FDA and the Rise of the Empowered Consumer

Abstract

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 successful social movement activism.

The Article explores these phenomena against a background of three societal and cultural trends during the past five decades: Americans’ declining trust in major institutions, the “rights revolution,” and the dramatic expansion of health care information accessible to consumers. It then analyzes a variety of specific regulatory developments during this period of change. In its discussion of food, the paper considers the evolution of standards of identity and nutrition labeling, the rise of health claims as facilitated by the First Amendment, and various popular movements for freedom of choice with respect to food ingredients and dietary supplements. The Article then turns to drug regulation, examining the rise of patient labeling and direct-to-consumer advertising of prescription drugs, the tidal wave of “switches” from prescription to over-the-counter status, and the development of social movements intended to shape FDA drug approval policy. The Article concludes by speculating on whether this new model of consumer is a permanent one and by considering the implications of this question for FDA regulation in the future.

Keywords: FDA, consumer, food, drug, prescription, labeling, advertising, over-the-counter, saccharin, vitamins, Laetrile, AIDS