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? :
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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
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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
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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
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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
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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 to meet
the particular requirements of a person: (a) in whom a physical or physiological condition exists as a result
of a disease, disorder or injury, or (b) for whom a particular effect, including but not limited to weight loss,
is to be obtained by a controlled intake of foods” - Canadian Food and Drug Regulations, Division 24 (1978).
In the 1970s Canada introduced the revised FSDU definition along with requirements for
formulated liquid diets (FLD) in Division 24 of the FDR. In the 1980s and 1990s this division grew, and
today it encompasses FLDs, meal replacements (MR), nutritional supplements (NS), gluten-free foods,
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foods represented for protein or amino acid restrictive diets, and foods represented for use in very low energy diets (FVLED).2 The Canadian definition of FSDU (above) is broader than the Codex definition created in 1985 (see section 4.0), which does not encompass part (b) of the Canadian regulatory definition.
Unlike other jurisdictions, Canada does not have Medical Foods or Foods for Special Medical Purposes
(FSMP), however many products within Division 24 in Canada are regulated as medical foods and FSMP elsewhere.
The piecemeal approach to create the FSDU regulations in Canada, with sections added over time, has led to inconsistencies.3 Several aspects of Division 24 cause confusion, hamper innovation and limit patient and health provider access to necessary products. These include: (1) lack of regulatory harmonization across Division 24 subgroups; (2) lack of harmonization in North America and globally for
FSDU-like products, impacting product accessDraft and safety; (3) strict compositional requirements based on outdated nutrient recommendations; (4) pre-market approval not required for most FSDU categories limiting our knowledge of what products are on the market; (5) unclear definitions; (6) confusing requirements located in different parts throughout the FDR; and (7) products included in Division 24 that may be better suited elsewhere in the FDR, such as follow-up formula for toddlers over 12 months of age and gluten-free products.
4. Regulation of Food for Special Dietary Use Globally
Globally there are several different approaches to the regulation of FSDU-like products. Overall, the Canadian regulations are the most rigid and the U.S. regulations are the most flexible, with other
2 Supplementary Table S1 provides an overview and definitions of the product categories included in Division 24 of the Food and Drug Regulations 3 Supplementary Table S1 provides an overview of the regulations (composition, labelling, marketing, etc.) for all categories within Division 24 of the Food and Drug Regulations
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countries falling in between. The following section provides an example of the regulations in the United
States, European Union, Australia/New Zealand and South Korea. 4, 5
United States
Medical Foods are “specially formulated oral intake products providing nutritional support for
distinct nutrient needs arising from disease, under active/ongoing medical supervision, for dietary
management of patients with limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary
food stuffs/certain nutrients or dietary management of patient with special medically determined nutrient
requirements that cannot be obtained from modification of diet alone.” - U.S Code of Federal Regulations,
Title 21 (1990). In the US medical foods encompassDraft a wide variety of products including sole source formulations6 and oral rehydration products. While there is also a FSDU category, it has had little practical use since the
early 1990s when most products transitioned to market themselves as medical foods. In 1990 the
Nutrition Labeling and Education Act (NLEA) established a regulatory definition for medical foods, and
exempted medical foods from conventional food labelling requirements, disease statement limitations
for health/function claims and labelling requirements for nutrient content claims. This incentivized
products to market themselves as medical foods. There are several requirements for products to qualify
as medical foods, including the need to fulfil a specific nutritional requirement that arises because of the
disease or condition which cannot be met from modification of the diet alone. For example, dietary
products for cardiovascular disease (CVD) do not qualify as medical foods as there is no recognized specific
nutritional need for management of CVD. Additionally, medical foods cannot claim to treat or cure specific
4 Supplementary Table S2 provides a summary of the global regulation of FSDU-like products, and makes comparisons with the Canadian FSDU regulations 5 Supplementary Table S3 summarizes and compares the compositional requirements for FSDU-like products in Canada, the European Union, and Australia/New Zealand 6 Throughout the paper, ‘sole source’ and ‘sole source nutrition’ refer to nutritionally complete products that individuals rely on exclusively to provide all necessary energy, macronutrients and micronutrients
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diseases. If they do claim to treat or cure a disease they are regulated as drugs. However, medical foods can state “for the dietary management of X disease”. There are also efficacy standards for medical foods in the US, meaning there must be documented scientific evidence supporting the products ability to fulfil a dietary requirement as a result of a disease or condition.
