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.
Agenda
- 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 Should Attend
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
