Day 1 - Wednesday, May 24, 2017

7:15
Registration and Continental Breakfast
8:15
Co-Chairs’ Opening Remarks
8:30
The Food Industry and the New Administration: Developing New Regulatory Strategies and Recognizing New Opportunities
9:30
Beyond the Label: Dealing with Practical Implications of the New Nutrition Facts Label
10:30
Morning Coffee Break
10:45
GMO Labeling: Analysis of the New Law and Strategies for Practical Implementation
11:45
Networking Luncheon
1:00
Structuring Claim Substantiation in the Face of New FTC and NAD Activities
1:45
Exploring Individual Liability Through the Invocation of the Corporate Officer Doctrine and Yates Memo as They Apply to the Food Industry
2:45
FDA Inspection Preparedness: Understanding Your Obligations
3:45
Afternoon Refreshment Break
4:00
Developing Strategies for Ensuring the Quality, Safety, and Security of Food Products in the Global Supply Chain
5:00
Conference Adjourns to Day Two

Day 2 - Thursday, May 25, 2017

8:00
Registration and Continental Breakfast
8:45
Co-Chairs’ Remarks and Recap of Day One
9:00
Class Action Litigation and Prop 65: Anticipating the Next Wave of Litigation in Order to Mitigate Risk
10:00
Morning Coffee Break
10:15
Ensuring Compliant Use of the Terms: “Organic,” “Natural,” and “All Natural”
11:15
Allergen Recall Conundrum: Devising Corrective Behaviors That May Prevent Necessity of a Recall
12:00
Conference Ends

Claims Substantiation Master Class

May 25, 2017 1:00pm - 4:00pm

Speakers

Jonathan W. Emord
Principal
Emord & Associates, P.C.

Jessica P. O’Connell
Special Counsel
Covington & Burling LLP

Jessica Campbell
Senior Counsel
Tyson Foods, Inc.

Day 1 - Wednesday, May 24, 2017

7:15
Registration and Continental Breakfast
8:15
Co-Chairs’ Opening Remarks

Karin Moore
Vice President and General Counsel
Grocery Manufacturers Association

Sarah Brew
Partner
Faegre Baker Daniels LLP

8:30
The Food Industry and the New Administration: Developing New Regulatory Strategies and Recognizing New Opportunities

Michael F. Jacobson
President
Center for Science in the Public Interest

Karin Moore
Vice President and General Counsel
Grocery Manufacturers Association

Laura Siegel Rabinowitz
Special Counsel
Kelley Drye & Warren LLP

  • Anticipating changes to the current regulatory environment for the food industry under the new administration
  • Addressing the impact of the President’s view that for every new regulation, two must be repealed
  • Analyzing new enforcement opportunities for state and local authorities in view of federal enforcement gap

9:30
Beyond the Label: Dealing with Practical Implications of the New Nutrition Facts Label

Rachel Edelstein
Deputy Assistant Administrator, Office of Policy and Program Development
FSIS

Randy Liebowitz
Global Food Regulatory Counsel
PepsiCo Inc.

Jessica P. O’Connell
Special Counsel
Covington & Burling LLP

This session is designed to address matters that companies should be looking at as part of changing their nutrition panels in 2017 to keep labels safe from lawsuits. Counsel will share
their thoughts on current dilemmas with respect to sugar content, fat content, starch content and more.

  • In depth analysis of new nutrition label and practical consequences of its implementation for food industry
    • Flavor labeling
    • Food and color additives
    • Definition of fiber
    • Total sugars
  • Assessing the need to reformulate and/or repackage under new labeling guidelines
  • Analyzing the economic and regulatory consequences of reformulation and repackaging

10:30
Morning Coffee Break
10:45
GMO Labeling: Analysis of the New Law and Strategies for Practical Implementation

Steve Armstrong
Independent Advisor, Food Law & Regulation
EAS Consulting Group

Adam R. Fox
Partner
Squire Patton Boggs

John Fuson
Partner
Crowell & Moring

Andrea F. Huberty
Senior Policy Analyst
Livestock, Poultry, and Seed, Agricultural Marketing Service USDA

  • Analysis of Federal GMO legislation and related labeling requirement
  • Status of the USDA’s proposed rule/advanced notice of proposed rule-making
  • What is the degree of diligence companies will need to know about the sourcing of their ingredients?
  • Understanding non-GMO claim in light of new legislation
  • Elements of an effective GMO label and implementing GMO labeling strategy

11:45
Networking Luncheon
1:00
Structuring Claim Substantiation in the Face of New FTC and NAD Activities

Rebecca L. Griffith
Senior Staff Attorney National Advertising Division
Council of Better Business Bureaus, Inc.

