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12TH ANNUAL LEGAL, REGULATORY, AND COMPLIANCE FORUM ON
12TH ANNUAL LEGAL, REGULATORY, AND COMPLIANCE FORUM ON
March 27–28, 2025 • New York City Bar Association, New York, NY
Co-Chairs:
Risa Drexler
General Counsel - Personal Care
North America
Unilever
Elizabeth Rotenberg-Schwartz
General Counsel Orveon Global
Key Insights From:
Jennifer Santos
Attorney
National Advertising Division
BBB National Programs
Dr. Akemi Ooka
Vice President, Supply Chain and Sustainability Resources
Independent Beauty Association (IBA)
Benchmark with Leading Industry Stakeholders:
• SEPHORA
• The Estée Lauder Companies Inc.
• L'Oréal
• Orveon Global
• SAKS OFF 5TH
• Beiersdorf, Inc.
• Unilever
• Sol de Janeiro
• Consumer Brands Association
• JO Cosmetics
• Maesa
• Jackfir
Key Program Highlights:
CHEVRON-RIGHT Navigating MoCRA’s New Requirements and FDA Enforcement Actions
CHEVRON-RIGHT Addressing ESG Risks and Environmental Marketing Claims in the Beauty Industry
CHEVRON-RIGHT Comprehending the Impact of Extended Producer Responsibility (EPR) and Recyclability Regulations on Manufacturing and Packaging
CHEVRON-RIGHT Tackling Contaminants: Benzene, PFAS, and Asbestos Safety Concerns
CHEVRON-RIGHT Managing Influencer Marketing and FTC Compliance in Advertising
CHEVRON-RIGHT Exploring Global Market Entry: Regulatory Challenges in China and Latin America
CHEVRON-RIGHT Safeguarding Data Privacy and Trade Secrets in the evolving AI-driven landscape
Beauty and the Law 101: Introduction to Cosmetics and Personal Care Products Law and Regulations
Next Stage MoCRA Working Group: Hands-On Guidance for Adverse Event Reporting, Recalls, and GMP Compliance
Claims Substantiation LAB for the Beauty Industry: Interactive Working Group on Reviewing and Adjusting Marketing Claims to Avoid Legal Pitfalls
Luncheon Sponsor:
Associate Sponsors:
Two years after the enactment of the Modernization of Cosmetics Regulation Act (MoCRA), the FDA’s expanded authority over the cosmetics industry is entering a critical new stage. From safety substantiation to recalls and adverse event reporting to labeling to product registration and anticipated cGMPS and standardized contaminant testing – MoCRA continues to reshape cosmetics regulations to ensure safe products for consumers.
ACI’s 12th Annual Legal Regulatory and Compliance Forum on Cosmetics & Personal Care Products will guide you through this next phase of MoCRA compliance as well as other key legal and regulatory matters of concern for the cosmetics and personal care industry.
Our speakers will delve into critical environmental topics such as ESG and related green product claims as well as Extended Producer Responsibility (EPR) in packaging, which is becoming a key area in sustainability efforts. Further on the environmental front, contaminants and PFAS- especially under MoCRA’s PFAS mandate- continue to be a concern and area of litigation risk.
Influencer marketing continues to present new challenges to the industry nearly two years after the FTC guidance. The growing complexities of data privacy in biometrics and AI usage are presenting unique challenges which we will also explore.
The plaintiffs’ bar is still going strong with suits over misleading advertising claims and a whole host of new theories of liability. We will explore successful defense strategies offering practical solutions to ensure your company is able to navigate these complex litigation scenarios
Our speakers will also address trade secrets protection, equipping you with the knowledge to protect your brand and safeguard your products.
Finally, we’ll explore new and developing areas of global interest for industry expansion as well as the challenges they pose.
Join us this March in New York City to learn from industry leaders, stay on top of emerging trends, and connect with peers confronting similar challenges.
Let this gathering serve as your compass as we prepare for the next wave of industry changes.
