Pre-Conference Workshops

Workshop A – The Foundation of Beauty: An Introduction to Cosmetics and Personal Care Products Law and Regulation

Sep 27, 2023 9:00am – 12:30 PM

Speakers

Riëtte van Laack
Director
Hyman, Phelps & McNamara

Cynthia Meyer
Partner
Kleinfeld, Kaplan & Becker LLP

Networking Break

Sep 27, 2023 12:30pm – 01:00 PM

Workshop B – MoCRA Compliance Working Group: A Practical and Tactical Guide to the Modernization of Cosmetics Regulation Act of 2022 (MoCRA)

Sep 27, 2023 1:30pm – 05:00 PM

Speakers

Xin Tao
Partner
Baker & McKenzie LLP

Suzie Trigg
Partner
Haynes Boone

Brigid DeCoursey Bondoc
Partner
Morrison Foerster

Angela Diesch
Partner & Cosmetics Industry Practice Lead
Amin Talati Wasserman

Day 1 - Thursday, September 28, 2023

7:15
Continental Networking Breakfast and Registration
8:15
Co-Chairs’ Welcome Remarks
8:30
MoCRA Status Report: An In-Depth Look at the Industry’s Response to the Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
9:30
Preparing for MoCRA Implementation: Practical Steps for Beauty Companies to Meet the December 29th Implementation Date
10:15
Morning Networking Coffee Break
10:45
Cracking the California Cosmetics Code: A Guide to Ensuring Compliance with California’s Laws and Regulations for Cosmetics and Personal Care Products
11:30
A Guide to West Coast Packaging and Labeling Requirements for Cosmetics Manufacturers: Ensuring Legal and Regulatory Compliance
12:30
Networking Lunch
1:30
Keynote Interview
2:00
A Practical Guide to State PFAS Legislation and Initiatives: What You Need to Know About Compliance and Mitigation
2:45
Embracing the Beauty of New Technologies While Avoiding the Dangers of Data Privacy Violations
3:30
Networking Break and Speaker Lounge
4:00
The Future of Clean Beauty: Trends and Regulations
4:45
Green is the New Beautiful: Navigating ESG for Environmentally and Socially Sustainable Cosmetics and Personal Care Products
5:30
Closing remarks
Cocktail Reception Sponsored by:

Sponsor

Day 2 - Friday, September 29, 2023

7:30
Continental Networking Breakfast and Registration
8:15
Co-Chairs’ Opening Remarks and Recap of Day One
8:30
Class Action and Prop 65 Litigation Report for Cosmetics and Personal Care Products
9:15
Keynote Address
9:45
Morning Networking Break
10:15
Insights from Past Advertising Mistakes: Case Studies in Claims Substantiation for Cosmetics and Personal Care Products
11:00
Breaking Barriers: A Journey Through Diversity and Inclusion in the Personal Care and Cosmetic Industry
11:35
Protecting Your Cosmetics Empire: Exploring IP Protections and Anti-Counterfeiting Strategies
12:20
International Affairs: Successfully Navigating Cosmetics and Personal Care Products Markets Across the Globe
1:05
Co-Chairs Closing Remarks and Recap of Day Two Conference Adjourns

Post-Conference Workshop

Workshop C – Recall Master Class: An Essential Guide to Cosmetics Adverse Events Reporting, and Recalls under MoCRA for Small and Large Companies

Sep 29, 2023 2:00pm – 05:30 PM

Speakers

Jessica Ringel
Partner
King & Spalding

Ryan Gooley
Director, Business Development – Recall & Remediation
Sedgwick

Day 1 - Thursday, September 28, 2023

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

Angela Diesch
Partner & Cosmetics Industry Practice Lead
Amin Talati Wasserman

Camille Friedlander
Legal Counsel
Benefit Cosmetics

8:30
MoCRA Status Report: An In-Depth Look at the Industry’s Response to the Modernization of Cosmetics Regulation Act of 2022 (MoCRA)

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

Angela Diesch
Partner & Cosmetics Industry Practice Lead
Amin Talati Wasserman

Dan Kolhoff
Director of Regulatory & Legal Affairs
John Paul Mitchell

MoCRA has been a game changer for the cosmetics industry. This panel will examine the status of the law and FDA guidance as well as where companies are and how they are adapting.

