Why Attend

Agenda

CLE

Subject to Change

Wednesday, March 24

11:20 – 11:40 AM
Technology and Connection Support Session
First virtual conference? Unsure about technology? Join FDLI staff for this informal, open session to make sure your audio and technology are prepared for the day’s sessions and to answer your questions about the virtual platform.

11:45 AM – 12:00 PM
FDLI Welcome
Amy Comstock Rick, President & CEO, FDLI
Steven Armstrong, Senior Regulatory Advisor, Haynes and Boone LLP and Chair, FDLI Food and Dietary Supplement Conference Planning Committee

12:00 – 12:45 PM
Keynote Address
Sharon Lindan Mayl, Senior Advisor for Policy, Office of Food Policy and Response, United States Food and Drug Administration (FDA)

12:50 –1:50 PM
Evaluating the Food Safety Modernization Act (FSMA) Proposed Rule for Food Traceability

Laurie J. Beyranevand, Director and Professor of Law, Center for Agriculture and Food Systems, Vermont Law School
Rebecca Goldberg, Associate Chief Counsel, FDA Office of the Chief Counsel
Bryan Hitchcock, Senior Director, Food Chain & Global Food Traceability Center, The Institute of Food Technologists (IFT)
Moderated by Allen Sayler, Senior Director of Food Consulting Services, EAS Consulting Group

As part of the New Era of Smarter Food Safety Blueprint, and as required by FSMA, FDA has proposed a new rule establishing additional traceability recordkeeping requirements for persons who manufacture, process, pack, or hold certain foods. Panelists will review the components of the proposed rule, then discuss its potential benefits, including improved food safety and outbreak response, against the additional costs it would impose on parties in the supply chain.

1:50 – 2:10 PM
Break

2:10 – 2:55 PM
Produce Safety: New Approaches to a Persistent Public Health Problem

William (Bill) Marler, Managing Partner, Marler Clark
Jennifer C. McEntire, Senior Vice President, Food Safety and Technology, United Fresh Produce Association
Moderated by Steven Armstrong, Senior Regulatory Advisor, Haynes and Boone LLP and Chair, 2021 Food and Dietary Supplement Safety and Regulation Conference Planning Committee

Contaminated produce remains one of the leading causes of recalls in the United States, and FDA has recently increased its efforts to combat this problem. This discussion will cover year-over-year trends in produce-related recalls, the impact of FSMA implementation on produce safety, FDA’s recent push to react to and post information on outbreaks more quickly, and remaining challenges to reducing the amount of contaminated produce that reaches consumers.

3:00 – 3:45 PM
Update on Allergen Labeling and Recalls

Evangelia C. Pelonis, Partner, Keller & Heckman LLP
Anita Roach, Vice President of Health Innovation Strategies & Corporate Ventures, Food Allergy Research and Education (FARE)
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

Allergen labeling continues to be a hotly debated topic, and undeclared allergens continue to be a frequent cause of both food and dietary supplement recalls. Attendees will hear the latest updates on efforts to include sesame in mandatory allergen labeling, standardize label warning language, and modernize the allergen listing process, as well as recent examples of and trends in allergen-related recalls.

3:45 – 4:00 PM
Break

4:00 – 5:00 PM
Examining FDA’s Increased Use of Warning Letters for Food and Dietary Supplements

Andrea G. Ferrenz, Food Law Counsel, Campbell Soup Company
Susan J. Hewlings, Director of Scientific Affairs, Nutrasource Pharmaceutical and Nutraceutical Services
John F. Johnson, Partner, Shook, Hardy & Bacon LLP
Moderated by Elizabeth Barr Fawell, Partner, Hogan Lovells

Warning letters remain a vital tool for FDA, and their many uses span enforcing FSMA compliance to protecting consumers from impermissible claims of COVID-19 prevention and treatment. Learn from industry experts how FDA has utilized warning letters during the pandemic, including increased specificity in Foreign Supplier Verification Program (FSVP)-related warning letters and issuing inspection violation citations based on record reviews alone and without conducting in-person inspections. Panelists will also make predictions on whether these trends are likely to continue post-pandemic and future FDA enforcement priorities.

