Today, the U.S. Food and Drug Administration released a proposed rule that, if finalized, would make cigarettes and certain other burned tobacco products little or no addictive by limiting the level of nicotine in these products . If this decision is finalized, the United States would be the first country in the world to take such a bold and life-saving step to prevent and reduce tobacco-related illness and death. The FDA first announced its intention to propose such a rule in 2018, and today’s announcement is an important next step in the rulemaking process. The agency intends to solicit comments on the proposal, including through public comment and the FDA’s Tobacco Products Scientific Advisory Committee.

Nicotine is the main addictive chemical found in tobacco products that tempts people to consume these products. In the case of burned products, such as cigarettes, nicotine addiction leads users to be repeatedly exposed to a toxic mix of chemicals in the smoke, which causes illness and death. Based on the scientific evidence presented 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 low-nicotine cigarettes do not cause smokers to compensate for low nicotine by smoking more.

Existing evidence shows that cigarettes and other burnt tobacco products (smoked products, such as cigars and pipe tobacco) are the most harmful types of tobacco products. In fact, tobacco use is the leading cause of preventable disease and death in the United States and a leading contributor to chronic disease nationwide. Each year, smoking alone is estimated to kill nearly half a million people in the United States and cost the country more than $600 billion annually in health costs and lost productivity.

“Several administrations have recognized the tremendous opportunity a proposal of this type provides to address the burden of tobacco-related disease,” said FDA Commissioner Robert M. Califf, MD. “Today’s proposal envisages a future where it would be less likely for young people. to use cigarettes and more people who currently smoke may quit or switch to less harmful products. This action, if finalized, could save many lives and significantly reduce the burden of serious illness and disability, while saving enormous amounts of money. I hope we can all agree that significantly reducing the leading cause of preventable death and disease in the United States is an admirable goal that we should all work toward.

Given the enormous public health burden of smoking, the proposed rule is expected to have an unprecedented benefit to society. Based on the FDA’s population health model, by 2100 this nicotine product standard could prevent an estimated 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 a year after the rule takes effect, including those who would switch completely to smokeless tobacco products; this estimate increases to 19.5 million people within five years of the rule’s finalization. Additionally, the model estimates that by 2060, the product standard would prevent 1.8 million tobacco-related deaths, and 4.3 million deaths avoided by the end of the century. Through lives saved and illnesses prevented, the estimated benefits of the proposed rule are more than $1.1 trillion annually over the first four decades. The FDA anticipates additional savings related to medical cost savings, productivity gains, and other impacts.

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 burnt tobacco products, which is significantly lower than the average concentration of such products on the market today. The FDA’s proposal would apply to cigarettes, cigarette tobacco, hand-rolling tobacco, most cigars (including little cigars, cigarillos, and most large cigars), and pipe tobacco. The proposed rule does not include electronic cigarettes, nicotine pouches, unburned cigarettes (such as heated tobacco products that meet the definition of a cigarette), waterpipe tobacco (hookah), smokeless tobacco products or premium cigars.

In addition to preventing initiation among youth and promoting cessation among all population groups, the FDA hopes the proposal will also help adults who smoke transition to lower-risk alternatives. For adults who smoke, switching completely to lower-risk tobacco products would reduce exposure to the many harmful chemicals found in cigarettes and other burned tobacco products. However, no tobacco product is safe; therefore, youth should not use tobacco products and adults who are not currently using tobacco products should not start.

“Today, we take a critical step in the rulemaking process by providing the public with a proposal they can review and engage with,” said Brian King, Ph.D., MPH , director of the FDA’s Center for Tobacco Products. “This proposal begins an important conversation about how we will meaningfully address one of the deadliest consumer products in history and profoundly change the landscape of tobacco product consumption in the United States. United.”

The agency is committed to providing multiple opportunities for public participation on the proposal. Such interactions help the FDA develop policies and strategies to best guide the nation toward a healthier future. Starting January 16, the public will have until September 15, 2025 to provide comments, which the agency will consider as it considers future actions. In addition to general comments, FDA specifically requests comments on several topics, including which products are covered by the proposed product standard; the proposed limit for the nicotine level; the proposed two-year effective date and the likelihood that businesses will be able to comply within that time frame; and the potential for illicit trade resulting from the proposed product standard and any related impacts on public health. As noted above, FDA also intends to submit this proposed product standard to the Tobacco Products Scientific Advisory Committee for a public meeting and to consider other opportunities for public input on the proposal.

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