Post by Sapphire Capital on Aug 8, 2008 20:14:37 GMT 4
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 - General
Peter Barton Hutt
affiliation not provided to SSRN
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.
papers.ssrn.com/sol3/Delivery.cfm/SSRN_ID1148279_code88245.pdf?abstractid=1097623&mirid=4
Lewis A. Grossman
American University - Washington College of Law
Richard A. Merrill
University of Virginia - School of Law; Covington & Burling - General
Peter Barton Hutt
affiliation not provided to SSRN
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.
papers.ssrn.com/sol3/Delivery.cfm/SSRN_ID1148279_code88245.pdf?abstractid=1097623&mirid=4