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Pre-Conference Workshops

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

Mar 19, 2024 9:00am – 12:30 PM

Speakers

Kyle Diamantas
Partner
Jones Day

Virginia Hill, M.S., RAC (US)
Director, Product Safety & Regulatory Affairs
Wella

In-Person Workshop B — MoCRA Comprehension Hub : A 360 Degree Deep Dive Into the Essential Components of the 2022 Modernization of Cosmetics Regulation Act

Mar 19, 2024 1:30pm – 05:00 PM

Speakers

Donald D. Ashley, J.D.
Executive Vice President, Regulatory Compliance
Greenleaf Health, Inc.

Day 1 - Wednesday, March 20, 2024

7:15
Continental Networking Breakfast and Registration
8:15
Co-Chairs’ Welcome Remarks
8:30
MoCRA – One Year Later: Examining how the Cosmetics Industry is Adapting to the New Regulatory Framework and Addressing Current Implementation Challenges
9:15
An Analysis of State Legislative Initiatives Impacting the Cosmetics and Personal Care Industries
10:00
Morning Networking Coffee Break
10:30
AI and ML in the World of Cosmetics: Navigating Data Privacy Concerns While Embracing New Technologies
11:15
Keynote on FDA Priorities for 2024
12:00
Networking Lunch

Sponsored by:
1:00
Spotlight on the PFAS Crisis: Examining The Beauty Industry’s Response to the Government and Consumer Clean-Up Call
1:45
ESG in Practice: Charting a Greener, More Sustainable, and Socially Responsible Path for Cosmetics and Personal Care Products
2:30
Adverse Events Reporting and Recalls under MoCRA: A Blueprint for Designing Your Safety Plan
3:15
Afternoon Break
3:30
Contaminants in Cosmetic and Personal Care Products: Addressing Risk and Remediation
4:30
Beauty for All: A Town Hall on Revolutionizing DEI Across the Cosmetics & Personal Care Industries
5:30
Closing Remarks – Conference Adjourns

Day 2 - Thursday, March 21, 2024

7:30
Continental Networking Breakfast and Registration
8:15
Co-Chairs’ Opening Remarks and Recap of Day One
8:30
Key Developments in Cosmetics Regulation from the Global Stage
9:15

FTC & NAD Townhall

Beauty Under the Influence: Adhering to the Latest FTC Guidance on Endorsements, Influencers and Consumer Reviews
10:30
Morning Networking Break
11:00
Litigation Landmines in Beauty: Status Report on Class Action and Prop 65 Activity
12:15
IP and Beauty Brand Resilience: Safeguarding Against Counterfeiting and Fraud
1:00
Co-Chairs Closing Remarks and Recap of Day Two
Conference Adjourns

Post-Conference Workshop

Day 1 - Wednesday, March 20, 2024

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

Monique Forrest
Head of North America Legal Affairs
Beiersdorf

Aleen Tomassian
Global Marketing Counsel
The Estée Lauder Companies Inc

8:30
MoCRA – One Year Later: Examining how the Cosmetics Industry is Adapting to the New Regulatory Framework and Addressing Current Implementation Challenges

Victor Mencarelli
Director - Regulatory Affairs
Orveon Global

John W.M. Claud
Counsel
Hyman, Phelps & McNamara PC

Laura Rich
Counsel
Venable LLP

With MoCRA officially implemented on December 29, 2023, it is crucial for industry stakeholders to understand the nuances of this transformative Act and examine how the cosmetics industry is adapting to meet FDA’s new requirements. Join us for our opening panel of industry leaders as they:

  • Exchange their views on adjusting to the ever-changing regulatory landscape
  • Examine the industry’s reaction to MoCRA-driven changes
  • Address common industry concerns with MoCRA
  • Identify best practices for compliance and plan for future phases of implementation

9:15
An Analysis of State Legislative Initiatives Impacting the Cosmetics and Personal Care Industries

David C. Dilk
Director, Regulatory & Government Affairs
Givaudan

Akemi Ooka
Head of Global Supply Chain Resources
Independent Beauty Association

Jeffrey Margulies
Partner-in-Charge
Norton Rose Fulbright US LLP

The cosmetics and personal care industries are experiencing a wave of state-level legislative initiatives focusing on enhanced consumer safety, ingredient transparency, and sustainability. This session will explore the developments in California, Maine, Washington and other states which are having a dramatic impact on the cosmetics industry.

