international perspective on patient foods intended …...division 24 –foods for special dietary...
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International Perspective on Patient
Foods Intended for the Dietary
Management of a Disease or Condition
Canada
Modernization of Division 24 (Foods for Special Dietary Use) Regulations
Division 24 – Foods for Special Dietary Use
Formulated Liquid Diet
Meal Replacement
Nutritional Supplement
Foods for protein-restricted diets, and low (specific) amino
acid diets
Foods for Very Low Energy Diet
Gluten-Free Foods
Regulatory modernization is needed
Outdated Not aligned with
other jurisdictions
Overly limit
manufacturing
flexibility
1999 Report on Health Canada Policy review on the addition of vitamins and minerals
2002 Consultation: Addition of Vitamins and Minerals Policy Review
2005 Proposal for targeted Nutritional Supplement
2008 Health Canada’s Regulatory Modernization Strategy for Food and Nutrition
2012 Regulatory Roadmap for Health Products and Food
Previous modernization initiatives
2017 Multi-Stakeholders Workshop
30 stakeholders
Objectives• Assess the scientific basis for Division 24
regulations • Discuss the evolution of Canadian populations
using Division 24 products and their nutrient needs
• Identify opportunities and barriers in Division 24 in relation to human health and innovation
• Determine the need and approach to modernizing the regulations
Format• Pre-workshop survey• Presentations • Breakout roundtables
Academia 26%
Industry 31%
Healthcare
21%
Consultants 11%
Governme
nt 8%
NGO 3%
Adapted from APNM 2019-0013
Sharing of Findings
Published on the web 03 June 2019.
Applied Physiology, Nutrition, and Metabolism, https://doi.org/10.1139/apnm-2019-0013
2019 Call for Data
Objectives
1. Better meet the unique nutrition needs of FSDU users
2. Provide more agile regulations that support scientific innovation
3. Ensure that FSDU products are safe and of high quality
Adapted from: Bureau of Nutritional Sciences, Food Directorate, Health Products and Food
Branch. Information document and request for data: Foods for Special Dietary Use Product
Information. May 2019.
Considerations for modernization
• Incorporation by Reference
• Provisions for special populations/health conditions
• Alignment with other jurisdictions
• Risk-based approach
• Notification prior to commercialization
• Special nutritional labelling requirements
• Reassess the need for advertising restrictions
Next Steps
• Pending prioritization and resources allocation
• Accepting Temporary Marketing Authorization (TMA) applications
• Face-to-Face meetings & Other stakeholders engagement sessions
• Elevation with the Minister of Health