This 2-day interactive virtual seminar will review the regulations that impact Dietary Supplements in the US, EU and Canada and discuss how to verify that products are compliant with these regulations. Differences with food and drug regulation in these countries will be noted as well. We will also cover what qualifies as a dietary supplement or dietary ingredient, how to ensure GMP compliance as well as detailed requirements for labeling and acceptable marketing claims. An update on current events within the Supplement industry and the potential impacts to Manufacturers and Distributors in the US, EU and Canada will also be presented and discussed.
Course Content
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
- 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
- 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
Course Provider
Travis Austin MacKay,
Plexus WorldwideTravis MacKay is the Director of Regulatory Affairs for Plexus Worldwide, a leading direct sales company with a range of products dedicated to helping others obtain health and happiness. He currently oversees international regulatory compliance activities driving strategic direction focused on claims development and substantiation strategy, product development and commercialization, international formulation considerations, and quality testing & validation.
Travis has 20 years of quality and regulatory experience, including prior regulatory affairs leadership positions within well-respected, global consumer product companies. He has a passion for mentoring regulatory professionals to develop robust compliance systems that keep business moving forward.
Travis Graduated from the University of Utah in 2002 with a B.S. in Behavioral Science and Health (Human Health Emphasis). He is a fly-fishing enthusiast, a college football fan, an exercise junky, and a lover of classic cars. He escapes the noise by spending time with his family in the outdoors of beautiful Arizona.
Who Should Attend
- Executives/Managers within Dietary Supplement or Natural Product companies
- Regulatory Compliance Professionals in the Supplements or Natural Products area
- Quality Assurance or Quality Control Professionals
- Dietary Supplement or Natural Product Manufacturers & Distributors
- Sales/Marketing Personnel in the Supplement or Natural Product Industries
