Jessica Tierney

Jessica Tierney has more than 15 years of experience with U.S. Food & Drug Administration (FDA) regulation, enforcement, and related litigation. A former FDA attorney, she draws on her insider's view of the agency to counsel and defend clients across every FDA-regulated product sector, including food, dietary supplements, tobacco, drugs, medical devices, and veterinary products.

Jessica advises companies bringing novel products to market, from pre-market strategy and submissions through labeling, advertising, and launch.

Clients turn to Jessica when the stakes with FDA are highest. She guides companies through recalls and market withdrawals, responses to FDA 483 inspectional observations and warning letters, import detentions, and other enforcement actions. She also advises on current good manufacturing practice (cGMP) and marketing compliance. When disputes escalate, Jessica represents clients in litigation and contested claims involving FDA-regulated products. This includes challenges to agency action, product liability and consumer class actions over labeling and marketing claims, false advertising disputes, and government investigations.

Before joining Jones Day in 2022, Jessica practiced at a Washington, D.C. law firm. Earlier, she held senior positions in FDA's Center for Tobacco Products and Center for Drug Evaluation and Research. There she developed regulations and guidance, drafted agency responses to citizen petitions, advised key stakeholders on the Federal Food, Drug, and Cosmetic Act (FD&C Act), and consulted on labeling disputes. That experience gives her a practical understanding of how the agency builds its regulatory and enforcement positions. She uses it to develop solutions for complex regulatory matters and to help clients engage with public health policy.