William Phelps, a spokesman 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 said.
A basis for regulation
It likely will take the government years to figure out the low-nicotine riddle, but if anything, research on the topic is growing broader and more intense. The NIH’s National Institute on Drug Abuse has purchased millions of the Spectrum-brand cigarettes, which are made from genetically altered tobacco leaves and contain varying degrees of nicotine. Stored in a warehouse in North Carolina, the cigarettes are distributed free of charge to researchers around the country.
The manufacturer that produces them, the 22nd Century Group, has sold the government 12 million low-nicotine cigarettes and plans to supply another 5.5 million soon, said founder and chief executive Joseph Pandolfino, whose company also has applied to the FDA to have one of its low-nicotine cigarettes licensed as a smoking-cessation device.
Anusionwu and most other participants in the study getting underway in Pittsburgh and nine other 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’re sleeping, and if the change in nicotine has altered their ability to concentrate.
Next year, Hatsukami plans to oversee a larger and longer federally funded study to examine whether reducing nicotine levels quickly or gradually over time is more effective.
Thomas J. Glynn, director of science and trends for the American Cancer Society, said that whatever the outcome, there’s 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.”
When and if that happens, former FDA commissioner David Kessler said in a 2010 interview, it could make a fundamental difference to the nation’s health.
“If you do this, you can save 200,000 to 300,000 lives a year,” Kessler said. “Everything else pales in comparison.”