Thursday, March 25

11:20 – 11:40 AM
Technology and Connection Support Session
First virtual conference? Unsure about technology? Join FDLI staff for this informal, open session to make sure your audio and technology are prepared for the day’s sessions and to answer your questions about the virtual platform.

11:50 AM – 12:00 PM
FDLI Welcome
Steven Leslie, Assistant Director, Educational Programs, FDLI

12:00 – 12:45 PM
Featured Presentation and Q&A
Vasilios (Bill) Frankos, Senior Vice President of Global Product Science, Safety, and Compliance, Herbalife International of America, Inc.

12:50 –1:50 PM
Dietary Supplements: Regulatory Challenges and Litigation Risks

Megan L. Olsen, Vice President and Associate General Counsel, Council for Responsible Nutrition
Judith M. Praitis, Partner, Faegre Drinker Biddle & Reath LLP
Jack Wenik, Member, Epstein Becker & Green, P.C.
Moderated by Robert Durkin, Of Counsel, Arnall Golden Gregory LLP

Already a growing product category, the pandemic has further accelerated consumer interest in dietary supplements. This panel will feature perspectives on the most pressing issues in the dietary supplement space, including what differentiates dietary supplements from drugs and foods, nuances in the new dietary ingredient notification process, regulatory risks, and recent trends in both class action and Prop 65 litigation.

1:50 – 2:10 PM
Break

2:10 – 2:55 PM
Navigating the Patchwork of State Hemp and CBD Regulation

Daniel R. Dwyer, Partner, Kleinfeld, Kaplan & Becker, LLP
Daniel McGee, Former Chief Legal Officer, Solari Hemp
Moderated by Sam Dietle, Senior Associate, Hogan Lovells LLP

 

In the absence of additional federal guidance, there remains a great deal of variation among state regulations for products with hemp-derived CBD. Panelists will survey the current “state” of these laws and requirements, including variations in testing and lab accreditation requirements, and predict what federal CBD regulation and enforcement will look like under the Biden administration and with a new FDA Commissioner, including whether Congress will step in and pass new legislation on hemp-derived CBD products.

3:00 – 3:55 PM
Considerations for Using Third-Party Certification for Ensuring Product Safety

Tara Lin Couch, Senior Director, EAS Consulting Group
Karil L. Kochenderfer, Principal, LINKAGES
Moderated by Jacqueline J. Chan, Partner, Kleinfeld, Kaplan & Becker, LLP

From Good Manufacturing Practices (GMPs) compliance to supplier inspections to ingredient and finished product testing, food and dietary supplement manufacturers rely heavily on third party certifiers to ensure their finished products are safe. This discussion will address how industry reliance on third parties has changed after the high-profile recalls from 2009-2011 (Peanut Corporation of America, Quality Egg, and Jensen Farms). Speakers will also discuss recent issues with dietary ingredient contamination, and the extent that domestic and international companies can and should rely on third parties when it comes to product safety assurance.

4:00 – 4:55 PM
Bioengineering, Cell-Cultured Products, and the Challenge of Regulating at the Same Pace that Technology Advances

Gregory Jaffe, Director of the Project on Biotechnology, Center for Science in the Public Interest (CSPI)
Kelly G. Laudon, Of Counsel, Jones Day
Larisa Rudenko, Research Affiliate, Program of Emerging Technologies (PoET), Massachusetts Institute of Technology (MIT) and Co-Founder, Biopolicy Solutions, LLC
Moderated by Jessica P. O’Connell, Partner, Covington & Burling LLP

Technology tends to outpace regulation in all product categories, and food and dietary supplements are no exception. Topics will include Federal Bioengineered Disclosure Standard definitions in light of evolving gene-editing technology, pending challenges faced by FDA and USDA for regulating cell-cultured meat and seafood, and big-picture suggestions for how regulatory bodies can keep pace with rapidly evolving technology.

4:55 PM
Closing Remarks and Adjournment