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Pre-Conference Workshop

Workshop A – Food Law and Regulation Fundamentals: An Essential Primer on Applicable Laws and Governing Agencies Having Authority over Food

Jul 18, 2023 1:30pm – 04:30 PM

Speakers

Kristen R. Klesh
Partner
Loeb & Loeb LLP

Kristi Wolff
Partner
Kelley Drye & Warren LLP

Day 1 - Wednesday, July 19, 2023

7:15
Registration and Continental Breakfast
8:15
Co-Chairs’ Opening Remarks
8:30
Navigating Key Regulatory Agencies for the Food Industry: Comprehending the Jurisdiction, Function, Organization and Interplay of the FDA, USDA, FTC and Local Health Agencies
9:15
FDA Food and Food Ingredient Classification: Examining GRAS, Premarket Review and the Approval Process for Food Additives
10:00
Morning Coffee Break
10:15
An Overview of Food Labeling Laws, Regulations, and the Components of a Compliant Label
11:15
A Practical Guide to The Revised Nutrition Facts Label
11:45
Label Bonus Round: Examining the FDA’s New Proposed Rule on Healthy and Allergen Label Guidance
12:45
Networking Luncheon
1:45
Food Marketing, Advertising and Promotion Essentials: Ensuring Claims Compliancy and Meeting Substantiation Standards Relative to Health, Nutrition, Structure and Function
2:45
Afternoon Coffee Break
3:00
FDA and USDA Food Safety Regulations 101: Preventing Adulteration and Contamination
4:00
Food Safety Modernization Act: An Overview of the Law, Subsequent FDA Guidances and Common Compliance Pitfalls to Avoid
5:00
Conference Adjourns to Day Two

Day 2 - Thursday, July 20, 2023

8:15
Co-Chairs’ Remarks and Recap of Day 1
8:30
Current Good Manufacturing Practices (cGMPs): Understanding their Unique Role in Food Safety Requirements
9:15
Inspections: What to Do if the Government Shows Up at Your Door
10:15
Morning Coffee Break
10:30
Understanding the Requirements for Importing Food into the U.S.
11:30
Recalls and Detentions: Understanding the Scope of FDA and Related Agencies’ Authority
12:30
Conference Ends

Post-Conference Workshop

Workshop B – Food Legal and Regulatory Essentials 2.0: A Guide to Plant-Based and Cell-Cultured Food Products

Jul 20, 2023 1:30pm – 05:30 PM

Speakers

Madeline Cohen
Senior Regulatory Attorney
The Good Food Institute

Bob Hibbert
Senior Counsel
Wiley Rein LLP

Day 1 - Wednesday, July 19, 2023

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

Veronica Colas
Counsel
Hogan Lovells LLP

Sharon Mayl
Partner
DLA Piper

8:30
Navigating Key Regulatory Agencies for the Food Industry: Comprehending the Jurisdiction, Function, Organization and Interplay of the FDA, USDA, FTC and Local Health Agencies

John Johnson
Senior Counsel
Shook Hardy & Bacon LLP

Evangelia (Eve) Pelonis
Partner
Keller & Heckman

  • 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
    • labeling
    • marketing, promotion and advertising
    • product recalls
  • Examining how each agency exercises its jurisdiction and regulatory authority
    • rule making
    • product decisions
    • enforcement
  • Exploring proposed changes at FDA for the Human Food program
  • Addressing preemption challenges between state and local authorities
    • understanding when federal laws preempt state regulation
    • examining how state authorities exercise their authority despite preemption

9:15
FDA Food and Food Ingredient Classification: Examining GRAS, Premarket Review and the Approval Process for Food Additives

Stuart Pape
Partner
Polsinelli

  • Defining food, food ingredients and food additives
  • Exploring the GRAS process and understanding its role in the premarket and approval process for food additives
  • Distinguishing GRAS classification made through scientific procedures vs. food additive safety determinations made by a sponsor
  • Understanding when a GRAS determination can be made based on “common use in food”
  • How to outline a substance’s intended condition of use in the food product

10:00
Morning Coffee Break
10:15
An Overview of Food Labeling Laws, Regulations, and the Components of a Compliant Label

Riëtte van Laack
Director
Hyman, Phelps, & McNamara, P.C.

  • 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

11:15
A Practical Guide to The Revised Nutrition Facts Label

Nury Yoo
Partner
Faegre Drinker Biddle & Reath LLP

In 2016, the FDA overhauled the Nutrition Facts label and gave most large Food manufacturers until 2022 to comply with the new requirements. This session will explain what the new label requires and some still outstanding points of controversy.

