Course Description:

Marketing claims that promote the nutritional value, ingredient quality, and health-related benefits of food have increased significantly in recent years because of consumer expectations and competitive pressures. The amount of product and scientific information being communicated is also greater due in part to the use of company web sites. This has resulted in more enforcement actions by regulatory agencies, complaints raised through industry self-regulatory bodies, and a flood of class action lawsuits under state consumer protection laws. When there is a threatened or filed class action lawsuit regarding food marketing claims, key decisions will be based on an analysis of both substantive and procedural issues, in light of regulatory and litigation developments.

This seminar will review the regulatory framework for food marketing claims and will discuss the strategies for effectively defending enforcement actions, self-regulatory matters and lawsuits.

It will focus on current food marketing regulations, enforcement actions, self-regulatory complaints, nutrient content claims, health claims, structure/function claims, substantiation criteria , food safety warning letters, factual defenses, proposition 37 on litigation claims, food labeling advertising, California (17200/CLRA) claim, CLRA Letters, dispositive motions, class certification motions.



Course Objectives:

  • Review the regulatory framework for food marketing claims.
  • Address the types of claims that have triggered enforcement actions, self-regulatory complaints and class action lawsuits.
  • Discuss strategies for effectively defending enforcement actions, self-regulatory matters and lawsuits.
  • Highlight best practices for evaluating claims and managing risk.
  • Present workshop, with hypotheticals, to allow attendees to apply information and learn practical skills


Who will Benefit:

  • Regulatory Affairs
  • Marketing Professionals
  • Legal Personnel
  • Senior Executives
  • Public Affairs Personnel
  • Advertising Agencies
  • Food Scientists




Course Outline:

Day One (8:30 AM – 5:00 PM) Day Two (8:30 AM – 12:30 PM)

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

  1. Statutory/Regulatory Framework
    1. FDA and FTC
    2. Industry Self-Regulatory Bodies
    3. Types of Claims
      1. Natural
      2. Nutrient Content Claims
      3. Health Claims
      4. Structure/Function Claims
    4. Substantiation Criteria (FDA and FTC)
    5. Warning Letters (Followed by Lawsuits)
    6. FTC Actions (Followed by Lawsuits)
    7. Responding to Agency Actions and Self-Regulatory Decisions
  2. Litigation
    1. Types of Claimants
    2. Common Challenges
    3. Causes of Action
    4. How to Develop Factual Defenses
    5. How to Utilize Legal Defenses
      1. Substantive
      2. Procedural
    6. What’s Working/What’s Not
    7. Class Certification Overview
    8. Preemption
    9. Impact of Proposition 37 on Litigation Claims
  3. Best Practices – Labeling and Advertising Review
  4. Best Practices – Litigation Risks

  1. Workshop – Assessing the Risks of Labeling and Advertising Claims
  2. Workshop – Cradle to Grave Handling of a California (17200/CLRA) Claim
    1. CLRA Letters
    2. Dispositive Motions
    3. Class Certification Motions
    4. Discovery
      1. Documents
      2. Depositions
    5. Experts
    6. Settlement Issues





Meet Your Instructors

Leslie T Krasny
Partner, Keller and Heckman LLP

Leslie T.Krasny, is a partner in the law firm of Keller and Heckman LLP, and manages the San Francisco office. She practices regulatory law, focusing on food and dietary supplements. Her areas of expertise include safety, labeling, advertising, recalls, inspections, ingredient evaluation, claim substantiation, Proposition 65, and biotechnology. Her clients include growers, manufacturers, distributors, importers, retailers, foodservice chains and trade associations, and she serves as General Counsel to the Produce Marketing Association. She is a frequent speaker and writer on food law issues, serves on the Food and Drug Law Institute's Board of Directors and its Food and Dietary Supplements Committee, and is a member of the Editorial Advisory Board of Food Processing Magazine.



Robert S Niemann
Partner, Keller and Heckman LLP

Robert Niemann joined Keller and Heckman in 2012 as a trial lawyer in the litigation department concentrating his practice in the areas of complex business and commercial litigation, trade secrets, restrictive covenants, unfair business practices, products liability, and environmental toxic torts. Mr. Niemann has extensive experience with class actions, multidistrict litigation, mass torts and major complex cases.

His experience in over 30 years of practice includes representation of manufacturers, distributors, inventors and component suppliers of pharmaceutical products, medical devices, healthcare and food products and various consumer products. In 1997, he was one of 300 attorneys worldwide selected for inclusion in the first edition of An International Who's Who of Product Liability Defense Lawyers, based on surveys and interviews with major corporations and leading products attorneys. He was selected again in 1998 and in several later editions.

He has represented manufacturing companies and numerous consumer and construction equipment manufacturers for contract disputes, royalties, indemnity issues, product labeling and product liability. He has also represented companies for breach of contract, fraud, business torts, unfair competition, unfair business practices and false advertising. He has arbitrated/mediated hundreds of matters in his career, and serves as a Judge Pro Tem for the San Francisco Superior Court for settlement conferences and trials. He is also an appointed arbitrator for the Counties of San Francisco and Marin. He is a panelist for the National Arbitration Forum, a national alternative dispute resolution provider. He has been "AV" rated by Martindale Hubbell his entire career. He was acknowledged in 2013 (and in prior years) as one of California's "Super Lawyers." Additionally, he was named a top rated IP lawyer by American Lawyer Media and Martindale-Hubbell for 2013.





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Testimonials

The information presented was very timely, well presented and exactly what I was looking for. This is my first experience with ComplianceOnline. As my company grows and becomes more vulnerable to consumer suits, we felt the need to learn as much as possible. Concerning this subject food marketing cIaims, I think this seminar was a very good example of this information. Thank you ComplianceOnline.
- Nutrition and Labeling Compliance Manager, Wells’ Enterprises, Inc.

This seminar was very interesting, eye opening and educational. This was highly interactive and was similar to an open forum class at school. ComplianceOnline has very professional system and approach in conducting their trainings.
- Manager Quality and Food Safety, Sun Orchard Inc..

Overall it was a good session. It was good to have the regulatory overview with the litigation training.
- Sr. Director Regulatory Affair’s, Pinnacle Foods Group LLC.

I like and value that the presenters didn’t just read from the slides but they were sharing generic case information and examples. Regulatory framework session was highly valuable for me.
- Product Developer, Reckitt Benckiser

The presenters are very knowledgeable. This seminar had a good discussion on food marketing claims.
- Research Scientist, R&D Regulatory, Morningstar Foods

This seminar was covering very specific information and topics. All current issues and events related to food marketing claims were discussed in this course.
- Regulatory/Technical Manager, TH Foods Inc.

Seminar instructors were highly knowledgeable.
- Technical & Regulatory Affairs Manager, North America, Barry Callebaut Canada





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