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Canada Announces Exemption Order to Secure Supply of Infant Formula and Other Special Foods

The Exemption Order creates a permanent framework for managing shortages of critical nutritional products such as infant formulas, human milk fortifiers, and formulated liquid diets in Canada. Transition Strategy products that applied for pre-market authorization by July 15, 2024 can continue to be marketed under targeted exemptions while Health Canada completes its regulatory reviews.

On December 17, 2025, Health Canada published the Exemption Order in Respect of Foods for a Special Dietary Purpose (SOR/2025-248) to establish a formal regulatory framework for managing shortages of critical nutritional products. This new order allows for the exceptional importation and sale of certain foods for a special dietary purpose (FSDP)—such as infant formulas, human milk fortifiers, and formulated liquid diets—to prevent supply disruptions for vulnerable populations. The order came into force upon its publication in the Canada Gazette, Part II.

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