In a significant regulatory move, the Biden administration’s Food and Drug Administration announced Wednesday, January 15, a proposed rule that would drastically reduce nicotine levels in cigarettes and certain combustible tobacco products to minimally or non-addictive levels, positioning the United States to become the first country globally to implement such measures.
The proposal comes as cigarette smoking remains the leading cause of preventable death and disease in the United States, killing nearly half a million Americans annually and causing more than $600 billion in medical costs, lost productivity, and other related societal costs each year, according to FDA data.
The proposal would cap nicotine content at 0.7 milligrams per gram of tobacco, representing a 95% reduction from the current market average of 13 milligrams per cigarette. The regulation would apply to cigarettes, cigarette tobacco, roll-your-own tobacco, most cigars, and pipe tobacco, but would not affect e-cigarettes, nicotine pouches, or other non-combusted products.
FDA Commissioner Robert M. Califf, M.D. emphasized that the proposal envisions a future with reduced youth cigarette use and increased opportunities for current smokers to quit or switch to less harmful products. He stated that this action, if finalized, could save lives and dramatically reduce severe illness and disability while generating substantial cost savings.
According to FDA projections, the regulation could prompt over 12.9 million smokers to quit within the first year of implementation, with that number potentially rising to 19.5 million within five years. The agency estimates the benefits could exceed $1.1 trillion annually over the first four decades and prevent approximately 48 million youth and young adults from initiating smoking.
Law enforcement experts have raised concerns about potential black market consequences. 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 organizations would likely amplify their tobacco operations, creating an economic opportunity for cartels, Chinese organized crime, and Russian mafia groups. He explained that Americans seeking higher-nicotine cigarettes would need to pursue illicit channels, similar to purchasing loose cigarettes on New York streets.
The timing of this proposal follows the administration’s earlier attempt to ban menthol cigarettes, which faced delays after public pushback. Health and Human Services Secretary Xavier Becerra acknowledged that the menthol rule generated significant feedback from civil rights and criminal justice movements, necessitating additional discussions.
Massachusetts’ experience offers a preview of potential challenges. After implementing a ban on menthol cigarettes and flavored tobacco in 2020, the state has encountered multiple cases of illegal sales. Recently, law enforcement uncovered 700 packs of unstamped menthol cigarettes alongside illicit drugs in a single bust, highlighting concerns about criminal enterprises filling market gaps.
The proposed regulation builds on the Family Smoking Prevention and Tobacco Control Act, signed by President Barack Obama in 2009, which granted the FDA authority to regulate tobacco products. The Trump administration previously pursued nicotine reduction in 2017 when then-FDA Commissioner Scott Gottlieb announced plans to require tobacco companies to cut nicotine levels in cigarettes to help adult smokers quit.
Currently, companies would have two years to comply with the new standards after the final regulation is published. The tobacco industry is expected to mount legal challenges, potentially delaying implementation. The FDA maintains 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 note that reducing nicotine levels to minimally addictive or non-addictive levels would decrease the likelihood of future generations becoming addicted to cigarettes while helping current smokers quit. The FDA is seeking public input through its Tobacco Products Scientific Advisory Committee, with comments accepted until September 15, 2025.
The regulation specifies precise technical requirements for manufacturers. Tobacco companies would need to demonstrate through 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. Additionally, 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. Research cited by the FDA indicates that smokers consuming low-nicotine cigarettes typically smoke fewer cigarettes per day and show increased attempts to quit, though concerns about compensatory smoking behaviors persist among industry observers.
The proposed rule arrives during Biden’s final week in office, and its fate may ultimately rest with the incoming administration.