Agenda
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Workshops
September 24, 2024
Workshop A – MoCRA Compliance Workshop: A Hands-On Guide to Navigating the Modernization of Cosmetics Regulation Act of 2022
John FusonPartnerKleinfeld, Kaplan & Becker LLP
Mishel ChusidFounder & OwnerCompliance Regulators
Following its enactment, the FDA has issued a series of guidelines, prompting the industry to prepare for forthcoming deadlines. Our workshop leaders will explore the necessary steps the industry must take to comply with the new framework and meet FDA deadlines.
These new federal standards are reshaping longstanding protocols for adverse event reporting, products and facilities listing, recordkeeping, recalls, safety substantiation, testing methods, GMPs, and more.
Points of discussion will include:
- Examining the transformative impact of MoCRA on FDA regulations for cosmetics
- Analyzing the latest MoCRA guidance and expected next steps from the FDA
- Reviewing the current guidance on product and facility registration
- Understanding standardized testing
- GMPs regulations
- Developing a comprehensive action plan to meet the latest provisions of MoCRA
- Identifying and procuring the necessary resources needed to implement the next phase of MoCRA requirements
- Assessing and minimizing the risk of litigation and consumer claims based on the new FDA requirements
Reviewing forthcoming FDA actions:
- Expected FDA regulations on fragrance allergens to be labelled when they exceed certain concentrations, by June 29, 2024
- Facility registration and product listing enforcement deadlines by July 1, 2024
Workshop B – Strategies and Best Practices for Solid Claims Substantiation in Cosmetics and Personal Care Products
Mishel ChusidFounder & OwnerCompliance Regulators
Qareena AhsanSenior Director of Safety & RegulatoryMaesa
This working group aims to provide you with the essential knowledge required to substantiate claims with solid scientific evidence, helping your company to stay compliant, avoid litigation, and foster consumer trust.
Ensuring proper claim substantiation for cosmetic or personal care products is a nuanced and collaborative effort, involving various departments within the company. Despite thorough and carefully conducted studies, claims and their support may still undergo scrutiny from regulators and, increasingly, from plaintiff’s attorneys. Topics of discussion include:
- Learning about the types of scientific evidence required to substantiate claims in the beauty and wellness sector
- Ensuring that your marketing materials across various media platforms are properly substantiated by clinical studies
- Gaining insights into testing requirements when a cosmetic product is classified as an over-the-counter drug
- Uncovering implied claims and the hidden dangers associated with these
- Accurately assessing and interpreting clinical data to determine its applicability to your product claims
- Analyzing key trends and concerns for products making ‘clean’, ‘natural’ and ‘organic’ claims
- Assessing what the FTC is looking for when studies are evaluated for claim substantiation
- Population and participants
- Data and outcomes measured
- Ingredient dose and formulation
- Examining recent FTC enforcement actions and understanding the implications when clinical studies fail to support claims
- A look at FTC’s 2022 Health Products Compliance Guidance, providing comprehensive insight into the specific evidence needed to support health-related product claims
- Determining the type of testing necessary to obtain clearance to market your product in
- US
- Canada
- EU
- UK
- China, and other Asian markets
Day 1
September 25, 2024
Continental Networking Breakfast and Registration
Claire HughesCorporate CounselIntegra Beauty
Kristine KrugerPartnerPerkins Coie LLP
Katlin McKelviePartnerGibson, Dunn & Crutcher LLP
Jon GawlakTechnical ManagerSGS
With the FDA currently focused on implementing the next phase of MoCRA, we’ve witnessed the release of several guidance documents and an influx of information regarding the registration and listing of cosmetic products and facilities. This session will provide practical information for executing current guidance requirement and devising strategies for the anticipated next wave of MoCRA guidances.
