Day 1 - Monday, April 23, 2018

Navigating Key Regulatory Agencies for the Food Industry: Comprehending the Jurisdiction, Function, Organization and Interplay of the FDA, USDA, FTC, and Local Health Agencies

Apr 23, 2018 8:30am - 11:30am

Speakers

Melissa Card
Associate Director of the Institute of Food Laws and Regulations
Michigan State University

12:00
Networking Lunch for Workshop Attendees
12:45
Registration
1:15
Co-Chairs’ Opening Remarks
1:30
Focus on FSMA
2:15
Best Practices for Managing FDA and USDA Inspections
3:15
Afternoon Networking Break
3:30
Keynote Address
4:00
A Mock Recall Exercise: How Does a Company Make a Decision on When a Recall Is Required?
5:00
Examining the Impact of the FDA’s Pronouncements and Rule-Making Processes on Class Action Litigation
5:30
Conference Adjourns to Day Two

Day 2 - Tuesday, April 24, 2018

7:30
Continental Breakfast
8:00
Co-Chairs’ Opening Remarks
8:15
Labeling Update: The Latest on the Nutrition Facts Panel, GMO Labeling, and FDA’s Definition of “Natural,” “Healthy” and Other Terms
9:15

FOCUS ON LITIGATION

Class Action Litigation Trends: What’s on Your Labels?
10:15
Morning Coffee Break
10:30
Prop 65 Developments: Litigation Trends and What Has Been the Economic as well as Public Health Impact of Prop 65?
11:30
Defending Class Actions and Pre-Suit Demand Letters: What Works and What Doesn’t?
12:00
Networking Lunch
1:15

FOCUS ON SUPPLY CHAIN MANAGEMENT

Practical Guidance on Developing a Foreign Supplier Verification Program and Safeguard Protocols to Ensure that Suppliers Are in Compliance with FDA, USDA, and Other Standards
2:30
Rethinking Historic Practices and Outdated Agreements
3:00
Afternoon Break
3:15
FTC Keynote Address
3:45
The Politics of Substantiating Claims: Encouraging Cooperation between Marketing and Legal Departments to Further the Goal of Claim Substantiation
4:45
Innovations in Food Technology and Production
5:30
Conference Ends

Day 1 - Monday, April 23, 2018

12:00
Networking Lunch for Workshop Attendees
12:45
Registration
1:15
Co-Chairs’ Opening Remarks

Sarah Brew
Partner
Faegre Baker Daniels LLP

Ebru Basaran-Shull
Director
Compliance and Government Affairs

Sargento Foods Inc. (Plymouth, WI)

1:30
Focus on FSMA

Cindy Kruger
Legal Senior Director – Food Safety & Regulatory
PepsiCo

Sarah Roller
Partner & Chair – Food & Drug Law Practice
Kelley Drye & Warren LLP

  • What is the current administration’s approach to FSMA and food safety?
  • What are the latest regulations and guidance documents and what’s coming next?
  • Preventative controls: what is FDA focused on and which hazards makes sense to control for based on the type of food company being inspected (e.g., ingredient supplier, food manufacturer, etc.)
  • Understanding environmental monitoring programs and hazard analysis piece for raw ingredients coming into facilities
  • Sanitary transportation: what you need to require in your transportation chain

2:15
Best Practices for Managing FDA and USDA Inspections

Daniel R. Dwyer
Partner
Kleinfeld, Kaplan and Becker, LLP

Jeanine Flaherty
Executive Director of Food Safety, Quality & Regulatory Compliance
Legal Sea Foods, LLC

Stuart M. Pape
Shareholder, Chair, FDA Practice Group
Polsinelli PC

  • What are the differences between USDA and FDA inspection of facilities and enforcement?
  • Who are FDA and USDA targeting with inspections?
  • What policies and practices should you have in place to prepare for inspections?
  • What is the scope of FDA’s post-FSMA power: documents, photographs, and environmental and product samples?
  • What are FDA’s “FSMA” inspections focused on and how to make sure your Food Safety Plan and environmental monitoring program pass FDA’s review?
  • Lessons learned from recent inspections: what to do when you have an FDA “swab-a-thon?”
  • Form 483s and Warning Letters – best practice for an effective response

3:15
Afternoon Networking Break
3:30
Keynote Address

Sharon Lindan Mayl
Senior Advisor for Policy Office of Foods and Veterinary Medicine
Food and Drug Administration

4:00
A Mock Recall Exercise: How Does a Company Make a Decision on When a Recall Is Required?

Monica A. Johnson
Assistant General Counsel
Ventura Foods, LLC

Heili Kim
Partner
Venable LLP

Shane Mulrooney
Vice President – Legal
Home Chef

Meredith Quinn Olearchik
Vice President and Associate General Counsel – Intellectual Property, Marketing and Food Law
Campbell Soup Company

  • This session will focus on a mock recall of a potentially contaminated food product, exploring issues such as:
  • When a potential food safety issue has been discovered, what steps should immediately be taken?
  • How does a company make an ultimate decision on what to do based on steps taken and evaluation of risk?
  • Who should have input into the decision to recall?
  • When it is determined that a recall is required, what are the immediate action steps? Who should be involved? When does the FDA need to be notified?
  • When do you need to make a report to the Reportable Food Registry?
  • How do you work with outside experts and PR firms while maintaining attorney-client privilege?
  • How does a Recall Plan work in tandem with a Crisis Management Plan and social media?

