Modernizing Canada’s Medical Nutrition Regulations for Food

Feature ArticlesFeature Articles | 24 June 2019 | Citation

This article addresses the Canadian government’s opportunity to modernize its medical nutrition regulations for food and presents key learnings from the structure and implementation of several regulatory frameworks for Food for Special Medical Purposes (FSMP) globally. The author recommends an improved framework in Canada to better address the needs of patients and healthcare professionals.
Malnutrition is defined as a deficiency, excess or imbalance of energy, protein and other nutrients causing measurable adverse effects on body tissues, functional abilities and clinical outcome.1-3 Nutrition therapy to address disease-related malnutrition involves the intake of foods to help maintain or improve a patient’s nutritional status. In clinical practice, the primary focus of nutrition therapy for malnutrition is to address an inadequate intake of energy, protein and nutrients.4 Complications from acute conditions, infections and disease can worsen undernutrition and make it more challenging to correct through nutrition intervention. In addition, extensive physiological changes, concomitant increases in nutritional needs and decreased appetite further exacerbate the challenge. The inverse to undernutrition is excess intake of specific macronutrients or micronutrients. For example, in a clinical situation, the chronic excess intake of the amino acid phenylalanine in a child with phenylketonuria will have irreversibly toxic effects on the child’s developing brain. A tailored nutrition intervention is critical to help manage the over and under nutrition needs of each patient.
Outside of Canada, foods for medical nutrition are referred to in legislation as enteral nutrition, medical food or Food for Special Medical Purposes (FSMP). Codex Alimentarius defines FSMP as:
“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 special 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.”5
There are no specific provisions defining food for special medical purposes in the Canadian regulatory framework; rather, special purpose foods are captured under Foods for Special Dietary Use (FSDU) and Infant Foods Regulations within the Food and Drug Regulations (FDR).6 The Canadian FSDU provisions were developed in the 1970s through the 1990s7 and have remained wholly unchanged to date. The Canadian FSDU Regulations are characterized by closed categorical definitions, detailed compositional and labelling requirements and restrictions related to their sale, advertising and monitoring. Given these characteristics and the contrast with developed international FSMP frameworks, it is evident that the Canadian FSDU Regulations are largely antiquated and overly restrictive, making their modernization urgently necessary.
Canada has a significant opportunity to modernize its regulatory framework in line with the more current international FSMP systems. The Canadian government has recently signalled its intent to over the next three years focus on “targeted reviews” of regulatory requirements and practices posing bottlenecks to innovation in multiple sectors, including food and health products.8 The outcome of these reviews may strengthen Canada’s government to mandate addressing the more specialized areas of food and health product regulations in unequivocal need of renovation. The Canadian government can demonstrate its mandate to modernize by better aligning inter-departmental resources to enable Health Canada to move forward with its identified legislative changes with greater efficiency. In 2017, a multi-stakeholder workshop of experts, including Canadian health professionals, researchers, industry and government met to discuss the technical aspects of FSDU in Canada in the context of global regulations, the importance of FSDU to nutrition and health and next steps for addressing challenges and opportunities for regulating and using FSDU. The outcome of this workshop was recently published.9
Regulatory modernization of the food and health product framework is critical as the healthcare needs of the Canadian population are changing and increasing in complexity as its population ages.10 Modernization is also necessary, as Health Canada has described, to keep pace with the constantly changing macro-environment that shapes the use of these products.11 As a regulator, Health Canada has the opportunity to become even more consumer and patient-focused, innovative and flexible to meet their vision that “all Canadians achieve optimal health outcomes through access to safe, effective, high quality health and food products and timely, relevant and useful health information.”12 A modernized regulatory framework for special purpose foods, including those for medical nutrition, will help enable this vision by providing a clear, coherent, open, adaptable and efficient regulatory structure.
The Current Canadian Regulatory Framework
In Canada, the Food and Drugs Act (the F&DA) is the primary legislation governing the safety and nutritional quality of food. The F&DA categorizes consumed products as either foods or drugs. Products for enteral nutrition, commonly known as tube feeding, are “food” under Part 2 of the F&DA and fall under Part B, Division 24 “Foods for Special Dietary Use” of the FDR. The FDR identifies a FSDU according to its intended use and by the discrete categories set out in Division 24. “Supplemented food”13 intended for healthy individuals and “Natural Health Products”14 as a subset of “drug” under the F&DA, are out-of-scope of Division 24.
