Crime and Punishment in the Twentieth Century

This chapter discusses changes in criminal law in the twentieth century, covering the decriminalization of sex and vice, defendants’ rights, the death penalty, and crime waves and the national response. As the federal government grew in size in the twentieth century, and as the federal statute book grew along with it, a whole new array of federal crimes came into existence. Income tax evasion or fraud was one of these—it was obviously no crime at all before the federal income tax law. Every regulatory law created a new federal crime: violating the food and drug law, or stock fraud under the SEC law, or killing a black-footed ferret, under the Endangered Species Act. Under J. Edgar Hoover, the Federal Bureau of Investigation became a major crime-fighter, at least with regard to crime that crossed state lines.

Riegel v. Medtronic, Inc.: Revisiting Pre-Emption for Medical Devices

The pre-emption doctrine as applied to food and drug law argues that manufacturers whose products gain Food and Drug Administration (FDA) marketing approval are immune from tort liability in state court solely on the basis of their FDA approval. This pre-emption protection applies both to claims of direct damages caused by the product and as well as indirect (failure to warn/labeling) damages claims.The recent 8-1 U.S. Supreme Court decision in Riegel v. Medtronic, Inc. upheld the manufacturer’s contention that the pre-emption provision in the 1976 Medical Device Amendments of 1976 (MDA) to the 1938 Federal Food, Drug and Cosmetic Act (FDCA) completely precluded civil damages suits by injured plaintiffs in state court. Justice Ginsburg was the lone dissenter.

Dietary Supplements: A Definition That is Black, White, and Gray

The Dietary Supplement Health and Education Act of 1994 (“DSHEA” or “the Act”) was a seminal event in the world of food and drug law. The Act took a controversial category of product traditionally regulated by FDA as either a food or a drug, depending upon the product claims and formulation, and created a new regulatory category called “dietary supplement” that was placed within the “food” definition. As such, products meeting the “dietary supplement” definition benefited in two significant ways, (1) dietary supplements could make “structure/function” claims traditionally within the realm of drug products; and (2) unlike food ingredients, dietary ingredients could be used in dietary supplements without being either approved food additives or generally recognized as safe (“GRAS”) ingredients. These legislative provisions significantly changed the legal, corporate, and consumer landscape, allowing products to enter the marketplace with broadbased claims without FDA premarket review or approval of the ingredients, formulation, or product claims.