The Foundation of Beauty: Cosmetics and Personal Care Products Law and Regulation 101

Mar 27, 2019 8:30am - 12:00pm

Speakers

Georgia Carole Ravitz, Esq.
Partner
Arent Fox LLP (Washington, DC)

Bringing Beauty Across Borders: Master Class on the International Commercialization of Cosmetics and Personal Care Products

Mar 27, 2019 1:00pm - 4:30pm

Speakers

Lisa Capote
FDA Regulatory Compliance Attorney
Capote Law Firm (Miami, FL)

Heili Kim
Partner
Venable LLP (Washington, DC)

Felicia Leborgne Nowels
Partner
Akerman LLP (Tallahassee, FL)

Day 1 - Thursday, March 28, 2019

7:30
Continental Breakfast
8:00
Co-Chairs’ Welcome Remarks
8:15
Keynote Address with the FDA on Agency Cosmetic Priorities for 2019
8:45
The Politics and Policies of Beauty: Deciphering the Implications of Proposed Legislative Reform for the Cosmetics and Personal Care Products Industries in 2019
9:45
Morning Coffee Break
10:00
Assessing the Impact of State Anticruelty Legislation and Other Reforms on the Cosmetics and Personal Care Industries
10:30
Updates on Sunscreen Monograph Regulation for Cosmetics and Personal Care
11:00
Assessing the Risks of using CBD and Hemp Oil in Cosmetics and Personal Care Products In Light of the Passage of the Farm Bill
12:00
Networking Lunch
1:00
China: Exploring the Short and Long- Term Business Implications of New Filing Regulations for Cosmetic Exports
1:45
Assessing Clean, Green and Natural Beauty: A Deep Dive into Definitions, Limitations, and Potential Liabilities for the Beauty Industry
2:45
Afternoon Refreshment Break
3:00
Claims Substantiation at First Blush: An In-Depth Approach to Ensuring Your Ads Can Prove Your Claim to Avoid Scrutiny
4:00
Assessing the Risks and Benefits of Social Media Influencers and Paid Promoters of Cosmetics and Personal Care Products
5:00
Conference Adjourns to Day 2

Day 2 - Friday, March 29, 2019

7:30
Continental Breakfast
8:00
Co-Chairs Welcome Remarks and Recap of Day One
8:15
Brand Protection in the Digital Age: Preventing Counterfeiting, Ensuring Trademark Enforceability, and Strengthening Other IP Protections in the Cosmetics and Personal Care Space
9:00
Riding the Coattails: The Latest Developments in Class Action Litigation Affecting the Cosmetics Industry
10:00
Morning Coffee Break
10:15
Prop 65 Spotlight: A Case Study on Reforms and Safe Harbors and Their Impact on the Beauty Industry
11:00
The New Face of Acquisitions: What Indie Companies Can Expect When Larger Companies Takes Over their Business
12:00
Networking Lunch
1:00
Crisis Management: Learning How to Protect Your Brand When Things Go Wrong
2:00
Cosmetic, Drug, or Both? Defining the Subtle Differences to Properly Promote a Product in the Market
3:00
Conference Ends

Day 1 - Thursday, March 28, 2019

7:30
Continental Breakfast
8:00
Co-Chairs’ Welcome Remarks

Andra Dallas
Senior Scientific Liaison & Manager, New Business Integration
Pulp Riot/L’Oreal (Los Angeles, CA)

Sharon Blinkoff
Counsel
Locke Lord LLP

8:15
Keynote Address with the FDA on Agency Cosmetic Priorities for 2019

Linda M. Katz, M.D., M.P.H.
Director, Office of Cosmetics and Colors, Acting Chief Medical Officer for Food Safety and Applied Nutrition
U.S. Food and Drug Administration

8:45
The Politics and Policies of Beauty: Deciphering the Implications of Proposed Legislative Reform for the Cosmetics and Personal Care Products Industries in 2019

Robert C. Harmala
Partner
Kilpatrick Townsend & Stockton LLP (Washington, DC)

Jordan B. Isrow, Esq.
General Counsel
Oxygen Development

Riëtte van Laack
Director
Hyman, Phelps, & McNamara, P.C. (Washington, DC)

In recent years, several bills have been introduced in Congress presenting differing policies on how cosmetics should be regulated. The Feinstein and Schakowsky bills were based upon the premise that cosmetics and cosmetic ingredients required significant additional regulatory oversight to protect public health and safety. The bill proposed to tax companies by levying significant fees to support expanded FDA oversight. The Sessions bills represented a different approach where National Uniformity was a key focus along with enhancing FDA’s authority. Topics of discussion will include:

