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The Food Enforcement and Compliance Conference brings leading regulators, attorneys, industry representatives, litigators, academics, and consultants together to discuss the increasing attention on food and dietary supplement regulation, including the latest developments and issues in enforcement and compliance, such as current FDA and USDA/FSIS enforcement priorities, inspection policies, and recent enforcement actions involving alleged violations of food safety or labeling requirements. This conference offers an important opportunity to delve into the latest trends and guidance concerning both enforcement risk factors and strategies for ensuring compliance and minimizing legal risk in the current environment.

Keynote Address: Stephen M. Ostroff, Deputy Commissioner for Foods and Veterinary Medicine, Office of the Commissioner, FDA

Attendees will:

  • Explore the latest trends behind enforcement actions in food and dietary supplements
  • Gain practical tips and best practices for succeeding during FSMA inspections
  • Learn how to comply with new and upcoming FDA rules and regulations
  • Discuss applications for developing technology to improve food safety verification

Panelists will also discuss:

  • Records Sharing Under FSMA
  • FDA’s New Enforcement Tools and How they are Being Used
  • Food Standards of Identity and Alternative Non-standardized Foods
  • Food Labeling Compliance
  • Defining New Dietary Ingredients

Venue Sponsor

Bronze Sponsor

Agenda

subject to change

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
Stephen M. Ostroff, Deputy Commissioner for Foods and Veterinary Medicine, Office of the Commissioner, FDA
Introduced by Sarah Roller, Partner, Kelley Drye & Warren LLP and Chair, FDLI Food Enforcement and Compliance Conference

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

Part I: Food Safety Enforcement and Compliance

10:00–11:00 AM
Inspections in the FSMA Environment
How are FDA policies concerning facility inspections evolving with the implementation of the Food Safety Modernization Act (FSMA)? How are inspectors adjusting their practices and procedures in light of the evolution from GMP inspections to full preventive control inspections? What can industry expect with regard to agency requests for records and other procedures during routine inspections versus investigations involving potential food safety risks? How have inspections of foreign facilities changed? What can importers expect with respect to inspections?

Elizabeth Fawell, Partner, Hogan Lovells US LLP
Anthony T. Pavel, Senior Food Lawyer, Cargill, Inc.
Priya Rathnam, Acting Director, Compliance Policy Staff, CFSAN, FDA
Moderated by Mark C. Levy, Member, Eckert Seamans Cherin & Mellott, LLC

11:00 AM–12:00 PM
Investigations of Foodborne Illness Outbreaks: The Growing Role of Environmental Monitoring and Whole Genome Sequencing
This session will examine recent developments in whole genome sequencing technology, how FDA is using this technology and their future plans for its use, and considerations for food companies in developing environmental monitoring programs and using whole genome sequencing.

Karen Blickenstaff, Acting Response Manager, Coordinated Outbreak Response and Evaluation (CORE) Network, FDA
Leslie Hintz
, Consumer Safety Officer, Office of Compliance, CFSAN, FDA
Smitha Stansbury, Partner, FDA & Life Sciences Practice, King & Spalding LLP
Moderated by Daniel Dwyer, Partner, Kleinfeld, Kaplan & Becker LLP

12:00–1:15 PM
Luncheon with Guest Speaker

Eric Brown, Director, Division of Microbiology, Office of Regulatory Science, CFSAN, FDA
Introduced by Laura Brown, Director, Educational Programs, FDLI

1:15–2:00 PM
Enforcement and Compliance Issues Presented by Dietary Ingredients
In this session, panelists will discuss issues related to dietary ingredients, including new dietary ingredients and FDA’s progress on developing a list of grandfathered ingredients. Panelists will also discuss FDA’s progress on a revised draft guidance for new dietary ingredients, as well as FDA enforcement activity.

