Pre-Conference Workshops

Workshop A – CBD Hemp Oil Working Group: An Analysis of FDA Guidance and State and Federal Laws for the Cosmetics Industry

Mar 25, 2020 9:00am – 12:30pm

Speakers

Kristi L. Wolff
Partner
Kelley Drye & Warren LLP (Washington, DC)

Shelly Garg
Partner
Amin Talati Wasserman, LLP (Washington, DC)

Workshop B – International Affairs Think Tank: Navigating Tariffs, Treaties and Trade Wars for Successful Cosmetic Product Entry Throughout the Globel Product Entry Throughout the Globe

Mar 25, 2020 1:30pm – 5:00pm

Speakers

Robert J. Kiefer
General Manager
REACH24H USA Inc. (Reston, VA)

Felicia Leborgne Nowels
Partner
Akerman LLP (Tallahassee, FL)

Donald S. Stein
Shareholder
Greenberg Traurig LLP (Washington, DC)

Day 1 - Thursday, March 26, 2020

7:15
Continental Breakfast and Registration
8:00
Co-Chairs’ Welcome Remarks
8:30
The United States of Beauty: An Analysis of Proposed Federal Legislation and Regulation Impacting the Cosmetics Industry
9:30
FDA Keynote Address on Perspectives and New Priorities for 2020
10:15
Morning Coffee Break
10:30
Beauty Within the States: Complying with New Laws and Adhering to Safety Requirements
11:45
CBD Hemp Oil in the Cosmetics Space: Lessons Learned One Year After the Farm Bill Made Hemp Legal
12:30
Networking Luncheon for Speakers and Attendees
1:30
Assessing the Risks of Socially Promoting Beauty: Legal Dilemmas and Controversies Associated with Influencers
2:30
The Make-Up of Claims Substantiation: Establishing Proofs and Avoiding Misrepresentation
3:30
Afternoon Refreshment Break
3:45
Privacy and Data Protection of Consumer Information in the New Era of E-Commerce Sites and Direct-to-Consumer Sales for Cosmetics Products
4:45
IP Protections and Anti-Counterfeiting Assurances for Cosmetics
5:30
Conference Adjourns to Day 2

Day 2 - Friday, March 27, 2020

7:00
Continental Breakfast
8:15
Co-Chairs’ Welcome Remarks and Recap of Day 1
8:30
Designing Recall Protocols to Contain Risk and Protect Brand Integrity
9:15
Defining Steps to Ensure Public Confidence in Your Brand When Adversity Hits: Practical Guidance on Cosmetics Crisis Management
10:00
Morning Refreshment Break
10:15
Fireside Chat: Exploring the Import/Export of Cosmetics
11:00
Balancing Consumer Demand for Clean Beauty, Sustainability, and Natural Products Against Potential Liabilities
12:00
Networking Luncheon for Speakers and Attendees
1:00
Prop 65 Think Tank: An Assessment and Analysis of Warnings and Case Law Affecting the Cosmetics Space
1:45
The Class Action Litigation Outlook: Forecasting the Next Wave of Activity with A Special Spotlight on California Specific Case Law
2:45
Creating a Legal Pathway for Ingredient Safety Similar to “GRAS”
3:30
Conference Ends

Day 1 - Thursday, March 26, 2020

7:15
Continental Breakfast and Registration
8:00
Co-Chairs’ Welcome Remarks

Sharon Blinkoff
Counsel, Locke Lord LLP Chair Advertising and Social Media Group
Member of the Board of Directors of Independent Cosmetic Manufacturers and Distributors

Taryn C. Looney
Director - Assistant General Counsel
Chanel

8:30
The United States of Beauty: An Analysis of Proposed Federal Legislation and Regulation Impacting the Cosmetics Industry

Nick Barnhorst
Head of Legal & Regulatory
Fresh, Inc. (New York, NY)

Kathleen M. Sanzo
Partner
Morgan Lewis (Washington, DC)

Valerie Ramsey, DRSc, MS, RAC
Director, Regulatory Affairs and Quality Assurance
Cosmetic Dermatology, LLC | dr. brandt® skincare (Miami, FL)

  • 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
    • Reviewing the status of the Personal Care Products Safety Act introduced by Feinstein and Collins and how it compares to The Safe Cosmetics and Personal Care Products Act
  • Interpreting provisions under the SAFE Banking Act of 2019 allowing safe harbor for financial institutions who provide financing for companies producing cosmetics containing CBD hemp oil
  • Assessing the pending Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 (included in the H.R. 269 the “Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019) and its potential impact on the beauty industry
  • Comprehending the impact of the introduction of the Humane Cosmetics Act for 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
    • Devising methods to overcome obstacles when color additives are allowed in Europe and China but prohibited in the U.S.
    • Understanding the limitations of color additives when producing cosmetic products that contain these prohibited color additives
  • Exploring the status of the FDA’s proposed final rule on sunscreen
    • Addressing ingredient safety, SPF, and other factors
    • Deciphering the FDA’s request for more data and information regarding sunscreen protections

9:30
FDA Keynote Address on Perspectives and New Priorities for 2020

Linda M. Katz, M.D., M.P.H.
Director, Office of Cosmetics and Colors
Center for Food Safety and Applied Nutrition
Office of Cosmetics and Colors

U.S. Food and Drug Administration (College Park, MD)

10:15
Morning Coffee Break
10:30
Beauty Within the States: Complying with New Laws and Adhering to Safety Requirements

Taryn C. Looney
Director - Assistant General Counsel
Chanel

Peggy Otum
Partner
WilmerHale (San Francisco, CA)

Part I: Wading through 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

California has recently 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:

  • Interpreting the following bills from California regarding ingredient safety:
    • B647 Bill on requirements to provide safety data sheets (SDS) and post these on a public website
    • 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
    • SB 1249 Bill to ban cosmetic testing on animals
      • Understanding grandfathered exceptions
      • Examining implications with China’s regulations on animal testing
  • Analyzing the national reach of these legislative measures
  • Anticipating which of the other states may follow California’s example

11:45
CBD Hemp Oil in the Cosmetics Space: Lessons Learned One Year After the Farm Bill Made Hemp Legal

Douglas “Duffy” MacKay, N.D
Senior Vice President Scientific & Regulatory Affairs
CV Sciences, Inc. (San Diego, CA)

12:30
Networking Luncheon for Speakers and Attendees
1:30
Assessing the Risks of Socially Promoting Beauty: Legal Dilemmas and Controversies Associated with Influencers

Thomas Cohn
Director and Senior Counsel, Sales, Marketing & Government Affairs
New Avon Company (New York, NY)

Jonathan A. Havens
Partner/Co-Chair, Cannabis Law Co-Chair, Food, Beverage & Agribusiness
Saul Ewing Arnstein & Lehr LLP (Baltimore, MD & Washington, DC)

Candace Sady
Chief Marketing Counsel – North America
Colgate-Palmolive Company (New York, NY)

  • Examining the role and reach of influencers in the promotion of beauty and personal care products
  • 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 influencer social media marketing

2:30
The Make-Up of Claims Substantiation: Establishing Proofs and Avoiding Misrepresentation

Karla Cohen
Assistant General Counsel
Edgewell Personal Care (Shelton, CT)

Deborah Marrone
Assistant Regional Director Northeast Region
Federal Trade Commission (New York, NY)

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

In this session, attendees will be given a rare opportunity to address their questions to speakers from the FTC, NAD/BBB, and the industry regarding recent trends and developments with claims substantiation.

This session is designed as an interactive town hall where attendees will be able to direct questions to the panel 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 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

3:30
Afternoon Refreshment Break
3:45
Privacy and Data Protection of Consumer Information in the New Era of E-Commerce Sites and Direct-to-Consumer Sales for Cosmetics Products

Cinthia Granados Motley
Member
Dykema Gossett PLLC (Chicago, IL)

California recently passed its Consumer Privacy Act signaling aggressive protections for consumer data and privacy of information. Other states may soon follow. In this session, our speakers will explore the current state of affairs for the cosmetic industry as more companies are expanding market share by selling cosmetic products on e-commerce sites as well as through direct-to-consumer sales.

Points of discussion include:

  • Assessing the impact of the California Consumer Privacy Act in the cosmetics space and how this will affect other states passing similar legislation
    • Comparing and contrasting the CCPA with GDPR: identifying similarities and differences
  • Analyzing ways companies can adhere to global privacy regulations in the cosmetic space as more products are sold in the cross-border context
  • Understanding different payment methods and systems as more products are sold on e-commerce sites and direct-to-consumer methods
    • Adhering to different legal and regulatory requirements

4:45
IP Protections and Anti-Counterfeiting Assurances for Cosmetics

Evan Gourvitz
Counsel
Ropes & Gray LLP (New York, NY)

Joshua S. Jarvis
Partner
Foley Hoag LLP (Boston, MA)

David Joyal
Vice President, Legal Patents
Coty Inc. (New York, NY)

Trademark Infringement

  • 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
  • Olaplex v. L’Oreal – interpreting the District of Delaware’s decision on the alleged theft of a key formula

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

5:30
Conference Adjourns to Day 2

Day 2 - Friday, March 27, 2020

7:00
Continental Breakfast
8:15
Co-Chairs’ Welcome Remarks and Recap of Day 1
8:30
Designing Recall Protocols to Contain Risk and Protect Brand Integrity

Aliza R. Karetnick
Partner
Ballard Spahr LLP (Philadelphia, PA)

Through the use of hypotheticals, our speakers will address how to devise successful protocols of containing a recall. In addition, they will outline and define ways to avoid recalls through internal processes and protocols.

Points of discussion include:

  • Breaking down the anatomy of a recall in the cosmetics space
  • Differences with approach in handling voluntary recall vs. FDA request for a recall
    • Lessons learned from recalls affecting Claire’s and Johnson & Johnson
    • Addressing concerns with safety and adulterated products
  • Outlining steps to manage once a recall occurs
    • Defining internal controls and processes after a recall has been announced
    • Establishing lines of communication with business partners
  • Devising ways to avoid recalls and manage the safety of your product
    • Focusing your attention on supply chain to avoid recalls

9:15
Defining Steps to Ensure Public Confidence in Your Brand When Adversity Hits: Practical Guidance on Cosmetics Crisis Management

Jessica P. O’Connell
Partner
Covington & Burling LLP (Washington, DC)

Svetlana N. Walker
Associate General Counsel – KCNA Baby & Child Care
Kimberly-Clark Corporation (Neenah, Wisconsin)

In this session, our speakers will explore steps and outline ways to build public confidence when adversity hits and your brand and company’s image is tarnished. Using a case study, they will address two scenarios: the first, involving a product contaminant and, the second, involving counterfeit products.

Points of discussion include:

  • Developing strategies for implementing an internal crisis management plan to ensure an effective and quick response once the public and media are aware of an adverse action
  • Examining all areas where a crisis may impact your brand and company:
    • Legal
    • Intellectual Property
    • Public Relations
  • Addressing ways to respond to counterfeit brands and safety concerns that follow
  • Examining the impact of recalls via a voluntary method or by FDA action
  • Taking advantage of social media outlets for a quick response to adverse actions

10:00
Morning Refreshment Break
10:15
Fireside Chat: Exploring the Import/Export of Cosmetics

Dr. Anastasia Xenias, PhD
Senior International Trade Specialist and Global Team Leader
International Trade Administration United States Department of Commerce (New York, NY)

11:00
Balancing Consumer Demand for Clean Beauty, Sustainability, and Natural Products Against Potential Liabilities

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

Susan Tanaka
Head of Legal
Amorepacific US, Inc. (New York, NY)

Clean Beauty and Sustainability

  • 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
    • 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

12:00
Networking Luncheon for Speakers and Attendees
1:00
Prop 65 Think Tank: An Assessment and Analysis of Warnings and Case Law Affecting the Cosmetics Space

Lynn Fiorentino
Partner
Arent Fox LLP (San Francisco, CA)

  • 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

1:45
The Class Action Litigation Outlook: Forecasting the Next Wave of Activity with A Special Spotlight on California Specific Case Law

Courtney E. Ozer, Esq.
Associate General Counsel – Litigation
Unilever United States, Inc. (Englewood Cliffs, NJ)

William F. Tarantino
Partner
Morrison & Foerster LLP (San Francisco, CA)

Class Action Litigation

  • 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
  • Spotlight on California Litigation

    • Examining how California specific litigation can be used as a benchmark for potential litigation in other states
      • Responding effectively to plaintiffs’ claims that products are not what they’re purported to be by testing and other measures
      • Reviewing litigation trends relevant to auto-ship programs and understanding why California law is stricter than federal law (RASCA)

    2:45
    Creating a Legal Pathway for Ingredient Safety Similar to “GRAS”

    Scott Faber
    Senior Vice President, Government Affairs
    Environmental Working Group (Washington, DC)

    Armia Guirguis
    Product Safety & Regulatory Affairs Director
    Henkel Beauty Care (Stamford, CT)

    With no clear guidance from the FDA and a lack of regulation, it is difficult for cosmetic companies to find the right path for ingredient safety. Should the industry have GMPs similar to food and dietary supplements? Can a method and structure similar to GRAS be suitable for the cosmetic space? These are some of the points that NGOs and the industry will debate in this session.

