In June 2009, the US Food and Drug Administration (FDA) received the authority to regulate tobacco. The following month, the FDA asked for public comments on the new regulatory process, and, in December, the American Association for Cancer Research (AACR) responded with advice on expediting scientific research on tobacco.

To jump-start new research, the AACR published nine research reviews in Cancer Epidemiology, Biomarkers & Prevention last month that detail strategies and trial designs that the agency could use to assess harm and risk.

Among the nine papers is a study addressing the limitations of smoking machine tests and toxicology assays that use nonhuman cells. The authors warn that extrapolating from these studies to determine the risks to humans can be problematic. Another study reviews methods used to determine addiction potential and how these approaches might apply to 'modified-risk tobacco products', a new class of tobacco products that the FDA will assess and regulate.

Relative to the quantity of safety research that exists for drugs safety, solid tobacco research is relatively scarce, according to Peter Shields, deputy director of the Lombardi Comprehensive Cancer Center at Georgetown Medical Center in Washington, DC, and editor of the reviews. Much of what exists comes from tobacco companies themselves and is either outdated or unreliable.

The FDA “will review the information submitted by AACR to our public docket regarding best practices on clinical trail and design,” says agency spokeswoman Kathleen Quinn.

But Philip Landrigan, head of preventive medicine at the Mount Sinai School of Medicine in New York, cautions that “there needs to be a proper balance between research and action.”

“While I don't want to discourage research, the FDA has all it needs to know now to take decisive action to reduce risks of tobacco,” he added.