Peter Barton Hutt, Richard A. Merrill & Lewis A. Grossman, FOOD & DRUG LAW: CASES AND MATERIALS, 3rd ed., Ch. 2, Foundation Press, 2007
64 Pages Posted: 28 Feb 2008 Last revised: 2 Jun 2013
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: 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