Regulating Food and Drug Companies Privately: A View of Lanham Act Cases Brought Against FDA-Regulated Products

Abstract

The Lanham Act provides a flexible self-help remedy to food and drug companies that are harmed by unfair competition in the marketplace. But is it desirable for private litigation to become the de facto regulation of the industry? In an FDA regulation concerning a warning on OTC drug labels, the agency asserted that “it is in the best interest of the consumer, industry, and the marketplace to have uniformity in presentation and clarity of message.â€99 However, increased regulation through private litigation can send a muddled and inconsistent message to food and drug companies. Private companies have their business interests in mind, and may even ask for damages. This is why the role of the FDA enforcement cannot be pushed aside, or replaced by private litigation. Although many of the cases discussed herein involved disputes over product claims that did not place public health at risk, ensuring truthful labeling and advertising for food and drugs nevertheless plays a vital role in protecting public health and safety.