The Family Smoking Prevention and Tobacco Control Act required the Food and Drug Administration (FDA) to include warning statements and graphic warning labels on cigarette packages and in cigarette advertisements. In 2011, FDA published a final rule on the matter requiring color graphics depicting the negative health consequences of smoking with nine accompanying textual warning statements about the dangers of cigarettes. This rule was challenged in court by several tobacco companies, and after litigation, in 2012, the United States Court of Appeals for the District of Columbia Circuit vacated the rule, stating that that FDA did not provide any shred of evidence that the graphic warning images would reduce the number of Americans who smoke (RJ Reynolds Tobacco Co v FDA, 696 F3d, 1205, 1219, DC Cir 2012). In March, 2013, the government decided not to seek further review of the Court's ruling and will likely only revisit the issue of graphic warning labels if and when research shows that they have a positive impact on public health. Consequently, the FDA urgently needs rigorous tests of the impact of graphic warning labels on individuals' propensity to smoke. The overall aim of the proposed research is to experimentally test the impact of graphic warning labels on display in a tobacco powerwall in an experimental point-of-sale retail environment. Specifically, with funds from the National Cancer Institute (R01CA175209), we have created an experimental convenience store (a StoreLab) that sells tobacco products (via a tobacco powerwall, behind the store cashier) in addition to other products typically found in convenience stores (e.g., soda, water, candy, etc.). Adult smokers, responding to ads for a study of convenience store purchase patterns, will be randomly assigned to shop for $15 worth of products in the Storelab with a tobacco powerwall stocked with either (1) cigarette packages without graphic warning labels (GWLs-absent); or (2) cigarette packages with graphic warning labels (GWLs-present). Dependent measures will be behavioral (e.g., in-store tobacco purchases, picking up cessation pamphlets, time to next cigarette purchase, and self-reported changes in smoking at one week follow-up). We will also test the moderating role of individual difference variables that may alter how GWLs impact behavior. The StoreLab will also be equipped with state-of-the-art, commercially available systems for recording and analyzing participant attention and emotional reactions (coded with Eckman's Facial Coding Action System) to graphic warning labels as they encounter them in our experimental yet ecologically valid point-of-sale environment. The results of this experiment will provide new and needed information to FDA about the value of adding graphic warning labels to cigarette packages available for purchase in typical retail environments.

Public Health Relevance

The Family Smoking Prevention and Tobacco Control Act of 2009 required the Food and Drug Administration (FDA) to include graphic warning labels on cigarette packages. However, FDA's final rule on the matter was challenged in court by tobacco companies, and after litigation, the United States Court of Appeals vacated the rule due to a lack of evidence. The FDA needs strong evidence demonstrating the impact of graphic warning labels on individuals' propensity to smoke. This project will experimentally test the impact of graphic warning labels on smoking behavior in an ecologically valid retail setting.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project (R01)
Project #
5R01CA196759-04
Application #
9540837
Study Section
Community Influences on Health Behavior Study Section (CIHB)
Program Officer
Reyes-Guzman, Carolyn
Project Start
2015-09-23
Project End
2019-08-31
Budget Start
2018-09-01
Budget End
2019-08-31
Support Year
4
Fiscal Year
2018
Total Cost
Indirect Cost
Name
Rand Corporation
Department
Type
DUNS #
006914071
City
Santa Monica
State
CA
Country
United States
Zip Code
90401
Gong, Min; Dunbar, Michael S; Setodji, Claude et al. (2017) ZonnicĀ®: a new player in an old field. Subst Abuse Treat Prev Policy 12:40