Tuesday, July 15, 2008

Grossman on the categories of "food" and "drug" in legal history

Food, Drugs, and Droods: A Historical Consideration of Definitions and Categories in American Food and Drug Law is a new article by Lewis A. Grossman, American University, Washington College of Law. It has been published in the Cornell Law Review (2008). Here's the abstract:
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 also important because the FDA has different degrees of power over different categories of products. The category to which the FDA assigns a product thus largely controls the shape of the regulatory regime the agency will impose on it.
The statutory definitions of these product categories are, for the most part, ambiguous and plastic, providing the agency with great regulatory flexibility. But while Congress and the courts have granted the FDA wide discretion, it does not follow that the agency is free to interpret the definitions however it chooses. The effective power of lawmakers to establish legal categories is significantly constrained by preexisting cultural understandings of these categories. Food and drug, the categories whose development and interaction I explore in this article, are not only the oldest defined product classes in federal food and drug law, but also fundamental cultural concepts. I demonstrate that FDA, as well as Congress and the courts, have operated within a constraining cultural matrix that has limited their freedom to impose their preferred understandings of these categories on American society.
Nonetheless, my research also provides ample evidence that lawmakers have had substantial power to mold the legal categories of food and drug so as to advance their desired policies. One explanation for this regulatory flexibility in the face of deep-seated cultural conceptions is the indeterminate nature of extralegal notions of food and drug. The terms, as commonly understood, embrace nebulous, overlapping, and constantly evolving realms. Moreover, the relationship between culture and law has not been a one-way street with respect to these categories. Although the regulatory apparatus has always had to take into account the extralegal understandings of food and drug, the law in turn has exerted significant influence over their meaning in broader culture.

1 comment:

Shag from Brookline said...

I had represented a medical device company before the federal medical device act came into being (was it in 1975?), Prior thereto, there had been concern that the definition of "drugs" could be applied to some medical "devices." The act provided grandfathering protection for medical devices then existing and extending this protection to newer devices closely related thereto that would require less FDA inquiry for "approval."