If approved, the United States would be the world's first government to adopt such a bold, life-saving step to prevent and decrease smoking-related disease and death. The FDA first announced its intent to propose such a ruleExternal Link Disclaimer in 2018, and this notification is a significant next step in the rulemaking process External Link Disclaimer. The government plans to solicit feedback on the idea, 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 largest cause of preventable disease and death in the United States, as well as a substantial contributor to chronic disease at the national level. Cigarette smoking is expected to kill about half a million individuals in the United States each year, costing the country more than $600 billion in healthcare expenses and productivity losses. 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.
Given the significant public health burden associated with 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. 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. 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.
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.