Brent Johnson
Partner
Holland & Hart LLP

  • Establishing best practices for claims substantiation by looking at current FDA and NAD activity
    • Determining what you can say and not say
    • Direct vs. implied claims
  • Identifying current FTC and NAD hot spots
  • Exploring Lanham Act challenges relative to false and misleading claims for competitor products
  • Assessing when health claims for a food product which has been cleared through FDA’s pre-market clearance procedures can be deemed unauthorized under the FDCA
  • Identifying circumstances under which disease prevention claims for a food product may relegate that product to the status of an unapproved new drug
  • When social media and websites can be viewed as a means of advertising and promotion

1:45
Exploring Individual Liability Through the Invocation of the Corporate Officer Doctrine and Yates Memo as They Apply to the Food Industry

Timothy G. Dietrich
Partner
Barley Snyder LLP

Cameron B. Smith
Senior Director, Counsel
Herbalife

Angela M. Spivey
Partner
McGuire Woods LLP

  • Survey of individual liability and corporate officer doctrine cases impacting the food industry
    • Application of Yates Memo
  • Conflict of interest and professional responsibility obligations of counsel that require more critical attention after the Yates Memo
  • Analyzing the implications of the responsible corporate officer doctrine in the food industry
  • How to ensure a continued culture of compliance in your company
  • Examining joint FDA and DOJ enforcement actions against bad actors

2:45
FDA Inspection Preparedness: Understanding Your Obligations

Sarah Brew
Partner
Faegre Baker Daniels LLP

Maile Gradison Hermida
Partner
Hogan Lovells US LLP

Adam M. Ekonomon
Vice President and Deputy General Counsel
The J.M. Smucker Company

  • Devising an inspection preparedness plan to meet with new regulatory requirements under FSMA and other regulations
  • Knowing what the Government will be looking for during an inspection
  • Formulating a Form 483 response post-inspection
  • Understanding the Government’s recourse when a response is not received at the end of the 15-day response period

3:45
Afternoon Refreshment Break
4:00
Developing Strategies for Ensuring the Quality, Safety, and Security of Food Products in the Global Supply Chain

Stuart M. Pape
Shareholder
Polsinelli P.C.

Christopher G. Van Gundy
Partner
Keller and Heckman LLP

  • Developing safeguard protocols to ensure that suppliers are in compliance with the FDA purity standards
  • Handling problems with traceability of imported raw materials
  • Exploring scope of supplier liability for ingredient contamination as well as subsequent liabilities for manufacturers and distributors
  • Ensuring that commercial agreements align with regulatory responsibilities
  • Best practices for incorporating safety standards into contracts
    • Identifying common contractual pitfalls
  • Addressing specific needs of small-to-mid-size companies

 

Export/Import concerns associated with the supply chain

  •  Foreign supplier verification program
  • Voluntary qualified importer program

 

Counterfeits and Diversions: Challenges and best practices for overcoming them

  • Best practices in investigating potential diversions and counterfeits
  • How to protect a brand when counterfeiting or diversion case becomes imminent?
  • What are some of the proactive measures that food companies can take to ensure that they have legal avenues?
  • What patent and trademark strategies should companies have in place?

5:00
Conference Adjourns to Day Two

Day 2 - Thursday, May 25, 2017

8:00
Registration and Continental Breakfast
8:45
Co-Chairs’ Remarks and Recap of Day One
9:00
Class Action Litigation and Prop 65: Anticipating the Next Wave of Litigation in Order to Mitigate Risk

Anthony Anscombe
Partner
Sedgewick LLP

Trenton H. Norris
Partner
Arnold & Porter Kaye Scholer LLP

Allyson Wilcox
Assistant General Counsel
Beam Suntory Inc.

