John 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 former 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 perspectives 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 advises on requirements under the Animal Welfare Act and 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, and 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