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Course Agenda
2 Day Dietary Supplement Regulatory Compliance Agenda
Day 1: U.S. Dietary Supplement Compliance
FDA framework, manufacturing, ingredients, labeling, claims, advertising, and enforcement.
An Overview of Dietary Supplements
- What is a dietary supplement?
- Supplements vs. pharmaceuticals
- OTC drugs
- Conventional foods
- Medical foods
- Natural products
- Herbal medicinal products
Organizations and Regulatory Structure
- FDA assembly concerning dietary supplements
- Industry groups
History of Dietary Supplement Regulation
- Early history
- DSHEA
- Code of Federal Regulations
Manufacturing Considerations
- Company and facility registration
- GMP requirements
- GMP inspections
Dietary Ingredients
- What qualifies as a dietary ingredient?
- New Dietary Ingredient Notification (NDIN)
- Old dietary ingredients vs. new dietary ingredients
- Updated New Dietary Ingredient Guidance from FDA
Labeling Considerations
- Display panels and layout
- Supplement Facts Panel
Labeling Claims
- Health claims
- Disease claims
- Structure / function claims
- Disclaimers and substantiation
- Notification of labeling claims to FDA
- Dietary Supplement Labeling Act
Advertising Considerations
- FDA vs. FTC jurisdiction
- Enforcement
- Expressed vs. implied claims
- Exercises and examples
- Disclosures
- Claim substantiation
- Testimonials
Day 2: EU Food Supplements & Canada Natural Health Products
EU supplement regulations, Canadian Natural Health Product requirements, labeling, advertising, and post-market expectations.
EU Overview
- What is a food supplement?
- Borderline products
- Medicinal foods
EU Organizations and Regulatory Structure
- EU regulatory structure
- Industry groups
EU Supplement Regulation
- Early history
- Food Supplement Directive
EU Manufacturing Considerations
- Company and facility registration
- GMP requirements
EU Dietary Ingredients
- What qualifies as a dietary ingredient?
- Ingredient safety
- RDA vs. RDI
- DRV vs. % Daily Value
EU Labeling and Advertising
- Display panels and layout
- Labeling claims
- Health claims
- Disease claims
- Reduction of disease risk claims
- Nutrition claims
- Notification requirements
- Enforcement
- Claim substantiation
Natural Health Product Regulation in Canada
- What is a Natural Health Product?
- Canadian regulatory structure
- Health Canada
- Canadian Health Products Directorate
Canada Supplement Regulation
- Natural Health Products Regulation
- Differences between Canada and the U.S.
- Supplement monographs
- Requirements for pre-market approval
Canada Manufacturing, Labeling, Advertising and Post-Market Controls
- Manufacturing requirements for Natural Health Products in Canada
- Dietary ingredients
- Labeling considerations
- Advertising considerations
- Enforcement and post-marketing surveillance
- Review of current events and other industry topics
- Questions and answers
Dietary Supplement Regulatory Compliance Training – Course Description
Producing high-quality dietary supplements that meet FDA, EU, and Canadian regulatory requirements requires more than good manufacturing practices—it demands a thorough understanding of cGMP, product quality, ingredient safety, labeling, and regulatory compliance. This comprehensive Dietary Supplement Regulatory Compliance Training provides practical guidance on the key regulations governing the development, manufacturing, labeling, advertising, and marketing of dietary supplements.
Whether you are a manufacturer, business owner, quality professional, regulatory affairs specialist, or product development manager, this course will help you understand the regulatory expectations that can reduce compliance risks, improve product quality, and prepare your organization for regulatory inspections.
Gain practical knowledge from an industry expert and learn how to successfully navigate today's evolving dietary supplement regulatory landscape.
Course Overview
As the global dietary supplement market continues to expand, manufacturers face increasing regulatory scrutiny from agencies such as the U.S. FDA, European Union, and Health Canada. Understanding current regulatory requirements is essential for ensuring product quality, maintaining compliance, and avoiding costly warning letters, recalls, and enforcement actions.
This 2-day live virtual seminar provides a comprehensive overview of dietary supplement regulations in the United States, European Union, and Canada. Participants will gain practical insights into FDA regulations, DSHEA, cGMP requirements, dietary ingredients, labeling, advertising claims, manufacturing controls, and global regulatory expectations.
