EARN CLE CREDITS
8th Annual Legal, Regulatory, and Compliance Forum on
COSMETICS & Personal Care Products
March 23, 2021 (EST) | VIRTUAL CONFERENCE A comprehensive guide to the latest developments affecting “articles intended for cleansing, beautifying, promoting attractiveness, or altering the appearance.”
Benefit from the Knowledge of our Distinguished Chair: Sharon Blinkoff Senior Counsel Locke Lord LLP Secretary and General Counsel and Member of the Board of Directors Independent Beauty Association
FDA Keynote on Agency Priorities for 2021: Linda M. Katz M.D., M.P.H. Director, Office of Cosmetics and Colors United States Food and Drug Administration
TOWN HALL Q&A WITH THE FTC AND NAD: Richard Cleland Assistant Director - Division of Advertising Practices United States Federal Trade Commission
Annie M. Ugurlayan Assistant Director, National Advertising Division BBB National Programs
Conference Contributors:
AmericanConference.com/Cosmetics | 888 224 2480
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Business Information in a Global Context
ACI’s 8th Annual Legal, Regulatory, and Compliance Forum on Cosmetics and Personal Care Products. Incoming federal and state legislative reforms increase regulatory pressures on the industry. Federal legislative efforts for safety reforms for the cosmetics and personal care industries are still ongoing. Pending bills concerning ingredient safety, FDA authority, and animal testing are forcing changes in industry practices. Moreover, monograph reform is now law under the CARES Act. This new law when coupled with the sunscreen monograph regulations from 2019 leave the industry to take a closer look at some of its OTC classified ingredients. On the state front, legislative measures concerning sunscreen, anti-cruelty measures and consumer safety are gaining traction. California has taken the legislative lead in efforts to monitor potentially harmful ingredients in cosmetics and has also passed a very stringent consumer privacy law which will affect industry practices relating to consumer data. As a result, other states are aligning to enact similar measures.
Increasing consumer demand for clean, natural and environmentally friendly products is changing industry behaviors and practices. With no clear FDA guidance on what defines “clean” and “natural,” companies are attempting to meet the customer demand for environmentally friendly products, amid regulatory uncertainty. As a result, retailers have implemented their own certifications and requirements by way of third-party verification. Without clear guidance, companies are often left using their own interpretations which can open them to liability.
HANDSHAKE WHO YOU WILL MEET Cosmetics and Personal Care Products Industry CHEVRON-RIGHT In-House Counsel, including
generalists and those having responsibility for FDA law and regulatory affairs; advertising and promotion; IP, Patents and Trademarks; Licensing and Business Development
CHEVRON-RIGHT 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: CHEVRON-RIGHT FDA CHEVRON-RIGHT Advertising and
Questions surrounding trade wars and tariffs remain significant even under a New Administration. Questions surrounding whether Trump-era tariffs and trade wars with China will continue under Biden and the anticipated fallout of Brexit are affecting beauty imports and exports, including the raw materials needed for their production. All these factors are tied to rising costs and have significant impact on a company’s bottom line. As such, in this unsettled international trade atmosphere, companies must develop a new approach to global commercialization and product entry. Attend ACI’s 8th Annual Legal, Regulatory, and Compliance Forum on Cosmetics and Personal Care Products to ensure you receive timely advice from our prestigious faculty of government officials, consumer protection advocates, leading in-house counsel, and premier law firm attorneys. We have created this year’s agenda to include more interactive formats to enhance session content as well as your overall conference experience. We hope to see you this spring.
Register Today
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by calling 1-888-224-2480 or visiting AmericanConference.com/Cosmetics
Trademarks
Promotion – FTC CHEVRON-RIGHT Litigation
CHEVRON-RIGHT Corporate
Matters
In-Depth Content Enhanced by Interactive Virtual Features: 1:1 NETWORKING with Delegates and Speakers
Defending product claims and mitigating the risk of class action litigation are an ongoing challenge. The cosmetics and personal care industry deflect constant scrutiny, as it endeavors to adhere to the Prop 65 regulations. But, this makes them targets for a litany of class action litigation activity, involving performance of products, false advertising, and mislabeling. Additionally, California specific litigation can be used as a benchmark for potential litigation in other states.
