American Conference Institute's 4th Food Law & Regulation Boot Camp - DS

Distinguished Co-Chairs:

Suzie Trigg Partner

Haynes & Boone LLP

July 17–18, 2024 | Virtual (CST)

American Conference Institute’s 4th

Food Law & REGULATION BOOT CAMP

Ashish Talati Founding Member Talati Law Firm

Join us for Pre- and Post-Conference Workshops

Pre-Conference Workshop – July 16:

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

Post-Conference Workshop – July 18:

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

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:

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

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

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

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

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

Š MASTER the critical principles of food safety protocols

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

ACI’s Food Law and Regulation Boot Camp serves as the training grounds for food law attorneys and executives to master the fundamentals of FDA, USDA, FTC and local health agency regulations governing the food industry.

Our virtual program has established itself as an essential, in-depth primer for attorneys and executives who work with or for food companies — whether you are a new practitioner, or a more established practitioner who is new to the food industry. This comprehensive training will include practical realworld examples that will help you to excel in your everyday practices.

Join us this July to benefit from the tutelage of the nation’s leading food law practitioners and walk away with a mastery of the fundamentals of food law, regulation and compliance including critical insights on:

į The interplay of FDA, USDA, FTC and local health agencies relative to food

į The GRAS process and its role in the premarket and approval process for food additives

į The ins and outs of food labeling laws and the components of a compliant label

į The impact of the FDA’s new definition of “healthy” on labels and new guidance on Allergen labelling

į Proofs required to substantiate product claims in food advertising and promotion under FDA and FTC expectations

į The critical principles of food safety protocols

į Best practices for food importing, inspections and product recalls and detentions

Continuing

Legal Education Credits

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.

Questions about CLE credits for your state? Visit our online CLE Help Center at www.AmericanConference.com/Accreditation/CLE/ EARN CLE CREDITS

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.

Speaker Faculty

DISTINGUISHED CO-CHAIRS:

Suzie Trigg Partner

Haynes & Boone LLP

ESTEEMED SPEAKERS:

Timothy Dietrich Partner

Barley Snyder LLP

Adam Ekonomon Vice President and Deputy General Counsel, Marketing & Advertising

The J.M. Smucker Company

Benjamin L. England

Founding Member/ CEO

Benjamin L. England & Associates, LLC

Bob Hibbert Senior Counsel Wiley Rein LLP

John F. Johnson III Senior Counsel

Shook Hardy & Bacon LLP

Ashish Talati Founding Member Talati Law Firm

Kristen R. Klesh Partner

Loeb & Loeb LLP

Riette van Laack Partner

Hyman, Phelps & McNamara, P.C.

Andrew Lustigman Partner

Olshan, Frome, Wolosky LLP

Sharon Mayl Partner

DLA Piper LLP

Brandon Neuschafer Partner

Arnold & Porter LLP

Justin J. Prochnow Shareholder

Greenberg Traurig, LLP

Alan Pryor Partner

Alston & Bird LLP

Meredith Quinn Olearchik

Vice President & Associate General Counsel Campbell Soup Co.

Rachel D. Spiegel Partner

Faegre Drinker Biddle & Reath LLP

Jasmine Wetherell Partner

Perkin Coie LLP

Kristi Wolff Partner

Kelley Drye & Warren LLP

Pre-Conference Workshop

Tuesday, July 16, 2024 (CST)

WORKSHOP A  1:00PM–4:00PM

Food

Law and Regulation

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

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

John F. Johnson III, Senior Counsel, Shook Hardy & Bacon 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

Wednesday, July 17, 2024 (CST)

8:15am

Co-Chairs’ Opening Remarks

Microphone-alt Suzie Trigg, Partner, Haynes & Boone LLP

Ashish Talati, Founding Member, Talati Law Firm

8:30am

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

Brandon Neuschafer, Partner, Arnold & Porter LLP

Alan Pryor, Partner, Alston & Bird LLP

• 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

9:30am

FDA

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

Microphone-alt Suzie Trigg, Partner, Haynes & Boone LLP

• 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

10:00am Morning Refreshment Break

10:15am

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

Microphone-alt Rachel D. Spiegel, Partner, Faegre Drinker Biddle & Reath LLP

• Defining “labeling” and the “label”

» 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

» 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

11:15am

A Practical Guide to The Revised Nutrition Facts Label

Microphone-alt

Jasmine Wetherell, Partner, Perkin Coie 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

11:45am

Label Bonus Round:

Examining the FDA’s New Proposed Rule on Healthy and Allergen Label Guidance

Microphone-alt Riette van Laack, Partner, Hyman, Phelps & McNamara, P.C.