Risa Drexler General Counsel - Personal Care North America Unilever
Elizabeth RotenbergSchwartz General Counsel Orveon Global
Laura Alos Associate General Counsel
Maesa
Joseph Aquilina Vice President & Deputy General Counsel
Consumer Brands Association
Sharon Blinkoff Counsel
Troutman Pepper Locke LLP
Cathy Burgess Partner Alston & Bird LLP
Maria Celis General Counsel JO Cosmetics
Marcha Isabelle Chaudry, Esq. Founder The Equity and Wellness Collaborative
John Claud Counsel
Hyman, Phelps & McNamara PC
Stefanie Fogel Partner DLA Piper US LLP
Andrew Graap VP - US Data Privacy Officer, Associate General Counsel – Digital L'Oréal
Erica R. Graves Partner Blank Rome LLP
Julia Hatcher Partner Latham & Watkins LLP
Christopher Hornig VP, Assistant General Counsel Saks OFF 5TH
Nilda M. Isidro Shareholder Greenberg Traurig LLP
Brent Johnson Partner Holland & Hart LLP
Robert J. Kiefer General Manager REACH24H USA Inc.
Winston S. Kirton Partner Baker Hostetler
Kristen Klesh Partner Loeb & Loeb LLP
Paavana Kumar Partner Davis+Gilbert LLP
Christina Kwok Senior Counsel Beiersdorf, Inc.
Emilie Lavirotte Senior Advisor Intellectual Property Sephora
Claudia A. Lewis Partner and Co-Chair of Venable’s FDA Group Venable LLP
Taryn Looney VP - Senior Counsel - Global Legal Marketing: Sustainability The Estée Lauder Companies Inc.
Seth Mailhot Partner Husch Blackwell
Cynthia Meyer Partner Kleinfeld Kaplan & Becker LLP
Dr. Akemi Ooka Vice President, Supply Chain and Sustainability Resources Independent Beauty Association
Sarah Peterman Bell Partner Farella Braun + Martel LLP
Raqiyyah Pippins Partner
Arnold & Porter Kaye Scholer LLP
American Conference Institute’s Advisory board is created as a part of ACI’s ongoing effort to provide industry leading content and a world-renowned speaker faculty. This ‘inner circle’ counsels ACI on the impact of legal, regulatory, and compliance trends and emerging topic in this rapidly evolving arena.
Sharon Blinkoff Counsel Locke Lord LLP
Jacqueline Chan Assistant General Counsel Unilever
Charlie Razook Founder Jackfir
Jane Rodriguez-Javier Director Global Regulatory Affairs Sol de Janeiro
Katie Rogers Special Counsel Kelley Drye & Warren LLP
Jennifer Santos Attorney National Advertising Division (NAD)
Aarani Stoneham General Counsel | Legal, Privacy, AI & Ethics ModiFace, Inc., a L'Oréal Group Company
Simone Swafford, DRSc, MS CEO and Founder Vogue Regulatory
Ashish Talati Founding Member Talati Law Firm PLLC
Will Wagner Shareholder Greenberg Traurig LLP
Ivan Wasserman Partner Amin Wasserman Gurnani LLP
Monique Forrest Head of NA Legal Affairs Beiersdorf
Rohini Gokhale Vice President & Global Marketing Counsel The Estée Lauder Companies Inc.
Nicole Lehr SVP, Legal - Litigation, Regulatory & Ethics L'Oréal
Diane McEnroe Partner Sidley Austin LLP
Wednesday, March 26, 2025
9:00 am–12:30 pm (Registration opens at 8:30 am)
A* Due to the hands-on nature of the workshops, they will only be available for in-person attendance.
Kickstart your understanding of the complex legal and regulatory framework that governs cosmetics and personal care products. This interactive workshop will provide the foundational knowledge you need to navigate the evolving regulatory landscape. Key topics will include:
• Understanding the FDA's Role in cosmetics and personal care products:
» Overview of the FDA's regulatory authority and its impact on the market
• Product Classification: cosmetic, drug, or something else?
