10th Annual Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products - DS

LEGAL, REGULATORY, AND COMPLIANCE FORUM ON COSMETICS

& Personal Care Products

March 28–29, 2023 | NY Hilton Midtown, New York, NY

A comprehensive guide to the latest developments affecting articles intended for cleansing, beautifying, promoting attractiveness, or altering the appearance.

2023 CO-CHAIRS

KEYNOTES

FROM THE FDA AND FTC

This year, we’ll dive deep into the following topics and more:

» MoCRA 2022

» AI and The Metaverse in Beauty

» ESG and DEI concerns and compliance procedures

» California Safe Cosmetics Program (CSCP)

» State PFAS legislation

» Cosmetic vs. Drug vs. Medical Device Status

» The Next Chapter of Monograph Reform

» Claims Substantiation Case Studies

ASSOCIATE SPONSORS LUNCHEON SPONSOR COCKTAIL RECEPTION SPONSOR

WORKSHOPS

A The Foundation of Beauty: Cosmetics and Personal Care Products Law and Regulation 101

B MoCRA Working Group: All You Need to Know about Modernization of Cosmetics Regulation Act of 2022 (MoCRA)

C Master Class on Cosmetics Adverse Events Reporting, and Recalls under MoCRA: A Blueprint for Designing Your Safety Plan

Sharon Blinkoff Counsel Locke Lord LLP

Michael Ostheimer Attorney FTC, Advertising Division

Rohini Gokhale Global Marketing Counsel Estée Lauder Companies

Linda M. Katz, M.D., M.P.H. Director, Office of Cosmetics and Colors FDA

ACI’s 10th Annual Legal, Regulatory, and Compliance Forum on Cosmetics and Personal Care Products

The Modernization of Cosmetic Regulation Act of 2022,” (MoCRA) is now a reality on the Federal level. State legislators and consumer groups will continue to push for further reforms.

Just before the end of the 2022, President Biden signed the “Modernization of Cosmetic Regulation Act of 2022,” (MoCRA) into law — essentially giving the FDA greater authority to regulate the cosmetic industry. This long-awaited law creates new requirements for manufacturers in terms of product safety, ingredients, labelling, and registration.

The states have also been active in the space, with legislative measures concerning the ban of PFAS chemicals, sunscreen regulation, anti-cruelty measures, and consumer safety. California continues to tighten rules and regulations the cosmetics and personal care industries, with new restrictions on products containing harmful chemicals, packaging and labelling requirements, and seemingly endless, Prop 65 litigation.

AI and the Metaverse are adding a whole new dimension to the marketing and promotion of cosmetics with new-founded privacy concerns.

Technological innovation has made its way into the cosmetics market, with brands now jumping on the trend of virtual reality stores, digital product try-ons, and crypto/blockchain integration. Manufacturers and retailers are pondering how to best combine physical and digital offerings and becoming more savvy in utilizing these technologies and their capabilities to provide a great consumer experience. This movement, however, is not without risk and is raising new concerns for privacy, the collection of personal data, and related consequences.

The adoption of ESG policies and transitioning to more sustainable and socially ethical practices in the beauty market marks new industry standards.

Many manufacturers and companies in the beauty and personal care space have adopted ESG policies and are striving to engage in more sustainable and ethical practices for their businesses. They are striving to be more environmentally and socially conscious, but this also comes with its own new set of challenges.

Class Action Litigation continues to plague the cosmetics industry.

The cosmetics and personal care industries continue to see a rise in class-action litigation activity, involving product performance, false advertising, and mislabeling. Examine how the industry can defeat these ongoing attacks by the plaintiff’s bar.

Learn about all this and more at this year’s conference.

Attend ACI’s 10th Annual Legal, Regulatory, and Compliance Forum on Cosmetics and Personal Care Products to ensure you receive timely advice, as always, from our prestigious faculty of government officials, consumer protection advocates, leading in-house counsel, and premier law firm attorneys. We have created this year’s agenda to bring new industry sessions and concerns, hear more beauty and personal care brands’ stories and experiences and include more interactive formats. We hope to see you this spring.

