Introduction
Student papers submitted for
IFLR
courses from 2006 onward have been or will be included in this electronic
book if the student consents. Many of these papers contain valuable research
information, which sometimes is available in no other print form. Some papers are of publishable quality.
Some have been
published. Others are more in the
nature of memoranda or working papers.
Each paper is included as it
was presented for grading, without editing or change of any kind.
Papers for my Food Regulation in the United States
(FRUS) course are for a briefer assignment than the assignment for my
Food and Drug Law (FDL) course. You may
cite to a paper in
this electronic collection as: [Author’s name], [Paper Title] ([year
of the paper]), in Neal Fortin,
ed., Food & Drug
Regulation: A
Web Book of Student
Papers (on file with
the Institute for Food Laws and Regulations at Michigan State University).
I hope this electronic book
gives well-deserved recognition to student scholarship in this important
field.
I wish to thank the students
of this class who have generously consented to being published in this
electronic book. The copyright for each paper remains with the student
author.
* I am indebted to Peter
Barton Hutt, a lecturer on law at Harvard University, for this concept
http://www.law.harvard.edu/faculty/hutt/index.php.
Summary of
Contents
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Table of Contents
A. Early Regulation of Food
And Drugs
B. The Federal Food and
Drugs Act of 1906
C. The Federal Food, Drug,
and Cosmetic Act of 1938
D. FDA Mission and
Resources
E. The Philosophy of
Regulation
F. Constitutional Issues
G. Related Federal Statues
and Agencies
H. History of Diseases
I. Food and Drug Law
in Literature and the Arts
J. Animal Welfare
K. Corporate Responsibility
L. FDA-Industry Relations
M. Consumer Advocacy
A. Jurisdiction over
Interstate Commerce
B. Jurisdiction over
Labeling
C. Regulation of Foreign
Commerce
1. Export
2. Import
3. Foreign Law
Frank McLaughlin,
A Brief Comparison of United States and European Union Standards for
Fluid Dairy Production (FRUS, Fall 2006).
4. International
Treaties
5. Mutual Recognition
Agreements
6. International
Harmonization
D. Factory Inspection
E. Seizure
F. Injunction
G. Criminal Liability
H. Civil Money Penalties
I. Debarment
J. Detention
K. Restitution
L. Disgorgement
M. Recall
N. Publicity
O. Informal Warnings
P. Enforcement Statistics
Q. Res Judicata
R. Enforcement Under Other
Federal Statutes
S. State Enforcement
T. Private Enforcement
U. Product Liability Tort
Law
V. Economic Analysis of
Enforcement
W. Regulation of the
Internet
X. Regulation of
Intellectual Property
Y. Bioterrorism
Z. Product Tampering
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top
A. Section 701(a)
Rulemaking
B. Section 701(e)
Rulemaking and Adjudication
C. Primary Jurisdiction
D. Advisory Committees
E. Freedom of Information
F. Environmental
Considerations
G. User Fees
A. State Laws
B. Federal Preemption
A. Definition of Food
B. Regulation of Food
Labeling
Julianna Jee,
US and Canadian Food Labelling: A Comparison
(FRUS, Fall 2006).
Mariam K. Kassem,
Why the Confusion between Health Claims and Whole Grains?
(FRUS,
Fall 2006).
Elijah L. Milne,
Protecting Islam’s Garden From the Wilderness: Halal Fraud Statutes
and the First Amendment, 2 Journal of Food Law & Policy
61-84 (FDL, Spring 2006).
C. Regulation of Food
Identity and Quality
D. Regulation Relating to
the Nutrient Content of Food
Michelle G. Cannon,
Food Fortification: For Profit or Health? (FRUS, Fall 2006).
E. Food Additives
Kathy Walker,
Use of Bacteriophages as Novel Food Additives (FRUS, Fall 2006).
F. Organic Food
Fanny Jiang, Canadian
Organic Regulation – How will this impact US organic imports to
Canada? (Spring 2007).
G. Medical Food
H. Food Sanitation
I. Food Safety
J. Restaurants
Jennifer Greene,
A Need for Disclosure of the Presence of Allergens in Restaurant Food
(FDL, Fall 2006).
K. Pesticide Residues
L. Environmental
Contaminants
M. Packaging and Other
Indirect Components
N. Irradiation
Angie Lawless,
Food Irradiation – What’s the Big Deal? (FRUS,
Spring 2007).
O. Alcoholic Beverages
P. Meat, Poultry and Eggs
Q. Fish and Shellfish
R. Other Specific Food
Products
S. Dietary Supplements
James
Durian,
Dietary Supplements: The Return of Snake Oil? (FDL, Fall 2006).
T. Obesity
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top
A. Definition of Drug
B. Prescription Drug
Promotion
C. Prescription Drug
Licensure
D. Regulation of
Nonprescription Drugs
E. Pediatric Testing and
Labeling
F. Geriatric Testing and
Labeling
G. Orphan Drugs
H. Contraceptive Drugs
I. Controlled Substances
J. Complementary and
Alternative Medicine
K. Regulation of Physician
Prescribing
L. Regulation of Drug
Distribution
M. Drug Prices
N. Managed Care
O. Pharmacy
P. Counterfeit Drugs
Q. Health Privacy
R. Advertising
Susan Fyan,
An Argument
for Banning Direct-To-Consumer Advertising of Prescription Drugs
(FDL, Fall 2006).
S. Tort
Kristen R. Laur,
Michigan’s Drug Immunity: Not a Model to Follow (FDL, Fall 2006).
A. Definition of Biological
Product
B. Biological Product
Licensure
C. Vaccines
D. Blood
E. Organs
F. Tissue
G. Gene Therapy
H. Genetic Testing
I. Cloning
J. Assisted Reproductive
Technology
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to top
A. Medical Device
Amendments of 1976
B. Radiation Control for
Health and Safety Act
C. Mammography
D. Technology Assessment
E. Reimbursement
F. Tobacco
G. Breast Implants
H. Telemedicine
I. Device Review
Karen Grushka,
Propast-Teflon Jaw Implants and FDA Review Standards for Medical
Device: A Case Study (FDL, Fall 2006).
A. General
B. Food
Colin
Boes,
Genetically Modified Foods: Mandatory Labeling and the Specter of
Fear (FDL, Fall 2006).
C. Drugs
D. Animal Drugs
E. Ethical Considerations
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Introduction
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