Day 1 - Monday, November 13, 2017

Pre-Conference Workshop A – Food Law and Regulation Fundamentals: An Essential Primer on Applicable Laws and Governing Agencies Having Authority Over Food

Nov 13, 2017 9:00am - 11:59am

Speakers

Trenton H. Norris
Partner
Arnold & Porter Kaye Scholer LLP (San Francisco, CA)

Jason W. Sapsin, JD, MPH
Counsel
Faegre Baker Daniels LLP (Boulder, CO)

12:00
Registration Opens
1:15
Co-Chairs’ Opening Remarks
1:30
Navigating Key Regulatory Agencies for the Food Industry: Comprehending the Jurisdiction, Function, Organization and Interplay of the FDA, USDA, FTC and Local Health Agencies
2:15
FDA Food and Food Ingredient Classification: Examining GRAS, Premarket Review and the Approval Process for Food Additives
3:00
Networking Break
3:15

Of Food Labeling and Food Labels

An Overview of Food Labeling Laws, Regulations, and the Components of a Compliant Label
4:00
A Practical Guide to The New Nutrition Facts Label
5:00
Conference Adjourns to Day Two

Day 2 - Tuesday, November 14, 2017

7:45
Registration and Continental Breakfast
8:30
Food Marketing, Advertising and Promotion Essentials: Ensuring Claims Compliance and Meeting Substantiation Standards Relative to Health, Nutrition, and Structure/Function Claims
9:30
FDA and USDA Food Safety Regulations 101: Preventing Adulteration and Contamination
10:30
Morning Coffee Break
11:00
Food Safety Modernization Act: An Overview of the Law, Related Final Rules and Implementation Timelines
2:00
Inspections in the Age of FSMA: What to Do if the Government Shows Up at Your Door
3:00
Afternoon Networking Break
3:30
Food Imports: New Safety Requirements Under FSMA’s Foreign Supplier Verification Programs (FSVP) Final Rule
4:30
Recalls and Detentions: Understanding the Scope of FDA and Related Agencies’ Authority Under FSMA
5:30
Conference Ends

Day 1 - Monday, November 13, 2017

12:00
Registration Opens
1:15
Co-Chairs’ Opening Remarks

Ebru Basaran-Shull
Director, Compliance and Government Affairs
Sargento Foods Inc. (Plymouth, WI)

Jason W. Sapsin, JD, MPH
Counsel
Faegre Baker Daniels LLP (Boulder, CO)

1:30
Navigating Key Regulatory Agencies for the Food Industry: Comprehending the Jurisdiction, Function, Organization and Interplay of the FDA, USDA, FTC and Local Health Agencies

Jeanine Flaherty, MPH
Executive Director of Food Safety, Quality & Regulatory Compliance
Legal Sea Foods, LLC (Boston, MA)

Anna K. Kakos
Managing Director, Corporate Counsel
Starbucks Corporation (Seattle, WA)

Christianna M.L. Reed
Vice President and General Counsel, Legal and Risk Management
Chicken of the Sea Int’l. (El Segundo, CA)

Georgia Ravitz
Partner
Arent Fox LLP (Washington, DC)

  • Understanding how the responsibilities and jurisdiction of FDA, USDA, FTC and local health agencies intersect and overlap
  •  Deciphering the organizational structure of each agency
    • 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
    • Labeling
    • Marketing, promotion and advertising
    • Product recalls
  • Examining how each agency exercises its jurisdiction and regulatory authority
    • Rule making
    • Product decisions
    • Enforcement
  • Addressing preemption challenges between state and local authorities
    • Understanding when federal laws preempt state regulation
    • Examining how state authorities exercise their authority despite preemption

2:15
FDA Food and Food Ingredient Classification: Examining GRAS, Premarket Review and the Approval Process for Food Additives

Stuart M. Pape
Head of FDA Practice & Shareholder
Polsinelli P.C. (Washington, DC)

  • Defining food, food ingredients and food additives
  • Exploring the GRAS process and understanding its role and relationship to the food additive process
  • Deciding between GRAS and food additive; advantages and disadvantages of each
  • Establishing “general recognition; ” comparing GRAS classification made through scientific procedures vs. food additive safety determinations
  • Understanding when a GRAS determination can be made based on “history of common use in food”
  • Identifying how to describe a substance’s intended condition of use
  • Clarifying what happens once you file

