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93 Cornell L. Rev. 901 (2007-2008)
The Little Agency That Could (Act with Indifference to Constitutional and Statutory Strictures)

handle is hein.journals/clqv93 and id is 911 raw text is: THE LITTLE AGENCY THAT COULD (ACT WITH
INDIFFERENCE TO CONSTITUTIONAL AND
STATUTORY STRICTURES)
Lars Noaht
INTRODUCTION    .................................................  901
I. INDIFFERENCE TO STATUTORY BOUNDARIES ................ 903
A. Taking Procedural Shortcuts ........................ 903
B. Making the Most of Limited Tools .................. 906
1. Encouraging Product Recalls ...................      908
2. Demanding Postapproval Restrictions ............... 911
C. Expanding Regulatory Jurisdiction .................. 917
II. INDIFFERENCE TO THE CONSTITUTION ..................... 920
CONCLUSION    ...................................................  924
INTRODUCTION
More than a century ago, Congress inaugurated federal regula-
tion of foods and drugs.1 By today's standards, the 1906 Act looked
terribly anemic, running just five pages in length. Thirty years later,
reacting to difficulties with enforcing the original statute (as tragically
revealed by a series of fatalities caused by a product called Elixir sulfa-
nilamide), Congress replaced it with the Food, Drug, and Cosmetic
Act (FDCA).2 Although more comprehensive, the new statute contin-
ued to eschew details in favor of broad prohibitions against adultera-
tion and misbranding. The original FDCA filled only fifteen pages in
the U.S. Code. In the intervening years, Congress has both tinkered
with the original language and appended brand new powers and re-
quirements, so that the amended version of the FDCA in the latest
edition of the U.S. Code occupies 230 pages. What started as a fairly
t Professor of Law, University of Florida. This paper provided the basis for a presen-
tation at the ABA's 2007 Administrative Law Institute in Washington, D.C.
1  See Pure Food and Drugs Act, Pub. L. No. 59-384, 34 Stat. 768 (1906) (repealed
1938). Congress had tackled vaccines and other biologics a few years earlier. See Bio-
logics Act, Pub. L. No. 57-244, 32 Stat. 728 (1902) (codified as amended at 42 U.S.C. § 262
(2000)). For additional history on the 1906 Act, see Arthur Hull Hayes, Jr., Food and Drug
Regulation After 75 Years, 246 JAMA 1223 (1981); Marc T. Law, How Do Regulators Regulate?
Enforcement of the Pure Food and Drugs Act, 1907-38, 22J.L. ECON. & ORG. 459 (2006).
2 Pub. L. No. 75-717, 52 Stat. 1040 (1938) (codified as amended at 21 U.S.C.
§§ 331-397 (2000)); see also David F. Cavers, The Food, Drug, and Cosmetic Act of 1938: Its
Legislative History and Its Substantive Provisions, 6 LAw & CONTEMP. PROBS. 2 (1939); Paul M.
Wax, Elixirs, Diluents, and the Passage of the 1938 Federal Food, Drug and Cosmetic Act, 122
ANNALS INTERNAL MED. 456 (1995).

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