ACI's Advanced Forum on Defending FDA-Regulated Consumer Products Class Actions - DS

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ACI’s Advanced Forum on

October 16–17, 2023 New York Bar Association, New York, NY

Defending FDA-Regulated Consumer Products Class Actions

The Latest Class Action Prevention, Preparedness and Litigation Strategies for the Food, Cosmetics, and Dietary Supplement Industries

Esteemed Co-Chairs: David Biderman Partner Firmwide Chair, Consumer Products & Services Litigation Perkins Coie LLP Lori Leskin Partner Co-Chair, Consumer Products Practice Group Arnold & Porter Kaye Scholer LLP

Gain Insights from Key Industry Stakeholders: Hih Song Kim Executive Vice President, General Counsel and Corporate BlueTriton Brands Sabrina Mizrachi VP, Litigation & Global Product Regulatory Estée Lauder Companies Amanda Weinberger Senior Counsel Sara Lee Frozen Bakery

Conference Highlights Include: y Think Tank on How MoCRA and the New FTC Health Products Compliance Guidance May Affect Class Action Activity y Focus Session on the Connection Between Consumer Groups, Independent Labs and the Plaintiff’s Bar y Cross-Circuit Analysis of Recent Class Certification Developments y Navigating the Nuances of PFAS and Titanium Dioxide Class Actions REGISTER NOW

Mark Brian Levine Associate General Counsel Reckitt Benckiser Joseph Conklin SVP & Global Deputy General Counsel Coty Inc. Chris Liwski Head of Legal North America and Global Head of Litigation Sanofi Consumer Healthcare ASSOCIATE SPONSORS

y Strategy Session on How Sound Claims Substantiation and Labeling Practices Are the Best Offense y Working Group on New Preemption Arguments in light of MoCRA and other FDA developments y Pre-Litigation Playbook: What to Do After Receiving a Demand Letter y Navigating Common Class-Action Settlement Challenges Across the Food, Cosmetics and Supplements Industries

AmericanConference.com/Class-Actions • 888 224 2480

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The plaintiffs’ bar is becoming increasingly aggressive in targeting food, cosmetic, and dietary supplement companies in class action lawsuits.

Many of these lawsuits range from the ridiculous to the absurd and are taking up too much time and money to defend.

The time to stop this madness is now. To help defense counsel address this never-ending barrage of class action filings, American Conference Institute (ACI) is pleased to introduce our Advanced Forum on Defending FDA-Regulated Consumer Products Class Actions.

Join us this Fall for two days of comprehensive strategy sessions which will equip you with the tactical tools needed to avoid, combat and defend against the latest class action lawsuits.

We look forward to seeing you in New York City for what is sure to be one of the most valuable gatherings of the year!

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MEET OUR FACULTY ESTEEMED CO-CHAIRS David Biderman Partner Firmwide Chair, Consumer Products & Services Litigation Perkins Coie LLP Lori Leskin Partner Co-Chair, Consumer Products Practice Group Arnold & Porter Kaye Scholer LLP DISTINGUISHED SPEAKERS Joseph Aquilina Sr. Director, Associate General Counsel Consumer Brands Association Kristine Argentine Partner Seyfarth Shaw LLP Kimberly Bousquet Counsel Davis Wright Tremaine LLP John W.M. Claud Counsel Hyman, Phelps & McNamara, P.C.

Dale Giali Partner King & Spalding LLP

Sabrina Mizrachi VP, Litigation & Global Product Regulatory Estée Lauder Companies

Ani Gulati Chief Litigation Counsel General Mills

Amy Mudge Partner and Chair Advertising, Marketing and Digital Media Team Baker & Hostetler LLP

Aliza R. Karetnick Partner Ballard Spahr LLP Hih Song Kim Executive Vice President, General Counsel and Corporate BlueTriton Brands Jonah Knobler Partner Patterson Belknap Webb & Tyler LLP Amy Lally Partner Sidley Austin LLP Mark Brian Levine Associate General Counsel Reckitt Benckiser

Joseph Conklin SVP & Global Deputy General Counsel Coty Inc.

