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This is the first chapter of a new casebook on food and drug regulation. 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, 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. Detailed slides are available for professors using the casebook.

(Please note that the "Download Full Text" link, above, is a link to the full text of the front matter and first chapter. It does not link to the full text of the entire book.)



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Carolina Academic Press


food and drug, FDA, food, food additive, dietary supplement, drug, pharmaceutical, animal drug, medical device, biologic, combination product, human tissue, HCT/P, cosmetic, color additive, tobacco product, preemption, medical research, regulation, administrative law, casebook


Administrative Law | Food and Drug Law


Adam I. Muchmore, Food and Drug Regulation: A Statutory Approach (Carolina Academic Press 2021).

Statutory Supplement available for download.

Food and Drug Regulation: A Statutory Approach