Abstract

http://ssrn.com/abstract=1097623
 


 



FDA Jurisdiction: A Matter of Definitions


Lewis A. Grossman


American University - Washington College of Law

Richard A. Merrill


University of Virginia - School of Law; Covington & Burling

Peter Barton Hutt


Covington & Burling; Harvard Law School


Peter Barton Hutt, Richard A. Merrill & Lewis A. Grossman, FOOD & DRUG LAW: CASES AND MATERIALS, 3rd ed., Ch. 2, Foundation Press, 2007
American University, WCL Research Paper No. 2008-38

Abstract:     
This chapter, new in the third edition, concerns how Congress, the Food and Drug Administration, and the courts have treated the definitions of "food," "drug," "cosmetic," "device," and "human biological product." The scope of FDA's power is delineated almost entirely by the list of product categories over which it has jurisdiction. As the materials in this chapter show, the product definitions are strikingly broad and thus confer jurisdiction over a vast range of goods. Furthermore, the definitions are remarkably plastic, providing FDA with great flexibility to decide whether and how to regulate products. Sometimes FDA has interpreted the definitions expansively, so as to expand its power. On other occasions, the agency has construed the definitions narrowly, so as to avoid taking responsibility for products it does not want to regulate or to minimize the burdensomeness of the requirements it does impose.

Number of Pages in PDF File: 64

Keywords: Food, Drug, Cosmetic, Device, Tobacco, Categories, Definitions, FDA

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Date posted: February 28, 2008 ; Last revised: June 2, 2013

Suggested Citation

Grossman, Lewis A. and Merrill, Richard A. and Hutt, Peter Barton, FDA Jurisdiction: A Matter of Definitions. Peter Barton Hutt, Richard A. Merrill & Lewis A. Grossman, FOOD & DRUG LAW: CASES AND MATERIALS, 3rd ed., Ch. 2, Foundation Press, 2007; American University, WCL Research Paper No. 2008-38. Available at SSRN: http://ssrn.com/abstract=1097623

Contact Information

Lewis A. Grossman (Contact Author)
American University - Washington College of Law ( email )
4801 Massachusetts Avenue N.W.
Washington, DC 20016
United States
Richard A. Merrill
University of Virginia - School of Law ( email )
580 Massie Road
Charlottesville, VA 22903
United States
Covington & Burling ( email )
1201 Pennsylvania Avenue, N.W.
Washington, DC 20004-2401
United States
Peter Barton Hutt
Covington & Burling ( email )
1201 Pennsylvania Avenue, N.W.
Washington, DC 20004-2401
United States
Harvard Law School
1575 Massachusetts
Hauser 406
Cambridge, MA 02138
United States
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