Diane McEnroe

Practice Areas

DIANE MCENROE has established long-standing relationships with domestic and international companies in the food, dietary supplement, drug, medical device, and cosmetic industries. She leads the New York Healthcare and Food, Drug and Medical Device practice group and is a member of the firmwide Food, Drug and Medical Device Regulatory practice.

As an industry expert, Diane provides clients with strategic counsel on Food and Drug Administration (FDA) regulatory questions on a broad range of issues, including product formulation and positioning, ingredient safety, claims substantiation, and post-marketing obligations, including adverse event reporting and food registry postings. With Diane’s deep knowledge of foods, including functional and medical foods, and dietary supplements, she has guided clients through the implementation of significant legislative amendments over the years. She regularly trains in-house counsel and regulatory teams on FDA compliance issues and assists companies in strengthening internal procedures to minimize compliance risks. Diane supports clients in responding to FDA Warning Letters, during facility inspections and recalls, 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.