Food Law FSC-421

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Food Law FSC-421
Dr. Thomas P. Wilson, J.D., Ph.D.Attorney at
Law / Assistant ProfessorDepartment of Food
Science and Human NutritionMichigan State
University lawdoc_at_msu.edu
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Course Basics

• Tues/Thur 800am - 920am
• 1235 Anthony Hall
• Primary computer generated presentations
• Strong Internet component
• Cyber-attendance
• Legal / Scientific Perspectives

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Course Materials

• Homepage
• http//www.msu.edu/course/fsc/421/
• Textbook
• Handouts
• External References
• Legal Research

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Grading

• 3 exams final
• Class participation
• Cyber-attendance

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Student / Instructor Communications

• MSU (Webtalk)
• ICQ - (I Seek You)
• Email
• Phone/Fax
• Office Hours (Real and Cyber)

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Internet Components

• Home Page
• Student/Instructor Communications
• Online Resources
• Nexis/Lexis
• Listservs
• Cyber-Attendance

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What 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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Law

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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Science
The observation, identification, description,
experimental investigation and theoretical
explanation of natural phenomena.
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Science
Such activity restricted to a class of
natural phenomenaSuch activity applied to any
class of phenomena
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Science

• Any methodological activity discipline or
  study
• Any activity that appears to require study and
  method

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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.
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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.
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Magic 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 Box

• Wrongful Death
• Defendants
• Responsible Parties
• Negligence
• Breach of Warranty
• Plaintiffs

• Damages
• Judgment
• Attorneys Fees
• Discovery
• Proximate Causation
• Punitive Damages

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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?

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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

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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

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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)

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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

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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