The US Food and Drug Administration and the National Institutes of Health announced a joint, large-scale, national study of tobacco users to monitor and assess the behavioural 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 US 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 US FDA’s Centre 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 US FDA Commissioner Margaret A. Hamburg. “The results will strengthen US 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, behaviours and key health outcomes in racial-ethnic, gender, and age subgroups.

“We are pleased to collaborate with the US 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, MD, PhD.

Westat, in Rockville, Md., was awarded the research contract in a competitive solicitation process. Study findings will help the US 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.

While smoking rates have dropped significantly since their peak in the 1960s, nearly 70 million Americans ages 12 and older were current users of tobacco products in 2010. As a result, death and disease caused by tobacco use is still a tremendous public health burden. Tobacco use is the leading preventable cause of disease, disability, and death in the United States. Cigarette smoking results in more than 443,000 premature deaths in the United States each year – more than alcohol, illegal drug use, homicide, suicide, car accidents, and AIDS combined.

The US FDA, an agency within the US Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

National Institutes of Health (NIH), the nation's medical research agency, includes 27 Institutes and Centres and is a component of the US Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases.