Washington, D.C. – January 15, 2025 – The U.S. Food and Drug Administration (FDA) has announced a groundbreaking proposal aimed at reducing the nicotine content in cigarettes and certain other combusted tobacco products to minimally or non-addictive levels. If finalized, the rule would make the United States the first country in the world to implement such a life-saving measure to combat smoking-related diseases and premature deaths.
The proposed regulation, unveiled today, seeks to address the immense public health crisis caused by nicotine addiction. The FDA’s goal is to limit nicotine in combusted tobacco products such as cigarettes, cigars, and pipe tobacco, making them less addictive while still allowing these products to be sold in the market. The agency is inviting public input on the proposal, including feedback from its Tobacco Products Scientific Advisory Committee.
Nicotine, the primary addictive substance in tobacco products, plays a central role in keeping users hooked on smoking. This addiction leads to repeated exposure to harmful chemicals in cigarette smoke that cause severe health problems, including heart disease, lung cancer, and respiratory illnesses. According to the FDA’s scientific research, reducing the nicotine content in cigarettes and other combusted tobacco products could significantly reduce addiction, without causing smokers to compensate by smoking more.
Cigarette smoking is the leading cause of preventable death in the United States, claiming nearly 500,000 lives annually. It also contributes to over $600 billion in healthcare costs and lost productivity each year. The proposed rule represents a monumental step toward reducing the nation’s smoking-related disease burden.
“Reducing nicotine levels in cigarettes is one of the most effective ways to prevent tobacco-related disease and death,” said FDA Commissioner Robert M. Califf, M.D. “This proposal envisions a future where fewer young people start smoking and more current smokers quit or switch to less harmful alternatives. This is a major opportunity to save lives and reduce healthcare costs, and I believe it’s a goal we should all work toward.”
The FDA’s population health model estimates that by 2100, the proposed nicotine reduction rule could prevent 48 million youth and young adults from starting to smoke. The proposal is also expected to help over 12.9 million adult smokers quit within a year of the rule’s implementation, with that number rising to 19.5 million within five years. The reduction in tobacco-related deaths could be as high as 4.3 million by the end of the century, with a potential annual societal benefit of more than $1.1 trillion in healthcare savings, improved productivity, and other economic impacts.
Under the proposed rule, the nicotine content of cigarettes and other combusted tobacco products would be capped at 0.7 milligrams per gram of tobacco—well below the current average levels in these products. This would apply to cigarettes, cigarette tobacco, roll-your-own tobacco, most cigars, and pipe tobacco, but does not include e-cigarettes, smokeless tobacco, or premium cigars.
While the proposal would not ban cigarettes or other tobacco products, it is intended to make them less addictive, with the hope that it will encourage smokers to switch to lower-risk alternatives. The FDA also aims to prevent youth initiation of smoking and promote cessation across all age groups.
Brian King, Ph.D., M.P.H., Director of the FDA’s Center for Tobacco Products, said, “This proposal marks a critical step in reshaping the landscape of tobacco use in the United States. We invite public input to guide us in tackling one of the deadliest consumer products in history.”
The public will have the opportunity to comment on the proposal from January 16 through September 15, 2025. The FDA is seeking feedback on a variety of issues, including the proposed nicotine limit, compliance timelines for manufacturers, and the potential for illicit trade. The FDA also plans to refer the proposed rule to the Tobacco Products Scientific Advisory Committee for further review.
As the FDA continues to refine this transformative regulation, it remains committed to engaging the public and gathering input to ensure that the final policy will have the greatest possible impact on public health.