Overall the US approach to medical foods has led to a lenient regulatory framework. Compared to the Canadian regulation of FSDU, the U.S. medical foods have no compositional requirements, few specialized labelling requirements, and no labelling or marketing restrictions. This has resulted in a wide range of products, which utilize the latest nutrition and food science knowledge, being made available to patients. On the other hand, this has also led to products reaching market as medical foods despite being outside of the medical food definition, and very little control over the products as there is no premarket approval required. An excellent example ofDraft this issue is Axona (Accera, Inc.). This product was launched in 2009 as a medical food for the dietary management of Alzheimer’s disease, and was composed of caprylic triglycerides from coconut oil. The medical and scientific communities expressed concern over the lack of proven efficacy. The U.S. Food and Drug Administration determined in 2013 that the product did not meet the medical food definition as there is no recognized distinct nutritional requirements for individuals with mild to moderate Alzheimer’s disease (U.S. Food and Drug Administration, 2013). The product was therefore misbranded, having false and misleading labelling, and is no longer on the market.
European Union
Foods for Special Medical Purposes “must be: (i) specially processed or formulated and intended for the dietary management of patients, including infants, (ii) used under medical supervision, (iii) intended for the exclusive or partial feeding of patients with a limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete ordinary food or certain nutrients contained therein, or metabolites, or with other medically-determined nutrient requirements, and (iv) for those which dietary management cannot
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be achieved by modification of the normal diet alone” - Commission Delegated Regulation (EU) 609/2013
(2013).
The EU has a modern framework7 for regulating FSDU-like products, revamped in 2016 with
further composition and labelling regulations coming into effect in 2019 and 2020 (Regulation (EU) No
609/2013 and No 2016/128). The regulations cover foods for special medical purposes (FSMPs), food
intended for infants and young children, and total diet replacements for weight control. FSMPs are
separated into three categories depending on the products formulation, nutritional completeness and
ability to be used for sole source nutrition. Unlike Canada, FSMPs intended for use in infants and young
children have unique regulations, acknowledging that nutritional needs differ between children and
adults. The FSMP composition requirements in the EU are generally more lenient and better match current nutrition recommendations. WhileDraft still regulating minimum and maximum levels of vitamins and minerals required (per 100 kcal or 100 kJ), the majority of the ranges are broader which facilitates
innovation and alleviates issues with product development and production (see section 5.0). Additionally,
products may exceed the maximum nutrient level if it is necessary for the intended use of the product.
Similar to Canada, there are specialized labelling requirements for FSMPs in the EU. While the
Canadian labelling requirements are specific for each FSDU category, the EU rules apply generally for all
FSMPs, with additional requirements for infant FSDU. EU FSMPs must include statements on labels for
use under medical supervision, suitability for sole source nutrition, intended age group, health hazards
and precautions, and the disease or condition the product is intended to manage. In addition, the label
must include a description of the product properties that make it useful for the disease or condition, a
warning to not use parenterally, and, similar to Canada, the preparation, use and storage instructions.
7 In this case, and throughout the paper, ‘modern regulations’ and ‘modern framework’ refer to regulations that have been updated/overhauled in a significant way to facilitate a market that best meet the needs of consumers/patients, are based on our current understanding of dietary needs in these populations, and support innovation
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Also similar to most FSDU in Canada (except MRs), the EU restricts nutrition information on FSMPs from being expressed as a %DV as the populations using FSMPs have unique nutrition needs. In the EU, FSMP manufacturers can not make nutrition or health claims as these types of claims are intended for the general population. A unique requirement for EU FSMPs is the need for manufactures to inform all member state national authorities of any FSMP being placed on the market and provide a model label and all relevant product information. This is to facilitate efficient monitoring of FSDU and verify compliance.
