Outline of Contents

Title Page Introduction Table of Contents Appendix

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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

1. Freedom of Speech

2. Freedom of Religion

3. The Takings Clause

4. Privacy

G. Related Federal Statues and Agencies

1. The Federal Trade Commission

2. The Centers for Disease Control

3. The Environmental Protection Agency

4. The Department of Transportation

5. The International Trade Commission

6. The United States Department of Agriculture

7. The Consumer Product Safety Commission

8. The United States Patent and Trademark Office

9. The Securities and Exchange Commission

10. The Antitrust Laws

11. False Claims Act

12. Taxation

13. Miscellaneous

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

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

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

H. Guidance

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

1. General

2. Biotechnology Labeling

3. Religious Dietary Labeling

4. The Fair Packaging and Labeling Act

C. Regulation of Food Identity and Quality

D. Regulation Relating to the Nutrient Content of Food

1. Nutrient Composition

2. Nutrition Labeling

3. Nutrient Descriptors

4. Disease Prevention and Treatment Claims

E. Dietary Supplements

F. Organic Food

G. Medical Food

H. Food Sanitation

1. Good Manufacturing Practices

2. Filth

3. Transportation

I. Food Safety

1. Toxicity / Food Additives

2. Pathogens

3. Allergens

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. Obesity

T. Eating Disorders

U. Hunger

VI. Human Drugs

A. Definition of Drug

B. Prescription Drug Promotion

1. Physician Labeling

2. Patient Labeling

3. Physician Advertising

4. Patient Advertising

5. Information on Unapproved Uses

6. Cost-Effectiveness Claims

7. Comparative Effectiveness

C. Prescription Drug Licensure

1. Drug Testing (IND)

2. FDA Review (NDA)

3. Specific Drug Products

4. Generic Drugs

5. Risk Management

6. Drug Manufacturing

7. Pharmacy Compounding

8. Patents

9. Financial Investment

10. Use of Academic Research

11. Regulatory Reform

12. Laetrile and Cancer Quackery

13. Unapproved Drugs

14. Incentives for Development

D. Regulation of Nonprescription Drugs

1. Switch from Prescription to Nonprescription Status

2. OTC Drug Monographs

3. OTC Drug Labeling

E. Pediatric Testing and Labeling

F. Geriatric Testing and Labeling

G. Orphan Drugs

H. Contraceptive Drugs

I. Controlled Substances

J. Complementary and Alternative Medicine

1. Homeopathic Drugs

2. Traditional Chinese Medicine

K. Regulation of Physician Prescribing

L. Regulation of Drug Distribution

M. Drug Prices

1. The Cost of Drugs

2. Government Reimbursement for Drug Costs

3. Americans with Disabilities Act

N. Managed Care

O. Pharmacy

P. Counterfeit Drugs

Q. Health Privacy

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

1. Definition of Device

2. Labeling

3. Safety

4. Premarket Review

5. Premarket Approval

6. Home Use Diagnostic Products

7. Combination Products

8. Pediatric Devices

B. Radiation Control for Health and Safety Act

C. Mammography

D. Technology Assessment

E. Reimbursement

F. [Reserved]

G. Breast Implants

H. Telemedicine

X. Cosmetics
XI. Regulation of Carcinogens
XII. Biotechnology

A. General

B. Food

C. Drugs

D. Animal Drugs

E. Ethical Considerations

XIII. Nanotechnology
XIV. Tobacco
XV. Miscellaneous
XVI. Appendix 

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Title Page Introduction Table of Contents Appendix

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