Promoting and Advertising Dietary Supplements in Compliance with FDA and FTC Regulations
Mark Gardner, M.B.A., J.D., Attorney and Adjunct Professor at DuVal & Associates
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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:
Who should attend the Course?
- 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?
- 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
- What is the current regulatory environment like?
- What is government concerned about?
- Role of the 1st Amendment free speech protections in advertising and promotion (e.g., Pearson v. Shalala and Whitaker vs. Thompson)
- Are the claims you are making about your products in compliance with FDA and FTC regulations?
- Are you misbranding your products because you are making drug-like claims when you market and sell products?
- Are you using (or overusing) disclosures and/or disclaimers in your promotional materials?
- How do you distinguish a violative claim from a lawful one?
- How do FDA and FTC regulations govern what you can say about your products?
- How to structure your claims in advertising and promotion?
COMPLIANCE AND ENFORCEMENT
- 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. How do you avoid this situation?
- If the issue above exists, are you prepared to address such promotional and advertising issues?
- What is your exposure? The government does not care if “everyone else is doing it.” If you are violating the law, sooner or later, FDA will come knocking.
- How the government finds out about your conduct (competitors, social media, company website, distributor conduct, etc.)
- How do you prepare for an inspection?
- What do you do if FDA contacts you or pays a visit?
- How should you start and structure your compliance program?
|DAY ONE — Thursday, September 19, 2013
|8:30 AM - 9:00 AM||Registration
|9:00 AM - 10:15 AM
||Introduction to program
- Brief history of dietary supplement legislation and political background and current environment
- A review of FDA/FTC regulations that govern the promotion and advertising of dietary supplements
|10:15 AM - 10:30 AM
|10:30 AM - 12:00 Noon
- Discuss types of claims FDA allows: i) Qualified Health Claims, ii) Structure/Function Claims; and iii) Nutrient Content Claims; and discuss the use of disclosures / disclaimers
- Share a practical approach to employ at your company on how to review claims made in advertising and promotional materials
|12:00 Noon - 1:15 PM
|1:15 PM - 2:45 PM
- Discuss how government enforces the regulations
- Insights on the direction FDA and Congress is headed today with dietary supplements
- Common mistakes made by companies
- Learning how to structure claims in order to meet FDA/FTC requirements
|2:45 PM - 3:00 PM
|3:00 PM - 4:00 PM
||Workshop on claims
|DAY TWO — Friday, September 20, 2013
|8:30 AM - 11:00 AM
- Enforcement actions and what to expect if government is investigating your firm
- Preparing for an inspection
- What to do when things do not go right
- Discuss case studies
- Working with FDA to resolve issues
- Compliance program development
- What you can do to protect yourself and your company (training, auditing, etc.)
|11:00 AM - 11:15 AM
|11:15 AM - 12:00 Noon
Workshop on addressing an enforcement action
Meet Your Instructor
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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