Conference Co-Chairs

Sharon Blinkoff Counsel Locke Lord LLP

Rohini Gokhale Global Marketing Counsel

Estée Lauder Companies

Government Insights

Michael Ostheimer Attorney Federal Trade Commission (FTC), Advertising Division

Linda M. Katz, M.D., M.P.H. Director, Office of Cosmetics and Colors

U.S. Food and Drug Administration (FDA)

In-House and Corporate Insights

Ming Zhao Co-founder & CEO

PROVEN Skincare

Dr Robb Akridge CEO/Founder OPULUS Beauty Labs

John Bailey Jr., Ph. D. Independent Advisor

EAS Consulting Group Former Director of FDA’s Office of Cosmetics and Colors

Claire Bing VP of Quality & Regulatory

Maesa

Monique Davis

Vice President, Global Local & Cultural Innovation The Estée Lauder Companies Inc

Camille Friedlander Legal Counsel Benefit Cosmetics

Madeleine Giaquinto Director, Regulatory Affairs Greenleaf Health

Ryan Gooley Director, Business Development –Recall & Remediation Sedgwick

Marietta Jo General Counsel Supergoop!

David Joyal VP, Legal – Patents Coty

Jaclyn Kaczmarek Counsel II Ulta Beauty

Robert Kiefer General Manager REACH24 USA

Dr Rick Kingston President of Regulatory and Scientific Affairs & Co-founder SafetyCall International

Carrie Kovalerchik Senior Legal Counsel Unilever

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

Akemi Ooka Head of Global Supply Chain Resources Independent Beauty Association

Emily Perez Owner & Founder Latinas in Beauty

Jamila Powell Owner & Founder Naturally Drenched

Andrew Shapero Senior Engineer Roux Inc.

Jennifer Santos Attorney National Advertising Division (NAD)

Kimberly Smith Owner

Marjani Beauty

Craig Weiss President Consumer Product Testing Co.

Larry Weiss CEO Symbiome

Margaret Whittaker, PHD Managing Director and Chief Toxicologist ToxServices LLC

Law Firms

Ann M. Begley Partner Wiley

Sophia B. Castillo Partner Downey Brand LLP

Tonya Esposito Shareholder GreenbergTraurig

Gustav W. Eyler Partner Gibson Dunn

Rachel Gartner Counsel

McDermott Will & Emery LLP

Heidi Forster Gertner Partner Hogan Lovells

Christopher Hanson Partner, Chair, FDA Regulatory Compliance & Litigation Group Nelson Mullins

Sam Jockel Attorney

Alston & Bird

Aliza R. Karetnick Partner

Ballard Spahr

Paavana L. Kumar Partner Davis & Gilbert LLP

Riëtte van Laack Director

Hyman, Phelps & McNamara

Cynthia B. Lieberman Partner Keller and Heckman LLP

Jeffrey Margulies

Partner-in-Charge

Norton Rose Fulbright US LLP

Diane McEnroe Partner

Sidley Austin

Cynthia L. Meyer Partner

Kleinfeld, Kaplan & Becker, LLP

Shawn R. Obi Partner Winston & Strawn LLP

Arameh Z O’Boyle Member Mintz

Jessica O’Connell Partner

Covington & Burlington

Jackson Pai Counsel, International Trade Group Crowell & Moring

Raqiyyah Pippins Partner

Arnold & Porter

Kiri Lee Sharon Partner Foley & Lardner

Sylvia E. Simson Shareholder GreenbergTraurig

Angela M. Spivey Partner

Alston & Bird

Harry Valetk Partner Baker & McKenzie LLP

Nury Helena Yoo Partner

Faegre Drinker Biddle & Reath

PRE-CONFERENCE WORKSHOPS

Monday, March 27, 2023

A9:00 am -12:30 pm – Registration to begin at 8:30 am (BREAK 10:30 am–11:00 am)

The Foundation of Beauty: Cosmetics and Personal Care Products Law and Regulation 101

Microphone-alt Cynthia L. Meyer, Partner, Kleinfeld, Kaplan & Becker, LLP

Carrie Kovalerchik, Senior Legal Counsel, Unilever

This interactive workshop will set the stage for the two-day main conference by providing you with a comprehensive overview of the laws and regulations affecting cosmetics and personal care products. Points of discussion will include:

• Understanding the role and authority of FDA in the cosmetics and personal care products market

• Regulatory classification: Is it a cosmetic, a drug or something else?

