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Fda Jurisdiction: A Matter Of Definitions, Lewis Grossman
Fda Jurisdiction: A Matter Of Definitions, Lewis Grossman
Contributions to Books
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, …
Legislative Updates, Dan Raposa
Title Iii Of The Bioterrorism Act: Sacrificing U.S. Trade Relations In The Name Of Food Security, Claire S. Boisen
Title Iii Of The Bioterrorism Act: Sacrificing U.S. Trade Relations In The Name Of Food Security, Claire S. Boisen
American University Law Review
Part I examines in detail the two conflicting laws that are the basis of this Comment—Title III of the Bioterrorism Act and the SPS Agreement—focusing on those portions of Title III that adversely impact international trade. Part I also presents the WTO case EC Measures Concerning Meat and Meat Products (Hormones), the first food regulation case disputed in the WTO system for a violation of the SPS Agreement. This case clarified the two major principles of the SPS Agreement that are explored in this Comment: the prohibition on discrimination and the obligation to support trade–restrictive measures with an analytical risk …