A FSDU is defined as “a food that has been specially processed or formulated to meet the particular requirements of a person: in whom a physical or physiological condition exists as a result of a disease, disorder or injury or for whom a particular effect, including but not limited to weight loss, is to be obtained by a controlled intake of foods.”15 Only the following seven categories16 of foods are permitted as FSDU:
  1. formulated liquid diet
  2. meal replacement
  3. nutritional supplement
  4. foods for very low energy diets
  5. foods for protein-restricted diets
  6. foods for low (name the amino acid) diets
  7. gluten-free foods
While each has prescriptive labelling requirements, several have detailed compositional requirements under Division 24 for energy, macronutrient and micronutrient levels, in addition to prohibitions for sale or advertising. Of note, in other global frameworks such as that of the European Union (EU) and Australia/New Zealand, only the formulated liquid diet, foods for low-protein diets, and foods for low (name the amino acid) diets are categorized as FSMP.
Most global FSMP frameworks cover foods intended for infants and non-infants together or in a coordinated FSMP system. Based on age, the Canadian FSDU category only applies to individuals older than 12 months, while foods for infants younger than 12 months are regulated under FDR B.25 “Infant Foods” that include foods for infants with “special dietary needs.” There are no further provisions in the FDR that elaborate on requirements beyond infant formula to address special dietary needs resulting from a disease, disorder or dysfunction in infants; thus, there is a need to coordinate modernization efforts for both Division 24 and Division 25 to help ensure a coherent regulatory structure.
Two of the hallmarks of a FSMP framework are: 1. FSMP are intended for use by patients, not healthy individuals and 2. FSMP should be used under medical supervision. Several categories within the Canadian FSDU framework are intended to be used under medical supervision, based on advertising restrictions or labelling provisions: formulated liquid diets, foods for very low energy diets, foods for low protein diets and foods for low (name the amino acid) diets. While the remaining categories, including meal replacements, nutritional supplements and gluten-free foods may be used under medical supervision, they do not require this oversight per se and are available with no or limited restriction on advertising and sale and can be consumed by otherwise “healthy” individuals.
The state of the current Canadian framework and the opportunities to move it forward can be understood from the context of its development. The substantive additions to the FSDU framework were formalized in the Canada Gazette between the early 1970s through 1995;17 with work ending around the time that Codex published CODEX STAN 180-1991 for the labelling of FSMP. This timing informs of the state of nutritional science from the 1990s, and the model of prescribing defined, although inflexible, compositional requirements in the regulation. When modernizing provisions for the meal replacement and nutritional supplement categories, for example, substantial compositional updates are required to address the narrow limits imposed in Division 24 to align with current recommendations. To illustrate, the upper limits for vitamin D18,19 were developed in context of Health Canada’s Recommended Nutrient Intake (RNI) for vitamin D of 5 mcg per day from 1990,20 while the Recommended Dietary Allowance (RDA) is currently 20 mcg per day for those age 70 and above.21 Therefore, one serving of a meal replacement is permitted to provide no more than 7-8% of the RDA22 for vitamin D, while a 150 kcal nutritional supplement must not exceed 4-5% of the RDA,23 making it challenging to address inadequate intake of vitamin D using either of these FSDUs.
Overall, the current Division 24 structure with fixed compositional limits, inclusive of the manufacturer’s overage, is unprecedented in other FSDU and FSMP frameworks. A categorical reassessment of these regulations will help ensure that they can accommodate current nutritional science and clinical practice to meet the special dietary needs they intend to address.
Global FSMP Frameworks of Particular Relevance to Canada
There are numerous international FSMP frameworks to inform Canada’s modernization opportunity, and a review of medical food and FSMP regulations across multiple countries shows remarkable regulatory similarities among them.24 Accordingly, this discussion will focus on three examples most relevant to the Canadian context: Codex Alimentarius, the EU and Australia/New Zealand. As the goal of modernizing Canada’s regulatory framework for FSMPs is to achieve an efficient, flexible and responsive system where healthcare professionals have the most optimal nutrition tools to provide patients the most appropriate nutrition care and to have an overall approach of healthcare that is cost-effective25
to help discover how best to achieve these outcomes, the following questions are intended to guide the reader and generate discussion.