  • Examining MoCRA and related FDA guidance issued thus far
  • Analyzing how MoCRA has affected the beauty industry and what companies are doing to adapt
  • Assessing where large, small, and independent manufacturers are with devising plans for product registration, listing, and good manufacturing practices (cGMPS)
  • Examining the new FDA cosmetics registration program

9:30
Preparing for MoCRA Implementation: Practical Steps for Beauty Companies to Meet the December 29th Implementation Date

Laurie Henry
Partner
Shook Hardy and Bacon

Don Frey
President & CEO
Independent Beauty Association

Sue Collins
Executive Vice President & General Counsel
Obagi Cosmeceuticals LLC

MoCRA takes full effect on December 29, 2023. This panel will delve deeper into the specific steps that cosmetic companies must take to achieve compliance with MoCRA and meet the end of year implementation deadline. Our renowned panelists will provide practical guidance to navigate the current regulatory landscape, highlighting key considerations and outlining actionable next steps.

  • How are companies responding to the tight compliance window, and what measures is the FDA take to assist them during this process?
  • Educating new and smaller brands about the implications of MoCRA for getting their products on the market
  • Developing best practices for compliance and how companies can go beyond the minimum requirements of MoCRA to ensure consumer safety and build trust with their customers
  • Exploring the new manufacturing practices required under MoCRA and how to implement them in a way that meets regulatory standards

10:15
Morning Networking Coffee Break
10:45
Cracking the California Cosmetics Code: A Guide to Ensuring Compliance with California’s Laws and Regulations for Cosmetics and Personal Care Products

Tia Feltner
US Regulatory Affairs Manager
Jafra Cosmetics

Dr. Simone Swafford
CEO/Founder
Vogue Regulatory

Sophie Castillo
Partner
Keller & Heckman LLP

California has been a pioneer in regulating the markets for cosmetics and consumer products. Washington State is also joining the bandwagon with its recently introduced ‘Toxic Free Cosmetics Act.’ With ever-changing laws and regulations, it can be challenging for companies to ensure compliance while also meeting consumer demand for safe and effective products.

Join our panelists for an in-depth review of the most important laws and regulations at the state and federal levels, that brands need to be aware of, such as:

  • Understanding California’s Safe Cosmetics Program and its reporting requirements
  • Ensuring compliance with Proposition 65 and its warning requirements
  • Staying up to date on evolving regulations and industry trends
  • Gaining a comprehensive understanding of the legal disputes between state and federal bodies and assessing the applicability of preemption

Washington State focus:

  • Preparing for Washington’s Toxics-Free Cosmetics Act, that will be banning the manufacture, sale, and distribution of cosmetics containing nine chemicals and chemical classes, including formaldehyde and “forever chemicals” starting in 2025

11:30
A Guide to West Coast Packaging and Labeling Requirements for Cosmetics Manufacturers: Ensuring Legal and Regulatory Compliance

Allyn Stern
Principal
Beveridge & Diamond

Qareena Ahsan
Director Safety & Regulatory
Maesa

Dennis Raglin
Partner
Steptoe & Johnson LLP

California and Washington state possess some of the most rigorous packaging and labeling regulations for cosmetics nationwide. These regulations present a significant challenge for companies as they strive to ensure compliance while simultaneously meeting consumer demands for creative and appealing packaging.

This session aims to provide you with a comprehensive understanding of the requirements, as well as guidance on how your business can best manage this challenge.

West Coast Laws Affecting Cosmetic Packaging and Labeling:

  • Analyzing the impact of the California Safe Cosmetics Act on packaging and labeling
  • Examining The Federal Fair Packaging and Labeling Act (FPLA) and its impact on consumer products labeling
  • California SB 54’s influence on manufacturers, with respect to recyclable and compostable packaging
  • The California Consumers Legal Remedies Act in ensuring companies do not engage in false and deceptive advertising on labels
  • Exploring Washington State’s Renewable Materials Packaging Law and how the legislation impacts manufacturers

Practical Applications of State Federal Packaging and Labeling Laws and Regulations

  • Considering state specific requirements for labeling ingredients, warnings, and claims relative to your products
  • Analyzing how large and small companies navigate product labeling harmonization this across different markets
  • Developing compliant and attractive packaging that meets consumer demands within the scope of federal and state guidelines
  • Examining claims regarding packaging and compostability, and exploring the role of Extended Producer Responsibility (EPR) schemes in this context
  • Maintaining current knowledge of ingredient disclosure obligations, warning prerequisites, and ensuring adherence to FDA regulations to prevent inaccurate or deceptive labeling
  • Assessing how cosmetic producers can assert federal preemption and defend against slack fill claims under the FD&C Act