» Definitions: Identifying the difference between a cosmetic product and a drug under the Food, Drug & Cosmetics Act

» Exploring circumstances in which a product can be considered a drug, medical device, dietary supplement, or consumer product

» Explaining structure/function claims

• Analyzing how a personal care product comes to market: Cosmetics vs. OTC drugs

» Notification vs. Listing

» cGMPs

» Labeling

» OTC Monographs

12:30 pm–1:00 pm Networking Break

• Identifying FDA requirements governing

» Ingredients, including color additives

Due to the hands-on nature of the workshops, they will only be available for in-person attendance.

• Reviewing FDA versus FTC jurisdiction for advertising and promotion of cosmetics and personal care products

• Comprehending pre and post market responsibilities

» Complaint monitoring and investigation

» Adverse event reporting

» Best practices for cosmetic recalls and product reintroduction

• Other “regulators”

» Retailers

» Consumers

» The States

• CPSC, EPA, other federal agencies

B1:30 pm–5:00 pm – Registration to begins at 12:30 pm (BREAK at 2:30 pm)

MoCRA Working Group: All You Need to Know about Modernization of Cosmetics Regulation Act of 2022 (MoCRA)

Microphone-alt Ann M. Begley, Partner, Wiley

Sam Jockel, Attorney, Alston & Bird

As the biggest end of the year surprise, MoCRA 2022 was signed into law, bringing new federal standards in the cosmetics industry for registration, adverse event reporting product listing, recordkeeping, recalls, safety substantiation and more.

Our workshop leaders will provide an in-depth analysis of the new cosmetics regulatory framework and help you and your company prepare for the upcoming changes and requirements. Points of discussion will include:

• Analyzing how MoCRA will change how the FDA regulates cosmetics

• Determining the next steps for cosmetic brands in view of this legislation and examining what resources they need to implement and key provisions

• Developing a comprehensive plan of action in view of complying with the new provisions

• Identifying and minimizing the risk of litigation and consumer claims based on the new FDA requirements

MAIN DAY ONE

Tuesday, March 28, 2023

7:15 Continental Networking Breakfast and Registration

8:15

Co-Chairs’ Welcome Remarks

Microphone-alt Sharon Blinkoff, Counsel, Locke Lord LLP

Rohini Gokhale, Global Marketing Counsel, Estée Lauder Companies

8:30

Overview Focus Session on the Modernization of Cosmetics Regulation Act of 2022 (MoCRA)

Microphone-alt John Bailey Jr., Ph. D., Independent Advisor, EAS Consulting Group, Former Director of FDA’s Office of Cosmetics and Colors

Gustav W. Eyler, Partner, Gibson Dunn

Arameh Z O’Boyle, Member, Mintz

Margaret Wittaker, PHD, Managing Director and Chief Toxicologist, ToxServices LLC

The new regulatory framework for cosmetics is set to have a great impact on the industry. It is important to understand the key takeaways from the new law and the upcoming changes in how companies operate their businesses.

• Preparing companies for MoCRA requirements

• Analyzing what the law entails for the regulatory framework for cosmetics

• Exploring mandatory reporting, product registration, listing, good manufacturing practices (cGMP)

9:15

Anticipating What’s Next for Beauty Brands in Light of New MoCRA Requirements

Microphone-alt Claire Bing, VP of Quality & Regulatory, Maesa

Heidi Forster Gertner, Partner, Hogan Lovells

Diane C. McEnroe, Partner, Sidley Austin LLP

Nury Helena Yoo, Partner, Faegre Drinker Biddle & Reath

We’ll dive deeper into the practicalities of how cosmetic companies should adapt to the new requirements and become compliant with the new regulatory regime.

