The U.S. Food and Drug Administration (FDA) today issued a proposed rule that, if finalized, would make cigarettes and certain other combusted tobacco products minimally or nonaddictive by limiting the level of nicotine in those products. If finalized, the United States would be the first country globally to take such a stand. The FDA first announced its intent to propose such a rule in 2018, and now intends to seek input on the proposal, including through public comment and the FDA’s Tobacco Products Scientific Advisory Committee.
Nicotine is the primary addictive chemical in tobacco products that keeps people using the products. In the case of combusted products, such as cigarettes, nicotine addiction leads to users being repeatedly exposed to a toxic mix of chemicals in the smoke that cause disease and death. Based on the scientific evidence outlined in the proposed rule, the proposed nicotine level for cigarettes and certain other combustible tobacco products would be low enough to no longer create or sustain addiction. Importantly, a large body of research also shows that reduced nicotine content cigarettes do not lead smokers to compensate for lower nicotine by smoking more.
“Multiple administrations have acknowledged the immense opportunity that a proposal of this kind offers to address the burden of tobacco-related disease,” said FDA Commissioner Robert M. Califf, M.D. “Today’s proposal envisions a future where it would be less likely for young people to use cigarettes and more individuals who currently smoke could quit or switch to less harmful products. This action, if finalized, could save many lives and dramatically reduce the burden of severe illness and disability, while also saving huge amounts of money. I hope we can all agree that significantly reducing the leading cause of preventable death and disease in the U.S. is an admirable goal we should all work toward.”
Based on the FDA’s population health model, by the year 2100, this nicotine product standard could prevent approximately 48 million U.S. youth and young adults from starting smoking. The model also projects that more than 12.9 million people who smoke cigarettes would stop doing so one year after the rule becomes effective, including those who would completely switch to noncombusted tobacco products; this estimate increases to 19.5 million people within five years of the rule being finalized. Additionally, the model estimates that by the year 2060, the product standard would result in 1.8 million tobacco-related deaths averted, rising to 4.3 million deaths averted by the end of the century.
The proposed rule would not ban cigarettes or any other tobacco products. The FDA is proposing to cap the nicotine level at 0.7 milligrams per gram of tobacco in cigarettes and certain other combusted tobacco products, which is significantly lower than the average concentration in these products on the market today. The FDA’s proposal would apply to cigarettes, cigarette tobacco, roll-your-own tobacco, most cigars (including little cigars, cigarillos, and most large cigars), and pipe tobacco. The proposed rule does not include e-cigarettes, nicotine pouches, noncombusted cigarettes (such as heated tobacco products that meet the definition of a cigarette), waterpipe tobacco (hookah), smokeless tobacco products, or premium cigars.
“Today, we’re taking a critical step in the rulemaking process by providing the public with a proposal they can review and engage on,” said Brian King, Ph.D., director of the FDA’s Center for Tobacco Products. “This proposal allows for the start of an important conversation about how we meaningfully tackle one of the deadliest consumer products in history and profoundly change the landscape of tobacco product use in the United States.”
