The Biden administration’s FDA took a major step on Wednesday toward banning current cigarettes in favor of those with lower nicotine levels. The proposed rule aims to make cigarettes and certain other tobacco products minimally or nonaddictive by limiting nicotine content. If finalized, the U.S. would become the first country to implement such a measure to combat smoking-related diseases and deaths, the FDA stated.
The agency first announced this plan in 2018, and Wednesday’s announcement marks a key step in the rulemaking process. The FDA will seek input through public comments and its Tobacco Products Scientific Advisory Committee. Earlier this month, the “Tobacco Product Standard for Nicotine Level of Certain Tobacco Products” cleared a regulatory hurdle, though the rule is not yet finalized.
FDA Commissioner Robert M. Califf, M.D., highlighted the potential of a new proposal to reduce tobacco-related disease, envisioning a future where fewer young people start smoking and more current smokers quit or switch to less harmful products. If finalized, this action could save lives, reduce severe illness and disability, and cut healthcare costs. Califf emphasized the importance of addressing the leading cause of preventable death in the U.S.
The FDA clarified that the proposal does not ban cigarettes or tobacco products but limits nicotine levels to 0.7 milligrams per gram of tobacco in cigarettes and certain other combusted products—significantly lower than current levels. However, experts warn that such regulations could boost black market activity. Former ATF assistant director Rich Marianos called the proposal a “gift” to organized crime, predicting that cartels and criminal groups would expand illicit tobacco operations, making cigarettes with higher nicotine levels accessible through illegal channels. This could increase public exposure to unregulated products and criminal risks.
The Biden administration’s push for this regulation follows its earlier attempt to ban menthol cigarettes, a key part of the Cancer Moonshot initiative. That effort faced backlash, with critics arguing it unfairly targeted minority communities and could spur illicit menthol sales. The administration eventually delayed the menthol ban amid public opposition.
“This rule has garnered historic attention and the public comment period has yielded an immense amount of feedback, including from various elements of the civil rights and criminal justice movement,” Health and Human Services Secretary Xavier Becerra said at the time. “It’s clear that there are still more conversations to have, and that will take significantly more time.”
The state of Massachusetts banned menthol cigarettes and flavored tobacco in 2020, with local police since uncovering illegal menthol cigarette sales in the state, including just this month when a man was busted with 700 packs of unstamped menthol cigarettes, as well as 38 bags of crack cocaine, the Boston Herald reported.
“Mass. banned menthols and dangerous criminals stepped right in to create an illegal supply chain and make millions in the underground market,” Marianos’ Tobacco Law Enforcement Network posted to X this week about the bust.
Former President Barack Obama signed the Family Smoking Prevention and Tobacco Control Act in 2009, which granted the FDA the power to regulate tobacco products. In the years since, the agency has worked to lower nicotine levels, including in July 2017 under the Trump administration, when then-FDA Commissioner Scott Gottlieb announced it would seek to require tobacco companies to drastically cut nicotine in cigarettes in an effort to help adult smokers quit.
The FDA announced in 2022 plans for the proposed rule that would lower levels of nicotine so they are less addictive or non-addictive.
“Lowering nicotine levels to minimally addictive or non-addictive levels would decrease the likelihood that future generations of young people become addicted to cigarettes and help more currently addicted smokers to quit,” FDA Commissioner Robert Califf said at the time.