- Examining proposed standardized testing methods for asbestos detection in talc-containing cosmetic products by December 29, 2023
- Anticipating new requirements for cosmetics Good Manufacturing Practices (GMP) regulations, expected by December 29, 2024
- Predicting the content of the PFAS (Per- and polyfluoroalkyl substances) risk report for cosmetic products, scheduled for completion by December 29, 2025
Navigating the Waters of the West: Spotlight on California and Washington State Legislative and Regulatory Activity Impacting Cosmetics and Personal Care Products
Allyn L. SternPrincipalBeveridge & Diamond PC
Will WagnerShareholderGreenberg Traurig, LLP
Akemi OokaVice President, Supply Chain And Sustainability ResourcesIndependent Beauty Association
At the forefront of cosmetics laws and regulations sits California’s pioneering initiatives and Washington State’s recent legislative strides. As California continues to set the standard for cosmetics and consumer product safety, Washington State continues to take steps forward. Additionally, Colorado and Oregon are also setting noteworthy examples in the cosmetics and personal care space nationwide.
Focus on California:
- Examining the current status and evolution of California’s Safe Cosmetics Program and compliance with its reporting requirements
- Understanding the role of California’s safe Cosmetics Act in influencing new related legislation, including:
- The 2020 Toxic-Free Cosmetics Act, with a focus on the recent Assembly Bill 496, banning an extra 26 ingredients in fragrances and cosmetics
- California Cosmetic Fragrance and Flavor Ingredient Right to Know Act of 2020
- California PFAS-Free Cosmetic Act
- California’s SB-54 Plastic Pollution Prevention and Packaging Producer Responsibility Act, with respect to the Extended Producer Responsibility
- California’s Consumer Legal Remedies Act (CLRA), protecting consumers against false advertising
- California’s proposed AB 2491 bill, looking to ban the sale of over-the-counter skin care products or cosmetic products to children under the age of 13
- California’s Child Content Creator Rights Act, under Senate Bill 764, which protects child influencers from financial exploitation
Focus on Washington State:
- Discovering how Washington State is advancing sustainable and eco-conscious standards within the cosmetics and personal care industries via the 2023 Toxic-Free Cosmetics Act (HB 1047)
- Analyzing’s Washington House Bill 1097 concerning the sale of cosmetics tested on animals
Colorado and Oregon:
- A look at Colorado’s Senate Bill 81, prohibiting PFAS chemicals and Oregon’s Toxic-Free Cosmetics Act
Morning Networking Coffee Break
Cosmetic Packaging and Labeling Standards: Navigating Legal and Regulatory Compliance on the West Coast
John FusonPartnerKleinfeld, Kaplan & Becker LLP
Greg SperlaPartnerDLA Piper LLP (US)
Join us for an engaging panel session as we delve into the intricate landscape of cosmetic packaging and labeling standards on the West Coast. With packaging and recycling initiatives gaining momentum across multiple states, California stands at the forefront, leading the charge with its stringent regulations on recyclability.
We’ll explore strategies for meeting compliance deadlines, managing costs, and staying ahead of regulatory changes, ensuring your company remains competitive in the dynamic cosmetics market.
- Analyzing The Sherman Food, Drug, and Cosmetic Law, with respect to the packaging and labelling regulation of cosmetics
- Understanding the impact of California’s SB-54 and its extended producer responsibility provision on cosmetics’ packaging
- Reviewing The California Consumers Legal Remedies Act in ensuring companies do not engage in false and deceptive advertising on labels
- Exploring Washington’s SB 5022 bill, requiring plastic packaging producers to meet minimum recycled content
Decoding State PFAS Legislation: Your Essential Handbook for Compliance and Risk Mitigation Strategies
Ellen RobbinsPartnerAkerman LLP
Cynthia StromanPartnerKing & Spalding LLP
With increasing regulatory pressure on the federal and state level, and pending FDA evaluation of PFAS safety in cosmetics, companies are facing intensified scrutiny in this area. Our panel will equip you with the tools and resources you need for PFAS compliance and risk mitigation. Join us as we cover current PFAS legislation, testing methods, and proactive measures to uphold product integrity and consumer confidence.
