NHP Regulatory Update 2011 Q2

Topics Covered

• Current Regulatory Environment:
• NHP (Unprocessed Product License Applications) Regulations (UPLAR)
• NHP Compliance & Enforcement Policy (POL -0044)
• Natural Health Product Tracking Survey 2010
• Status of Applications – Quarterly Report Q4:
• Continued Growth
• Pre UPLAR PLAs and Amendments
• Failed Applications
• Consultations and Regulatory Initiatives:
• Project 1431: Addition of Quinine to Schedule F
• Product and Ingredient Information:
• NHP Ingredient Database: Oil of Oregano
• Products Currently “On Hold”
• Schedule F Amendments
• Food Initiatives:
• Functional Food and Agriculture and Agrifood Canada (AAFC)
• Allergen Labelling: Wheat Allergy
• Dietary Supplements (Changes in US):
• FDA Launches a Compliance and Enforcement Database
• FDA is Set to Launch a New Dietary Ingredient Guidance Document
• US Food Safety Modernization Act (Changes):
• Amendments to Food Safety Modernization Act: Amendment #1
• EU:
• EU Traditional Herbal Medicinal Products Directive: Effective April 2011
• Regulations Are Changing Around the World