Australia and New Zealand
Foods for Special Medical Purposes “are: (i) specially formulated for the dietary management of individuals by way of exclusive or partial feeding, who have special medically determined nutrient requirements or whose capacity is limitedDraft or impaired to take, digest, absorb, metabolise or excrete ordinary food or certain nutrients in ordinary food and whose dietary management cannot be completely achieved without the use of the food; (ii) intended to be used under medical supervision; and (iii) represented as being a FSMP or for the dietary management of a disease, disorder or medical condition”
- Australia New Zealand Food Standards Code, Part 2.9 (2016).
Similar to the EU, the Food Standards Australia New Zealand (FSANZ) have recently (2016) modernized their regulations for FSDU-like products. Part 2.9 of the Australia New Zealand Food
Standards Codes, Special Purpose Foods, encompass Infant Formulas (currently under review), Foods for
Infants, Formulated Meal Replacements and Formulated Supplementary Foods, Formulated
Supplementary Sport Foods, and FSMPs. Similar to Canada, the general FSMP requirements apply to
FSMPs for children. There are however higher levels of calcium and vitamin D permitted in FSMPs for children 1 – 10 years of age.
The compositional requirements for FSMPs are dependent on its intended use for either sole source nutrition or not. For products not represented for sole source nutrition, the product may contain
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acceptable forms of any of the nutrients outlined in Schedule 29 (Table 7 and 20) of the code. There are
no minimum or maximum levels indicated, and the nutrients are not mandatory. Additionally, substances
outside of those listed in Schedule 29 tables 7 and 20, regardless of form, permitted under the food code
are allowed to be used in FSMPs. Sole source FSMPs have more prescriptive composition requirements
compared to non-sole source. Akin to the Canadian FSDU regulations, sole source products must contain
a minimum level of the vitamins and minerals outlined in Schedule 29 Table 21, and not exceed the
maximum level. However, unlike the Canadian regulations and similar to the EU, products do not need to
abide by the composition requirements if the deviation is necessary for the medical purpose of the
product. In this case, the nutrient levels which do not comply with the standard composition requirements
must be clearly labelled. FSMPs in Australia and New Zealand have several labelling requirements. These include ingredients, expiry date, directionsDraft for use and storage, nutrition information, and advisory statements such as use under medical supervision, precautions, the medical purpose of the food, the
intended age group, and whether it is suitable for sole source nutrition. Additionally, if it is a sole source
nutrition product it must include a statement to not use parenterally and any composition modifications
from schedule 29 table 21. FSMP claims must not refer to the prevention, diagnosis, cure or alleviation of
a disease or condition, and cannot compare the food to a product that is for therapeutic use. There are
also sale restrictions on FSMPs, only being sold to consumers by a registered medical practitioner or
dietitian, pharmacy or medical institution, or a majority seller of the FSMP 8. Overall, FSMP regulations in
Australia and New Zealand are comparable to those in the EU, and are more flexible and current than the
Canadian regulation of FSDU.
8 Majority seller of an FSMP is defined in the Australia New Zealand Food Standards Code (2.9.5) as a person which, during a 24-month period, sold that FSMP to medical practitioners, dietitians, medical practices, pharmacies or responsible institutions, and the sales represent more than 50% of the total amount of that FSMP sold by the person during that period.
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South Korea
Medical Foods “are: (i) products that have been specifically formulated for patients with a decreased capacity to ingest, digest, absorb, or metabolize foods; or (ii) for patients with a disease or a clinical condition in which the nutritional requirements differ from a healthy individual; and (iii) that can replace their diet, in its entirety or in part, by oral- or enteral-means” - Korean Food Code, Section 5-19.
