FDA Proposes Significant Step Toward Reducing Nicotine to Minimally or Nonaddictive Level in Cigarettes and Certain Other Combusted Tobacco Products

Today, the U.S. Food and Drug Administration 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 bold, life-saving action to prevent and reduce smoking-related disease and death. The FDA first announced its intent to propose such a rule in 2018, and today’s announcement is an important next step in the rulemaking process. The agency 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 reduced nicotine content cigarettes do not lead smokers to compensate for lower nicotine by smoking more.

Existing evidence shows that cigarettes and other combusted tobacco products—products that are smoked, such as cigars and pipe tobacco—are the most harmful types of tobacco products. In fact, cigarette smoking is the leading cause of preventable disease and death in the United States and is a major driver of chronic disease nationally. Each year, cigarette smoking alone is estimated to kill nearly half a million people in the United States and has been estimated to cost the country more than $600 billion annually in healthcare costs and lost productivity.

“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.”