Pre-Conference Workshops

In-Person Workshop A — The Foundation of Beauty: Cosmetics and Personal Care Products Law and Regulation 101

Mar 27, 2023 9:00am – 12:30 PM

Speakers

Carrie Kovalerchik
Senior Legal Counsel
Unilever

Cynthia L. Meyer
Partner
Kleinfeld, Kaplan & Becker, LLP

In-Person Workshop B — MoCRA Working Group: All You Need to Know about Modernization of Cosmetics Regulation Act of 2022 (MoCRA)

Mar 27, 2023 1:30pm – 05:00 PM

Speakers

Ann M. Begley
Partner
Wiley

Sam Jockel
Attorney
Alston & Bird

Day 1 - Tuesday, March 28, 2023

7:15
Continental Networking Breakfast and Registration
8:15
Co-Chairs’ Welcome Remarks
8:30
Overview Focus Session on the Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
9:15
Anticipating What’s Next for Beauty Brands in Light of New MoCRA Requirements
10:00
Spotlight on State PFAS Legislation and Its Impact on Cosmetics and Personal Care Products
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
12:00
Networking Lunch
1:00
FDA Keynote on Priorities for 2023
1:45
Aesthetic Market Focus: Is it a Cosmetic? or a Drug? or a Device?
2:45
Networking Break and Speaker Lounge
3:00
The 2023 Litigation and Class Actions Outlook for The Cosmetics and Personal Care Products Industries
4:00
Defining Clean and Natural Beauty: Formulating Claims from the Biggest Trends in 2023
4:45
Understanding IP Protection and Anti-Counterfeiting Measures for Cosmetics
5:30
Exploring Diversity and Inclusion in the Cosmetic and Personal Care Industry
6:00
Closing remarks and Recap of Day One

Day 2 - Wednesday, March 29, 2023

7:30
Continental Networking Breakfast and Registration
8:15
Co-Chairs’ Opening Remarks and Recap of Day One
8:30
ESG – Moving Forward with Environmental and Social Sustainability in the Cosmetics and Personal Care Products Industries
9:30
Claims Substantiation Case Studies: Lessons Learned from Past Ads for Cosmetics and Personal Care Products
10:30
Morning Networking Break
10:45
Federal Trade Commission Keynote
11:30
Avoiding Data Privacy and Ethical Violations in Claims from Using New Technologies in Cosmetics
12:15
International Outlook on Export Regulations & Compliance: Focus on Asia
1:00
Co-Chairs’ Closing Remarks and Recap of Day Two
Conference Adjourns

Post-Conference Workshop

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

Mar 29, 2023 2:00pm – 05:30 PM

Speakers

Diane C. McEnroe
Partner
Sidley Austin

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

Ryan Gooley
Director, Business Development – Recall & Remediation
Sedgwick

Day 1 - Tuesday, March 28, 2023

7:15
Continental Networking Breakfast and Registration
8:15
Co-Chairs’ Welcome Remarks

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)

Arameh Z O’Boyle
Member
Mintz

Gustav W. Eyler
Partner
Gibson Dunn

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

Margaret Whittaker
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

Heidi Forster Gertner
Partner
Hogan Lovells

Diane C. McEnroe
Partner
Sidley Austin

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

Cynthia Liebernam
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

    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

    12:00
    Networking Lunch
    1:00
    FDA Keynote on Priorities for 2023

    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?

    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

    Madeleine Giaquinto
    Director, Regulatory Affairs
    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, and 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 and Speaker Lounge
    3:00
    The 2023 Litigation and Class Actions Outlook for The Cosmetics and Personal Care Products Industries

    Jessica O’Connell
    Partner
    Covington & Burlington

    Shawn R. Obi
    Partner
    Winston & Strawn LLP

    Sylvia E. Simson
    Shareholder
    Greenberg Traurig LLP (New York, NY)

    Class Actions
    • Examining new FDA warning letters on labeling 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

    Tonya Esposito
    Shareholder
    GreenbergTraurig

    Raqiyyah Pippins
    Partner
    Arnold & Porter

    Larry Weiss
    CEO and Founder
    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

    Camille Friedlander
    Legal Counsel
    Benefit Cosmetics (San Francisco Bay Area, CA)

    David Joyal
    VP Legal, Global Supply and Patents
    COTY (New York, NY)

    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

    Emily Perez
    Owner & Founder
    Latinas in Beauty

    Jamila Powell
    Owner & Founder
    Naturally Drenched

    Kimberly Smith
    Attorney and Beautypreneur
    Marjani (Washington, DC)

    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

    Day 2 - Wednesday, March 29, 2023

    7:30
    Continental Networking Breakfast and Registration
    8:15
    Co-Chairs’ Opening Remarks and Recap of Day One

    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

    Rachel Gartner
    Counsel
    McDermott Will & Emery LLP

    Akemi Ooka
    Head of Global Supply Chain Resources
    Independent Beauty Association

    Jaclyn Kaczmarek
    Counsel II
    Ulta Beauty

    • 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

    Marietta Jo
    General Counsel
    Supergoop!

    Aliza R. Karetnick
    Partner
    Ballard Spahr LLP (Philadelphia, PA)

    Jennifer Santos
    Attorney
    National Advertising Division (NAD)

    Craig Weiss
    President
    Consumer Product Testing (Fairfield NJ)

    • 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

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

    11:30
    Avoiding Data Privacy and Ethical Violations in Claims from Using New Technologies in Cosmetics

    Paavana L. Kumar
    Partner
    Davis & Gilbert LLP

    Ming Zhao
    Co-founder & CEO
    PROVEN Skincare

    Harry Valetk
    Partner
    Baker & McKenzie LLP

    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

    Robert J. Kiefer
    General Manager
    REACH24H USA Inc.

    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

    In-Person Workshop A — The Foundation of Beauty: Cosmetics and Personal Care Products Law and Regulation 101

    Mar 27, 2023 9:00am – 12:30 PM

    Carrie Kovalerchik
    Senior Legal Counsel
    Unilever

    Cynthia L. Meyer
    Partner
    Kleinfeld, Kaplan & Becker, LLP

    What is it about?

    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
      • Labeling
      • cGMPs
      • OTC Monographs
    • Identifying FDA requirements governing
      • Ingredients, including color additives
    • 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

    In-Person Workshop B — MoCRA Working Group: All You Need to Know about Modernization of Cosmetics Regulation Act of 2022 (MoCRA)

    Mar 27, 2023 1:30pm – 05:00 PM

    Ann M. Begley
    Partner
    Wiley

    Sam Jockel
    Attorney
    Alston & Bird

    What is it about?

    As the biggest end-of-the-year surprise, MoCRA 2022 was introduced as 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. This workshop will be:

    • Analyzing how MoCRA will change how the FDA regulates cosmetics
    • Determining the next steps for cosmetic brands and examining what resources they need to implement
    • 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

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

    Mar 29, 2023 2:00pm – 05:30 PM

    Diane C. McEnroe
    Partner
    Sidley Austin

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

    Ryan Gooley
    Director, Business Development – Recall & Remediation
    Sedgwick

    What is it about?

    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
    • 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