Introduction While many countries have adopted prominent pictorial warning labels (PWLs) for cigarette packs, the USA still requires only small, text-only labels located on one side of the cigarette pack that have little effect on smoking-related outcomes. Tobacco industry litigation blocked implementation of a 2011 Food and Drug Administration's (FDA) rule requiring large PWLs. To inform FDA action on PWLs, this study provides research-based estimates of their public health impacts.

Methods Literature was reviewed to identify the impact of cigarette PWLs on smoking prevalence, cessation and initiation. Based on this analysis, the SimSmoke model was used to estimate the effect of requiring PWLs in the USA on smoking prevalence and, using standard attribution methods, on smoking-attributable deaths (SADs) and key maternal and child health outcomes.

Results Available research consistently shows a direct association between PWLs and increased cessation and reduced smoking initiation and prevalence. The SimSmoke model projects that PWLs would reduce smoking prevalence by 5% (2.5%–9%) relative to the status quo over the short term and by 10% (4%–19%) over the long term. Over the next 50 years, PWLs are projected to avert 652 800 (327 000–1 190 500) SADs, 46 600 (17 500–92 300) low-birth-weight cases, 73 600 (27 800–145 100) preterm births and 1000 (400–2000) cases of sudden infant death syndrome.

Conclusions Requiring PWLs on all US cigarette packs would be appropriate for the protection of the public health, because it would substantially reduce smoking prevalence and thereby reduce SADs and the morbidity and medical costs associated with adverse smoking-attributable birth outcomes.