Food and Drug Law (LAW-648-002)
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Approximately 25 cents out of every dollar spent by American consumers is spent on a product regulated by the federal Food and Drug Administration (FDA). Food and drug regulation is a thriving area of legal practice, pursued by lawyers in government, law firms, public interest organizations, and industry. It plays a central role in the growing fields of life sciences law and health law, and it weaves its way through an extraordinary amount of litigation and corporate transactional work. Finally, food and drug law is a matter of great public concern, and FDA-related stories are featured in the major news media on a regular basis. This course surveys FDA’s responsibilities generally and focuses intensively on its regulation of food and drugs in particular. It also introduces students to issues in administrative law and statutory interpretation. No science background is necessary. Students who take this course will not be eligible for the general Food and Drug Law course (LAW-648) in the second, third, or fourth years. The method of assessment will be an exam.
Textbooks and Other Materials
The textbook information on this page was provided by the instructor. Students should use this information when considering purchases from the AU Campus Store or other vendors. Students may check to determine if books are currently available for purchase online.
Hutt, Food & Drug Law, 4th edition (2013), Foundation Press (ISBN 9781609301750)
Hutt, Food and Drug Law: 2014 Statutory Supplement Revised (2014), Foundation Press (ISBN 9781634591904)
First Class Readings
Class 1: Introduction to FDA and to Administrative Rulemaking
Administrative Procedure Act (APA) at 5 U.S.C. § 553 (in Statutory Supplement at p. 858); Food, Drug &Cosmetic Act § 701(a) (in Statutory Supplement at p. 508)
Hutt, Merrill & Grossman (casebook) pp. 3-4, 5-8, 9-20, 24-25, 29-33, 41-44, 55-59 (last line in note 3 should say “does not have the force of law”)