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Food Law FSC-421. Dr. Thomas P. Wilson, J.D., Ph.D. Attorney at Law / Assistant Professor Department of Food Science and Human Nutrition Michigan State University lawdoc@msu.edu. Course Basics. Tues/Thur 8:00am - 9:20am 1235 Anthony Hall Primary computer generated presentations
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Food LawFSC-421 Dr. Thomas P. Wilson, J.D., Ph.D.Attorney at Law / Assistant ProfessorDepartment of Food Science and Human NutritionMichigan State University lawdoc@msu.edu
Course Basics • Tues/Thur 8:00am - 9:20am • 1235 Anthony Hall • Primary computer generated presentations • Strong Internet component • Cyber-attendance • Legal / Scientific Perspectives
Course Materials • Homepage • http://www.msu.edu/course/fsc/421/ • Textbook • Handouts • External References • Legal Research
Grading • 3 exams + final • Class participation • Cyber-attendance
Student / Instructor Communications • MSU – (Webtalk) • ICQ - (I Seek You) • Email • Phone/Fax • Office Hours (Real and Cyber)
Internet Components • Home Page • Student/Instructor Communications • Online Resources • Nexis/Lexis • Listservs • Cyber-Attendance
What is the Internet? Reno v. American Civil Liberties Union117 S.Ct. 2329 (1997) • “international network of interconnected computers” • ARPANET – 1969 • Military, defense contractors, universities doing military research • Redundant channel communication in case of war • World Wide Web (www) is best known network
Law • A rule established by authority, society or custom • A body of rules governing the affairs of man within a community or among states • A declaration or position which is never to be questioned or disputed
Science The observation, identification, description, experimental investigation and theoretical explanation of natural phenomena.
Science Such activity restricted to a class of natural phenomenaSuch activity applied to any class of phenomena
Science • Any methodological activity discipline or study • Any activity that appears to require study and method
Policy “Any plan or course of actions adopted by a government, political party, business organization, or the like, designed to influence and determine decisions action and other matters.”
Food “Any material, usually of plant or animal origin, containing or consisting of essential body nutrients as carbohydrates, fats, proteins, vitamins, or minerals as taken in and assimilated by an organism to maintain life and growth.”
Adulteration Misbranding Jurisdiction Enabling Legislation Federal Preemption Harmonization Standardization Common Law Pre-market Approval Liability Administrative vs. Judicial Interstate Commerce “Caveat Emptor” Magic Words
Wrongful Death Defendants Responsible Parties Negligence Breach of Warranty Plaintiffs Damages Judgment Attorney’s Fees Discovery Proximate Causation Punitive Damages Jack in the Box
Philosophy of Food Law • Food law primarily about “things” • Manufacture, distribution, sale, are secondary • Purpose of FDCA is to protect consumer from regulated products that are unsafe • Job delegated to FDA and USDA • Law revised as new risks recognized • Law vs. Science?
Philosophy of Food Law • Law makes it legally to market any product which is adulterated or misbranded or which does not have FDA approval in interstate commerce • FDA must show that the product (thing) violates the statute in one of these ways
Philosophy of Food Law • FDA acts through the Department of Justice to prevent future violations by seeking injunction or punishment • FDA philosophy is “premarket approval” • To the greatest extent possible, all significant benefits and risks should be accessed before product is marketed
Philosophy of Food Law • If risks are justified, product should be marketed • If risk justified only if product used in accordance with certain conditions, those conditions must be listed • If risks are not justified, product should not be marketed (olestra, saccharin, nutra-sweet)
Philosophy of Food Law • FDA/USDA are essentially scientific regulatory agencies • Protect public by screening unsafe products • Courts typically defer to FDA views (exception: Supreme Beef) on validity of regulatory requirements
Philosophy of Food Law • Relationship between regulator and regulated community (food industry) • Voluntary compliance vs. enforcement • Must rely on consumer to protect their own health to some extent • Comparative negligence