ACI's Annual Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products - WEB

ON COSMETICS

WestCoastEdition & Personal Care Products

28–29, 2023

Join us as our prestigious faculty of leading in-house counsel and regulatory executives, premier law firm attorneys, government officials, and consumer protection advocates help you:

y Devise an implementation plan for the next phase of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA)

y Analyze California’s laws and regulations governing cosmetics and personal care products and understand their impact on the rest of the country

y Exploring Washington State’s Toxic Free Cosmetics Act of 2023

y Address the latest developments in PFAS legislation and litigation

y Deep-Dive into West Coast product labelling, packaging and recycling laws

y Navigate the legal and regulatory landscape of Clean Beauty

y Explore the evolving role, reach, and risks of influencers and social media in product promotion and advertising

y Develop a blueprint for AI and other innovative technologies while still prioritizing data privacy and security

y Secure IP protections and anti-counterfeiting assurances for cosmetics

DISTINGUISHED CO-CHAIRS

WORKSHOPS

B A C

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

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

Recall Master Class: An Essential Handbook for Cosmetics Adverse Events Reporting and Recalls under MoCRA for Small and Large Companies

Insights from Leading Stakeholders: Exhibitor: Cocktail Reception Sponsor: Premier Exhibitor: Associate Sponsor:

» NAD

» JAFRA Cosmetics

» Benefit Cosmetics

» Anastasia Beverly Hills

» Hero Cosmetics

» John Paul Mitchell Systems

» Unilever

» Kendo Brands

ACI’s ANNUAL LEGAL, REGULATORY, AND COMPLIANCE FORUM

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

September

| Le Meridien Delfina Santa Monica, California

CAMILLE FRIEDLANDER Legal Counsel Benefit Cosmetics

ANGELA DIESCH Partner Amin Talati Wasserman LLP

Welcome to American Conference Institute’s (ACI’s) Legal, Regulatory, and Compliance Forum on Cosmetics and

Personal Care Products – West Coast edition

National focus with a particular emphasis on West Coast laws and regulation

WHO YOU WILL MEET

Cosmetics and Personal Care Products Industry

.

ACI is delighted to bring our Legal, Regulatory, and Compliance Forum on Cosmetics and Personal Care Products to the West Coast this fall. This conference, like its East Coast sister event held in New York each spring, will be national in scope, however, it will have a special focus on legal and regulatory initiatives in West Coast states. There will be featured sessions on the Golden State of California which is known for setting the bar high not only for itself- but for the rest of the nation -- on product safety and compliance as well as privacy. We will also examine the latest developments in Washington state with its new Toxic Free Cosmetics Act.

MoCRA is now law- Prepare for the next stage of implementation.

Since its passage last December, the Modernization of Cosmetics Act (MoCRA) is dramatically changing the personal care and cosmetics industries. Our forum will provide an opportunity to stay ahead of the curve and gain critical insights into MoCRA’s latest implementation measures and provide you with a blueprint to design your MoCRA compliance plan in time for the year-end deadline.

Get critical information from the “who’s who” of cosmetics law and regulation on key developments affecting cosmetics and personal care products.

Get critical information and analyses on the latest hot-button challenges impacting the cosmetics and personal care products industries. Our renowned speakers will cover a wide range of topics, including crucial challenges surrounding packaging and recycling laws, advertising claims, AI, clean beauty, ESG and more. We will also address developments in PFAS, Prop 65, and class action litigation.

Connect and stay ahead of the curve

Our West Coast forum is the perfect platform to meet key industry stakeholders as well as your peers and learn about how to stay compliant in an ever-evolving regulatory landscape. Attend our forum and develop best practices to ensure compliance with the latest regulations and help drive innovation and growth in your company. Join us this September for ACI’s West Coast Legal, Regulatory, and Compliance Forum on Cosmetics and Personal Care Products to receive timely advice from our prestigious faculty of government officials, consumer protection advocates, leading in-house counsel, and premier law firm attorneys.

‰ In-House Counsel, including generalist and those having responsibility for FDA law and regulatory affair; advertising and promotion; IP, Patents and Trademarks; Licensing and Business Development

‰ 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

Media Partners

Conference Co-Chairs

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

Angela Diesch Partner Amin Talati Wasserman LLP (Los Angeles, CA)

Speakers

Qareena Ahsan Director Safety & Regulatory Maesa (New York, NY)

John Bailey Jr., Ph. D. Independent Advisor EAS Consulting Group (Arlington, VA)

Former Director of FDA’s Office of Cosmetics and Colors

Brigid DeCoursey Bondoc Partner Morrison & Foerster LLP (Washington, DC)

Sarah Bruno Partner Reed Smith LLP (San Francisco, CA)

Sophie Castillo Partner Keller & Heckman (San Francisco, CA)

Sue Collins Executive Vice President & General Counsel Obagi Cosmeceuticals LLC (Irvine, CA)

Carlo Felizardo Attorney Gibson, Dunn & Crutcher (Washington, DC)

Tia Feltner US Regulatory Affairs Manager Jafra Cosmetics (Westlake Village, CA)

Don Frey President & CEO Independent Beauty Association (West Holywood, CA)

