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Outdated Not aligned with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