• John D Kraemer and Sabeeh A Baig.
• Department of Health Systems Administration, School of Nursing and Health Studies, Washington DC 20007, USA. jdk32@georgetown.edu
• Am J Prev Med. 2013 Sep 1;45(3):334-42.

AbstractSmoking 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. To be on safest ground, the FDA should adopt images that depict factual health consequences of smoking and should avoid images that could be interpreted as opinions. The FDA will have a high likelihood of prevailing in legal challenges to the warnings if there is evidence demonstrating that graphic warnings are necessary to counter past industry deception or that graphic warnings affect smoking behavior better than textual warnings. Even without evidence of the impact of graphic warnings on behavior, strong evidence that they affect behavioral intent, and that intent predicts behavior, should be sufficient for the warnings to be upheld. Alternatively, evidence that graphic warnings lead to more accurate consumer assessment of smoking risks should also be sufficient.Copyright © 2013 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

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