Canada Proposes Exemption Order for Exceptional Importation of Certain Foods for a Special Dietary Purpose (FSDP)

On October 1, 2024, Health Canada issued a Notice of Intent to introduce the proposal of a ministerial class exemption order for the exceptional importation of certain foods for special dietary purposes (FSDP). This measure aims to mitigate the current and potential shortage of these products. Public comments can be submitted via email to [email protected] before November 15.

FSDP shortage in Canada 

FSDP are specifically formulated to meet the nutritional needs of individuals with specific health conditions or to serve as a primary source of nutrition. Due to small market size and limited number of suppliers, Canada is particularly vulnerable to FSDP shortages. Since early 2022, shortages have impacted certain FSDPs, including infant formula, human milk fortifiers, and metabolic products.

Currently, although the shortages experienced in 2022 and 2023 have mostly subsided, the market has not fully recovered, leaving the risk of future shortages. The proposed ministerial exemption order is a new regulatory tool that will allow Health Canada to implement responsive measures to address these challenges.

Involved products 

The proposed exemption order applies to three categories of FSDPs: infant formula (human milk substitutes), human milk fortifiers, and formulated liquid diets. The shortages of these categories are considered to pose the greatest risk to human health. However, dietary products for individuals over the age of one year with inherited metabolic disorders (also known as metabolic products) are excluded from the exemption.

Proposed exemptions 

Under specific conditions, the exemption order would relax the requirements related to labeling, composition, and pre-market review outlined in the Food and Drug Regulations (FDR). As a result, it would facilitate the importation of safe and nutritionally adequate infant formula, human milk fortifiers, and formulated liquid diets that may not fully comply with FDR standards. Specific exemptions include:

• Labelling exemptions cover how labeling items are presented, bilingual labeling requirements, as well as special labeling provisions for infant formula, human milk fortifiers, and formulated liquid diets, including the action or effect of vitamins and mineral nutrients in food.

• Compositional exemptions include compositional standards for infant formula, human milk fortifiers, and formulated liquid diets, as well as the addition of vitamins, minerals, amino acids, food additives, agricultural chemical levels, and packaging materials.

• Pre-market review exemptions apply to the pre-market notification of new infant formula and those undergoing significant changes, as well as new human milk fortifiers and those with significant alterations.

Proposed conditions 

To ensure that exceptionally imported FSDPs are safe and meet nutritional standards, the proposed order establishes the following conditions:

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

• Certain core information about the imported FSDP must be available in both English and French for sale in Canada.

• The Minister of Health must be notified in writing at least five days before an FSDP shipment arrives in Canada.

• The Minister of Health must be immediately informed of any health or safety issues related to an imported FSDP.

• The Minister of Health must be notified of any significant changes to an imported FSDP.