FDA, NIH award $20M grant to create UNC Center for Regulatory Research on Tobacco Communications

Sept. 19, 2013

 

Although cigarette use has declined among Americans, regulators face the challenge of communicating the dangers of new tobacco products along with reaching smokers in diverse communities who may not respond to traditional forms of anti-tobacco communication. To address these issues, the U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH) announced today the award of a $20 million, five-year grant to fund a University of North Carolina center that will study issues related to tobacco prevention communication and regulation.

The UNC Center for Regulatory Research on Tobacco Communication (CRRTC) is one of 14 Tobacco Centers of Regulatory Science (TCORS) scheduled to receive up to $53 million for tobacco-related research in fiscal year 2013.

Kurt Ribisl, PhD, professor of health behavior at UNC’s Gillings School of Global Public Health, will direct the new center, which is based at UNC Lineberger Comprehensive Cancer Center. Ribisl also is program leader of Cancer Prevention and Control Program at UNC Lineberger.

 

The center will house projects headed by Adam Goldstein, MD, MPH, director of UNC Tobacco Intervention Programs; Noel Brewer, PhD, associate professor of health behavior at UNC’s Gillings School of Global Public Health; and Erin Suftin, PhD, assistant professor of social sciences and health policy at Wake Forest School of Medicine, and will include faculty members from the UNC School of Journalism and Mass Communication.

 

The 46 faculty and staff members and students at the center will work on three major studies to reinforce communication with the public about 1) the dangers of alternative tobacco products such as electronic cigarettes, hookahs and smokeless tobacco; 2) the harmful effects of chemicals found naturally in tobacco and cigarette smoke; 3) increasing the credibility of risk communications and health risks to audiences from diverse ethnic and LGBT communities; and 4) how to optimally communicate FDA authority over tobacco products.

 

“The goal is to inform and shape how the FDA regulates tobacco products by doing high-impact research that will ultimately help reduce tobacco use,” Ribisl said. Despite decades of work to reduce tobacco use in the United States, it continues to be the leading cause of preventable death and disease.

 

A new, first-of-its-kind regulatory science tobacco program, TCORS is designed to generate research to inform the regulation of tobacco products to protect public health. Using designated funds from FDA, TCORS will be coordinated by NIH’s Office of Disease Prevention, directed by David M. Murray, PhD, and administered by three NIH institutes—the National Cancer Institute, the National Institute on Drug Abuse, and the National Heart, Lung and Blood Institute.

 

“For the first time, under the Family Smoking Prevention and Tobacco Control Act, the federal government, through the FDA Center for Tobacco Products (CTP), is able to bring science-based regulation to the manufacturing, marketing and distribution of tobacco products,” said FDA Commissioner Margaret A. Hamburg, MD. “The FDA is committed to a science-based approach that addresses the complex public health issues raised by tobacco product regulation.” The agency is establishing science and research programs designed to increase understanding of the risks associated with tobacco use.

The TCORS program brings together investigators from across the country to aid in the development and evaluation of tobacco product regulations. Each TCORS application 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.

“While we’ve made tremendous strides in reducing the use of tobacco products in the U.S., smoking still accounts for one in five deaths each year, which is far too many,” said NIH Director Francis S. Collins, MD, PhD. “FDA/NIH partnerships like the Tobacco Centers of Regulatory Science keep us focused on reducing the burden and devastation of preventable disease caused by tobacco use.”

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 FDA’s prior, ongoing and potential future tobacco regulatory activities implemented by CTP under the direction of Mitch Zeller, JD.  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.

Designed to generate vital research in seven core areas, as well as ensure innovation in the field, the research supported by this initiative will provide scientific evidence within the following seven FDA tobacco-related research interest areas:

• Diversity of tobacco products
• Reducing addiction
• Reducing toxicity and carcinogenicity
• Adverse health consequences
• Communications
• Marketing of tobacco products
• Economics and policies

TCORS proposals were selected for funding based on their scientific and technical merit as determined by NIH scientific peer review, availability of funds, and relevance of the proposed projects to program priorities.

The other 13 TCORS were awarded to:

• Aruni Bhatnagar, PhD, and Rose M. Robertson, MD, American Heart Association, Dallas
• Pamela I. Clark, PhD, University of Maryland, College Park
• Thomas E. Eissenberg. PhD, Virginia Commonwealth University, Richmond
• Michael P. Eriksen, PhD, Georgia State University, Atlanta
• Stanton A. Glantz, PhD, University of California-San Francisco
• Stephen T. Higgins, PhD, University of Vermont and State Agriculture College, Burlington
• Robert C. Hornik, PhD, and Caryn Lerman PhD, University of Pennsylvania, Philadelphia
• Suchitra Krishnan-Sarin, PhD, and Stephanie S. O’Malley, PhD, Yale University, New Haven
• Joshua E. Muscat, PhD, and Jonathan Foulds, PhD, Penn State University Hershey Medical Center, Hershey
• Mary Ann Pentz, PhD, and Jonathan Samet, MD, University of Southern California, Los Angeles
• Cheryl L. Perry, PhD, University of Texas Health Sciences Center, Houston
• Peter G. Shields, MD, and Mary Ellen Wewers, PhD, The Ohio State University, Columbus
• Robert Tarran, PhD, University of North Carolina at Chapel Hill, School of Medicine

For more information:

• FDA: Center for Tobacco Products
• Tobacco Centers of Regulatory Science (TCORS)
• NIH: Office of Disease Prevention
• NIH: Tobacco Regulatory Science Program

FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments and cures for both common and rare diseases. More information about NIH and its programs is available online.

---

Gillings School of Global Public Health contact: David Pesci, director of communications, (919) 962-2600 or dpesci@unc.edu.