  • Analyzing California’s 2020 Toxic-Free Cosmetics Act, with a focus on the recent Assembly Bill 496, banning an extra 26 ingredients in fragrances and cosmetics
  • Explore how Maine’s Safer Chemicals in Personal Care Products Act is setting new standards for ingredient transparency and consumer protection
  • Learn about Washington’s efforts to promote sustainable and eco-friendly practices in the cosmetics and personal care sectors through the 2023 Toxic-Free Cosmetics Act (HB 1047)
  • Understand how these state laws are reshaping consumer expectations, demands, and purchasing behaviors in the cosmetics and personal care markets
  • Looking into Prop 65 litigation activity in California

10:00
Morning Networking Coffee Break
10:30
AI and ML in the World of Cosmetics: Navigating Data Privacy Concerns While Embracing New Technologies

Gary Mozer
Vice President, Global Digital Data & Privacy Legal Leader
Shiseido Company, Limited

Jeffrey Rosenthal
Partner
Blank Rome

Emerging technologies such as AI and the Metaverse are being increasingly utilized by beauty brands, however these promising advancements are accompanied by various critical considerations and concerns – the paramount one being privacy.

  • Analyzing how the beauty industry is utilizing the Metaverse and various digital technologies including AI, ML, AR, and VR
  • Reviewing state enforcement activity concerning the use of biometrics and its impact on the cosmetics industry such as the Illinois Biometric Information Privacy Act
  • Identifying privacy and ethics concerns with the use biometric data
  • Examining how personalized tools that incorporate artificial intelligence and biometric data (face scanning tools) can lead to privacy violations
    • Assessing privacy risks in AI-based personalized tools, including face scanning tech
Generative AI Focus:
  • Uncovering how generative AI is reshaping product innovation, from custom formulations to personalized beauty recommendations
  • Addressing the ethical concerns and privacy considerations that come with this technological advancement

11:15
Keynote on FDA Priorities for 2024
12:00
Networking Lunch

Sponsored by:
1:00
Spotlight on the PFAS Crisis: Examining The Beauty Industry’s Response to the Government and Consumer Clean-Up Call

Laura Hammargren
Shareholder
GreenbergTraurig

Ellen Robbins
Partner
Akerman LLP

  • Examining the current regulatory framework governing the manufacturing, production, packaging, and distribution of products containing PFAS chemicals
  • Exploring MoCRA’s Mandate: FDA’s 3-Year Deadline to Evaluate PFAS in Cosmetics
  • Adapting to changing consumer demands for PFAS-free products
  • Focusing on California’s Assembly Bill (AB) 2771 and how to ensure compliance
  • Analyzing
    • Oregon’s ‘Toxic-Free Cosmetics Act’, banning PFAS in cosmetics from 2027
    • Washington’s Toxic-Free Cosmetics Act 2023
  • Understanding PFAS testing challenges and how companies can better navigate this complex arena
  • Understanding the theories that plaintiffs are relying on in PFAS contamination claims — what defense strategies are proving to withstand the latest plaintiff challenges?
  • Examining how product testing/sourcing and recorded regulatory approval can yield additional defense strategies for PFAS lawsuits

1:45
ESG in Practice: Charting a Greener, More Sustainable, and Socially Responsible Path for Cosmetics and Personal Care Products

Jamie Richards
Director of ESG
amika + Eva NYC

Maggie Spicer
Founder
Source Beauty ESG

Stefanie Fogel
Partner
DLA Piper LLP

  • Examining the latest industry measures to adopt and ensure compliance with ESG protocols
  • Evaluating sustainable packaging as a crucial element of ESG initiatives
  • Highlighting the importance of ethically sourced ingredients and the responsible treatment of labor within the cosmetics and personal care supply chains
  • Understanding the importance of ESG reporting and how to align with stricter regulations to avoid legal enforcement
  • Enhancing initiatives to bolster corporate social responsibility in response to the growing desire for eco-friendly products

