Director
CurrentMy practice focuses on regulation of food (including dietary supplements) by FDA, FTC, and USDA. I advise clients ranging from start-ups to multinational companies at all points in the supply chain, including bulk ingredient manufacturers, distributors of packaged goods, and retailers. I counsel clients on the regulatory status of ingredients and finished products, and provide advice on compliance with labeling and advertising requirements. I help clients interpret and comment on the implementation of new requirements, such as those arising from the Food Safety Modernization Act, and those applicable to the production and marketing of hemp and its derivatives. I also have expertise in FDA's regulation of bioengineered plants and animals, and work with clients in emerging sectors such as cell-derived foods. In enforcement matters, I counsel clients on managing inspections, responding to warning letters and other enforcement actions by federal and state regulators, and resolving import detentions. I also help clients navigate product recalls and related corrective actions. I apply my subject matter expertise to corporate transactions by issuing opinions and conducting due diligence for acquisitions and IPOs, and occasionally serve as an expert in litigation matters. My approach to counseling clients draws on insights gained in my former role as an Associate Chief Counsel at FDA, where I counseled the agency on a variety of rulemaking and enforcement activities and policy initiatives. I currently serve on the Board of Directors of the Food and Drug Law Institute. I'm also a professional member of the Institute of Food Technologists, and a member of the American Bar Association and the European Food Law Association.