» Defining cosmetics vs. drugs under the Food, Drug & Cosmetics Act
» When products may be classified as drugs, medical devices, or dietary supplements
• Understanding structure/function claims
• Bringing products to market: Cosmetics vs. OTC Drugs
» The difference between notification and listing requirements
» Navigating cGMPs, labeling rules, and OTC Monographs
• FDA requirements for ingredients
» Special considerations for color additives and other regulated ingredients
• Advertising and promotion: FDA vs. FTC
» Jurisdictional distinctions and compliance for marketing claims
• Pre- and post-market obligations
» Monitoring complaints and adverse event reporting
» Best practices for recalls and product reintroduction
• Other regulatory influences
Cathy Burgess Partner Alston & Bird LLP
Jane Rodriguez-Javier Director Global Regulatory Affairs Sol de Janeiro
» Retailers, consumers, state regulations, and additional federal agencies like CPSC and EPA
BThis workshop is designed to equip counsel and regulatory executives with the knowledge and practical tools needed to ensure compliance with the next stage of MoCRA compliance and deliverables. Attend and learn about MoCRA’s adverse events and recall requirements, as well as forthcoming cGMP regulations.
Key Workshop Highlights:
• Adverse Event Reporting and Recalls: Gain practical insights on establishing robust systems for monitoring and reporting adverse events, handling recalls, and ensuring compliance with MoCRA’s stringent requirements
• GMP Compliance: Develop a comprehensive cGMP compliance plan in anticipation of the FDA’s release of new cosmetics cGMPs
• Inspection Readiness: Explore best practices for preparing for FDA inspections, including how to implement preventive measures and conduct internal audits to maintain compliance
» Mitigating the risk of receiving warning letters related to GMP violations
Maria Celis General Counsel JO Cosmetics
Winston S. Kirton Partner Baker Hostetler
Thursday, March 27, 2025
7:15 Continental Networking Breakfast and Registration
8:15 Opening Remarks from the Co-Chairs
Risa Drexler General Counsel - Personal Care North America Unilever
Elizabeth Rotenberg-Schwartz General Counsel Orveon Global
8:30 MoCRA Rollout Status Report–What’s Next for the Cosmetics and Personal Care Industries? Where Are We Now?
As MoCRA continues to reshape the regulatory landscape, understanding what comes next is essential for your business, ensuring you remain compliant and mitigate potential risks.
This panel will provide a comprehensive analysis of the progress made under MoCRA so far and explore key areas in which the FDA is expected to act.
• Examining the new administration's influence on MoCRA enforcement changes
• Assessing forthcoming regulatory updates and guidance under MoCRA
• Understanding upcoming FDA deadlines and potential enforcement actions
• Practical steps and strategies for reporting compliance data, including safety substantiation and adverse events
Cynthia Meyer Partner Kleinfeld, Kaplan & Becker LLP
Simone Swafford, DRSc, MS CEO and Founder Vogue Regulatory
Ashish Talati Founding Member Talati Law Firm PLLC
9:30 Roundtables: The Cosmetics Industry’s Green Gamble Working Group: Assessing ESG Risks and Evaluating Environmental Marketing Claims
Join us for this exciting interactive session on the increasing scrutiny around ESG marketing claims including ethical obligations in marketing to under-age consumers.
This session will feature a tabletop exercise in which participants will break into roundtables, each reviewing a different hypothetical.
• Analyzing the rise of “environmentally friendly" claims for sunscreens, recyclable packaging, and other popular marketing hooks
» Why "reef-friendly" and sustainability claims are becoming high-risk targets for litigation
• Keeping ESG protocols and risks in mind when developing new products as well as product innovation
• Examining ethical concerns and regulatory requirements in Gen Alpha marketing when targeting cosmetics to minors
10:15 Morning Networking Coffee Break
Joseph Aquilina Vice President & Deputy General Counsel Consumer Brands Association
Erica R. Graves Partner Blank Rome LLP
Katie Rogers Special Counsel Kelley Drye & Warren LLP
The choice of hot topics allowed for great discussions between speakers and participants. Chief Marketing Counsel, Oral Care, Colgate Palmolive Company
Sustainability is non-negotiable for today’s cosmetics industry. The scrutiny over plastic packaging and recyclability is intensifying for the cosmetics industry. New state extended Producer Responsibility (EPR) laws and other new state and federal regulations focusing on reducing waste and improving recyclability are reshaping how manufacturers approach packaging.
This panel will help your company stay compliant and avoid litigation risks by providing a roadmap for navigating these complex regulations while aligning with both U.S. and international standards.
• Surveying existing and proposed EPR legislation at the state and federal levels, particularly California's groundbreaking plastics legislation and Washington's evolving framework
» What can we learn from California’s new textile EPR legislation?
