NIH/FDA study to monitor and assess impacts of new government tobacco regulations

Landmark collaboration is the first since the passing of the 2009 Tobacco Control Act

The U.S. Food and Drug Administration and the National Institutes of Health today announced a joint, large-scale, national study of tobacco users to monitor and assess the behavioral and health impacts of new government tobacco regulations.

The initiative, called the Tobacco Control Act National Longitudinal Study of Tobacco Users, is the first large-scale NIH/FDA collaboration on tobacco regulatory research since Congress granted FDA the authority to regulate tobacco products in the Family Smoking Prevention and Tobacco Control Act of 2009.

Scientific experts at NIH's National Institute on Drug Abuse and the FDA's Center for Tobacco Products will coordinate the effort.

"The launch of this study signals a major milestone in addressing one of the most significant public health burdens of the 21st century," said FDA Commissioner Margaret A. Hamburg. "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."

Investigators will follow more than 40,000 users of tobacco-product and those at risk for tobacco use ages 12 and older. They will examine what makes people susceptible to tobacco use; evaluate use patterns and resulting health problems; study patterns of tobacco cessation and relapse in the era of tobacco regulation; evaluate the effects of regulatory changes on risk perceptions and other tobacco-related attitudes; and assess differences in attitudes, behaviors and key health outcomes in racial-ethnic, gender, and age subgroups.

"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," said NIH Director Francis S. Collins, M.D., Ph.D.

Westat, in Rockville, Md., was awarded the research contract in a competitive solicitation process. Study findings will help the FDA assess the impact of the Tobacco Control Act and will inform the agency about how to best use its tobacco regulatory authorities, such as making decisions about marketing of products, setting product standards, and communicating the risks from tobacco use to protect the public health.