Diane McEnroe

DIANE MCENROE has established long-standing relationships with domestic and international companies and trade associations in the food, dietary supplement, drug, medical device, and cosmetic industries. She is a member of the firmwide Food, Drug and Medical Device Regulatory practice and co-leads the firm’s Global Agribusiness and Food industry group.

Drawing from nearly three decades of experience, Diane provides clients practical, business-focused, strategic counsel on a broad range of complex Food and Drug Administration (FDA) regulatory issues. She helps clients navigate sometimes confounding regulatory frameworks and assists with product formulation and positioning, ingredient safety, and claims development decisions. She provides expertise during product challenges, including supporting clients when responding to FDA Warning Letters, during facility inspections, recalls, and import refusals, and in addressing product integrity issues. In addition to her FDA advisory role, she has also assisted clients with Federal Trade Commission investigations and claims substantiation obligations relating to the full range of consumer products. Diane collaborates regularly with Sidley colleagues on multidisciplinary matters, supporting Sidley’s transactional group to provide integrated regulatory advice on a variety of transactions, and Sidley’s litigation teams on consumer fraud or products liability cases in the FDA regulated space.