Rutgers awarded $18M to research tobacco for FDA

A Rutgers University-led consortium has been awarded $18 million to help tobacco regulators by providing the U.S. Food and Drug Administration with real-time data on tobacco and nicotine marketing, products and consumer behaviors.

“Nothing like this has ever been attempted before now,” Cristine Delnevo, director of the Rutgers Center for Tobacco Studies and principal investigator of the rapid surveillance center, said. “No one has collected such comprehensive information, let alone organized and disseminated it rapidly. We think it will provide the FDA with meaningful and timely data to inform their congressionally authorized regulation of the tobacco market.”

The five-year grant will enable researchers to rapidly identify and analyze critical information in real time and generate timely information for appropriate regulatory and enforcement action by the FDA.

For example, when e-cigarette use among young people dramatically increased from 2017 to 2018, the Centers for Disease Control and Prevention and FDA believed that it was driven by the popular brand JUUL, but, because federal surveys did not ask specifically about the brand, they could only speculate. Once brand-specific information was collected in 2019, which clearly showed that JUUL was the most popular brand among young e-cigarette users, the FDA finalized an enforcement policy aimed at this problem.

“The signals about JUUL’s popularity with youth were there as early as 2017, but without identifying early, meaningful signals and subsequently implementing nationally representative large surveys with appropriate measures, it took much longer to evaluate the problem,” Delnevo said. “Successful rapid surveillance will facilitate a comprehensive understanding of the problem in a timely manner.”

The grant money will fund the Rutgers Center of Excellence in Rapid Surveillance in Tobacco, which officially began operations Thursday, pulling information from numerous data sources.

Researchers will:

  • Collect information from marketing company databases, tobacco maker websites, social media and merchant outlets to spot new marketing strategies;
  • Analyze retail scanner data to track tobacco-product sales and spot trends involving new product characteristics such as innovative flavors or delivery mechanisms;
  • Triangulate responses from surveys of youth, young adults and adults who use tobacco and nicotine products to understand preferences and behaviors;
  • Synthesize the data to identify meaningful trends early and provide the FDA with actionable information to improve its regulation of tobacco products.

Another seven faculty members from the Center for Tobacco Studies will join Delnevo on the rapid surveillance project, as will 13 co-investigators from Roswell Park Cancer Institute, East Carolina University, Stanford University, the University of Kentucky, the Ohio State University, Columbia University and Westat Inc.