All times listed are in Eastern Time

Wednesday, March 30

11:00 AM – 12:00 PM
FDLI Welcome and Keynote Address
Amy Comstock Rick, President & CEO, FDLI
Heili Kim, Partner, Faegre Drinker Biddle & Reath LLP and Chair, FDLI Food and Dietary Supplement Conference Planning Committee
Leslie Kux, Deputy Director for Nutrition, Regulatory Policy, and Engagement, Center for Food Safety and Nutrition (CFSAN), United States Food and Drug Administration (FDA)

12:10 – 1:00 PM
Food and Dietary Supplement Regulation Year-in-Review
John F. Johnson, Of Counsel, Shook Hardy & Bacon LLP
Elizabeth B. Fawell, Partner, Hogan Lovells
Moderated by Stuart M. Pape, Senior Partner, Polsinelli PC

This session will recap the most significant recent developments in food and dietary supplement regulation and enforcement, including updates on FDA and United States Department of Agriculture (USDA) inspections, FDA and Federal Trade Commission (FTC) warning letters and enforcement, and compliance challenges faced by manufacturers and retailers. Panelists will also discuss the extent to which federal regulation and enforcement may have impacted private litigation over the past year.

1:00 –1:30 PM

1:30 –2:30 PM
Ingredients and Food Contact Substances: Assessing the US Approach to Safety
Trenton H. Norris, Partner, Arnold and Porter LLP
Evangelia C. Pelonis, Partner, Keller and Heckman LLP
Nury Helena Yoo, Partner, Faegre Drinker Biddle & Reath LLP
Moderated by Steven Armstrong, Senior Regulatory Advisor, Haynes and Boone, LLP

Recently, FDA received a petition seeking to rescind its approval of bisphenol-A (BPA) in food packaging. This is just the latest example of safety concerns surrounding substances added to our food and food packaging, both intentionally and unintentionally. Panelists will discuss a wide range of ingredient and contact substance safety topics, including allergen disclosures and recalls, “Generally Recognized as Safe” (GRAS) notices, and the role of Proposition 65 and other state regulations in food and dietary supplement safety.

2:40 – 3:40 PM
Technology and Innovation: Can it Improve Both Food Safety and Food Access?
Laurie Beyranevand, Director and Professor of Law, Center for Agriculture and Food Systems, Vermont Law School
Keith A. Matthews, Of Counsel, Wiley Rein LLP
Moderated by Brian Sylvester, Special Counsel, Covington & Burling LLP

Technologies such as blockchain traceability and AI-guided complaint monitoring have the potential to improve food safety. Additionally, other technologies such as automated delivery and shelf life extending packaging could potentially improve access to nutritious foods. However, cutting-edge technologies tend to be expensive, and widespread adoption could lead to higher food prices and potentially worsening food access for disadvantaged populations. This session will feature an overview of several new and emerging technologies, followed by a discussion on how they can be implemented while also removing barriers to food access, including what party or parties could or should bear the associated costs.

3:50 – 4:50 PM
Dietary Supplements: Finished Product Specifications, Serious Adverse Events (SAEs), and More

Jonathan M. Cohen, Partner, K&L Gates LLP
Tara Lin Couch, Senior Director, Dietary Supplement and Tobacco Services, EAS Consulting Group
Moderated by Robert Durkin, Of Counsel, Arnall Golden Gregory LLP

Dietary supplements continue to thrive as consumers become increasingly health-conscience and health-focused. Panelists will address an array of considerations for dietary supplement manufacturers, including nutrient content verification, complaint monitoring, reporting SAEs, conducting recalls, third-party contracting, and insurance.

4:55 – 5:30 PM
Welcome Reception and Food Law Trivia Contest

Thursday, March 31

10:30 – 11:00 AM
The FDLI Student Member Debrief

The FDLI Student Member Debrief will feature a space for student members to discuss the ongoing conference, network with other FDLI student members, and hear about other opportunities for those new to the food and drug law field.

11:00 AM – 12:00 PM
FDLI Welcome and Keynote Address
Sandra Eskin, Deputy Under Secretary for Food Safety, Office of Food Safety, United States Department of Agriculture (USDA)
Steven Leslie, Deputy Director, Educational Programs, FDLI

12:10 – 1:10 PM
Environmental Challenges and Impacts on Product Safety
Samuel D. Jockel, Senior Associate, Alston & Bird LLP
Marisa Kreider, Principal Science Advisor, Cardno ChemRisk
Timothy York, Chief Executive Officer, California Leafy Greens Marketing Agreement (LGMA)
Moderated by 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 

Heavy metals, man-made chemicals, and bacteria-contaminated water are just a few of the environmental hazards that impact food safety. Panelists will survey current federal and state initiatives to combat these problems, including FDA’s Closer to Zero: Action Plan for Baby Foods, the proposed Agricultural Water Rule, and Environmental Protection Agency (EPA) and state efforts to limit exposure to per- and polyfluoroalkyl Substances (PFAS) and pesticides.

1:10-1:40 PM

1:40 –2:40 PM
Preparing for a World Where Cannabis-Derived Ingredients are Legal for Food and Dietary Supplements
Holly J. Bayne, Founder, The Law Office of Bayne & Associates
Rodney Butt, Senior Vice President – Strategic Solutions, Nutrasource Pharmaceutical and Nutraceutical Services
T. Daniel Logan, Associate, Kleinfeld, Kaplan & Becker, LLP
Moderated by Kate W. Hardey, Partner, McGuireWoods LLP

While still prohibited by FDA as a food or dietary supplement ingredient, products containing cannabinoids such as Cannabidiol (CBD) and delta-8 Tetrahydrocannabinol (THC) have exploded onto the market. This session will address what a federal regulatory scheme might look like before turning to the practical issues facing companies seeking to enter the market, including sourcing, testing, documenting, and marketing considerations.

2:50 – 3:50 PM
Alternative Proteins and Regulating Novel Products
José Alberto Campos-Vargas, Partner, Sánchez Devanny 
Amaru J. Sánchez, Associate, Wiley Rein LLP 
Eric Schulze, Vice President of Product and Regulation, UPSIDE Foods
Moderated by Deepti A. Kulkarni, Partner, Sidley Austin LLP

Alternative proteins are a growing and highly innovative product category, with products ranging from cell-cultured meats to those derived from plants, fungi, microbes, and even insects. They also present unique and complex regulatory challenges, as do other novel foods and dietary supplements. Panelists will discuss the state of alternative protein products, current questions regarding regulation and safety, and how regulators can keep pace with rapid innovation while navigating uncertain science.

4:00 – 4:50 PM
The Future of Food and Dietary Supplement Regulation: Looming Challenges and Bold Predictions
Ricardo Carvajal, Director, Hyman, Phelps and McNamara P.C. and Member, FDLI Board of Directors
Michael T. Roberts, Executive Director for the Resnick Center for Food Law and Policy, UCLA School of Law
R. Trent Taylor, Partner, McGuireWoods LLP

This session will offer perspectives on the future of food and dietary supplement regulation, including the interplay between enforcement and private litigation, the increasingly complex global food market, and whether international trends may influence domestic policy. The discussion will conclude with each panelists making one bold prediction about food and/or dietary supplement regulation in the next 5 to 10 years.

4:50 PM
Closing Remarks and Adjournment