This course explores the Food and Drug Administration’s development of regulatory controls in response to Congress’ legislative enactments regarding the safety of food and the safety and effectiveness of drugs. Coursework entails an analysis of FDA’s enforcement tools; the agency’s substantive regulatory authority over foods, drugs, and selected other regulated commodities; and the agency’s creative use of its legislative authority to develop regulatory mechanisms for the protection of the public health. While focusing on substantive food and drug law, the course also scrutinizes the operation and problems an administrative agency faces in dealing with sometimes conflicting legal, scientific, and policy concerns regarding a given issue. To this end, the course focuses on FDA’s efforts to establish safe levels for added carcinogens in food, to ensure the safety of foods produced by recombinant DNA technology, to improve the public health by comprehensive food labeling reform, and to establish the safety and effectiveness of pharmaceuticals in an ethical and timely manner. This course is highly recommended for persons interested in the regulatory process and in the practical aspects of administrative law.

Upper-level course for:
I. Administrative and Legislative Law
XVI. Health Law/Law and Medicine
XXII. Law and Public Policy