5:00
Examining the Impact of the FDA’s Pronouncements and Rule-Making Processes on Class Action Litigation

Anthony Anscombe
Partner
Steptoe & Johnson LLP

Given that litigation often turns on what FDA weighed in or didn’t weigh in on, the panelist will focus on providing some suggestions as to how courts should treat statements by the FDA and what companies can do to try to avoid lawsuits based on those pronouncements.

 

  • Determining if any boundaries are visible in terms of what claims won’t necessarily cause a class action suit
  • Does the food industry see any slowing down in class action trends and/ or letters sent to companies threatening to sue based on certain claims?
  • Does the review of recent court decisions give a better understanding of some safe zones?
  • Where does the preemption argument fit and does it help?

5:30
Conference Adjourns to Day Two

Day 2 - Tuesday, April 24, 2018

7:30
Continental Breakfast
8:00
Co-Chairs’ Opening Remarks
8:15
Labeling Update: The Latest on the Nutrition Facts Panel, GMO Labeling, and FDA’s Definition of “Natural,” “Healthy” and Other Terms

Andrea Bruce
Sr. Counsel, Global Regulatory Law
The Hershey Company

Cassandra Soltis
Director, Corporate Counsel
Starbucks Coffee Company

Kimberly Wingfield
Director, Science Policy Labeling and Standards
Grocery Manufacturers Association

  • Current status of the labeling requirements: what to make of the proposed extension of compliance dates?
  • In light of the new regulations, lack of clear guidance from the FDA, and class actions, among other challenges, how are companies labeling sugar, dietary fibers, and protein?
  • Examining current efforts to get FDA to change its position on added sugars
  • State and local initiatives on labeling sugar, sodium, antibiotics and pesticides
  • Will FDA define “natural,” ”healthy” and other claims and what does it mean if they don’t?
  • GMO labeling: Status of implementation and proposed rules

9:15

FOCUS ON LITIGATION

Class Action Litigation Trends: What’s on Your Labels?

Sarah Brew
Partner
Faegre Baker Daniels LLP

Lorie S. Foster
Division Counsel
Abbott Laboratories (Columbus, OH)

Justin J. Prochnow
Shareholder
Greenberg Traurig, LLP

  • Within recent years, the terms “natural,” “evaporated cane juice,” and “healthy” have taken the center stage, what are some of the new terms and claims being challenged in class action litigation?
  • Given the litigation history and recent FDA statements on “natural”, is it still worth making “natural” claims?
  • Ingredient claims: Sugar, salt, protein, dietary supplements and other ingredients being tested and challenged
  • “Slack fill”: What is it, how do you defend slack fill class actions and how do you safeguard your products from “slack fill” challenges?
  • The latest trends: clean label and “no, no, no” claims

10:15
Morning Coffee Break
10:30
Prop 65 Developments: Litigation Trends and What Has Been the Economic as well as Public Health Impact of Prop 65?

Kristin Ashurst
VP, General Counsel & Corp. Secretary
Peet’s Coffee, Inc.

Sarah Esmaili
Counsel
Arnold & Porter LLP

Matthew R. Dornauer
General Counsel
Phusion Projects, LLC

Kelly McLain
Senior Lawyer
Cargill (Minneapolis, MN)

  • Reviewing recent developments under California’s Proposition 65: pending regulatory proposals and increased enforcement activity in CA
  • New listings and new safe-harbor warning regulations
  • How to proceed if no safe harbor has been established for a particular substance listed?
  • What has been the impact of Prop 65 on the food industry thus far? Has it helped the public health?
  • Are there legislative options to address Proposition 65?

11:30
Defending Class Actions and Pre-Suit Demand Letters: What Works and What Doesn’t?

Ronald Y. Rothstein
Partner
Winston & Strawn LLP

  • What are the trends in class action filings and pre-suit demand letters challenging products’ labeling?
  • When to fight and when to settle – what factors should be considered?
  • Preemption, Primary Jurisdiction, The First Amendment, “no reasonable consumer,” “puffery” and other defenses – when do they work?
  • Defeating class certification: the latest and best arguments on commonality, ascertainability and damages

12:00
Networking Lunch
1:15

FOCUS ON SUPPLY CHAIN MANAGEMENT

Practical Guidance on Developing a Foreign Supplier Verification Program and Safeguard Protocols to Ensure that Suppliers Are in Compliance with FDA, USDA, and Other Standards

Timothy G. Dietrich
Partner
Barley Snyder

Odalys Perez Dines
General Counsel and Chief Compliance Officer
Mitsui Foods, Inc.

