John Fuson is a nationally recognized expert on U.S. Food and Drug Administration (FDA) enforcement and counseling matters.
John’s FDA counseling is informed by his role as associate chief counsel at the FDA. In this position, he had broad law enforcement responsibilities, handling significant enforcement actions brought by the agency, including seizure actions, injunction actions, actions for civil money penalties, and contempt actions. His cases involved drugs, devices, food, and veterinary drugs.
Building on his FDA experience, John can offer clients invaluable perspective on FDA matters. He has an insider’s understanding of how the agency thinks, applying its public health focus to his client’s needs regarding product risks and benefits. John also understands the importance of having a robust and trusted relationship with the FDA. He regularly counsels clients on their critical interactions with the agency, including advising on product approval strategies, reporting obligations, manufacturing practice compliance, labeling concerns, and product recalls. Clients also turn to John for help answering agency inquiries, handling facility inspections, and responding to observations and warning letters.
Based on his FDA experience, John works primarily with pharmaceutical, medical device, cosmetic, and food industry clients. He also provides clients in the electronic nicotine delivery industry regulatory guidance related to the Family Smoking Prevention and Tobacco Control Act.
John was born in Ohio, grew up in Southern California, attended college in Iowa and law school in Pennsylvania. After law school, he clerked for Judge Marsha S. Berzon on the U.S. Court of Appeals for the Ninth Circuit and now lives with his family in Washington, D.C.
Drug Manufacturers: John assists drug manufacturers with compliance and enforcement matters, focusing on FDA inspections, current good manufacturing practice (GMP) requirements, and data integrity responsibilities. When clients receive inspectional observations, warning letters, and other communications, he helps clients efficiently and effectively respond to agency concerns.
Medical Device Manufacturers: John helps medical device manufacturers understand their pathways to market, particularly as FDA seeks to open access to new digital technologies. As they develop claims on labeling and other materials, John helps clients understand risk in competitive marketing environments, including safety concerns, reporting obligations, and Quality System Regulation compliance.
Food Industry: John helps food industry clients navigate obligations under the Food Safety Modernization Act, handle the burdens of preventive control inspections, evaluate safety risks, and manage product recalls. He also counsels clients on food labeling questions. In these matters, he considers the regulatory requirements and helps clients balance competitive marketing claims and the threat of false advertising litigation.
Cosmetic Industry: John counsels clients on emerging obligations under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), particularly regarding registration, listing, manufacturing, and reporting requirements.
B.A., Grinnell College