The Biden administration’s Food and Drug Administration (FDA) announced a proposal on Wednesday, January 15, that could significantly reduce the nicotine content in cigarettes and certain other tobacco products. This move would put the United States in the forefront globally to set such measures in place.
This proposal has arrived as cigarette smoking continues to be the number one cause of preventable illness and death in the United States. Almost half a million Americans die each year from it, and it incurs over $600 billion in annual medical costs, lost productivity, and other social costs, as per FDA data.
The proposed rule would limit nicotine content to 0.7 milligrams per gram of tobacco, a 95% decrease from the current average of 13 milligrams per cigarette found on the market. The rule would apply to cigarettes, cigarette tobacco, roll-your-own tobacco, most cigars, and pipe tobacco. However, e-cigarettes, nicotine pouches, and other non-combusted products would remain unaffected.
FDA Commissioner Robert M. Califf, M.D. stressed that the proposal aims for a future with less youth cigarette usage and more opportunities for current smokers to quit or switch to less harmful alternatives. He mentioned that this step, if finalized, could save lives, reduce severe illness and disability, and result in substantial cost savings.
The FDA estimates that this regulation could motivate over 12.9 million smokers to quit within the first year of its implementation. This figure could potentially escalate to 19.5 million within five years. The benefits could exceed $1.1 trillion annually over the first 40 years and deter roughly 48 million young people from starting to smoke.
However, law enforcement experts have voiced concerns about the potential development of a black market. Rich Marianos, former assistant director of the U.S. Bureau of Alcohol, Tobacco, Firearms and Explosives and current chair of the Tobacco Law Enforcement Network, warned that criminal groups may seize this as an opportunity to expand their tobacco operations, similar to the illegal sale of loose cigarettes on New York streets.
The timing of this proposal follows the administration’s previous attempt to ban menthol cigarettes, which was postponed due to public backlash. Health and Human Services Secretary Xavier Becerra recognized that the menthol rule sparked considerable reactions from civil rights and criminal justice communities, necessitating further dialogue.
The experience of Massachusetts provides a glimpse of potential obstacles. The state has faced multiple incidents of illegal sales since the implementation of a ban on menthol cigarettes and flavored tobacco in 2020. A recent raid revealed 700 packs of unstamped menthol cigarettes alongside illicit drugs, fueling worries about criminal groups exploiting market gaps.
This proposed regulation builds upon the Family Smoking Prevention and Tobacco Control Act, signed by President Barack Obama in 2009, which empowered the FDA to regulate tobacco products. The Trump administration also attempted to reduce nicotine levels in 2017, with then-FDA Commissioner Scott Gottlieb announcing plans to mandate tobacco companies to cut nicotine levels in cigarettes to aid adult smokers in quitting.
Under the current proposal, companies would have two years to comply with the new standards once the final regulation is published. Expected legal challenges from the tobacco industry could delay this process. The FDA affirms that the proposed rule does not equate to a total ban on cigarettes or tobacco products but merely sets new standards for nicotine content.
Public health officials note that reducing nicotine levels to minimally addictive or non-addictive levels could deter future generations from becoming addicted to cigarettes and assist current smokers in quitting. The FDA is soliciting public feedback through its Tobacco Products Scientific Advisory Committee, with comments accepted until September 15, 2025.
This regulation demands specific technical requirements from manufacturers. Tobacco companies would have to show through lab testing that their products meet the new 0.7 milligrams per gram standard. The FDA estimates that this reformulation process could cost the industry between $1.2 billion and $2.3 billion. Moreover, the FDA’s public health impact analysis projects that reducing nicotine content could prevent more than 4.3 million tobacco-related deaths by the end of the century. FDA-cited research indicates that smokers who consume low-nicotine cigarettes typically smoke fewer cigarettes per day and display increased attempts to quit, although concerns about compensatory smoking behaviors persist among industry observers.
This proposed rule was announced during Biden’s final week in office, and its ultimate destiny may be determined by the new Trump administration.