What can be learned about the relationship between the current food for special dietary use framework and that for food for special medical purposes?
The Canadian context is set in an existing FSDU framework; today, this term has a different association among many countries outside of “dietary management of disease” that is associated with FSMP. Ideally, a modern Canadian system integrates both FSDU and FSMP provisions to provide coherence. Codex offers standards and guidelines that have influenced the FSDU and FSMP frameworks worldwide,26 owing to Codex’s organization of FSMP as a subtype of FSDU. A distinction between the two is that FSMPs are more narrowly described for “patients” presenting with specifically defined impairments or distinct nutrient requirements, and can be used “only under medical supervision” for the “dietary management of a disease.”27 By contrast, FSDUs are more broadly intended for “consumers” following “advice from a qualified person” to “satisfy particular dietary requirements which exist because of a specific disease.”28 The distinction is subtle, but important.
Codex has published multiple standards covering both FSDU and FSMP with an emphasis on requirements for labelling and claims of FSMP rather than composition. To illustrate, CODEX STAN 146-1985 covers labelling and claims of FSDU;29 CODEX STAN 180–1991 covers the labelling and claims of FSMP (non-infants);30 CODEX STAN 72–198131 Section B applies to formulas for special medical purposes intended for infants; and CODEX STAN 203–1995 covers formula for use in very low energy diets for weight reduction.32 With the exception of very low energy diets for weight reduction, Codex has not established compositional requirements for non-infant FSDU and FSMP, given the complexity they must cover. The Codex Standard for infant formula (CODEX STAN 72-1981) has established compositional requirements in Section A, but also states that their composition may be modified to meet the special needs of infants suffering from diseases, disorders or medical conditions.33,34 Overall, the broad Codex FSDU framework offers many examples that could help reframe a variety of age and health contexts across the categories covered under Canada’s current Division 24 and 25 structure. Therefore, a modern Canadian framework can reframe existing FSDU categories and also integrate FSMP provisions.
What can be learned about the general structure of the other FSMP frameworks?
Presently, the Canadian framework for most Division 24 foods encompasses highly prescriptive compositional requirements and, accordingly, represents the single greatest opportunity to modernize in order to meet the nutritional needs of more individuals and also offer additional nutrition tools to healthcare professionals. Barring a significant reassessment of the Canadian framework resulting in the complete removal of prescribed compositional requirements, such as the case for US medical foods,35 a flexible regulatory structure is critical, particularly once a “standard” composition is set.
Whereas Codex offers limited compositional standards for FSMPs and the opportunity for each country to determine additional requirements, the EU has a well-defined FSMP framework with compositional criteria, specific labelling provisions and provisions for monitoring products in the market.36 A full review of the EU FSMP framework over a seven-year revision period between 2010 and 2017, has resulted in a modern and pragmatic system, one globally notable for its example. A comprehensive overview and discussion of the revised EU FSMP system details the principled, multi-stakeholder approach that was implemented to develop this pragmatic regulatory structure.37
Among the principles of the EU’s pragmatic structure is the flexibility in the FMSP composition, whereby the framework broadly groups nutritionally complete and incomplete formulas to accommodate the varieties that can exist. Article 2(1) of Delegated Regulation (EU) 2016/12838 lists three categories of FSMP classification: (a) nutritionally complete food with a standard nutrient formulation, that may provide a sole source of nutrition, (b) nutritionally complete food with a nutrient-adapted formulation for a specific disease, disorder or medical condition, that may provide a sole source of nutrition and (c) nutritionally incomplete food with a standard formulation or a nutrient-adapted formulation specific for a disease, disorder or medical condition which is not suitable as a sole source of nourishment. Standard compositional requirements are set out in Part B of Annex 1 of the Delegated Regulation (EU) 2016/128 while deviations from the standard are permitted for parts (b) and (c), as necessary and based on the intended use of the product.