  • Percent daily value classifications
  • Serving size revisions
  • Sugar and fat content information
  • Nutrient updates

11:45
Label Bonus Round: Examining the FDA’s New Proposed Rule on Healthy and Allergen Label Guidance

Veronica Colas
Counsel
Hogan Lovells LLP

FDA’s New Proposed Rule on Healthy

  • Comparing the current definition of healthy to the definition under the proposed new Rule
  • Understanding how the definition of healthy under the proposed new Rule would affect food labels
  • Examining the “specific nutrient-related criteria to use the nutrient content claim “healthy” under the proposed new Rule
  • Exploring how the new definition would expand the healthy food category

FDA’s New Guidances on Allergen Labeling requirements

  • Analyzing the FDA’s two new guidance documents on Allergen Labeling requirements – what are the differences:
  • Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5): Guidance for Industry
    • Draft Guidance
    • Final Guidance
  • Examining ingredients on the new allergen list under the guidances

Label Status Updates on:

  • Bioengineered/ GMO
  • Organic
  • Gluten-free
  • Natural

12:45
Networking Luncheon
1:45
Food Marketing, Advertising and Promotion Essentials: Ensuring Claims Compliancy and Meeting Substantiation Standards Relative to Health, Nutrition, Structure and Function

Miriam Guggenheim
Partner
Covington & Burling LLP

Andrew Lustigman
Partner
Olshan, Frome, Wolosky LLP

  • Examining the relationship between the food product label and advertising and promotion
  • Distinguishing “claims made” from “claims substantiated”
  • Understanding what you can and cannot say in food advertising and promotion
  • Overview of food product claims and the regulatory requirements for making each:
    • nutrient and health
    • structure/function – dietary supplements vs. conventional foods
    • mental performance and focus
    • disease
    • comparative
    • calories/ingredients
  • Distinguishing FDA and FTC jurisdiction and authority relative to claims substantiation in food advertising and promotion
  • Identifying proofs required to substantiate product claims under FDA and FTC expectations
    • clinical studies
    • scientific evidence and testing
    • consumer surveys
    • taste and internal expert panels
    • market research firms
  • When are social media and websites can be viewed as a means of advertising and promotion
  • Understanding what recent enforcement actions reveal about food and beverage 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
  • Assessing when health claims for a food product which have 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

2:45
Afternoon Coffee Break
3:00
FDA and USDA Food Safety Regulations 101: Preventing Adulteration and Contamination

Meredith Quinn Olearchik
Vice President & Associate General Counsel
Campbell Soup Co

Justin Prochnow
Partner
Greenberg Traurig LLP

  • Overview of essential food safety regulations
  • Defining “adulteration” and “adulterants” under the FDCA and the Federal Meat Inspection Act
    • poisonous or deleterious substances
    • added vs. non-added substances
    • chemical contaminants and carcinogens
    • filth and extraneous materials
    • pesticides
    • metals
  • Update on STECs and E. coli prevention protocols
  • Differentiating allergens from pathogens
    • understanding how they differ
    • FDA vs. USDA
  • 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
4:00
Food Safety Modernization Act: An Overview of the Law, Subsequent FDA Guidances and Common Compliance Pitfalls to Avoid

Daniel Dwyer
Partner
Kleinfeld Kaplan & Becker LLP

The Food Safety Modernization Act (FSMA) is one of the most sweeping laws in the history of FDA and dramatically changed food safety standards. FSMA shifted the focus of food safety from a reactionary approach to a preventative one. This session will provide an in-depth overview of the FSMA as well as significant subsequent FDA Guidances and common compliance pitfalls to avoid.

  • 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
  • An overview of relevant FDA Guidances for FSMA Compliance

5:00
Conference Adjourns to Day Two

Day 2 - Thursday, July 20, 2023

8:15
Co-Chairs’ Remarks and Recap of Day 1

Veronica Colas
Counsel
Hogan Lovells LLP

Sharon Mayl
Partner
DLA Piper

8:30
Current Good Manufacturing Practices (cGMPs): Understanding their Unique Role in Food Safety Requirements

Claudia A. Lewis
Partner
Venable LLP

  • Defining cGMPs and the scope of their importance to food commercialization
  • Understanding how cGMPs factor into the scope and authority of the FDA
  • Changes to food cGMPs under FSMA’s Preventive Controls for Human Food Final Rule
  • Deciphering HACCP/ HARPC applicability as per the rule and its relationship with cGMP compliance
  • Validation and proofs of preventative controls
  • Examining requirements for qualified individuals

9:15
Inspections: What to Do if the Government Shows Up at Your Door

Timothy Dietrich
Partner
Barley Snyder LLP

  • Examining 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
    • how to prep your records and employees for an inspection
    • how to handle a “surprise” inspection
    • how to respond to agent’s requests on-site
    • distinguishing a valid investigation from a fishing expedition and how your staff should react to each
  • 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

10:15
Morning Coffee Break
10:30
Understanding the Requirements for Importing Food into the U.S.

