According to this week’s announcement by the U.S. Food and Drug Administration and the National Institutes of Health, a joint, large-scale national study, the ‘Tobacco Control Act National Longitudinal Study of Tobacco Users’ will be conducted monitoring and assessing smoker’s behavioral and health impacts of new government tobacco regulations.

In the United States tobacco usage is the largest preventable cause of disease, disability and mortality, and despite the substantial drop of smokers since their peak in the 1960’s, there are still almost 70 million Americans aged 12 years and older using tobacco products in 2010, representing an enormous public health burden due to the associated risk of disease and mortality risk caused by tobacco. More than 443,000 premature deaths are caused by smoking cigarettes – more deaths than those of AIDS, illegal drug use, alcohol, suicide, homicide and car accidents combined.

Since Congress granted the authority to regulate tobacco products in the Family Smoking Prevention and Tobacco Control Act of 2009 to the FDA, this initiative, coordinated by scientific experts at NIH’s National Institute of Drug Abuse and the FDA’s Center for Tobacco products, is the first large-scale NIH/FDA collaboration on tobacco regulatory research.

FDA Commissioner Margaret A. Hamburg commented on the new initiative saying:

“The launch of this study signals a major milestone in addressing one of the most significant public health burdens of the 21st century. The results will strengthen FDA’s ability to fulfill our mission to make tobacco-related death and disease part of America’s past and will further guide us in targeting the most effective actions to decrease the huge toll of tobacco use on our nation’s health.”

Researchers will carry out their investigation on over 40,000 tobacco users and those at risk for tobacco use aged 12 and older, examining what makes individuals susceptible to tobacco use and establishing patterns and resulting health problems. They will also investigate patterns of tobacco cessation and relapse during the time period that tobacco regulation has come into effect. Other factors of investigation during the study include studying the effects of regulatory changes on risk perceptions and other tobacco-related attitudes as well as determining differences in attitudes, behaviors and key health outcomes that will be categorized by gender, racial-ethnic and age.

NIH Director Francis S. Collins, M.D., Ph.D. Westat, in Rockville, Md., who was awarded the research contract in a competitive solicitation process said:

“We are pleased to collaborate with the FDA on this study that may provide us with a better understanding of the impact of product regulation on tobacco prevention and cessation.”

The results of the study will assist the FDA in evaluating the impact of the Tobacco Control Act and enable them to find the best strategies in their authority to regulate tobacco, such as setting product standards, determining product marketing and protecting the public health by communicating the risks of tobacco.

Written by Petra Rattue