Law Commons^™

Fda Regulatory Compliance Reconsidered, Carl W. Tobias

Law Faculty Publications

Many observers consider the Food and Drug Administration (FDA) vital for the protection of consumer health and safety. One hundred years ago, Congress established the entity that would become the FDA and authorized it to regulate foods and drugs, critical responsibilities that the agency has long discharged carefully. Throughout the past century, the FDA's regulatory power has expanded systematically, albeit gradually, while legislatures and courts in the fifty American jurisdictions broadened liability exposure for manufacturers that sold defective products that injured consumers. Observers have recently criticized the agency for overseeing pharmaceuticals too leniently, even as states increasingly narrowed manufacturers' liability …

Regulation Of Dietary Supplements: Five Years Of Dshea, Laura A.W. Khatcheressian

Law Faculty Publications

On October 25, 1994, President Clinton signed into law the Dietary Supplement Health and Education Act (DSHEA),2 passed unanimously by both houses of Congress. This law radically changed the regulatory landscape for the sale and labeling of dietary supplements, restricting the Food and Drug Administration's (FDA's) authority in certain ways, and encouraging the sale of dietary supplements, including vitamins, minerals, herbs, botanicals, and amino acids.

This article examines DSHEA and discusses current FDA attempts to regulate dietary supplements. Part II provides a brief background and discusses FDA's concerns and attitude toward dietary supplements before the passage of DSHEA. Part III …