• Understanding how EPR laws shift the responsibility for waste management onto manufacturers, importers, and retailers, driving the push for more sustainable packaging solutions
• Key insights into the recyclability of cosmetic packaging and how brands can meet increasing sustainability expectations
• Examining the litigation risks surrounding misleading recyclability claims or noncompliance with EPR laws
• Developing best practices for manufacturers navigating both U.S. and European regulations on packaging, recyclability, and waste reduction
11:30
Understanding the risks associated with ingredients like benzene, titanium dioxide (TiO2), and asbestos is crucial for safeguarding both consumers and your business. This panel will look at the latest developments, litigation trends, and safety concerns surrounding harmful contaminants in cosmetic and personal care products.
• Benzene Contamination: Exploring recent recalls (sunscreens, dry shampoos), contamination causes and prevention
• Titanium Dioxide (TiO2): Reviewing safety concerns, best practices for labeling, and litigation updates
• Asbestos in Talc: Understanding FDA testing standards, asbestos contamination risks, and current class actions
• Other Contaminants: Examining risks associated with microcontaminants, formaldehyde (hair relaxers) and heavy metals
12:30 Networking Luncheon
Sponsored by
1:45 Fireside Chat: Up Starts and Start Ups
Get an insider’s perspective from a dynamic cosmetics startup owner on how to navigate today’s ever-evolving legal and regulatory landscape.
Stefanie Fogel Partner
DLA Piper US LLP
Dr. Akemi Ooka
Vice President, Supply Chain and Sustainability Resources
Independent Beauty Association (IBA)
Sarah Peterman Bell Partner
Farella Braun + Martel LLP
Will Wagner Shareholder
Greenberg Traurig LLP
Nilda M. Isidro Shareholder
Greenberg Traurig LLP
Christina Kwok Senior Counsel Beiersdorf, Inc.
Charlie
Our panelists will explore state level bans on PFAS as well as the MoCRA mandate to help guide you through compliance and safety standards as well as growing regulatory and legal scrutiny.
• Assessing the status of MoCRA’s PFAS mandate and its 3-year deadline for FDA evaluations of PFAS in cosmetics
• Surveying state PFAS activity affecting cosmetics
» California’s Assembly Bill (AB 2771) banning the manufacture, delivery or sale of any cosmetic product containing “intentionally added” PFAS
Julie (Julia A.) Hatcher
Partner
Latham & Watkins LLP
Seth Mailhot Partner
Husch Blackwell
» Oregon's 'Toxic-Free Cosmetics Act' (banning PFAS from 2027) and Washington's 2023 Toxic-Free Cosmetics Act
• Analyzing recent PFAS-related lawsuits, particularly class actions focusing on deceptive marketing and false "green" or "safe" claims
• Understanding the complexity of PFAS testing, how contamination often occurs during production, and the challenges of identifying all 9,000+ PFAS chemicals
3:00 Afternoon Break
3:30 Beauty in Developing World Markets: Contrasting Opportunities and Challenges in the Latin American and Chinese Cosmetics Markets
This panel will explore two areas of global focus for the cosmetics industry: Latin America and China. In recent year’s Latin America’s rising appeal as a key market for the cosmetics industry has made it an attractive target for expansion. While shifting regulatory dynamics, economic developments, changes in consumer demands and tariffs are having an impact on China’s cosmetics market.
This panel will provide insights to help your company adapt its growth strategies in each region.
Latin America Focus
John Claud
Counsel
Hyman, Phelps & McNamara, P.C.
Robert J. Kiefer General Manager REACH24H USA Inc.
• Navigating Latin American regulations for cosmetics, focusing on compliance deadlines and registration processes
• Analyzing the shift of manufacturing operations to Latin America and the potential benefits over China, including cost and supply chain resilience
China Focus
• Survey of China’s Cosmetics Supervision and Administration Regulation (CSAR) and the new restrictions’ impact on market entry for cosmetics companies
• Understanding the implications of NMPA Circular No. 50: Recent developments and how they affect market entry and product registration
• Considering the impact of possible changes in U.S.-China relations on tariffs and market entry, and how companies can adapt their strategies
Accreditation will be sought in those jurisdictions requested by the registrants which have continuing education requirements. This course is identified as nontransitional for the purposes of CLE accreditation.