The Korean Food Code outlines the regulations for FSDU in South Korea, further divided into seven subcategories including medical foods (defined above), infant foods (not infant formula), foods for weight maintenance, and foods for pregnant or lactating women. Medical foods are separated into 4 types – foods for patients, foods for patients with inborn errors of metabolism, foods for infant and toddlers with milk protein allergies, and specially formulated foods for infants and toddlers. All medical foods must have scientific justification for their nutritionalDraft composition, somewhat similar to the U.S. medical food definition of having distinct nutrition requirements based on recognized scientific principles. Similar to
FSDU regulation in Canada, FSMP regulations in the EU, and sole source FSMPs in Australia and New
Zealand, the foods for patients category of medical foods in South Korea have nutritional composition standards. Medical foods in South Korea also have many labelling requirements, similar to Canada, EU and Australia and New Zealand. These include nutritional information and ingredient list, storage conditions, expiry dates, and statement to be consumed according to physician’s instructions. South Korea allows ‘usefulness claims’ on medical foods, which include general statements related to growth and maintenance, health effects attributed to nutrients, statements related to the target patients such as ‘for diabetics’, and statements related to providing balanced nutrition. Usefulness claims and statements however cannot infer that the product treats diseases or symptoms of a disease. Unlike Canada, the EU and Australia and New Zealand, there are few sales restrictions of medical foods in South Korea, however this is under consideration.
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Codex Alimentarus Standards
Foods for Special Dietary Use are “those foods which are specially processed or formulated to
satisfy particular dietary requirements which exist because of a particular physical or physiological
condition and/or specific diseases and disorders and which are presented as such. The composition of these
foodstuffs must differ significantly from the composition of ordinary foods of comparable nature, if such
ordinary foods exist” - Codex Standard 146 – 1985 (1985).
Foods for Special Medical Purposes are “a category of foods for special dietary uses which are
specially processed or formulated and presented for the dietary management of patients and may be used
only under medical supervision. They are intended for the exclusive or partial feeding of patients with
limited or impaired capacity to take, digest, absorb or metabolize ordinary foodstuffs or certain nutrients
contained therein, or who have other specialDraft medically-determined nutrient requirements, whose dietary
management cannot be achieved only by modification of the normal diet, by other foods for special dietary
uses, or by a combination of the two” - Codex Standard 180 – 1991 (1991).
The Codex Alimentarus, a collection of internationally adopted food standards and guidelines,
defines both FSDU and FSMPs (a subsection of FSDU). Codex outlines labelling and claim standards for
FSDU and FSMPs, but does not provide specific standards for product composition, and offers few sale
restrictions.
The standards for FSDU are not as stringent as FSMPs. Mandatory labelling standards for FSDU
and FSMP include the name of the food, quantitative labelling of ingredients, country of origin, net
content and weight, name and address, lot identifier, date marking, storage conditions and indication if
the product is irradiated. The standard also outlines nutrition labelling requirements for FSDU and FSMP
including the amount of energy (kcal and kJ per 100 g or 100 mL and recommended serving), amount of
protein, available carbohydrate and fat (g per 100 g or 100 mL and recommended serving), and the total
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quantity of specific nutrients and other essential components (per 100 g or 100 mL and recommended serving).
Codex provides additional general principles and recommendations for FSMPs. These products should have demonstrated scientific evidence showing their safety and benefit for the intended population and provide sufficient information for their proper use. Unlike FSDU, the Codex standard for
FSMPs suggests prohibiting advertising to the general public. FSMPs are exempt from certain labelling standards and follow similar nutrition labelling standards as FSDU for energy, macro- and micronutrients.
When appropriate, nutrients should be expressed on the label as a %DV, and information on osmolality and osmolarity and animal or plant proteins should be provided. Any modifications to the nature of the proteins, fats or carbohydrates of the FSMP should be described. Other labelling standards include statements to be used under medical supervision,Draft warnings of health hazards, not safe for parenteral administration, and its suitability for sole source nutrition. The product should also state its intended use, any precautions or known side effects, rationale for the use of the product, intended age group, modification of nutrients, and feeding instructions.
