Cosmetics & Personal Care Products – Legal, Regulatory and Compliance

Continental Breakfast and Registration

Co-Chairs’ Welcome Remarks

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

• 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

FDA Keynote Address on Perspectives and New Priorities for 2020

Morning Coffee Break

Beauty Within the States: Complying with New Laws and Adhering to Safety Requirements

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

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

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

Networking Luncheon for Speakers and Attendees

Assessing the Risks of Socially Promoting Beauty: Legal Dilemmas and Controversies Associated with Influencers

• 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

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

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

Afternoon Refreshment Break

Privacy and Data Protection of Consumer Information in the New Era of E-Commerce Sites and Direct-to-Consumer Sales for Cosmetics Products

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

IP Protections and Anti-Counterfeiting Assurances for Cosmetics

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

Conference Adjourns to Day 2
Champagne Reception Hosted By

Continental Breakfast

Co-Chairs’ Welcome Remarks and Recap of Day 1

Designing Recall Protocols to Contain Risk and Protect Brand Integrity

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

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

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

Morning Refreshment Break

Fireside Chat: Exploring the Import/Export of Cosmetics

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

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

Networking Luncheon for Speakers and Attendees

Prop 65 Think Tank: An Assessment and Analysis of Warnings and Case Law Affecting the Cosmetics Space

• 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

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

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

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)

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

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

Conference Ends