Benefits of Attending
By attending this seminar, you will learn how to:
- Understand FDA, EU, and Canadian dietary supplement regulations
- Apply Dietary Supplement cGMP requirements to improve manufacturing quality
- Prepare for regulatory inspections and audits
- Understand New Dietary Ingredient (NDI) requirements and ingredient safety
- Develop compliant product labeling and advertising claims
- Improve quality systems, manufacturing processes, and regulatory compliance
- Understand stability considerations and formulation requirements
- Reduce regulatory risks while maintaining product quality and consumer confidence
The seminar is divided into two comprehensive days. Day One focuses on U.S. FDA dietary supplement regulations, while Day Two covers European Union food supplement regulations and Canadian Natural Health Product (NHP) requirements, providing participants with a practical understanding of global regulatory compliance.
Who will benefit from the course?
The course is designed to benefit professionals associated with different departments of dietary supplement manufacturing units, such as:
- Quality testing and assurance: Helps them understand the basic parameters of testing the final product and by-products.
- In-house auditors: Assists them in doing strict audits to avoid product recalls and FDA inspection failures
- Suppliers and distributors: Makes them aware of licensing, marketing, and basic compliance related to dietary supplement distributions.
- Labelling and packaging: Labels play an essential role in maintaining transparency about the ingredients. Hence, one must give the highest priority to the norms associated with labeling and packaging. This course consists of 3 rounds of discussion on this topic.
This live training seminar includes the following for each registered attendee:
- A copy of the presentation slides by download
- A certificate of attendance can be downloaded from the WCS Learning Portal following the event
- Q/A Session with the Faculty
- Free Handouts on Dietary Supplements
✅ How to Attend
All WCS Seminar Live Training Programs are delivered via GoToWebinar, providing both audio and visual content for an interactive learning experience.
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🎯 System Requirements:
A computer with stable internet access is all you need.
No GoToWebinar account is required to attend. -
📧 Access Details:
Once you register, you will receive an email invitation containing all the necessary access information to join the live training session. -
🎓 Audience Learning Level:
Basic to Intermediate – Suitable for professionals at all stages seeking foundational to advanced knowledge.
📞 For Questions or Support
Contact our Customer Care Team:
- 📱 Call: 347-282-5400
- 📧 Email: events@worldcomplianceseminars.com
(Operating Hours: 8:30 AM – 5:30 PM EST, Monday – Friday)
Hear from Our Learners: Real Experiences in Dietary Supplement Compliance Training
⭐⭐⭐⭐⭐
"Essential course for global regulatory compliance!
This course gave me deep insights into the complex regulatory frameworks across the US, EU, and Canada. The content was up-to-date and highly practical, with clear explanations of cGMP, labeling, and safety assessment requirements. Perfect for anyone in the dietary supplement industry!"
– Regulatory Affairs Specialist
⭐⭐⭐⭐⭐
"Comprehensive and easy to understand
A well-structured course that breaks down the regulatory processes into clear steps. I especially appreciated the detailed comparison between US, EU, and Canada regulations. It helped me streamline our product registration process across multiple markets."
– Quality Assurance Manager
✅ Frequently Asked Questions (FAQ)
Q1: What is the main focus of this Dietary Supplement Regulatory Compliance course?
A: This course provides in-depth knowledge of regulatory frameworks governing dietary supplements in the US, EU, and Canada. It covers cGMP requirements, labeling rules, product registration, safety assessments, adverse event reporting, and compliance strategies for successful market entry.
Q2: Who should attend this course?
A: Ideal for Regulatory Affairs Specialists, Quality Assurance Managers, Product Development Scientists, Compliance Officers, Dietary Supplement Manufacturers, and Distributors seeking to understand and meet regulatory requirements across multiple international markets.
Q3: Are there any prerequisites to join the course?
A: No formal prerequisites are required, but a basic understanding of the dietary supplement industry or quality management systems is recommended for better comprehension of the regulatory processes.
Q4: How is the course delivered and how long does it take?
A: The course is delivered online, typically over 3 days, combining interactive lessons, real-life case studies, and practical examples. Learners can access the content anytime and revisit it at their own pace.
Q5: Will I receive a certificate after completing the course?
A: Yes, all participants will receive a Certificate of Completion that validates their understanding of regulatory compliance for dietary supplements in the US, EU, and Canada.
Know Your Faculty
Course Faculty
Faculty
Travis Mackay
Travis 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 30 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 enthusiast, and a lover of classic cars. He escapes the noise by spending time with his family in the outdoors of beautiful Arizona.