Notice to stakeholders: Health Canada's strategy to manage shortages of infant formula and other foods for a special dietary purpose and to modernize related regulations
May 16, 2023
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The purpose of this notice is to announce Health Canada's strategy to continue addressing shortages of infant formula and other foods for a special dietary purpose by extending the 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. This notice also communicates Health Canada’s commitment to initiate work on the modernization of the regulations for infant formula and other foods for a special dietary purpose and the department’s plans for a public consultation in the fall of 2023.
Foods for a special dietary purpose (FSDP) play an integral role in the nourishment of certain vulnerable groups (e.g., infant formula) and in the dietary management of individuals with medical conditions (e.g., formulated liquid diets for tube feeding). Canada's current regulations for FSDP are set in Division 24 and 25 of the Food and Drug Regulations (FDR). Division 24 sets out the requirements for foods for individuals with medical conditions over 1 year of age, while Division 25 sets out the requirements for foods for infants.
These regulations are out of date and would benefit from better harmonization with other jurisdictions. For example, Canada's current regulations are prescriptive and restrict the sale of FSDP to a limited number of product categories. The compositional requirements for existing FSDP categories are based on outdated nutrition recommendations and do not provide flexibility for specific medical conditions that have unique nutrient requirements, such as renal disease.
As a result, many globally available FSDP products are not permitted in Canada. This makes Canada particularly vulnerable to FSDP shortages. Shortages can result in excessive pricing of the limited products available to consumers. FSDP shortages also pose a significant burden to the healthcare system, forcing healthcare providers to expend limited resources and time to acquire alternative products. This can delay patient access to FSDP, potentially resulting in adverse patient outcomes.
To help mitigate shortages, Health Canada published an interim policy in 2022 recommending that the Canadian Food Inspection Agency apply its enforcement discretion with respect to certain provisions of the FDR for infant formula and other FSDP to facilitate the importation of products from other jurisdictions that have high quality and manufacturing standards similar to Canada.
The recent shortages of infant formulas and other FSDP have underscored the need for updated regulations. While the interim policy was necessary to ensure continued access to these products for vulnerable groups in the short-term, lasting regulatory solutions are needed to reduce the risk of future shortages.
Modernization of regulations for FSDP has taken place internationally over the last decade, including in the European Union, Australia and New Zealand. There is an opportunity for Health Canada to address the shortcomings of the existing regulatory framework for FSDP by considering similar updates and flexibilities introduced in other jurisdictions. Comprehensive regulatory modernization will provide cohesive, efficient, and effective regulations that are tailored to the Canadian context.
Strategy to manage shortages and modernize the regulations
To help alleviate the shortage of certain infant formulas, Health Canada has been working closely with manufacturers to increase the availability of formulas normally found on the Canadian market. In addition, Health Canada's 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 has been an essential tool to mitigate the shortages by facilitating the importation of formula from countries which hold comparably high quality and manufacturing standards. More than 70 products are currently eligible for temporary importation under this policy, and the list is updated regularly. To continue addressing potential shortages, Health Canada is extending the interim policy from December 31, 2023, to December 31, 2024.
In order to improve the regulatory framework for FSDP, Health Canada is taking a comprehensive approach that will modernize Divisions 24 and 25 of the FDR. This will include a review of regulatory requirements that may pose unnecessary barriers to market access. By undertaking this regulatory modernization initiative, Health Canada aims not only to improve its ability to respond to any future shortages but also to establish a more robust regulatory framework that minimizes the risk of shortages.
Health Canada intends to launch a public consultation in the fall of 2023 to seek input on its proposed modernized framework for Divisions 24 and 25 of the FDR. The proposed framework will be described in a consultation paper, which will also include questions for stakeholders. Interested stakeholders will have a 60-day period to provide feedback to Health Canada that will help inform the development of proposed regulations for pre-publication in the Canada Gazette, Part I at a later date.
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