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Notice of Intent to make a ministerial class exemption order for the exceptional importation of certain foods for a special dietary purpose to mitigate a shortage or risk of a shortage

October 1, 2024

Table of contents

Summary

The purpose of this Notice of Intent is to inform interested parties of the Minister of Health's intention, pursuant to 30.05(1) of the Food and Drugs Act (FDA), to make a ministerial class exemption order (hereafter referred to as "the proposed order") for the exceptional importation of certain foods for a special dietary purpose (FSDP) to mitigate a shortage or the risk of a shortage of these products.

The proposed order would replace Health Canada's administrative Interim policy on the importation and sale of infant formulas, human milk fortifiers and dietary products for the treatment of inborn errors of metabolism to mitigate shortages (hereafter referred to as " the shortages interim policy"), which has been in place since March 2022 and is set to expire December 31, 2025.

Similar to the shortages interim policy, the objective of the proposed order is to ensure that, in the event of a shortage or risk of a shortage, Canadians can continue to access the FSDP they need to meet their nutritional needs.

The proposed order is intended to be a temporary measure. It would remain in force until shortage-related regulations for FSDP are made as part of Health Canada's Regulatory modernization of foods for special dietary use and infant foods: Divisions 24 and 25 of the Food and Drug Regulations (FDR).

Background

Foods for a special dietary purpose

Foods for a special dietary purpose (FSDP) are food products that have been specially processed or formulated to meet the particular nutritional requirements of individuals with health conditions or to serve as the sole or primary source of nutrition. Examples include human milk substitutes (commonly known as 'infant formula'), human milk fortifiers, formulated liquid diets, and foods to address special dietary needs for a medical condition, such as inherited metabolic disorders (e.g., metabolic products).

FSDP serve as a critical source of energy and essential nutrients for vulnerable Canadians. A significant disruption in access to these products can have serious, potentially fatal consequences on the health of the individuals who rely on them.

Shortages and risk of shortages

Shortages can arise from a range of circumstances, including manufacturing disruptions, difficulties in accessing raw materials, surges in demand, and unforeseen events affecting the global supply chain. In recent years, shortages of FSDP have become a significant concern due to global supply chain issues and product recalls.

Canada is particularly susceptible to shortages of FSDP due to its small market size and reliance on a limited number of suppliers. Compounding this vulnerability are the outdated regulations under Divisions 24 and 25 of the FDR, which are not harmonized with international jurisdictions. This can exacerbate shortages because it restricts the importation of FSDP available from other countries with similar safety standards. Moreover, unlike drugs and medical devices for which shortage regulations exist, there is no regulatory framework under the FDR for the exceptional importation of FSDP in the event of a shortage.

Since early 2022, Canada has experienced shortages of certain FSDP, including infant formula, human milk fortifiers, and metabolic products. In the absence of a shortages regulatory framework for FSDP, Health Canada has relied on the shortages interim policy. This temporary and administrative mechanism relies on enforcement discretion by the Canadian Food Inspection Agency (CFIA) to deprioritize the enforcement of the FDR where circumstances warrant lower enforcement priority, such as the exceptional importation of certain products from other countries that adhere to high-quality manufacturing standards comparable to those upheld in Canada.

While the shortages experienced in 2022 and 2023 have largely subsided, the market has not yet fully recovered and the risk of future shortages remains. A ministerial exemption order is a new regulatory tool designed to provide Health Canada with a way to implement appropriate and responsive solutions within the framework of the Food and Drugs Act.

Ministerial exemption authority

Under subsection 30.05(2) of the Food and Drugs Act, the Minister of Health may make a ministerial class exemption order only if they believe on reasonable grounds that

  1. it is necessary for a health or safety purpose or is otherwise in the public interest; and
  2. having regard to its benefits and conditions, it is unlikely to result in
    1. unacceptable health, safety or, if applicable, environmental risks, or
    2. an unacceptable degree of uncertainty respecting health, safety or, if applicable, environmental risks.

Proposed ministerial exemption order

Objective(s)

Proposed scope

FSDP categories eligible for exceptional importation

The proposed order would apply to the following FSDP:

These categories of FSDP are considered to pose the highest risk to human health if a shortage occurs. In addition, the risk of a shortage may be more likely for these foods.

