Estimated Prevalence of Smoking and Smoking-Attributable Mortality Associated With Graphic Health Warnings on Cigarette Packages in the US From 2022 to 2100

IMPORTANCE: Starting in 2022, the US Food and Drug Administration (FDA) plans to require all cigarette packages in the US to display graphic health warnings depicting health harms associated with smoking. The FDA originally planned to implement such warnings in 2012, but tobacco industry litigation delayed the effort. OBJECTIVE: To assess the estimated population health outcomes associated with a policy requiring graphic health warnings on cigarette packages in the US and with a 10-year delay in implementation. DESIGN, SETTING, AND PARTICIPANTS: This decision analytical model used simulation modeling of smoking prevalence and smoking-attributable mortality in the US from 2012 to 2100, using the Cancer Intervention and Surveillance Modeling Network smoking population model. The study was conducted from October 2020 to July 2021. MAIN OUTCOMES AND MEASURES: The primary outcomes were annual adult smoking prevalence, smoking-attributable deaths averted, and life-years gained vs the baseline scenario. A baseline scenario assuming no graphic health warnings was compared with expected outcomes of implementing graphic health warnings in 2022 vs 2012. Policy effects were considered under varying assumptions of the association of the policy with smoking initiation and cessation, ranging from most conservative to most optimistic. A maximum smoking reduction scenario in which all smoking would stop by the end of 2022 was evaluated. RESULTS: In the baseline scenario, an estimated 13.2 million smoking-attributable deaths would have occurred from 2012 to 2100. Under a maximum smoking-reduction scenario, 5.5 million of these deaths would be averted. Implementation of graphic health warnings from 2022 to 2100 would be associated with 539 000 (range, 275 000-794 000) smoking-attributable deaths averted and 7.9 million (range, 4.0-11.6 million) life-years gained, representing less than 10% of the 5.5 million estimated smoking-attributable deaths averted and 81.8 million life-years gained in the maximum smoking-reduction scenario. Implementation from 2012 to 2100 would be associated with 33.2% (range, 32.9%-33.5%) more deaths averted (718 000; range, 365 000 to 1.1 million) and 42.7% (range, 42.3%-43.1%) more life-years gained (11.2 million; range, 5.7-16.6 million) compared with implementation in 2022. CONCLUSIONS AND RELEVANCE: This decision analytical model estimated that FDA cigarette graphic health warnings, if implemented in 2022, would be associated with public health benefits. The model also estimated that more smoking-attributable deaths would have been averted if the policy had been implemented in 2012. Industry litigation and delays to implementing tobacco regulations may have been harmful for public health.