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
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
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- China!
- FDA inspections
- Who really regulates commercial speech - FTC or Google?
Loren Israelsen, President, UNPA
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
