United States: FDA proposes regulations to reduce nicotine content in tobacco

The United States Food and Drug Administration (FDA) proposed this Wednesday, January 15, 2025, a regulation aimed at establishing a maximum nicotine level in cigarettes and other combustible tobacco products. This initiative, which is likely to reduce the addictive nature of these products, marks an important step in reducing the prevalence of tobacco use in the country.

Tobacco use remains the leading cause of preventable disease and premature death in the United States, with nearly 480,000 lives lost each year to tobacco-related illnesses. It is estimated that tobacco use costs the country more than $600 billion annually in health care costs and lost productivity.

The scope of the regulation includes cigarettes, rolling tobacco, pipe tobacco and cigars, excluding premium cigars, shisha tobacco, chewing tobacco and other nicotine-containing products such as e-cigarettes and nicotine pouches.[1].

Making it easier for smokers to quit and limiting the initiation of young people

Under the proposed rule, nicotine content in cigarettes would be capped at 0.70 milligrams per gram of tobacco, a dramatic reduction from the current average of 17.2 milligrams per gram found in most cigarette brands. By lowering nicotine content to what the FDA calls minimally addictive or nonaddictive levels, the agency seeks to address several key issues: making it easier for smokers to quit, preventing addiction among new users, particularly youth, and reducing the economic and health burden associated with smoking.

Decades of research has shown that reducing the nicotine content of cigarettes can reduce smoking behavior, dependence, and the likelihood of relapse among people trying to quit. Research also shows that very low-nicotine cigarettes do not trigger compensatory behaviors, such as deeper inhalation or increased cigarette consumption. This phenomenon occurred with so-called “light” cigarettes that were marketed by tobacco companies but were much higher in dosage than currently required. The agency’s review of research findings helps dispel concerns about possible compensation that are often raised by skeptics of the measure.

Nearly 90% of adults who smoke regularly started before age 18. By reducing nicotine levels, the agency hopes to prevent young people from moving from experimentation to addiction. Adolescent brains are particularly vulnerable to nicotine, and early exposure can lead to long-term cognitive and emotional consequences, as well as an increased likelihood of continuing tobacco use into adulthood.

A protective measure that could save millions of lives

FDA projections underscore the significant potential for public health benefits of this measure. By 2060, the agency estimates that this regulation could prevent 1.8 million tobacco-related deaths. This would represent a gain of nearly 20 million life years. By the end of the century, these figures could increase to 4.3 million deaths averted and more than 76 million life years saved. In addition, the FDA projects that more than 19.5 million smokers could quit smoking within five years of the regulation taking effect. Through lives saved and illnesses prevented, the benefits of this measure are estimated at more than $1.1 trillion per year over the first four decades. The FDA projects additional savings from reduced medical costs, productivity gains, and other beneficial effects.

This rule is also part of a broader strategy by the Department of Health and Human Services (HHS) to reduce tobacco-related disparities. This initiative includes improving public education and expanding cessation support. FDA is seeking comments from healthcare professionals, researchers, and the public on this proposed rule so that we can refine it and address potential challenges before final implementation.

This regulation remains at the draft stage to date and its future depends on the directions of the Trump administration.

AE

[1] Press release, FDA Proposes Significant Step Toward Reducing Nicotine to Minimally or Nonaddictive Level in Cigarettes and Certain Other Combusted Tobacco Products, FDA published January 15, 2025, accessed January 16, 2025