Despite decades of efforts to control its use, tobacco continues to be the leading cause of preventable death and disease in the United States. USC is one of 14 academic institutions designated to receive significant funding to contribute to a new, first-of-its-kind regulatory science tobacco program intended to support tobacco product regulations.
The Keck School of Medicine of USC’s Department of Preventive Medicine will receive $20 million over five years to establish one of 14 Tobacco Centers of Regulatory Science (TCORS) in Los Angeles. Jonathan Samet, professor and chair of preventive medicine at the Keck School, and Mary Ann Pentz, professor of preventive medicine and director of the Institute for Prevention Research at the Keck School, are the principal investigators for USC.
The funding comes from the U.S. Food and Drug Administration (FDA) through the National Institutes of Health (NIH).
The purpose of the TCORS program is to give the FDA the scientific base it needs to regulate the manufacturing, marketing and distribution of tobacco products to the public in a rapidly changing tobacco control landscape, Samet said.
“Our center’s mission is to address smoking in vulnerable populations, including those with high rates of smoking and those likely to be targeted by the tobacco industry, including racial and ethnic minorities, those with less education and with lower incomes,” he said. “TCORS will have a broad program of research that will develop methods and produce evidence to help reduce the impact of tobacco on public health.”
The advent of new nicotine-delivering tobacco products such as e-cigarettes, compliance by shop owners with new and existing regulations, and tobacco industry efforts in social media are some of the challenges that the FDA faces, Samet said.
Its location in the Los Angeles area puts the Keck School TCORS team in a unique position to study the effects of tobacco marketing and regulation.
“The Los Angeles basin represents one of the largest, most diverse ‘laboratories’ for studying vulnerable populations,” Pentz said. “In addition to current smokers, there are those who may not have smoked yet but are being targeted through social media and other methods that are not as easily monitored as conventional advertising.
“Besides current and prospective tobacco users, another of our vulnerable populations is small retail vendors, especially in Latino, African-American, Korean and tribal areas. They are subject to FDA regulations but may not yet be knowledgeable about how exactly to comply with these regulations,” Pentz said.
Designed to generate vital research in seven core areas, as well as ensure innovation in the field, the research supported by the TCORS initiative will provide scientific evidence within the following areas: diversity of tobacco products; reducing addiction; reducing toxicity and carcinogenicity; adverse health consequences; communications; marketing of tobacco products; and economics and policies.
The TCORS program brings together investigators from across the country to aid in generating research to inform the development and evaluation of tobacco product regulations. Each TCORS site identified a targeted research goal. Taken together, the TCORS sites will increase knowledge across the full spectrum of basic and applied research on tobacco and addiction.
The program also provides young investigators with training opportunities to ensure the development of the next generation of tobacco regulatory scientists.
“That we were able to compete successfully for this grant reflects the depth of tobacco-related experience at USC,” Samet said. “We are working with colleagues throughout the university, including USC Annenberg School for Communication and Journalism, and the state, including health departments and community groups.”
Comprised of scientists with expertise in fields including epidemiology, behavior, biology, medicine, economics, chemistry, toxicology, addictions, public health, communications and marketing, the TCORS program is the centerpiece of the FDA/NIH collaboration to foster research relevant to tobacco regulatory science.
New research from TCORS will help inform and assess the impact of the FDA’s prior, ongoing and potential future tobacco regulatory activities. In addition, the TCORS investigators will have the flexibility and capacity to begin new research to address issues raised in today’s rapidly evolving tobacco marketplace.
The TCORS awards represent a significant investment in federal tobacco regulatory science, including $53 million in the first year and a potential total of more than $273 million over the next five years. TCORS funding may not exceed $4 million in total costs per year per center, and an investigator could request a project period of up to five years.
Other institutions awarded TCORS grants include the American Heart Association, University of Maryland, Virginia Commonwealth University, Georgia State University, the University of California, San Francisco, University of Vermont, University of Pennsylvania, Yale University, Penn State, University of Texas, The Ohio State University and University of North Carolina.