Much is known about the use of tobacco products, especially their effects on the health of those who smoke cigarettes. What’s known includes two grim facts: Tobacco use is the leading cause of preventable, premature death in the United States. And thousands of kids start smoking every day in the United States, many starting a lifetime of addiction.
But what federal regulators and researchers know less about is exactly why people start using a specific tobacco product such as cigarettes, cigars, pipes and/or chewing tobacco. They also want to know why and when people stop smoking or using other tobacco products, and why they start up again.
To find some of the missing pieces of that puzzle, the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) have launched a major, nationwide study of more than 40,000 smokers and non-smokers, including about 7,000 youths age 12 to 18.
The $118.3 million “Population Assessment on Tobacco Health Study (PATH)” will recruit these participants from across the country and study them over the course of five years.
“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. CTP is the FDA center that regulates the manufacture, marketing, and distribution of tobacco products to protect public health and to reduce tobacco use by minors.
The study participants will be interviewed annually by researchers from Westat, a company in Rockville, Md. that specializes in health surveys and public health research. These investigators will examine such issues as
- 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;
- 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,” says Cathy Backinger, Ph.D., M.P.H., deputy director for research in CTP’s Office of Science at FDA.
Researchers will visit homes nationwide in all nine census regions. The resulting data will help inform FDA’s future regulatory actions and assess the impact of the 2009 Family Smoking Prevention and Tobacco Control Act, which granted FDA the authority to regulate tobacco products. CTP oversees its implementation.
This study is the first large-scale collaboration of the two federal agencies since the landmark legislation became law.
According to CTP, approximately 20 percent of U.S. high school students currently smoke. Additionally, data shows an increase in use of other tobacco products such as hookah (water pipes used to smoke tobacco), small cigars, and smokeless tobacco among teens. And the smoking rate among adults has been stalled since 2004, the center reports.
The Tobacco Control Act provided FDA with broad new authority to reduce initiation of tobacco use among young Americans. FDA’s activities include banning the manufacturing and sale of fruit or candy flavored cigarettes, restricting the use of “light,” “low,” or “mild,” or other similar descriptors in the labeling and advertising of tobacco products, and developing new graphic health warnings for cigarette packages and advertisements as well as requiring health warnings on smokeless tobacco.
FDA has also been working with state and territorial authorities to require proof of age in the sale of cigarettes and smokeless tobacco. As part of its ongoing effort to reduce tobacco use among children, FDA has issued more than 1,750 warning letters to retailers, the majority of which are for violations related to selling cigarettes or smokeless tobacco to kids under the age of 18. If the violations persist, the retailers will be fined.
This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.
Feb. 23, 2012