Personal Care & Cosmetics

We counsel cosmetic and over-the-counter (OTC) drug companies on a comprehensive range of Food and Drug Administration (FDA)-related issues. We assist clients with:

• Regulatory compliance, including clinical research, formulation development, and current good manufacturing practices (cGMPs) and quality programs
• Product logistics, including distribution, state licensing, and FDA registration and listing requirements
• Labeling and claims, including product labeling and compliance for imports and exports
• Enforcement management, including avoiding and responding to FDA enforcement actions (e.g., 483s, warning letters, recalls, import alerts and detentions, and consent decrees)
• Cosmetic-drug product compliance with the FDA’s OTC drug administrative orders under the CARES Act 
• OTC monograph order requests to help ensure products meet FDA standards

Beyond this work, we help ensure compliance with the Modernization of Cosmetics Regulation Act (MoCRA) by guiding clients through new facility registration, product listing, and cGMP requirements—including counsel on ingredient reviews, color additive approvals, and adverse event reporting as well as product safety substantiation and ongoing regulatory compliance.

Our team also advises companies on Consumer Product Safety Commission (CPSC) compliance for child-resistant packaging, hazard reports, recalls or corrective action programs, and other CPSC-related issues.

Where litigation is unavoidable, we help clients manage the legal, financial, marketing, and public relations impacts of litigation by:

• Swiftly fielding trial-ready teams tailored to each matter by collaborating across our firm’s practices
• Engaging experienced local counsel and expert witnesses to strengthen defense strategies
• Using advanced techniques to manage information, streamline document reviews, and file pretrial motions that effectively limit case scope
• Employing a model plan to coordinate the defense of both existing and anticipated product liability claims

We advise on marketing and promotional strategies for OTC drug and cosmetic products to comply with FDA, Federal Trade Commission (FTC), state law, and substantiation standards. Our work on behalf of clients includes:

• Reviewing claims related to product performance, environmental benefits (“green” claims), country of origin, and health effects
• Helping to ensure substantiation of claims in compliance with regulatory standards and guidelines
• Advising on the use of endorsements, testimonials, and social media strategies
• Supporting promotional initiatives such as discounts, gift cards, and loyalty programs
• Responding to FDA and state attorneys general assertions of improper product claims
• Assisting in the assertion and defense of competitor marketing complaints, including proceedings before the National Advertising Division (NAD) of the Better Business Bureau
• Negotiating agreements and disputes involving branding, promotion, and endorsement issues related to celebrities and well-known figures
• Developing advertising campaigns and combating false advertising claims
• Advising on use and misuse of brands on social media and the internet

Our lawyers help businesses consider complex risks and optimize results by employing creative approaches to multidimensional challenges. Our experience includes:

• Defending clients in high-stakes matters involving consumer fraud, false advertising, and unfair business practice claims
• Monitoring the legal landscape to identify and advise on emerging trends and new waves of potential exposure
• Staying ahead of the changing regulatory landscape in the beauty, health, and wellness industries
• Foreseeing and mitigating risks tied to individual, consumer class, and enforcement actions
• Helping ensure compliance for product labels, claims, and advertising before launch
• Revising consumer terms, privacy policies, and other disclosures and practices to minimize litigation risk and avoid disputes

We represent clients in complex product liability and mass tort class actions, including multidistrict litigation. Our lawyers frequently act as national coordinating counsel and trial counsel in large-scale serial litigation involving chemicals and contaminants such as talc, asbestos, benzene, per- and polyfluoroalkyl substances (PFAS), lead, silica, and other sources of contamination. We also advise on cases involving flavoring ingredients and additives, including specialized chemical and food-related products.