ACI certifies this activity has been approved for CLE credit by the New York State Continuing Legal Education Board.
ACI certifies this activity has been approved for CLE credit by the State Bar of California.
ACI has a dedicated team which processes requests for state approval. Please note that event accreditation varies by state and ACI will make every effort to process your request.
For more information on ACI’s CLE process, visit: www.AmericanConference.com/Accreditation/CLE
With AI technology reshaping the cosmetics and personal care industry, companies must address legal risks and regulatory requirements surrounding data privacy and biometrics. This panel will explore the emerging challenges with AI-driven tools, particularly those aimed at teenagers, and the evolving legal landscape surrounding biometric data.
• Exploring the emerging legal risks for cosmetics and personal care companies using AI-powered apps, especially those marketed toward teenagers
» How are these technologies impacting and influencing children and teenagers with respect to cosmetics products?
Andrew Graap
VP - US Data Privacy Officer, Associate General Counsel – Digital L'Oréal
Aarani Stoneham
General Counsel | Legal, Privacy, AI & Ethics ModiFace, Inc., a L'Oréal Group Company
• Examining new legal trends in Texas and Illinois regarding biometric data, and the risks of non-compliance
• Understanding evolving privacy, data security, and liability concerns tied to these technologies
• Assessing transparency and disclosure requirements when utilizing AI in personal care apps and platforms
• Delving into the implications of AI for cosmetics product development, marketing, and customer interaction
• Determining what is permissible in terms of data usage, AI-driven recommendations, and product claims
ROUNDTABLE LEADER:
Sharon Blinkoff Counsel
Troutman Pepper Locke LLP Advertising Compliance Litigation Concerns Contaminants in Cosmetics
6:00
Good presentations by subject matter experts on a wide variety of regulatory matters in the cosmetic world.” Director, Counsel, Regulatory Matter, Target Corporation
The C5 Group, comprising American Conference Institute, the Canadian Institute and C5 in Europe, is a leading global events and business intelligence company.
For over 40 years, C5 Group has provided the opportunities that bring together business leaders, professionals and international experts from around the world to learn, meet, network and make the contacts that create the opportunities. Our conferences and related products connect the power of people with the power of information, a powerful combination for business growth and success.
Friday, March 28, 2025
7:30 Continental Networking Breakfast and Registration
8:15
Risa Drexler General Counsel - Personal Care North America Unilever
Elizabeth Rotenberg-Schwartz General Counsel Orveon Global
This panel will explore how regional initiatives on both coasts are continuing to influence national standards and what your company needs to know to stay ahead of the changing tide.
• Examining how California and New York continue to pioneer regulations that set the tone for broader industry standards
• Understanding how state-specific regulations, including PFAS bans and other environmental concerns, are reshaping industry practices as well as federal initiatives
• Understanding how California’s Prop 65 continues to influence industry practices
• Navigating overlapping state and federal regulation
• Exploring current and pending state legislation having the greatest industry impact:
» California's AB 2771
» Oregon's Toxic-Free Cosmetics Act (2023)
» Washington’s Toxic-Free Cosmetics Act (2023)
» Colorado’s PFAS Ban (HB22-1345)
» New York’s Toxic Chemicals in Children’s Products Law
Marcha Isabelle Chaudry, Esq. Founder The Equity and Wellness Collaborative
Kristen Klesh Partner Loeb & Loeb LLP
Delve into effective defense tactics, and risk mitigation strategies as we examine the latest maneuvers from the plaintiffs’ bar in beauty industry class actions.
