FDA, NIH Launch Study to Learn Why People Use Tobacco

SILVER SPRING, Md. -- The Food and Drug Administration (FDA) and National Institutes of Health (NIH) are joining forces to find out why people use tobacco. The two agencies have officially launched a nationwide study they first announced in October.

The $118.3-million "Population Assessment on Tobacco Health Study" (PATH) will recruit more than 40,000 smokers and non-smokers from across the country and study them over the course of five years. Study participants will include about 7,000 youths between 12 and 18 years old.

"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, M.D. "The results will strengthen FDA's ability to fulfill our mission to make tobacco-related disease and death 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."

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

According to the FDA, the study participants will be interviewed every year by researchers from Westat, a company in Rockville, Md., that specializes in health surveys and public health research. The investigators will be looking at susceptibility to tobacco use; frequency of use patterns; characteristics of smoking cessation and relapse; effects of regulatory changes on the perception of risk and other tobacco-related attitudes; and differences in attitudes, behaviors and key health outcomes in racial-ethnic, gender and age subgroups.

"Data we obtain from the PATH study will provide us with important information that will inform our future regulatory options to protect the public health, including setting tobacco product standards and communicating the risks of tobacco use," explained Cathy Backinger, deputy director for research in CTP's Office of Science at FDA.

The information mined from the study will help shape FDA's future regulatory actions and assess the impact of the 2009 Family Smoking Prevention and Tobacco Control Act. The study is the first large-scale collaboration of the FDA and NIH since the legislation became law in June 2009.