Why Attend

 Agenda

Location & CLE

Subject to change
All times listed are in Eastern Time

Thursday, March 23

9:00–9:30 AM  
Registration and Continental Breakfast

9:30–10:50 AM  
FDLI Welcome, Keynote Addresses, and Joint Q&A
Christine M. Simmon, President & CEO, FDLI
Neal D. Fortin, Director, Institute for Food Laws and Regulations, Michigan State University and Professor, Department of Food Science and Human Nutrition, Michigan State University College of Law and Chair, 2023 Food and Dietary Supplement Safety and Regulation Conference Planning Committee
Mark Moorman, Director, Office of Food Safety, CFSAN, FDA
Sandra B. Eskin, Deputy Under Secretary, Food Safety, USDA

10:50–11:10 AM
Networking and Refreshment Break

11:10 AM–12:10 PM
Food Regulation Year-in-Review and Agency Regulatory Initiatives on Food Safety
Andrea G. Ferrenz, Food Law Counsel, Campbell Soup Company
Diane C. McEnroe, Partner, Sidley Austin LLP
Moderated by John F. Johnson, Senior Counsel, Shook, Hardy & Bacon LLP

This session will look back at 2022 and discuss significant FDA activities and regulations concerning food safety. Panelists will discuss 1) The Reagan-Udall Foundation Food Report; 2) FDA’s proposal to redesign the Human Foods Program; 3) Developments pertaining to inspections to Foreign Food Establishments and FDA’s Foreign Supplier Verification Program; 4) The final rule on Food Traceability; and 5) FDA updates on Generally Recognized as Safe (GRAS).

12:10–1:10 PM
Networking Luncheon

1:10–2:10 PM
Dietary Supplement Regulatory Updates and Impacts of Recent FDA/FTC Regulatory Initiatives  
Haijing Hu, Branch Chief for Regulation, Implementation Branch, FDA-CFSAN
Christine Lee Delorme, Attorney, Division of Advertising Practices, FTC
Maged Sharaf, Senior Director, EAS Consulting Group 
Jack Wenik, Member, Epstein Becker & Green, PC

FDA and FTC share responsibility for overseeing dietary supplements and related promotion. FDA is generally responsible for ensuring safety, quality, and labeling, and FTC is generally responsible for advertising. Panelists will discuss FDA’s recent draft guidance on the New Dietary Ingredients notification process and examine FTC advertising guidelines, endorsements, and recent cases. 

2:20–3:20 PM
Food Standards of Identity:  Barriers to Innovation or Necessary to Protect Product Identity?
Kris DeAngelo, Academic Specialist, Institute for Food Laws and Regulations Michigan State University
Stuart M. Pape, Senior Partner and Chair, FDA Practice, Polsinelli
Moderated by Pamela Grinter, Partner, Fox Rothschild LLP

Are there alternative approaches to protect product identity without stifling innovation? This panel will discuss whether standards of identity are still needed and review the role of standards of identity in preventing adulteration. Panelists will also address the new joint FDA and USDA effort to publish a proposed rule on Principles for Food Standards Modernization, which was included in the Fall Unified Agenda.

3:20–3:35 PM
Break

3:35–4:35 PM
Dietary Supplements: Quality Components, Inspection Identity, and Criminalization
Ernest Fung, Senior Managing Health Scientist, Cardno ChemRisk
Dr. Omar Oyarzabal, Senior Consultant, EAS Consulting Group 
Patrick Runkle, Trial Attorney, DOJ

This session will discuss ingredient identity, chemical contamination, active pharmaceutical ingredient contamination, and practical implications of not following proper good manufacturing practices to prevent microbial contamination that could result in finished product adulteration. Panelists will discuss intentional vs. accidental quality issues and how a lack of attention to quality can result in criminalization, as illustrated by DOJ’s enforcement actions on dietary supplements.