12:30
Networking Lunch
1:30
Keynote Interview

Jessica Iclisoy
Founder/CEO
California Baby

Camille Friedlander
Legal Counsel
Benefit Cosmetics

2:00
A Practical Guide to State PFAS Legislation and Initiatives: What You Need to Know About Compliance and Mitigation

Julie Hatcher
Partner
Latham & Watkins LLP

Aliza Karetnick
Partner
Ballard Spahr

Jeff Parker
Partner
Sheppard Mullin

The presence of PFAS “Forever Chemicals” has startled the cosmetics industry, prompting companies to adopt proactive and strategic approaches in order to regain consumer trust. With the introduction of PFAS bans by states like California, Washington, and Maine, it appears that this is only the start. In this session, we will delve into the details of how to ensure that your company remains compliant and assist you in taking appropriate measures to address PFAS challenges.

  • Reviewing the state legislation and other initiatives on restricting PFAS and how this activity will impact your company
  • Anticipating the likelihood of federal PFAS legislation
  • Examining PFAS testing and the various ways it can be interpreted
  • Devising a plan for smaller brands conduct product testing while staying within their budget
  • Mitigating existing PFAS risks in your products
  • Developing PFAS- free formulas that will meet the complexity of the complying with the new regulatory landscape
  • Exploring other areas ox toxicity of concern to the cosmetics and personal care industries: titanium dioxide, heavy metals

2:45
Embracing the Beauty of New Technologies While Avoiding the Dangers of Data Privacy Violations

Carlo Felizardo
Attorney
Gibson, Dunn & Crutcher

Amy P. Lally
Partner
Sidley Austin LLP

Elliott Siebers
Special Counsel
Kelley Drye

As the cosmetics industry continues to adopt more advanced technologies, including AI in the development and promotion of its products there is a growing need to address data privacy concerns. With the rise of digital personalization tools and other data-driven innovations, it is critical that companies prioritize data privacy and security to protect their customers’ sensitive information.

  • Analyzing the industry’s response to the use of AI, ML, AR, VR technologies, and the Metaverse
  • Balancing the benefits of AI and other new technologies with the need for data privacy and security in cosmetic product development and promotion
  • Developing a blueprint for incorporating AI and other technologies into cosmetic product development and promotion while still prioritizing data privacy and security
  • Identifying privacy and ethics concerns associated biometric technologies and try-on tools
  • Exploring state legislation such as the California Consumer Privacy Act (CCPA), the Biometric Information Privacy Act (BIPA) and related enforcement actions

3:30
Networking Break and Speaker Lounge
4:00
The Future of Clean Beauty: Trends and Regulations

Sarah Bruno
Partner
Reed Smith LLP

Mallory McMahon
Senior Director, Research and Innovation
The Honest Company

Tarek Nasser
Senior Manager, Global Regulatory Affairs
Hero Cosmetics

Clean beauty is a fast-growing cosmetics trend where consumers seek products which are free of harmful chemicals and aligned with their values of sustainability and social responsibility. However, this trend requires that companies substantiate their claims to comply with regulations and win consumer confidence.

This session will explore the world of clean beauty and the legal, regulatory, and business considerations that come with it. Our panel will provide insights into:

  • Identifying what clean beauty means for the industry and the consumer
  • Exploring skin microbiome trends, safety, and claims of novel ingredients (enzymes, pro/prebiotics, bacteria) and the FDA’s stance on these
  • Developing accurate product labeling for clean and natural claims to ensure substantiation
  • Striking the right balance between sustainability and safety when developing products
  • Ensuring ethical sourcing of clean ingredients and fair trade and labor practices

4:45
Green is the New Beautiful: Navigating ESG for Environmentally and Socially Sustainable Cosmetics and Personal Care Products

Brent Johnson
Partner
Holland & Hart LLP

Maggie Spicer
Founder
Source Beauty ESG

Jessica Trujillo
Director, Trade & Corporate Compliance
Young Living

Our panelists will share insights on how companies can integrate ESG considerations into their operations and explore innovative approaches to advance sustainable practices within the cosmetics and personal care products industry.

