Rutgers Tobacco Surveillance Center Will Provide FDA With Unprecedented Data

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

“Nothing like this has ever been attempted before now,” said Cristine Delnevo, director of the Rutgers Center for Tobacco Studies and principal investigator of the rapid surveillance center. “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 5-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 CDC 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 on June 1, 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.

The Rutgers-led consortium beat competing bids from several other institutions that wanted to run the rapid surveillance center. Rutgers’ application touted not only its proposed surveillance methodology but also its deep expertise in tobacco surveillance across all categories of tobacco products and its history of spotting trends early.

Historically federal tobacco monitoring has largely focused on cigarettes, which remain the most commonly used tobacco product. But the tobacco market is much more diverse today. Sales patterns have shifted as manufacturers have innovated rapidly in less taxed and less regulated product categories such as cigars, smokeless tobacco and e-cigarettes.

Investigators from the Rutgers consortium have expertise that extends beyond cigarettes. Group members include some of the world’s leading experts on cigars, e-cigarettes, nicotine pouches and other tobacco products that have become increasingly popular.

This longstanding interest in various tobacco products led Rutgers to track usage and issue warnings years before they became widely discussed. Rutgers has been conducting New Jersey’s Youth Tobacco Survey since its inception in 1999 and asked about e-cigarettes, hookahs and bidis — flavored cigarettes from India — years before the Centers for Disease Control investigated such products in nationwide surveys. The results of such efforts led Rutgers to warn about such products when few people had even heard of them.

“Every aspect of this market is constantly evolving,” Delnevo said. “The goal here is to shorten the time between identifying a signal and fully understanding it since these large data systems that FDA and CDC rely on are difficult to modify quickly to capture emerging tobacco products. Rapid tobacco surveillance will help FDA not only with appropriate enforcement and regulatory responses but will also help evaluate the impact of pending policy changes, like a ban on menthol in cigarettes. Will people who smoke menthol cigarettes quit? Switch to non-menthol cigarettes? Switch to e-cigarettes or nicotine pouches? Our goal is to monitor market and consumer changes as close to real time as possible.”