2:30
Adverse Events Reporting and Recalls under MoCRA: A Blueprint for Designing Your Safety Plan

Beth P. Weinman
Partner
Ropes & Gray LLP

Laurie A. Henry
Partner
Shook, Hardy & Bacon LLP

Nicole Lehr
VP, Associate General Counsel and Ethics Officer
L'Oréal USA

  • Examining FDA’s recall and oversight authority with cosmetics and personal care products under MoCRA
  • Identifying events which would trigger a mandatory recall under MoCRA
  • Developing best practices to design and implement an FDA-mandated MoCRA recall
  • Examining circumstances in which a voluntary recall is warranted
  • What is the nature of the recall?
  • What corrective actions should be taken?
  • Implementing Adverse Event reporting protocols in compliance with MoCRA?
  • When and what AER instances are manufacturers now required to report?
  • Invoking crisis management protocols

3:15
Afternoon Break
3:30
Contaminants in Cosmetic and Personal Care Products: Addressing Risk and Remediation

Monique Forrest
Head of North America Legal Affairs
Beiersdorf

Carl D’Ruiz, M. Ph.
Senior Manager, Science, Advocacy and Business Development - Personal Care, North America
DSM- Firmenich

Aliza R. Karetnick
Partner
Morgan Lewis

  • Exploring the recurrent presence and safety concerns regarding asbestos in talc-based cosmetics
    • What new authorities does MoCRA give the FDA to address asbestos exposure risks from cosmetics?
    • Assessing the status of proposed FDA regulations for standard testing methods to detect asbestos in talc products
  • Analyzing recent recalls of benzene-contaminated cosmetics and personal care products and the future implications for industry
  • Examining the latest regulatory developments and litigation activity related to titanium dioxide
    • What are the common themes, allegations and takeaways from recent litigation involving allegations of TiO2 in cosmetic and personal care products?
    • Best practices for safety assessments and labeling requirements
    • How companies and their counsel should be reviewing product formulations and label claims to mitigate enforcement and litigation risks associated with the presence of TiO2

4:30
Beauty for All: A Town Hall on Revolutionizing DEI Across the Cosmetics & Personal Care Industries

Monique Davis
Vice President, Global Local & Cultural Innovation
The Estée Lauder Companies Inc

It is increasingly important that the beauty industry evolves to better reflect the diverse needs and desires of consumers. During this interactive Town-Hall segment, our panelists will shed light on the industry’s commitment to inclusivity and its response to the ever-changing landscape of consumer demands. Let your voice be heard in this unique “open floor” session, designed to give
attendees an opportunity to grab the microphone and add to the dialogue.

Topics of discussion will include:

  • The impact of diversity-focused marketing campaigns and their role in redefining beauty standards
  • Understanding how brands can deliver on their promised values to better resonate with specific diverse groups of consumers
  • Listening to your audience: Leveraging communication between the consumer and your brand to better align inclusivity efforts with the needs and expectations of your target audience
  • Assessing how decisions about product placement, pricing, accessibility, marketing and messaging can impact how a product is perceived from a diversity & inclusion perspective

5:30
Closing Remarks – Conference Adjourns

Day 2 - Thursday, March 21, 2024

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

Aleen Tomassian
Global Marketing Counsel
The Estée Lauder Companies Inc

Monique Forrest
Head of North America Legal Affairs
Beiersdorf

8:30
Key Developments in Cosmetics Regulation from the Global Stage

Nadine Goldman
Director of Regulatory Affairs
Vivify Company

Christopher Gottfried
Attorney
Greenberg Traurig LLP

Miki Kolton
Of Counsel
GreenbergTraurig

In the future, the US may also align more closely with European regulations, especially in areas like ingredient bans, animal testing, and potentially increased restrictions on certain chemicals. This alignment reflects the global trend toward increased scrutiny and regulation of the cosmetics industry, as well as heightened consumer demands for safer and more sustainable products. Moreover, the panel will address key laws and regulations globally, including China. Panelists will be:

