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

Jidong Huang,Geoffrey T Fong,Frank J Chaloupka

doi:10.1136/tobaccocontrol-2013-051170

Abstract

BackgroundThe estimated effect of cigarette graphic warning labels (GWL) on smoking rates is a key input to the Food and Drug Administration's (FDA) regulatory impact analysis (RIA), required by law...

Highlights

The estimated effect of cigarette graphic warning labels (GWL) on smoking rates is a key input to the Food and Drug Administration’s (FDA) regulatory impact analysis (RIA), required by law as part of its rulemaking process
Our analysis demonstrates that FDA’s approach to estimating the impact of GWLs on smoking rates is flawed
In the economic analysis conducted for its graphic warning label regulations, FDA relied on the Canadian experience to estimate the effect of GWLs on US smoking rates

Summary

Objective

The goal of this paper is to critically analyse 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 USA as a control. Findings We found a statistically significant reduction in smoking rates after the adoption of GWLs in Canada in comparison with the USA. Our analyses show that implementation of GWLs in Canada reduced smoking rates by 2.87–4.68 percentage points, a relative reduction of 12.1–19.6%; 33–53 times larger than FDA’s estimates of a 0.088 percentage point reduction. We 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 analysed

Conclusions

BACKGROUND

METHODS

RESULTS

CONCLUSION AND DISCUSSION