4:35–6:00 PM
Conference Reception

Friday, March 24

8:30–9:00 AM
Registration and Continental Breakfast           

9:00–10:05 AM
FDLI Welcome and Panel Discussion
Bianca Cardona Melendez, Assistant Director, Educational Programs, FDLI

The Future of New Business Models in Retail
Andreas Keller, Director, Multi-Commodity Foods, Office of Food Safety, FDA-CFSAN
Steve Mandernach, Executive Director, Association of Food and Drug Officials (AFDO)
Suzie Trigg, Partner, Haynes Boone LLP
Alicia White, Vice President and Associate General Counsel-Operational Transactions and Regulatory Compliance, Whole Foods Market, Inc.
Moderated by Sharon Lindan Mayl, Partner, DLA Piper LLP (US)

FDA’s efforts to modernize and emphasize retail food safety, including e-commerce, continue. Foods are increasingly being produced and sold using new direct-to-consumer business models ranging from restaurant and grocery delivery to meal kit subscriptions. FDA, in collaboration with state and other regulatory partners, held a summit in 2021 to explore these issues. This session will explore case studies in retail food safety, e-commerce footprint and how to ensure the safety of foods sold through retail and new business models, and how to incorporate the support of food manufacturers and processors to strengthen retailers’ food safety programs.

10:15–11:15 AM
Regulation and Consultation Process on Cultivated Meat and Cell-Cultured Proteins in the U.S.
Jeremiah Fasano, Senior Policy Advisor, Office of Food Additive Safety, FDA CFSAN
Amaru Sanchez, Associate, Wiley LLP
Eric Schulze, Vice President of Product and Regulation, UPSIDE Foods
John E. Wyand, Senior Partner Squire Patton Boggs LLP
Moderated by Deepti Kulkarni, Partner, Covington & Burling LLP

On November 15, 2022, the FDA issued a “No Questions” letter for a cell-based chicken product, the first of its kind for cell-cultured animal protein for human consumption. This panel will discuss the regulation and pre-market consultation process for cultivated meat and cell-cultured proteins; lessons learned from the consultation process; implications for non-US based industry, including import requirements; implications for plant-based and cultivated meat; and how industry can ensure product safety and sustainability.

11:15–11:30 AM
Networking and Refreshment Break

11:30 AM–12:15 PM
Heavy Metals, PFAS, and Other Contaminants: Making Sense of the State and Federal Regulatory Landscape
Marisa Kreider, Principal Science Advisor, Cardno ChemRisk
Mark Thompson, Partner, Keller & Heckman LLP 
Moderated by Judith M. Praitis, Partner, Faegre Drinker Biddle & Reath LLP

FDA continues to solicit industry commentary, data, and input regarding appropriate levels for naturally occurring heavy metals in many foods. This session will explore state and federal regulations surrounding contaminants in foods, such as the regulatory climate around PFAS and other contaminants. Panelists will also compare PFAS vs. heavy metal regulations, FDA actions surrounding PFAS and heavy metals, and discuss the future of contaminants regulation.

12:15–1:15 PM
Networking Luncheon

1:15–2:00 PM
The Use of Bioactive Substances in Food and Dietary Supplements
Andrea Bruce, Senior Counsel, Hogan Lovells US LLP
Dennis Keefe, Former Director of the Office of Food Additive Safety, FDA-CFSAN
Duffy MacKay, Senior Vice President, Dietary Supplements, Consumer Healthcare Products Association (CHPA)
Moderated by Ricardo Carvajal, Director, Hyman, Phelps and McNamara PC and Member, FDLI Board of Directors

This session will explore an increasing interest in using bioactive substances in food and dietary supplements. Panelists will address the regulatory difference between food and dietary supplements when utilizing bioactive substances and the challenges they present to the FDA and industry, such as how to properly evaluate the safety of such substances and proper use of label claims.

2:00–2:15 PM
Networking Break

2:15–3:15 PM
Food Safety at USDA – What Companies Need to Know
Dr. Phillip Bronstein, Assistant Administrator, Office of Field Operations, USDA-FSIS
Brian Ronholm, Director of Food Policy, Consumer Reports
Brian Sylvester, Special Counsel, Covington & Burling LLP
Moderated by Bob Hibbert, Senior Counsel, Wiley LLP

USDA’s Food Safety and Inspection Service (FSIS) ensures that meat, poultry, and the processed egg supply is wholesome, safe, and properly labeled. This session will cover USDA’s proposed regulatory framework for a new strategy for controlling salmonella contamination in poultry products and reducing foodborne illness attributed to these products.

3:15 PM
Closing Remarks and Adjournment