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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

64 Pages Posted: 28 Feb 2008 Last revised: 2 Jun 2013

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

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.

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

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: https://ssrn.com/abstract=1097623

Lewis A. Grossman (Contact Author)

American University - Washington College of Law ( email )

4300 Nebraska Avenue, NW
Washington, DC 20016
United States

Richard A. Merrill

Covington & Burling ( email )

1201 Pennsylvania Avenue, N.W.
Washington, DC 20004-2401
United States

University of Virginia - School of Law ( email )

580 Massie Road
Charlottesville, VA 22903
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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