The U.S. Food and Drug Administration (FDA) has introduced a proposal to reduce nicotine levels in cigarettes and other smoked tobacco products. The aim is to make these products minimally or nonaddictive. If approved, the United States would take the lead globally in addressing smoking-related illnesses and deaths.
Nicotine, the chemical responsible for addiction, keeps tobacco users dependent. As a result, smokers are repeatedly exposed to toxic chemicals in the smoke, which causes serious health problems. To break this cycle, the FDA’s plan would lower nicotine to levels that cannot sustain addiction. Moreover, research shows that smokers are unlikely to increase smoking to make up for reduced nicotine.
Cigarette smoking remains the leading cause of preventable deaths in the United States. Each year, it claims nearly 500,000 lives, costing the nation more than $600 billion in healthcare expenses and lost productivity. The new rule would apply to cigarettes, roll-your-own tobacco, cigars, and pipe tobacco. However, it would not include e-cigarettes, nicotine pouches, or premium cigars.
How This Rule Could Impact Public Health
If implemented, the proposed rule could bring life-changing results. For example, the FDA estimates that by 2100, it could prevent 48 million people, including young individuals, from starting smoking. Additionally, more than 12.9 million smokers could quit within one year of the rule’s enactment, and this number could grow to 19.5 million within five years.
The benefits would increase over time. By 2060, the rule could prevent 1.8 million tobacco-related deaths. By the end of the century, the number of lives saved could rise to 4.3 million. Furthermore, the economic benefits could exceed $1.1 trillion annually due to lower healthcare costs and increased productivity.
FDA Leaders Stress the Proposal’s Importance
FDA Commissioner Dr. Robert M. Califf called the proposal a groundbreaking step in public health. “By making cigarettes less addictive, we can save lives, reduce illnesses, and significantly cut financial burdens,” he said.
Dr. Brian King, director of the FDA’s Center for Tobacco Products, emphasized the importance of collaboration. “This proposal marks an essential step in tackling one of the deadliest consumer products in history. It allows us to reshape tobacco use in the U.S. for the better,” he said.
FDA is inviting public input on the proposal
To move forward, the FDA is inviting public input on the proposal. Individuals and organizations can share their thoughts from January 16 to September 15, 2025. Specifically, the FDA is seeking feedback on nicotine limits, the proposed two-year timeline for compliance, and potential challenges, such as illegal trade.
Additionally, the FDA plans to consult its Tobacco Products Scientific Advisory Committee and hold a public meeting. This feedback will help refine the rule before finalization. To participate or learn more, visit the FDA’s website.