Food Law & Regulation Boot Camp - WEB

July 19–20, 2023 (CST) | Virtual Conference

American Conference Institute’s

Food Law & REGULATION BOOT CAMP

Basic Training on Essential Legal and Regulatory Requirements for the Food Industry

Preeminent Members of The Food Law Bar Will Drill You In The Essentials

Of Food Law And Regulation And Help You:

‰ UNDERSTAND the structure, responsibilities, jurisdiction and interplay of FDA, USDA, FTC and local health agencies relative to food

‰ COMPREHEND the GRAS process and its role in the premarket and approval process for food additives

‰ DISTINGUISH the differences and nuances between food “labeling” and the “label”

‰ DECIPHER the components of the revised Nutrition Facts Label, New Guidances for Allergen Labelling and the impact of the New Definition of “Healthy” on labels

‰ IDENTIFY proofs required to substantiate product claims in food advertising and promotion under FDA and FTC expectations

‰ MASTER the critical principles of food safety protocols

‰ NAVIGATE FSMA and related Final Rules relative to cGMPS, inspections, imports, recalls and more

Distinguished Conference Chairs: Veronica Colas Counsel Hogan Lovells LLP Sharon Mayl Partner DLA Piper

Join us for Pre and Post Conference

Workshops:

Pre-Conference Workshop

Food Law and Regulation

Fundamentals: An Essential Primer on Applicable Laws and Governing Agencies Having Authority Over Food

Post-Conference Workshop

Food Legal and Regulatory Essentials

2.0: A Guide to Plant-Based and Cell-Cultured Food Products

Food and Food Ingredient Classification…GRAS…food labeling requirements as opposed to the actual food label… marketing and promotion… food safety regulations…FSMA… cGMPs… imports… inspections…recalls… all are critical aspects of the food commercialization process and all in some way are governed by an agency troika consisting of FDA, USDA and FTC.

The passage of new laws and the implementation of new regulations concerning food as well as high profile laws suits, and related controversies have made it abundantly clear that it is essential for attorneys who do not have regulatory practices — but who deal with food products — to have an intimate familiarity with these topics and agency protocols. The changing business dynamics of the food and beverage industry have also made it critical for business executives, policy analysts and securities experts who work with food to have a greater working knowledge of key regulatory concepts as well as the applicable governing agencies.

Boost Your Food and Beverage Regulatory IQ

Learn the regulatory essentials as well as the “ins and outs” of the administrative bodies which govern them.

We have developed this program to specifically provide a forum for in-house counsel and executives as well as private practice lawyers working for the food industry to obtain the essential regulatory knowledge which is critical to their practice. This conference’s distinguished faculty is comprised of the “who’s who” of the food and beverage regulatory bar who will provide instruction and insights on the laws and regulations governing:

į Food ingredients and additives

į GRAS

į Labeling regulations

į Product labels including the revised Nutrition Facts Label

į Marketing and advertising

į Food safety essentials and FSMA

į cGMPs

į Food imports

į Inspections

į Recalls

Attend the pre and/or post- conference workshops to get the necessary background and in-depth information you need to maximize your learning

WORKSHOP A Food Law and Regulation Fundamentals: An Essential Primer on Applicable Laws and Governing Agencies Having Authority Over Food

WORKSHOP B Food and Beverage Legal and Regulatory Essentials 2.0: A Guide to Plant-Based and Cell-Cultured Food

Attend this conference and learn to navigate your way through the regulatory maze that plays such a crucial part in your cases, practice areas and business.

Connect the dots of food regulatory law and gain a clear understanding of how the FDA, USDA, and FTC work together to regulate the food industry.

Meet Our Faculty

DISTINGUISHED CO-CHAIRS

Veronica Colas Counsel

Hogan Lovells LLP

ESTEEMED SPEAKERS

Madeline Cohen Senior Regulatory Attorney The Good Food Institute

Timothy Dietrich Partner Barley Snyder LLP

Daniel Dwyer Partner

Kleinfeld Kaplan & Becker LLP

Miriam Guggenheim Partner

Covington & Burling LLP

Bob Hibbert Senior Counsel

Wiley Rein LLP

John Johnson Senior Counsel

Shook Hardy & Bacon LLP

Sharon Mayl Partner

DLA Piper

WHO YOU WILL MEET:

In-house counsel, officers and directors for Food Manufacturers, Retailers, Distributors, Suppliers, Servers and Restaurants counsel, having responsibility for:

‰ Regulatory Affairs

‰ Government Affairs

Kristen R. Klesh Partner

Loeb & Loeb LLP

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

Claudia A. Lewis Partner Venable LLP

Andrew Lustigman Partner

Olshan, Frome, Wolosky LLP

Brandon Neuschafer Partner

Bryan Cave

Meredith Quinn Olearchik

Vice President & Associate General Counsel

Campbell Soup Co

Stuart Pape Partner Polsinelli

Evangelia (Eve) Pelonis Partner

Keller & Heckman

Justin Prochnow Partner

Greenberg Traurig LLP

Kristi Wolff Partner

Kelley Drye & Warren LLP

Nury Yoo Partner

Faegre Drinker Biddle & Reath LLP

‰ Litigation

‰ IP

‰ Compliance

‰ Business Development

‰ Securities

Attorneys practicing in the following areas and industries:

‰ FDA Law

‰ Food Law

‰ Food & Beverage

‰ Consumer Products

PRE-CONFERENCE WORKSHOP A

Tuesday, July 18

2:00–4:30 pm (CST)

Food Law, Regulation and Agency Fundamentals: An Essential Primer on Applicable Laws and Governing Agencies having Authority Over Food

microphone-alt Kristi Wolff, Partner, Kelley Drye & Warren LLP

Kristen R. Klesh, Partner, Loeb & Loeb LLP

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)

ƒ National Institutes of Health (NIH)

ƒ 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

MAIN CONFERENCE DAY ONE

Wednesday, July 19 (CST)

8:15

Co-Chairs’ Opening Remarks

microphone-alt 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

microphone-alt 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

microphone-alt 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

microphone-alt 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

A Practical Guide to The Revised Nutrition Facts Label

microphone-alt 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

microphone-alt Veronica Colas, Counsel, Hogan Lovells LLP

Kristen R. Klesh, Partner, Loeb & Loeb 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

1:45

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

microphone-alt 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

microphone-alt 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

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

MEDIA PARTNER:

MAIN CONFERENCE DAY TWO

Thursday, July 20 (CST)

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

microphone-alt 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

microphone-alt 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.

microphone-alt 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

microphone-alt 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

POST-CONFERENCE WORKSHOP B

Thursday, July 20

1:30–4:30 pm (CST)

Food and Beverage Legal and Regulatory Essentials 2.0: A Comprehensive Guide to Plant-Based and Cell-Cultured Food Products

microphone-alt Madeline Cohen, Senior Regulatory Attorney, The Good Food Institute

Bob Hibbert, Senior Counsel, Wiley Rein LLP

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

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Accreditation will be sought in those jurisdictions requested by the registrants which have continuing education requirements. This course is identified as nontransitional for the purposes of CLE accreditation.

ACI certifies this activity has been approved for CLE credit by the New York State Continuing Legal Education Board.

ACI certifies this activity has been approved for CLE credit by the State Bar of California.

ACI has a dedicated team which processes requests for state approval. Please note that event accreditation varies by state and ACI will make every effort to process your request.

For more information on ACI’s CLE process for virtual events visit: www.americanconference.com/accreditation-instructions-for-virtual-attendance/

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