In comparison, FSDUs in Canada must either meet all the complete nutrition requirements, similar to part (a) of the EU FSMP classification or they offer some ability to meet the nutrient-adapted complete nutrition requirements under part (b). However, only foods specifically intended for low-protein or low (name the amino acid) diets in Division 24 may be offered as incomplete per part (c) of the EU classification. Nutritionally incomplete foods, whether partially fortified or unfortified, cannot be considered FSDU in Canada as defined by B.24.003 of the FDR. Foods intended for individuals with dysphagia, foods intended for ketogenic diets or modular foods providing a concentrated source of one or more nutrients offer examples where the intended use of the food meets the definition for FSDU under Division 24, yet the food may not meet one of the categorical definitions. Nutritionally incomplete foods under the EU FSMP standard that do not meet the composition set in Canadian regulation, demonstrate the need to increase the inclusiveness of the categories defining an FSMP in Canada.
The compositional requirements for formulated liquid diet (enteral feeding formulas) offer some nutritional adaptability with limits on 18 vitamins and minerals; however, these parameters encompass all ages beyond one year as well as all disease, disorder and dysfunction conditions, within one compositional standard. This creates an impractical reality for one compositional standard to cover all situations. This reality is further exacerbated without a regulatory mechanism in Division 24 to deviate from the prescribed limits of any vitamins or minerals; irrespective of the formula being intended as a “standard composition” or “nutrient-adapted.” To illustrate, a 70 year old adult consuming a tube feed at less than 1500 kcal per day may not be meeting the RDA for vitamin D despite the formula being set at the compositional maximum per 100 kcal for the formulated liquid diet category.39 The inverse is also possible, whereby a one-year-old child consuming approximately 1000 kcal per day of formulated liquid diet may be reaching the Tolerable Upper Intake Level for a nutrient, such as zinc, despite the product being formulated to the minimum limit for that nutrient.40 Clinical practice guidelines that recommend adaptation of the nutrient profile beyond what formulas are capable to provide due to the prescribed limits of Division 24; for example, in renal disease where protein, calcium and copper intakes need to be restricted; may exacerbate the challenge that clinicians face to address malnutrition. Misalignments are of particular concern in individuals on the low end of energy intake, when using formula that is optimized, to the extent possible, to be compliant with the prescribed compositional standard yet the formula is not optimal to address their malnutrition needs.
A noteworthy learning from the general structure of international frameworks is how, based on the definition of an FSMP, they address the intended use for the “feeding of patients… whose dietary management cannot be achieved only by modification of the normal diet.”41 “Modification of the normal diet” is intentionally restrictive to prevent misbranding of products as FSMPs; however, the concept becomes problematic to interpret when only partial replacement of the diet is with FSMPs, and particularly with incomplete FSMPs.42 In the redevelopment of the EU FSMP framework, key principles considered to assess the potential for modification of the diet, were the context of the patient and the challenges of their disease, disorder or medical condition; as well as whether modification of the diet alone may be unsafe, impractical or disadvantageous.43
A modern regulatory framework for FSMP in Canada, if it considers “modification of the normal diet,” should interpret the concept to the extent that it remains patient-centered, practical and clinically meaningful.
What can be learned about the adaptability of other FSMP frameworks?
