Course Description:
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.
Please join us at this interactive Workshop that will tackle the following questions:
If you are looking for answers to these questions, you would certainly benefit by attending this seminar:
- Is your organization in compliance with FDA and FTC advertising and promotion regulations?
- Are you fearful of getting an FDA Warning Letter?
- Is FDA investigeting your firm right now?
- Is your competitor blowing the whistle on you?
Who should attend the Course?
- Owners, CEOs and executive management
- Regulatory Affairs, Quality Assurance
- Marketing, Sales, Business Analysts,
- Clinical, Legal, Attorneys, R&D, Program Editors, IT/Technical
PROMOTION AND ADVERTISING
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COMPLIANCE AND ENFORCEMENT
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Course Outline:
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Meet Your Instructor
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Mark Gardner Attorney and Adjunct Professor at DuVal & Associates Mark Gardner, M.B.A., J.D., is an attorney at DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, dietary supplement, drug, biotech, and food industries. His practice focuses on FDA regulation, health care fraud and compliance, design and implementation of regulatory compliance programs, promotional review, FDA enforcement actions and aggregate spend. Prior to his legal career, he worked in product management and sales for three medical device companies over a 10-year span where he focused on commercializing and developing products used for surgical, wound healing, and diagnostic applications. Gardner is also an adjunct professor at Hamline University School of Law where he teaches food and drug law and serves as a health law regulatory and compliance competition coach. He currently serves as a Co-Chair for LifeScience Alley's Regulatory Special Interest Group. He is the Chairman of the Minnesota State Bar Association Food, Drug and Device Law Section. He serves as a steering committee member of the Minnesota Medical Device Alliance. He is a member of the Medtech Resource Alliance. Gardner speaks and writes on issues that impact FDA regulated products. |
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