    Points of discussion include:

    • Implementing GMP standards similar to other industries and how this can apply to the cosmetic space
      • Requiring a mandatory product registry and adverse event reporting
    • Reviewing ingredients where safety may pose a risk:
      • Parabens
      • Nano particles
      • Plasticizers
      • Phalates
    • Ensuring the quality and safety of materials when sourcing ingredients overseas from various countries

    3:30
    Conference Ends

    Workshop A – CBD Hemp Oil Working Group: An Analysis of FDA Guidance and State and Federal Laws for the Cosmetics Industry

    Mar 25, 2020 9:00am – 12:30pm

    Kristi L. Wolff
    Partner
    Kelley Drye & Warren LLP (Washington, DC)

    Shelly Garg
    Partner
    Amin Talati Wasserman, LLP (Washington, DC)

    What is it about?

    In recent years, the use of CBD hemp oil in cosmetics has grown profusely. Innovation of these products continues to evolve as new products enter the market. However, with these products come a heightened risk, as the potential liabilities which companies may face cannot be ignored. In this session, our speakers will explore current regulation as well as market trends. They will also offer practical guidance for achieving success in this market and help ensure that you are meeting applicable regulatory requirements. Points of discussion to include:

    • Assessing the impact of the Farm Bill a year later and how it has created opportunities for cosmetic companies relative to the use of CBD-hemp oil
      • Examining limitations and risk associated with prohibition from the various states regarding the use of cannabis
      • Exploring pre-emption challenges
    • Examining the FDA’s stance on CBD usage as an ingredient
      • Interpreting FDA’s position that CBD in cosmetics cannot be used if “misbranded or adulterated”
    • Understanding the impact of FDA’s issuing warning letters to 15 companies selling CBD in violation of the Food, Drug, & Cosmetic Act
    • Understanding the market forces behind the use of CBD hemp oil in cosmetic products
    • Outlining the risks and liabilities associated with using CBD hemp oil in your product
    • Ensuring your product contains the CBD ingredients you purport it to be will improve skincare
    • Effective strategies to ensure proper claims substantiation and labeling which can withstand scrutiny
    • Understanding what we can glean about the future of CBD hemp oil in cosmetics through the FDA’s approval of the drug Epidiolex

    Workshop B – International Affairs Think Tank: Navigating Tariffs, Treaties and Trade Wars for Successful Cosmetic Product Entry Throughout the Globel Product Entry Throughout the Globe

    Mar 25, 2020 1:30pm – 5:00pm

    Robert J. Kiefer
    General Manager
    REACH24H USA Inc. (Reston, VA)

    Felicia Leborgne Nowels
    Partner
    Akerman LLP (Tallahassee, FL)

    Donald S. Stein
    Shareholder
    Greenberg Traurig LLP (Washington, DC)

    What is it about?

    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 only add to this complexity. 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:

    Addressing challenges associated with tariffs and treaties
    • Assessing the ongoing challenges with tariffs and how that might affect supply chain and pricing
    • Understanding the impact of the tariffs America imposed on European products and what this means for the cosmetics space
    • Analyzing the ongoing trade wars and tariffs between the US and China and how these affect cosmetics products
    • Exploring the impact of the renegotiated NAFTA– now renamed USMCA–and how this impacts the cosmetics space
      • Assessing the impact on labor, intellectual property, and investments
    • Examining the Trump Administration’s position on leveling the playing field with other countries
      • Intellectual property protections
      • Restrictions on US investment in other countries
    CBD Hemp Oil Exports and Imports
    • 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
    Europe
    • Analyzing EU regulations on cosmetics and personal care products
    • Adhering to labeling requirements
    • Exploring the continuing impact of Brexit with US companies who have manufacturing facilities or are headquartered in the UK
    Japan
    • Testing and inspecting products by the MHLW
    • Understanding how your product may be viewed by a sophisticated consumer base who research and have the money to spend in this area
    • Overcoming the burdens and hurdles of product registration
    China
    • Complying with licensing and registration requirements for your product
    • Interpreting the applicable laws for product entry
    • Identifying the appropriate agencies who oversee the cosmetics space including the CFDA, AQSIQ, SAIC, and SMRA
    • Understanding the difficulties when companies ban cosmetic animal testing but China strictly requires it
    • Outlining ways to enter into this huge market and taking advantage of market growth in this area
    Australia
    • Understanding cosmetics regulations in Australia
    • Assessing whether the ingredients in your product is allowed in Australia
    • Registering your product with NICNAS