- Reviewing current state legislation, banning or restricting the use of PFAS:
- California’s PFAS-Free Beauty Act of 2022 (AB 2771) and The Toxic-Free Cosmetic Act of 2020 (AB 2762)
- Colorado’s Perfluoroalkyl and Polyfluoroalkyl Chemicals Consumer Protection Act of 2022 (HB 22-1345)
- Maine’s Act to Stop PFAS Pollution
- Oregon’s Toxic-Free Cosmetics Act of 2023 (SB 546) and Washington’s Toxic-Free Cosmetics Act of 2023 (SHB 1047)
- Managing inconsistencies across state PFAS testing standards, compliance deadlines, and the repercussions of non-compliance
- Developing a remedial action plan and strategy for instances where PFAS is detected in your products
- Grasping the concept of ‘unintentional PFAS’ and exploring risks posed to your brand by third-party manufacturing and testing methods
- Examining the latest federal activity concerning PFAS chemicals, including recent EPA rules
- Anticipating how the FDA’s findings will play into state and federal PFAS activity in the cosmetics space
Networking Lunch
Suzie TriggPartnerHaynes Boone
During this session, we’ll delve into the latest legal and regulatory updates concerning contaminants such as benzene, titanium dioxide (TiO2), formaldehyde, lead and asbestos in cosmetics and personal care products.
- Examining recent recalls of cosmetics and personal care products contaminated with benzene and considering their potential industry-wide implications for the future
- Assessing risks and regulatory responses for asbestos found in talc-based cosmetics
- Investigating the new authorities granted to the FDA under the MoCRA to address asbestos exposure risks from cosmetics
- Highlighting Washington States’ imposed lead limits, under the ‘Toxic-Free Cosmetics Act’
Navigating Clean Beauty Trends and Environmental, Social, and Governance (ESG) Practices in the Cosmetics Industry
Mabel YeeSenior Director, Associate General Counsel Kendo Brands
Sara FarahmandDirector, Toxicology, Product Safety and RegulatoryThe Honest Company
Join us for a timely discussion into the future of clean beauty and the integration of ESG principles in the cosmetics industry. Our panelists will explore the evolving landscape of clean beauty trends and regulations, offering valuable legal, regulatory, and business insights and strategies for companies aiming to align with consumer demands for safer, more sustainable products.
Key topics of discussion include:
- Understanding the evolving concept and “blurred” definition of clean beauty and its significance for both industry stakeholders and consumers
- Comprehending the relationship between clean beauty and ESG principles
- Striving for sustainability, safety and environmental responsibility in cosmetics formulation and manufacturing, whilst maintaining product efficacy
- Regulatory landscape and developing accurate product labeling strategies to substantiate ‘clean’ claims, ensuring compliance with regulatory standards
- Predicting the future of clean beauty, and factoring in key considerations for our consumers
Networking Break and Speaker Lounge
Claire BingFounderConfiance Cosmetic Group LLC
Helen OgunyanwoCounselCrowell & Moring LLP
John W.M. ClaudCounselHyman, Phelps & McNamara P.C
This panel session offers a strategic blueprint for crafting a robust safety plan tailored to MoCRA requirements, ensuring proactive compliance and effective crisis management. We will delve into the critical aspects of adverse events reporting and recalls within this legal framework and equip you with the tools and knowledge to respond to these effectively.
- Understanding FDA’s authority for recalls and adverse event reporting concerning cosmetics and personal care products under MoCRA
- Developing best practices to design and implement an FDA-mandated recall
- Examining the circumstances under which a voluntary recall is warranted
- Outlining the nature of recalls and appropriate corrective action
- Implementing crisis management protocols for swift and decisive action
- Understanding what standard operating procedures are now required under MoCRA
In-House Counsel and Regulatory Affairs ROUNDTABLE: Navigating Legal and Regulatory Challenges and Harmonizing In-House and External Legal Expertise
Rebecca PelayoDirector, Quality Assurance and Regulatory AffairsSun Bum
Nikita PatelGeneral CounselFutureWise, Julie, Starface & Blip
Marietta JoGeneral CounselSupergoop!
