DIANE MCENROE has established long-standing relationships with domestic and international companies in the food, drug, medical device and personal care industries. As a member of the Food, Drug and Medical Device Regulatory practice, she provides clients strategic counsel on Food and Drug Administration regulatory questions on a broad range of issues, including product formulation and positioning, ingredient safety, claims substantiation, over-the-counter drug monograph issues and post-marketing obligations, including adverse event reporting and food registry postings. Diane also has extensive experience advising on drug sampling programs, track and trace systems, and state licensure issues. She supports clients in responding to Warning Letters, during facility inspections and recalls, and in addressing product integrity issues. In addition to her FDA advisory role, Diane has also assisted clients with Federal Trade Commission investigations relating to consumer products.
With her deep knowledge of foods, including functional and medical foods, and dietary supplements, Diane 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 FDA’s announcements on Nutrition Innovation and Responsible Innovation in Dietary Supplements, she is supporting clients in assessing what the future might look like from a regulatory perspective for those marketing in the food, medical food, foods for special dietary use and dietary supplement markets.
She 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, Diane often leads FDA, DEA, FTC, and state pharmacy due diligence reviews for food and drug companies on behalf of major industry leaders and investment firms. She also closely coordinates with Sidley litigators nationwide to defend consumer fraud and product liability litigation targeting consumer products.
Diane is recognized in the 2016–2020 editions of The Best Lawyers in America. Additionally, Diane is an Adjunct Professor of Law at Fordham University Law School, teaching Food and Drug Law.