Web Book of Student Papers
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 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
XII. USDA
Table of Contents
I. General Background
A. Early Regulation of Food And Drugs
B. The Federal Food and Drugs Act of 1906
- Ashley McIntyre, Upton Sinclair’s The Jungle: The Legal and Social Impacts of a Classic Novel (FRUS, Spring 2008)
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
- Melanie Joy Neumann, The Duty Dilemma: Regulatory and Legal Duties to Recall Food Products and Warn of Substantial Product Risks(FRUS, Spring 2008).
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
- David Arias, Analysis of FDA Action on Chilean Grapes in March 11th, 1989 (FRUS, Fall 2008).
3. Foreign Law
- Carolina Abrigo, Food Safety Regulations on Labeling Requirements in the United States and Mexico (FRUS, Spring 2008)
- Patricia Bageine-Ejalu, U.S. and Ugandan Food Safety Systems: A Challenge to Create Development Partners (FRUS, Spring 2008)
- Frank McLaughlin, A Brief Comparison of United States and European Union Standards for Fluid Dairy Production (FRUS, Fall 2006).
- Sukanya Sirikeratikul, Differences or Similarities of U.S. and Thai Nutrient Labeling and How Nutrient Labeling Harmonization Helps Promote the Exports of U.S. Food Products to Thailand (FRUS, Fall 2008).
Ester Johé Tornero, Food labeling requirements in the US and Catalonia (EU). Similarities and differences (FRUS, Fall 2012).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
- Bradley Andrus, Improved Traceability of the Food Supply (FRUS, Fall 2012)
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
- Cassidi Williams, Small vs Large, Elements of the Food Safety Modernization Act (FRUS, Fall 2012).
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
- Keith B. Johnson, National Uniformity in Food Regulation: A Closer Look at National Uniformity for Food Act (FDL, Fall 2008).
V. Food
A. Definition of Food
B. Regulation of Food Labeling
- Megan Connor, "Made in ???": Labeling All Foods with the Country-Of-Origin (FDL, Fall 2008).
- Lori Feanside, Revisiting NLEA: Updating the Nutrition Facts Panel (FRUS, Spring 2008).
- Julianna Jee, US and Canadian Food Labelling: A Comparison(FRUS, Fall 2006).
- Jana Johnson,It's Only Natural (FRUS, Fall 2008).
- Mariam K. Kassem, Why the Confusion between Health Claims and Whole Grains? (FRUS, Fall 2006).
- Minghua Li, Health Claims on Dietary Supplements in the US: Regulations, Consumer Perceptions and Concerns(FRUS, Fall 2012).
- 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).
- Nicole J. Olynk,Labeling of Credence Attributes in Livestock Production: Verifying Attributes Which are More Than “Meet The Eye” (FRUS, Fall 2008).
- Michael Richardson, ‘Caution – Presupposing a Successful Outcome May Be Hazardous To Achieving Your Policy Goals’: Evaluating Whether Mandatory Warnings For Soft and Semi-Soft Cheeses Would Be Effective (LLM, Winter 2013.
C. Regulation of Food Identity and Quality
- Robin Kurpiewski , Overview of Product Categories and the Pros and Cons (FRUS Spring 2008).
- Monica To,Food Standards Should be Reviewed and Extended (FRUS, Spring 2007).
D. Regulation Relating to the Nutrient Content of Food
- Michelle G. Cannon, Food Fortification: For Profit or Health? (FRUS, Fall 2006).
- Alfredo Diaz Nava,Vitamin D – Are We Getting Our Fair Share? (FRUS, Fall 2008).
E. Food Additives
- Kathy Walker, Use of Bacteriophages as Novel Food Additives (FRUS, Fall 2006).
F. Organic Food
G. Medical Food
H. Food Sanitation
I. Food Safety
- Janet B. Rowat Kraiss, Listeria Regulations In The FDA And USDA: Implications For Dual-Jurisdiction Facilities (FRUS, Fall 2008).
- Steve Leitch, Microwave Instructions for Prepared but Not Ready-to-eat foods – It’s Just Not Worth the Risk (FRUS, Fall 2008).
- Israel A. Ramos, Beef “Mega Reg” and the Produce Voluntary Program (FRUS, Fall 2008).
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).
- Kanav Bhatheja, A Functional Remedy for a Dysfunctional Regulatory Policy of Functional Foods: An Analysis of the Current Regulations of Functional Foods (FDL, Fall 2008).
T. Obesity
VI. Human Drugs
A. Drug Approval, Generally
- Shawn Goldman, Privatization of the FDA: Toward a Faster Drug Approval Process (FDL, Fall 2008).
- Katie Zingg, FDA Post-Market Drug Surveillance: In Need of an Overhaul (FDL, Fall 2008).
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
- Jared Geist, Focusing in on Adderall (FDL, Fall 2008).
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).
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
- Karen Grushka, Propast-Teflon Jaw Implants and FDA Review Standards for Medical Device: A Case Study (FDL, Fall 2006).
X. Cosmetics
XI. Biotechnology
A. General
B. Food
- Colin Boes, Genetically Modified Foods: Mandatory Labeling and the Specter of Fear (FDL, Fall 2006).
- Ravinder K Goyal,Role of Public Perception and Regulations in the Acceptance of Genetically Engineered Foods (FRUS, Fall 2008).
- Teresa Marek, Is the US FDA Regulation and Evaluation of Genetically Engineered Foods Sufficient? (FRUS, Spring 2008).
C. Drugs
D. Animal Drugs
E. Ethical Considerations
- Brittany Peet, The Ethical Implications of Genetically Modified Pigs (FDL, Fall 2008).
XII. USDA
- Laura McCready, All Sandwiches Should Be Regulated by the USDA (FRUS, Fall 2008).