AACR offers a compendium of best research practices to aid the FDA in regulating tobacco

When President Barack Obama signed the Family Smoking Prevention and Control Act in June, he ushered in a new era of tobacco policy that empowers the Food and Drug Administration to regulate one of the world's most controversial and deadly consumer products.

However, the FDA can only act in the context of scientific inquiry and proof, and while the tobacco legislation represents a step forward, those who have made tobacco research their life's work see challenges ahead.

The American Association for Cancer Research is responding to that challenge by offering a compendium of best research practices in a collection of nine reviews, published in the December issue of Cancer Epidemiology, Biomarkers & Prevention.

"This is completely virgin territory. Tobacco and alcohol are the only two products that people take into their bodies that, to this point, have not had to undergo any product regulation," said Kenneth Warner, Ph.D., dean of the School of Public Health at the University of Michigan, who wrote the introduction for the reviews."The FDA will need to build a solid scientific base for its decisions, and the efforts of the American Association for Cancer Research are a big part of that."

The reviews, authored by leading experts in the field, cover everything from proper clinical trial design to how to best assess toxicity levels in the wealth of new tobacco products the industry has introduced as "safe."

Beyond the peer reviewed literature, the AACR has also convened an AACR Task Force on Tobacco and Cancer, which is chaired by Roy Herbst, M.D., Ph.D., chief of the section of thoracic medical oncology at the University of Texas M. D. Anderson Cancer Center.

In December, the task force will release an official AACR statement on tobacco. The task force has already publicly commented on the FDA law and nominated members of an advisory panel.

The FDA regularly convenes advisory panels before making regulatory decisions. The panels are made up of independent experts from industry and academia. While the agency is not bound by the panel's recommendations, it typically follows a panel's advice. The advisory panel meetings are open and closely watched by the media and the public.

"Under the new legislation, the tobacco companies will be not be allowed to simply introduce new or modified tobacco products without first providing evidence to the FDA proving that the new or modified product is less harmful than the conventional products that they are intended to replace," said Michael Cummings, Ph.D., M.P.H., chairman of the Department of Health Behavior at the Roswell Park Cancer Institute and author of several of the reviews.

The challenge, according to Cummings, will be in making sure that the FDA has sufficient data upon which to make reasoned judgments about whether a new or modified product is, in fact, less harmful to the individual user and the population as at large.

"Tobacco products are complex. A smoker gets about 4,000 chemicals in every puff. However, the FDA will need to consider much more than just the toxicity of the product when judging a new or modified products' harm potential," Cummings said. "Tobacco products are harmful because they are engineered to be addictive. Thus, the abuse potential of a product and how it is packaged and labeled will need to be considered by the FDA when judging the relative harm of new and modified tobacco products."

The reviews in this issue of Cancer Epidemiology, Biomarkers & Prevention describe some of the strategies that might be applied when assessing differences in product risk and population harm, said Cummings.

Additionally, the issue features several studies on lung cancer in minorities, risk for experimentation, impact of popular culture and the effect of alternative products like herbal cigarettes.

"No one questions any more that smoking is extremely dangerous. The big question is whether the flood of novel products like low-nitrosamine smokeless tobacco, modified cigarettes, and pseudo-cigarette nicotine delivery devices can substantiate their safety claims," said Warner.

In the past, the tobacco companies have continuously rolled out new products without conducting the studies to back up their claims, or at least not releasing those studies publicly. Experts say the scientific research supporting these new products has fallen short.

"All of a sudden the FDA has to start acting like the FDA and get into the tobacco world by regulating all types of nicotine-delivery devices, including tobacco products. However, compared to the wealth of pharmaceutical research available, the tobacco field is substantially behind and we are going to be challenged for years," said Peter Shields, M.D., deputy director of the Lombardi Comprehensive Cancer Center at Georgetown University Medical Center and editor of the reviews. "The tobacco companies have been claiming to be socially responsible since the 1960s, but the new legislation will require them to disclose everything."