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.
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
Who Will Benefit:
This webinar will provide valuable assistance to the following personnel in dietary supplement companies and food companies promoting dietary supplements:
Executives and managers
Regulatory Affairs professionals
Quality Assurance professionals
The recent announcement that the Department of Justice, Health and Human Services’ Office of Inspector General, and the Food and Drug Administration plan to aggressively pursue individual criminal charges against executives for illegal off label marketing deservedly caused a stir in the drug and medical device manufacturing community. The government continues to pressure makers of dietary supplements. Regulatory actions are increasing. Smart makers of dietary supplements will monitor labeling and claims and stay current with changes in the law and the enforcement climate.
Questions you should be asking: are the claims we are making about our products in compliance with FDA and FTC regulations? Or are we misbranding our products because we are making drug claims when we market and sell our products? If you are making drug claims, then you are misbranding the product and it is considered an unapproved new drug by FDA. This is a serious violation. The government does not care if “everyone else is doing it,” if you are violating the law, sooner or later, FDA will come knocking. Are you prepared?
Areas Covered in the Seminar:
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.
Mark Gardner, M.B.A., J.D., is an attorney at DuVal & Associates, P.A., a law firm dedicated to counseling companies in the dietary supplement, medical device, 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, and FDA enforcement actions.
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 an Adjunct Professor at Hamline University School of Law. He currently serves as a Co-Chair for LifeScience Alley's Regulatory Special Interest Group, as Vice Chairman for the Minnesota State Bar Association Food, Drug and Device Law Section and as an Advisory Committee Member for LifeScience Alley. Gardner speaks and writes often on issues that impact FDA regulated products.
Promoting and Advertising Dietary Supplements
Product Type : On Demand Webinar
Author : Mark Gardner
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