Notice to stakeholders: Transition strategy to prepare for the expiration of Health Canada's interim policy to mitigate infant formula shortages

December 18, 2023

On this page

• Purpose
• Background
• Overview of the transition strategy

Purpose

The purpose of this notice is to announce Health Canada's transition strategy to prepare for the expiration of 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. The transition strategy provides a fair and transparent approach to address new requests to add products to the interim policy and a clear plan for manufacturers interested in maintaining their products on the Canadian market beyond the expiration of the interim policy on December 31, 2024. Refer to the guidance for infant formula and human milk fortifier manufacturers for additional information regarding this strategy.

Background

The interim policy was published by Health Canada in March 2022 in response to important market disruptions affecting the infant formula supply in Canada. The policy recommends that the Canadian Food Inspection Agency apply its enforcement discretion with respect to certain provisions of the Food and Drug Regulations for eligible infant nutrition products imported to Canada on a temporary basis to mitigate shortages.

The interim policy has been an essential tool to strengthen the supply by facilitating the importation of products from countries with standards that are comparable to those in Canada. Many products are currently eligible for temporary importation under the interim policy, including formula available for consumers and products reserved for medical use.

The interim policy was extended until December 31, 2024, to provide market stability and continuity of care while Health Canada works on a longer-term approach to manage shortages of infant formula and other foods for a special dietary purpose and modernize related regulations.

Now that the infant formula market is showing signs of recovery, there is a need to clarify the regulatory pathway to enable the continued sale of listed products after the interim policy has expired.

Overview of the transition strategy

The transition strategy clarifies the pathway for products listed under the interim policy to become fully compliant with the Food and Drug Regulations. The transition will be completed through discrete steps leading to the submission of a full data package by the manufacturer.

The continued sale of products will be permitted until the completion of Health Canada's review, provided that all conditions and requirements of the transition strategy are met.

The steps of the transition strategy are outlined below. Please refer to the related guidance document for more information.

• Step 1: Provide a letter of intent by January 17^th, 2024.
• Step 2: Provide a detailed plan to address data requirements by March 18^th, 2024.
• Step 3: Submission of full data package by July 15^th, 2024.