• Determining how your company can best use the one-year window, to prepare for new FDA requirements for cosmetics

• Assessing resources from staffing to infrastructure: identifying and filling gaps to comply with new legislative and regulatory requirements

• Designing a MoCRA implementation plan

10:00

Spotlight on State PFAS Legislation and Its Impact on Cosmetics and Personal Care Products

Microphone-alt Cynthia B. Lieberman, Partner, Keller and Heckman LLP

Jeffrey Margulies, Partner-in-Charge, Norton Rose Fulbright US LLP

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

• Exploring various state initiatives and legislative activity on restricting and excluding the use of PFAS chemicals and their impact on the beauty industry

• Delving into the stricter PFAS approach some state laws have in place: California, Maine, Maryland

• Examining current regulations regarding manufacturing, packaging, and distribution of products containing PFAS chemicals

• Anticipating federal activity on PFAS chemicals

10:30 Morning Networking Coffee Break

11:15

The Golden State of Beauty: Update on California Legislative and Enforcement Activity Affecting the Cosmetic and Personal Care Industries

Microphone-alt Sophia B. Castillo, Partner, Downey Brand LLP

Andrew Shapero, Senior Engineer, Roux Inc.

• Analyzing the California Safe Cosmetics Program’s (CSCP) success rate and compliance effectiveness

• Understanding how the California Consumer Privacy Act (CCPA) impacts consumer data collection in the cosmetic and personal care industries

• Assessing the impact of Senate Bill 312 (SB 312), now known as the Cosmetic Fragrance and Flavor Ingredient Right to Know Act

• Understanding the potential impact and anticipating next steps for Bill SB 343 which calls for significant restrictions for recycling claims on product packaging

• Examining questions of preemption relative to such legislation

Focus on Prop 65 Activity

• Identifying the latest wave of plaintiff’s claims made under Prop 65

• Examining defenses the industry is employing

1:00

FDA Keynote on Priorities for 2023

Microphone-alt Linda M. Katz, M.D., M.P.H., Director, Office of Cosmetics and Colors, U.S. Food and Drug Administration (FDA)

1:45

Aesthetic Market Focus: Is it a Cosmetic? or a Drug? or a Device?

Microphone-alt Dr Robb Akridge, CEO/Founder, OPULUS Beauty Labs

Madeleine Giaquinto, Director, Regulatory Affairs, Greenleaf Health

Christopher Hanson, Partner, Chair, FDA Regulatory Compliance & Litigation Group, Nelson Mullins

Riëtte van Laack, Director, Hyman, Phelps & McNamara

With the beauty industry constantly evolving and new cosmetic procedures appearing year by year, there has been a need for more guidance and regulation regarding what classifies as a cosmetic vs a drug vs a device. This session will highlight the challenges in these two industries:

• Assessing the overlap between cosmetics and so-called cosmetic devices from a regulatory point of view

• Determining the differences between micro needling, dermal fillers, microbiome

» Are they cosmetics, drugs, devices, or some form of hybrid?

• Looking into approval processes and regulatory structures for these products

• Analyzing current and potential future monograph activity affecting cosmetics and personal care products

2:45 Networking Break

3:00

The 2023 Litigation and Class Actions Outlook for the Cosmetics and Personal Care Products Industries

Microphone-alt Shawn R. Obi, Partner, Winston & Strawn LLP

Jessica O’Connell, Partner, Covington & Burlington

Sylvia E. Simson, Shareholder, GreenbergTraurig

Class Actions

• Examining new FDA warning letters on labelling claims, product performance and deceptive advertising

• Reviewing the latest wave of PFAS benzene in cosmetics litigation

• How to: prepare for a class action and the steps involved, for cosmetics and personal care product companies

• Examining how California specific litigation can be used as a benchmark for potential class-action litigation in other states

Focus on Preemption Defense

• Understanding the resurgence of the preemption defense regarding class actions for FDA-regulated consumer products