3:00
Networking Break
3:15

Of Food Labeling and Food Labels

An Overview of Food Labeling Laws, Regulations, and the Components of a Compliant Label

Andrea Bruce
Senior Counsel, Global Regulatory Law
The Hershey Company (Hershey, PA)

Zachary Chapman
Vice President – Corporate Counsel
TreeHouse Foods, Inc. (Oak Brook, IL)

  • Defining “labeling” and the “label”
    • Identifying the role of packaging, package inserts, websites and advertisements relative to the label and to labeling
  • A summary of applicable laws and regulations applicable to food labeling and labels
    • 21 CFR parts 100-199
    • FDCA Chapter IV
    • Fair Packaging and Labeling Act of 1966
  • Identifying the FDA’s responsibility for food labeling and labels
  • Understanding the USDA’s role in food labeling and labels
    • The scope of authority of FSIS and AMS
    • Labels approved under the prior label approval system vs. the generic label approval
  • Defining the product “label”
    • Front-of-pack, information panel, package insert
    • Label requirements – contents, ingredients, allergens
    • How to list label information posted on websites and advertisements
  • How to avoid allegations of misrepresentation and misbranding

4:00
A Practical Guide to The New Nutrition Facts Label

Kelly D. Horton, MS, RD, CSG
North America Policy Director
Mars, Incorporated (Washington, DC)

Riëtte van Laack
Director
Hyman, Phelps, & McNamara, P.C. (Washington, DC)

Last May the FDA unveiled its new Nutrition Facts Label for food. This was the first time the nutrition facts label has been updated and according to the FDA, the purpose of the update was “to reflect new scientific information, including the link between diet and chronic diseases such as obesity and heart disease…[and] to make it easier for consumers to make better informed food choices. This panel will discuss the new label and what the significance of this new label to the industry. Points of discussion include:

 

  • Percent daily value classifications
  • Serving size revisions
  • Sugar and fat content information
  • Nutrient updates
  • Potential changes under the Trump Administration

5:00
Conference Adjourns to Day Two

Day 2 - Tuesday, November 14, 2017

7:45
Registration and Continental Breakfast
8:30
Food Marketing, Advertising and Promotion Essentials: Ensuring Claims Compliance and Meeting Substantiation Standards Relative to Health, Nutrition, and Structure/Function Claims

Adam M. Ekonomon
Vice President and Deputy General Counsel
The J. M. Smucker Company (Orrville, OH)

Miriam J. Guggenheim
Partner
Covington & Burling LLP

  • Overview of food product claims and applicable regulatory requirements
  • Understanding what you can and cannot say in food advertising and promotion
  • Examining the relationship between the food product label and advertising and promotion
  • Distinguishing FDA and FTC jurisdiction and authority relative to claims substantiation in food advertising and promotion
  • Crafting health benefit claims to avoid the risk of FDA deeming the product a drug
  • Identifying proofs required to substantiate product claims under FDA and FTC expectations
  • Ensuring claims compliance on websites and in social media
  • Understanding what recent enforcement actions reveal about food marketing and advertising vulnerabilities
  • Monitoring of food advertising by National Advertising Department of Better Business Bureau (NAD)
  • Exploring Lanham Act challenges relative to false and misleading claims for competitor products

9:30
FDA and USDA Food Safety Regulations 101: Preventing Adulteration and Contamination

Jason W. Sapsin, JD, MPH
Counsel
Faegre Baker Daniels LLP (Boulder, CO)

  • Overview of essential food safety regulations
  • Defining “adulteration” and “adulterants” under the FDCA and the Federal Meat Inspection Act
  • Update on prevention protocols for STECs, E. coli, listeria, and more
  • Differentiating allergens from pathogens
  • How to establish effective food safety guidelines, protocols and screening measures – traceback, HACCP, sanitation SOPs and testing procedures
  • Update on the Reportable Food Registry and how the FDA has used information provided in the Registry to address food safety issues

10:30
Morning Coffee Break
11:00
Food Safety Modernization Act: An Overview of the Law, Related Final Rules and Implementation Timelines

Elizabeth Barr Fawell
Counsel
Hogan Lovells US LLP (Washington, DC)

The Food Safety Modernization Act (FSMA) is one of the most sweeping laws in the history of FDA and dramatically changed food safety standards. The focus of safety is no longer based on
reactionary measures, but rather on preventative actions. This session will provide an in-depth overview of the law as well as its applicable Rules, implementation dates, and a discussion of what has been learned over the last year.

