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

Dietary Supplements Regulation Course Description

Faculty - Travis Austin MacKay, Director of Regulatory Affairs, Plexus Worldwide ( 25+ yrs exp.)

A nutraceutical product with quality as good as a pharmaceutical drug is possible when you apply the required GMP norms. Technological feasibility, safety, and cost efficiency are a few things to take into consideration when applying these GMP principles. This dietary supplement formulation training covers various instrumental topics to understand critical regulations.

If you are looking for training that is way beyond content-draining and one-sided seminars, this dietary supplement course is perfect for you. Whether you are a business owner or a manufacturing unit director, warning letters and injunctions are the last things you would wish for.

Get enrolled in this course and absorb all the useful insights related to the industry! 

Course Overview 

The main problem arises when manufacturers, distributors, and consumers don’t understand the efficacy of dietary supplements. Due to a boom in the market, producers are coming up with supplements that are deficient. 

Additionally, the ease of access and over-the-counter availability have diluted the importance of dietary supplements. This course is here to change the narrative and bridge the existing gaps.

Dietary supplement formulation training gives a comprehensive introduction to programming the entire manufacturing unit. Moreover, you will get to know the possible issues you might face while testing the products.

Here are some benefits of taking a course on regulatory compliance for dietary supplements:

•    Understanding FDA expectations
•       Knowing the rules and regulations to follow during the audits
•       Improving the GMPs to upgrade operations in the unit
•       Fundamentals of physical and chemical properties of the ingredients
•       Stability studies and categorization
•       Techniques to create a formulation that passes multiple checkpoints.

At World Compliance Seminar, we want to equip you with the best knowledge to pursue your career progressively. The detailed seminar is divided into 3 Half days and the first day consists of dietary supplements regulation in the US. As a result, the session will cover the following topics:

3 Day Course Agenda

Day 1 Agenda

•       An Overview of Dietary Supplement
•       What is a dietary supplement all about?
•       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 & 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

Labelling Considerations

•       Display Panels & Layout
•       Supplement Facts Panel

Labelling 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 2 and Day 3 Agenda

Day 2 and Day 3 of the seminar covers the food supplement regulations in the EU. Hence, the topics discussed are:

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

·      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
•       Labelling Considerations
•       Advertising Considerations
•       Enforcement and Post-Marketing Surveillance
•       Review of Current Events and other Industry Topics
• Questions and Answers

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.

• 🎯 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: [email protected]
• 
  (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.