• Learning from recent class actions victories and how federal preemption was used to defend companies

4:00

Defining Clean and Natural Beauty: Formulating Claims from the Biggest Trends in 2023

Microphone-alt Tonya Esposito, Shareholder, GreenbergTraurig

Raqiyyah Pippins, Partner, Arnold & Porter

Larry Weiss, CEO, Symbiome

• Identifying what clean, green, natural and vegan means to the industry vs. the consumer

• Analyzing the legal requirements for marketing skin microbiome products

• Discussing skin microbiome trends, safety & claims of these novel ingredients (enzymes, pro and prebiotics, bacteria) as well as the FDA’s position on these

• Devising proper product labelling on clean and natural, to ensure claim substantiation

4:45

Understanding IP Protection and Anti-Counterfeiting Measures for Cosmetics

Microphone-alt Camille Friedlander, Legal Counsel, Benefit Cosmetics

David Joyal, VP, Legal – Patents, Coty

Kiri Lee Sharon, Partner, Foley & Lardner

• Trademark protection and case law developments, including the Hermès / MetaBirkins NFT trial

• Patent protection and best practices, including internal controls, and case law developments

• Trade secrets, FOIA and MOCRA considerations, and brand protection in action

• Counterfeiting trends and implementing anti-counterfeiting strategies

5:30

Exploring Diversity and Inclusion in the Cosmetic and Personal Care Industry

Microphone-alt Emily Perez, Owner & Founder, Latinas in Beauty

Jamila Powell, Owner & Founder, Naturally Drenched

Kimberly Smith, Owner, Marjani Beauty

Moderator: Monique Davis, Vice President, Global Local & Cultural Innovation, The Estée Lauder Companies Inc

Our esteemed panel will discuss how the cosmetics and personal care industry continues to make strides to be more inclusive and listen to consumer needs.

6:00

Closing Remarks and Recap of Day One

MAIN DAY TWO

Wednesday, March 29, 2023

7:30 Continental Networking Breakfast and Registration

8:15

Co-Chairs’ Opening Remarks and Recap of Day One

Microphone-alt Sharon Blinkoff, Counsel, Locke Lord LLP

Rohini Gokhale, Global Marketing Counsel, Estée Lauder Companies

8:30

ESG - Moving Forward with Environmental and Social Sustainability in the Cosmetics and Personal Care Products Industries

Microphone-alt Rachel Gartner, Counsel, McDermott Will & Emery LLP

Jaclyn Kaczmarek, Counsel II, Ulta Beauty

Akemi Ooka, Head of Global Supply Chain Resources, Independent Beauty Association

• Examining industry measures to adopt and ensure compliance with ESG protocols

• Exploring ways to reduce the carbon footprint and increase sustainable practices

» Best practices for sustainable and circular packaging in cosmetics: Re-use & re-fill

» Microplastics in Cosmetics: Why do we use them and how can they be replaced?

• Recognizing the social and economic opportunities that sustainability brings for businesses

• Ensuring ingredients are ethically sourced and the ethical treatment of labor

• Highlighting the importance of the corporate/governance commitment to environmental sustainability and social integrity efforts

• Reporting on ESG and complying with upcoming stricter regulations to avoid legal enforcement

9:30

Claims Substantiation Case Studies: Lessons Learned from Past Ads for Cosmetics and Personal Care Products

Microphone-alt Marietta Jo, General Counsel, SuperGoop

Aliza R. Karetnick, Partner, Ballard Spahr

Jennifer Santos, Attorney, National Advertising Division (NAD)

Craig Weiss, President, Consumer Product Testing Co.

