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.
Diane provides clients 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, over-the-counter drug monograph and Monograph Reform issues, and post-marketing obligations, including adverse event reporting and food registry postings. She also has extensive experience advising on drug sampling programs, track and trace systems, and the interplay between federal and state laws on drug distribution. 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.
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, including the Nutrition Labeling and Education Act, the Dietary Supplement Health and Education Act, the Organic Foods Production Act, the Food Allergen Labeling and Consumer Protection Act, the Bioterrorism and Drug Preparedness Act, and the Food Safety Modernization Act. With the recent passage of the OTC Monograph Reform Act of 2020, and the Modernization of Cosmetic Regulation Act of 2022, Diane is currently advising domestic and international companies on how to meet their obligations for products marketed within these new legal frameworks.
Diane supports Sidley’s transactional practice group, leading on most of the consumer product due diligence for firm clients. She also assists Sidley’s class action practice group, when defending clients facing litigation which raises FDA regulatory arguments.
Diane regularly trains in-house counsel and regulatory teams on FDA compliance issues and assists companies in strengthening internal procedures to minimize compliance risks. In addition, she leads FDA, DEA, FTC, and state related due diligence reviews of food, drug, dietary supplement, drug, and medical device companies on behalf of major industry leaders and investment firms, and often assists with post-close integration initiatives. Diane also closely coordinates with Sidley litigators nationwide to defend consumer fraud and product liability litigation targeting consumer products.
Diane has been ranked by Chambers USA for Food & Beverages: Regulatory & Litigation in USA – Nationwide (2023). She was named to the 2022 “Notable Women in Law” list by Crain’s New York Business for her professional achievements, her pro bono work, her involvement in the firm’s SidleyWomen initiative, and her support of industry and community organizations. She is also recognized in the 2016–2020 editions of The Best Lawyers in America. Additionally, Diane has taught food and drug classes as an adjunct professor of law at Fordham University School of Law and Quinnipiac School of Law.