In this session, we encourage both panelists and audience members to openly discuss the significant challenges currently facing the industry, while also seeking collaborative solutions and insights on how best to address them. Our aim is to cultivate an atmosphere of constructive dialogue, where together, we can pinpoint effective strategies to overcome these challenges and adapt to the ever-changing landscape of consumer preferences.
Points of discussion include:
- Challenges with MoCRA Implementation
- Addressing PFAS and other contaminants in cosmetic products
- Advertising compliance in the digital age
- Ensuring supply chain diversification
Additionally, the panel will explore the importance of harmonizing in-house and external legal expertise amidst increasing legal and regulatory scrutiny and impending FDA deadlines.
- Strategies for cross-department collaboration to achieve compliance goals
- Optimizing engagement between regulatory affairs functions in smaller companies and external counsel
- Understanding mutual expectations for an ideal collaborative environment
- Understanding the mutual expectations in an ideal environment
Closing remarks and Recap of Day One
Day 2 & Post-Conference Workshop
September 26, 2024
Continental Networking Breakfast and Registration
Anthony J AnscombePartnerSteptoe LLP
As consumers advocate for heightened ingredient safety standards and truthful advertising in the cosmetics industry, class-action litigation has surged, notably concerning contaminants like benzene, TiO2, talc, and formaldehyde. Additionally, disputes over marketing claims such as ‘clean’ or ‘organic,’ as well as the utilization of consumer data in personalized online beauty tools, have fueled new legal scrutiny.
Join us as we examine recent prominent cases and provide valuable insights and strategies to equip your company in preemptively addressing potential class-action scenarios.
- Analyzing recent Prop 65 and PFAS enforcement and litigation in California
- Examining the latest class action lawsuits pertaining to product performance, deceptive advertising, and mislabeling
- Investigating related litigation surrounding the presence of potentially hazardous chemicals and contaminants
- Evaluating the resurgence of the pre-emption defense and potential new interpretations under MoCRA
- Assessing the rise of data privacy litigation, particularly under California’s Invasion of Privacy Act (CIPA) and the California Consumer Privacy Act
Faye Chen BarnouwAssistant Director, Western RegionFederal Trade Commission
Jennifer SantosAttorneyNational Advertising Division (NAD)
Lauren AronsonPartnerAmin Wasserman Gurnani LLP
Join us for a pivotal panel discussion delving into the latest FTC guidelines concerning influencer marketing, consumer reviews, and endorsements. Discover NAD’s best practices and guidelines and learn how to navigate marketing pitfalls effectively to ensure compliance.
- Exploring the influence, scope, and potential risks associated with influencers in endorsing beauty and personal care products
- Understanding current FTC and NAD guidelines and how to ensure compliance
- Reviewing FTC’s ‘Trade Regulation Rule on the Use of Consumer Reviews and Testimonials’, banning fake reviews and testimonials
- Highlighting FTC’s newly revised Endorsement Guides
- Analyzing examples of litigation resulting from deceptive reviews and endorsements
Morning Networking Break
Amy LallyPartnerSidley Austin LLP
Rachel EhlersPartnerBaker & McKenzie LLP
Lauri MazzuchettiPartnerKelley Drye & Warren
In an era dominated by emerging technologies like AI/AR-enabled applications that demand intricate personal data, the need for stringent data control is paramount. Legislators are responding to this demand, prompting businesses to heighten their data protection measures.
