Health Canada Pathway for Licensing Natural Health Products with Modern Health Claims

Foreword

Guidance documents provide assistance on complying with statutes and regulations for industry and health care practitioners, and help staff implement Health Canada mandates fairly and consistently. They allow flexibility, and alternate approaches may be discussed with the Natural and Non-prescription Health Products Directorate. Health Canada may request additional information to assess safety, efficacy, or quality, ensuring justifiable decisions are documented. Read in conjunction with Natural Health Products Regulations and other guidance. Source: https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/legislation-guidelines/guidance-documents/pathway-licensing-making-modern-health-claims.html

Document Change Log

Version 1.0 (December 2012) replaces Evidence for Safety and Efficacy of Finished Natural Health Products, Version 2.0 (December 2006), split into two documents to reflect Natural Health Product Program Advisory Committee recommendations. Extensive revisions including appendices, annexes, and reorganization. Source: https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/legislation-guidelines/guidance-documents/pathway-licensing-making-modern-health-claims.html

1.0 Introduction

This document helps applicants determine evidence for safety and efficacy of NHPs making modern health claims, ensuring rigorous levels to protect health while providing a clear market pathway. Other options may be considered. NHPR govern sale, manufacture, etc., aiming for safe, efficacious, high-quality products. Evidence must support section 5 requirements. Source: https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/legislation-guidelines/guidance-documents/pathway-licensing-making-modern-health-claims.html

1.1 Policy Objective

Provide reasonable assurance NHPs are safe and effective under recommended conditions. Source: https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/legislation-guidelines/guidance-documents/pathway-licensing-making-modern-health-claims.html

1.2 Policy Statement

Evidence level varies by health claim and risk profile. Source: https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/legislation-guidelines/guidance-documents/pathway-licensing-making-modern-health-claims.html

1.3 Scope and Application

Applies to NHPs with modern claims; excludes traditional/homeopathic, those attesting to labelling standards, or under 60-day clause. For those, refer to respective guidances. Source: https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/legislation-guidelines/guidance-documents/pathway-licensing-making-modern-health-claims.html

1.4 Background

2006 document replaced by this and traditional medicines pathway, reflecting advisory committee recommendations. Includes annexes on combinations and general claims. Source: https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/legislation-guidelines/guidance-documents/pathway-licensing-making-modern-health-claims.html

1.5 Definitions

• Natural Health Product: Substance/homeopathic/traditional medicine for pharmacological effects in diagnosis/treatment/mitigation/prevention/restoration/modification.
• Medicinal Ingredient: Biologically active Schedule 1 substance for diagnosis/treatment/etc.
• Non-medicinal Ingredient: Added for consistency/form; no pharmacological effects, safe, minimal concentration.
• Recommended Conditions of Use: Use/purpose, form, route, dose, duration, risk info.
• Modern Health Claims: Based on clinical/animal/in vitro studies, pharmacopoeias, etc.
• Traditional Health Claims: Based on cultural knowledge/practices. Source: https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/legislation-guidelines/guidance-documents/pathway-licensing-making-modern-health-claims.html

2.0 Guidance for Implementation

2.1 Roles and Responsibilities

Applicant: Provide complete application with safety/efficacy/quality evidence. Directorate: Review to assess, ensure benefits outweigh risks, document decisions. Pre-submission meetings available. Source: https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/legislation-guidelines/guidance-documents/pathway-licensing-making-modern-health-claims.html

2.2 Health Canada Authorization Process

Submit licence application with safety/efficacy evidence. Assessment determines if benefits outweigh risks. Source: https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/legislation-guidelines/guidance-documents/pathway-licensing-making-modern-health-claims.html

2.3 Risk-Based Approach to Safety and Efficacy

Categorize into low/medium/high risk based on ingredient form, claim seriousness, performance impact. Figure 1 outlines approach. Table 1: Minimum evidence by category. Source: https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/legislation-guidelines/guidance-documents/pathway-licensing-making-modern-health-claims.html

2.4 Types of Health Claims

By health condition/effect; general claims. Appendix A examples. Source: https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/legislation-guidelines/guidance-documents/pathway-licensing-making-modern-health-claims.html

2.5 Safety Evidence Recommendations

Proportionate to risk; for non-medicinal. Source: https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/legislation-guidelines/guidance-documents/pathway-licensing-making-modern-health-claims.html

2.6 Efficacy Evidence Recommendations

High: Phase II/III trials; Medium: Phase II; Low: Published studies. Qualifying claims, Appendix F criteria. Source: https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/legislation-guidelines/guidance-documents/pathway-licensing-making-modern-health-claims.html

2.7 Combination Ingredients

Annex II principles: No increased risk, no decreased efficacy, compatible uses. Source: https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/legislation-guidelines/guidance-documents/pathway-licensing-making-modern-health-claims.html

2.8 Linking Evidence to Conditions of Use, Ingredient Form and Use of Extracts

Appendices B, C, D. Source: https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/legislation-guidelines/guidance-documents/pathway-licensing-making-modern-health-claims.html

2.9 Additional Guidance

Appendix E. Source: https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/legislation-guidelines/guidance-documents/pathway-licensing-making-modern-health-claims.html

2.10 Final Check before Submitting Product Licence Application

Ensure complete evidence. Source: https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/legislation-guidelines/guidance-documents/pathway-licensing-making-modern-health-claims.html

Appendices

A: Claims examples. B: Linking to conditions. C: To ingredient form. D: To extracts. E: Additional. F: Evidence criteria. G: Expert opinions. Annex I: General claims. Annex II: Combinations. Source: https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/legislation-guidelines/guidance-documents/pathway-licensing-making-modern-health-claims.html