  • Analyzing the potential impact that the EU’s recent ban on animal testing will have on future alternative testing methods in the US
    • Comparing and contrasting testing developments and trends in China and what may be coming down the pike
    • Understanding the key changes in China’s Cosmetics Supervision and Administration Regulation (CSAR)
  • Examining the disparities in fragrance allergen labeling standards between the EU and the US – how could this impact how cosmetic product ingredients are disclosed?
  • Reviewing the differences between restricted substances and regulations around certain cosmetic ingredients within Europe and the US

9:15

FTC & NAD Townhall

Beauty Under the Influence: Adhering to the Latest FTC Guidance on Endorsements, Influencers and Consumer Reviews

Annie M. Ugurlayan
Assistant Director, National Advertising Division
BBB National Programs, Inc. (New York, NY)

Marietta Jo
General Counsel
Supergoop!

Katie Bond
Partner
Keller & Heckman LLP

Lane Verlenden
Assistant General Counsel
e.l.f. Beauty

Michael Ostheimer
Attorney
Federal Trade Commission (FTC)

Since we last met, the FTC released its finalized new Endorsement Guides, and also issued a proposed Rule on the Use of Consumer Reviews and Testimonials. Join us for this critical discussion of how the latest FTC guidance will impact social media advertising of cosmetics and personal care products and potential new areas of focus moving forward.

  • Analyzing FTC’s guidelines for social media and influencer endorsements
  • Understanding FTC’s take on dark patterns and consumer deception tactics
  • Examining problematic claims and areas of NAD and FTC focus
  • Gaining insight into the current class action threats associated with environmental claims

10:30
Morning Networking Break
11:00
Litigation Landmines in Beauty: Status Report on Class Action and Prop 65 Activity

Kristen Klesh
Partner
Loeb & Loeb LLP

Claudia A. Lewis
Partner
Venable LLP (Washington, DC)

Elizabeth M. Chiarello
Partner
Sidley Austin LLP

The plaintiffs’ bar is becoming increasingly aggressive in targeting cosmetic and personal care companies in class action lawsuits. This critical session will explore the types of litigation that are currently impacting the sector, strategies to minimize risk, and potential new areas of class action risk arising from MoCRA.

  • Taking a look at the latest cosmetic company practices which are triggering class action claims
  • Examining proactive measures that companies can implement to reduce the risk of class action litigation, including compliance strategies, accurate product labeling, and consumer education
  • Analyzing how MoCRA and heightened FDA enforcement is impacting litigation in the industry
    • What litigation trends are emerging?
    • Assessing recent FDA warning letters
    • Preparing for enforcement and potential new class actions
  • Exploring lessons from recent successes in class-action lawsuits and the utilization of federal preemption as a defense strategy
Prop 65 Focus:
  • Identifying the latest wave of plaintiffs’ claims made under Prop 65 • Examining defenses the industry is employing
Spotlight on Chemical Hair Relaxer Litigation
  • Examining the recent wave of products liability and consumer protection lawsuits against hair relaxing/straightening products
  • Analyzing the allegations, common themes, legal nuances and takeaways from these actions
  • Understanding how companies and their counsel should be reviewing product formulations and label claims to mitigate litigation risks associated with the presence of allegedly harmful phthalates, parabens or phenols

12:15
IP and Beauty Brand Resilience: Safeguarding Against Counterfeiting and Fraud

Brandee Winikoff
Assistant General Counsel
Unilever Health & Wellbeing

Yungbi Jang
General Counsel
Amorepacific US, INC.

Brad M. Scheller
Member
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

Join us for an insightful panel discussion into the world of intellectual property protection in the cosmetics industry. Tune in as we explore strategies to strengthen your trademark portfolio and secure your brand as well as fortify your brand’s defenses against counterfeiting and fraud.

  • Examining optimal strategies for fortifying your trademark portfolio and safeguarding your cosmetics and personal care brands
  • Establishing in-house safeguards to shield your brand and minimize the presence of counterfeit products
  • Analyzing recent legal precedents influencing cases related to trademark infringement and counterfeit merchandise

1:00
Co-Chairs Closing Remarks and Recap of Day Two
Conference Adjourns

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

Mar 19, 2024 9:00am – 12:30 PM

Kyle Diamantas
Partner
Jones Day

Virginia Hill, M.S., RAC (US)
Director, Product Safety & Regulatory Affairs
Wella

What is it about?

