FDA regulation of tobacco - Pitfalls and possibilities (2008)

After more than half a century of debate and discussion, it is likely that during the coming year, Congress will pass legislation bringing tobacco products under the regulatory authority of the Food and Drug Administration (FDA). The regulatory status of cigarettes arguably represents one of the most paradoxical stories in American medicine and public health: the single most dangerous legal product in U.S. consumer society has eluded virtually all federal regulation until now. Using a combination of scientific misinformation, intensive political lobbying, and a culturally resonant argument that smokers must take personal responsibility for harms they incur from its product, the tobacco industry has fought off all attempts to bring the manufacture, marketing, and sale of cigarettes under the authority of the FDA or any other federal agency. While competing aggressively against one another for market share (see historical cigarette ads), the tobacco companies drew together for the purposes of denying the harms of smoking and exerting their political influence to deflect any serious form of regulation. Indeed, in response to the proposal put forward by former FDA Commissioner David Kessler in the mid-1990s that tobacco be regulated as a drug, the industry fought tooth and nail to deny the FDA this authority. After a protracted legal battle, in 2000 the Supreme Court found in a 5-to-4 decision that the FDA did not have statutory authority to regulate cigarettes. If the agency were to begin regulating tobacco, it would require explicit legislative approval from Congress. [Extract]