On December 17, 2025, Health Canada published SOR/2025-248, Exemption Order in Respect of Foods for a Special Dietary Purpose in the Canada Gazette, Part II. This Order creates a formal mechanism to help maintain access to medically important nutrition products when Canada faces a shortage or risk of shortage. It also supports continued market access for certain infant nutrition products that are part of Health Canada’s Transition Strategy while pre-market reviews are still underway.
Health Canada now has a clearer regulatory tool to permit exceptional importation and sale of specific products during supply disruptions, while still requiring conditions designed to protect health and safety. For manufacturers, importers, and distributors, the key is understanding which pathway applies, what triggers eligibility, and what operational obligations remain.
- What Is SOR/2025-248 and Why It Was Introduced
- Which Products Are Covered
- How the Order Works: Part 1 vs Part 2
- Part 1: Shortage or Risk of Shortage Pathway
- Part 2: Transition Strategy Products
- Key Compliance Obligations for Importers and Manufacturers
- Recap: How the New Framework Differs From the Previous Approach
- Final Remarks
What Is SOR/2025-248 and Why It Was Introduced
SOR/2025-248 is a class exemption order issued under section 30.05 of the Food and Drugs Act. It allows Health Canada to temporarily exempt certain foods for a special dietary purpose from specified provisions of the Food and Drug Regulations when exceptional circumstances arise.
The Order was introduced to address structural vulnerabilities in Canada’s supply chain for critical nutrition products, particularly following recent infant formula and medical nutrition shortages. It replaces reliance on temporary administrative policies with a predictable, transparent regulatory tool.
Which Products Are Covered
The Order applies to foods that pose a high risk to health if unavailable, particularly for infants and individuals who rely on them as a sole or primary source of nutrition. The scope is limited to the following regulated categories under the Food and Drugs Act and the Food and Drug Regulations:
Infant Formulas (New Human Milk Substitutes)
Infant formulas, referred to in the Food and Drug Regulations as new human milk substitutes, are foods represented for use by infants as a substitute for human milk. These products are formulated to meet the complete nutritional requirements of infants and are often the sole source of nutrition for this population. Due to their critical role in infant health and development, disruptions in supply can have immediate and serious health implications.
Human Milk Fortifiers (HMFs)
Human milk fortifiers are specialized products intended to be added to human milk to increase its nutritional content, typically for premature or medically vulnerable infants. They are designed to supplement energy, protein, vitamins, and minerals where human milk alone may not meet clinical needs. Because HMFs are used under medical supervision and are essential in neonatal and hospital care settings, access disruptions pose significant clinical risk.
Formulated Liquid Diets (FLDs)
Formulated liquid diets are foods specially processed or formulated to be consumed orally or by tube feeding and are often used as a sole or primary source of nutrition for individuals with specific medical or physiological conditions. These products are commonly used in hospitals, long-term care, and home care settings for individuals who cannot meet nutritional needs through conventional foods. Interruptions in availability can directly affect patient safety and continuity of care.
How the Order Works: Part 1 vs Part 2
The Order is structured around two distinct regulatory pathways, each designed to address a different supply-chain scenario. While both pathways allow for limited regulatory flexibility, they apply in different circumstances, are triggered in different ways, and serve different policy objectives.
Part 1: Shortage or Risk of Shortage Pathway
Part 1 is a forward-looking emergency response mechanism. It is designed to be activated when Health Canada determines that the Canadian supply of certain foods for a special dietary purpose is insufficient or at risk of becoming insufficient to meet demand.
This pathway enables Health Canada to respond quickly to supply disruptions by permitting the exceptional importation or sale of specific products that would not otherwise fully meet Canadian regulatory requirements, provided strict eligibility criteria and conditions are met.
When Part 1 Applies
Part 1 does not apply automatically. It is only triggered when Health Canada formally identifies a shortage or risk of shortage for a specific category of infant formula, human milk fortifier, or formulated liquid diet.
The Incorporated List as the Trigger
Eligibility under Part 1 depends entirely on whether the relevant product category has been added to the incorporated-by-reference List of Human Milk Fortifiers, Infant Formulas and Formulated Liquid Diets for Exceptional Importation and Sale in the Case of a Shortage or Risk of Shortage.
If a product category is not included on the List, Part 1 cannot be used, even if a company believes supply pressures exist. The List is the formal regulatory switch that activates this pathway.
Health Canada may amend the List as needed based on evidence from manufacturers, importers, health care professionals, provincial or territorial governments, or its own market monitoring.
Eligible Products Under Part 1
Once a product category is added to the List, Part 1 of the Order may be used to facilitate access to specific products within that category, provided the eligibility conditions are met.
This includes foreign-manufactured products that are authorized for sale by a specified foreign regulatory authority and imported into Canada from the corresponding jurisdiction. In such cases, Health Canada is relying on the regulatory oversight and safety standards of trusted foreign authorities to permit timely access to products that may not yet fully align with all Canadian requirements, but are needed to address a supply gap.
Part 1 may also apply to Canadian-manufactured products that were originally produced for export and subsequently redirected to the Canadian market. To qualify, these products must be authorized for sale in a specified foreign jurisdiction and must no longer be intended for export. This pathway allows domestically manufactured products that already meet comparable international standards to be temporarily retained in Canada, rather than leaving the market during a shortage.
Importantly, only the specific quantities of product that meet these conditions are eligible for exceptional sale in Canada. The Order does not create blanket approval for all products or future production runs. Each shipment or lot must independently satisfy the criteria and associated notification requirements, ensuring that the exceptional access remains targeted, proportionate, and directly tied to addressing the identified shortage or risk of shortage.