  • Providing an overview of the ESG framework, and how it applies to the cosmetics and personal care products industry
  • Exploring ways to reduce the carbon footprint and increase sustainable practices
  • Highlighting best practices for sourcing, manufacturing, and distributing sustainable ingredients
  • Assessing the role of consumer education in promoting sustainability, and exploring effective ways to communicate the importance of responsible consumption to customers

5:30
Closing remarks
Cocktail Reception Sponsored by:

Sponsor

Day 2 - Friday, September 29, 2023

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

Angela Diesch
Partner & Cosmetics Industry Practice Lead
Amin Talati Wasserman

Camille Friedlander
Legal Counsel
Benefit Cosmetics

8:30
Class Action and Prop 65 Litigation Report for Cosmetics and Personal Care Products

Arameh O’Boyle
Member
Mintz

Claudia Lewis
Partner
Venable LLP

Emily Leongini
Partner
ArentFox Schiff LLP

The cosmetics industry has been a frequent target of class action lawsuits, with many consumers taking legal action over alleged false advertising and misleading claims. The West Coast has been a particularly active region for such litigation, with numerous high-profile cases being filed against cosmetics companies in recent years.

Class Action Activity

  • Analyzing recent class action litigation activity involving product performance, false and misleading advertising, and mislabeling
    • Linkage to FDA warning letters, NAD and FTC activity
  • Addressing California specific litigation, and court decisions and how this may influence class action activity in the rest of the county
  • Examining titanium dioxide (TiO2), PFAS, and heavy metal class actions in cosmetics and how this litigation is progressing Assessing the resurgence of the pre-emption defense and possible new interpretations under MoCRA

Prop 65 Focus:

  • Identifying the latest wave of plaintiffs’ claims made under Prop 65
  • Examining defenses the industry is employing

9:15
Keynote Address

Prashiela Manga
Deputy Director, Office of Cosmetics and Colors, CFSAN
Food and Drug Administration (FDA)

9:45
Morning Networking Break
10:15
Insights from Past Advertising Mistakes: Case Studies in Claims Substantiation for Cosmetics and Personal Care Products

Amy Ralph Mudge
Partner
BakerHostetler

Michael Ostheimer
Attorney
Federal Trade Commission

Jennifer Santos
Attorney
National Advertising Division

Advertising claims can be a source of potential legal and reputational risk if they are false, misleading, or unsubstantiated. Regulatory agencies such as the Federal Trade Commission (FTC) and consumer groups such as NAD closely monitor these and have their own guidelines that manufacturers need to be aware of.

  • Analyzing case studies of successful (and unsuccessful) cosmetics advertising and social media campaigns
  • Examining the role, reach, and risk of influencers in the promotion of beauty and personal care products
  • Mastering the art of beauty advertising: Tips for achieving compliance and avoiding legal challenges
    • Identifying risks associated with false or misleading advertising claims
    • Outlining the importance of accurate and truthful advertising claims
    • Emphasizing the significance of proper testing and research to support product claims
  • The Naked Truth: Uncovering the validity of ‘natural,’ ‘organic,’ and ‘clean’ claims in beauty products
  • Understanding the role of NAD and FTC in advertising for cosmetics and personal care products

11:00
Breaking Barriers: A Journey Through Diversity and Inclusion in the Personal Care and Cosmetic Industry

Kenya Garrett
Senior Director, Global Head, Diversity, Equity, & Inclusion
Kendo Brands

Beauty companies are striving to become more inclusive and appreciative of all consumers who use their products through accessible and tailored products to the individualized needs of one’s skin and hair, skin shade ranges, gender-neutral products and inclusive beauty campaigns. With all of these, consumers still feel there is much work that needs to be done as an industry.

Don’t miss out on this enlightening and engaging panel discussion and hear directly from brands themselves on what measures they’re taking to promote diversity and inclusivity at all business levels.

11:35
Protecting Your Cosmetics Empire: Exploring IP Protections and Anti-Counterfeiting Strategies

Emilie Lavirotte
Senior Advisor Intellectual Property
Sephora

Michael R. Murphy
Partner
K&L Gates

John Wiseman
Vice President, Deputy General Counsel, Intellectual Property, FDA/Regulatory
Mary Kay Inc.

Many businesses don’t realize the severity of the counterfeiting, until it’s too late, and they have already suffered the consequences of counterfeit products bearing their brand name. Join our panelists in an insightful dialogue on what IP strategies you can implement to protect your brand and company from the get-go and minimize counterfeit products.