Public and governmental focus on data privacy and security has intensified alongside the rapid proliferation of artificial intelligence (AI), raising complex legal questions about data rights and usage. Our experience for clients includes:

• Addressing data security issues governed by regulations specific to industries and sensitive personal information such as biometrics
• Helping to ensure compliance with privacy laws impacting consumer data, employee data, and online activities
• Defending cutting-edge privacy class actions involving biometric data practices and software alleged to track consumers' online activities
• Managing high-stakes claims tied to AI-driven data use and associated risks
• Coordinating with cybersecurity experts to contain exposure, determine notification requirements, and conduct the necessary notifications
• Implementing remedial measures and defending against resulting litigation

Our lawyers support cosmetics and personal care clients facing litigation or regulatory challenges under environmental laws. We have successfully tried cases to verdict or resolved them favorably at all levels of federal and state courts. We advocate for our clients by:

• Advising on compliance with California’s Proposition 65, which mandates warnings for exposures to chemicals listed as “known to the State to cause cancer or reproductive toxicity”
• Handling risk assessments, warning content, significance levels, and specific enforcement issues
• Defending against claims brought by private litigants under Proposition 65
• Representing clients in cases involving titanium dioxide, toluene, lead, cadmium, phthalates, and other listed substances
• Addressing occupational, consumer product, and environmental exposure matters tied to these chemicals
• Filing petitions with administrative agencies and legal actions in federal and state courts to challenge health-based standards issued by regulatory authorities
• Challenging Proposition 65 listings and other unfavorable agency determinations through administrative mandamus actions

We also advise on ESG claims amid growing regulatory scrutiny and increased attention from plaintiffs’ attorneys. Companies seeking to advance ESG initiatives face heightened risks, particularly for claims perceived as false or misleading. We advise on:

• Marketing and labeling claims such as “natural,” “recyclable,” “clean,” and “sustainable” to help ensure accuracy and compliance
• Allegations of misrepresentation or exaggeration of environmental or sustainability efforts
• Class actions and regulatory challenges stemming from ESG claims
• Disputes over ESG commitments in court and administrative forums
• Strategies to reduce exposure to ESG-related claims—tailored to companies of all sizes
• Alignment of ESG efforts with legal and regulatory frameworks to enhance credibility and avoid disputes

Recognizing the intense competition that drives innovation in this industry, our IP lawyers regularly help producers of personal care and cosmetic products protect and profit from their unique IP and carefully craft branding and advertising programs. We advise on:

• Strategies to safeguard trademarks, copyrights, patents, trade secrets, trade dress/designs, and other IP assets from infringement and unfair competition
• Global patent and trademark portfolio development, management, and enforcement
• Enforcing rights against counterfeiters and unauthorized uses through litigation, customs enforcement, and alternative dispute resolution
• IP disputes and challenges, including opposition and cancellation proceedings as well as appeals
• Negotiation of licensing, co-branding, advertising, sponsorship, and distribution agreements to expand brand presence and market reach
• Due diligence of IP assets in mergers, acquisitions, and joint ventures

Leveraging our worldwide reach, we help clients traverse international challenges. We provide experience in regulatory compliance, global product launches, litigation and dispute resolution, and global platforms and integration, among other areas. Our work for clients includes:

• Advising on compliance with the EU Cosmetics Regulation, REACH, and other international standards
• Addressing jurisdiction-specific requirements for labeling, product formulation, and safety testing
• Guiding companies through cross-border product launches, helping to ensure alignment with diverse regulatory frameworks
• Coordinating with local authorities to secure approvals and resolve compliance issues
• Defending clients in cross-border disputes, including IP enforcement, contract disputes, and regulatory investigations
• Managing jurisdiction-specific enforcement actions and related litigation
• Drawing on our global platform to deliver integrated solutions that align regulatory litigation and operational strategies
• Collaborating across regions to provide seamless support in international markets

Our firm provides strategic corporate counsel to industry leaders, emerging brands, investors, and manufacturers, helping them navigate critical business decisions and transactions.

Our work for clients includes:

• Advising on strategic acquisitions, divestitures, and joint ventures within the industry
• Supporting investors in acquiring and funding beauty and personal care brands
• Assisting with corporate formation, governance, and operational structuring
• Drafting and negotiating manufacturing, distribution, supply, and licensing agreements