American Journal of Preventive Medicine   |  September 1, 2013

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Smoking is the leading preventable cause of death in the U.S., yet cigarette health warnings in the U.S. are among the weakest in the world. In 2011, the FDA issued regulations mandating that graphic warnings be displayed on every cigarette pack sold in the U.S. Almost immediately, the tobacco industry challenged the warnings on First Amendment grounds. In March 2013, the FDA withdrew the graphic warning mandate, choosing instead to pursue additional research and then issue requirements for a new set of warnings. These warnings almost certainly will be challenged by the tobacco industry. The current paper describes the legal standards that will be used to assess the warnings, and the empirical questions that must be answered in order to determine whether each standard has been met. The paper also identifies errors the FDA could make in choosing images to be evaluated that would cause the images to be unable to meet the standards, regardless of the scientific evidence the FDA can establish.

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