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

March 10, 2022

Modified December 31, 2024

UPDATE: Targeted extension of interim policy to December 31, 2025 – removal of products not part of the Transition Strategy

As the market for infant formula in Canada has stabilized, Health Canada continues to implement its Transition Strategy to enable products to move to full compliance with the Food and Drug Regulations (FDR) and long-term sale on the Canadian market. To ensure market stability and continuity of care, the interim policy has been further extended until December 31, 2025, specifically for foods that have completed the steps outlined in the Transition Strategy.

This targeted extension of the interim policy allows foods that have completed the steps outlined in the Transition Strategy to remain available in Canada while their full pre-market review is completed. By providing additional time for the review of a significant volume of products, this extension helps maintain a stable supply of critical nutrition products, reducing the likelihood of returning to a shortage situation.

During this one-year extension period, there will be changes to the list of products in Appendix A of the interim policy to reflect the progress made in Health Canada's Transition Strategy. Once a product has been reviewed and a decision letter has been issued by Health Canada, it will be removed from the list in Appendix A. Infant formula products available to consumers in retail stores and pharmacies (products from Table 1 of the list) that have satisfied all Health Canada requirements for infant formula and are compliant with the Food and Drugs Regulations will then be added to the online list of infant formulas reviewed by Health Canada. For inquiries regarding products from Table 2, please contact the Bureau of Nutritional Sciences, Food and Nutrition Directorate via email at: bns-bsn@hc-sc.gc.ca.

Effective January 1st, 2025:

• Products that have not completed the steps outlined in the Transition Strategy have been removed from the list in Appendix A. Products imported before this date may continue to be sold until the end of their shelf-life, while supplies last.
• Metabolic products are no longer included under this Interim Policy. These products are now managed under the Interim Policy for Foods for Special Dietary Uses (FSDU)  for Inherited Metabolic Disorders (IMD)

On this page

• Policy statement
• Purpose
• Scope
• Roles and responsibilities
• Background
• Interim policy
• Appendix A: List of products eligible for enforcement discretion
  • Table 1: Products imported for consumers
  • Table 2: Products imported for medical use

Policy statement

Health Canada recognizes that the temporary closure of a large manufacturing plant in the United States continues to affect the supply of infant formulas, human milk fortifiers (HMF), and dietary products for the treatment of inborn errors of metabolism (herein referred to as metabolic products) for vulnerable populations in Canada, including infants and children.

Health Canada recommends that the Canadian Food Inspection Agency (CFIA) temporarily exercise enforcement discretion with respect to certain labelling and composition requirements on the importation and sale of products listed in Appendix A to prevent and mitigate shortages.

Purpose

This document sets out Health Canada's recommendation to the CFIA with respect to the temporary importation and sale of infant formula, HMF, and metabolic products that may not fully meet Canadian regulatory requirements with respect to labelling and/or composition, but are manufactured to comparable standards, and that provide information that ensures the safe preparation and use of the foods. The purpose of the enforcement discretion recommendation is to help prevent and mitigate shortages of these products in Canada in relation to the temporary closure of a large manufacturing plant in the United States, while ensuring a safe supply of these products to the vulnerable Canadians that rely on them.

Scope

The following policy applies only to the infant formulas, HMF, and metabolic products listed in Appendix A. Health Canada has conducted a safety assessment of each product prior to their inclusion in this list in order to support the CFIA in its food safety mandate and exercising its enforcement discretion.

It is recommended that the CFIA apply its enforcement discretion to foods listed in Appendix A, in respect of the provisions of Parts B and D of the Food and Drug Regulations (FDR). It is also recommended that the CFIA apply its enforcement discretion in respect of sections A.01.014, A.01.016, A.01.041 and A.01.044, to the extent necessary to give effect to the enforcement discretion.

Bilingual labelling provisions continue to apply with enforcement discretion recommended where there are reasonable alternative means of providing the required information in both official languages.

It is further recommended that the CFIA also apply its enforcement discretion, in respect of paragraphs 4(1)(a) and (d) of the Food and Drugs Act to foods listed in Appendix A, in relation to the use or presence of any of the following substances:

1. a food additive;
2. any nutritive material that is used as an ingredient of the food;
3. vitamins, mineral nutrients and amino acids;
4. agricultural chemicals;
5. food packaging materials and components of those materials; and
6. drugs recommended for administration to animals that may be consumed as food.

Roles and responsibilities

Health Canada: federal authority responsible for establishing standards and regulations regarding, among other things, the labelling and compositional requirements of infant formula, HMF, and dietary products for inborn errors of metabolism sold in Canada, under the Food and Drugs Act

Canadian Food Inspection Agency: federal authority responsible for the compliance and enforcement of regulatory food requirements including those relating to the import, production and sale of infant formulas, HMF, and metabolic products under the Food and Drugs Act and the Safe Food for Canadians Act.

Manufacturers and Importers: responsible for ensuring that their food products comply with applicable food policies, standards, and legislation.

Background

Protecting the health of Canadians is Health Canada's priority. Infant formulas and HMFs are regulated under Division 25 of the FDR, while metabolic products are regulated under Division 24 of the FDR. These provisions establish the regulatory requirements for the sale of these products in Canada, while Part A of the FDR establishes requirements applicable to the importation of these products. Part B of the FDR sets out additional applicable requirements, including with respect to labelling.

On February 17^th, 2022, the CFIA issued a food recall warning in relation to certain powdered infant formula products produced in Abbott's Sturgis, Michigan manufacturing facility. Following this recall, the Sturgis facility was closed temporarily. This facility is a key supplier of infant formula, HMF, and metabolic products for the American and Canadian markets, as well as many countries.

Interim policy

Health Canada has determined that a shortage of infant formulas, HMF, and metabolic products in Canada related to the closure of the Abbott facility may be detrimental to the health of vulnerable Canadians. Therefore, Health Canada recommends that the CFIA apply its enforcement discretion to the importation and sale of certain infant formula, HMF, and metabolic products. This discretionary enforcement is limited to only those products that are included in the list in Appendix A. These products 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. However, they may not fully meet Canadian labelling and/or composition requirements set out in Part B, in particular, Division 24 and 25, and Part D of the FDR.

In the event that food safety issues arise with the products covered by this notice, licenced importers of these products must notify Health Canada and the CFIA immediately. In such case, appropriate action will be taken.

Health Canada continues to implement its Transition Strategy to normalize the regulatory pathway to market for products impacted by the shortage. To ensure market stability and continuity of care, the interim policy has been further extended until December 31, 2025, specifically for products that have completed the steps outlined in the Transition Strategy.

Appendix A

This list will be updated regularly.

Last updated: December 31, 2024

Products listed below include both hypoallergenic and regular infant formulas that are imported to alleviate the shortage. Hypoallergenic products will be available in pharmacies.

Products listed below are for the treatment of hereditary metabolic conditions and are used only under strict medical supervision. These products are not available in pharmacy or in retail. The National Food Distribution Centre manages their distribution in collaboration with the healthcare community.

Manufacturers or importers of infant formula, HMF, or metabolic products wishing to add products to the list in Appendix A may contact the Bureau of Nutritional Sciences, Food Directorate via email at: bns-bsn@hc-sc.gc.ca.

Note that all other applicable Canadian laws and regulations remain in force, including those related to import (e.g. licensing) and food safety (evidence of meeting Canadian food safety controls).