CHEVRON-RIGHT Patents and
TOWN HALL Q&A WITH UNIVERSITY The THE FTC AND NAD Make-Up of Claims
Substantiation: Establishing Proofs and Avoiding Misrepresentation
ROUNDTABLE DELIBERATIONS & LIVE POLLING The United States of Beauty: An Analysis of Proposed Federal Legislation and Regulation Impacting the Cosmetics Industry
HYPOTHETICALS ON SOCIAL MEDIA AND INFLUENCER USE Question-Circle Assessing the Risks of Socially Promoting Beauty
SPEAKER’S LOUNGE Comments Join the Speakers for an Extended Q&A Session in an Open Forum
BONUS “ON DEMAND” FOCUS SESSIONS Watch pre-recorded sessions on cosmetics regulation and commercialization in Europe and Asia at your convenience
#ACICosmetics twitter: @ACILegal linkedin: ACI: OTC Drugs & Dietary Supplements Group
Speaker Faculty CONFERENCE CHAIR: Sharon Blinkoff Senior Counsel Locke Lord LLP Secretary and General Counsel, and Member of the Board of Directors Independent Beauty Association
DISTINGUISHED FACULTY: Takanori Abe Managing Partner Abe & Partners Richard Cleland Assistant Director - Division of Advertising Practices United States Federal Trade Commission Thomas Cohn General Counsel & Corporate Secretary The Avon Company Risa M. Drexler, Esq. Associate General Counsel - Litigation Unilever USA Lynn R. Fiorentino Partner Arent Fox LLP Shelly Garg Partner Amin Talati Wasserman, LLP
Armia Guirguis Product Safety & Regulatory Affairs Director Henkel Beauty Care
Trenton H. Norris Partner Arnold & Porter Kaye Scholer LLP
Robert C. Harmala Partner Jenner & Block LLP
Jessica P. O’Connell Partner Covington & Burling LLP
David Joyal Vice President Legal, Global Supply and Patents COTY
Laura Siegel Rabinowitz Shareholder Greenberg Traurig, LLP
Linda M. Katz M.D., M.P.H. Director, Office of Cosmetics and Colors United States Food and Drug Administration
Candace Sady Chief Marketing Counsel North America Colgate-Palmolive Company
Robert J. Kiefer General Manager REACH24H USA Inc.
D. Kyle Sampson Partner, FDA and Life Sciences King & Spalding LLP
Daniel J. Kolhoff Director of Regulatory & Legal Affairs John Paul Mitchell Systems
Kimberly Smith Esq. Founder Marjani Beauty LLC
Scott Miller Co-Managing Partner MBM Intellectual Property Law Dr. Mojgan Moddaresi PhD, PharmD, FRSB, CBiol, MRSB (Aka Dr M) Managing Director Personal Care Regulatory Ltd
Annie M. Ugurlayan Assistant Director National Advertising Division BBB National Programs, Inc.
A compliance regulatory company specialised in cosmetic products in the EU and UK
Continuing Legal Education Credits EARN CLE CREDITS
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. For more information on ACI’s CLE process for virtual events visit: www.americanconference.com/accreditation-instructions-for-virtual-attendance/
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AmericanConference.com/Cosmetics | 888 224 2480
a C5 Group Company
Business Information in a Global Context
Virtual Event |
Tuesday, March 23rd, 2021 (EST)
9:00
Chair’s Welcome Remarks
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Sharon Blinkoff, Senior Counsel, Locke Lord LLP, Secretary and General Counsel, and Member of the Board of Directors, Independent Beauty Association
In March 2020, the OTC drug approval process under the monograph system was finally revised — and rather strangely under the Coronavirus Aid, Relief, and Economic Security Act or CARES Act. We will explore how this came about and why OTC monograph reform impacts the Cosmetics and Personal Care industries.
