FDA Proposes Nicotine Reduction Rule
Per the notice below, the United States Food and Drug Administration (FDA) is proposing a rule to reduce the amount of nicotine in cigarettes and other combustible tobacco products.
FDA Proposes Significant Step Toward Reducing Nicotine to Minimally or Nonaddictive Level in Cigarettes and Certain Other Combusted Tobacco Products
Agency Encourages Public Input on Proposal That Aims to Prevent Millions of Premature Deaths
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.”
Given the massive public health burden of smoking, the proposed rule is estimated to have an unprecedented benefit for society. 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. 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. 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 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. In addition to preventing initiation among young people and promoting cessation among all population groups, the FDA expects that the proposal would also help adults who smoke switch to lower-risk alternatives. For adults who smoke, switching completely to lower-risk tobacco products would reduce exposure to the many harmful chemicals present in cigarettes and other combusted tobacco products. However, no tobacco product is safe; therefore, youth should not use tobacco products and adults who do not currently use them should not start.
“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., M.P.H, 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.”
The agency is committed to providing multiple opportunities for public engagement on the proposal. Such interactions help the FDA develop policies and strategies to best guide the nation toward a healthier future. Starting on January 16, the public will have through September 15, 2025, to provide comments, which the agency will review as it considers future action. In addition to general comments, the FDA is specifically requesting input on several topics, including, the products covered by the proposed product standard; the proposed limit to the nicotine level; the proposed two-year effective date and likelihood that companies will be able to comply within that timeframe; and the potential for illicit trade resulting from the proposed product standard and any related impact to public health. As noted above, the FDA also intends to refer this proposed product standard to the Tobacco Products Scientific Advisory Committee for a public meeting and consider additional opportunities for public engagement on the proposal.