• Examining problematic claims and areas of NAD and FTC focus

• Looking at past claims from products using “natural, organic and clean” labels

• Getting beauty advertising right and minimizing the potential for legal action

• Highlighting the importance of testing requirements and studies to substantiate product claims

10:30 Morning Networking Break

10:45

Federal Trade Commission Keynote

Microphone-alt Michael Ostheimer, Attorney, Federal Trade Commission (FTC), Advertising Division

11:30

Avoiding Data Privacy and Ethical Violations in Claims from Using New Technologies in Cosmetics

Microphone-alt Paavana L. Kumar, Partner, Davis & Gilbert LLP

Harry Valetk, Partner, Baker & McKenzie LLP

Ming Zhao, Co-founder & CEO, PROVEN Skincare

New Technologies such as AI have brought opportunity to the cosmetics and personal care industries, but they have also brought risks and challenges — especially in the area of privacy.

• Understanding how we can tackle the privacy challenges arising from the increasing use of digital technologies: AI, ML, AR, and VR, and in the Metaverse

• Identifying privacy and ethics concerns with the use biometric data

• Examining how personalized tools that incorporate artificial intelligence and biometric data (face scanning tools) can lead to privacy violations

• Reviewing state enforcement activity concerning the use of biometrics and its impact on the cosmetics industry

12:15

International Outlook on Export Regulations & Compliance: Focus on Asia

Microphone-alt Robert Kiefer, General Manager, REACH24 USA

Jackson Pai, Counsel, International Trade Group, Crowell & Moring

• Complying with international licensing and registration requirements for your product

• Interpreting the applicable laws for product entry

• Understanding the difficulties when companies ban cosmetic animal testing, but China strictly requires it

• Outlining ways to enter this huge market and taking advantage of market growth in this area

1:00

Co-Chairs’ Closing Remarks and Recap of Day Two Conference Adjourns

POST-CONFERENCE WORKSHOP

Wednesday, March 29, 2023

C2:00 pm–5:30 pm – Registration to begin at 12:30 pm

Due to the hands-on nature of the workshop, it will only be available for in-person attendance.

Master Class on Cosmetics Adverse Events Reporting, and Recalls under MoCRA: A Blueprint for Designing Your Safety Plan

Microphone-alt Ryan Gooley, Director, Business Development – Recall & Remediation, Sedgwick

Dr Rick Kingston, President of Regulatory and Scientific Affairs & Co-founder, SafetyCall International

Diane C. McEnroe, Partner, Sidley Austin LLP

Safety is the core element of MoCRA legislation. Among other things, the law has given FDA mandatory recall authority and created adverse events reporting requirements. Understanding how to execute a recall has always been a critical competency for legal and business executives in these industries. However, MoCRA has taken the concept to a whole new level. This Master Class will ensure that you are prepared for the inevitability of a recall, how to develop and implement MoCRA compliant plans for recall execution, as well as AER reporting.

• Examining FDA’s recall and oversight authority with cosmetics and personal care products under MoCRA

VENUE INFORMATION

Hotel: NY Hilton Midtown

Address: 1335 6th Ave, New York, NY 10019

Reservations: (212) 586-7000

• Identifying events which would trigger a mandatory recall under MoCRA

• Developing best practices to design and implement an FDA-mandated MoCRA recall

• Examining circumstances in which a voluntary recall is warranted

• What is the nature of the recall?

• What corrective actions should be taken?

• Implementing Adverse Event reporting protocols in compliance with MoCRA?

• When and what AER instances are manufacturers now required to report?

• Invoking crisis management protocols

A MUST ATTEND EVENT FOR:

Cosmetics and Personal Care Products Industry

y In-House Counsel, including generalists and those having responsibility for FDA law and regulatory affairs; advertising and promotion; IP, Patents and Trademarks; Licensing and Business Development

American Conference Institute is pleased to offer our delegates a limited number of hotel rooms at a negotiated rate. To take advantage of these rates, please contact the hotel directly and quote “ACI’s Cosmetics”.

Please note that the guest room block cut-off date is March 6, 2023. After that date OR when the room block fills, guestroom availability and rate can no longer be guaranteed.

y Officers, Directors and Executives for Regulatory Affairs; Quality Assurance; Research & Development; Business Development

Law Firm Attorneys for the Cosmetics and Personal Care Products Industry whose practices focus on:

y FDA

y Advertising and Promotion –FTC

y Corporate Matters

y Patents and Trademarks

y Litigation

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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.

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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