FDA Funding Low-Nicotine Cigarette Research

Published in CSP Daily News

Study could give agency data it would need to set new, lower nicotine levels

PITTSBURGH -- Beverly Anusionwu, 54, a smoker for three decades, is among the first of nearly 850 participants around the country who over the next year will help researchers and federal regulators try to answer the question: How much does nicotine need to be reduced in cigarettes to make them less addictive?

The answer has taken on renewed urgency now that the U.S. Food & Drug Administration (FDA) has the authority to regulate the amount of nicotine in cigarettes, although it can't ban the substance outright, said a report by The Washington Post. Congress gave the agency that power in 2009, and the FDA has faced growing pressure to use it to reduce smoking. To advocates, the power to set limits on nicotine could hold the key.

"Imagine a world where a cigarette wasn't addictive," Mitch Zeller, director of the FDA's Center for Tobacco Products (CTP), which provided millions of dollars to fund the University of Pittsburgh study and others like it, told the newspaper.

"The question is, how low would [FDA] have to go to produce a beneficial public health impact?" Eric Donny, a University of Pittsburgh psychology professor overseeing the one-year project, told the paper.

The study unfolding in Pittsburgh and at nine other sites around the country is the largest of its type to date and eventually could give the agency the data it needs to set new, lower nicotine levels in cigarettes.

Participants in the study underway in 10 cities, including at Johns Hopkins University, will smoke cigarettes containing a wide range of nicotine. After six weeks, researchers will ask them not to smoke for a day to see if they suffer withdrawal symptoms. They also will follow up to see whether the users' smoking habits have changed, how they are sleeping and if the change in nicotine has altered their ability to concentrate.

"What's been found so far is that when people are given low-nicotine cigarettes, they do seem to reduce the number of cigarettes that they smoke. There are some promising results," Dorothy Hatsukami, a psychiatry professor and director of the University of Minnesota's Tobacco Research Programs who is working with Donny on the study in Pittsburgh, told the Post.

Next year, Hatsukami will oversee a larger and longer federally funded study to examine whether reducing nicotine levels quickly or gradually over time is more effective.

"I really don't think we know what's going to happen as we reduce nicotine levels," Gregory Connolly, a Harvard professor of public health and anti-smoking advocate who served on an FDA tobacco advisory panel before resigning in 2010, told the paper. "Are people going to increase their smoking behavior [to compensate]? Are they going to reject the product? Tobacco addiction is very complex."

Connolly supports cutting nicotine levels, but notes that tobacco companies use other chemicals to create tastes and smells that enhance dependence on cigarettes. Focusing solely on nicotine could leave the door open for the industry to craft other creative ways to keep smokers hooked, he said.

Richmond lawyer Bryan Haynes, whose firm Troutman Sanders represents multiple tobacco firms, said the FDA should think long and hard before making major changes. "One consideration would be whether people smoke more cigarettes" if nicotine levels fall, he told the paper. Another consideration: "If you alter the fundamental properties of a product, people will start looking toward contraband. It could create black market."

William Phelps, a spokesperson for Altria, the parent company of Philip Morris, said the company hopes the FDA will base any new nicotine regulations only on sound scientific data. "We're aware the agency is funding research related to lower-nicotine cigarettes and will wait to see the outcome of that research," he told the Post.

Thomas Glynn, director of science and trends for the American Cancer Society, said that whatever the outcome of the Pittsburgh study, there is little doubt that the FDA will move cautiously. But he said research like the kind taking place in Pittsburgh will help the agency build a case for exercising its newfound powers down the road.

"This study will not be enough for FDA to say, 'We're ordering the reduction [in nicotine]'," he said. "But it's going to take them a long way toward being able to do that if it shows people do smoke fewer cigarettes."

Click here to read the full Washington Post report.