Tobacco, the Food and Drug Administration, and Congress

Smoking has been the number-one target of public health professionals in the United States for more than a decade because it is the leading cause of premature death. Nonetheless, no unified public health strategy has been developed. In 1995, with the strong endorsement of President Bill Clinton and Vice President Al Gore, the commissioner of the Food and Drug Administration (FDA), Dr. David Kessler, announced that the agency had jurisdiction over tobacco and would regulate cigarettes as “drug-delivery devices.”1 The tobacco companies objected and sued the FDA, arguing that Congress had not given the FDA jurisdiction over their product. The Supreme Court, in a five-to-four opinion issued in March 2000, agreed with the tobacco companies.2 Although many public health experts were outraged by the result, the most remarkable thing about the case from our perspective was not the result, but the fact that four justices dissented. In this article, we outline the historical background of the opinion, explain why we feel it was not surprising, and offer a proposal for congressional action to reduce the harm caused by tobacco