2021 - Regulatory Compliance for Dietary Supplements in the US, EU and Canada

Day 01(9:00 AM - 5:00 PM EDT)
Session Start Time: 9:00 AM
Dietary Supplement Regulation in the U.S.
Dietary Supplement Overview
What is a dietary supplement?
Supplements vs.
Pharmaceuticals
OTC Drugs
Conventional Foods
Medical foods
Natural products
Herbal medicinal products
Organizations and Regulatory Structure
FDA Structure regarding Dietary Supplements
Industry Groups
History of Dietary Supplement Regulation
Early History
DSHEA
Code of Federal Regulations
Manufacturing Considerations
Company & Facility Registration
GMP Requirements
GMP inspections
Dietary Ingredients
What qualifies as a dietary ingredient?
Old dietary ingredients vs. New dietary ingredients
New Dietary Ingredient Notification (NDIN)
Updated New Dietary Ingredient Guidance from FDA
Labeling Considerations
Display Panels & Layout
Supplement Facts Panel
Labeling Claims
Health claims
Disease Claims
Structure/Function claims
Disclaimers/Substantiation
Notification of labeling claims to FDA
Dietary Supplement Labeling Act
Advertising Considerations
FDA vs. FTC jurisdiction
Enforcement
Expressed vs. Implied Claims
Exercises & examples
Disclosures
Claim Substantiation
Testimonials
Day 02(9:00 AM - 5:00 PM EDT)
Food Supplement regulation in the EU
Overview
What is a food supplement?
Borderline products
Medicinal Foods
Organizations and Regulatory Structure
EU Regulatory Structure
Industry Groups
Supplement Regulation
Early History
Food Supplement Directive
Manufacturing Considerations
Company & Facility Registration
GMP Requirements
Dietary Ingredients
What qualifies as a dietary ingredient?
Ingredient safety
RDA vs RDI
DRV vs % Daily Value
Labeling Considerations
Display Panels & Layout
Labeling Claims
Health claims
Disease Claims
Reduction of Disease Risk Claims
Nutrition Claims
Notification requirements
Advertising Considerations
Enforcement
Claim Substantiation
Natural Health Product regulation in Canada
Overview
What is a Natural Health Product?
Organizations and Regulatory Structure
Canadian Regulatory Structure
Health Canada
Canadian Health Products Directorate
Supplement Regulation
National Health Products Regulation
Differences between Canada and US
Supplements monographs
Requirements for pre-market approval
Manufacturing Requirements for Natural Health Products in Canada
Dietary Ingredients
Labeling Considerations
Advertising Considerations
Enforcement and Post-Marketing Surveillance