PMID- 24218057 OWN - NLM STAT- MEDLINE DCOM- 20141006 LR - 20240109 IS - 1468-3318 (Electronic) IS - 0964-4563 (Print) IS - 0964-4563 (Linking) VI - 23 Suppl 1 IP - 0 1 DP - 2014 Mar TI - Cigarette graphic warning labels and smoking prevalence in Canada: a critical examination and reformulation of the FDA regulatory impact analysis. PG - i7-12 LID - 10.1136/tobaccocontrol-2013-051170 [doi] AB - BACKGROUND: 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 rule-making process. However, evidence on the impact of GWLs on smoking prevalence is scarce. 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 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 analysed. CONCLUSIONS: Adopting GWLs on cigarette packages reduces smoking prevalence. Applying our analysis of the Canadian GWLs, we estimate that if the USA had adopted GWLs in 2012, the number of adult smokers in the USA would have decreased by 5.3-8.6 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. FAU - Huang, Jidong AU - Huang J AD - Health Policy Center, Institute for Health Research and Policy, University of Illinois at Chicago, , Chicago, Illinois, USA. FAU - Chaloupka, Frank J AU - Chaloupka FJ FAU - Fong, Geoffrey T AU - Fong GT LA - eng GR - P01 CA138389/CA/NCI NIH HHS/United States GR - P50 CA111236/CA/NCI NIH HHS/United States GR - R01 CA100362/CA/NCI NIH HHS/United States PT - Journal Article PT - Research Support, N.I.H., Extramural PT - Research Support, Non-U.S. Gov't DEP - 20131111 PL - England TA - Tob Control JT - Tobacco control JID - 9209612 SB - IM MH - Adult MH - Canada/epidemiology MH - Humans MH - Prevalence MH - Product Labeling/*legislation & jurisprudence MH - Smoking/adverse effects/epidemiology/*legislation & jurisprudence MH - Smoking Cessation/statistics & numerical data MH - Tobacco Products/*adverse effects MH - United States/epidemiology MH - United States Food and Drug Administration PMC - PMC4254709 MID - NIHMS588034 OTO - NOTNLM OT - Economics OT - Packaging and Labelling OT - Public policy EDAT- 2013/11/13 06:00 MHDA- 2014/10/07 06:00 PMCR- 2014/12/03 CRDT- 2013/11/13 06:00 PHST- 2013/11/13 06:00 [entrez] PHST- 2013/11/13 06:00 [pubmed] PHST- 2014/10/07 06:00 [medline] PHST- 2014/12/03 00:00 [pmc-release] AID - tobaccocontrol-2013-051170 [pii] AID - 10.1136/tobaccocontrol-2013-051170 [doi] PST - ppublish SO - Tob Control. 2014 Mar;23 Suppl 1(0 1):i7-12. doi: 10.1136/tobaccocontrol-2013-051170. Epub 2013 Nov 11.