Tobacco Regulation and Addiction Center (A-TRAC)

Aiding Tobacco Product Regulation

to Protect Public Health

The American Heart Association Tobacco Regulation and Addiction Center (ATRAC) produced scientific data on the cardiovascular effects of new and emerging tobacco products and developed expertise to respond to new developments in regulatory science. As a part of the larger Tobacco Center of Regulatory Science (TCORS), A-TRAC aided the development and evaluation of tobacco product regulation by the FDA, contributing to the protection of public health and reduction of tobacco-related disease, disability and death.


Tobacco Centers of Regulatory Science (TCORS)

The U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH), as part of an on-going interagency partnership, funded 14 Tobacco Centers of Regulatory Science (TCORS) in 2013 to conduct research to inform regulation of tobacco products. After a successful five-year program, they funded nine new Tobacco Centers of Regulatory Science (TCORS 2.0) in 2018, committing more than $151 million in grants. to research centers, some of which were also part of the previous network.

The American Heart Association Tobacco Regulation and Addiction Center (A-TRAC) received new funding as part of this initiative and partnered with eight institutions to form the American Heart Association Tobacco Center of Regulatory Science, bringing together investigators from across the country to aid in the development and evaluation of tobacco product regulations. TCORS sites were expected use the full spectrum of basic and applied sciences on tobacco and addiction to generate research to inform and assess the FDA’s existing, upcoming and future regulatory initiatives. The program also provided young investigators with training and seed funding to ensure the development of the next generation of tobacco regulatory scientists. The program was designed with the flexibility to provide answers to emerging research questions in a continually shifting tobacco marketplace.

The goal of the American Heart Association Tobacco Center of Regulatory Science was to provide the FDA with scientific evidence regarding the cardiovascular toxicity and health effects of tobacco products and their components, with a larger focus on new and emerging tobacco products. The Center supported a multi-disciplinary research program to assess toxicity in human tissue and animal models; evaluate short- and long-term cardiovascular health effects of tobacco products, and assess the cardiovascular disease risk associated with non-cigarette tobacco products in multiple large NIH-supported cardiovascular cohorts.

man holding a vape pen and cigarettes

Seven Scientific Areas

TCORS 2.0 focused on generating scientific evidence in seven scientific domains:

  • Testing the toxicity of tobacco smoke, aerosol or specific elements
  • Effects of tobacco product characteristics on addiction and abuse liability
  • Short- and long-term health effects of tobacco products
  • Knowledge, attitudes and behaviors related to tobacco product use
  • How to effectively communicate the health effects of tobacco products
  • Influences of tobacco marketing
  • Impact of potential FDA regulatory actions

Outcomes

  • Improved our understanding of the cardiovascular and, more recently, cardiopulmonary effects of tobacco products.
  • Demonstrated that tobacco products and tobacco product components have a significant impact on cardiovascular function, health and disease risk.
  • Significant contributions to science base needed to support policy recommendations and the regulatory authority of the FDA. This has been especially important over the past decade, with a plethora of new and emerging tobacco products reversing years of effective work to reduce nicotine addiction, particularly in youth.
  • More than 30 submissions to the federal docket, providing comments on proposed rules. The work has been cited in more than 25 policy documents from organizations such as the World Health Organization that referenced 19 of the program’s publications.
  • To date, 300 papers  published in prestigious journals, including Circulation, Lancet, Nature Communications, Archive of Internal Medicine, Circulation Research and others.
  • The ATRAC 2014 position paper on e-cigarettes has been cited more than 400 times; 100 of these papers were co-authored by students and trainees in the program - many continue to include tobacco and nicotine regulatory science in their career interests.

American Heart Association Tobacco Center for Regulatory Science Publications