Sharon Mayl
Partner
DLA Piper

Foods imported into the U.S. must meet the same requirements as foods produced domestically. Because U.S. regulatory agencies cannot inspect foreign facilities at the same rate as domestic facilities, the oversight tools differ. This session will help you understand what it takes to legally import food into the country, including:

  • Overview of laws and regulations relative to food imports in the U.S.
  • Understanding how the FDA USDA and other US regulatory bodies ensure compliance with U.S. law
  • Analyzing the requirements of the Final FSVP Rule, including issues covered in FDA’s January 11, 2023 final FSVP guidance document such as:
    • The definitions of “FSVP importer” and “foreign supplier”
    • FDA’s enforcement discretion policies;
    • Requirements regarding hazard analysis and supplier verification activities;
    • FSVP documentation and audit procedures;
    • Consequences for non-compliance
  • Hearing about other FSMA import programs
  • Learning about the import process at the border

11:30
Recalls and Detentions: Understanding the Scope of FDA and Related Agencies’ Authority

Brandon Neuschafer
Partner
Bryan Cave

  • Exploring FDA’s recall and detention authority and how this changed under FSMA
  • Tips on how to effectively remove products from the marketplace 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

12:30
Conference Ends

Workshop A – Food Law and Regulation Fundamentals: An Essential Primer on Applicable Laws and Governing Agencies Having Authority over Food

Jul 18, 2023 1:30pm – 04:30 PM

Kristen R. Klesh
Partner
Loeb & Loeb LLP

Kristi Wolff
Partner
Kelley Drye & Warren LLP

What is it about?

This primer will provide attendees with an essential an in-depth working knowledge of the cornerstone laws and regulations applicable to food 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 laws, regulation and governance of food and related products.

  • Defining the terms “food” and “beverage” as per the Food, Drug and Cosmetic Act
  • Overview of governing agencies having jurisdiction and authority over food regulation
  • Understanding the role of the Department of Health and Human Services in food regulation
    • U.S. Food and Drug Administration (FDA)
      • National Institutes of Health (NIH)
      • Center for Disease Control (CDC)
  • Review of applicable laws from which FDA derives its authority over food regulation
    • Food, Drug, and Cosmetics Act (FDCA)
    • Fair Packaging and Labeling Act
    • Food Safety Modernization Act (FSMA)
  • Comprehending the U.S. Department of Agriculture’s (USDA’s) authority in food regulation and how it compares to that of FDA’s authority
    • Food Safety and Inspection Service
  • Review of applicable laws from which USDA derives its authority over food regulation
    • Meat, Poultry, and Egg Products Inspection Acts
    • Egg Products Inspection Act
    • Federal Meat Inspection Act
    • Poultry Products Inspection Act
  • Appreciating the FTC’s unique role in food regulation
    • Federal Trade Commission Act
    • The Lanham Act
  • Identifying other applicable agencies responsible for food regulation
    • 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

Workshop B – Food Legal and Regulatory Essentials 2.0: A Guide to Plant-Based and Cell-Cultured Food Products

Jul 20, 2023 1:30pm – 05:30 PM

Madeline Cohen
Senior Regulatory Attorney
The Good Food Institute

Bob Hibbert
Senior Counsel
Wiley Rein LLP

What is it about?

This unique workshop will take your knowledge of food and beverage law to the next level by addressing cutting edge topics which will greatly impact the future of the laws and regulations governing food. Outside influences from social movements to dietary trends to scientific advancements have put such matters as plant-based meats and milks, and now cell-cultured meats into the spotlight.

Our workshop leaders will address these topics and to familiarize you with this next wave of regulatory essentials as well as provide a status report on some other novel legal and regulatory food concepts. Points of discussion will include:

Plant-Based “Meats” and “Milks”: Examining the Standards of Identity

  • Exploring the latest developments on standards of identity for:
    • Plant-based “meat” products
    • Plant-based dairy alternatives
  • Analyzing the new FDA proposed guidance on plant-based milks and how it will impact the market
  • Analyzing the various states’ approaches to plant-based “meats” and “milks”
    • Questions of preemption
  • Understanding the process for developing and labeling of protein-alternative foods
  • Exploring labelling and usage requirements by plant-based food companies

Cell Cultivated Meat, Alternative Proteins, Precision Fermentation

This past fall, the FDA gave the first go ahead for a company to move forward on animal cellular technology for human food. This significant step opens the door for a new era of food, and a starting point for a brand new food product sector. This panel will cover this breaking development and several others.

  • Understand the industry significance of FDA’s First (2022) Pre-Market Consultation for Human Food Made Using Animal Cell Culture Technology, and subsequent Pre-Market Consultation in 2023
  • Take stock of recent developments regarding the GRAS Pathway and Pre-market Consultations for Novel Food Ingredients
  • Understand the industry significance of GRAS Notifications for alternative proteins and use of precision fermentation