Why Attend

Last Year’s Agenda

A preliminary agenda will be announced in December 2019.

Location & CLE

Wednesday, March 20

5:00 – 6:00 PM
Hosted by Squire Patton Boggs

Thursday, March 21

8:15 – 8:55 AM
Registration and Continental Breakfast

8:55 – 9:00 AM
FDLI Welcome
Amy Comstock Rick, President & CEO, FDLI

9:00 – 9:45 AM
Keynote Address
Frank Yiannas
, Deputy Commissioner for Food Policy and Response, Office of the Commissioner, FDA
Introduced by John M. Packman, Of Counsel, DLA Piper LLP (US) and Chair, FDLI Food Enforcement and Compliance Conference Planning Committee

9:45 – 10:00 AM
Coffee and Networking Break

10:00 – 11:00 AM
Inspections, Warning Letters, and Compliance: FSMA Begins to Take Hold
Is FDA moving from education to enforcement? Recently issued warning letters show that FDA is beginning to actively enforce the new Preventive Controls rule. On the other hand, FDA continues to educate companies about its new Intentional Adulteration rule. During this panel, speakers will focus on FDA’s current approach to the enforcement of FSMA requirements, as well as discuss inspection trends, warning letters, and other areas on which companies should focus to ensure compliance.

Steve H. Armstrong, Independent Advisor, Food Law & Regulation, EAS Consulting Group, LLC
William A. Correll, Director, Office of Compliance, CFSAN, FDA
Meredith Q. Olearchik, Vice President and Associate General Counsel – Intellectual Property, Marketing and Food Law, Campbell Soup Company
Moderated by Elizabeth B. Fawell, Partner, Hogan Lovells US LLP

11:00 AM – 12:00 PM
Traditional Meat and Dairy Foods and Innovative Substitutes: Key Regulatory and Enforcement Issues
Learn about labeling issues and compliance challenges for alternative foods like lab-grown meat and plant-based “dairy”. Panelists will discuss any insights learned from submissions during FDA’s open comment period on the use of names of dairy foods in labeling plant-based products. Further, speakers will discuss recent developments affecting products in these categories and regulatory risks faced by industry.

Elan Abrell, Senior Regulatory Specialist, The Good Food Institute
Eitan N. Bernstein, Associate, Latham & Watkins LLP
Clay Detlefsen, Senior Vice President, Environmental and Regulatory Affairs & Staff Counsel, National Milk Producers Federation
Moderated by Sarah Roller, Partner, Kelley Drye & Warren LLP

12:00 – 1:15 PM
Luncheon with Guest Speaker: “What Does the Legalization of Hemp Mean for Supplements and Food?”
Douglas (Duffy) MacKay
, Senior Vice President, Scientific and Regulatory Affairs, CV Sciences
Introduced by Laura Brown, Director, Educational Programs, FDLI

1:15 – 2:00 PM
Supply Chain Verification Challenges and Realities
This panel will take a practical look at supply chain verification in light of the realities of the food supply chain and how companies are working to comply with FDA’s supply chain verification requirements under FSMA. Panelists will discuss the challenges and hurdles with effective supplier verification and compliance with FDA’s rules.

Lillian Hsu, Microbiologist, CFSAN, FDA
Jessica O’Connell, Partner, Covington & Burling LLP
Jenna Robeson
, Senior Director, Regulatory Affairs & Compliance, Plated
Moderated by
Kelly Laudon, Of Counsel, Jones Day

2:00 – 2:45 PM
Managing Through and Learning from Recalls
This panel will focus on practical tools for managing a recall, from the test result or consumer complaint to the close out. While an outbreak of a foodborne illness can lead to a high-profile, national recall, many situations are simply not as clear-cut. This panel will discuss how a firm should define and control the scope of a “voluntary” recall initiated as a result of mislabeling, insanitary conditions, and other frequently occurring issues. When do you know whether to conduct a recall? The panel will use the recent romaine lettuce outbreaks as a lens through which to discuss recall management and avoidance.

Joseph A. Levitt, Partner, Hogan Lovells US LLP
Scott MacIntire, Director, Division of Enforcement, ORA, FDA
Hilary Thesmar, Senior Vice President, Food Safety and Chief Food and Product Safety Officer, Food Marketing Institute
Moderated by
Smitha G. Stansbury, Partner, King & Spalding LLP

2:45 – 3:00 PM
Networking Break

3:00 – 3:45 PM
Criminal Enforcement
Some companies have may have a perception that they don’t have to worry about criminal enforcement in the food sphere—this panel will dispel that myth. Speakers will include a review of recent prosecutions and give practical advice for clients facing or hoping not to face that reality.

John Claud, Assistant Director, Consumer Protection Branch, US Department of Justice
Howard R. Sklamberg, Partner, Akin Gump Strauss Hauer & Feld LLP
Jack Wenik, Member of the Firm, Epstein Becker & Green, PC

3:45 – 4:45 PM
Class Actions: The Next Phase
During this panel, speakers will address current and recent class actions in the food space. Considering the increasingly active role of class action suits as a form of enforcement, what are best practices to protect your client? What should be your first priorities when the complaint is served? What are some of the key issues to consider in connection with relabeling and settlement?

Angela Agrusa, Partner, DLA Piper LLP (US)
Anthony Anscombe, Partner, Steptoe & Johnson LLP
Christina Eisenhard, General Counsel, Danone North America, P.B.C. 
Marisol C. Mork, Partner, Squire Patton Boggs LLP

4:45 PM
Closing Remarks and Adjournment