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An experimental assessment of FDA graphic warning labels

Institution: University of California, San Francisco
Investigator(s): Joseph Guydish, Ph.D.
Award Cycle: 2013 (Cycle 22) Grant #: 22XT-0049 Award: $252,794
Subject Area: Regulatory Science/New Products
Award Type: Exploratory/Developmental Award

Initial Award Abstract

In 2009, the Tobacco Control Act gave the Food and Drug Administration (FDA) regulatory authority over tobacco products. Under the Act, the FDA became responsible to regulate tobacco products in order to protect public health. For example, the FDA banned most cigarette flavorings, published the “final rule” restricting sale of tobacco to children, and banned misleading cigarette advertising terms such as “low,” “light,” and “mild”. The FDA also developed graphic warning labels to communicate the risks of tobacco use, and these were intended to take the place of existing text labels currently on cigarette packs since 1984. Tobacco companies challenged the new warnings as a violation of their first amendment rights, and the court ruled for tobacco in R.J. Reynolds v. FDA. The court found that available research did not show that graphic warnings placed on cigarette packs were associated with changes in tobacco use behavior. This is because experimental research available to date has relied on brief exposure to graphic labels, where smokers are shown the label and then asked how the label affects their beliefs about tobacco, and risks associated with tobacco. One-time exposure to a graphic label is too brief to measure actual changes in smoking behavior.

What is needed is an experimental procedure, or set of procedures, whereby smokers can be exposed to graphic labels on their own cigarette packs, over a period of time, and under real-world conditions. With some innovative procedures, this can be done in residential treatment programs, and we propose such a study in residential treatment for other drug use. Key features of residential treatment are: a concentration of smokers, daily patient contact in which experimental labels can be affixed to the patient’s own cigarette packs, ability to directly observe use of cessation services as the behavioral outcome.

The project creates the 9 approved FDA warning labels and text using adherence paper, so that labels can be affixed to the cigarette packs of each patient. The design is a sequence of off-on-off-on recruitment periods, each lasting 4 months, during which participants are either exposed to transparent labels or to graphic warning labels placed on their own cigarette packs. The transparent labels are used as a control condition, so that these patients receive all of the same procedures, attention, and incentives as patients who receive graphic warning labels. In this way we know that any difference between patients who get the transparent labels and those who get the graphic labels are due to the labels themselves. 204 male smokers will be enrolled, evenly distributed across conditions. For each participant there is a baseline interview, a 30 day exposure period (to transparent or graphic labels) and a one month follow up interview.

Behavioral measures include initiation of cessation services, intent to quit, quit attempts, and cigarettes per day. Communication measures include tobacco risk perception, impacts of cigarette pack warnings, thoughts about abstinence, attitudes toward cessation services. The main study hypothesis is that persons exposed to graphic labels, compared to those in an attention control condition, are more likely to initiate smoking cessation services.