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 Guidance 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 guidance

Label Status Updates on:

• Bioengineered/ GMO

• Organic

• Gluten-free

• Natural

12:45pm Lunch Break

1:45pm

Food Marketing, Advertising and Promotion Essentials: Ensuring Claims Compliancy and Meeting Substantiation

Standards Relative to Health, Nutrition, Structure and Function

Microphone-alt Andrew Lustigman, Partner, Olshan, Frome, Wolosky LLP

Adam Ekonomon, Vice President and Deputy General Counsel, Marketing & Advertising, The J.M. Smucker Company

• 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 premarket 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

2:45pm Afternoon Refreshment Break

3:00pm

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

Microphone-alt Meredith Quinn Olearchik, Vice President & Associate General Counsel, Campbell Soup Co.

• 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

4:00pm

Food Safety Modernization Act: An Overview of the Law, Subsequent FDA Guidance and Common Compliance Pitfalls to Avoid

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 Guidance 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 Guidance for FSMA Compliance

5:00pm Day 1 Adjourns

With conferences in the United States, Canada, Latin America and Europe, the C5 Group of Companies: American Conference Institute, Canadian Institute, and C5 Group, provides a diverse portfolio of conferences, events and roundtables devoted to providing business intelligence to senior decision makers responding to challenges around the world.

Don’t miss the opportunity to maximize participation or showcase your organization’s services and talent. For more information please contact us at: SponsorInfo@AmericanConference.com

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Thursday, July 18, 2024 (CST)

8:15am

Co-Chairs’ Remarks and Recap of Day 1

Microphone-alt Suzie Trigg, Partner, Haynes & Boone LLP

Ashish Talati, Founding Member, Talati Law Firm

8:30am

Current Good Manufacturing Practices (cGMPs):

Understanding their Unique Role in Food Safety Requirements

• 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

9:15am

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

10:15am Morning Refreshment Break

10:30am

Food Imports: Analyzing Safety Requirements Pursuant to FDA’s Final Guidance on Foreign Supplier Verification Programs (FSVPs)

Microphone-alt Benjamin L. England, Founding Member/CEO, Benjamin L. England & Associates, LLC

Sharon Mayl, Partner, DLA Piper LLP

On January 11, 2023, FDA released its final guidance on foreign supplier verification program (FSVP) requirements for importers of food for humans and animals. This session will provide an overview of the laws and regulations relative to food imports in the U.S, as well as an analysis of the core elements and notable changes reflected in FDA’s final guidance on FSVPs.

• 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/export activity outside the US

• Analyzing the requirements of the Final FSVP Rule, as well as FDA’s 2018 guidance intended to help importers develop and implement an FSVP

• Examining FDA’s recent Final Guidance on FSVPs, including clarification on issues such as:

» The FSVP “importer” definition and the scope of FDA’s FSVP requirements;

» FDA’s enforcement discretion policies;

» FSVP compliance, approval, and verification requirements;

» FSVP documentation and audit procedures;

» Requirements regarding hazard analysis, hazard reports, and controls for identified hazards

» FSVP requirements for importers of dietary supplements

• Identifying circumstance under which a foreign supplier verification program is required and when it is not

11:30am

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

Microphone-alt Justin

J. Prochnow, Shareholder, Greenberg Traurig, LLP

• 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

12:30pm Main Conference Adjourns

Post-Conference Workshop

Thursday, July 18, 2024 (CST)

WORKSHOP B  1:30PM–4:30PM

Food and Beverage Legal and

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

Microphone-alt 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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