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

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 Heidi Forster Gertner, Partner, Hogan Lovells

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

• 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

Angela Diesch, Partner, Amin Talati Wasserman LLP

Lynn R. Fiorentino, Partner, ArentFox Schiff

• 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

12:00 Networking Lunch

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

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

Riëtte van Laack, Director, Hyman, Phelps & McNamara

Maura Norden, Executive Vice President, Medical Devices and Combination Products, General Counsel, Greenleaf Health

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 Protections and Anti-Counterfeiting Assurances for Cosmetics & Personal Care Products

Microphone-alt Camille Friedlander, Legal Counsel, Benefit Cosmetics

David Joyal, VP, Legal – Patents, Coty

Kiri Lee Sharon, Partner, Foley & Lardner

• Analyzing recent case law developments affecting trademark infringement and counterfeit goods

• Outlining best practices for building your trademark portfolio and protecting your cosmetics and personal care brands

• Developing internal controls to protect your brand and reduce counterfeit products

• Understanding the threat that the use of NFTs and The Metaverse may pose to branding and how to combat this

• Examining the approval path of novel biotechnology ingredients in cosmetics

5:30

Exploring Diversity and Inclusion in the Cosmetic and Personal Care Industry

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