Dietary products for individuals over the age of one year with inherited metabolic disorders (i.e., metabolic products), are excluded from the scope of the proposed order. Their access will continue to be managed through the 2023 Interim policy statement on foods for special dietary use for inherited metabolic disorders. Health Canada considered incorporating these products within the scope of the proposed order. However, the decision was made to continue to manage these products through the interim policy given the unique circumstances and conditions needed to access these specialty products.

Definition of a shortage

For the purposes of the proposed order, a 'shortage' would be defined as a situation in which the manufacturer of an FSDP is unable to meet the demand for the product in Canada. Based on this definition, a 'risk of a shortage' would be a situation where the manufacturer of an FSDP is at risk of (or anticipates) being unable to meet the demand for the product in Canada.

This proposed definition mirrors the one put forward by Health Canada in its pre-consultation document 'Regulatory modernization of foods for special dietary use and infant foods: Divisions 24 and 25 of the Food and Drug Regulations' for consideration for future regulatory amendments within Divisions 24 and 25 of the FDR, including the addition of FSDP shortage provisions. The proposed definition also aligns with the shortage definitions for drugs and medical devices, as defined under Part C of the Food and Drug Regulations and section 1 of the Medical Devices Regulations, respectively.

Evidence of a shortage

The intent is for the exceptional importation of products to only occur where there is credible evidence of a shortage or risk of a shortage in the Canadian supply, and where enabling the exceptional importation of a non-compliant FSDP is, in the view of the Minister, necessary to mitigate the shortage or risk of a shortage.

Evidence of a shortage or risk of a shortage would be considered on a case-by-case basis and may be brought to Health Canada and/or the CFIA's attention from a number of sources, such as an FSDP manufacturer, importer, distributor or the healthcare community. Health Canada and/or the CFIA may also identify a shortage or risk of a shortage through their own monitoring and intelligence gathering activities.

Proposed exemptions

The proposed order would exempt, subject to conditions, products from certain labelling, compositional and pre-market review requirements of the FDR. These exemptions are needed to permit the exceptional importation of safe and nutritionally adequate infant formula, human milk fortifiers and formulated liquid diets that may not comply with the FDR.

The proposed exemptions would be consistent with the regulatory provisions of the FDR for which the CFIA is presently exercising enforcement discretion under the existing shortages interim policy.

The Minister of Health would notify an FSDP manufacturer, if the exceptional importation for sale of an FSDP is exempt from relevant FDA and FDR provisions. The Minister may also specify for the product the duration of the exemption based on information available to them.

Proposed labelling exemptions

The proposed order would exempt from the following labelling requirements of the FDR:

Proposed compositional exemptions

The proposed order would exempt from the following compositional requirements of the FDR:

The proposed order would not exempt from provisions under Division 15 concerning the presence of contaminants and other adulterating substances in food nor existing provisions in Division 23 regarding the presence of vinyl chloride and acrylonitrile in food.

Proposed pre-market review exemptions

The proposed order would exempt from the following pre-market review requirements of the FDR:

The proposed order would not exempt from the 'stop sale' provisions prescribed under B.25.018 and B.25.060 that apply to human milk fortifiers and infant formula, respectively.

Proposed conditions

The proposed order would establish certain conditions to ensure that those FSDP exceptionally imported for sale in Canada are safe and nutritionally adequate. These conditions would also ensure Health Canada and the Canadian Food Inspection Agency can take action where needed to effectively manage a shortage as well as address potential risks to health, while also making sure consumers, parents and caregivers have access to the information needed to use these foods safely.

For any of the proposed conditions, the Minister of Health may request that additional information be provided to support their determination that conditions are being met.

To that end, the proposed order would include the following conditions:

  1. The Minister of Health must be satisfied that the FSDP is safe and nutritionally adequate for its intended dietary purpose.

    In the event of a shortage, parties seeking to exceptionally import non-compliant FSDP for sale in Canada would be required to provide information about their product to Health Canada for consideration. Each product would undergo an abbreviated assessment and only those products determined to be safe and nutritionally adequate may be exceptionally imported for sale.

    A similar assessment process was used to identify products for which enforcement discretion would be afforded pursuant to the 2022 shortages interim policy. Health Canada's intent is to carry over this review process for the purposes of the proposed order. Supporting guidance would detail the information required for Health Canada to evaluate a product for exceptional importation.