& Speaker’s Lounge Comments Break Open Forum
9:15 ROUNDTABLE DELIBERATIONS & LIVE POLLING
Join the early morning speakers for an extended Q&A session. Delegates will have the opportunity to turn on their camera as this session will not be recorded.
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The United States of Beauty: An Analysis of Proposed Federal Legislation and Regulation Impacting the Cosmetics Industry Robert C. Harmala, Partner, Jenner & Block LLP Sharon Blinkoff, Senior Counsel, Locke Lord LLP Secretary and General Counsel, and Member of the Board of Directors, Independent Beauty Association
Participate in live polling to discuss which legislation and regulations will likely move forward under the new Administration. • Analyzing the latest developments surrounding The Safe Cosmetics and Personal Care Products Act of 2019 » Examining the impact of how this pending legislation would amend provisions of the Federal Food, Drug and Cosmetic Act including ingredient safety and animal testing • Comprehending how the introduction of the Humane Cosmetics Act would promote the advancement of animal welfare while still balancing the need for innovation in cosmetics and personal care products • Identifying challenges with FDA’s regulations on color additives 9:45
FDA Keynote on Priorities for 2021
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Linda M. Katz M.D., M.P.H., Director, Office of Cosmetics and Colors, United States Food and Drug Administration
10:15
Focus on Monograph Reform Under the CARES Act: Understanding What this Means for the Cosmetics and Personal Care Industries
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Jessica P. O’Connell, Partner, Covington & Burling LLP
» AB647 Bill on requirements to provide safety data sheets (SDS) and post these on a public website
10:45
Focus on Federal Legislative and Regulatory Developments
» Comparing and contrasting the CCPA with GDPR: identifying similarities and differences • Interpreting the following bills from California regarding ingredient safety:
11:15
Beauty Within the States: Complying with State Laws and Adhering to Safety Requirements for Cosmetics and Personal Care Products
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Daniel J. Kolhoff, Director of Regulatory & Legal Affairs, John Paul Mitchell Systems
Sharon Blinkoff, Senior Counsel, Locke Lord LLP Secretary and General Counsel, and Member of the Board of Directors, Independent Beauty Association
Part I: Wading through the Patchwork of State Laws on Cannabis, Sunscreen, and Cosmetic Safety • Assessing the overall state of cosmetics safety legislations in various jurisdictions • Comparing and contrasting different state sunscreen laws and how this may impact the commercial viability of your product • Understanding the limitations and risks with introducing cosmetics products containing • CBD hemp oil in various states with federal prohibitions despite the passage of the Farm Bill
Part II: Special Spotlight on California Specific Reforms Last year, California introduced legislation that may have far reaching implications as well as out of-state reach for cosmetics. Other states may soon follow California’s lead. As a result, companies need to brace themselves for potential restrictions as proposed reforms may become a likely reality. Points of discussion include: • Assessing the impact of the California Consumer Privacy Act (CCPA) in the cosmetics space and how this will affect other states passing similar legislation
» SB-574 Cosmetic Fragrance and Flavor Ingredient Right to Know Act which requires disclosure of ingredients in fragrances and list of flavors that may pose a health hazard 12:00
An International Perspective on the Use of CBD Hemp Oil in the Cosmetics and Personal Care Space: Imports, Exports, and Domestic Concerns
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Shelly Garg, Partner, Amin Talati Wasserman, LLP
D. Kyle Sampson, Partner, FDA and Life Sciences, King & Spalding LLP
• Assessing the FDA’s current stance on CBDhemp oil: new ingredient or something different? • Realizing the difficulties and challenges with introducing cosmetics with CBD hemp oil into foreign countries that have strict regulations for the regulation of such products • Recognizing challenges with the import of CBD cosmetics from foreign countries » Devising ways to overcome this challenge by establishing a sound plan for market entry 12:30
1:1 Networking 12:40
Lunch Break
HYPOTHETICALS ON SOCIAL MEDIA 1:30 AND INFLUENCER USE
the Risks of Socially Question-Circle Assessing Promoting Beauty
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Thomas Cohn, General Counsel & Corporate Secretary, The Avon Company Candace Sady, Chief Marketing Counsel North America, Colgate-Palmolive Company
Through the use of hypotheticals, we will explore challenges, legal dilemmas, and controversies associated with managing contracted influencer and non-contract influencers • Examining the role and reach of influencers in the promotion of beauty and personal care products
#ACICosmetics twitter: @ACILegal linkedin: ACI: OTC Drugs & Dietary Supplements Group
• Understanding the heightened risk with contracting with an influencer, blogger, or celebrity to promote your product » Outlining the “do’s and don’ts” of what an influencer can say about your product without making disease claims » Devising effective and detailed legal contracts with the influencer to limit liability • Enforcing guidelines with the influencer to ensure effective marketing and promotion of the product • Ensuring ways to avoid pitfalls with fake employee reviews following the Sunday Riley case • Adhering to FTC guidelines on influence social media marketing and on endorsements/ testimonials
3:00
Comments
Join the morning and afternoon speakers for an extended Q&A session. Delegates will have the opportunity to turn on their camera as this session will not be recorded.