Chris Liwski Head of Legal North America and Global Head of Litigation Sanofi Consumer Healthcare

Jessica Davidson Partner Skadden, Arps, Slate, Meagher & Flom LLP

Christine McInerney Head of Litigation Nestle Health Science

Risa Drexler Associate General Counsel – Global Litigation Unilever

Jason Meltzer Partner Gibson, Dunn & Crutcher LLP

Thomas A. Evans Partner Alston & Bird

Abby Meyer Partner Sheppard, Mullin, Richter & Hampton LLP

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AmericanConference.com/Class-Actions • 888 224 2480

Trenton Norris Partner Hogan Lovells Megan Olsen Senior Vice President & General Counsel Council for Responsible Nutrition Patrick Oot Partner Shook, Hardy & Bacon LLP Matthew Orr Partner Amin Talati Wasserman LLP Sylvia Simson Shareholder Greenberg Traurig LLP Jason Stiehl Partner Crowell & Moring LLP Thomas Sullivan Partner Shook Hardy & Bacon LLP Julie L. Tersigni Senior Counsel, Products Liability Kenvue Amanda Weinberger Senior Counsel Sara Lee Frozen Bakery

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Day One

Monday, October 16, 2023 8:30

10:15

Co-Chairs’ Opening Remarks

Exploring How New Legislation and Agency Guidance Will Impact Future Class Action Litigation Involving FDA Consumer Products

Microphone-alt David Biderman, Partner, Firmwide Chair, Consumer Products & Services Litigation, Perkins Coie LLP

Microphone-alt Megan Olsen, Senior Vice President & General Counsel,

Lori Leskin, Partner, Co-Chair, Consumer Products Practice Group, Arnold & Porter Kaye Scholer LLP

Council for Responsible Nutrition

Joseph Conklin, SVP & Global Deputy General Counsel, Coty Inc.

The food, cosmetics and dietary supplements industries remain a consistent target of putative class action litigation, with plaintiffs’ counsel continuing to scrutinize the labels of FDA-regulated consumer products for potential lawsuits. In this opening session, our esteemed co-chairs will set the stage for the conference with a high-level “state of the industry” and a statistical analysis of the last year’s case filings.

• Assessing how the Modernization of Cosmetics Regulation Act of 2022 (MOCRA) will impact class actions against the cosmetics and personal care industries

9:00

• Examining how the FTC’s recent revisions to the Health Products Compliance Guidance may trigger new class action activity against the food and dietary supplement industries

Cross-Industry Class Action Roundup: Examining the Latest Class Action Trends in Food, Cosmetics and Dietary Supplements Microphone-alt Sabrina Mizrachi, VP, Litigation & Global Product Regulatory, Estée Lauder Companies Amanda Weinberger, Senior Counsel, Sara Lee Frozen Bakery Mark Brian Levine, Associate General Counsel, Reckitt Benckiser Christine McInerney, Head of Litigation, Nestle Health Science

Joseph Aquilina, Sr. Director, Associate General Counsel, Consumer Brands Association

• Exploring how the FDA’s new proposed rule on Food Labeling will impact class action activity involving making “healthy” claims on food labels • Understanding how potential updates to the FTC Green Guides may impact future claims across the food, cosmetic and supplements industry 11:00

Morning Coffee Break

11:30

Ani Gulati, Chief Litigation Counsel, General Mills

A Cross-Circuit Analysis of Recent Class Certification Developments in Food, Cosmetics and Supplement Class Actions

Moderator: David Biderman, Partner, Firmwide Chair, Consumer Products & Services Litigation, Perkins Coie LLP

Microphone-alt Lori Leskin, Partner, Arnold & Porter Kaye Scholer LLP

In our morning roundup, leading in-house counsel from the food, cosmetic, and dietary supplements industries will provide an analysis of the latest class action activity targeting their respective industries.

Topics of discussion will include: • The latest advertising and labeling practices which are triggering class action claims » Healthy

» Sustainable

» Natural

» Health claims vs. structure function

• Key lessons and takeaways from the latest class litigations • Insights on where the next class action hot spots may occur

Thomas J. Sullivan, Partner, Shook, Hardy & Bacon LLP Sylvia Simson, Shareholder, Greenberg Traurig LLP • Assessing the latest class certification rulings and trends across key circuits relating to food, cosmetics and supplements • What plaintiff strategies are winning the day in certifying classes in FDA-regulated consumer product cases?

• Identifying defense challenges to class certification that are seeing the most success in these industries

» Supplements and illegal drug claims, Li et al v. Amazon (N.D. Cal. 2023) • Predicting when you may be a class action target

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Contamination Class Actions

12:15

To Respond or Not Respond? What to Do After You Receive the Demand Letter Microphone-alt Matthew Orr, Partner, Amin Talati Wasserman LLP Class actions lawsuits affecting food cosmetics, and supplements usually begin with a demand letter. This session will provide a look at recent demand letter trends affecting these industries and strategies to employ for when one arrives on your desk.

• Examining demand letter trends in these FDA-Consumer industries » Recent labeling and marketing triggers » State consumer protection law violations » Reasonable consumer standard • Developing internal protocols to address demand letters • Evaluating the class action probability from the letter » What can we glean about the potential of the case from the law firm/attorney who sent the letter?

