Marriott Biscayne Bay
1633 North Bayshore Drive
Miami, FL 33132
8:30 a.m. Thursday, May 2, 2013
Promoting and Advertising Dietary Supplements in Compliance with FDA and FTC Regulations & Addressing Government Enforcement Actions—An Ounce of Prevention is Worth a Pound of Cure.
This seminar and workshop will review the applicable dietary supplement 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.
On day one, Mr. Gardner will teach you the basics and advanced knowledge of promotional and advertising regulations governing dietary supplements.
On day two, Mr. Gardner will spend a half day focusing on FDA and FTC enforcement actions and compliance measures.
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 making drug-like claims that the product can treat, cure, prevent, mitigate or diagnose disease. Sometimes the Department of Justice gets involved on behalf of these agencies and prosecutes firms for violations. Such prosecutions often involve lawsuits against individuals running the companies, and can lead to Consent Decrees for the companies, their owners and responsible corporate officers. These threats can be avoided by training and educating staff and with proper review of promotional materials $1199