Dietary Supplements in North America and Europe - Training Bundle

Training#1 Promoting and Advertising Dietary Supplements in Compliance with FDA and FTC Regulations (2 hrs)

Training#2 Regulatory Compliance Mastery: Dietary Supplements in North America and Europe (15 hrs)

Training#3 Strategies for Substantiating Structure-Function Claims for Dietary Supplements in the United States (3hrs)

• Compliance and what you can do to protect yourself and your company.
• Tips on how to market dietary supplements that benefit health
• Regulations governing the promotion and advertising of dietary supplements
• Types of claims FDA allows will be discussed, e.g., Qualified Health Claims, Structure/Function Claims and Nutrient Content Claims
• Risk-based approach to efficacy substantiation
• Enforcement actions and what to expect if government is investigating your firm
• How FDA and FTC regulations intertwine
• Real world examples of acceptable versus unacceptable product claims

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 two days and the first day consists of dietary supplements regulation in the US. As a result, the session will cover the following topics:

• 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

The second day 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
  

• Regulatory requirements for substantiating dietary supplement claims for advertising and labeling
• Identifying different types of dietary supplement claims
• Competent and Reliable Scientific Evidence
• How to characterize/rank product claims
• Risk-based approach to scientific substantiation
• Scientific evidence recommendations (based on risk)
• Qualifying claims
• Linking scientific evidence to finished products
• Linking scientific evidence to botanical extracts
• Regulatory requirements for substantiating dietary supplement claims for advertising and labeling
• Identifying different types of dietary supplement claims
• Competent and Reliable Scientific Evidence
• How to characterize/rank product claims
• Risk-based approach to scientific substantiation
• Scientific evidence recommendations (based on risk)
• Qualifying claims
• Linking scientific evidence to finished products
• Linking scientific evidence to botanical extracts
• Regulatory requirements for substantiating dietary supplement claims for advertising and labeling
• Identifying different types of dietary supplement claims
• Competent and Reliable Scientific Evidence
• How to characterize/rank product claims
• Risk-based approach to scientific substantiation
• Scientific evidence recommendations (based on risk)
• Qualifying claims
• Linking scientific evidence to finished products
• Linking scientific evidence to botanical extracts

This course will be beneficial to the following personnel in Dietary Supplement manufacturing companies:

• Executives of Dietary Supplement companies
• Regulatory Compliance Professionals
• Quality Assurance Professionals
• Dietary Supplement Manufacturers
• Dietary Supplement Distributors
• Sales/Marketing Personnel
  

Becoming a attendee is easy.

• Enroll: Register for the complete 7 hrs course program. You will receive an email with instructions on accessing the courses.
  
• Learn: Attend each of the courses and successfully pass the self-assessment with a score of 80% or higher.
  
• Earn: Once you have fulfilled all the program requirements, you will receive a certificate recognizing your achievement.
  

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 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.

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