RAPS - This course has been pre-approved by RAPS as eligible for up to 2 credits towards a participant's RAC recertification upon full completion.
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
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.