Regulatory Flexibilities Under Part 1
Qualifying products may be exempt from specific labelling, compositional, and pre-market requirements under the Food and Drug Regulations, as explicitly set out in the Order.
These flexibilities are intended to reduce delays associated with reformulation, relabelling, or pre-market review during a shortage. However, they are paired with mandatory safeguards, including advance notifications, core product information requirements, and immediate risk reporting obligations.
Part 2: Transition Strategy Products
Part 2 serves a different purpose. Rather than responding to future shortages, it provides regulatory continuity for a defined group of products already in the Canadian market under Health Canada’s Transition Strategy.
This pathway applies to a closed list of infant formulas and human milk fortifiers for which manufacturers committed to transitioning toward full compliance with Canadian requirements and submitted the required pre-market materials within Health Canada’s established timelines.
How Part 2 Works
Products captured under Part 2 may continue to be exceptionally imported and sold while Health Canada completes its pre-market review. This prevents sudden market withdrawal of medically important products solely due to regulatory timing.
Once Health Canada issues a final regulatory decision, whether authorization or refusal, the product immediately exits the Part 2 framework and becomes subject to all applicable requirements of the Food and Drug Regulations.
Unlike Part 1, Part 2 is not triggered by shortages and does not rely on the incorporated List. It exists solely to support the orderly transition of specific products already under regulatory review.
Key Compliance Obligations for Importers and Manufacturers
Although the Order provides targeted regulatory exemptions, it does not remove oversight or accountability. Importers and manufacturers remain subject to specific conditions designed to maintain transparency, enable regulatory oversight, and protect patient and consumer safety.
Advance Notification Requirements
Importers and domestic manufacturers must provide advance written notification to Health Canada before products are imported or sold under the Order. In most cases, this notification must be submitted at least five days in advance and must include detailed information about the product, quantities, and timing. This requirement allows Health Canada to monitor supply movements, assess the appropriateness of exceptional access, and coordinate responses during shortages or transition periods.
Core Product Information Document
When a product’s label does not fully comply with Canadian labelling requirements, the responsible importer or manufacturer must prepare a core product information document. This document ensures that purchasers, caregivers, and health care professionals have access to essential information needed for safe preparation, use, and storage of the product in both official languages. A copy of the document must be provided to Health Canada prior to first sale and made available at the point of sale.
Immediate Risk Notification
If an importer or manufacturer becomes aware of any information indicating a potential risk of injury to human health associated with a product sold under the Order, Health Canada must be notified immediately. This obligation supports timely risk assessment and intervention and aligns with post-market vigilance expectations for medically significant nutrition products.
Notification of Changes in Foreign Authorization Status
Continued eligibility under the Order depends on the product maintaining authorization for sale by the relevant foreign regulatory authority. If that authorization is withdrawn, suspended, or otherwise no longer valid, the importer or manufacturer must notify Health Canada without delay. Loss of foreign authorization removes the regulatory basis for exceptional access in Canada.
Restricted Sale Pathways for Human Milk Fortifiers
Human milk fortifiers are subject to additional controls due to their clinical use and vulnerability of the populations they serve. Sales are limited to pathways tied to medical supervision and written orders, ensuring that these products are used appropriately and only where clinically indicated.
What This Means for Labels and Bilingual Information
While the Order allows flexibility during exceptional circumstances, Health Canada continues to require that purchasers and caregivers have access to essential product information in both official languages. Businesses should plan for translation, document control, and point-of-sale availability well in advance.
Recap: How the New Framework Differs From the Previous Approach
Before SOR/2025-248, Health Canada managed shortages of foods for a special dietary purpose primarily through a temporary interim policy that relied on administrative measures and enforcement discretion. While effective during the immediate infant formula crisis, that approach was time-limited, non-regulatory, and reactive, offering limited predictability for industry and no standing mechanism to address future shortages.
The current framework established under SOR/2025-248 replaces that interim approach with a formal class exemption order made under the Food and Drugs Act. Unlike the previous policy, the new framework is legally grounded, transparent, and reusable, with clearly defined eligibility criteria, conditions, and safeguards. It introduces an incorporated-by-reference List to activate exemptions during shortages and formally supports Transition Strategy products while pre-market reviews are completed. In effect, Health Canada has moved from an ad hoc, crisis-driven model to a structured regulatory tool designed to manage future supply disruptions in a predictable and controlled manner.
Final Remarks
The introduction of SOR/2025-248 marks a meaningful shift in how Health Canada manages access to foods for a special dietary purpose during supply disruptions. By replacing temporary, discretionary measures with a formal class exemption order, Health Canada has established a more predictable and transparent framework that can be activated when shortages or risks of shortages arise, while maintaining safeguards to protect patient and consumer health.
For manufacturers, importers, and distributors of infant formulas, human milk fortifiers, and formulated liquid diets, this change brings both opportunity and responsibility. While the Order provides targeted regulatory flexibility, it also introduces clearly defined eligibility criteria, notification requirements, documentation obligations, and controls over distribution, particularly for clinically sensitive products. Businesses that understand these pathways and prepare in advance will be better positioned to respond quickly and compliantly when the framework is activated.
Ultimately, SOR/2025-248 reflects Health Canada’s effort to strengthen the resilience of Canada’s medical nutrition supply chain without compromising safety or oversight. As the regulatory landscape continues to evolve, proactive planning, ongoing monitoring of Health Canada’s incorporated List, and alignment with regulatory expectations will be essential for ensuring continued access to these critical products when they are needed most.
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