Tobacco Regulatory Science

Integrating Population and Biobehavioral Sciences to Inform Regulation of Electronic Cigarettes

Background and Significance

Tobacco is the leading preventable cause of death in the United States, accounting for nearly half a million lives lost and incurring close to $300 billion in costs to society each year. Although cigarettes remain the primary preventable killer, electronic cigarette (“e-cigarette”) use is increasing, with U.S. annual sales expected to soon exceed $1 billion.

E-cigarette use prevalence is highest among young adults, a group where transitions from experimentation to regular tobacco use often occur; a population targeted by tobacco industry marketing; and a priority group for tobacco control.

The 2009 Family Smoking Prevention and Tobacco Control Act authorized the U.S. Food and Drug Administration (FDA) to regulate cigarettes, smokeless, and roll-your-own tobacco products, positioning the FDA to implement regulations to reduce the massive public health toll incurred by tobacco use. The FDA has authority to regulate tobacco advertising, marketing, and packaging, including requiring health-warning labels on tobacco advertisements to communicate the risks of tobacco product use to consumers.

Scientists and policy experts have described e-cigarettes as the wild, wild, west because they are not currently regulated by the FDA and they are heavily advertised through media (e.g., TV, social media) that appeal to young people. Although the potential long-term health risks of e-cigarette use are unknown, they contain the addictive drug nicotine, they may expose users to harmful chemicals (albeit, fewer than cigarettes).

Evidence suggests e-cigarette use among young people is associated with use of more harmful tobacco products in the future (e.g., cigarette smoking).


This study sought to develop and deploy a rapid, efficient approach for estimating the population-level effects of warning labels for e-cigarette advertisements among US young adults. This was done through two steps: first, developing and pilot testing a population-representative sampling methodology using an internet-based crowdsourcing data collection platform, and second, applying this sampling approach to experimentally investigate the effects of e-cigarette warning label size, messaging, and coloring on young adults’ perceptions and other cognitive precursors to e-cigarette use behavior.

Public Health Impact

The findings of the study fill an important gap in the existing tobacco regulatory research evidence-base and will inform the Food and Drug Administration’s decision-making surrounding ecigarette regulations. It is a timely and important topic from a regulatory science standpoint, and is in line with FDA priority area #8: strengthening social and behavioral science at FDA by enhancing audience understanding and evaluating the effectiveness of communication about regulated products. A highly collaborative, multidisciplinary research team carried out this work to enhance the long-term impact and innovation of this line of investigation.

Principal Investigator: Darren Mays, PhD

Georgetown CERSI Pilot Research in Regulatory Science

The Georgetown University Center of Excellence in Regulatory Science and Innovation (CERSI) awarded this pilot research project in 2016. The Georgetown CERSI engages scientists from across the university and its partners, including the Georgetown-Howard CTSA and MedStar Health, to promote regulatory science. Eligible applicants include Georgetown University or Howard University faculty or students, or MedStar Health investigators. CERSI pilot projects focus on one of the priority areas defined by the FDA as necessary for advancing regulatory science for public health.