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Unless the prevalence of smoking falls substantially, 0.5 billion of the world's present population will die prematurely from disease caused by tobacco.1 Without considerable changes in the regulation of products that deliver nicotine it will be difficult to achieve substantial further falls in mortality in the United States or to reduce tobacco consumption worldwide. Under the direction of its commissioner, David Kessler, the United States Food and Drug Administration is taking on this challenge. The federal agency is considering taking over regulatory responsibility for tobacco products and developing new regulatory approaches for tobacco. What has brought about its involvement, and what can it do? We provide some insight into these issues from the perspective of public health scientists who do not represent the Food and Drug Administration or other federal agencies.
Tobacco products are not regulated in a way
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