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

EARN CLE CREDITS

July 17–18, 2024 | Virtual (CST) American Conference Institute’s 4th

Food Law & REGULATION BOOT CAMP

Basic Training on Essential Legal and Regulatory Requirements for the Food Industry Distinguished Co-Chairs: Suzie Trigg

Partner Haynes & Boone LLP

Ashish Talati

Founding Member Talati Law Firm

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

Join us for the Pre-Conference Workshop on July 16 Food Law and Regulation Fundamentals: An Essential Primer on Applicable Laws and Governing Agencies Having Authority over Food

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

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

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AmericanConference.com/FoodLawBootCamp • 888 224 2480

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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

BOOK YOUR VIRTUAL SEAT TODAY! Continuing Legal Education Credits EARN CLE CREDITS

ccreditation will be sought in those jurisdictions requested by A 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.

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

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Speaker Faculty DISTINGUISHED CO-CHAIRS: Suzie Trigg

Partner Haynes & Boone LLP

Ashish Talati

Founding Member Talati Law Firm

ESTEEMED SPEAKERS: Rend Al-Mondhiry Partner Amin Wasserman Gurnani, LLP

Nigel Barrella

Attorney Barrella Law PLLC

Timothy Dietrich Partner Barley Snyder LLP

Brian D. Eyink

Partner, Global Regulatory Hogan Lovells LLP.

Adam Ekonomon

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

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Benjamin L. England

Brandon Neuschafer

Todd A. Harrison

Justin J. Prochnow

Partner Venable LLP

Shareholder Greenberg Traurig, LLP

John F. Johnson III

Alan Pryor

Founder and CEO FDAImports

Senior Counsel Shook Hardy & Bacon LLP

Partner Arnold & Porter LLP

Partner Alston & Bird LLP

Rachel D. Spiegel Kristen R. Klesh Partner Loeb & Loeb LLP

Partner Faegre Drinker Biddle & Reath LLP

Riette van Laack

Jasmine Wetherell

Partner Hyman, Phelps & McNamara, P.C.

Sharon Mayl Partner DLA Piper LLP

AmericanConference.com/FoodLawBootCamp • 888 224 2480

Partner Perkin Coie LLP

Kristi Wolff

Partner Davis Wright Tremaine LLP

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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, Davis Wright Tremaine 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) National Institutes of Health (NIH) Center for Disease Control (CDC) • Review of applicable laws from which FDA derives its authority over food regulation

• 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

» Food, Drug, and Cosmetics Act (FDCA)

» Department of Commerce

» Fair Packaging and Labeling Act

» Department of Transportation

» Food Safety Modernization Act (FSMA)

» Department of Justice

• 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

• 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

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DAY ONE

9:30am

Wednesday, July 17, 2024 (CST)

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

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 » 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)

• 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 Rend Al-Mondhiry, Partner, Amin Wasserman Gurnani, LLP • 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

» FTC – Bureau of Consumer Protection

» FDCA Chapter IV

» State and local health agencies • Defining the scope of each agency’s jurisdiction and authority » labeling » marketing, promotion and advertising

» 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

» product recalls • Examining how each agency exercises its jurisdiction and regulatory authority » rule making

» labels approved under the prior label approval system vs. the generic label approval • Defining the product “label” » front-of-pack, information panel, package insert

» product decisions

» label requirements – contents, ingredients, allergens

» enforcement • Exploring proposed changes at FDA for the Human Food program • Addressing preemption challenges between state and local authorities

» how to list label information posted on websites and advertisements • How to avoid allegations of misrepresentation and misbranding

» understanding when federal laws preempt state regulation » examining how state authorities exercise their authority despite preemption

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AmericanConference.com/FoodLawBootCamp • 888 224 2480

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11:15am

12:45pm Lunch Break

A Practical Guide to The Revised Nutrition Facts Label

1:45pm

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

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

• Natural

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

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

Microphone-alt Brian D. Eyink, Partner, Global Regulatory, Hogan Lovells LLP

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

3:00pm

• 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

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

» chemical contaminants and carcinogens

• Title I – prevention of food safety hazards

» filth and extraneous materials

• Title II – detection and response to food safety problems

» pesticides

• Title III – improving safety of imported food

» metals

• Title IV –Miscellaneous

• Update on STECs and E. coli prevention protocols

• Final FSMA Rules recap

• Differentiating allergens from pathogens

• Preventive Controls for Human Food Final Rule

» understanding how they differ

» Preventive Controls for Food for Animals Final Rule

» FDA vs. USDA

» Standards for Produce Safety Final Rule

• How to establish effective food safety guidelines, protocols and screening measures — traceback, HACCP, sanitation SOPs and testing procedures

» Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals Final Rule

• Update on the Reportable Food Registry and how the FDA has used information provided in the Registry to address food safety issues

» Accredited Third-Party Certification Final Rule » Sanitary Transportation of Human and Animal Food Final Rule

4:00pm

» Mitigation Strategies to Protect Food Against Intentional Adulteration Final Rule • An overview of relevant FDA Guidance for FSMA Compliance 5:00pm

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Day 1 Adjourns

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DAY TWO

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 Microphone-alt Todd A. Harrison, 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

10:15am Morning Refreshment Break 10:30am

Food Import Regulation and FDA’s Foreign Supplier Verification Program Microphone-alt Benjamin L. England, Founder and CEO, FDAImports 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;

• Validation and proofs of preventative controls

» FSVP compliance, approval, and verification requirements;

• Examining requirements for qualified individuals

» FSVP documentation and audit procedures;

9:15am

Inspections: What to Do if the Government Shows Up at Your Door Microphone-alt Timothy Dietrich, Partner, Barley Snyder LLP Ashish Talati, Founding Member, Talati Law Firm

• 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

» 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

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12:30pm

Food and Beverage Legal and Regulatory Essentials 2.0: A Comprehensive Guide to Plant-Based and Cell-Cultured Food Products Microphone-alt Nigel Barrella, Attorney, Barrella Law PLLC 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 1:30pm

Main Conference Adjourns

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