Canada is taking proactive steps to prevent disruptions in access to foods for special dietary purposes (FSDP) with a new proposal from Health Canada. On June 30, 2025, the department published an updated Notice of Intent outlining a proposed Ministerial class exemption order aimed at mitigating shortages and maintaining access to essential nutritional products.
This proposal comes as a response to supply chain vulnerabilities, evolving global market dynamics, and ongoing risks tied to infant formula and other medically necessary foods. The proposed order introduces a framework to temporarily allow the importation and sale of specific FSDPs that do not meet all Canadian regulatory requirements but are authorized in comparable international jurisdictions.
Why This Matters
FSDPs such as infant formula, human milk fortifiers, and formulated liquid diets serve as a vital source of nutrients for Canadians with unique health needs. Interruptions in the availability of these products, as seen during shortages in 2022 and 2023, can result in serious health consequences.
Recognizing Canada’s reliance on foreign suppliers and outdated domestic regulations under Divisions 24 and 25 of the Food and Drug Regulations (FDR), Health Canada is seeking to bridge regulatory gaps until its broader modernization initiatives take effect.
What the Proposed Order Includes
The proposed exemption order introduces a two-part structure:
Part 1: Establishes a process to permit the exceptional importation and sale of designated FSDPs during a shortage or the risk of one. Products must be authorized for sale in specific foreign jurisdictions deemed to have equivalent food safety standards.
Part 2: Ensures continuity for transition strategy products currently being imported under interim measures, such as certain infant formulas and human milk fortifiers. These products would remain available until Health Canada completes pre-market evaluations.
Conditions and Oversight
To protect public health, exempted products must meet strict conditions. These include:
- Documentation of core labelling information in English and French
- Pre-notification of imports and sales
- Ongoing reporting of safety or regulatory concerns
- Compliance with sale restrictions for human milk fortifiers
While certain labelling and compositional requirements under the Food and Drugs Act and Regulations would be temporarily relaxed, importers and manufacturers must still hold a Safe Food for Canadians licence and comply with applicable provisions of the Safe Food for Canadians Regulations (SFCR).
Public Comment Period Open
Health Canada is currently inviting comments on the proposed order until August 14, 2025. Feedback from stakeholders, including healthcare professionals, manufacturers, importers, and advocacy groups, is encouraged to ensure the framework is both responsive and enforceable.
Industry stakeholders can submit their feedback following directions outlined here.
Looking Ahead
The exemption order is intended as a temporary solution while Health Canada finalizes its regulatory modernization of foods for special dietary use and infant foods. Once finalized, this framework would be repealed in favour of permanent regulations.
This effort demonstrates Canada’s commitment to ensuring equitable access to safe, essential nutrition, especially for vulnerable populations.
Navigating the regulatory complexities surrounding FSDPs and import exemptions requires strategic insight and operational agility. SNI supports food and dietary product companies with:
- Regulatory consulting on foods for special dietary use
- Compliance under the Safe Food for Canadians Regulations
- Compliance strategies for labelling exemptions and documentation requirements
- Stakeholder engagement support for public consultations
Whether you’re seeking market continuity during a shortage or looking to prepare your products for long-term compliance, SNI is here to help.
Partner with us and focus on what you do best, and we’ll handle the rest!
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FAQ
What are Foods for Special Dietary Purposes (FSDPs) in Canada?
FSDPs include products such as infant formulas, human milk fortifiers, formulated liquid diets, and foods designed to meet the nutritional needs of individuals with specific medical or physiological conditions. These products are regulated under Divisions 24 and 25 of the Food and Drug Regulations and are essential for individuals who cannot meet their nutritional requirements through conventional diets.
Why is Health Canada allowing the import of products that don’t meet all Canadian regulatory requirements?
Due to recent and ongoing shortages, especially of infant formulas, Health Canada is proposing a temporary exemption order that would permit the importation and sale of specific FSDPs authorized in comparable international jurisdictions. This approach helps maintain access to critical nutrition while longer-term regulatory reforms are underway.
What are the conditions for importing and selling exempted FSDPs under the proposed order?
Even though some Canadian regulatory requirements would be temporarily relaxed, exempted products must still meet strict safety and oversight conditions, including:
- English and French core labelling
- Pre-notification to Health Canada
- Ongoing safety reporting
- Holding a valid Safe Food for Canadians licence
- Compliance with the Safe Food for Canadians Regulations (SFCR)
Which international jurisdictions are considered equivalent for product approval?
The proposal allows importation of products that are authorized for sale in jurisdictions deemed to have comparable food safety systems. While Health Canada has not published a definitive list in the Notice of Intent, this often includes the United States, European Union, Australia, and other countries with robust regulatory frameworks.
How can stakeholders provide feedback on the proposed exemption order?
Health Canada is accepting public comments until August 14, 2025. Feedback can be submitted by email or hard copy to the Bureau of Policy, Intergovernmental and International Affairs (BPIIA), with the subject line “NOI_FSDP Order/AI_Arrêté AFDS.” Details on submission procedures are available in the official Notice of Intent and through Health Canada’s website.
