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


  • 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?

  • 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?

Course Outline:

DAY ONE — Thursday, September 19, 2013
8:30 AM - 9:00 AMRegistration
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 Break
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 Break
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 Break
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 Break
11:15 AM - 12:00 Noon Workshop on addressing an enforcement action

Meet Your Instructor

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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Local Attractions

Built in 1915 on the highest point in the city, this cathedral is one of the largest in the country. A replica of St. Peter's in Rome, the building boasts a newly restored 175-foot-high copper dome, a massive rose window, and granite-and-travertine construction.

Set on a bluff overlooking the Mississippi River, the Weisman Art Museum is part of the University of Minnesota campus. You won't miss the trademark Frank Gehry-designed building; its fluid form defies conventional architectural lines, and its metallic finish gleams in the sunlight. The permanent collection is especially strong in American modernist paintings, ceramics, Mimbres pottery, and Korean furniture.

This living history museum commemorates the establishment of a fort here in the wilderness in 1819 by Col. Josiah Snelling and his troops, who opened the area for homesteaders. Costumed guides are the focus of a living history reenactment during the summer months, re-creating the activities of everyday army life during the 1820s.

Minneapolis's Mill City Museum recounts the history of the flour industry that earned the city the nickname "Mill City" in the late 19th century. Set in the ruins of what was once the world's largest flour mill the museum re-creates old milling techniques with period equipment railroad cars and interactive exhibits. Visitors also learn the impact of the nation's first high-quality finely milled flour on the gastronomy of the Twin Cities and the country.

More than 5,000 years and 80,000 pieces of fine and decorative arts comprise the permanent collection at the MIA, including a 2,000-year-old mummy, European masters (Rembrandt, Titian, and Monet, among others), architectural and decorative arts, and a comprehensive photography exhibit. If you're short on time, ask for the "Highlights" brochure to make sure you don't miss the museum's best.

An impressive array of artifacts is housed in this three-story museum, including photographs, music, and videos, all of it celebrating Minnesota history. Kids enjoy sitting in the re-created basement of a Minnesota farmhouse while a simulated tornado passes overhead. Adults enjoy listening to recordings of Minnesota musicians, including Bob Dylan, Steven Greenberg, and Prince.

Temporary exhibits are the rule at the Minnesota Museum of American Art, which overlooks the Mississippi River. Expect edgy, contemporary installation pieces, as well as paintings, fiber art, ceramics, works on paper, and works created from found objects.

"Russia's Grizzly Coast" became the Minnesota Zoo's newest exhibit in 2008 bison pumas and wolverines -- as well as exotic mainstays like tigers camels dolphins and monkeys. The Minnesota Zoo also includes an IMAX theater and a monorail for easy navigation of the grounds.

Located inside the entrance to the Science Museum of Minnesota , the Mississippi River Visitor Center is operated by the National Park Service and designed to educate visitors about the Mississippi National River & Recreation Area. Park rangers can assist travelers with planning outdoor excursions, including canoe and riverboat trips, hiking, biking, and birding. If you're at all outdoorsy, it's worth a stop.

Hands-on exhibits introduce visitors to natural history, science, and technology in this massive museum. Highlights include the Human Body Gallery, navigating a virtual towboat down the Mississippi River, and a collection of fossils and prehistoric specimens. In warm months check out EarthScapes Mini Golf, a new activity designed to teach earth surface dynamics. There's also an Omnitheater.

One of the Midwest's oldest (1851) and most important universities, with 50,000 students on the Twin Cities campus, the UMN offers three significant museums -- the James Ford Bell Museum of Natural History, the University Art Gallery, and the Frederick R. Weisman Art Museum .The 4,800-seat Northrop Auditorium has been a home for distinguished performances since 1929, and the University Theatre has four separate stages.

The Walker Art Center is as well known for its striking architectural features as for the edgy, contemporary art inside: paintings, sculptures, drawings, photographs, and multimedia installations. A fine-dining restaurant and cafe, both by Wolfgang Puck, and gift shop are also new. Across the street is the Minneapolis Sculpture Garden, the largest urban sculpture garden in the country. A variety of 20th-century sculpture shares space with horticultural plantings, including the famous "Spoonbridge and Cherry" sculpture.

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