  • Addressing undefined claims that are creating the potential for class action litigation in the food industry
    • Assessing litigation and risks associated with words: “natural,” “wholesome,” “real”
  • Exploring the pitfalls of “Made in USA” claims under the federal standard and the new California statute
    • Survey of various court decisions
  • Evaluating a potential increase in consumer fraud litigation associated with terms: “fresh,” “gluten free,” “organic”
  • Reviewing the issue of “non-functional slack fill” in food packaging
    • Comparing class action and regulatory enforcement action risks
  • Examining whether sugar will be at the center of the next wave of this type of litigation
  • Drawing parallels between current interest in sugar and prior litigation against tobacco industry – similarities and differences? What’s been learned in the tobacco litigation
    that might apply to current sugar litigation?
  • Reviewing recent developments under California’s Proposition 65
    • Lead and the regulatory response to the Beech-Nut decision
    • Bisphenol A warnings
    • New listings and new safe-harbor warning regulations
  • Examining first amendment protection for food labeling
    • What are the defenses and how might they be presented in the context of food labeling?
  • Addressing class certification and ascertainability challenges
    • Even if Plaintiffs get past a motion to dismiss, what defenses are available to defense attorneys?
  • Developing strategies for effectively responding to claims letters
    • Understanding when no response is the best response

10:00
Morning Coffee Break
10:15
Ensuring Compliant Use of the Terms: “Organic,” “Natural,” and “All Natural”

Jo E. Osborn
Vice President & Assistant General Counsel
TreeHouse Foods Inc.

Miriam Maxwell
Senior Principal Regulatory Scientist, Corporate Scientific and Regulatory Affairs
Ocean Spray Cranberries, Inc.

Corey L. Gordon
Partner
Blackwell Burke P.A.

Use of the terms “non-GMO,” “natural,” “all natural” has caused considerable amount of confusion. This session will explore risk assessment associated with the use of these terms in the absence of the FDA definition.

11:15
Allergen Recall Conundrum: Devising Corrective Behaviors That May Prevent Necessity of a Recall

Tracey Phillips Beck
Vice President, Chief Counsel —Marketing, & Gov’t Affairs
Conagra Brands, Inc.

Maureen English Carroll
Associate General Counsel, Regulatory
Post Holdings, Inc.

  • Review of allergen requirements under FSMA and other applicable law
  • Devising methods to fill the knowledge gap which testing doesn’t always provide
    • Contamination from soy and dairy inside facilities and dealing with bad results
  • Using experts effectively for allergen identification and recall process
  • In-house counsel strategies for allergen recall
    • What is the reasonable timeline?
    • When should FDA be contacted?
  • Weighing the benefits between making “free of” claim vs. making no claim at all

12:00
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

May 23, 2017 1:45pm - 4:15pm

$600

Speakers

Diane J. Romza-Kutz
Partner
Thompson Coburn LLP

What is it about?

With new administration, the interplay between agencies and regulatory enforcement activity hang in the balance. This session will examine current interplay in jurisdiction of these various agencies as well as assessments for an increase in power of state and local authorities in absence of federal enforcement and regulations. Points of discussion will include:

 

  • Understanding how the responsibilities and jurisdiction of FDA, USDA, FTC and local health agencies intersect and overlap
  • Deciphering the organizational structure of each agency and their respective roles in food regulation
    • DHHS: FDA – CFSAN (Center for Food Safety and Applied Nutrition); (ODSP) Office of Dietary Supplement Programs; CDC (Center for Disease Control)
    • USDA – FSIS (Food Safety Inspection Service), AMS (Agriculture Marketing Service), APHIA (Animal Plant Health Inspection Service)
    • FTC – Bureau of Consumer Protection
    • State and local health agencies
  • Defining the scope of each agency’s jurisdiction and authority
  • Examining how each agency exercises its jurisdiction and regulatory authority
    • Enforcement
  • Addressing preemption challenges with state and local authorities
    • Understanding when federal laws preempt state regulation
    • Examining how state authorities exercise their authority despite preemption
  • If federal enforcement declines, will state and local authorities fill the gap?

Claims Substantiation Master Class

May 25, 2017 1:00pm - 4:00pm

$600

Speakers

Jonathan W. Emord
Principal
Emord & Associates, P.C.

Jessica P. O’Connell
Special Counsel
Covington & Burling LLP

Jessica Campbell
Senior Counsel
Tyson Foods, Inc.

What is it about?

  • Understanding the importance of developing a global claims substantiation compliance program
  • Review of claim substantiation standards
  • The art of designing the right study to back your claim
  • Identifying implied claims and identifying hidden dangers
  • Review of promotional activities across various media outlets and social media platforms which have raised red flags with government enforcers and consumer watch-dog groups

ElitePass – Both Workshops

$1,000