  • Analyzing the role of enforcement agencies in preventing counterfeiting and infringing activities
  • Safeguarding your brand, products, and revenue through the various technologies and tools used to detect and combat counterfeit products
  • Exploring counterfeiting trends and implementing anti-counterfeiting strategies
  • Examining trademark protections and case law developments

12:20
International Affairs: Successfully Navigating Cosmetics and Personal Care Products Markets Across the Globe

Nadine Goldman
Director, Regulatory
Anastasia Beverly Hills

Felicia Leborgne Nowels
Partner, Government Affairs and Public Policy
Akerman LLP

Jackson Pai
Counsel
Crowell & Moring

Our speakers will provide a detailed overview and in-depth analysis for the successful global entry of your product by helping you understand this highly complex international market, and devise strategies for regulatory approval and export.

  • An overview of US, Europe and China’s most relevant regulatory requirements for cosmetics and personal care products
  • Streamlining Business Processes: Solutions for simplifying registration, labeling, and free sample imports and more
  • Identifying what companies need to have on their radar and how to proactively take steps to avoid detention of merchandise

1:05
Co-Chairs Closing Remarks and Recap of Day Two Conference Adjourns

Workshop A – The Foundation of Beauty: An Introduction to Cosmetics and Personal Care Products Law and Regulation

Sep 27, 2023 9:00am – 12:30 PM

Riëtte van Laack
Director
Hyman, Phelps & McNamara

Cynthia Meyer
Partner
Kleinfeld, Kaplan & Becker LLP

What is it about?

Registration to begin at 8:30 am (BREAK 10:30-11:00)

This informative and engaging workshop will pave the way for the two-day main conference by offering a thorough overview of the laws and regulations governing the cosmetics and personal care products industry. Whether you are a newcomer on the market or wish to stay up to date with the latest legal developments, join our workshop leaders for an in-depth resource and training session.

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

Networking Break

Sep 27, 2023 12:30pm – 01:00 PM

Workshop B – MoCRA Compliance Working Group: A Practical and Tactical Guide to the Modernization of Cosmetics Regulation Act of 2022 (MoCRA)

Sep 27, 2023 1:30pm – 05:00 PM

Xin Tao
Partner
Baker & McKenzie LLP

Suzie Trigg
Partner
Haynes Boone

Brigid DeCoursey Bondoc
Partner
Morrison Foerster

Angela Diesch
Partner & Cosmetics Industry Practice Lead
Amin Talati Wasserman

What is it about?

Registration to begins at 12:30 pm (BREAK at 2:30 pm)

With more than six months since MoCRA 2022 was introduced as law, companies are now turning to FDA and industry for guidance and support on complying with new federal standards in the cosmetics industry for registration, adverse event reporting product listing, recordkeeping, recalls, safety substantiation and more.

Join our workshop leaders for a deep dive into the MoCRA framework, which will provide you with essential knowledge to help your company ensure compliance with current guidelines and prepare for upcoming changes and requirements. Points of discussion will include:

  • Examining how MoCRA changed the way cosmetics are regulated by the FDA
  • Analyzing the latest MoCRA guidance and anticipating when the FDA will release more guidance
  • Creating a robust strategy to ensure compliance with the latest MoCRA provisions
  • Identifying and procuring the necessary resources needed to implement the next phase of MoCRA requirements
  • Identifying and minimizing the risk of litigation and consumer claims based on the new FDA requirements

Workshop C – Recall Master Class: An Essential Guide to Cosmetics Adverse Events Reporting, and Recalls under MoCRA for Small and Large Companies

Sep 29, 2023 2:00pm – 05:30 PM

Jessica Ringel
Partner
King & Spalding

Ryan Gooley
Director, Business Development – Recall & Remediation
Sedgwick

What is it about?

The safety of consumers is at the heart of the MoCRA legislation, which grants the FDA mandatory recall authority and mandates adverse event reporting requirements for the cosmetics and personal care industries. With the stakes higher than ever, it’s critical for legal and business executives to have the necessary competencies to execute a recall effectively.

In this resource and training session, our workshop leaders will provide practical guidance on how to develop and implement MoCRA compliant plans for recall execution and adverse event reporting.

In addition to:

  • 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?

Participants will gain insights on the following:

  • Preparing for a recall:
    • Examining the steps companies need to take to prepare for recalls and adverse events
    • Exploring best practices for developing and implementing effective plans
  • MoCRA-compliant recall execution:
    • Detailing the specific requirements for executing a recall in compliance with MoCRA, including notification and record-keeping requirements
  • Adverse event reporting:
    • Highlighting the importance of adverse event reporting in promoting safety and compliance, and outlining best practices for executing reporting requirements
  • Crisis Management Protocols
    • Determining the right messaging during a recall
    • Winning back public trust and consumer confidence-post recall