Personal-Care-and-Cosmetic-Products: Wiley

Overview

Wiley advises leading cosmetics, beauty, and personal care companies on the evolving regulatory, compliance, advertising, and product stewardship landscape. Amid growing scrutiny of ingredients, sustainability claims, supply chain transparency, and digital marketing practices, companies face complex and shifting obligations under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), the Federal Trade Commission Act, federal environmental laws, multiple state chemical disclosure laws, and expectations under Environmental, Social, and Governance (ESG) policies.

Our team draws on deep experience with matters across the U.S. Food and Drug Administration (FDA), Federal Trade Commission (FTC), and U.S. Environmental Protection Agency (EPA) jurisdictions to help clients navigate product development, launch, and post-market activities with assurance. We routinely support manufacturers, responsible persons, own-label distributors, and retailers as they interpret new federal requirements, respond to competitor challenges, and operationalize policies across global organizations. Wiley’s work includes counseling on claims strategy, reviewing promotional materials for multidisciplinary teams, addressing enforcement matters, and advising on emerging environmental and chemical controls that directly affect product design, sourcing, and marketing.

Regulatory & Compliance

We guide clients through MoCRA implementation, including facility registration and product listings, safety substantiation frameworks, serious adverse event reporting, inspection readiness, health hazard assessments, and recall considerations. Our attorneys advise on product classification and cosmetic/OTC drug boundaries, labeling and ingredient reviews, “free-from” considerations, voluntary fragrance allergen disclosures, and state-by-state chemical restrictions and bans. We work with clients to submit scientific comments in response to Calls for Data from the FDA, and Insufficient Data Announcements issued by the Cosmetic Ingredient Review (CIR) Expert Panel for Cosmetic Ingredient Safety. We also develop compliance programs, conduct gap assessments, and build standard operating procedures (SOPs), corrective and preventive action plans (CAPAs), and training modules tailored to a company’s marketing, regulatory, and research and development teams.

Advertising & Claims

Wiley helps companies develop and substantiate performance, safety, and environmental/ESG claims, including “clean,” “sustainable,” and “green” marketing. We review packaging, digital advertising, influencer content, and product launch materials to mitigate regulatory and litigation risks. Our team also represents clients in FTC and nonprofit National Advertising Division (NAD) matters, competitor challenges, and substantiation disputes.

Enforcement Defense

We support clients through FDA inspections, Form 483 responses, Warning Letters, and related enforcement actions. Our litigators and regulatory attorneys defend companies in FTC inquiries, state attorney general investigations, competitor complaints, and consumer class actions.

Environment & Product Stewardship

Our practice advises on perfluoroalkyl and polyfluoroalkyl substances (PFAS), other chemicals of concern, state chemical disclosure mandates, packaging sustainability, recyclability claims, and environmental marketing standards under the FTC Green Guides and state consumer protection laws. We help clients interpret and operationalize new ingredient restrictions, safety reporting programs, and ESG-driven supply chain transparency requirements.

Representative Work

Our experience includes leading MoCRA readiness programs for multi-national personal care brands; defending companies in FTC and NAD challenges involving performance, environmental, and other marketing claims; and conducting integrated regulatory, labeling, and advertising reviews for U.S. market entry, innovation pipelines, and product line expansions.

We review safety dossiers, conduct gap analyses, and identify appropriate scientific consultants to address data limitations, including the appropriateness of New Approach Methodologies (NAMS) in lieu of animal testing. We assist with the development and management of strategies for meeting with agency regulators and scientific review panels. We help guide trade associations and industry coalitions with the development of science-based responses to authoritative reviewing bodies, including the FDA, EPA, U.S. Pharmacopeia, CIR, and International Nomenclature Cosmetic Ingredient (INCI) system.

Wiley attorneys represent individual cosmetic and topical drug manufacturers on their regulatory and scientific responses to FDA requests for scientific data, formulation changes, manufacturing process modifications, and analytical testing adjustments due to suspected or alleged safety concerns (e.g., nitrosamines, benzene, residual solvents, and other impurities and so-called contaminants). For example, we advised a manufacturer of antibacterial handwash products on its coordination with the American Cleaning Institute to address FDA’s proposed rule and Call for Data on the bacterial resistance and hormonal effects of certain active ingredients. We also acted as coordinating counsel for a coalition of manufacturers of topical skin lightening products in response to an FDA Call for Data under the OTC Drug Monograph process. We also advise on evaluating “chemicals of concern” in consumer products and on conducting an alternatives analysis (AA) to evaluate safer ingredient substitutes.