    Health Canada would publish an online list of products that may be exceptionally imported pursuant to the order, similar to Appendix A of the 2022 shortages interim policy.

  2. Certain core information about an exceptionally imported FSDP must be made available in English and in French when the product is sold in Canada.

    Products exceptionally imported for sale pursuant to the proposed order would not, in most cases, carry bilingual labels. To ensure consumers, parents and caregivers have access to the information needed to consume and store these foods safely and properly, the proposed order would require that products bear a label or are accompanied by a document that clearly sets out the following 'core' labelling information in one or both official languages, as the case may be:

    1. In English or French, the name of the manufacturer as well as their address and contact information
    2. In both English and French:
      1. the common name of the product
      2. the special dietary purpose for which the food is represented;
      3. a list of the food's ingredients;
      4. information on the food's nutrient content;
      5. precautionary statements and warnings (such as allergen labelling, 'may contain' statements, enteral labelling, etc.), as applicable;
      6. directions for the safe preparation, use and storage of the food;
      7. the food's expiration date; and
      8. the lot number for the food, if applicable.

    Examples of an accompanying document include inserts in product packages, information sheets affixed to products, brochures or other handouts provided at the point of purchase, etc. The accompanying document must include all the information noted above. For instance, it would not be acceptable for the accompanying document to simply direct the reader to a web site where the information may be found.

    The manufacturer would be responsible for ensuring that the accompanying document is provided along with the product to Canadian retailers and distributors.

  3. The Minister of Health must be notified in writing of incoming shipments of an FSDP that is subject to the order at least five days ahead of the product's arrival in Canada.

    This condition would ensure officials have access to the information needed to effectively manage a shortage as it unfolds. The shipment notification would be required to provide information about the product, including:

    1. the intended port of entry into Canada;
    2. the estimated date of arrival into Canada of the shipment of the food;
    3. the customs identification number for the shipment; and
    4. the total quantity of the food that is intended to be imported.
  4. The Minister of Health must be immediately notified in writing of any health and/or safety issues that arise with an FSDP that is subject to the order.

    This would ensure that exceptionally imported FSDP are subject to the same post-market safety requirements of all foods sold in Canada.

  5. The Minister of Health must be notified in writing of any major change to an FSDP that is subject to the order.

    This would ensure that Health Canada is made aware of any major changes to an exceptionally imported FSDP and can consider the impacts of the change(s) to the safety and nutritional quality of the product. A product that has undergone a major change could not be sold in Canada until Health Canada has completed its review and confirmed that the food can be exceptionally imported for sale.

    What constitutes a major change would be based on the existing definition of major change set out under B.25.001 of the Food and Drug Regulations.

    This condition would apply to all FSDP subject to the proposed order, including formulated liquid diets (FLDs). Even though FLDs are not subject to major change provisions under the Food and Drug Regulations, Health Canada is of the view that, for the purposes of the order, subjecting FLDs to conditions with respect to major changes is reasonable and appropriate in light of the exceptional circumstances under which these products would be imported for sale in Canada.

The 2022 shortages interim policy and the proposed order

Health Canada's intent is that the proposed order come into force before the expiration of the shortages interim policy on December 31, 2025. At the time the order is made, products listed in Appendix A of the shortages interim policy would be added to the list of FSDP for exceptional importation under the proposed order. In accordance with Health Canada's Transition strategy to prepare for the expiration of Health Canada's interim policy to mitigate infant formula shortages, those products would remain on the proposed order's exceptional importation list until Health Canada has completed its review and issued a Letter of No Further Questions pursuant to either B.25.012 or B.25.046 of the FDR or the shortage situation has fully resolved.

Public Comments

Interested persons may make representations regarding the Minister of Health's proposal as described in this notice within 45 calendar days after the date of publication of this notice (by November 15, 2024).

Representations may be submitted by email or in paper format to Health Canada's Bureau of Policy, Intergovernmental and International Affairs (BPIIA) at the contact information provided below. Please specify 'NOI_ FSPD Order/AI_Arrêté ADFS' in the subject line of your correspondence.

Contact Information

Bureau of Policy, Intergovernmental and International Affairs,
Food and Nutrition Directorate,
Health Canada
251 Sir Frederick Banting Driveway
Tunney's Pasture, PL: 2204C
Ottawa, Ontario (CANADA) K1A 0K9
E-mail: bpiia-bpaii@hc-sc.gc.ca

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