New England Journal of Medicine: New Policy Could End Smoking

Wednesday, Sept. 30, 2015

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Experts Call on FDA to Use Authority to Lower Nicotine in Cigarettes Below Addictive Levels; New Study Shows Policy Would Potentially Eliminate Smoking

A new study in the New England Journal of Medicine (NEJM) found that reducing nicotine levels in cigarettes led to less smoking and more quit attempts, and experts are calling for the Food and Drug Administration (FDA) to use its regulatory powers to reduce nicotine levels in conventional cigarettes to below addictive levels.

“The new NEJM study adds to a growing body of research supporting the feasibility and potential benefits of a policy to reduce the levels of nicotine in cigarettes,” said Dr. Michael Fiore, director of the University of Wisconsin Center for Tobacco Research and Intervention (UW-CTRI), who along with Dr. Tim Baker penned a NEJM perspective calling for the FDA to act. “This action could potentially end the epidemic of smoking-caused illness and death in the United States,” Fiore said. Neither Dr. Fiore nor Dr. Baker was an author on the research study.

Smoking kills half the people who engage in it long-term, robbing them on average of 10 to 15 years of life, according to the Centers for Disease Control and Prevention. “That would result in 20 million future deaths—about equivalent to the entire populations of Minnesota, Wisconsin and Michigan combined,” Fiore said. “But all of these deaths are preventable. Reducing the nicotine content of combustible tobacco below addictive levels is an important way to start.”

In June 2009, President Barack Obama signed legislation that permits the FDA to regulate levels of nicotine, tobacco’s primary addictive agent, below addictive levels, but not to zero. Section 917 of the Family Smoking Prevention and Tobacco Control Act states that the Tobacco Products Scientific Advisory Committee of the FDA shall provide advice, information, and recommendations to the Secretary of Health and Human Services on several issues, including nicotine levels in cigarettes.

But would requiring less nicotine in cigarettes really help current smokers reduce their smoking? Would it increase quit attempts? Or would those smokers just smoke more cigarettes to compensate for the reduced nicotine and get their fix anyway?

In the new NEJM study, Dr. Eric Donny and colleagues found that, as compared with smokers of standard-strength cigarettes (containing 15.8 mg of nicotine per gram of tobacco), smokers who were switched to very-low-nicotine cigarettes (0.4 mg per gram) for 6 weeks had reductions in nicotine exposure, numbers of cigarettes smoked, and nicotine dependence. Moreover, they attempted to quit smoking at a rate double that of participants smoking standard-strength cigarettes (34.7% vs. 17% at 30-day follow-up).

“We believe that a policy of nicotine reduction in cigarettes, coupled with greater access to less harmful nicotine delivery systems, will help more people stop smoking, and also prevent the development of a new generation of smokers,” Baker said. “This policy, combined with other policy changes—such as higher taxes on combustible tobacco, raising the legal age to buy cigarettes, and more inclusive smoking bans, holds potential to help millions of Americans avoid the leading preventable cause of death—smoking cigarettes.”

Fiore and Baker acknowledge that, while lowering nicotine levels in cigarettes shows promise, it’s not without risk. As the nicotine yield of combustible cigarettes declines, addicted smokers might switch to other nicotine-containing products, including smokeless-tobacco products or electronic nicotine delivery systems, such as e-cigarettes, e-cigars, and e-pipes. Even so, this type of a shift might confer a net health benefit, since such products are likely less harmful than combustible tobacco.

Fiore said the development of new products, such as an FDA-approved device that safely and effectively delivers nicotine to the lungs, might further accelerate a decline in smoking and improve public health.

To read the perspective piece or listen to a podcast with Fiore, click here.

For free help with quitting tobacco use, call 1-800-QUIT-NOW or visit

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UW-CTRI is a nationally recognized research center founded in 1992 and committed to determining the nature of tobacco dependence and developing evidence-based treatments to assist smokers. UW-CTRI is part of the University of Wisconsin School of Medicine and Public Health. For more information, visit