This paper explores the history of the “food-drug line” in U.S. product regulation: the classification boundary developed by public health regulators and medical professionals to demarcate medical products, with stricter safety standards, from food and dietary products normally governed by more lax, informal marketing standards. The paper will describe the American Medical Association (AMA) and U.S. Food and Drug Administration’s (FDA) 100+-year history of using product classification to allot risk decision-making in consumer food and drug markets, linking these practices to regulators’ ideas about “gatekeeper theory,” the belief that access to risky products like drugs should be mediated by expert gatekeepers such as medical doctors. The paper will focus on the debates over food and drug labeling in the 1960s prompted by several new health food trends: vitamania and industry use of vitamin-enrichment, artificial sweeteners and low-cal foods, and the “cholesterol controversy” that fueled broad interest in low-fat foods and preventive medicine. Marketing campaigns in these health foods transgressed the classification barrier the FDA and AMA sought to build between food and drug, at a time when they were trying to develop clear guidelines on prescription drugs in the wake of the thalidomide scandal. The paper examines the food-drug line, its rise and fall over the course of the twentieth-century, as an example of institutional framing linked to and shaped by changes in the ways regulatory science addresses risk and responsibility, shifting retailing environments for health products, and the evolving relationship of a consuming public to medical and regulatory experts.