The closed definitions and compositional requirements for FSDU in Canada illustrate current limitations of adaptability of this framework to accommodate new FSMP that deviate from fixed criteria. The seven subcategories of Canadian FSDU support, on their face, the intent behind the Division 24 regulation, which is to prevent fraud and the sale of food containing harmful substances44 by narrowly defining their scope; however, these restrictions have consequences. They may prohibit access to FSMP otherwise available outside of Canada or create the potential for confusion if healthcare professionals and patients are challenged to distinguish an FSMP from foods available in the normal diet. For example, the ability to communicate clinically meaningful differences could be made clearer, distinguishing between modular thickeners designed for the specific use of adapting the diet of individuals with dysphagia and a kitchen-pantry thickener. In Canada, both foods must be labelled as general prepackaged foods and the thickener intended for special medical purpose cannot make reference to “dysphagia.”45
Modernizing the Canadian framework requires imbedding systemic adaptability into its structure given FSMPs are very specialized foods and their use frequently evolves. The EU FSMP framework offers a notable example of how the theme of adaptability is integrated into the core of its design, as illustrated in the Delegated Regulation (EU) 2016/128:
(4) The composition of food for special medical purposes may differ substantially depending, among others, on the specific disease, disorder or medical condition for the dietary management of which the product is intended, on the age of the patients and the place in which they receive health care support, and the product's intended use. In particular, food for special medical purposes can be classified in different categories depending on whether its composition is standard or specifically nutrient-adapted for a disease, disorder or medical condition and on whether or not it constitutes the sole source of nourishment for the persons for whom it is intended.46
As the understanding of disease and the role of nutrition continually evolves, so will clinical practice and the evidence that supports the role of FSMPs on health outcomes. A significant investment in time and resources will be required for regulatory modernization, so any fulsome effort must future proof, to the extent possible, a system through imbedded adaptability that will weather the otherwise constant need to make significant revisions every one or two decades. The Delegated Regulations (EU) 2016/128 capture a pragmatic approach to this future orientation for the EU:
(5) Because of the wide diversity of food for special medical purposes, the rapidly evolving scientific knowledge on which it is based, and the need to ensure adequate flexibility to develop innovative products, it is not appropriate to lay down detailed compositional rules for such food products. It is however important to set principles and requirements specific to them in order to ensure that they are safe, beneficial and effective for the persons for whom they are intended on the basis of generally accepted scientific data.47
Overall, it is clear that a modern FSMP framework for Canada must focus on adaptability as a characterizing feature to address the gaps and deficiencies of the current FSDU setup and to foster innovation in FSMPs. It is equally important to sustain a modernized framework by pre-empting for evolving scientific knowledge at the nutrition/health/disease interface through flexible requirements, and efficient regulatory mechanisms for these to remain current.
What can be learned about global interfacing among other FSMP frameworks?
The majority of Canadian FSDUs and particularly the products generally recognized as FSMPs outside of Canada are from a relatively small number of companies that import them from places like the US and the EU. Given this predominant import status of products, access to them in Canada presupposes that most have come through a FSMP or FSDU framework from somewhere in the rest of the world. Modernizing the Canadian system should consider these realities and reflect the interconnectedness of FSMP frameworks designed to meet the specialized needs of a relatively small numbers of patients, when developing its requirements. By design, a modern Canadian framework should be harmonized with, or mutually recognize, other FSMP frameworks. For some types of diseases, such as inborn errors in metabolism, the incidence is very rare and the number of patients requiring nutritional interventions may be 50 or fewer per year. Access to these highly specialized formulas is predicated on manufacturers generating sufficient scale to commercialize them; an outcome considered when product development can be lengthy, costly and require specific expertise and technical capability to produce. Sometimes, the only commercially viable option may be to generate scale by creating one global formula that must accommodate all local regulations; a difficult task at best, and often an impractical one given differing requirements across countries. In this context, harmonization and mutual recognition of composition and labelling requirements across geographies can help maximize the likelihood that patients will have access to the specific formulas most suitable for their needs.
The Australia/New Zealand framework for FSMP48 offers an applied example of a region with similarities to Canada relative to population size and diversity, maturity of its regulatory framework for food and therapeutic products and how FSMP products are sourced. Australia and New Zealand are predominantly import markets that interface with global FSMP systems, such as the EU and the US to access these foods, and their regulatory system is set up to minimize the risk of imposing trade barriers.49
Under Standard 2.9.5 of the Australia New Zealand Food Standard Code (FSANZ),50 compositional requirements are set for vitamins, minerals and electrolytes for FSMPs represented as a sole source of nutrition. The standard permits variation from the maximum or minimum amounts as required for a particular medical purpose, similar to the EU system. The compositional requirements for vitamin and mineral ranges required under the Standard are closely harmonized with those defined in EU Regulation 2016/128. The requirements adopted by Australia and New Zealand align with the EU and the other countries where those levels have been accepted.
Along similar lines, Standard 2.9.5-1151 offers flexibility in the labelling of ingredients. The requirements of the Food Standard Code, the EU or the US regulations are all permitted to be met on the FSMP label. Thereby, a technical barrier is removed to facilitate multiple market labelling and enable trade and compliance. This example is relevant to the Canadian experience, as it is impractical to share FSMP labels between other markets due to conflicting technical requirements for ingredient lists, nutritional information or other mandatory elements, including English and French labelling.
