Food & Drug

Operating at the intersection of law, policy, business, technology, and scientific innovation, Wiley provides indispensable counsel to clients in the pharmaceutical, medical device, biotechnology, food, dietary supplement, agriculture, and cosmetic sectors.

What We Do

Wiley advises companies regulated by or stakeholders of the U.S. Food and Drug Administration (FDA) and U.S. Department of Agriculture (USDA). We provide integrated regulatory, legal, and strategic counsel across the food, agriculture, pharmaceutical, medical device, biotechnology, cosmetics, and life sciences industries. Drawing on decades of experience and deep working relationships with federal regulators and key decision-makers at all levels of government, we help clients navigate agency requirements, resolve enforcement and compliance issues, and anticipate legislative, regulatory, and policy changes. Our integrated practice supports companies at every stage – from product development and approval to market access, enforcement response, and innovation-driven growth.

Our focus areas include:

Agriculture, Food, and Food Ingredients: Wiley helps agribusinesses manage USDA regulation, policy, and enforcement across food safety, labeling, and emerging agricultural technologies.

Wiley helps food and beverage companies navigate FDA and USDA requirements from ingredient approval and product formulation to labeling, marketing, and emerging alternative protein technologies. Wiley’s agriculture and food practice is recognized nationwide in Chambers USA.

Cosmetics: Wiley provides regulatory, advertising, and litigation counsel to cosmetic, beauty, and personal care companies addressing Modernization of Cosmetics Regulation Act of 2022 (MoCRA) compliance issues, claims strategy, and emerging ingredient and sustainability requirements.

Pharmaceuticals: Wiley helps prescription and over-the-counter (OTC) drug companies navigate FDA requirements across the full product lifecycle. We assist with research and development strategy, clinical trial design, human subject protections, and marketing pathways, including OTC monograph requirements and product approval submissions, as well as labeling, marketing, and post-approval compliance.

Why We Are Different

We have an exceptionally broad network of working relationships inside the key federal regulatory agencies. Our attorneys are thought leaders on major government initiatives affecting the food, agriculture, cosmetic, and pharmaceutical industries. We’re familiar with the processes, the language, and the priorities of regulators. We help clients anticipate, shape, and implement the regulations and programs that significantly impact their businesses.

For food, drug, cosmetics, and life sciences companies, Wiley is the frontline partner for any legal or regulatory issue that may arise. What sets us apart is the breadth of what we can handle under one roof. Beyond core FDA and USDA regulatory matters, we advise clients across virtually every aspect of their business operations: product recalls, class action litigation, Hatch-Waxman intellectual property disputes, complex transactions, advertising and marketing compliance, antitrust concerns, supply chain and trade issues (including import/export, tariffs, and customs), cyber and privacy investigations, FCC-regulated device requirements, employment matters, and PAC and lobbying compliance. Because all Wiley attorneys operate out of a single Washington, DC office, we bring the full weight of the firm to every matter. Whether a client is navigating a federal grant issue, an enforcement action, an IP dispute, or a technology or advertising question, our colleagues in the Government Contracts, White Collar Defense & Government Investigations, Environment & Product Regulation, FTC and Consumer Protection, Intellectual Property, and Telecom, Media & Technology practices are ready to step in.