Kenya Garrett Senior Director, Global Head, Diversity, Equity, & Inclusion Kendo Brands (San Francisco, CA)

Nadine Goldman Director, Regulatory Anastasia Beverly Hills (New York, NY)

Ryan Gooley Director, Business Development – Recall & Remediation Sedgwick (Indianapolis, IN)

Julie (Julia A.) Hatcher Partner Latham & Watkins LLP (Washington, DC)

Laurie Henry Partner Shook, Hardy & Bacon LLP (Kansas City, MO)

Jessica Iclisoy Founder/CEO California Baby (Los Angeles, CA)

Brent Johnson Partner Holland & Hart LLP (Salt Lake City, UT)

Dan Kolhoff Director of Regulatory & Legal Affairs

John Paul Mitchell Systems (Los Angeles, CA)

Aliza Karetnick Partner Ballard Spahr LLP (Philadelphia, PA)

Amy P. Lally Partner Sidley Austin LLP (Los Angeles, CA)

Emilie Lavirotte Senior Advisor Intellectual Property Sephora

Felicia Leborgne Nowels Partner, Government Affairs and Public Policy Akerman LLP (Tallahassee, FL)

Emily Leongini Partner ArentFox Schiff LLP (Los Angeles, CA)

Claudia Lewis Partner Venable LLP (Washington, DC)

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

Mallory McMahon Senior Director, Research and Innovation The Honest Company (Los Angeles, CA)

Cynthia Meyer Partner Kleinfeld, Kaplan & Becker LLP (Washington, DC)

Amy Ralph Mudge Partner Baker & Hostetler LLP (Washington, DC)

Michael R. Murphy Partner K&L Gates (Boston, MA)

Tarek Nasser Senior Manager, Global Regulatory Affairs Hero Cosmetics (Oakland, CA)

Arameh O’Boyle Member Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C (Los Angeles, CA)

Michael Ostheimer Attorney U.S. Federal Trade Commission (Washington, DC)

Jackson Pai Counsel Crowell & Moring LLP (Los Angeles, CA)

Jeffrey Parker Partner Sheppard Mullin (Los Angeles, CA)

Dennis Raglin Partner Steptoe & Johnson LLP (San Francisco, CA)

Jessica Ringel Partner King & Spalding (Washington, DC)

Jennifer Santos Attorney National Advertising Division (NAD) (New York, NY)

Elliott Siebers Special Counsel Kelley Drye & Warren LLP (Los Angeles, CA)

Maggie Spicer Founder Source Beauty ESG (Washington, DC)

Allyn Stern Principal Beveridge & Diamond PC (Seattle, WA)

Dr. Simone Swafford CEO/Founder Vogue Regulatory (Chattanooga, TN)

Xin Tao Partner Baker & McKenzie LLP (Washington, DC)

Suzie Trigg Partner Haynes Boone (Dallas, TX)

Jessica Trujillo Director, Trade & Corporate Compliance Young Living (Salt Lake City, UT)

Riëtte van Laack Director Hyman, Phelps & McNamara (Silver Spring, MD)

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

PRE-CONFERENCE WORKSHOPS

Wednesday, September 27th, 2023

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

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

Microphone-alt Riëtte van

Laack, Director, Hyman, Phelps

& McNamara

Cynthia Meyer, Partner, Kleinfeld, Kaplan & Becker LLP

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

12:30–1:00 pm Networking Break

B1:30–5:00 pm – Registration to begin at 12:30 pm

(BREAK at 2:30 pm)

MoCRA Compliance Working Group: A Practical and Tactical Guide to the

Microphone-alt Suzie Trigg, Partner, Haynes Boone

Xin Tao, Partner, Baker & McKenzie LLP

• 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

Modernization of Cosmetics Regulation Act of 2022 (MoCRA)

Brigid DeCoursey Bondoc, Partner, Morrison & Foerster LLP

Angela Diesch, Partner & Cosmetics Industry Practice Lead, Amin Talati Wasserman

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

linkedin: FDA-Regulated Consumer Products: Dietary Supplements, Cosmetics, OTC Drugs

MAIN DAY ONE

Thursday, September 28th, 2023

7:15 Continental Networking Breakfast and Registration

8:15

Co-Chairs’ Welcome Remarks

Microphone-alt Angela Diesch, Partner, Amin Talati Wasserman LLP

Camille Friedlander, Legal Counsel, Benefit Cosmetics/LVMH

8:30

MoCRA Status Report: An In-Depth Look at the Industry’s Response to 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

Angela Diesch, Partner, Amin Talati Wasserman LLP

Dan Kolhoff, Director of Regulatory & Legal Affairs, John Paul Mitchell Systems

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

Microphone-alt Laurie Henry, Partner, Shook, Hardy & 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

» How can companies 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 West Coast Cosmetics Code: A Guide to Ensuring Compliance with California and Washington State Laws and Regulations for Cosmetics and Personal Care Products

Microphone-alt Tia Feltner, US Regulatory Affairs Manager, JAFRA Cosmetics

Dr. Simone Swafford, CEO/Founder, Vogue Regulatory

Sophie Castillo, Partner, Keller & Heckman

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 indepth 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,

