Exceptional Access to Infant Formulas and Fortifiers

Summary#

The Canada Gazette published the final Exemption Order in Respect of Foods for a Special Dietary Purpose: SOR/2025-248 under the Food and Drugs Act. Coming into force on publication (December 17, 2025), it lets certain imported and some Canada-made infant formulas, human milk fortifiers and liquid medical diets be sold in Canada during a shortage or while they're moving through Health Canada’s transition review, subject to conditions.

What it does#

• Creates a standing mechanism to allow exceptional importation and sale of specific foods for special dietary purposes (mainly infant formulas, human milk fortifiers, and formulated liquid diets) when there is a shortage or a risk of shortage.
• Allows continued sale of a closed list of products that were part of Health Canada’s Transition Strategy while their pre-market reviews are still pending.
• Temporarily exempts those foods from some labelling, compositional and pre-market rules in the Food and Drug Regulations, so products approved in certain foreign jurisdictions can be used in Canada more quickly.
• Imposes conditions on these exemptions, including:
  • advance notifications to Health Canada by importers or manufacturers before shipments or sales (usually at least five days);
  • preparation and supply of a paper document in both official languages with key product information when labels don’t comply with Canadian rules;
  • immediate reporting to the Minister of any health risk or if a foreign regulator withdraws authorization for the product;
  • limits on sales of human milk fortifiers so they are used under medical supervision (sales to hospitals or to individuals only with a written medical order).
• The Order is structured in two parts: one (shortage response) that can be updated via a government “List” of affected product categories and jurisdictions, and one (transition) covering a fixed set of transition products.

Who's affected#

• Health Canada (decision-maker and monitor) and the Canadian Food Inspection Agency (enforcement) — they will run the list, receive notifications and oversee compliance.
• Importers and manufacturers of infant formulas, human milk fortifiers and formulated liquid diets — they must follow notification, labelling-document and reporting rules, and may use the exemptions to import or sell products more quickly.
• Hospitals, physicians, nurse practitioners, dietitians and patients/caregivers who use these products — access rules for human milk fortifiers require medical orders and hospital involvement.
• Consumers who rely on these specialized foods (including infants and medically fragile people) — they are the intended beneficiaries because the Order aims to keep essential products available during supply problems.

Why it matters#

• It gives Canada a predictable, legal tool to keep critical nutrition products available when supply chains break — instead of relying on temporary administrative policies.
• The conditions (paper bilingual product information, advance notice, and health-risk reporting) aim to reduce safety and communication gaps when non‑Canadian-labelled products enter the market.
• Health Canada estimates the Order will have low net costs to society and could produce net savings (estimated net present value $5.5 million) by avoiding long delays and costly pre-market reviews (410 calendar days service standard) for products in a shortage. Estimated administrative and implementation costs cited in the analysis include $231,249 present value (annualized $63,593) and specific items like $46,028 per year for assessing shortages and up to $17,231 per year for CFIA enforcement activities. Industry notification costs were estimated at about $334 per year and some compositional exemption savings were estimated up to $712,601.
• The Order is limited in scope to certain product types and foreign jurisdictions; Health Canada will publish and update the specific list of product categories and acceptable foreign regulators as needed. If anything in the source is unclear (for example, exact products on the List at any moment), Health Canada will publish that administrative list and guidance.