Promoting and Advertising Dietary Supplements in Compliance with FDA and FTC Regulations

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 case studies, help you address compliance, and tell you how to respond to an enforcement action. You will have opportunities to ask questions.

Learning Objectives:

At the end of this presentation, participants will

• Learn how to distinguish a violative claim from a lawful one
• Understand FDA and FTC regulations that govern what you can say about your products
• Know what to do if FDA contacts you or pays a visit
• Learn how to get started with a compliance program

Areas Covered in the Webinar:

• 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.
• Case studies and examples offered.
• Enforcement actions and what to expect if government is investigating your firm.
• How FDA and FTC regulations intertwine.
• The role of the Department of Justice.
• Case law on point.

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

Travis Austin MacKay
Director of Regulatory Affairs, Plexus Worldwide

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.

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 junky, and a lover of classic cars. He escapes the noise by spending time with his family in the outdoors of beautiful Arizona.

Frequently Asked Questions:

1. Does total weight include excipients for proprietary blends and any overages added?
2. Say one of the ingredients has 80% maltodextrin, and is present at 5% weight of supplement, thus maltodextrin is at 4% of finished supplement, would this be listed on ingredient listing?

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