FDA Proposes Significant Step Toward Reducing Nicotine to Minimally or Nonaddictive Level in Cigaret

The U.S. Food and Drug Administration (FDA) announced a proposed product standard to  limit the level of nicotine in cigarettes and certain other combusted tobacco products to 0.7 milligrams per gram of tobacco. 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.

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.

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. 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.