 

  • FSMA Overview
    • Title I – prevention of food safety hazards
    • Title II – detection and response to food safety problems
    • Title III – improving safety of imported food
    • Title IV – Miscellaneous
  • Final FSMA Rules recap
    • Preventive Controls for Human Food Final Rule
    • Preventive Controls for Food for Animals Final Rule
    • Standards for Produce Safety Final Rule
    • Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals Final Rule
    • Accredited Third-Party Certification Final Rule
    • Sanitary Transportation of Human and Animal Food Final Rule
    • Mitigation Strategies to Protect Food Against Intentional Adulteration Final Rule
  • FSMA Rule Implementation dates
  • Understanding how FSMA amends current food safety regulations

 

 

2:00
Inspections in the Age of FSMA: What to Do if the Government Shows Up at Your Door

Timothy G. Dietrich, Esquire
Partner
Barley Snyder, LLP (Reading, PA)

  • Examining new inspection mandates under FSMA
  • Defining the jurisdiction and authority of each agency to conduct inspections – FDA, USDA – FSIS, Department of Public Health
  • Assessing how these agencies work together in the context on an inspection
  • Knowing what the Government will be looking for during an inspection
  • Distinguishing a valid investigation from a fishing expedition and how your staff should react to each
  • Evaluating what has been seen over the last year during the initial implementation
  • Discussing the impact of the change to topic area specialized inspectors
  • 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

3:00
Afternoon Networking Break
3:30
Food Imports: New Safety Requirements Under FSMA’s Foreign Supplier Verification Programs (FSVP) Final Rule

Leslie T. Krasny
Partner
Keller & Heckman LLP (San Francisco, CA)

  • Overview of laws and regulations relative to food imports in the U.S.
  • Understanding how the FDA, USDA and other US regulatory bodies monitor food import activity outside the US
  • Analysis of the Final FSVP Rule and its requirements
    • How has this Rule amended prior import requirements?
  • Examining key definitions under the Final FSVP Rule
    • Who is an importer?
    • Who is a foreign supplier?
    • Who is a U.S. owner or consignee?
  • Deciphering the relationship between the Final FSVP Rule and Preventive Controls for Human Food Final Rule
  • Identifying circumstance under which a foreign supplier verification program is required and when it is not
  • Examining how the FSMA Final Rule on Accredited Third-Party Certification ties to food imports
    • Voluntary Qualified Importer Program (VQIP)
  • Exploring FDA embargo authority for food imports

4:30
Recalls and Detentions: Understanding the Scope of FDA and Related Agencies’ Authority Under FSMA

Claudia A. Lewis
Partner
Venable LLP (Washington, DC)

  • Exploring FDA’s recall and detention authority under FSMA
  • Tips on how to effectively remove products from the market place once an issue is discovered — making the decision when and how to recall
  • Identifying and correcting regulatory and compliance mishaps that led to the recall
  • Working with state and federal government to streamline the recall process
  • Maintaining proper documentation during a recall in anticipation of litigation that may result from the recall
  • Developing a strategy to address publicity issues that arise as the direct result of a recall

5:30
Conference Ends

Pre-Conference Workshop A – Food Law and Regulation Fundamentals: An Essential Primer on Applicable Laws and Governing Agencies Having Authority Over Food

Nov 13, 2017 9:00am - 11:59am

$600

Speakers

Trenton H. Norris
Partner
Arnold & Porter Kaye Scholer LLP (San Francisco, CA)

Jason W. Sapsin, JD, MPH
Counsel
Faegre Baker Daniels LLP (Boulder, CO)

What is it about?

(Registration begins at 8:00 am)

 

This primer will provide attendees with an essential an in-depth working knowledge of the legal and regulatory landscape for food. It will also give an extensive overview of the cornerstone laws as well as the administrative bodies responsible for the regulation of food in the United States.

 

Topics addressed during this workshop will set the stage for the main conference by helping you to thoroughly comprehend the complexities and challenges
associated with the governance and regulation of food and related products.

