Agenda
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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 27, 2023 9:00am – 12:30 PM
Speakers
Carrie Kovalerchik
Senior Legal Counsel
Unilever
Cynthia L. Meyer
Partner
Kleinfeld, Kaplan & Becker, LLP
In-Person Workshop B — MoCRA Working Group: All You Need to Know about Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
Mar 27, 2023 1:30pm – 05:00 PM
Speakers
Ann M. Begley
Partner
Wiley
Sam Jockel
Attorney
Alston & Bird
Day 1 - Tuesday, March 28, 2023
Day 2 - Wednesday, March 29, 2023
Post-Conference Workshop
In-Person Workshop C — Master Class on Cosmetics Adverse Events Reporting, and Recalls under MoCRA: A Blueprint for Designing Your Safety Plan
Mar 29, 2023 2:00pm – 05:30 PM
Speakers
Diane C. McEnroe
Partner
Sidley Austin
Dr. Rick Kingston
President of Regulatory and Scientific Affairs & Co-founder
SafetyCall International
Ryan Gooley
Director, Business Development – Recall & Remediation
Sedgwick
Day 1 - Tuesday, March 28, 2023
| 7:15 |
Continental Networking Breakfast and Registration |
| 8:15 |
Co-Chairs’ Welcome Remarks Sharon Blinkoff  Rohini Gokhale |
| 8:30 |
Overview Focus Session on the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) Arameh Z O’Boyle  Gustav W. Eyler  John Bailey Jr., Ph. D.  Margaret Whittaker The new regulatory framework for cosmetics is set to have a great impact on the industry. It is important to understand the key takeaways from the new law and the upcoming changes in how companies operate their businesses.
|
| 9:15 |
Anticipating What’s Next for Beauty Brands in Light of New MoCRA Requirements Heidi Forster Gertner Diane C. McEnroe  Nury Helena Yoo We’ll dive deeper into the practicalities of how cosmetic companies should adapt to the new requirements and become compliant with the new regulatory regime.
|
| 10:00 |
Spotlight on State PFAS Legislation and Its Impact on Cosmetics and Personal Care Products Cynthia Liebernam  Jeffrey Margulies  Sabina Mizrachi
|
| 10:30 |
Morning Networking Coffee Break |
| 11:15 |
The Golden State of Beauty: Update on California Legislative and Enforcement Activity Affecting the Cosmetic and Personal Care Industries Sophia B. Castillo  Andrew Shapero
Focus on Prop 65 Activity
|
| 12:00 |
Networking Lunch |
| 1:00 |
FDA Keynote on Priorities for 2023 Linda M. Katz, M.D., M.P.H. |
| 1:45 |
Aesthetic Market Focus: Is it a Cosmetic? or a Drug? or a Device? Dr. Robb Akridge  Christopher Hanson  Riëtte van Laack  Madeleine Giaquinto With the beauty industry constantly evolving and new cosmetic procedures appearing year by year, there has been a need for more guidance and regulation regarding what classifies as a cosmetic vs a drug vs a device. This session will highlight the challenges in these two industries:
|
| 2:45 |
Networking Break and Speaker Lounge |
| 3:00 |
The 2023 Litigation and Class Actions Outlook for The Cosmetics and Personal Care Products Industries Jessica O’Connell  Shawn R. Obi  Sylvia E. Simson Class Actions
Focus on Preemption Defense
|
| 4:00 |
Defining Clean and Natural Beauty: Formulating Claims from the Biggest Trends in 2023 Tonya Esposito  Raqiyyah Pippins  Larry Weiss
|
| 4:45 |
Understanding IP Protection and Anti-Counterfeiting Measures for Cosmetics Camille Friedlander  David Joyal  Kiri Lee Sharon
|
| 5:30 |
Exploring Diversity and Inclusion in the Cosmetic and Personal Care Industry Emily Perez  Jamila Powell  Kimberly Smith Moderator: Monique Davis Our esteemed panel will discuss how the cosmetics and personal care industry continues to make strides to be more inclusive and listen to consumer needs. |
| 6:00 |
Closing remarks and Recap of Day One |
Day 2 - Wednesday, March 29, 2023
| 7:30 |
Continental Networking Breakfast and Registration |
| 8:15 |
Co-Chairs’ Opening Remarks and Recap of Day OneSharon Blinkoff Rohini Gokhale |
| 8:30 |
ESG – Moving Forward with Environmental and Social Sustainability in the Cosmetics and Personal Care Products Industries Rachel Gartner  Akemi Ooka  Jaclyn Kaczmarek
|
| 9:30 |
Claims Substantiation Case Studies: Lessons Learned from Past Ads for Cosmetics and Personal Care Products Marietta Jo  Aliza R. Karetnick  Jennifer Santos  Craig Weiss
|
| 10:30 |
Morning Networking Break |
| 10:45 |
Federal Trade Commission Keynote Michael Ostheimer |
| 11:30 |
Avoiding Data Privacy and Ethical Violations in Claims from Using New Technologies in Cosmetics Paavana L. Kumar  Ming Zhao  Harry Valetk New Technologies such as AI have brought opportunity to the cosmetics and personal care industries, but they have also brought risks and challenges — especially in the area of privacy.
|
| 12:15 |
International Outlook on Export Regulations & Compliance: Focus on Asia Robert J. Kiefer  Jackson Pai
|
| 1:00 |
Co-Chairs’ Closing Remarks and Recap of Day Two
|
In-Person Workshop A — The Foundation of Beauty: Cosmetics and Personal Care Products Law and Regulation 101
Carrie Kovalerchik
Senior Legal Counsel
Unilever
Cynthia L. Meyer
Partner
Kleinfeld, Kaplan & Becker, LLP
What is it about?
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 Working Group: All You Need to Know about Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
Ann M. Begley
Partner
Wiley
Sam Jockel
Attorney
Alston & Bird
What is it about?
As the biggest end-of-the-year surprise, MoCRA 2022 was introduced as law, bringing new federal standards in the cosmetics industry for registration, adverse event reporting product listing, recordkeeping, recalls, safety substantiation and more.
Our workshop leaders will provide an in-depth analysis of the new cosmetics regulatory framework and help you and your company prepare for the upcoming changes and requirements. This workshop will be:
- Analyzing how MoCRA will change how the FDA regulates cosmetics
- Determining the next steps for cosmetic brands and examining what resources they need to implement
- Developing a comprehensive plan of action in view of complying with the new provisions
- Identifying and minimizing the risk of litigation and consumer claims based on the new FDA requirements
In-Person Workshop C — Master Class on Cosmetics Adverse Events Reporting, and Recalls under MoCRA: A Blueprint for Designing Your Safety Plan
Diane C. McEnroe
Partner
Sidley Austin
Dr. Rick Kingston
President of Regulatory and Scientific Affairs & Co-founder
SafetyCall International
Ryan Gooley
Director, Business Development – Recall & Remediation
Sedgwick
What is it about?
Safety is the core element of MoCRA legislation. Among other things, the law has given FDA mandatory recall authority and created adverse events reporting requirements. Understanding how to execute a recall has always been a critical competency for legal and business executives in these industries. However, MoCRA has taken the concept to a whole new level. This Master Class will ensure that you are prepared for the inevitability of a recall, how to develop and implement MoCRA compliant plans for recall execution, as well as AER reporting.
- 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