FDA, NIH to Study Tobacco Users

Will assess behavioral, health impacts of new government regulations

Published in CSP Daily News

WASHINGTON -- The U.S. Food & Drug Administration (FDA) and the National Institutes of Health(NIH) have announced a joint, national study of tobacco users to monitor and assess the behavioral and health impacts of new government tobacco regulations.

The initiative--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 & Tobacco Control Act of 2009.

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.

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.

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

Westat, Rockville, Md., was awarded the research contract in a competitive solicitation process.

NIH, the nation's medical research agency, includes 27 institutes and centers and is a component of the U.S. Department of Health & Human Services (HHS). It is the primary federal agency conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments and cures for both common and rare diseases.