Food and Drug Regulation: A Statutory Approach

Book Synopsis: To view or download the 2023 Supplement to this book, click here. The 2023 Supplement reflects numerous changes made to the FFDCA since publication of the 2022 Supplement. This includes many changes made by the Consolidated Appropriations Act, 2023, including the portion of the statute known as the Modernization of Cosmetics Regulation Act. The 2023 edition also includes an updated set of Chapter Guides for the casebook. Each Chapter Guide lists the supplement readings assigned within that chapter of the casebook. It includes both the casebook page on which each reading is assigned and the Supplement page on which each reading begins.

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.