Young Living Auditorium
1538 Sandalwood Dr.
Overview (Program Summary)
8:00 am-8:30 am: Registration/Breakfast
8:30 am-9:50 am: Legal Risks: Demand Letters and Litigation Trends
Often, a demand letter is the first piece of paper a company receives to put them on notice of a potential legal threat. Matt and William will identify the different types of demand letters, how best to handle them and, more importantly, how to avoid being a target in the first place. In doing so, they will discuss the latest trends in complex consumer litigation.
Matthew Orr, Partner; William Cole, Partner; Amin Talati Wasserman, LLP
10:00 am- 11:50 am: Regulatory Updates Session
- FDA Updates
Laura Rich, Senior Policy Advisor, Office of Dietary Supplement Programs, FDA
- Mandatory Product Listing and Dietary Supplements
Two recent legislative proposals that would require product listing for dietary supplements have received significant attention in the trade press and been the topic of heated debate. This presentation will (1) provide a background on product listing and why advocates are seeking this requirement for dietary supplements, (2) discuss recent legislative proposals for product listing and what they would mean for industry, and (3) provide insight on the current outlook for these proposals and what may be on the horizon.
Krista Hekking, Associate, Covington
- Three Things the COVID-19 Pandemic Changed in the Dietary Supplement World
- FDA inspections
- Who really regulates commercial speech - FTC or Google?
Loren Israelsen, President, UNPA
- Regulatory Q&A
12:00 pm-12:50 pm: A Look at Global Trends for Nutrition Supplement Businesses
Taking a nutritional supplements business global can be challenging for a number of reasons. First, companies need to navigate a range of regulatory approaches that affect labeling, manufacturing practices and certifications. Even the definition of what is a supplement varies widely from country to country. Second, tariffs, supply chain issues and energy costs post-Covid have combined to make the trade and logistics aspect of a consumer business as hard as it has been in modern times. Finally, the war in the Ukraine has disrupted key markets. But technology advances and recent policy developments suggest there are reasons for optimism going forward.
Troy Keller, Partner, Dorsey Whitney
12:50 pm-1:30pm : Lunch
1:30 pm-2:20 pm: CBD Enforcement and the Growing Threat of Drug Preclusion of Dietary Supplements
DSHEA’s Drug Preclusion Provision has come to the public’s attention with FDA’s enforcement policy on CBD supplements. This presentation provides the latest on CBD in the marketplace. In addition, we will examine recent concerns regarding how FDA may be seeking to use or alter the Drug Preclusion Provision to limit the marketing of other cutting-edge dietary supplements.
Brent Johnson, Partner, Holland & Hart, Nabil Rodriguez, Associate, Holland & Hart
2:30 pm-3:20 pm: It’s Not Mythical After All: A Case Study of a Class Action Trial
Because a jury can render a potentially outsized, catastrophic verdict, few class actions are ever tried. And, as a result of that, numerous questions abound regarding certain issues arising only in connection with trial, post-trial, and appeal. But a recently tried class action case may finally provide the answers to those questions. Join us for a one-hour case study on the Montera v. Premier case, examining the following:
- Why a class was certified (and whether certification will survive appeal)
- Why the matter proceeded to trial despite the existence of federal preemption of state law with respect to structure/function claims
- How the trial shook out (e.g., witnesses, evidence, etc.)
- The applicability of statutory damages under NY GBL 349 and NY GBL 350
- The constitutionality of statutory damages
- How a judgment might get paid out
- What the Ninth Circuit appeal might look like
This presentation will better prepare companies to think through the pros and cons of either settling a case or going to trial.
William Delgado, Partner, DTO Law; Megan O'Neill, Partner, DTO Law
3:30 pm-4:20 pm: Best Practices for Responding to a Recall
Justin Prochnow, Shareholder, Greenberg Traurig
William Cole is a skilled trial attorney and former federal prosecutor with over 25 years’ experience. William focuses his practice on consumer class actions, intellectual property, business litigation, and FTC matters. He successfully defended at trial a high-profile, false advertising class action against a leading dietary supplement company; the plaintiff received nothing. He has repeatedly obtained dismissals or summary judgment for clients in the food, beverage, and dietary supplement industries. William is also a skilled appellate advocate, having successfully briefed and argued dozens of federal and state appeals, resulting in many published opinions, including an important Ninth Circuit decision preventing a federal district court from sending a class action back to state court.
