University of Illinois at Chicago
FDA Graphic Warning Label Analysis TC final version.pdf (935.43 kB)

Cigarette graphic warning labels and smoking prevalence in Canada: a critical examination and reformulation of the FDA regulatory impact analysis

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journal contribution
posted on 2015-03-09, 00:00 authored by Jidong Huang, Frank J Chaloupka, Geoffrey T Fong
Background The estimated effect of cigarette graphic warning labels (GWLs) on smoking rates is a key input to FDA’s regulatory impact analysis (RIA), required by law as part of its rulemaking process. However, evidence on the impact of GWLs on smoking prevalence is scarce. Objective The goal of this paper is to critically analyze FDA’s approach to estimating the impact of GWLs on smoking rates in its RIA, and to suggest a path forward to estimating the impact of the adoption of GWLs in Canada on Canadian national adult smoking prevalence. Methods A quasi-experimental methodology was employed to examine the impact of adoption of GWLs in Canada in 2000, using the U.S. as a control. Findings We found a statistically significant reduction in smoking rates after the adoption of GWLs in Canada in comparison to the U.S. Our analyses show that implementation of GWLs in Canada reduced smoking rates by 2.87 to 4.68 percentage points, a relative reduction of 12.1 to 19.6% — 33 to 53 times larger than FDA's estimates of a 0.088 percentage point reduction. We also demonstrated that FDA's estimate of the impact was flawed because it is highly sensitive to the changes in variable selection, model specification, and the time period analyzed. Conclusions Adopting GWLs on cigarette packages reduces smoking prevalence. Applying our analysis of the Canadian GWLs, we estimate that if the U.S. had adopted GWLs in 2012, the number of adult smokers in the U.S. would have decreased by 5.3 to 8.6 million in 2013. Our analysis demonstrates that FDA's approach to estimating the impact of GWLs on smoking rates is flawed. Rectifying these problems before this approach becomes the norm is critical for FDA's effective regulation of tobacco products.


The ITC Surveys in the United States and Canada were supported by grants from the U.S. National Cancer Institute (R01 CA100362, P50 CA111236, and P01 CA138389), the Canadian Institutes of Health Research (57897, 79551, and 115216), and the Robert Wood Johnson Foundation (045734). Geoffrey T. Fong was supported by a Senior Investigator Award from the Ontario Institute for Cancer Research and by a Prevention Scientist Award from the Canadian Cancer Society Research Institute. None of the funding agencies played any role in study design; in the collection, analysis and interpretation of data; in the writing of the report; and in the decision to submit the article for publication. The opinions expressed here are those of the authors, and do not necessarily reflect those of the sponsors.


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