FDA Proposes Nicotine Limits on Cigarettes, Certain Tobacco Products

On Wednesday, January 15 the FDA proposed a rule to cap nicotine levels in cigarettes and certain tobacco products at minimally or nonaddictive levels. This initiative, first announced in 2018, would make the United States the first country to take what the FDA calls a “significant step” toward reducing smoking-related disease and death. The rule would go into effect 2 years after finalization.

The proposed nicotine cap of 0.7 milligrams per gram of tobacco would apply to cigarettes, cigarette tobacco, roll-your-own tobacco, most cigars (including little cigars, cigarillos, and most large cigars), and pipe tobacco. However, it would exclude e-cigarettes, nicotine pouches, noncombusted cigarettes, waterpipe tobacco, smokeless tobacco, and premium cigars.

“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,” said Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products. The FDA emphasizes that this proposal, based on extensive scientific evidence, is a critical step in reducing smoking prevalence, preventing youth initiation, and saving millions of lives, while inviting public input to guide the process.

Nicotine, the primary addictive component of tobacco, perpetuates smoking behaviors, exposing users to toxic chemicals in smoke that cause disease and death. The FDA estimates that by 2100, the proposed rule could prevent 48 million young people from starting to smoke and lead 19.5 million adults to quit or switch to less harmful products within five years. By 2060, 1.8 million tobacco-related deaths could be averted, rising to 4.3 million by the end of the century. The societal benefits, including healthcare savings and productivity gains, are projected to exceed $1.1 trillion annually over the first 40 years.

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. The FDA also intends to refer this proposed product standard to the Tobacco Products Scientific Advisory Committee.

Reference
FDA Proposes Significant Step Toward Reducing Nicotine to Minimally or Nonaddictive Level in Cigarettes and Certain Other Combusted Tobacco Products. US Food and Drug Administration. January 15, 2025. Accessed January 16, 2025. https://www.fda.gov/news-events/press-announcements/fda-proposes-significant-step-toward-reducing-nicotine-minimally-or-nonaddictive-level-cigarettes