 

  • Examining the key differences in approach of each of the bills and the affect that the proposed change in the FDA’s oversight would have on the cosmetics industry.
  • Understanding the political forces that are at work and the significance of the Senate HELP and House Energy and Commerce Committee’s interest in cosmetic reform legislation
  • Assessing the importance of the findings of the FDA’s Survey on allergens in cosmetics
  • Reviewing the history of the legislative process from the beginning when political forces were in play
    • Understanding different approaches in the industry’s role spearheaded by two different industry groups with varying approaches
  • Discussing the changes in the Congressional landscape after the mid-term elections and where cosmetic reform falls amongst current legislative initiatives

9:45
Morning Coffee Break
10:00
Assessing the Impact of State Anticruelty Legislation and Other Reforms on the Cosmetics and Personal Care Industries

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

  • Interpreting how California’s anticruelty legislation and its ban on animal testing will impact the cosmetics industry
    • Determining how the cosmetic industry is complying with state anticruelty legislation
    • Lessons learned and practical examples of compliance challenges and success stories
  • Assessing how other similar state anticruelty activity will affect industry business practices
  • State-by-state comparison of other significant legislation for consumer and personal care products
    • Status of sunscreen ingredient legislation in Hawaii
  • Survey of current state enforcement activity in the cosmetics arena
  • Examining questions of federal preemption

10:30
Updates on Sunscreen Monograph Regulation for Cosmetics and Personal Care
Diane McEnroe

Diane C. McEnroe
Partner
Sidley Austin LLP (New York, NY)

This February 26,2019 the FDA published its proposed rule on Sunscreen Products for Over-the-Counter Human Use which modernize and alter the sunscreen final monograph.
The proposed rule addresses “sunscreen active ingredient safety, dosage forms, and sun protection factor (SPF) and broad-spectrum requirements” and the ways in which sunscreens can be marketed. This latest FDA measure dovetails with recent legislative measures in a Hawaii and other states and municipalities concerning sunscreen safety. This session will explore the significance and requirements of the proposed Final Rule as well as other state and local activity in this area.

11:00
Assessing the Risks of using CBD and Hemp Oil in Cosmetics and Personal Care Products In Light of the Passage of the Farm Bill

Rory J. Radding
Partner
Locke Lord LLP (New York, NY)

Craig R. Weiss
President
Consumer Product Testing Company (Fairfield, NJ)

The use of CBD’s generally and hemp oil containing CBD’s is of great interest in many consumer products including cosmetics and personal care products. Products derived from hemp have low concentrations of THC – the
hallucinogenic component of cannabis. This panel will explore the controversy and contention concerning the use of CBD.

 

  • Reviewing the impact of the Farm Bill on hemp products that contain CBD’s
  • Interpreting the FDA laws and regulations that govern cosmetics and applying them to hemp and CBD products, in light of the pronouncements of the FDA Commissioner following passage of the Farm Bill
    • Reviewing FDA’s historic position on personal care products which have been distributed in the U.S. following the DEA’s issuance of its 2003 Guidance document.
  • Recognizing that while the Farm Bill provides preemption of state laws governing hemp usage due to limited Federal Preemption of cosmetic regulation, issues could arise under state cosmetic laws

12:00
Networking Lunch
1:00
China: Exploring the Short and Long- Term Business Implications of New Filing Regulations for Cosmetic Exports

Robert J. Kiefer
General Manager
Reach24H USA Inc. (Reston, VA)

  • Addressing legal and business challenges  associated with the changes mandated by the China National Medical Products Administration relative to the registration of first-imported non-specials cosmetics
  • Exploring the new requirement for designating a domestic responsible person to file registrations in one of 11 trade free zones
  • Examining new criteria for import and distribution
  • Assessing FCPA considerations when importing cosmetic and personal care products into China

1:45
Assessing Clean, Green and Natural Beauty: A Deep Dive into Definitions, Limitations, and Potential Liabilities for the Beauty Industry

Claire Bing
Director of Regulatory
Tarte Cosmetics

Kathryn Farrara
Assistant General Counsel, Marketing
Unilever

Sonali P. Gunawardhana
Counsel
Shook Hardy and Bacon (Washington, DC)

Moderator:

Katie Bond
Partner
Amin Talati Upadhye LLP (Washington DC)

Natural

 