• Examining the classes of chemicals that are banned under the Act

» Formaldehyde and “forever chemicals” Key implementation dates

» How does the Washington State law compare with California’s Safe Cosmetics Act

11:30

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

Microphone-alt 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

Microphone-alt Jessica Iclisoy, Founder/CEO, California Baby

Camille Friedlander, Legal Counsel, Benefit Cosmetics/LVMH

2:00

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

Microphone-alt Aliza Karetnick, Partner, Ballard Spahr LLP

Julie (Julia A.) Hatcher, Partner, Latham & Watkins LLP

Jeffrey 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

Microphone-alt Elliott Siebers, Special Counsel, Kelley Drye & Warren LLP

Amy P. Lally, Partner, Sidley Austin LLP

Carlo Felizardo, Attorney, Gibson, Dunn & Crutcher

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

Microphone-alt Tarek Nasser, Senior Manager, Global Regulatory Affair, Hero Cosmetics

Mallory McMahon, Senior Director, Research and Innovation, The Honest Company

Sarah Bruno, Partner, Reed Smith LLP

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

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

Microphone-alt 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

MAIN DAY TWO

Friday, September 29th, 2023

7:30 Continental Networking Breakfast and Registration

8:15

Chairs’ Opening Remarks and Recap of Day One

8:30

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

Microphone-alt 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

Microphone-alt 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

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

Jennifer Santos, Attorney, National Advertising Division (NAD)

Amy Ralph Mudge, Partner, Baker & Hostetler LLP

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

Microphone-alt 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

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

Emilie Lavirotte, Senior Advisor Intellectual Property, Sephora

Michael R. Murphy, Partner, K&L Gates

Many cosmetics companies 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

Microphone-alt Jackson Pai, Counsel, Crowell & Moring

Nadine Goldman, Director, Regulatory, Anastasia Beverly Hills

Felicia Leborgne Nowels, Partner, Akerman LLP

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

linkedin: FDA-Regulated Consumer Products: Dietary Supplements, Cosmetics, OTC Drugs

POST-CONFERENCE WORKSHOP

Friday, September 29th, 2023

C2:00 pm–5:30 pm – Registration to begin at 1:00 pm (BREAK at 3:00 pm)

Recall Master Class: An Essential Handbook for Cosmetics Adverse Events Reporting, and Recalls under MoCRA for Small and Large Companies

Microphone-alt Jessica Ringel, Partner, King & Spalding

Ryan Gooley, Director, Business Development – Recall & Remediation, Sedgwick

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

ACI’s 7th Annual Legal, Regulatory and Compliance Forum on

October 16 – 17, 2023 | New York

February 2 – 3, 2024 | New York

hands-helping BECOME A SPONSOR

With conferences in the United States, Europe, Asia Pacific, and Latin America, the C5 Group of Companies: American Conference Institute, The Canadian Institute, and C5 Group, provides a diverse portfolio of conferences, events and roundtables devoted to providing business intelligence to senior decision makers responding to challenges around the world.

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

& Personal Care Products 11TH ANNUAL LEGAL, REGULATORY, AND COMPLIANCE FORUM ON COSMETICS

March 2024 | New York

Continuing Legal Education Credits

EARN

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.

C5 celebrates 40 years of excellence! We are thrilled to have provided exceptional conference experiences globally with our outstanding team, speakers, sponsors, partners, and attendees. To mark this milestone, we're launching a new logo which represents our commitment to innovation, growth, and excellence, represented by the five Cs of C5: Current, Connected, Customer-Centric, Conscientious, and Committed.

Looking back on 40 years, we are grateful for our achievements—hosting global conferences, uniting industry leaders, and supporting business growth. However, we are not done yet! We are committed to pushing boundaries and creating impactful experiences and we're excited for the next 40 years of success.

Venue Information

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”.

Hotel: Le Meridien Delfina Santa Monica

Address: 530 Pico Boulevard, Santa Monica, CA 90405

Reservations: 888-627-8532

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

Book with confidence!

WORRY FREE Registration GUARANTEE

Register and pay to lock in your early rate and be eligible for a full refund until September 13, 2023. 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 September 13, 2023.

PRICING SAVE $300 Register & Pay by July 28, 2023 SAVE $200 Register & Pay by August 25, 2023 Register & Pay after August 25, 2023 IN-PERSON BEST VALUE! All-Access Pricing $3,195 $3,295 $3,495 Conference Only $1,995 $2,095 $2,295 Workshop A: The Foundation of Beauty $600 Workshop B: MoCRA Compliance Working Group $600 Workshop C: Recall Master Class $600

Bringing

3–4 10% Conference Discount

5–6 15% Conference Discount

7 20% Conference Discount

ACI offers financial scholarships for government employees, judges, law students, non-profit entities and others. For more information, please email or call customer service.

All program participants will receive an online link to access the conference materials as part of their registration fee. Additional copies of the Conference Materials available for $199 per copy.

To update your contact information and preferences, please visit https://www.AmericanConference.com/preference-center/.

Terms & conditions and refund/cancellation policies can be found at AmericanConference.com/company/faq/