Optimizing foods for special dietary use in Canada: key outcomes and recommendations from a tripartite workshop

Many health conditions result in unique nutritional requirements (e.g., protein restriction, low energy, fortification) and the need to consume foods in nontraditional formats (e.g., liquid diets, supplements, tube feeding). In Canada, 45% of hospital patients are malnourished upon admission, resulting in prolonged hospital stays, increased health care costs, and higher mortality rates. Fortunately, advances in nutrition and food science enabled the development of products that provide nutritional support for individuals in hospital and at home. In Canada, these products are defined as Foods for Special Dietary Use (FSDUs). Canada's regulation of FSDUs (Division 24 of the Food and Drug Regulations) is particularly stringent and outdated, which results in products that do not meet current nutritional recommendations or allow application of current technologies, and lack harmonization with other countries. Many of these issues also apply to the Infant Food regulations in Canada. To provide vulnerable populations with optimal nutrition, experts have suggested modernization of Canadian FSDU regulations. A multi-stakeholder workshop established several recommendations and goals toward that end while ensuring the safety of consumers. These include (i) assessing other jurisdictions' regulations; (ii) tracking products currently on the market; (iii) temporary marketing authorizations to permit products on the market and collect data; (iv) use of incorporation by reference for compositional requirements; (v) support for research of FSDU and nutritional needs of special population; and (vi) better understanding accessibility to these products. Overall, the proposed vision is for a modern, safe, flexible, innovative, and health-driven regulatory framework for FSDU in Canada.