By extending the interim policy on the importation and sale of infant formulas, human milk fortifiers, and dietary products to treat inborn errors of metabolism, Health Canada intends to continue addressing shortages of infant formula and other foods for a particular nutritional purpose. This Health Canada notice also outlines the department’s plans for public consultation in the fall of 2023 and Health Canada’s commitment to begin revising the regulations for baby formula and other foods for a particular dietary purpose.
This article will give a background on how the current interim policy came into effect and the need for modernized regulations.
The context for the interim policy is as follows:
Foods for a Special Dietary Purpose (FSDP) are essential for both the dietary management of people with medical disorders (such as specialized liquid diets for tube feeding) and the nutrition of some vulnerable groups (such as infant formula). Divisions 24 and 25 of the Food and Drug Regulations (FDR) include the current FSDP provisions for Canada. Division 25 specifies the requirements for food for newborns, while Division 24 specifies the needs for people with medical issues older than one year.
Better harmonization with other jurisdictions would help with these outdated regulations. For instance, Canada’s existing rules are prescriptive and only permit the sale of FSDP in a few specific product categories.
FDSP products—what should I know?
The nutritional specifications for the currently available FSDP categories are based on old-fashioned nutritional advice and do not allow for flexibility for particular medical conditions that have specific nutrient needs, such as renal illness.
The few things that are readily available to consumers may be overpriced as a result of poverty. As a result, many FSDP products that are offered globally are prohibited in Canada. Canada is hence particularly susceptible to FSDP shortages. FSDP shortages also cost the healthcare system, requiring providers to spend precious time and money searching for alternatives. This can cause a patient’s access to the FSDP to be delayed, which might hurt the patient.
Health Canada’s interim policy:
Health Canada released an interim policy in 2022 that encouraged the Canadian Food Inspection Agency to use its enforcement discretion concerning specific provisions of the FDR for infant formula and other FSDP to facilitate importing goods from other nations with high-quality and manufacturing standards comparable to Canada. This was done to lessen shortages.
FDSP framework and baby formula shortages:
The recent FSDP and baby formula shortages have highlighted the demand for new restrictions. While the temporary policy was required to continue providing vulnerable individuals access to these products in the near term, long-term regulatory solutions are necessary to lower the likelihood of further shortages.
Over the past ten years, there has been global modernization of FSDP rules, especially in the European Union, Australia, and New Zealand. Health Canada has the chance to remedy the deficiencies of the current FSDP regulatory framework by considering comparable changes and flexibilities implemented in other countries. Comprehensive regulatory modernization will result in cohesive, effective regulations tailored to the Canadian context.
How is Health Canada modernizing the regulations and managing shortages?
Health Canada has been working closely with producers to boost the availability of formulas typically sold on the Canadian market to help reduce the shortage of some newborn procedures. Additionally, Health Canada’s interim policy on the importation and sale of infant formula, human milk fortifiers, and dietary products for the treatment of inborn errors of metabolism has been a crucial tool in reducing shortages by making it easier to import formula from nations with comparable high manufacturing and quality standards. Over 70 products can be imported temporarily under this regulation, and the list is periodically updated. Health Canada is extending the interim policy from December 31, 2023, to December 31, 2024, to address shortages.
Health Canada is implementing a comprehensive approach that will modify Divisions 24 and 25 of the FDR to enhance the legal basis for FSDP. This will entail a review of any regulations that might unnecessarily restrict market access. Health Canada hopes that by launching this regulatory modernization program, it will be better able to address any upcoming shortages and create a more solid regulatory framework that reduces the likelihood of formula shortages.
In the fall of 2023, Health Canada plans to start a public consultation to get feedback on its suggested updated framework for Divisions 24 and 25 of the FDR. A consultation paper will outline the proposed framework and include questions for stakeholders. A 60-day opportunity will be given to interested parties to provide Health Canada with feedback that will help shape the creation of draft regulations for subsequent pre-publication in the Canada Gazette, Part I.
Strategy to manage shortages and modernize the regulations. https://www.canada.ca/en/health-canada/services/food-nutrition/public-involvement-partnerships/notice-stakeholders-strategy-manage-shortages-modernize-regulations-infant-formula-other-foods-special-dietary-purpose.html
How can Quality Smart Solutions serve you?
Firstly, QSS can help with formula review, product labeling, and nutrition facts creation (for Canada and the USA).
Secondly, we can also help with registering supplemented foods with TMALs (Temporary Market Authorization License) or reviewing when the new Supplemented Food Regulations are published.
Thirdly, we help with Safe Foods for Canadians Regulations (HACCP, PCP, Importer of Record Licensing, NDIN/GRAS Ingredients and GRAS Notifications).
Help with facility registration, FSVP agent, and US Agent.