 

  • Defining the terms “food” and “beverage” as per the Food, Drug and Cosmetic Act
  • Overview of applicable food laws and corresponding agencies responsible for regulation promulgation and enforcement
    • FDA
      • Food, Drug, and Cosmetics Act (FDCA)
      • Fair Packaging and Labeling Act
      • Food Safety Modernization Act (FSMA)
    • USDA
      • Meat, Poultry, and Egg Products Inspection Acts
      • Egg Products Inspection Act
      • Federal Meat Inspection Act
      • Poultry Products Inspection Act
    • FTC
      • Federal Trade Commission Act
      • The Lanham Act
  • Comprehending USDA’s authority in food regulation; how it compares to that of FDA’s authority
    • Food Safety and Inspection Service
  • Understanding the role of the Department of Health and Human Services in food regulation
  • Identifying other applicable agencies responsible for food
    • Department of Commerce
    • Department of Transportation
    • Department of Justice
  • Overview of other laws governing or otherwise impacting the regulation of food products
    • Public Health Service Act
    • Poultry Products Inspection Act
    • Bioterrorism Act
    • Sanitary Food Transportation Act

 

Networking Lunch for Workshop A Attendees only

Post-Conference Workshop B – Food Claims Regulation Master Class: Today’s Consumer Friendly Marketing and What is on the Horizon

Nov 15, 2017 9:00am - 12:00pm

$600

Speakers

Cameron B. Smith
Senior Director, Counsel
Herbalife (Los Angeles, CA)

What is it about?

(Registration Opens at 8:30 pm)

 

This unique workshop will take your knowledge of food to the next level by addressing innovative topics, which will greatly impact the future of the laws and regulations governing food. Outside influences from social movements to dietary demands to scientific advancements have put such matters as natural and organic, GMO and gluten-free into the spotlight. Our workshop leaders will address these topics, familiarize you with the regulatory essentials, and take you through a mock trial of an up-and-coming term. Points of discussion will include:

 

Keeping it Kosher: Understanding the Limits of the Terms Natural, Organic, and GMO

 

Despite, its call for public comment last spring, the FDA has yet to define the term ‘natural’. Instead, the agency has stated that it has “not objected to the use of the term if the food does not contain added color, artificial flavors, or synthetic substances.” As for the term organic, FDA has not defined the term, but has deferred to the authority of USDA through the Natural Organic Program (“NOP”).

 

  • Exploring the significance of the FDA’s call for public comment concerning the term natural
  • Understanding why the FDA continues to be cautious about defining the term natural
    • Positions of other applicable agencies on the term ‘natural’
    • What of the designation of ‘natural’ to products other than food?
  • Assessing when the term ‘natural’ can or cannot be used for food products in light of agency pronouncements
  • Overview of USDA’s NOP program and requirements
  • Defining organic under the NOP program
  • Review of NOP standards
  • What is a GMO?
    • Understanding GMOs relationship to Organic
  • Identifying the FDA and USDA positions on GMOs and GMO labeling
  • Examining the FDA Non-GMO guidance document
  • Discussing the federal legislative measures that have superseded the state legislation on GMO labeling

 

Fresh Terms: Demystifying the Legal Implications of Labels Consumers are Looking for Today

  • Free From Terms: Gluten-Free; Allergen Free; BPA Free; Sugar-Free; Fat Free
    • Overview of the Gluten-Free Food Labeling Final Rule
      • Understanding the importance of voluntary nature of the program
    • Definition of and requirements for gluten and gluten-free food
    • Status of proposed rule on for Gluten-Free Labeling of Fermented or Hydrolyzed Foods
    • The Food Allergen Labeling and Consumer Protection Act of 2004
  • Environmental
  • Animal Welfare Labels
    • Cage-Free
    • Free Range
    • Humane

 

Mock Marketing Pitch Session

 

After a review of the more common terms above and how the different agencies have ruled on them, we will take this information to a mock marketing pitch session. This portion of the workshop will have attendees take the place of a decision-maker at a company and hear both the legal and marketing teams discuss a possible marketing campaign using one of these new hot terms and its possible merits and challenges. After both sides have discussed some possible options, attendees will vote on which option they think is in the best interests of the company. Providing hands-on experience with a real world situation professionals in the field often deal with, this is an excellent opportunity to do a deep dive into the development of these claims and gain deeper understanding of the process from all sides.