Maile Gradison Hermida
Partner
Hogan Lovells US LLP

Tony Pavel
Senior Food Lawyer
Cargill

  • Dealing with the lack of clarity in regulations surrounding FSVP importer
    • Who should be the FSVP importer in the supply chain?
    • Addressing the difficulties in implementing this program given that nothing has been tested nor approved by the FDA
    • Protecting yourself against liability when it is unclear which party is responsible for what; how to deal with difficult suppliers who are trying to shift the responsibility?
  • Suggested ways of creating templates/set of procedures that food companies can use to develop their FSV programs; What should that template contain?
  • Suggestions as to what FDA might be looking for in this program
    • What has FDA actually looked for in this program since the inception of its inspections?

Developing Safeguard Protocols to Ensure that Suppliers Are in Compliance with FDA, USDA, and Other Standards

 

  • Handling problems with traceability of imported raw materials
  • Ensuring that commercial agreements align with regulatory responsibilities
  • Best practices for incorporating safety standards into contracts
  • Should you audit or not: implications of first-party and third-party audits
  • What level of substantiation should suppliers provide for “non-GMO,” “organic” animal welfare and other claims?
  • Exploring scope of supplier liability for labeling claims and ingredient contamination as well as subsequent liabilities for manufacturers and distributors

2:30
Rethinking Historic Practices and Outdated Agreements

Kelly G. Laudon
Attorney
Ballard Spahr LLP

  • In light of new FSMA regulations focused on supplier verification, what is the best model for managing supplier relationships?
  • How should you qualify, monitor, review and potentially disqualify suppliers?
  • What do you do if a supplier had a recall or a warning letter issued against it?
  • When do you need to require a supplier to do a root cause analysis and take corrective actions?
  • What do you need in your supplier program and agreements to address both regulatory requirements and risk reduction and liability?
  • How important are specifications and COAs and how do you handle changing requirements?

3:00
Afternoon Break
3:15
FTC Keynote Address

David A. O’Toole
Senior Staff Attorney
Federal Trade Commission

3:45
The Politics of Substantiating Claims: Encouraging Cooperation between Marketing and Legal Departments to Further the Goal of Claim Substantiation

Ebru Basaran-Shull
Director
Compliance and Government Affairs

Sargento Foods Inc. (Plymouth, WI)

Robert G. Hibbert
Partner
Morgan, Lewis & Bockius LLP

Stephen L. Lacey
Divisional Vice President & Associate General Counsel
Abbott Laboratories

Given the involvement of local district attorneys, plaintiffs’ lawyers, state attorneys general, etc., adequately substantiating the claims is becoming extremely important. While collaboration between the two departments is essential to ensure a company’s goal of reaching consumers without getting sued, practically achieving that collaboration within the realities of what looks like competing interests between the two departments poses a challenge. This discussion will look to offer some suggestions as to how attorneys can approach this conundrum in order to make their jobs easier. Topics of discussion will include:

 

  • Practical realities of dealing with a company’s marketing department
  • Communicating effectively with claims team members so that they understand the risks of pursuing particular claims
  • Suggesting adjustments to claims language to reach the joint goal of developing a creative and a compliant claim rather than rejecting the claim at the outset

4:45
Innovations in Food Technology and Production

Deepti A. Kulkarni
Attorney
Sidley Austin LLP

DeAnn Liska
Sr. Director, Nutrition Science & Biostatistics
Biofortis – Merieux NutriSciences

Eric Schulze, PhD
VP of Product and Regulation
Memphis Meats

Breakthrough innovations in food technology, such as gene editing and cellular agriculture, have the potential to reshape entire industries and transform consumer perceptions regarding food production. This discussion will focus on how these emerging technologies challenge current regulatory frameworks that were designed well before these technologies were even contemplated, let alone executed. The panelists will discuss how the regulators may approach these technologies, including anticipated labeling ramifications, as well as how stakeholders can play a role in reshaping the regulatory landscape.

5:30
Conference Ends

Navigating Key Regulatory Agencies for the Food Industry: Comprehending the Jurisdiction, Function, Organization and Interplay of the FDA, USDA, FTC, and Local Health Agencies

Apr 23, 2018 8:30am - 11:30am

$500

Speakers

Melissa Card
Associate Director of the Institute of Food Laws and Regulations
Michigan State University

What is it about?

In the modern regulatory state, the attorney or regulatory affairs manager is looked to for more than just the meaning of black letter law, but also for guidance and leadership in dealing with agencies, particularly in adverse or high-stakes situations. This session will provide attendees with an introduction to regulatory affairs as these issues apply to food.

 

Points of discussion include:

 

  • The nature of the regulatory process and the role of regulatory affairs
  • Understanding the responsibilities and jurisdiction of FDA, USDA, FTC and local health agencies
  • Exploring the organizational structure of each agency and their respective roles in food regulation
  • Examining how each agency exercises its jurisdiction and regulatory authority
  • Compliance and enforcement issues
  • Understanding when federal laws preempt state regulation
  • Judicial review of federal agency decisions