Workshop is available In-Person only.

This interactive workshop will set the stage for the two-day main conference by providing you with a comprehensive overview of the laws and regulations affecting cosmetics and personal care products. Points of discussion will include:

  • Understanding the role and authority of FDA in the cosmetics and personal care products market
  • Regulatory classification: Is it a cosmetic, a drug or something else?
    • Definitions: Identifying the difference between a cosmetic product and a drug under the Food, Drug & Cosmetics Act
    • Exploring circumstances in which a product can be considered a drug, medical device, dietary supplement, or consumer product
    • Explaining structure/function claims
  • Analyzing how a personal care product comes to market: Cosmetics vs. OTC drugs
    • Notification vs. Listing
    • Labeling
    • cGMPs
    • OTC Monographs
  • Identifying FDA requirements governing
    • Ingredients, including color additives
  • Reviewing FDA versus FTC jurisdiction for advertising and promotion of cosmetics and personal care products
  • Comprehending pre and post market responsibilities
    • Complaint monitoring and investigation
    • Adverse event reporting
    • Best practices for cosmetic recalls and product reintroduction
  • Other “regulators”
    • Retailers
    • Consumers
    • The States
  • CPSC, EPA, other federal agencies

In-Person Workshop B — MoCRA Comprehension Hub : A 360 Degree Deep Dive Into the Essential Components of the 2022 Modernization of Cosmetics Regulation Act

Mar 19, 2024 1:30pm – 05:00 PM

Donald D. Ashley, J.D.
Executive Vice President, Regulatory Compliance
Greenleaf Health, Inc.

What is it about?

Workshop is available In-Person only.

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) marks the first time in over 80 years that Congress and the President together have passed legislation affecting cosmetics companies specifically. The Act has initiated a brand-new era of government oversight and authority for the cosmetics market, including new federal standards for registration, adverse event reporting, product listing, recordkeeping, recalls, safety substantiation and more.

Join this essential MoCRA primer where our workshop leaders will provide an in-depth analysis of the new cosmetics regulatory framework and help you and your company navigate FDA’s new requirements and guidance. Points of discussion will include:

  • Analyzing how MoCRA has changed the way FDA regulates cosmetics
  • Need something on MoCRA requirements
  • Developing a comprehensive plan of action in view of complying with the new provisions
  • Understanding the implications of MoCRA for cosmetics commercialization

In-Person Workshop C — The Science of Beauty: A Master Class on Using Reliable Scientific Evidence to Substantiate Claims About Cosmetics and Personal Care Products

Mar 21, 2024 2:00pm – 05:30 PM

Alexander Smith
Partner
Jenner & Block LLP

What is it about?

Workshop is available In-Person only.

Ensuring proper claims substantiation for a cosmetic or personal care product is often a complex, fact-specific process. Even with substantial, well-designed studies, claims and their support may still draw scrutiny from regulators and increasingly, plaintiff’s attorneys. In this working group, we will provide the critical building blocks for ensuring proper science-backed claims substantiation, all with the goal of compliantly promoting your products, staying out of trouble, and winning consumer confidence. Points of discussion, include:

  • Identifying the types of scientific evidence needed to support beauty and wellness claims in the cosmetic and personal care product space
  • 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
    • Developing proper research methodologies to substantiate claims
    • Examining how practitioners can assess the clinical study early on in the research process
  • Evaluating clinical study data interpretation and how results apply to your claims
  • Interpreting recent FTC enforcement actions where the clinical study did not support the claim being made
  • Identifying implied claims and their hidden dangers
  • Reviewing marketing materials and promotional activities across various media outlets and social media platforms to ensure the claims are properly substantiated and supported by the clinical study
  • Understanding how testing differs when the cosmetic is classified as an OTC drug
  • Comprehending the benefits of using independent third-party testing to provide scientific support of the claims for your product
  • Determining the type of testing necessary to obtain clearance to market your product in
    • US
    • Canada
    • EU
    • UK
    • China, and other Asian market