FDA Proposes Reduction in Nicotine Levels for Cigarettes

The U.S. Food and Drug Administration (FDA) has issued a groundbreaking proposed rule that, if finalized, would significantly reduce the level of nicotine in cigarettes and certain other combusted tobacco products. The goal is to make these products minimally or nonaddictive, potentially saving countless lives and reducing the immense burden of smoking-related disease and death in the United States.

If implemented, the United States would become the first country in the world to take such a bold action to prevent and reduce smoking-related harm. The FDA first announced its intention to propose this rule in 2018, and today’s announcement marks an important milestone in the rulemaking process. The agency plans to seek input on the proposal through public comment and the FDA’s Tobacco Products Scientific Advisory Committee.

Nicotine, the primary addictive chemical in tobacco products, keeps users hooked on these products. In the case of combusted products like cigarettes, nicotine addiction exposes users repeatedly to a toxic mix of chemicals in the smoke that cause disease and death. The proposed nicotine level for cigarettes and certain other combustible tobacco products would be low enough to no longer create or sustain addiction, based on the scientific evidence outlined in the proposed rule. Importantly, research shows that reduced nicotine content cigarettes do not lead smokers to compensate by smoking more.

Cigarettes and other combusted tobacco products are the most harmful types of tobacco products, with cigarette smoking being the leading cause of preventable disease and death in the United States. Each year, cigarette smoking alone kills nearly half a million people in the country and costs more than $600 billion annually in healthcare expenses and lost productivity.

Potential Benefits of the Proposed Rule

The proposed rule is estimated to have an unprecedented benefit for society. By the year 2100, the FDA’s population health model projects that this nicotine product standard could:

Prevent approximately 48 million U.S. youth and young adults from starting smoking
Encourage 12.9 million people who smoke cigarettes to quit within one year of the rule becoming effective, increasing to 19.5 million within five years
Result in 1.8 million tobacco-related deaths averted by 2060, rising to 4.3 million by the end of the century
Generate estimated benefits of more than $1.1 trillion per year over the first four decades, due to lives saved, diseases averted, and additional savings related to medical costs, productivity gains, and other impacts

The proposed rule would not ban cigarettes or any other tobacco products. Instead, it would cap the nicotine level at 0.7 milligrams per gram of tobacco in cigarettes and certain other combusted tobacco products, which is significantly lower than the current average concentration. The proposal would apply to cigarettes, cigarette tobacco, roll-your-own tobacco, most cigars (including little cigars, cigarillos, and most large cigars), and pipe tobacco. E-cigarettes, nicotine pouches, noncombusted cigarettes (such as heated tobacco products), waterpipe tobacco (hookah), smokeless tobacco products, and premium cigars are not included in the proposed rule.

In addition to preventing initiation among young people and promoting cessation among all population groups, the FDA expects the proposal to help adult smokers switch to lower-risk alternatives. While no tobacco product is safe, switching completely to lower-risk products would reduce exposure to the many harmful chemicals present in cigarettes and other combusted tobacco products. However, youth should not use any tobacco products, and adults who do not currently use them should not start.

The FDA is committed to providing multiple opportunities for public engagement on the proposal, recognizing that such interactions help develop policies and strategies to guide the nation toward a healthier future. The public will have from January 16 to September 15, 2025, to provide comments, which the agency will review as it considers future action. The FDA is specifically requesting input on several topics, including the products covered, the proposed nicotine limit, the proposed two-year effective date, and the potential for illicit trade resulting from the proposed product standard.

As the United States takes this significant step toward reducing the devastating impact of cigarette smoking, the FDA’s proposed rule has the potential to transform the landscape of tobacco product use and save countless lives. While the proposal does not apply to vapes and other non-combustible products, it represents a crucial milestone in the ongoing effort to protect public health and create a healthier future for generations to come.

Author
Recent Posts

Matthew Ma

Marketing at Ecigator

With over a decade of experience in the e-cigarette industry, Matthew Ma is a seasoned expert in both the manufacturing and usage aspects of vaping products. His extensive background has provided him with a deep understanding of the intricacies and evolving dynamics of e-cigarettes.