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Industry Insights: Balancing Consumer Demand for Clean Beauty, Sustainability, and Natural Products Against Potential Liabilities
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Armia Guirguis, Product Safety & Regulatory Affairs Director, Henkel Beauty Care
Kimberly Smith Esq., Founder, Marjani Beauty LLC
Proofs and Avoiding Misrepresentation
Clean Beauty
Annie M. Ugurlayan, Assistant Director, National Advertising Division, BBB National Programs, Inc.
• Understanding how retailers are addressing clean beauty and sustainability by requiring companies to certify their products with their own standards or the use of third-party verification seals
Richard Cleland, Assistant Director Division of Advertising Practices Federal Trade Commission
This session is designed as an interactive town hall where attendees will be able to direct questions to the panel – including FTC and NAD representatives -- regarding recent activity with popular products in the cosmetics space as well as labeling challenges. In addition, the speakers will offer forecasts on the next wave of claims enforcement and offer practical insights on how to avoid such activity. • Analyzing the trends and developments of the past year for claims on popular products involving: » Wrinkle reduction, tattoo ink usage, eyelash growth products » Natural, clean beauty, “free from”, and sustainability • Devising effective ways where R&D, Legal, and Marketing teams can work seamlessly together to ensure all claims can withstand scrutiny » Understanding how you can use independent third-party testing to provide scientific support of your product » Assessing the impact of having no real industry standard on testing requirements » Differentiating the various types of claims you can make: numerical, comparative, clinical, superiority, and more and how this affects testing • Assessing recent NAD and FTC claims substantiation activity » Examining recent settlement activity with MLM companies
Class Action and Prop 65 Litigation Outlook for Cosmetics: Forecasting the Next Wave of Activity
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Trenton H. Norris, Partner, Arnold & Porter Kaye Scholer LLP
Risa M. Drexler, Esq., Associate General Counsel - Litigation, Unilever USA
Lynn R. Fiorentino, Partner, Arent Fox LLP
3:30
2:15 TOWN HALL Q&A WITH THE FTC AND NAD
Make-Up of Claims UNIVERSITY The Substantiation: Establishing
4:30
Break & Speaker’s Lounge Open Forum
» Assessing the risks and liabilities with potential litigation due to a lack of uniform standard or FDA regulation on this matter • Identifying what “clean beauty” means to the industry vs. the consumer • Strengthening efforts to improve corporate social responsibility in the increasing demand for environmentally friendly products • Responding to consumer demand for cruelty free products
Natural • Addressing the ongoing challenges with lack of definition of “natural” from the FDA » Evaluating FDA warning letters on “natural” products • Assessing what consumers demand and reasonably expect from natural cosmetics products » Educating consumers on how preservatives are needed to protect from bacteria and mold • Ensuring your claim is labeled properly and you can substantiate your product with the definition of “natural” you provided to the consumer » Defining your risk points when labeling your product as natural • Analyzing recent case law on “natural” products: how the courts are asking the FDA to provide a definition
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Class Actions • Analyzing recent class action litigation activity involving performance of products, false advertising, and mislabeling » Interpreting findings relevant to recent cases regarding aloe vera • Assessing ways to defeat class action litigation at the certification phase • Examining how California specific litigation can be used as a benchmark for potential litigation in other states
Prop 65 • Identifying the latest wave of plaintiff’s claims made under Prop 65 • Assessing the impact of retailers who require manufacturers to certify products are compliant with Prop 65 warnings » Knowledge of source of materials and testing ingredients • Understanding the safe harbor provisions under Prop 65 and whether your product is exempt • Devising defense strategies to respond to warning letters from bounty hunters who search for products containing ingredients in violation of Prop 65 • Examining the impact of proposed legislation in New York called the “Right to Know Act”: similarities and differences with Prop 65 5:15
