FDA: Cutting Nicotine Levels Will Prevent Smoking-Related Death and Illness

A proposed rule from the US Food and Drug Administration seeks to lower the amount of nicotine in cigarettes and other combustible tobacco products to minimally or nonaddictive levels to reduce smoking-related illness and death, the agency said today.

The reduction in levels could help 12.9 million people stop smoking within the first year and 19.5 million within 5 years of the proposed ruling being finalized, the FDA said in a press release. Even for those who don’t quit, “switching completely to lower-risk tobacco products would reduce exposure to the many harmful chemicals present in cigarettes and other combusted tobacco products,” they add.

The FDA also estimates that the strategy would prevent 1.8 million tobacco-related deaths by 2060, and 4.3 million deaths by the end of the century.

“Due to these lives saved and diseases averted, the estimated benefits of the proposed rule are more than $1.1 trillion per year over the first four decades,” the FDA notes.  

Rather than calling for a ban on cigarettes or nicotine, the agency wants to see a cap on nicotine levels such that the maximum amount of tobacco would be 0.7 mg/g. The average nicotine content of cigarettes varies by brand and is estimated to be anywhere from 6-28 mg/g. Cigars, pipe tobacco, and loose tobacco for rolling cigarettes, all of which would be included in the FDA’s proposed cap, contain even higher levels. The proposed rule does not include e-cigarettes, tobacco used in water-heated hookahs, smokeless tobacco, or premium cigars.

According to the FDA, the goal is to impose a level of nicotine on these products where it no longer creates or sustains addiction. They add that a large body of research suggests that low-nicotine-content cigarettes do not cause smokers to compensate by smoking more.

In response, American Heart Association CEO Nancy Brown said in a press release that the action on the part of the agency is “a major step to protect public health from an industry whose addictive products kill nearly half a million people in this country every year.”

In addition to maximizing quitting, Brown says nicotine reduction also is crucial for reducing initiation of youth smoking. “The public must also be made aware that even reduced-nicotine cigarettes remain harmful and deadly products,” she notes.

The FDA will take public comments on the proposal from tomorrow until September 15, 2025, and plans to refer the matter to the Tobacco Products Scientific Advisory Committee for a public meeting.