FDA Starts Rulemaking to Slash Nicotine in Cigarettes

The Food and Drug Administration (FDA) took what it called a “historic” first step to making smoking less addictive on March 16 by starting the regulatory process to lower nicotine in cigarettes.

Although it is likely to be a long and controversial process, the FDA is considering creating a product standard that would make cigarettes “minimally addictive or nonaddictive.” The agency plans to do this by setting a maximum level for nicotine. The FDA is seeking public input through June 14 on which potential nicotine maximum would best protect public health, it wrote in an advance notice of proposed rulemaking.

According to the notice, the agency is “particularly interested” in the merits of setting nicotine levels at 0.3 mg/gram to 0.5 mg/gram tobacco per cigarette. Regular cigarettes now have as much as 50 times that amount: about 15 mg nicotine/gram tobacco.

Manufacturers have long been able to manipulate the nicotine level in cigarettes by blending or cross-breeding tobacco or by chemical extraction. In 2009, the FDA was given regulatory authority over tobacco products, including the authority to reduce the nicotine content.

There is evidence that low-nicotine cigarettes can reduce smoking. A large clinical trial of adults given very low-nicotine cigarettes found they smoked nearly one-third fewer cigarettes a day and were twice as likely to try to quit, compared with smokers given regular cigarettes.

The FDA’s comprehensive tobacco plan, which was announced last July, centers on the idea that nicotine is delivered through products on a continuum of risk—from the least harmful medicinal products to the most harmful, combustible cigarettes.

“Cigarettes are the tobacco product category that causes the greatest burden of harm to public health,” the FDA wrote in the advance notice of proposed rulemaking. The agency is requesting comments on the scope of any new policy, and whether it should cover likely substitutes for cigarettes, such as roll-your-own tobacco, little cigars, pipe tobacco, and waterpipe tobacco.

The agency projected that a very low-nicotine tobacco policy put in place by 2020 would result in 5 million adults quitting smoking within a year, and 8 million lives being saved by the end of the century. However, the agency’s projections assume a sweeping policy that would apply to cigarettes as well as all likely combusted substitutes. With such a policy, the FDA assumes the percentage of Americans who smoke would drop to 1.4 percent by the end of the century, from today’s 15 percent.

The FDA is also seeking input on whether a new nicotine level should be implemented all at once or gradually and what unintended consequences might result, such as illicit trade or an increase in the number of cigarettes smoked.

Very Low-Nicotine Cigarettes Could Cut Cravings or Cause Compensation

Jennifer W. Tidey, Ph.D., a professor of psychiatry and human behavior at Brown University, said she is optimistic about the FDA’s move.

“Cigarette smoking kills more than 480,000 Americans every year,” said Tidey, who has studied the effects of very low-nicotine cigarettes on smoking at Brown’s Center for Alcohol and Addiction Studies. “The FDA’s proposal is a bold and exciting action. When people smoke very low-nicotine cigarettes, they do help reduce cravings and withdrawal symptoms. Over time, they help people reduce smoking by cutting their nicotine intake and replacing the behavioral component of smoking.”

Douglas M. Ziedonis, M.D., M.P.H., the associate vice chancellor for health sciences and professor of psychiatry at the University of California, San Diego, cautioned that some people using very low-nicotine cigarettes might adjust their smoking habits and inhale more tar and other toxic and carcinogenic substances.

“There is still a concern with very low-nicotine cigarettes that certain smokers might draw harder, take more puffs per cigarette, or increase the number of cigarettes smoked to try to compensate for the reduced nicotine levels,” he said.

People With Mental Illness Could Benefit

Although smoking rates have steadily dropped since the landmark report “Smoking and Health: Report of the Advisory Committee to the Surgeon General of the United States” was issued in 1964, people with serious mental illness continue to smoke at an alarmingly high rate. More than 75 percent of people with mental illness say they want to quit, but cannot.

Tidey’s research on smokers with major depressive disorder and schizophrenia given only very low-nicotine cigarettes found that they, too, smoked less and were more likely to quit without suffering detrimental psychological effects than those given traditional cigarettes. One study found smokers with major depressive disorder tended to have fewer depressive symptoms after dramatically reducing their nicotine intake compared with those who did not.

“People with psychiatric disorders are just as motivated as others to stop smoking, but have more trouble quitting,” Tidey said. “If we can shift them to a safer product, such as patches or e-cigarettes, hopefully we can wean them off tobacco products entirely. It’s a harm-reduction approach, and that’s part of what is so exciting about what the FDA is doing.”

Ziedonis predicts that a very low-nicotine rule would likely increase switching to other equally harmful combustible tobacco products, such as cigarillos (little cigars) and roll-your-own cigarettes, particularly among those with serious mental illness, who tend to take in more nicotine than other smokers.

In a statement after the FDA announcement, Harold Wimmer, president and CEO of the American Lung Association, emphasized the need for the FDA to establish policies that reduce nicotine in all combustible tobacco products. “While today’s notice envisions a game-changing scenario, the FDA must not limit its focus solely to cigarettes,” he said. ■