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Optimizing Foods for Special Dietary Use in Canada: Key Outcomes and Recommendations from a Tripartite Workshop Applied Physiology, Nutrition, and Metabolism Optimizing Foods for Special Dietary Use in Canada: Key Outcomes and Recommendations from a Tripartite Workshop Journal: Applied Physiology, Nutrition, and Metabolism Manuscript ID apnm-2019-0013.R2 Manuscript Type: Current opinion Date Submitted by the 10-Apr-2019 Author: Complete List of Authors: Wiggins, Ashleigh; University of Toronto, Nutritional Sciences Grantham, Andrea; Canadian Nutrition Society, Anderson, DraftG. Harvey; University of Toronto, Nutritional Sciences Foods for Special Dietary Use, Food Regulation, Medical Foods, Foods for Keyword: Special Medical Purpose, Malnutrition, nutrition < nutrition Is the invited manuscript for consideration in a Special Not applicable (regular submission) Issue? : https://mc06.manuscriptcentral.com/apnm-pubs Page 1 of 26 Applied Physiology, Nutrition, and Metabolism Optimizing Foods for Special Dietary Use in Canada: Key Outcomes and Recommendations from a Tripartite Workshop Ashleigh K. A. Wiggins1*, Andrea Grantham2, G. Harvey Anderson1,3 1Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Toronto, ON, Canada 2Canadian Nutrition Society, Ottawa, ON, Canada 3Department of Physiology, Faculty of Medicine, University of Toronto, Toronto, ON, Canada Draft *Corresponding author: Email: [email protected] Telephone: (416) 978-5007 Address: Department of Nutritional Sciences Faculty of Medicine, University of Toronto Medical Sciences Building, 5th Floor 1 King's College Circle, Toronto, Ontario, Canada M5S 1A8 1 https://mc06.manuscriptcentral.com/apnm-pubs Applied Physiology, Nutrition, and Metabolism Page 2 of 26 Abstract Many health conditions result in unique nutritional requirements (e.g., protein restriction, low energy, fortification) and the need to consume foods in non-traditional 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 which provide nutritional support for individuals in hospital and at home. In Canada, these products are defined as Foods for Special Dietary Use (FSDU). Canada’s regulation of FSDU (Division 24 of the Food and Drug Regulations) is particularly stringent and out-dated which results in products that do not meet current nutritional recommendations or allow application of current technologies, and lack harmonizationDraft 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. Key Words Foods for Special Dietary Use, Food Regulation, Medical Foods, Foods for Special Medical Purpose, Nutrition, Malnutrition 2 https://mc06.manuscriptcentral.com/apnm-pubs Page 3 of 26 Applied Physiology, Nutrition, and Metabolism 1. Introduction Chronic disease rates in Canada are at an all-time high, with type 2 diabetes, heart disease, obesity and cancer rates skyrocketing (Public Health Agency of Canada 2018; Canadian Cancer Statistics Advisory Committee 2018). In addition to chronic diseases, Canadians are faced with congenital disorders, childhood illnesses, accidents and age-related health decline. A commonality of these health issues is the role of proper nutrition as an aide in their management and treatment. Many of these conditions result in unique nutrient requirements and/or the need for non-traditional food formats to deliver energy and nutrients. Fortunately, through advances in nutrition and food science, there are a plethora of innovative products that provide patients and consumers with the nutrition they need in an appropriate format. However, out-dated regulations in Canada that are in place with the goal of protecting Canadians, are in actuality limiting access to many new productsDraft and hinder Canadian innovation. Division 24 of the Food and Drug Regulations (FDR) outlines the requirements and restrictions for ‘Foods for Special Dietary Use (FSDU)’ in Canada. This division covers a variety of products ranging from enteral diets (tube feeding) to meal replacements and gluten free products. Please see section 3.0 for more information on the regulation of these products in Canada. As these products are vital for many vulnerable populations, the regulations are strict and outline specific composition requirements, necessary labelling, advertising restrictions and other factors. Since the promulgation of Division 24 in 1974, the types of products available and the users of these products have evolved, yet few changes have been made to the regulations. This has led to discrepancies between our understanding of nutrient requirements and product innovation, and the products available to Canadians to support their unique and important needs. Canadian health professionals, researchers, industry, government and patients/consumers have requested modernization of Division 24 to become a top priority for regulators. In November 2017 a group 3 https://mc06.manuscriptcentral.com/apnm-pubs Applied Physiology, Nutrition, and Metabolism Page 4 of 26 of 30 multi-stakeholder experts met to discuss the technical aspects and global regulation of these products, the importance of FSDU to nutrition and health, and next steps for addressing challenges and opportunities for regulating and using FSDU.1 The following sections provide an overview of the clinical impact of FSDU, their regulation in Canada and internationally, product development and patient access barriers, and key outcomes and recommendations from the workshop. 2. Role of Nutrition and Foods for Special Dietary Use Products in the Health of Vulnerable Populations Malnutrition is a common and very complex problem facing many hospital patients and individuals living with acute and chronic illness.Draft In Canada over 45% of medical or surgical hospital patients (2+ day stays) are malnourished, leading to further health issues as well as additional health care costs (Curtis et al. 2017). Malnourished patients, most commonly deficient in energy, protein and/or micronutrients (Teigen et al. 2018; McKinlay 2008; Cederholm et al. 2017) regardless of body size (Leibovitz et al. 2013), have prolonged hospital stays ~ 3 days longer (Allard et al. 2016), higher rates of readmission within 30 days (Jeejeebhoy et al. 2015), double the rates of mortality (Agarwal et al. 2013), and have 31-55% higher medical costs than well-nourished patients (Curtis et al. 2017). Malnutrition often has multiple causes, including barriers to food intake in the community and hospital and their conditions leading to poor appetite, nausea and/or unique nutritional needs (Allard et al. 2016). In Canada, 21% of patients are on oral nutrition when admitted to hospital, and only 2.6% of those patients receive oral nutrition during their hospital stay (Allard et al. 2016). Even when nutritional interventions are recommended, they are often delayed and lead to prolonged hospital stays. 1 Supplementary Figure S1 provides as overview of the workshop program 4 https://mc06.manuscriptcentral.com/apnm-pubs Page 5 of 26 Applied Physiology, Nutrition, and Metabolism In Canada the top three risk factors for malnutrition at time of hospital admission are living alone at home, others being responsible for grocery shopping, and having 3 concurrent diseases/diagnoses (Allard et al. 2016). Malnutrition is a serious condition, but easily prevented, easy to identify and easy to treat, but unfortunately not well documented and often goes undiagnosed (Keller et al. 2015). FSDU, including meal replacements, nutritional supplements and formulated liquid diets, with a combination of nutritive supplementation and dietary advice can provide effective management (Cawood et al. 2012). Unfortunately, many Canadians can not access necessary FSDU products, partially due to cost, onerous tax credit systems, and strict regulations restricting their sale in Canada. The dated Division 24 regulations outline stringent compositional requirements that are based on outdated Dietary Reference Intakes (DRIs), resulting in FSDU products having nutrient levels below amounts currently recommended. For example, the RDAs for vitamin D, calcium andDraft phosphorous have increased but are not acknowledged in FSDU formulations. Vulnerable populations that rely on these products are at risk of inadequate macro- and micronutrient intakes and being disadvantaged compared to those who do have access to newer formulations, and the general population who consume traditional foods. 3. Regulation of Food for Special Dietary Use in Canada Foods for Special Dietary Use are “foods that have been specially processed or formulated
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