Editor's note: This is Part 2 of a 2-part series on cancer prevention research. Part 1 was published in the June 1 issue of “CancerScope.”

When the Family Smoking Prevention and Tobacco Control Act (TCA) became law in 2009, giving the US Food and Drug Administration (FDA) the power to regulate tobacco products, the FDA created the Center for Tobacco Products.

The center's principal mission is to regulate the manufacture, marketing, and distribution of tobacco products. According to David Ashley, PhD, director of the center's Office of Science, scientific research is necessary to inform the FDA's regulations, which involve reducing initiation, promoting cessation, and reducing harms for those who use tobacco products.

The FDA's priority research areas are:

  • Understanding the diversity of tobacco products;

  • Reducing addiction to tobacco products;

  • Reducing the toxicity and carcinogenicity of tobacco products and smoke;

  • Understanding the adverse health consequences of tobacco use;

  • Understanding communications about tobacco products;

  • Understanding tobacco product marketing; and

  • Understanding how economics and policies affect tobacco product use.

Center representatives add that scientists also can submit basic research proposals if they can inform regulatory issues. Within this framework, the FDA recently announced 56 questions they would like to see answered through research. (For the full list of questions, visit the Center for Tobacco Products' summary of its meeting on research priorities at and click on “News & Events.”)

“They're growing a regulatory and research arm from scratch, in a paradigm that's totally foreign to the FDA,” says Peter Shields, MD, president of the American Society of Preventive Oncology and deputy director at the Lombardi Comprehensive Cancer Center at Georgetown University Medical Center. “If they applied any of the rules they use for drugs or food to tobacco, they would get rid of it, but the law prohibits them from banning it.”

Because Congress will never ban tobacco, the FDA is trying to limit as much as possible the harm of tobacco products, he says. “Tobacco research has been underfunded for 20 years, and now the FDA needs data that doesn't exist,” says Dr. Shields. “There are fundamental, basic questions that need to be answered.”

National Study Will Assess Regulation Impact

The first large-scale FDA/National Institutes of Health (NIH) study to be announced since the FDA gained authority to regulate tobacco products is a national study of tobacco users to monitor and assess the behavioral and health impacts of new government tobacco regulations. The effort is a collaboration between the NIH's National Institute on Drug Abuse and the Center for Tobacco Products.

Researchers will follow more than 40,000 users of tobacco products and those at risk of tobacco use who are aged 12 years and older. They will evaluate the following:

  • What makes people susceptible to tobacco use;

  • Use patterns and resulting health problems;

  • Patterns of tobacco cessation and relapse in the era of tobacco regulation;

  • The effects of regulatory changes on risk perceptions and other tobacco-related attitudes; and

  • Differences in attitudes, behaviors, and key health outcomes in racial/ethnic, gender, and age subgroups.

Tobacco research has been underfunded for 20 years, and now the FDA needs data that doesn't exist. There are fundamental, basic questions that need to be answered.Peter Shields, MD

Knowledge gleaned from this study will help the FDA target the most effective actions to decrease the toll of tobacco use on the nation's health, said Margaret Hamburg, FDA commissioner, when the study was announced last fall. More specifically, the results will help the FDA assess the impact of the TCA and understand how best to use its regulatory authority regarding product marketing and standards and communicating the risks of tobacco use.

Additional Efforts

Similar to the Department of Defense funding breast cancer research, the FDA is contracting with the NIH to award additional grants. Among the questions to be answered is whether the FDA should regulate levels of nicotine.

In addition, researchers need to test the blood and urine of people using the new tobacco products to understand their impact. Tobacco companies claim these products reduce carcinogens, but scientists currently do not have those tests. As a result, the best options now are testing individuals for certain biomarkers and developing and validating specific modeling that will determine how regulators can best impact public health, Dr. Shields says.

Researchers also need to understand how people use the new products and what they think of them. Clinical trials are difficult to conduct because the typical tobacco user does not want to participate in a trial, Dr. Shields adds. “Tobacco is a complex problem that's been around a long time, and it won't be solved overnight,” he says.