Download This PaperFood and Drug Regulation: A Statutory Approach (Chapter 1)
Penn State Law Legal Studies Research Paper Series 21-2021
Adam I. Muchmore, Food and Drug Regulation: A Statutory Approach iii-xli, 1-37 (Carolina Academic Press 2021)
77 Pages Posted: 17 Sep 2021 Last revised: 10 Jan 2022
Date Written: September 9, 2021
Abstract
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.
Note:
Funding Information: Penn State University. This consisted of multiple summer research stipends and a one-semester sabbatical.
Declaration of Interests: None to declare.
Keywords: food and drug, FDA, food, food additive, dietary supplement, drug, pharmaceutical, animal drug, medical device, biologic, combination product, human tissue, cosmetic, color additive, tobacco product, preemption, medical research, regulation, administrative law, casebook
JEL Classification: H1, H11, I1, I18, K23, K32, Q1, Q18
Suggested Citation: Suggested Citation