FDA backs low-nicotine cigarette research as it weighs new regulatory power

Beverly Anusionwu, a smoker for three decades who favors Maverick menthols, was enticed to the small lab inside the University of Pittsburgh’s psychology department by an ad promising free cigarettes and a few bucks for her time.

She spent a couple of hours on a recent morning answering questions about her medical history and undergoing a battery of cognitive tests. When she finished, researchers handed her five gray packs of cigarettes unlike any she had ever seen, along with instructions to report back daily on how much she was smoking and whether her cravings and moods changed.

“Spectrum menthol,” Anusionwu said, reading the label aloud. “All right, then. I guess nicotine is nicotine.”

Not quite. The Spectrum cigarettes she’ll be smoking for the next six weeks could contain as much as 95 percent less nicotine than her usual brand. Anusionwu, 54, 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 an important question: How much does nicotine need to be reduced in cigarettes to make them less addictive?

The answer to that question, long explored by academics, has taken on renewed urgency now that the Food and Drug Administration has the authority to regulate the amount of nicotine in cigarettes — although it can’t ban the substance outright.

Congress gave the agency that unprecedented power in a landmark 2009 tobacco control law, and the FDA has faced growing pressure to use it — along with other efforts such as anti-smoking ad campaigns and graphic warning labels on cigarette packages — to reduce the estimated 443,000 deaths caused by smoking each year in the United States.

Few experts argue that lowering levels of nicotine is the only solution to cutting the deadly toll of tobacco. And some say doing so too quickly risks unintended consequences, such as creating a black market for high-nicotine cigarettes or pushing smokers to compensate by smoking more or seeking equally harmful alternatives. But to advocates of the idea, the power to set limits on nicotine could hold the key to ending the checkered history of the cigarette.

“Imagine a world where a cigarette wasn’t addictive,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products, which provided millions of dollars to fund the Pittsburgh study and others like it.

In that sort of world, the theory goes, longtime smokers might find it easier to drop the habit. Perhaps more important, the estimated 3,000 teenagers who try their first cigarette each day might not travel down the path of addiction and eventual disease. Harmful chemicals such as tar might remain, but without the ingredient most responsible for keeping people hooked — nicotine — the urge to smoke might wane.

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

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.

“It’s been a key question in research for a while,” said Joni Rutter, acting director of the division of basic neuroscience and behavioral research at the National Institutes of Health, which has distributed the FDA’s tobacco research money through grants. “These studies are geared toward helping the FDA come up with these guidelines. They want evidence-based research to help them do that. We’re trying to help them achieve that goal.”

The role of nicotine

Nearly two decades ago, in a seminal 1994 article in the New England Journal of Medicine, academics Neal Benowitz and Jack Henningfield proposed giving federal regulators the authority to reduce the nicotine content of cigarettes gradually until it reached a level that wouldn’t cause addiction.

Their proposal came during a period of intense debate over the role of nicotine in keeping smokers smoking. An FDA advisory panel that year rejected the tobacco industry’s long-held position that the nicotine wasn’t addictive, and the following year an internal memo from tobacco manufacturer Philip Morris surfaced calling cigarettes “nicotine delivery systems” and asserting that nicotine was “the primary reason” people keep smoking.

Despite the FDA’s efforts to regulate nicotine as a drug at the time, the agency would have to wait another 15 years for Congress to give it the ability to dictate how much nicotine companies could put in cigarettes.

During the decades of political fights over whether — and how — the government should be allowed to regulate tobacco, researchers continued building a body of research on low-nicotine cigarettes.

“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,” said 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. “There are some promising results.”

But plenty of unanswered questions remain.

“I really don’t think we know what’s going to happen as we reduce nicotine levels,” said Gregory N. Connolly, a Harvard professor of public health and anti-smoking advocate who served on an FDA tobacco advisory panel before resigning in 2010. “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.

Richmond lawyer Bryan M. 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, Haynes said. Another consideration: “If you alter the fundamental properties of a product, people will start looking toward contraband. It could create black market.”

Haynes also said any changes partly come down to fairness. While companies shouldn’t be allowed to increase nicotine levels to maximize addiction — one Massachusetts study years ago found that the amount of nicotine in most cigarettes actually rose an average of almost 10 percent from 1998 to 2004 — they shouldn’t be required to remove the nicotine that occurs naturally in tobacco.

“It’s one thing to ensure that companies aren’t manipulating levels of nicotine to help keep people addicted,” he said. “But it’s another whole thing to tell the industry to alter a product and destroy its inherent properties when the public health benefit could be negligible.”

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.”

Brady Dennis is a national reporter for The Washington Post, focusing on food and drug issues.
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