Food and Drug Regulation

To view or download the 2024 Supplement to this book, click here. The 2024 Supplement reflects changes made to the excerpted statutes and regulations since publication of the 2023 Supplement. The 2024 Edition also includes an updated chart listing the U.S. Code section numbers that correspond to each section of the Federal Food, Drug, and Cosmetic Act (pp. 29-59) and an updated set of Chapter Guides for the casebook (pp. 495-522).

This book presents food and drug regulation as a statutory subject. It is organized around the structure of the Federal Food, Drug, and Cosmetic Act (FFDCA), and emphasizes guided reading of statutes, regulations, and federal register documents. Cases are presented primarily when they involve major issues of statutory interpretation, are historically significant, or are in one of the areas where case law plays a major role. The book is designed to work with a statutory and regulatory supplement provided as a PDF. The statutes and regulations in this free supplement have been aggressively edited, like the cases in a traditional casebook, to make it easier for students to engage with them directly.

The book begins by introducing the Food & Drug Administration, the product categories it regulates, and the basics of administrative procedure. It then presents three cross-cutting issues: regulation of research, marketing authorization processes, and background requirements. Following this, the book proceeds to address individual product categories. This segment, which occupies a large portion of the book, is organized by the chapter of the FFDCA (or related statute, such as the Public Health Services Act) under which a product category is regulated. The book concludes by returning to cross-cutting issues, including FDA enforcement, federal preemption, and regulation of imports.