Web Book of Student Papers



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 Professor Fortin's Food Regulation in the United States course are for a briefer assignment than the assignment for his Food and Drug Law 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).

We hope this electronic book gives well-deserved recognition to student scholarship in this important field. 

We 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. The authors authorize the Institute for Food Laws and Regulations to retain a digital copy of their scholarship and to provide, without charge, individual users the ability to view or print copies of a document for private, non-commercial use.  Authors retain all other rights, including the rights of subsequent publication.

*  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

I.    General Background
II.    FDA Enforcement
III.   FDA Practice and Procedure
IV.   Relation of FDCA to State Laws
V.    Food
VI.   Human Drugs
VII.  Animal Feed and Drugs
VIII. Human Biological Products
IX.   Medical Devices
X.   Cosmetics
XI.  Biotechnology

Table of Contents

I.     General Background

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

II.     FDA Enforcement

A. Jurisdiction over Interstate Commerce

B. Jurisdiction over Labeling

C. Regulation of Foreign Commerce

1. Export

2. Import

3. Foreign Law

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 & Traceability

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

AA.  Food Safety Modernization Act

III.    FDA Practice and Procedure

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

IV. Relation of FD&C Act to State Laws

A. State Laws

B. Federal Preemption

V. Food

A. Definition of Food

B. Regulation of Food Labeling

C.  Regulation of Food Identity and Quality

  D.  Regulation Relating to the Nutrient Content of Food

E.  Food Additives

F.  Organic Food

G.  Medical Food

H.  Food Sanitation

I.   Food Safety

  J.   Restaurants

K.   Pesticide Residues

L.   Environmental Contaminants

M.  Packaging and Other Indirect Components

N.  Irradiation

O.  Alcoholic Beverages

P.  Meat, Poultry and Eggs

Q.  Fish and Shellfish

R.  Other Specific Food Products

S.  Dietary Supplements

T.  Obesity

VI. Human Drugs

A. Drug Approval, Generally

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

S.  Tort

VII. Animal Feed and Drugs
VIII. Human Biological Products

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

IX. Medical Devices

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

X. Cosmetics
XI. Biotechnology

A. General

B. Food

C. Drugs

D. Animal Drugs

E. Ethical Considerations