The Canadian framework for FSMP products is covered under FSDU and infant food provisions within the FDR. The FSDU Regulations characterize closed categorical definitions of FSDU, and detailed compositional and labelling requirements that are largely antiquated and overly restrictive. Based on precedents from international regulatory systems for FSMPs, the key to modernizing the Canadian framework will be to address the regulation’s inherent limitations in flexibility, adaptability and capacity to interface congruently with other FSMP systems. The Codex Alimentarius FSMP categorization, as a type of FSDU, offers a relevant starting point to evolve and reframe the Canadian framework. The EU model demonstrates how a mature and well-reasoned FSMP system can operate pragmatically with flexible and adaptable compositional requirements that can evolve to meet the needs of patients. Finally, the Australia/New Zealand FSMP framework exemplifies tailored flexibility in their approach to interface with larger markets like the EU and the US; a relationship among markets that parallels the Canadian context. Inclusive of the similarities between FSMP frameworks, each example offers particular aspects that inform the development of a clear, coherent and efficient future framework for Canada. The need to modernize is clear, the timing is urgent, and a path forward is evident to provide healthcare professionals better access to optimal nutrition tools and patients the most appropriate nutrition care.
  1. McKinlay AW. “Malnutrition: The Spectre at the Feast.” J R Coll Physicians Edinb. 2008;38:317–21.
  2. Sobotka L, editor. Basics in Clinical Nutrition. 3rd ed. Prague: Galen; 2004.
  3. Canadian Malnutrition Taskforce. Malnutrition Overview. Accessed 17 June 2019.
  4. Medical Nutrition International Industry (2018). Better Care Through Better Nutrition: Value and Effects of Medical Nutrition. A Summary of the Evidence Base. 4th edition. Accessed 17 June 2019.
  5. Codex Standard for the Labelling of and Claims for Foods for Special Medical Purposes. CODEX STAN 180-1991. file:///C:/Users/ghall/Downloads/CXS_180e%20(1).pdf. Accessed 17 June 2019.
  6. Health Canada. Regulatory Roadmap for Health Products and Food. Appendix A. Summary of Where we are. Accessed 17 June 2019.
  7. Ruthsatz, M. “Food Supplements and Food for Special Medical Purposes” 2017. International Fundamentals of Regulatory Affairs. 3rd Ed. Chapter 30, p. 338. RAPS.
  8. Government of Canada. Background: Regulatory Reviews. What we Heard Report on Regulatory Reviews and Modernization Stakeholder Consultations. Accessed 17 June 2019.
  9. Wiggins A, Grantham A and Anderson G. “Optimizing Foods for Special Dietary use in Canada: Key Outcomes and Recommendations From a Tripartite Workshop.” Appl Physiol Nutr Metab. June 2019. Accessed 17 June 2019.
  10. Jackson T, Clemens J and Palacios M. “Canada’s Aging Population and Implications for Government Finances.” Fraser Institute. October 2017. Accessed 17 June 2019.
  11. Health Products and Food Directorate Strategic Plan 2016-2021. June 2016. Accessed 17 May 2019.
  12. Ibid.
  13. Health Canada. Category Specific Guidance for Temporary Marketing Authorization: Supplemented Food. February 2016. Accessed 17 June 2019.
  14. Natural Health Product Regulations. SOR/2003-196. Accessed 17 June 2019.
  15. B.24.001, Food and Drug Regulations. SOR/95-474, s.3.,_c._870/FullText.html. Accessed 17 June 2019.
  16. B.24.003, Food and Drug Regulations. SOR/95-474, s.3.,_c._870/FullText.html. Accessed 17 June 2019.
  17. Canada Gazette II. 1995. Vol 129. No. 21. Accessed 17 June 2019.
  18. B.24.200(1)(f)(ii), Food and Drug Regulations. SOR/95-474, s.3.,_c._870/FullText.html. Accessed 17 June 2019.
  19. B.24.201(1)(d)(ii), Food and Drug Regulations. SOR/95-474, s.3.,_c._870/FullText.html. Accessed 17 June 2019.
  20. Health Canada. Nutrition Recommendations. The Report of the Scientific Review Committee 1990. Ottawa, ON: Canadian Government Publishing Centre; 1990:92.
