In a major shift in public health policy, the Biden administration’s Food and Drug Administration (FDA) has proposed a rule that aims to drastically cut nicotine levels in cigarettes and some combustible tobacco products to minimal or non-addictive levels. If implemented, the United States would be the first nation worldwide to enforce such regulations.
This proposal comes in response to the alarming statistics of cigarette smoking, which remains the primary cause of preventable death and disease in the U.S., resulting in nearly half a million American deaths each year and causing over $600 billion in healthcare costs, lost productivity and other costs, according to FDA data.
The proposed rule would limit nicotine content to 0.7 milligrams per gram of tobacco, a stark 95% drop from the current market average of 13 milligrams per cigarette. This regulation would apply to cigarettes, cigarette tobacco, roll-your-own tobacco, most cigars, and pipe tobacco, but would not impact e-cigarettes, nicotine pouches, or other non-combusted products.
FDA Commissioner Robert M. Califf, M.D. highlighted that the proposal aims to reduce youth cigarette use and enhance opportunities for current smokers to quit or switch to less harmful products. He affirmed that if enacted, this measure could save lives and significantly decrease severe illness and disability while generating substantial cost savings.
Projections by the FDA suggest that the regulation could lead over 12.9 million smokers to quit within the first year of its enforcement, with this figure potentially climbing to 19.5 million within five years. The agency estimates the benefits could surpass $1.1 trillion annually over the first 40 years and deter approximately 48 million youths and young adults from starting smoking.
However, law enforcement experts voiced concerns about potential black market implications. 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, cautioned that criminal organizations might expand their tobacco operations. He argued that Americans seeking higher-nicotine cigarettes could turn to illegal channels, akin to buying loose cigarettes on New York streets.
This proposal follows the administration’s earlier attempt to ban menthol cigarettes, which was delayed due to public opposition. Health and Human Services Secretary Xavier Becerra admitted that the menthol rule sparked substantial feedback from civil rights and criminal justice movements, necessitating further conversations.
Massachusetts’ experience with a ban on menthol cigarettes and flavored tobacco implemented in 2020 offers insight into potential difficulties. The state has seen multiple instances of illegal sales since the ban, with law enforcement recently finding 700 packs of unstamped menthol cigarettes alongside illicit drugs in a single bust, underlining concerns about criminal entities filling market voids.
The proposed regulation builds on the Family Smoking Prevention and Tobacco Control Act, enacted by President Barack Obama in 2009, which gave the FDA the authority to regulate tobacco products. The Trump administration also sought to reduce nicotine in 2017 when then-FDA Commissioner Scott Gottlieb announced plans to mandate tobacco companies to cut nicotine levels in cigarettes to assist adult smokers in quitting.
Upon finalization of the regulation, companies would have two years to comply with the new standards. The tobacco industry is likely to mount legal challenges, which could delay implementation. The FDA asserts that the proposed rule does not constitute an outright ban on cigarettes or tobacco products, but rather establishes new standards for nicotine content.
Public health officials believe that reducing nicotine levels to minimal or non-addictive levels will lessen the chances of future generations becoming addicted to cigarettes while assisting current smokers to quit. The FDA is soliciting public input through its Tobacco Products Scientific Advisory Committee, with comments accepted until September 15, 2025.
The regulation outlines specific technical requirements for manufacturers. Tobacco firms would be required to prove via laboratory testing that their products meet the new 0.7 milligrams per gram standard. The FDA estimates this reformulation process could cost the industry between $1.2 billion and $2.3 billion. The agency’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 generally smoke fewer cigarettes per day and show increased attempts to quit, though concerns remain about compensatory smoking behaviors among industry observers.
The proposed rule has landed during Biden’s final week in office, and its ultimate fate may rest with the administration.