• Understanding when and how to enlist outside counsel

2:00

Contaminant Class Actions: What Every Defense Attorney for an FDA-Regulated Consumer Industry Needs to Know About PFAS, Heavy Metals, and Titanium Dioxide Microphone-alt Dale Giali, Partner, King & Spalding LLP Aliza R. Karetnick, Partner, Ballard Spahr LLP Contaminants such as PFAS — forever chemicals, heavy metals, and other trace substances are spawning a new breed of highly aggressive class action litigation. They are affecting almost every industry but are of particular concern to the FDA-regulated consumer goods sector. What’s more, the plaintiffs’ bar has begun bringing putative class actions alleging that the presence of Titanium Dioxide makes consumer products unsafe. This panel will examine recent contaminant class actions affecting these industries and provide insights on what to do if your company is hit with one of these lawsuits. This panel will examine:

PFAS, Heavy Metals & Other Trace Chemicals

• Weighing the risk of responding vs. not responding while being mindful of the response deadline

• Understanding the legal nuances of contaminant litigations — How are these lawsuits different from other class action claims?

• Identifying who else may have received the same demand letter and how this should factor into your decision

• What theories are plaintiffs relying on in these claims, and what defense strategies are proving to withstand the latest plaintiff challenges?

• Understanding how to make the “fish or cut bait” decision

• Examining how product testing/sourcing and recorded regulatory approval can yield additional strategies for class-action defense of PFAS and other related trace chemical lawsuits

» Which actions are worth fighting and which should be settled right away? » Grasping what types of cases settle, which don’t, and how much should be paid » Identifying claims that never win, e.g., FDC&A defeat 1:00

Networking Luncheon

Spotlight on Titanium Dioxide: The Latest Target in FDA-Regulated Consumer Product Class-Action Lawsuits • Examining the rising trend of Titanium Dioxide class actions being brought across the food, cosmetic and supplements industry • Common themes, allegations and takeaways • How companies and their counsel should be reviewing product formulations and label claims to mitigate litigation risks associated with the presence of TiO2

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AmericanConference.com/Class-Actions • 888 224 2480

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3:15

Afternoon Break

4:15

3:30

Understanding How Prop 65 Activity is Influencing Class Actions Against FDA-Regulated Consumer Product Companies

How Proper Claims Substantiation and Sound Labeling Practices Can Be Your Best Offense Microphone-alt John W.M. Claud, Counsel, Hyman, Phelps & McNamara, P.C. Abby Meyer, Partner, Sheppard, Mullin, Richter & Hampton LLP

Microphone-alt Amy Lally, Partner, Sidley Austin LLP Rohit Sabnis, Partner, Keller & Heckman • Examining the latest trends in Prop 65 activity that the food, cosmetic and dietary supplements industries should be paying attention to • Understanding how the Prop 65 acrylamide ruling may have ended class actions against food companies in this category • Examining the new dark chocolate class actions and their similarity to Prop 65 actions

• Examining claims language, advertising methods and other actions a company can take to reduce the risk of a class action • Understanding how proper and compliant labeling can defeat a class » FDC&A compliance • Being proactive in substantiating marketing and labeling claims with competent and reliable scientific evidence 5:00

MEDIA PARTNERS:

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Conference Adjourns

Day Two

Tuesday, October 17, 2023 8:45

9:45

Co-Chairs’ Welcome Back and Recap of Day 1

Addressing the Role of Flawed Science in Driving Mass Litigation in the Food, Cosmetic and Supplements Industries

9:00

Understanding How Consumer Protection Groups and the Plaintiff’s Bar Are Working in Tandem to Police Claims, Labeling, and Other Marketing Practices Leading to Class Actions Microphone-alt Thomas A. Evans, Partner, Alston & Bird Amy Mudge, Partner and Chair Advertising, Marketing and Digital Media Team, Baker & Hostetler LLP Claudia Lewis, Partner, Venable • How is the plaintiff’s bar targeting labeling practices governed by the FDCA and other statutes that do not include a private right of action?

• Understanding the role that consumer protection groups (and third parties that hold themselves out as consumer protection organizations) play in policing claims and labeling practices that springboard into class actions » Assessing the DC Consumer Protection Procedures Act and precedent allowing third-party consumer protection groups the right to sue for allegedly false or misleading claims » How can companies defend against third-party lawsuits and reduce the risk of these lawsuits? » Understanding how industry can work with regulators and consumer protection groups to ensure proper claims and self-police thereby avoiding class actions • Examining the plaintiff’s bar’s recent attempts to police claims and labeling like government regulators through recent class action activity

Microphone-alt Patrick Oot, Partner, Shook, Hardy & Bacon LLP Risa Drexler, Associate General Counsel – Global Litigation, Unilever Chris Liwski, Head of Legal North America and Global Head of Litigation, Sanofi Consumer Healthcare Julie L. Tersigni, Senior Counsel, Products Liability, Kenvue Testing labs have recently filed citizen petitions with the FDA in attempts to provide support for economic loss class actions and personal injury mass tort litigation in the consumer products space. This panel will address the rising role of independent laboratories spawning FDA consumer product class actions, and examine topics including: • What types of products are they targeting for independent testing?

