission and the market needs (for example, if a risk of shortage is identified).
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:
- The data package for products and new manufacturing facilities should be submitted as separate submissions via the Transport Form for submitting additional documents to Health Canada.
- The case number associated to the products or new manufacturing facility must be referenced on the form.
- A descriptive title should also be inserted for each file submitted
- Health Canada will confirm receipt of the data package.
- Products for which the data package was not submitted as per the scheduled plan will be excluded from further consideration within the scope of the transition strategy. Health Canada will initiate the review of the data package submitted by manufacturers by the end of the year 2024. The review time will depend on the completeness of the data package, submission complexity (e.g., submissions with one or more new manufacturing facilities), the quality of the data and the timeliness of responses to clarification questions during the review phase.
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 |
|
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 |
|
|
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 |
Packaging material |
Include:
|
|
Evidence |
Include:
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 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) |
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:
|
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 |
---|---|---|
|
|
|
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.
- Brand and product name under which the infant formula or human milk fortifier will be sold or advertised for sale (including protein source, format and packaging type).
- Name and address of the principal place of business of the manufacturer and the names and addresses of each establishment in which the infant formula or human milk fortifier is to be manufactured.
- History of safe use.
- Clinical study supporting the growth and safety of the (term/preterm) infant formula submitted (if available).
- Quantity of formula available for import, distribution plan and timelines, and lot numbers of product to be imported (if available).
- Nutritional information: ingredients quantitative formulation (compare Finished Product Specifications against nutrient values in Appendix 5 of the Guide for preparing infant formula and human milk fortifier submissions with recommended min-max levels as per FDR, Codex Standard 72-1981, Life Sciences Research Office (LSRO, 1998), and if available, test results for nutrients in recent batches).
- List of food additives used in the infant formula (see Lists of Permitted Food Additives)
- Product label text (French and English), and packaging modality.
- For powdered infant formula, for the most recent batch/lot produced at each applicable facility, a summary of all test results for microbiological contamination, including Cronobacter sp. and Salmonella sp., conducted at the final product stage for 3 non-consecutive batches (see Table 1, Section 3.10 of Good Manufacturing Practices for details).
- For each new manufacturing facility:
- Attestation that the products are produced according to good manufacturing practices and the Hazard Analysis and Critical Control Point (HACCP) principles that are equivalent to Health Canada Good Manufacturing Practices for Infant Formula or equivalent such as – US FDA Infant Formula Current Good Manufacturing Practices, Codex Alimentarius International Food Standards, "General Principles of Food Hygiene" (CAC/RCP 1- 969); last updated in 2003, last revised in 2020, Codex Alimentarius International Food Standards, Code of Hygienic Practice for Powdered Formulae for Infants and Young Children, CAC/RCP 66 – 2008; last updated in 2009.
- Manufacturing process flow diagram or a flow diagram with processing times, temperatures and conditions, including all controls and critical control points. Show the sequence and interaction of all processing steps in the operation, including where raw materials, ingredients and intermediate products enter the flow and where intermediate products, by-products and waste are released or removed; storage and distribution of final product.
- Provide detailed text describing the diagram or process flow/procedure for production, as indicated above.
- The most recent inspection report from the country of manufacture and third-party audit report or summary of findings of the inspection and audit, including any action taken by the manufacturer and final letter from authority to indicate that the issues were resolved. For both cases, the standards or regulations against which the inspections or audit were conducted must be specified.
- Export certificate from regulatory agency (if available).
Appendix 3: frequently asked questions
- 1. What products are covered in this transition strategy?
The types of products covered by the transition strategy are listed in Appendix A of the Interim Policy for infants (less than 12 months of age), and include regular and specialty infant formula, metabolic formula for those with inborn errors of metabolism, as well as human milk fortifiers.
- 2. What is the purpose of the letter of intent?
This letter will clarify the manufacturer's intention to stay in the Canadian market long term and commit to provide a full data package to Health Canada for review.
- 3. What if manufacturers send a submission package that is determined to be incomplete?
Products on the interim policy will not be permitted to be imported after December 31, 2024, if the data submitted by the petitioner was determined by Health Canada to be incomplete. It will also result in the closure of any submission under the transition strategy without prejudice to resubmit at a later date under the standard premarket notification process
- 4. What can manufacturers do if they have questions about the transition strategy or submission process?
The guidance document on the transition strategy includes a variety of supporting material in Appendix 1 to help manufacturers understand the data and submission requirements. If manufacturers have additional questions, they can send their questions to SMIU (email: smiu-ugdi@hc-sc.gc.ca). Please specify in the subject line "Transition strategy: Additional Questions" to ensure a timely response.
- 5. What is the purpose of a pre-submission consultation meeting?
Pre-submission consultation meetings are intended to provide manufacturers with more details on the data required for a full premarket notification package. Requests for pre-submission consultation meetings with Health Canada should be addressed to SMIU at smiu-ugdi@hc-sc.gc.ca.
- 6. Can manufacturers request more time to provide the required information beyond the deadline for Step 3?
As per step 2 of the guidance document on the transition strategy, manufacturers are required to submit a detailed plan. The manufacturer's plan should signal to Health Canada when certain information may require more time. In this case, manufacturers should include a rationale for any delays beyond July 17th, 2024. Health Canada will then determine whether the proposed timeline is acceptable and if the submission can proceed to the review phase.
- 7. What is the difference between the interim policy data request and the full premarket notification submission?
A full premarket notification is a comprehensive set of data (see Appendix 1) required to assess the safety and adequacy of the product for the intended population. The information requested for addition to the interim policy (see Appendix 2) is an abbreviated version of a full premarket notification for products that have been approved by a foreign regulatory authority or are allowed to be sold in foreign jurisdictions that have high quality and manufacturing standards similar to Canada.
- 8. Are manufacturers permitted to continue the sale of a product listed on the interim policy after the policy expires on December 31, 2024?
Yes. In line with the interim policy, the Canadian Food Inspection Agency will allow manufacturers to continue selling products listed on the interim policy if they were imported before December 31, 2024, until the end of products shelf-life and while supplies last. However, only products participating in the transition strategy will be considered for sale once the interim policy has expired.
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