On January 15, the Biden administration released a landmark regulatory proposal through the Food and Drug Administration (FDA). The proposed rule aims to dramatically lower nicotine levels in cigarettes and certain other combustible tobacco products to minimally addictive or non-addictive levels. This would position the United States as the first country worldwide to implement such measures.
The proposal is a response to the ongoing health crisis caused by cigarette smoking. According to FDA data, smoking is the primary cause of preventable death and illness in the U.S., causing nearly 500,000 deaths each year and costing more than $600 billion in medical expenses, lost productivity, and other related societal costs.
The rule would limit nicotine content to 0.7 milligrams for every gram of tobacco. This represents a 95% reduction from the current average of 13 milligrams per cigarette. The regulation would apply to products such as cigarettes, cigarette tobacco, roll-your-own tobacco, most cigars, and pipe tobacco. It would not, however, affect e-cigarettes, nicotine pouches, or other non-combusted products.
FDA Commissioner Robert M. Califf, M.D. stated that the proposal anticipates a future with decreased youth cigarette use and increased opportunities for current smokers to quit or switch to less harmful alternatives. If finalized, he emphasized that this action could save lives, significantly reduce severe illness and disability, and generate substantial cost savings.
Based on the FDA’s projections, the regulation could motivate over 12.9 million smokers to quit in the first year of its implementation. This number could rise to 19.5 million within five years. The agency anticipates that the societal benefits could exceed $1.1 trillion annually over the first 40 years, potentially preventing about 48 million young people from starting smoking.
However, some law enforcement experts, including 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, have voiced concerns about potential black market implications. Marianos warned of the possibility of criminal organizations exploiting the situation, leading Americans to seek higher-nicotine cigarettes through illicit channels, similar to the purchase of loose cigarettes on New York City streets.
This proposal follows a previous attempt by the administration to ban menthol cigarettes, which experienced delays due to public opposition. Health and Human Services Secretary Xavier Becerra noted that the menthol rule provoked substantial feedback from civil rights and criminal justice movements, necessitating further discussions.
Massachusetts’ experience in banning menthol cigarettes and flavored tobacco in 2020 provides a glimpse into potential obstacles. The state has reported several instances of illegal sales since the ban. In one case, law enforcement discovered 700 packs of unstamped menthol cigarettes along with illegal drugs, underlining concerns about criminal enterprises exploiting market voids.
This proposed rule builds on the Family Smoking Prevention and Tobacco Control Act of 2009, signed by President Barack Obama, which gave the FDA the authority to regulate tobacco products. The Trump administration also pursued nicotine reduction in 2017, when then-FDA Commissioner Scott Gottlieb announced plans to mandate tobacco companies to slash nicotine levels in cigarettes to aid adult smokers in quitting.
Once the final regulation is published, companies will have a two-year window to comply with the new standards. The tobacco industry is expected to launch legal challenges, which could potentially delay the rule’s implementation. The FDA insists 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 believe that reducing nicotine levels to minimally addictive or non-addictive levels would decrease the chances of future generations getting addicted to cigarettes while aiding current smokers in quitting. The FDA is welcoming public input through its Tobacco Products Scientific Advisory Committee, accepting comments until September 15, 2025.
The regulation stipulates technical requirements for manufacturers, requiring them to demonstrate through laboratory 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. The agency’s public health impact analysis predicts that this reduction in nicotine content could prevent more than 4.3 million tobacco-related deaths by the end of the century. However, concerns about compensatory smoking behaviors persist among industry observers.
The proposed rule was introduced during the final week of Biden’s tenure, and its ultimate fate may depend on the incoming administration.