  • Addressing the challenges with the lack of definition of the word “natural” by the FDA
  • What are the implications and risks associated with labeling cosmetics and personal care products as “natural”
    • Assessing the challenges with labeling products as “preservative free” and natural preservatives
  • Making other “trendy” claims such as vegan, gluten free, peanut free, and others
  • Analyzing the current litigation landscape where plaintiffs have challenged the use of the word “natural”?
    • Assessing the problems with a water based product of “preservative-free” “ or all natural which would include natural preservatives” and may well lead to mold, bacteria, and microcontaminants
  • What is the current standard for USDA requirement for “organic” and how does this apply to cosmetics?
  • Lessons learned from FDA requirements for natural versus synthetic flavors and how the cosmetics industry adapt to these standards

 

Clean Beauty and Sustainability

 

  • Examining NAD pronouncements on advertising of “clean beauty” products and their implications
  • Addressing the impact of companies producing products which are “green” for the purposes of sustainability and being environmentally friendly
  • Establishing evidentiary support for products that are “green”
  • Assessing the current class action litigation landscape when consumers challenge the viability of “clean beauty” products

2:45
Afternoon Refreshment Break
3:00
Claims Substantiation at First Blush: An In-Depth Approach to Ensuring Your Ads Can Prove Your Claim to Avoid Scrutiny

Deborah Marrone
Assistant Regional Director Northeast Regional Office
Federal Trade Commission

Anu Gokhale
Staff Attorney
National Advertising Division Advertising Self-Regulatory Council

Thomas Cohn
Director and Senior Counsel, Sales, Marketing & Government Affairs
New Avon LLC.

Moderator:

David G. Mallen
Co-Chair, Advertising Disputes, Co-Chair, Retail and Consumer Brands
Loeb & Loeb LLP (New York, NY)

  • Overview of the latest trends in cosmetics and personal care products claims substantiation: natural, organic, preservative free, paraben and sulfate free, wrinkle reduction, eyelash growth, etc.
    • Providing the proper substantiation to support your claim
    • Using third-party independent companies to provide evidentiary support of specific ingredient(s)
    • Assessing and industry standard for testing requirements
    • Devising creative strategies to remain compliant and make your claim work for your product
  • Comparing and contrasting different types of claims including scientific, consumer, clinical, comparative, and superiority
    • Measuring when to step in and stage a response and assessing the strength of your answer
  • Review of the recent NAD and FTC decisions impacting the cosmetics industry

4:00
Assessing the Risks and Benefits of Social Media Influencers and Paid Promoters of Cosmetics and Personal Care Products

Rita Gomes
Chief Marketing Counsel North America
Colgate-Palmolive Company (New York, NY)

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

In today’s advertising realm, companies have a variety of avenues to choose from as social media outlets have given influencers, paid promoters, and celebrities a voice. These outlets have extreme weight to consumers
who rely on reviews and product assessment before making a purchase.

In this session, our speakers will explore the weight of these influencers and paid promoters as well as the FTC regulatory guidelines for improper influencer marketing.

 

Points of discussion will include:

  • Creating an effective strategy of marketing and advertising in the cosmetics and personal care products space using social media, the internet, YouTube channels, and other avenues
    • Devising ways to prevent or counteract trolls, fake reviews by competitors, or other adverse marketing methods
  • Exploring the impact of FTC warning letters on influencers and paid promoters in social media
  • Examining FTC guidelines on influencer marketing on social media including the use of hashtags
  • Understanding the relationship between the cosmetics company and influencers/ promoters who market products but don’t mention they are paid to do so
    • Examining potential liability concerns

5:00
Conference Adjourns to Day 2

Day 2 - Friday, March 29, 2019

7:30
Continental Breakfast
8:00
Co-Chairs Welcome Remarks and Recap of Day One
8:15
Brand Protection in the Digital Age: Preventing Counterfeiting, Ensuring Trademark Enforceability, and Strengthening Other IP Protections in the Cosmetics and Personal Care Space

Rebecca Brunswick
Executive Director & Chief Marketing and Intellectual Property Counsel
Avon (New York, NY)

Alisa D. Hurlburt
Counsel
Miles & Stockbridge, P.C. (Frederick, MD)

Theodore C. Max
Partner
Sheppard, Mullin, Richter & Hampton LLP (New York, NY)

Counterfeiting

 

  • Implementing prevention management plans for counterfeit products entering the market
  • Dealing with public relations challenges when news of counterfeit products goes viral via social media posts

 

Trademarks

 

