Training Overview

This 2-hr webinar will review the FDA and FTC regulations for promoting and advertising dietary supplements, walk you through real-life case studies, help you address compliance, and provide practical advice on how to respond to an enforcement action.

Why Should You Attend

FDA and FTC routinely initiate enforcement actions, including Untitled Letters, Warning Letters, Recalls, etc., against dietary supplement makers who misbrand their products by violating FDA advertising and promotion regulations, e.g., by claiming the product can treat, cure, prevent, mitigate or diagnose disease. Sometimes the Department of Justice gets involved and prosecutes firms on behalf of these agencies for violations. Such prosecutions often involve lawsuits against individuals running the companies, and can lead to Consent Decrees for the companies and their owners and responsible corporate officers. These threats can be avoided with proper review of promotional materials and by training and educating staff.

Is your organization in compliance with FDA advertising and promotion regulations?

Is FDA investigating your firm right now?

Is your competitor blowing the whistle on you?

This webinar will review the applicable regulations, walk you through real-life situations, help you address compliance, and provide practical strategies to mitigate enforcement actions. You will have opportunities to ask questions.

Learning Objective

At the end of this presentation, participants will:

  • Learn how to distinguish a violative claim for dietary supplements from a lawful one
  • Understand FDA and FTC regulations that govern what you can say about your products
  • Recognize “other advertising challengers”
  • Learn how to get started with a compliance program

Webinar Takeaway

  • 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

Who Will Benefit

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

  • Owners
  • Executives and managers
  • Regulatory Affairs professionals
  • Quality Assurance professionals
  • Attorneys

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FDA Faculty Travis Austin MacKay

Faculty Travis Austin 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 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.

Our Participants Testimonial

The presentation by Carolyn Troiana today was fantastic, both I and the QA Manager (Aaron Neighbour) loved it and had extensive conversation afterward about it. ( FDA Compliance and Mobile Applications Webinar )

Robert Friedland ( IT Manager) NUTEK BRAVO, LLC.

Thank you for providing the information in such detail. It was helpful to gain the perspective of somebody that has implemented these regulations in a working lab. Virtual Seminar on ( Training on Life cycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines )

Tracey Kessler ( Director of R&D) CEL-SCI Corporation

I felt the seminar was very helpful and provided good insight for DataIntegrity and what the FDA is looking for per the regulations. ( Current Regulatory Thinking on Data Integrity 2 Days Virtual Seminar )

Margaret A. Clifton ( Manager, Quality Systems) CSL Plasma

The presenters subject matter knowledge is extensive which enables information to be shared in detail. (Training Attended on Risk Based Verification and Validation Planning to Meed US FDA and ISO 13485 Requirements )

Stuart Chisholm (Sr. Principal Device Engineer) Teva Pharmaceuticals