From premarket clearance requirements through manufacturing and marketing, our team brings a unique, wide-angled legal perspective to help clients achieve their business objectives for foods, functional foods, medical foods, dietary supplements, foods/feeds for pets and livestock, cosmetics, nonprescription drugs and devices, and other health products.
Kelley Drye’s food and drug team is experienced in the full spectrum of regulatory and legal risk management issues that food and drug companies must navigate to comply with Food and Drug Administration (FDA), U.S. Department of Agriculture (USDA) and Federal Trade Commission (FTC) requirements, and be successful in the U.S. marketplace. We represent companies throughout product development and marketing, including all premarket clearance requirements for product safety, labeling, advertising and other marketing promotions. We also represent companies in food and drug law matters concerning product manufacturing, distribution, supply chain management and import/export requirements. In addition, our food and drug team represents companies in matters concerning defective products in the U.S. marketplace, including post-market adverse-event reporting obligations, recalls, investigations, warning letters and adverse publicity. We defend companies when the safety, labeling or marketing of their products is challenged in cases brought by the government, competitors, or on behalf of consumers.
Our attorneys counsel throughout the full product life cycle, including at the following stages:
Launching New Products, Labeling and Marketing Claims–We provide strategic legal counsel to clients engaged in the development, introduction/import and marketing of products that are new to the U.S. market, including a wide range of food and beverage products (e.g., conventional and functional foods, medical foods, dietary supplements, foods/feeds for pets and livestock); cosmetics and other skincare products; consumer health products (e.g., nonprescription drugs and devices); and a wide range of medical and healthcare products, and other health products. The Food and Drug Law team counsels manufacturers and importers on premarket clearance requirements and helps clients comply with federal and state product safety, consumer protection and import/export laws before products enter the marketplace, and ensures that product benefit claims are adequately substantiated by scientific research and other evidence.
Ensuring Regulatory Compliance and Managing Liability Risk–We provide strategic legal counsel to clients concerning regulatory requirements and enforcement policies of FDA, USDA, FTC and related state laws, equipping our clients to ensure that their products, labeling and marketing practices meet regulatory requirements and reflect sound liability risk management practices. We also develop and submit comments, propose regulatory policies and model legislation to federal agencies, on behalf of clients.
Defending and Challenging Product Safety, Labeling and Marketing Claims–We defend companies when product safety, quality, labeling or marketing claims are challenged by the FDA, USDA or FTC, by state governments in enforcement proceedings, or in Congressional investigations. We also defend companies when the safety, quality, labeling or marketing claims for their products are challenged in private lawsuits, including those brought by competitors and on behalf of consumers. We have substantial experience defending clients in cases presenting significant First Amendment and Federal Preemption issues. Additionally, we help clients defend their product brands and markets by challenging the unlawful products and deceptive marketing products of their competitors, including both domestic and international competitors. We initiate competitor challenges on behalf of our clients through litigation, regulatory and legislative initiatives.
Recalling Unlawful Products, Postmarket Reporting and Crisis Management–We advise clients on regulatory compliance and liability risk management matters arising after products have entered the U.S. market, including recalls of unsafe or mislabeled products, and post-market adverse-event reporting obligations (e.g., the Reportable Food Registry, Medwatch Reports, etc.). We counsel clients concerning the development of effective regulatory compliance, product recall, post-market reporting, and crisis prevention and management plans. We mobilize the range of legal, scientific and technical resources that clients need to respond effectively when products in the marketplace are unsafe, mislabeled or may be otherwise defective.
Kelley Drye’s Food and Drug team coordinates with lawyers specializing in complementary areas of the firm’s practice, including Advertising and Marketing Law, Litigation, Product Liability, International Trade, Government Relations and Public Policy, Insurance Recovery, Environmental, Intellectual Property and White Collar Crime and Investigations.