The U.S. Food and Drug Administration made a bold announcement in July to address the leading cause of preventable death in the United States: tobacco use.
The agency wants to reduce the amount of nicotine in cigarettes to make them less addictive. At the same time, the FDA delayed regulating factors like marketing and health warnings for e-cigarettes and cigars.
“The overwhelming amount of death and disease attributable to tobacco is caused by addiction to cigarettes ― the only legal consumer product that, when used as intended, will kill half of all long-term users,” FDA Commissioner Scott Gottlieb said in a statement.
Indeed, cigarette smoking kills 480,000 Americans each year, according to the U.S. Centers for Disease Control and Prevention. Another 16 million people live with diseases that were caused by smoking, including cancer, lung diseases, emphysema and chronic bronchitis.
“Because nicotine lives at the core of both the problem and the solution to the question of addiction, addressing the addictive levels of nicotine in combustible cigarettes must be part of the FDA’s strategy for addressing the devastating addiction crisis that is threatening American families,” Gottlieb said.
Public health experts applauded the nicotine reduction effort, but they also urged caution. So far, there’s no clear plan for what reducing nicotine in cigarettes would look like, and the effectiveness of such a policy would greatly depend on how it is implemented.
There’s also the possibility of negative consequences, such as creating a black market for nicotine cigarettes, or of smokers changing their inhalation habits and smoking more cigarettes if the agency lowers the nicotine levels gradually, rather than all at once.
The second part of the announcement, to delay general regulation on e-cigarettes and cigars, was more controversial. That’s in part because teenagers and kids are increasingly likely to eschew cigarettes in favor of e-cigarettes, which are sometimes flavored to taste like gummy bears and cotton candy that appeal to youth tastes.
We asked eight researchers and academics working in public health, who have specific expertise in areas like addiction, behavioral health and tobacco regulation, to weigh in on the FDA’s decision. Their reactions ranged from enthusiasm about potential lives saved by reducing nicotine in cigarettes to disappointment about e-cigarettes being unregulated for the next few years.
Professor of public health emeritus and dean emeritus, University of Michigan School of Public Health
Mandating the reduction of nicotine in cigarettes (and by extension, in all combustible tobacco products) to non-addicting levels ― something the agency has within its authority to require ― would dramatically reduce the number of young people in future generations who would become addicted to smoking...
For the policy to work effectively, however, with minimal risks of a large black market, addicted smokers must be given the opportunity to use reduced-risk nicotine-delivery products that they can substitute for their cigarettes.
Professor of community health and health behavior, University at Buffalo School of Public Health and Health Professions
We need to have more experience in the marketplace with optional trace-nicotine cigarettes before ever making a decision to require that they be the only legal cigarette. When marketed years ago, they were a commercial failure, despite heavy promotion.
Professor of psychiatry and human behavior, Brown University
People with psychiatric disorders smoke almost half of the cigarettes consumed in the U.S., and most want to quit smoking but have difficulty quitting. I’m particularly hopeful that a nicotine reduction policy would help these smokers to quit, especially when combined with smoking cessation treatments and other tobacco control policies.
Assistant professor of experimental psychology, Idaho State University
It is difficult to predict outcomes from the announcement as it does not provide a timeline or information on what method of reduction will be pursued (e.g., sharp decline quickly or gradual cuts over a long period of time)...
I do think it’s commendable that the FDA is focusing on trying to reduce the likelihood that future generations become addicted to cigarettes (and potentially helping current smokers to reduce their consumption or quit), and pursuing the possibility of this relatively new regulatory avenue.
Whether or not it works will depend on how it’s implemented, how it’s received by the public, how the industry responds, etc., all of which are things we won’t know for some time.
Associate professor of psychology, University of Pittsburgh
It seems highly likely that reducing nicotine in cigarettes will reduce smoking, especially with the emergence of non-combusted products that provide an alternative for those that want or need to continue to use nicotine. If so, given that 480,000 Americans die each year from smoking, the impact on public health could be dramatic.
Associate professor of applied health science, Indiana University Bloomington School of Public Health
Reducing the level of nicotine in cigarettes to non-addictive levels, as proposed by Dr. Gottlieb, is one important part of a comprehensive plan that we need to implement sooner rather than later to address what is still the #1 preventable cause of death in the U.S. ― tobacco use. In addition to lowering the amount of nicotine in cigarettes, the FDA should ban menthol and other flavors from cigarettes and other combustible tobacco products, and we need to develop more effective tobacco cessation treatment options to help smokers who want to quit.
The sooner we can implement a comprehensive plan, the sooner Americans’ health will be changed for the better.
Assistant professor of sociomedical sciences, Columbia University Mailman School of Public Health
FDA’s decision to reduce the addictive potential of cigarettes ― products that are overwhelmingly responsible for the death and disease caused by tobacco use ― is a major public health win...
More controversial is FDA’s delay in the regulation of other tobacco products. On the one hand, the extension of compliance deadlines for electronic nicotine delivery devices could foster innovation in the development of lower-risk nicotine products, but many in the public health community are disappointed that dangerous combustible products that appeal to youth, such as hookah and flavored cigars, will remain relatively unchecked over the next few years.
Director of the Center for Global Tobacco Control, Harvard T.H. Chan School of Public Health (Rees has also been a temporary consultant on small projects for the FDA, but his views are independent of the agency)
FDA Commissioner Gottlieb’s announcement regarding a proposal to lower nicotine levels in conventional cigarettes is a welcome idea whose time has come. We need new and radical approaches to fight the tobacco epidemic, which kills almost half a million Americans every year. With new NIH-supported research, we now have a better scientific understanding on how we can prevent a new generation of young people becoming addicted to tobacco cigarettes.
At the same time, rational approaches to the regulation of e-cigarettes will help to ensure that a lower risk alternative to smoking is available to current smokers. These twin strategies offer great promise for an end to this devastating epidemic.
This article has been updated to include additional expert commentary and to reflect Vaughan Rees’ relationship with the FDA.