5. Impact of Regulations on the Development and Manufacturing of FSDU
Improving the dietary management of diseases and conditions requires development of innovative foods products utilizing current nutrition knowledge and food science, but is heavily dependent on food regulations. When developing a new food product, such as a meal replacement, the regulations of the targeted market jurisdiction are the first consideration, however during product development there are many considerations beyond the regulations. When deciding what nutrients to incorporate, the manufacturer must consider not only the health benefits and amount required for the desired effect, but also if the nutrients are permitted and if there are minimum and/or maximum macro- and micronutrient
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concentrations defined in the regulations. While ingredient quality and cost are important considerations,
the regulations are the true authority and consider safety of the ingredient, microbiological concerns, and
ability to control lot-to-lot variability of that ingredient. Beyond the chemistry and food science,
regulations also determine the possible forms of the product (liquid, powder, etc.), and how it can be
manufactured and packaged. Meeting the regulatory provisions for a product also requires evaluation of
the interactions of selected ingredients, which impact nutrient degradation, nutrient interactions, shelf
life and storage conditions.
Stringent regulations make the entire product development cycle more difficult. While
regulations are necessary to ensure the safety of our food system and prevent consumers from being
misled, they often hinder innovation. The summary of global FSDU-like regulations (section 4.0) and the
pre-workshop survey (section 6.0) indicate Draftthat the Canadian FSDU regulations are particularly restrictive
and limit the ability for manufacturers to deliver products utilizing current science. One example of this is
the narrow content range required of FSDU in Canada for most nutrients. Ensuring nutrient composition
compliance within the regulatory limits is challenged by several factors that determine the nutrient level
in a final product, including inherent nutrient contributions of the food, lot-to-lot nutrient variability of
the ingredients, nutrient loss during manufacturing, nutrient loss over time (shelf life), as well as variability
in analytical testing. The tighter the minimum and maximum nutrient levels allowed in a product, the
more difficult it is to stay within the limits taking into consideration the above listed contributing factors.
Compared to many other food categories, and all other evaluated jurisdiction’s FSDU regulations (section
4.0), Canada’s FSDU provisions have the most narrow nutrient thresholds. For example, a 235 kcal meal
replacement in Canada is required to contain 200 – 400 mg of calcium, a 200 mg range. In the EU an equal
calorie product would require between 117 – 588 mg, a 471 mg range. Similarly, Vitamin D allowance for
the same product would be between 1.25 – 2.5 ug in Canada (range of 1.25 ug) and 1.18 – 7.05 ug in the
EU (range of 5.88 ug). These narrow limits increase risk of non-compliance to the manufactures, negatively
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impacting investment in Canada to develop, manufacture and market FSDU that reflect current science and address the nutritional needs of specific populations.
The strict FSDU regulations in Canada have also impacted manufacturers ability to meet consumer preference and demands. Two recent examples of this are the FLD Liquid Hope (Nutritional Medicinals,
LLC) and the MR Soylent (Rosa Foods). Liquid Hope is a dairy and soy-free whole food FLD, a category of products with increasing consumer interest in the last decade. The majority of FLD on the Canadian market are dairy or soy based, with added synthetic nutrients. Liquid Hope is a whole food alternative, however it does not meet the minimum protein quality requirements9 for FLDs in Canada and exceeds the FLD
Vitamin A maximum level. The Vitamin A in the product is from whole-food carotenoids, not retinol which is responsible for side effects and the basis for the upper limit. Division 24 Vitamin A requirements do not distinguish the two formats, so despite posingDraft minimal risk the strict FSDU regulations prevented patients in Canada from using the product. Recently the manufacturers reformulated to increase the protein quality, and the product is now temporarily available in Canada through an agreement with Health Canada
(Health Canada, 2018). Soylent on the other hand is an MR in ready-to-drink and powder formats, manufactured in the U.S. and available for purchase online. Soylent is marketed as the nutrition solution for people on the go that need a convenient and quick alternative to traditional foods. It is plant-based
(soy) with sunflower oil, beet disaccharides and added micronutrients, however it is non-compliant with several composition and labelling provisions for MR in Canada. The Canadian Food Inspection Agency has advised Soylent to stop imports into Canada, which has sparked outrage from Canadian users.10 Soylent is an excellent example of the evolution of FSDU users, with the general healthy population now making
9 Several issues have previously been identified with respect to the protein quality requirements and the official method for protein quality measurement in the Canadian Food and Drug Regulations. A workshop held in Fall 2016 summarizes key issues and suggests a path forward (Wiggins et al. 2019). 10 The import ban on Soylent garnered national media coverage in October 2017. The Soylent website discusses the ban and provided updates on the status [https://faq.soylent.com/hc/en-us/articles/115005267426-Canadian- Availability-Update]
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up a major stake in the FSDU market. This emphasizes the need to re-evaluate the definition and
regulation of FSDU in Canada, as these groups have differing needs and preferences for products such as
MR compared to the vulnerable populations the FSDU framework was initially designed for.