Case Studies: IP Protections and Anti-Counterfeiting Assurances for Cosmetics
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David Joyal, VP Legal, Global Supply and Patents, COTY
Scott Miller, Co-Managing Partner, MBM Intellectual Property Law
• Analyzing recent case law developments affecting trademark infringement • Managing trademark squatters especially with counterfeit products in Asia • Outlining best practices for building your trademark portfolio
Patents • Developing patent strategies to address the latest trends in the cosmetics space • Assessing challenges with patents as the demand grows in the global market a C5 Group Company
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Counterfeit Products • Developing internal controls to protect your brand and reduce counterfeit products • Handling the public relations in the aftermath of counterfeit products hitting retailers and becoming viral on social media 5:45
Live Q&A: International Affairs Think Tank: Navigating Tariffs and Treaties for Successful Cosmetic Product Entry Throughout the Globe
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BONUS “ON DEMAND” FOCUS SESSIONS
• Understanding the impact of the tariffs America imposed on European products under Trump and whether this will continue under Biden – and what this means for the cosmetics space • Analyzing the probability of continuing trade wars and tariffs between the US and China under a Biden Administration and how this might affect cosmetics products • Exploring the status of the renegotiated NAFTA (renamed) USMCA under a Biden Administration– and how this impacts the cosmetics space
Watch the pre-recorded video in advance of the afternoon’s live Q&A with speakers. Audience members will be able to view these sessions at any time.
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» Assessing the impact on labor, intellectual property, and investments
Laura Siegel Rabinowitz, Shareholder, Greenberg Traurig, LLP
Cosmetics comprise a multi-billion-dollar international industry spanning the globe. Navigating the international market and the many laws and regulations which govern it is difficult. Trade wars and tariffs under the Trump Administration only added to this complexity. All eyes are now on the Biden Administration in anticipation of its trade policies. In this session, our speakers will provide a detailed overview and in-depth analysis for the successful global entry of your product. Points of discussion will include:
Focus on Europe: A Guide to Compliant Commercialization Dr. Mojgan Moddaresi PhD, PharmD, FRSB, CBiol, MRSB (Aka Dr M), Managing Director, Personal Care Regulatory Ltd A compliance regulatory company specialised in cosmetic products in the EU and UK
Europe • Analyzing EU regulations on cosmetics and personal care products • Adhering to labeling requirements • Exploring the continuing impact of Brexit with U.S. companies who have manufacturing facilities or are headquartered in the UK
• Forecasting the Biden Administration’s view on the prior Administration’s policies of leveling the playing field with other countries » Intellectual property protections » Restrictions on U.S. investment in other countries
2
6:15
Closing Comments
Focus on Asia: Complying with Licensing and Product Requirements
China
• Assessing the status of tariffs in the U.S. under a Biden Administration and throughout the globe that may affect supply chain and pricing
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Robert J. Kiefer, General Manager, REACH24H USA Inc.
• Introducing China’s new cosmetic regulation framework, including competent authority, reform background, CSAR and sub-regulations • Complying with notification and registration requirements for your products (definition, classification, notification & registration, flow chart, labeling) • Discussing new cosmetic ingredient compliance • Analyzing animal testing updates and trends • Outlining ways to enter into this huge market and taking advantage of market growth in this area - e.g., CBEC channels
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