Health Canada Proposes 3-Tier Risk-Based Authorization Framework for Infant Foods

On November 26, 2025, Health Canada opened a public consultation on a proposed risk-based approach for the authorization of Infant Food for a Special Dietary Purpose (FSDP). This category encompasses infant formula and medical foods for infants.

This proposal represents a significant pivot from the approach consulted on in 2023. Instead of requiring pre-market authorization for nearly all products, the new framework introduces oversight scaled to product complexity and risk. The consultation period is open until January 25, 2026.

The following outlines the key components of the proposed regulatory modernization for Divisions 24 and 25 of the Food and Drug Regulations (FDR).