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Food and Drug Law

American University Washington College of Law

Food

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Fda And The Rise Of The Empowered Consumer, Lewis Grossman May 2013

Fda And The Rise Of The Empowered Consumer, Lewis Grossman

Articles in Law Reviews & Other Academic Journals

This Article traces the still-evolving view of consumers of FDA-regulated products as capable, rational, and rights-bearing decision makers. It also examines the corresponding diminution of FDA’s role as a paternalistic gatekeeper collaborating with medical and scientific experts to prevent products and manufacturer-provided information from reaching the public. Compared with their 1960s counterparts, today’s consumers of food and drugs have far greater freedom to make unmediated choices among a wider variety of products, guided by a relative deluge of labeling and advertising information. Moreover, food and drug regulation, once the exclusive domain of bureaucrats and experts, has become a focus of …


Food, Drugs, And Droods: A Historical Consideration Of Definitions And Categories In American Food And Drug Law, Lewis Grossman Jan 2008

Food, Drugs, And Droods: A Historical Consideration Of Definitions And Categories In American Food And Drug Law, Lewis Grossman

Articles in Law Reviews & Other Academic Journals

This article explores the development and interaction of the legal and cultural categories food and drug from the late nineteenth century to the present. It is based not only on legal and historical research, but also on theories of category formation from the fields of linguistics and psychology.The scope of the Food and Drug Administration's power is defined primarily by the list of product categories over which it has jurisdiction. The statutory definitions of these categories (food, drug, cosmetic, device, and human biological product) thus delineate the outer boundaries of the arena within which the agency operates. The definitions are …


Fda Jurisdiction: A Matter Of Definitions, Lewis Grossman Jan 2007

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, …