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Food LawFood Law FSC-421FSC-421

Dr. Thomas P. Wilson, J.D., Ph.D.

Attorney at Law / Assistant ProfessorDepartment of Food Science and Human Nutrition

Michigan State University

lawdoc@msu.edu

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Course BasicsCourse Basics

•Tues/Thur 8:00am - 9:20am

•1235 Anthony Hall

•Primary computer generated presentations

•Strong Internet component

•Cyber-attendance

•Legal / Scientific Perspectives

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Course MaterialsCourse Materials

• Homepage

• http://www.msu.edu/course/fsc/421/

• Textbook

• Handouts

• External References

• Legal Research

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GradingGrading

• 3 exams + final

• Class participation

• Cyber-attendance

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Student / Instructor Student / Instructor CommunicationsCommunications

•MSU – (Webtalk)

•ICQ - (I Seek You)

•Email

•Phone/Fax

•Office Hours (Real and Cyber)

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Internet ComponentsInternet Components

• Home Page

• Student/Instructor Communications

• Online Resources

• Nexis/Lexis

• Listservs

• Cyber-Attendance

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What is the InternetWhat is the Internet??Reno v. American Civil Liberties Union

117 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

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LawLaw

1. A rule established by authority, society or custom

2. A body of rules governing the affairs of man within a community or among states

3. A declaration or position which is never to be questioned or disputed

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ScienceScience

The observation, identification, description, experimental investigation and theoretical explanation of natural phenomena.

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ScienceScience

Such activity restricted to a class of natural phenomena

Such activity applied to any class of phenomena

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ScienceScience

1. Any methodological activity discipline or study

2. Any activity that appears to require study and method

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PolicyPolicy

“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.”

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FoodFood

“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.”

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Magic WordsMagic Words

Adulteration Misbranding Jurisdiction Enabling Legislation Federal Preemption Harmonization Standardization

Common Law Pre-market Approval Liability Administrative vs.

Judicial Interstate Commerce “Caveat Emptor”

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Jack in the BoxJack in the Box

Wrongful Death Defendants

– Responsible Parties

Negligence Breach of Warranty Plaintiffs

Damages Judgment Attorney’s Fees Discovery Proximate Causation Punitive Damages

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Philosophy of Food LawPhilosophy 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 USDALaw revised as new risks recognizedLaw vs. Science?

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Philosophy of Food LawPhilosophy 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

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Philosophy of Food LawPhilosophy 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

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Philosophy of Food LawPhilosophy 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)

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Philosophy of Food LawPhilosophy of Food Law

FDA/USDA are essentially scientific regulatory agencies

Protect public by screening unsafe productsCourts typically defer to FDA views

(exception: Supreme Beef) on validity of regulatory requirements

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Philosophy of Food LawPhilosophy 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