Contact Lens (Mis)Labeling as Misbranding and Overwarning

Abstract

One of the most important functions of the Food and Drug Administration (FDA) is the administration of labeling requirements promulgated pursuant to the Federal Food, Drug, and Cosmetic Act (FDCA). This function is especially important in the area of medical devices. Although consumers may use such devices on a routine basis, most lack both the scientific knowledge to adequately inform themselves of the risks of device usage and the resources to keep abreast of developments in the device field. But protecting consumers involves more than merely informing them of risks. The FDA has also sought to restrain its regulatory power in this area in order to provide device manufacturers with the flexibility needed to innovate and to ensure widespread device distribution. Any FDA decision in the device labeling context, therefore, inevitably involves the weighing of these two often contradictory goals.