  • Assessing the trademark lawsuits impacting cosmetics and personal care items
  • Establishing practical strategies and best practices for building your trademark portfolio
  • Understanding the importance of trade dress protection for cosmetic packaging

 

Patents

  • Developing novel and creative patent strategies for the latest trends in the cosmetics and personal space including natural, organic, vegan, and more
  • Addressing the global demand for cosmetic and personal care products as the number of patents has increased every year
  • Examining how smaller indie companies can protect their brand and innovation as the demand for cosmetics has reached the global market

9:00
Riding the Coattails: The Latest Developments in Class Action Litigation Affecting the Cosmetics Industry

Nick Barnhorst
Vice President, Legal Counsel
Fresh (New York, NY)

Ronie M. Schmelz
Counsel
Tucker Ellis LLP (Los Angeles, CA)

  • Overview of the current survey of class action litigation in the cosmetics space
  • Exploring how plaintiffs are looking to state consumer protection activity to find their next cause of action
  • Comparing a state-by-state analysis of consumer protection statutes
  • Examining slack- fill litigation: challenges with weights and measures
    • Assessing the functional reason for false bottoms on jars
    • Addressing defective pumps preventing access to containers
  • Assessing the arguments made by plaintiffs at the class certification phase
    • Using consumer purchasing experts to provide an analysis of the economic damage suffered by plaintiffs
    • Overcoming the obstacles posed when plaintiffs try to disguise personal injury  claims as economic damage claims
  • Devising strategies to defeat class certification

10:00
Morning Coffee Break
10:15
Prop 65 Spotlight: A Case Study on Reforms and Safe Harbors and Their Impact on the Beauty Industry

Maureen F. Gorsen
Partner
Alston & Bird LLP (Sacramento, CA)

Sarah Esmaili
Counsel
Arnold & Porter Kaye Scholer LLP (San Francisco, CA)

  • Analyzing how California law is impacting the cosmetics industry and how these laws are setting standard for other states
    • Exploring the latest changes to Prop 65 on cosmetics and personal care
    • Unraveling the compliance challenges on warning labels relative to Prop 65
    • Exploring the repercussions of the seeming disconnect between certain Prop 65 rulings and FDA determinations
    • Deciphering the impact of Prop 65 reforms and safe harbor utilization for the cosmetics and personal care industries

11:00
The New Face of Acquisitions: What Indie Companies Can Expect When Larger Companies Takes Over their Business

Suzan Onel
Partner
Kleinfeld Kaplan & Becker LLP (Washington, DC)

Andra Dallas
Senior Scientific Liaison & Manager, New Business Integration
Pulp Riot/L’Oreal (Los Angeles, CA)

Robert L. Lawrence
Partner
Kane Kessler, P.C. (New York, NY)

The proliferation of smaller “indie” cosmetics companies has marked a shift in the industry. Larger and more established cosmetic companies are seeking to acquire these smaller companies in order to attract younger consumers with seemingly disposable incomes. As a result, the acquisition challenges unique to the cosmetics industry cannot be ignored. In this session, our speakers will address how to overcomes these obstacles and establish best practices for a seamless transition. Points of discussion will include:

 

  • Assessing the legal and compliance challenges associated with the acquisition of smaller “indie” companies with larger more established companies
  • Devising strategies to create a seamless transition when the acquisition process is complete
  • Developing a comprehensive business plan for the acquisition process
  • Addressing consumer perceptions when different brands are under the same umbrella
  • Overcoming the difficulties associated with marketing products post-acquisition

12:00
Networking Lunch
1:00
Crisis Management: Learning How to Protect Your Brand When Things Go Wrong

Nancy Husnik
Director, Counsel
Target Corporation

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

In today’s current climate, consumers are quick to complain about a product via social media channels. Consumers’ posts can go viral in minutes and a company’s brand, reputation, and image can be altered quickly. The court of public opinion can have huge weight and influence among consumers. In this session, our speakers will address the “ins and outs” of brand protection and how you can respond effectively to a public relations fallout when things go wrong:

 

  • Assessing the “first call” to make when your brand’s reputation is in danger
  • Managing and addressing all sides of crisis management:
    • Science
    • Intellectual Property
    • Legal
    • Public Affairs/Perception
  • Devising strategies for your company when a counterfeit hits the market and consumers are in danger of harmful ingredients
    • Creating counterfeit prevention measures to protect your brand
  • Establishing early prevention plans and ways to monitor a crisis before it starts