- Reviewing current and proposed data privacy legislation, impacting the cosmetics and personal care industries:
- The ‘California Invasion of Privacy Act (CIPA)’ and the latest wave of litigation surrounding pen register and trap and trace claims
- The ‘California Consumer Privacy Act (CCPA’)
- Washington’s ‘My Health My Data Act’ and the concerns on its broad definitions on ‘sensitive health data’
- Illinois’ Biometric Information Privacy Act’ (BIPA)
- The recently proposed federal bill ‘The American Privacy Rights Act of 2024’ (APRA)
- Pinpointing the privacy and ethical considerations linked with biometric technologies and virtual try-on tools
- Striking the balance between providing personalized beauty tools requiring consumer data and ensuring compliance with both national and global privacy regulations
Networking Lunch
Industry Think Tank for Global Success: Winning Strategies of Successfully Introducing Your Products into a Dynamic World Marketplace
Paul SumbiAssistant Center DirectorCustoms and Border Protection
Laura Gomez JD, LL.BPartnerGowling WLG
Yi HuangCounselCrowell & Moring LLP
From trade developments to newly proposed sanctions and supply chain challenges, our panel will provide valuable insights and guidance to help your company navigate the intricacies of global commerce and operations.
Key discussion topics include:
- Overview of CSAR (compared to the old regulation) as well as the latest development (NMPA Circular No. 50) regarding the safety assessment requirement as well as the extension of deadline.
- Reviewing recent regulatory updates in Canada, including labeling requirements, allergen updates, and recyclability initiatives
- Commercializing your products in Canada
- Restrictions of import of ingredients
- Learning more about the logistics process/admissibility of the products and CBP’s collaboration with Partner Government Agencies like the FDA
Jolly NorthropOf CounselHolland & Hart LLP
Kiri Lee SharonPartnerFoley & Lardner LLP
Marylauren IlaganSenior Counsel & Head of IPOlaplex, Inc
Implementing a proactive online brand protection strategy is imperative for companies facing the threat of counterfeit items being sold online or imported. Continuous vigilance in detecting and removing brand infringements and counterfeit goods is crucial. The stakes are high, encompassing potential revenue loss, erosion of consumer confidence, and even risks to consumer health.
- Examining comprehensive IP tactics, from trademarks and copyrights to trade secrets and customs registration for safeguarding against counterfeit products
- Considering the use of high-tech features than can distinguish real products from fake, such as microscopic dots, QR codes or holographic stickers on packaging
- Reviewing the role of AI and how this is impacting IP rights
- Establishing a worldwide, reliable, and secure supply chain with suppliers and distributors, supported by robust contracts and non-disclosure agreements
- Analyzing the role of enforcement agencies in preventing counterfeiting and infringing activities
Co-Chairs Closing Remarks and Recap of Day Two
Conference Adjourns
Workshop C – Words of Wisdom from Seasoned industry Leaders on Navigating Legal and Regulatory Challenges in the Cosmetics and Personal Care Products Industries
Vipashi Trivedi-ShethDirector of Quality/RegulatoryHaus Labs by Lady Gaga
Cyndie M. ChangPartnerDuane Morris LLP
In the competitive landscape of cosmetics and personal care products, small companies often face unique challenges in navigating legal and regulatory hurdles. In this workshop, seasoned industry leaders from larger companies will offer invaluable insights and advice to smaller businesses, providing a roadmap for success.
Drawing from their wealth of experience, they will share practical strategies and tips on how to anticipate and address legal and regulatory issues from the outset. From understanding compliance requirements to establishing effective internal processes, you will gain actionable guidance on how to safeguard your business and products.
Key discussion topics include:
- Looking out for the early warning signs and recognizing common legal and regulatory pitfalls
- Learning to anticipate regulatory changes and market trends to stay ahead of the curve
- Outlining practical steps for small companies to prepare for regulatory compliance from the outset
- Establishing robust quality control measures and documentation processes to ensure product safety and efficacy
- Understanding the importance of cross-departmental collaboration in achieving compliance
- Reviewing strategies for fostering communication and collaboration between legal, regulatory, and product development teams
- Extracting valuable lessons and insights from industry experiences to inform decision-making and risk mitigation strategies
Whether you’re a startup or a growing company, this workshop offers practical advice and actionable strategies to help you navigate the complex legal and regulatory landscape of the cosmetics and personal care products industries and help you thrive in a competitive market.