Regulatory Obstacles to Harm Reduction: The Case of Smoking

Cigarette use remains the leading cause of avoidable death in the United States. The inability of many smokers to quit is a significant public health problem. The demand for a product that can help smokers kick the habit is an entrepreneurial opportunity. Yet government regulation threatens to hamper welfare-enhancing innovation and discourage the use of life-saving technologies, such as electronic cigarettes. In particular, the Food & Drug Administration (FDA) decision to “deem” electronic cigarettes as “tobacco products” to be regulated as tobacco cigarettes threatens to cartelize and ossify a dynamic, harm-reducing industry. FDA restrictions on truthful health information and comparative risk claims further inhibit potentially life-saving innovation by threatening to keep smokers and other consumers in the dark about the harm-reducing potential of e-cigarettes and reducing the economic incentives to develop safer forms of nicotine delivery. However well-intentioned, the FDA’s regulatory initiatives may inhibit the life-saving potential of alternatives to cigarettes and conventional tobacco products