• Analyzing innovative tactics employed by the plaintiffs' bar and how to counter them successfully
• Unpacking common claims in beauty litigation, from product safety and labeling to advertising controversies, and identifying the best defenses
• Exploring the impact of MoCRA’s safety substantiation and adverse event reporting requirements on current and emerging cosmetic product claims
• Examining pivotal cases and recent rulings to anticipate trends and challenges in class action defense
Christopher Hornig VP, Assistant General Counsel Saks OFF 5TH
Brent Johnson Partner Holland & Hart LLP
Raqiyyah Pippins Partner Arnold & Porter, Kaye & Scholer LLP
10:30
• Understanding how the FTC guidelines have affected influencer marketing campaigns and what companies have learned about aligning marketing practices with compliance
• Developing strategies for building compliant and practical influencer partnerships, from disclosure requirements to contract essentials
• Exploring the rise of AI influencers and the legal risks in cosmetics advertising, including avoiding fake reviews and misleading endorsements
• Exploring National Advertising Division’s (NAD) oversight in this area and how NAD rulings influence cosmetics marketing tactics on social media platforms
Paavana Kumar Partner Davis+Gilbert LLP
Claudia A. Lewis
Partner and Co-Chair of Venable’s FDA Group Venable LLP
Elizabeth Rotenberg-Schwartz General Counsel
Orveon Global
Jennifer Santos Attorney
National Advertising Division (NAD)
As the cosmetics industry continues to innovate with cutting-edge ingredients, AI technology, as well as facing evolving consumer trends, brands are seeing increased risks in the areas of intellectual property (IP) protection and regulatory compliance.
• Identifying the critical steps for safeguarding your IP in a competitive market, with a focus on trademarks, copyrights, and patents
» Ensuring confidentiality agreements and legal protections are robust enough to guard proprietary formulas, production techniques, and product innovations
» Key strategies for protecting trade secrets, especially in collaborative environments where brands work closely with third-party manufacturers and suppliers
Laura Alos
Associate General Counsel Maesa
Emilie Lavirotte
Senior Advisor Intellectual Property Sephora
• Understanding the risks and ethical considerations tied to using AI for advertising, product recommendations, creation of new formulations, as well as the potential for infringement on privacy or IP rights
» Exploring the risks of IP theft or misuse when relying on AI-driven tools and platforms
• Understanding the global challenges of IP protection and securing your brand and across international markets
1:00
Brought
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
Friday, March 28, 2025
2:00–5:30 pm (Registration opens at 1:30 pm)
C* Due to the hands-on nature of the workshops, they will only be available for in-person attendance.
Claims Substantiation LAB for the Beauty Industry: Interactive Working Group on
Welcome to our LAB, where you’ll ‘Learn, Apply and Benchmark’ proper claims substantiation techniques for the beauty and personal care industries.
Ensuring proper claims substantiation for cosmetic and personal care products is a complex, fact-specific process. Even with solid, well-designed studies, marketing claims can attract scrutiny from regulators and plaintiff’s attorneys.
To help you design solid claims, our LAB instructors will walk you through hypothetical scenarios on product claims and focus on proper claims substantiation protocols.
We also invite you to bring your own hypothetical scenarios into the LAB for review and analysis.
What happens in the LAB, stays in the LAB!
What you’ll learn:
Taryn Looney
VP - Senior Counsel - Global Legal Marketing: Sustainability
The Estée Lauder Companies Inc.
Ivan Wasserman Partner
Amin Wasserman Gurnani
• Designing thorough studies to support the advertising and marketing claims in the cosmetics and personal care space
» What scientific evidence is necessary to support beauty and wellness claims?
• Understanding what the FTC expects from clinical studies for claim substantiation, including research methodologies and data interpretation
» Lessons from recent FTC enforcement actions and how to avoid similar missteps
• Recognizing implied claims and hidden risks in marketing materials across media and social platforms
• Testing requirements for cosmetics, with a focus on U.S., Canada, EU, UK, and Asian markets
• Examining growing scrutiny over clean/natural claims and ingredient-specific marketing (e.g., preservative-free)
American Conference Institute is pleased to offer our delegates a limited number of hotel rooms at a negotiated rate at the Sofitel Hotel. To take advantage of these rates, please contact the hotel directly and quote “ ACI's March 2025 Block ”. Please note that the guest room block cut-off date is February 24, 2025. After that date OR when the room block fills, guestroom availability and rate can no longer be guaranteed.
Register and pay to lock in your early rate and be eligible for a full refund until March 13, 2025. If you are unable to attend for any reason, you will have the following options:
y A full credit note for you, or a colleague to attend another event.
y A full refund.
All cancellations and changes must be submitted to CustomerService@AmericanConference.com by March 13, 2025.
or customerservice@americanconference.com to learn more about this option.