1. FDA: History and Organization
Edward P. Richards Harvey A. Peltier Professor of Law Louisiana State University School of Law
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2. Colonial Efforts Public Health and Safety Central Concern
Raked by Diseases
Unsanitary Food
Nuisance
No Good Science

3. An Act against selling unwholesome Provisions.
Whereas some evilly disposed persons, from motives of avarice and filthy lucre, have been induced to sell diseased, corrupted, contagious or unwholesome provisions, to the great nuisance of public health and peace:
Be it therefore enacted by the Senate and House of Representatives, in General Court assembled, and by the authority of the same, That if any person shall sell any such diseased, corrupted, contagious or unwholesome provisions, whether for meat or drink, knowing the same without making it known to the buyer, and being thereof convicted before the Justices of the General Sessions of the Peace, in the county where such offence shall be committed, or the Justices of the Supreme Judicial Court, he shall be punished by fine, imprisonment, standing in the pillory, and binding to the good behaviour, or one or more of these punishments, to be inflicted according to the degree and aggravation of the offence. Massachusetts, March 8, 1785

4. 1800s - Era of the States Not Laissez-Faire
Police Powers Were Reserved to the States
Mostly Local, not State-Wide
Strong Protectionist Bias
Not Well-Suited to a National Market

5. 1862 - Agriculture Department
Chemical Division
One Chemist
Adulterated Food
Foods and Food Adulterants, a ten-part study published from 1887 to 1902
Many Potted Meats Contained None of the Labeled Meat
Many Adulterants were Dangerous

6. 1862 - 1940 - USDA 1862-1890 Chemical Division
Division of Chemistry
Food, Drug, and Insecticide Administration
Food and Drug Administration

7. 1940 - Present - FDA 1940-1953 Federal Security Agency
Department of Health, Education, and Welfare
Department of Health and Human Services

8. Organization Executive Branch Agency Under the Secretary of HHS
Senate Confirmation
Much More of a Political Appointment than in the Past

9. Early Laws The Vaccine Act of 1813 Biologics Act of 1902
Bad Smallpox Vaccine
First Federal Law Dealing with Consumer Protection and Drugs
Short-lived
Biologics Act of 1902
Passed after Deaths Due to Bad Diphtheria Antitoxin

11. The Jungle
Story of the Plight of Workers in the Food Processing Industry
The Public was Horrified by the Food Processing, not the Workers
Lead to the 1906 Act

12. 1906 Act Basic Structure of the FDA Followed in Broad Outline Today
Authority over Interstate Shipment of Adulterated Foods and Drugs
Narrow Use of Commerce Clause Power

13. 1938 Act Had been proposed 5 years earlier
Pediatric Elixir Put Up In Ethylene Glycol
Sweet and Viscous
Deadly
Public Outcry Lead to the Passage of the 1938 Act
Included Cosmetics
Broadened Definitions of Adulteration and Misbranding

14. 1962 Amendments
Shifted from Premarket Notification to Premarket Approval
Required Drugs to be Effective
Required Reevaluation of All Marketed Drugs
Still not Done

15. MDA - 1976 Medical Device Amendments
Passed after Pacemaker and other Medical Device Scandals
Risk Class Regulation
New Devices Must Be Safe and Effective
510(k) Grandfathering
Substantially Equivalent to a 1976 Device
Most Devices Qualify

16. Subsequent Acts Added User Fees to Pay for Reviews
Reorganized FDA Functions
Took Away Most Power over Food Supplements
Still a Work in Progress

17. Other Laws Biologics Radiation Products
Nuclear Medicine
X-rays
Microwaves and Ultrasound
Some Role in Food Service and Carriage

18. Key Principles Regulates Products Must Be Interstate Commerce
Does Not Regulate Practice of Medicine
Docs can give what they want, as long as they do not ship it
Can be regulated by the States
Growing Free Speech Questions