Rend Al-Mondhiry, Senior Counsel, Amin Talati Upadhye, LLP
Robert J. Durkin, Deputy Director, Office of Dietary Supplement Programs, CFSAN, FDA
Megan Olsen, Assistant General Counsel, Council for Responsible Nutrition

 

 

 

Part II: Food Labeling Enforcement and Compliance

2:00–2:45 PM
Food Labeling Enforcement and Compliance Priorities in the Current Environment
This session will look at trends in FDA warning letters and FDA enforcement/compliance policies with respect to nutrition labeling, menu labeling, and FDA’s use of enforcement discretion to allow noncompliant uses of “healthy” claims, etc. The panel will additionally address the intersection of FDA enforcement and consumer class actions as plaintiffs’ lawyers use material from FDA warning letters and FDA’s lack of regulation of certain labeling claims, such as “natural” as the basis for filing suit. The panel will also cover AMS rulemaking on GMO labeling.

Veronica Colas, Senior Associate, Hogan Lovells US LLP
Evangelia Pelonis, Partner, Keller and Heckman LLP
Moderated by Ricardo Carvajal, Director, Hyman, Phelps & McNamara, PC

2:45–3:00 PM
Networking Break

3:00–3:45 PM
Food Standards of Identity: Enforcement and Compliance Issues
This session will review the historical role that established food standards of identity have played and the related public debate concerning the future role of standards of identity and related implications for product innovation. Panelists will address current issues, including the growth of non-standardized foods that are marketed as alternatives to standardized foods (e.g., plant-based alternatives) and the role states are playing to fill perceived gaps by adopting new state standards of identity for certain foods.

Steven Gendel, Senior Director, Food Science, U.S. Pharmacopeia
Deepti A. Kulkarni, Associate, Sidley Austin LLP
Jessica O’Connell, Special Counsel, Covington & Burling LLP
Moderated by Robert Hibbert, Partner, Morgan, Lewis & Bockius

3:45–4:45 PM
Private Enforcement Mechanisms
Panelists will discuss other enforcement mechanisms, including class action litigation as an “enforcement tool” and retailer oversight programs as a mechanism to shield retailers from liability.

Maile Hermida, Partner, Hogan Lovells US LLP
John M. Packman, Senior Counsel, Food Law and Advertising Substantiation, The Coca-Cola Company
Sarah Roller, Partner, Kelley Drye & Warren LLP
Moderated by Emily Strunk, Associate, Mayer Brown LLP

4:45 PM
Closing Remarks and Adjournment

 

 

Planning Committee

Committee Chair

Sarah Roller, Partner, Kelley Drye & Warren LLP

Committee Members

Steven Armstrong, Independent Advisor, EAS Consulting Group, LLC
Rend Al-Mondhiry, Senior Counsel, Amin Talati Upadhye
William Correll, Director, Office of Compliance, FDA –CFSAN
Elizabeth Barr Fawell, Partner, Hogan Lovells US LLP
Robert Hibbert, Partner, Morgan, Lewis & Bockius LLP
Leslie Krasny, Partner, Keller and Heckman LLP
Megan Olsen, Assistant General Counsel, Council for Responsible Nutrition
John Packman, Senior Counsel, Food Law, The Coca-Cola Company
Emily Strunk, Associate, Mayer Brown LLP

Continuing Legal Education

FDLI applies for CLE credits in Ohio, Pennsylvania, and Virginia. These CLE approvals may also be honored by other states; please check with your bar association for guidance. The CLE credits will be posted as they are granted and you can request to be notified when approval is received.

Approved for: 5.0 credits in Ohio, 5.0 credits in Virginia, 5.5 credits in Pennsylvania

 

Location and Overnight Accommodations

Location

Hogan Lovells US LLP
555 13th St., NW
Washington, DC 20004

Driving, Parking, and Public Transportation

The course location is directly above Metro Center (red, orange, silver, and blue lines). Exit towards the Metro Sales office. Limited parking is available in the building through the 12th Street entrance.

Overnight Accommodations 

A block of rooms has been reserved at the Courtyard by Marriott Washington Convention Center, located in walking distance of the course location. Reservations can be made online. The group rate is $339/night. Reservations must be received by February 26, 2018 in order to receive the group rate. After this date, rooms will be subject to prevailing rates and availability.

Please contact the Conference Department with any accessibility requirements or dietary restrictions, or for other questions.

2018-11-16T10:05:00+00:00