2:00
Cosmetic, Drug, or Both? Defining the Subtle Differences to Properly Promote a Product in the Market

Jennifer Nelson
Senior Associate General Counsel
Prestige Brands

Heidi Gertner
Partner
Hogan Lovells (Washington, DC)

Consumers are being inundated with products that appear to be cosmetics, but promise benefits more akin to a drug. As such, certain products can be a cosmetic, drug, or both. The FDA has defined a drug “as those products that cure, treat, mitigate or prevent disease or that affect the structure or function of the human body, if a product makes such claims it will be regulated as a drug, whereas cosmetics are defined as “products intended to beautify, promote attractiveness, alter appearance or cleanse.” In this session, our speakers will address the sometimes fine- line of difference between each product and clear up any confusion about products that may cross the line. Points of discussion will include:

 

  • Defining the parameters of what constitutes cosmetics, drugs, or both
  • Assessing the risk when your product has benefits of a drug
    • Recent FDA activity on products that act like a drug
  • Determining which ingredients can alter the legal status of the product

3:00
Conference Ends

The Foundation of Beauty: Cosmetics and Personal Care Products Law and Regulation 101

Mar 27, 2019 8:30am - 12:00pm

$600

Speakers

Georgia Carole Ravitz, Esq.
Partner
Arent Fox LLP (Washington, DC)

What is it about?

Registration begins at 8:30 am

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
    • cGMPs
    • Labeling
  • 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

Bringing Beauty Across Borders: Master Class on the International Commercialization of Cosmetics and Personal Care Products

Mar 27, 2019 1:00pm - 4:30pm

$600

Speakers

Lisa Capote
FDA Regulatory Compliance Attorney
Capote Law Firm (Miami, FL)

Heili Kim
Partner
Venable LLP (Washington, DC)

Felicia Leborgne Nowels
Partner
Akerman LLP (Tallahassee, FL)

What is it about?

Registration begins at 12:30 pm

The international sales of cosmetics and personal products fuel a billion-dollar global industry. In some instances, exported products surpass sales for domestic products. This demand has led companies to enter into the international market, both established and emerging with the hopes of taking a slice of this growing area. In this session, our workshop leaders will help you understand this highly complex international market and help you devise strategies for regulatory approval and export. They will advise you of all of the regulatory challenges and give you an update on all of the relevant international laws governing cosmetics and personal care products. They will also provide a comprehensive and detailed review of labeling requirements, tariff and taxation laws, and the finer points of registration in order to ensure you are ready to enter the foreign markets with a clear idea and a specific business plan in place to avoid any missteps. Points of discussion will include:

 

Overview

  • Defining cosmetics, personal care, and drugs in international markets
  • Understanding the risks when importing products with structure/function claims
  • Examining the need for a single label for international harmonization
  • Assessing GMP requirements for international markets
  • Exploring matters of trade, tariffs and taxation affecting the global cosmetics and personal care industries

 

Addressing challenges associated with tariffs, treaties and customs

  • Assessing opportunities to sell products outside of the US in view of the current Administration’s policies
  • Exploring the present trade atmosphere in Asia for the cosmetics/personal care
    industry
  • Understanding how the renegotiation of NAFTA might impact the cosmetics industry
  • Dissecting concerns with customs controls, and tariffs and their impact on the cosmetics industry growth worldwide

 

Europe

  • Overview of EU regulations on cosmetics and personal care products
    • Strengthening the safety of the product
    • Outlining the responsibilities of the “responsible person” to manage the product
    • Using the CPNP for centralized notification
    • Use of nanomaterials as ingredients in the product
  • Understanding standards for cGMP
  • Examining advertising and labeling requirements
  • Identifying testing requirements
  • Exploring new requirements relative to Brexit

China

  • Obtaining pre-market approval
  • Examining post-market compliance responsibilities
  • Exploring Labeling requirements
  • Understanding the repercussions of new import requirements
  • Examining the present status of our relationship with China and the status of One China policy

 

South Korea

  • Understanding The Cosmetics Act
  • Adhering to the MFDA’s requirements for cosmetics
  • Identifying and defining the different types of cosmetics: general and functional
  • Labeling requirements

 

Japan

  • Identifying and defining the different categories of cosmetics
  • Testing and inspecting products by the MHLW
  • Labeling guidelines ASEAN countries
  • Update on the Agreement on the ASEAN Harmonized Cosmetic Regulatory Scheme
  • Clarifying registration requirements
  • Labeling requirements
  • Good manufacturing practices