6. Key Outcomes from Workshop Survey and Discussion
Prior to the multi-stakeholder workshop, a survey was circulated to workshop attendees, health
professionals, industry, government and researchers. A summary of the survey responses is located in
Figure 1.11 From the 38 completed responses, there was representation across stakeholder groups (27%
academia, 32% industry, 21% healthcare, 11% consultants, 8% government, 3% NGO). Half (50%) of
respondents indicated they have experienced challenges using or complying with current Division 24 regulations, with the most common challengesDraft being: (i) complying with compositional requirements; (ii) regulations not applicable or appropriate for products; (iii) complying with non-compositional
requirements such as labelling; and (iv) uncertainty in interpreting the regulations. There was consensus
that the current Division 24 regulations do not best utilize current nutrition recommendations and food
science/technology research, do not allow for innovation, do not meet the needs of users in clinical and
non-clinical settings, and do not allow users access to preferred products. Compared to other countries,
Canadian regulation of these products does not meet the needs of consumers and limits innovation.
Modernization of Division 24 regulations was overwhelmingly identified as being important (75% very
important, 25% important, 0% not important), and would help to: (i) strengthen the scientific basis of
regulations; (ii) improve patient outcomes through access to broader products; (iii) harmonize with other
jurisdictions to facilitate trade and consumer/health system demands; and (iv) create flexibility in the
framework enabling innovation and access to the market.
11 Supplementary Figure S2 provides the complete survey results
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The workshop presentations and group discussions led to several recommendations:
1) Update the nutrient composition provisions to better match current nutrition
recommendations (DRIs). Further, the composition requirements were generally regarded as
too strict and the minimum and maximum nutrient thresholds are too narrow. This is
particularly problematic for product development and FSDU formulations as there are many
factors that impact the level of nutrients in a final product, including shelf life (stability), lot-
to-lot variability, product form, ingredient interactions, and analytical detection methods. It
was also recommended that different categories within Division 24 may benefit from varying
levels of composition stringency.
2) Assess and consider nutrient needsDraft of specialized populations to ensure their nutrition needs
are properly captured in the FSDU regulations. These populations include children, elderly,
medical conditions, and others.
3) Consider incorporating proof of efficacy for FSDU into the regulations. Some jurisdictions
require evidence that the product is beneficial and meets the needs for its intended use.
Despite this being potentially labour intensive, it does deter non-FSDU products from
marketing themselves as an FSDU and provides an additional layer of confidence in the
products. This concept could also apply to only specific categories within Division 24.
4) Assess the FSDU labelling requirements. Labelling is an important tool to properly relay
information about products to consumers and health care providers. FSDU currently have
different labelling requirements from traditional foods, and this should be evaluated. It may
be beneficial for some FSDU to adhere to specialized labelling (such as FLDs) while others may
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benefit from regular food labelling (such as MRs). Other issues related to the labelling of FSDU
include the use of a Nutrition Facts Table on products that are consumer facing such as MRs,
the appropriateness of using health and nutrient content claims on FSDU, and the usefulness
of current quantity listings (for example, mg required for very small quantities is not practical).