  21. Institute of Medicine of the National Academies. Dietary Reference Intakes for Calcium and Vitamin D. March 2011. Accessed 17 June 2019.
  22. Op cit 18.
  23. Op cit 19.
  24. Ruthsatz M and Morck T. "Medical Food/Food for Special Medical Purposes: Global Regulatory Challenges and Opportunities." Regulatory Focus. August 2016. Regulatory Affairs Professionals Society.
  25. Op cit 5.
  26. Ochieng Pernet A. "International Food Regulatory Framework: the Codex Alimentarius Commission." Regulatory Focus. August 2016. Regulatory Affairs Professionals Society.
  27. Op cit 5.
  28. General Standard for the Labelling of and Claims for Prepackaged Foods for Special Dietary Uses. CODEX STAN 146-1985. Accessed 17 June 2019.
  29. Ibid.
  30. Op cit 5.
  31. Standard for Infant Formula and Formulas for Special Medical Purposes Intended for Infants. CODEX STAN 72-1981. Amendment 2007. Accessed 17 June 2019.
  32. Codex Standard for Formula Foods for Use in Very Low Energy Diets for Weight Reduction CODEX STAN 203-1995. Accessed 17 June 2019.
  33. Op cit 31.
  34. Codex Standard for Infant FSMPs. CODEX STAN 72-1981. Accessed 17 June 2019.
  35. Regulation of Medical Foods, Advance Notice of Proposed Rulemaking. Federal Register. Vol. 61, No. 231, 60661–60671. GPO website. Accessed 17 June 2019.
  36. Op cit 7.
  37. Bushell C and Ruthsatz M. “Revising the EU FSMP Regulatory Framework: Laying the Foundation for Future Nutritional Patient Care.” Regulatory Focus. July 2018. Regulatory Affairs Professionals Society.
  38. Commission Delegated Regulation (EU) 2016/128 of 25 September 2015 Supplementing Regulation (EU) 609/2013 of the European Parliament and of the Council as in Regards to Specific Compositional and Information Requirements for Food for Special Medical Purposes. Accessed 17 June 2019.
  39. B.24.102(2)(a), Food and Drug Regulations. SOR/78-64, s.1; SOR/78-698, s.4; SOR/94-35, s.1; SOR/95-474, s.3.,_c._870/FullText.html. Accessed 17 June 2019.
  40. Ibid.
  41. Op cit 5.
  42. Commission Notice on the Classification of Food for Special Medical Purposes (2017/C 401/01), Official Journal of the European Union. Accessed 17 June 2019.
  43. Op cit 37.
  44. Op cit 6.
  45. Canadian Food Inspection Agency. Labelling Requirements for Foods for Special Dietary Use – Texture Modified Diets. Accessed 17 June 2019
  46. Op cit 38.
  47. Ibid.
  48. Australia New Zealand. Standard 2.9.5. Food for Special Medical Purposes. June 2016. Accessed 17 June 2019.
  49. Ruthsatz M and Morck T. "Medical Food/Food for Special Medical Purposes: Global Regulatory Challenges and Opportunities." Regulatory Focus. August 2016. Regulatory Affairs Professionals Society.
  50. Op cit 48.
  51. Ibid.
This article reflects the personal opinion and experience of the author. By no means should it be construed as an official position by any organization with which the author is affiliated.

About the Author

David Oosterveld, MSc, RAC, is the regulatory affairs lead at Nestlé Health Science in Canada. He has a background in nutritional science and more than 15 years of experience working in the regulations of food, natural health products, cosmetics, pharmaceuticals and specialty chemicals. He has worked in consulting and industry roles with leadership responsibilities in regulatory and scientific affairs, product development and quality assurance. He can be contacted at

Cite as: Oosterveld D. “Modernizing Canada’s Medical Nutrition Regulations for Food. What can be learned from international frameworks?” Regulatory Focus. June 2019. Regulatory Affairs Professionals Society.


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