• What should consumer product companies be doing to stay out of their spotlight?

• Crafting successful challenges to the legitimacy of the independent testing of these groups and the science behind their studies » How to educate the court about the junk science that FRE 702 is designed to protect against 10:30

Morning Coffee Break

11:00

Crafting Successful Jurisdiction and Standing Arguments at the Motion to Dismiss Stage Microphone-alt Kristine Argentine, Partner, Seyfarth Shaw LLP Jonah Knobler, Partner, Patterson Belknap Webb & Tyler LLP • Identifying primary jurisdiction and standing arguments which may be effective in eliminating or narrowing a class at the motion to dismiss stage • Understanding the primary jurisdiction challenges which are most prevalent in FDA-regulated consumer product class actions, as well as how to manage and overcome them • Navigating standing in the aftermath of TransUnion LLC v. Ramirez: incorporating takeaways from the latest court rulings into your class action litigation practices and strategies

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AmericanConference.com/Class-Actions • 888 224 2480

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11:45

2:30

A New Look at Preemption: Recent Developments Impacting How Food, Cosmetic and Supplement Defendants May Rely on this Defense in Future Class Actions

Advanced Settlement Strategies for FDA-Regulated Consumer Product Class Actions Microphone-alt Kimberly Bousquet, Counsel, Davis Wright Tremaine LLP

Microphone-alt Jessica Davidson, Partner, Skadden, Arps, Slate, Meagher & Flom LLP • Examining the impact of MoCRA on future class action preemption defenses, particularly with regard to PFAS • Assessing how recent FDA guidances (e.g. guidance for determining and declaring the protein grams in a serving) has helped to provide preemption defenses to false advertising in the food, cosmetic, as supplement space • Analyzing recent case law developments impacting express and implied preemption and how this may be useful to FDA-regulated consumer goods companies » Truss v. Bayer Healthcare Pharmaceuticals Inc. » Nexus Pharmaceuticals Inc. v. Central Admixture Pharmacy 12:15

Hih Song Kim, Executive Vice President, General Counsel and Corporate, BlueTriton Brands • Identifying common challenges arising in FDA consumer product class settlements as well as key strategies for tackling those challenges • Comparing class settlement trends by jurisdiction » Identifying favorable jurisdictions to settle in, as well as jurisdictions to avoid settlement in • Proven defense strategies for drafting settlement agreements, structuring the settlement benefit and noticing the class • Working with a settlement administrator to ensure the settlement is implemented with efficiency and accuracy • Understanding how to make the decision of whether to settle or go to trial • Structuring your settlement agreement so you don’t leave yourself exposed to future lawsuits

Networking Luncheon

1:15

3:15

Combatting New and Creative Plaintiff’s Bar Tactics in FDA Consumer Product Class Actions

3:30

Microphone-alt Jason Meltzer, Partner, Gibson, Dunn & Crutcher LLP Jason Stiehl, Partner, Crowell & Moring LLP • Examining creative plaintiffs’ bar tactics being used in these types of class actions as well as winning defense strategies to combat them • Identifying new types of causes of actions being brought: what do current trends in class claims predict about potential future class action activity?

• Tracking government and consumer protection group enforcement activity which the plaintiff’s bar might try to piggy-back on • Exploring examples where plaintiff’s counsel has been successful in defeating preemption defenses • In light of new developments in preemption, predicting how plaintiff’s bar tactics may change going forward

Afternoon Break

LAB - Learn, Apply, and Benchmark: Interactive FDA Consumer Product Class Action Defense Exercise Microphone-alt Trenton Norris, Partner, Hogan Lovells Lori Leskin, Partner, Arnold & Porter LLP This hands-on session will test your litigation savvy through a series of complex, hypothetical scenarios which may arise in an FDA-regulated consumer product class action. Discover how your approach to mounting and tackling a class action defense compares to your peers. Benefit from a practical discussion and walk away with winning strategies for all phases of a class action litigation, including: • Designing thorough internal class action preparedness protocols • Forging pre-suit defense strategies • Establishing document hold and retention policies • Pre-suit demand letter protocols • Considerations for budgeting and forecasting of litigation costs

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• Building joint litigation agreements • Class formation challenges • Discovery challenges • Knowing when going to trial is the right thing to do • Understanding when settlement is your best option 4:30

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Conference Ends

Building Venue Information New York Bar Association

42 West 44th Street, New York, NY 10036

Bed Hotel Accommodations The Iroquois New York

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Please note that the guest room block cut-off date is September 17th, 2023. After that date OR when the room block fills, guestroom availability and rate can no longer be guaranteed.

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