Could FDA’s Proposed Plan Help Smokers With Mental Disorders Quit For Good?

The Food and Drug Administration’s plan to reduce nicotine in combustible cigarettes to non-addictive levels could be good news especially for people with mental illness. That’s because they are more prone to smoking and have more difficulty quitting than the general population, said Jennifer Tidey, Ph.D., a professor of psychiatry and human behavior at Brown University.

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“This is a different direction for the FDA. Instead of trying to get people to stay away from the product, they are trying to make the product less addictive,” said Tidey, who has conducted research on very-low-nicotine cigarettes at Brown’s Center for Alcohol and Addiction Studies.

Cigarette smoking and tobacco use have fallen dramatically among the U.S. population over the past few decades, but the use has remained stubbornly high among people with psychiatric disorders. They consume nearly half of all cigarettes smoked in the United States, and more than 75 percent of people with mental illness say they want to quit, but cannot, Tidey said.

Although very-low-nicotine cigarettes will not make smoking safe (because these cigarettes still contain other harmful chemicals), Tidey said research has shown they may help smokers cut back on cigarettes, switch to less harmful options such as e-cigarettes, and make it easier to quit.

The FDA proposes that lowering nicotine levels could decrease the likelihood that future generations will become addicted to cigarettes and encourage current smokers to quit.

“Unless we change course, 5.6 million young people alive today will die prematurely later in life from tobacco use,” said FDA Commissioner Scott Gottlieb, M.D., in a statement announcing a comprehensive plan for tobacco and nicotine regulation in late July.

“Envisioning a world where cigarettes would no longer create or sustain addiction, and where adults who still need or want nicotine could get it from alternative and less harmful sources, needs to be the cornerstone of our efforts—and we believe it’s vital that we pursue this common ground,” he said.

Addiction psychiatrist Doug Ziedonis, M.D., Ph.D., a professor of psychiatry at the University of California, San Diego, said he believes that more effort and resources should be directed toward helping people with mental illness quit smoking altogether, rather than move to a middle ground of ver-low-nicotine or e-cigarettes. “E-cigarettes don’t seem to be a route that would lead to smoking cessation,” he said.

The FDA stated it would issue a regulatory notice to seek public comment on the potential public health benefits and any possible adverse effects of lowering nicotine in cigarettes. The FDA also plans to file an “Advance Notice of Proposed Rulemaking” on nicotine levels, which is the first step in a time-consuming regulatory process that includes public comment periods that can last months.

Additionally, the FDA intended to seek public comment on the role that flavors, including menthol, in tobacco products may play in attracting youth and helping some smokers switch to potentially less harmful forms of nicotine delivery; and to solicit additional comments and scientific data related to the patterns of use and resulting public health impacts from premium cigars.

No dates have been set for these directives, but Michael Filberbaum, a press officer with the FDA, told Psychiatric News, “We expect to take meaningful steps in 2017 to advance important regulatory components that address the key aspects of this new policy.”

Very low-nicotine cigarettes mentioned in the FDA’s plan differ from “light” cigarettes, which Congress removed from the market in 2009. The tobacco in light cigarettes contained the same amount of nicotine, but had ventilated filters attached to deliver less nicotine. However, light cigarettes made smokers puff harder and inhale more deeply, which ended up providing similar doses of nicotine as regular cigarettes, according to researchers. ■