William attended the University of California, Berkeley School of Law. Following law school, he clerked for the United States Court of Appeals for the Tenth Circuit. For 13 years, he was an Assistant United States Attorney for the Southern District of California, where he served as Chief of the Criminal Division, and then First Assistant U.S. Attorney.
Matthew Orr is a highly sought after, seasoned litigator with a proven track record of success defending many of the nation’s leading retailers and manufacturers of food, beverage, dietary supplement, and cosmetic products. Particularly known for his extensive experience in consumer class actions, Matt has successfully defended clients in matters arising under California’s Unfair Competition Law (UCL), Proposition 65, the Consumer Legal Remedies Act (CLRA), the False Advertising Act, Wire Tapping statutes, Slack-Fill statutes, the Unruh Act, the Americans with Disabilities Act (ADA), California’s Gift Card Laws, and the Song-Beverly Credit Card Act, among others.
After graduating from University of California, Berkeley School of Law, Matt cut his teeth on project finance with ‘biglaw’ for several years before spending the next 18 years at a leading, California-based boutique law firm, where he ultimately decided to dedicate his practice to the food, dietary supplement and cosmetic industries. He regularly represents companies facing consumer class actions, investigations and enforcement actions brought by state and federal enforcement agencies (including state attorneys general), mass and class privacy claims, trademark and trade dress claims.
Krista Hekking is an associate in Covington's Los Angeles office where she is a member of the Food, Drug, and Device group. She provides strategic advice to food and biotechnology companies on regulatory and compliance issues. Specifically, she counsels food and dietary supplement manufacturers and trade associations on a range of product development and marketing issues, from product claims and substantiation to ingredient status and safety, to help minimize the risk of regulatory enforcement and class action litigation.
Loren Israelsen is the Founder and President of the United Natural Products Alliance (UNPA), an international trade association of dietary supplement companies committed to safety, science and quality, since 1992.
He has been deeply involved in the commercial and political issues facing the global dietary supplement industry since 1980. He has served as president of Nature’s Way Products, Inc., vice president to the American Herbal Products Association (AHPA), co-founder of the European American Phytomedicine Coalition (EAPC), founding member of the International Alliance of Dietary/Food Supplement Associations (IADSA), industry liaison to FDA’s Expert Advisory Committee on Ephedra, industry advisor to the Office of Dietary Supplements (ODS), and expert panel member to the Department of Defense study on dietary supplement use among military personnel.
His work to secure passage of the Dietary Supplement Heath and Education Act (DSHEA) of 1994, was central to the growth of the Natural Products Industry as we know it today.
Mr. Israelsen has authored over 150 articles, book chapters and lectured in over 30 countries on dietary supplement issues. He is the inaugural recipient of the NBJ Lifetime Achievement Award, the NNFA President’s Award, New Hope Natural Media’s Hall of Legends, the Mark Blumenthal Community Builder award, the AHPA Herbal Insights Award, and the Personalized Lifestyle Medicine Institute Distinguished Service and Leadership Award.
Brent Johnson is a commercial litigation and regulatory compliance partner in the Salt Lake City office of Holland & Hart. Brent guides clients through the complex litigation process, representing corporations in litigation matters in federal and state courts throughout the country, particularly in California. His work includes defending corporate clients in consumer class actions related to product liability and advertising and labeling. In addition, Brent counsels food, beverage, dietary supplement, alcoholic beverage and consumer product companies regarding FDA, USDA, FTC, Alcohol and Tobacco Tax and Trade Bureau, Consumer Product Safety Commission and California Proposition 65 compliance. He speaks internationally on regulatory matters and consumer class action litigation.
Nabil Rodriguez is a first generation Puerto Rican attorney. Nabil helps clients navigate the ever-evolving patchwork of state, local, and federal requirements to start, maintain, and expand business operations across the nation. A passionate advocate for cannabis, Nabil has established connections and relationships with a range of industry stakeholders that he uses to assist clients in identifying, preparing for, and capitalizing on strategic business opportunities. Nabil works with growers, operators, and distributors of marijuana as well as companies developing CBD-infused food and beverage and natural products. Before joining Holland & Hart, Nabil practiced cannabis law as an associate at Greenspoon Marder LLP. He founded the first student National Cannabis Bar Association.
Thanks to our Sponsors!
Platinum Sponsor: Amin Talati Wasserman
Gold Sponsors: Covington, Dorsey Whitney, DTO Law, Greenburg Traurig, Holland & Hart, UNPA