5) Harmonization of FSDU-like product regulations and the availability of products in the
marketplace in North America (and ideally, globally). Many FSDU-like products available in
the U.S. as medical and traditional foods, and globally under various categories, are currently
restricted in Canada. This creates frustration for health care providers and consumers, and
ultimately impacts vulnerable populations who may benefit from these innovative products. Within reason, and ensuring safetyDraft above all, consistency of products available in Canada and the U.S. would benefit consumers/patients, health care providers and industry. Workshop
attendees recognized limitations of the flexible U.S. regulatory framework and recommend
assessing the Australia/New Zealand and EFSA regulatory frameworks (recently updated and
adopting several Codex recommendations) for guiding FSDU-like products. If deemed
appropriate, these may be adapted for the modernization of Division 24 in Canada.
6) Utilize the regulatory tool of Incorporation by Reference (IBR). IBR have recently been used in
the updates to nutrition labeling and allow for parts of the regulations to be housed in a
document separate from the FDR. The document is referenced in the FDR, but it’s location
outside the text of the FDR allows for updates without the formal and lengthy regulatory
amendment process. It was suggested that IBR be utilized in Division 24, in particular for the
compositional requirements. This will allow for more regular and timely updates as science,
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nutrition recommendations, and FSDU users evolve, and supports innovation in the Canadian
market.
7) Modernize Division 24 through a comprehensive approach. An initial exercise should
deconstruct the FSDU regulations, assess all components, and then build back together. This
will allow for a thorough evaluation and likely lead to a more efficient framework, rather than
simply making one-off amendments. One possible opportunity is to separate ‘medical’ and
‘non-medical’ FSDU products, allowing for more stringent regulations for medical FSDU and
relaxing requirements for those used more generally. This may also allow for products that
have landed in Division 24 to move to more appropriate sections of Canada’s FDR. One example is follow-up formulas Draft(toddler milk), currently regulated as a FSDU in Division 24 and therefore have composition provisions based on adult nutrient requirements. These products
may benefit from being regulated instead as Infant Formula and Foods (Division 25). The
definitions of FSDU should also be assessed during this exercise, particularly if the second part
of the Canadian FSDU definition ‘for whom a particular effect, including but not limited to
weight loss, is to be obtained by a controlled intake of foods’ should continue to be utilized.
8) Give attention to the disconnect between physicians/dieticians/ health care providers and
regulations/regulators. Many professionals responsible for providing patients with nutritional
support are not informed of the regulations of FSDU, and do not understand why products
available for use in Canada are limited compared with other countries. They need to be
involved in the regulatory modernization and there is a need for continued education.
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Goals and Next Steps for Modernization of Division 24
The workshop generated several short- term goals and long-term outcomes for Division 24
modernization.
Short-term goals include:
1) make Division 24/FSDU a regulatory priority for the Canadian government
2) perform a scan to capture and document the FSDU products currently on the Canadian market
3) continue use of temporary marketing authorization (TMA) letters to allow innovative products
currently outside of the Division 24 requirement to reach the market. This will simultaneously
allow for data to be collected on these products to inform final regulations. Note that this is a short-term action and not sustainableDraft long-term. 4) undertake an assessment of other jurisdictions regulatory frameworks for FSDU-like products
5) move the compositional requirements contained in Division 24 to an IBR document to allow for
more frequent updates as the science and nutrition recommendations change
Long-term outcomes anticipated include:
1) A modern, safe, flexible, innovative and health driven regulatory framework for FSDU in Canada
2) More research funding to support exploration of nutrition needs of specialized populations and
FSDU
3) Better understanding of accessibility of these products to Canadians
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Acknowledgements
This work benefited from the experts who presented at the “How to Optimize Foods for Special Dietary
Use in Canada – Nutritional Requirements, Innovation, and Regulation” workshop held in November
2017 in Toronto Ontario, workshop attendees, and Dr. Heather Keller (University of Waterloo).
Conflict of Interest Statement
The authors have no conflicts of interest to report.
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Figure Captions
Figure 1. Summary of the pre-workshop survey responses distributed through the PFSNRA and CNS, and
completed by 38 experts from academia, government, health professionals and industry. The entire
survey results can be found in Supplementary Figure S2.
Draft
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Draft
455x341mm (300 x 300 DPI)
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