FDA Proposal Aims to Reduce Smoking Addiction and SCLC Cases

The FDA has announced a landmark proposal to cap nicotine levels in cigarettes and other combusted tobacco products, aiming to make these products minimally or nonaddictive, according to an FDA news release.¹

If finalized, this rule could transform public health by reducing the prevalence of smoking and its associated diseases, including small cell lung cancer (SCLC), one of the most aggressive forms of lung cancer.²

Nicotine is the primary addictive substance in tobacco products, driving repeated use and exposing individuals to a toxic mix of chemicals in cigarette smoke that can lead to numerous chronic diseases, including SCLC.¹ Smoking is by far the leading risk factor for lung cancer, contributing to about 80% of lung cancer deaths, with SCLC being particularly linked to heavy tobacco use.^2,3

The proposed rule aims to cut nicotine levels from 13 mg to 0.7 mg per cigarette. | Image credit: Nopphon – stock.adobe.com

The FDA's proposed limit of 0.7 mg of nicotine per gram of tobacco represents a significant reduction from the average nicotine content in cigarettes currently available, with brands averaging 13 mg of nicotine per cigarette.⁴ This change is designed to reduce the addictive potential of these products, which could lead to fewer individuals starting smoking and encourage more to quit.¹

“This action, if finalized, could save many lives and dramatically reduce the burden of severe illness and disability, while also saving huge amounts of money,” said Robert M. Califf, MD, FDA commissioner. “I hope we can all agree that significantly reducing the leading cause of preventable death and disease in the U.S. is an admirable goal we should all work toward.”

The FDA estimated that by the year 2060, this new standard could prevent 1.8 million tobacco-related deaths, with that number rising to 4.3 million by 2100. The agency’s population health model also suggested that within a year of the rule’s implementation, more than 12.9 million people who smoke could quit entirely or switch to noncombusted tobacco products, a number that could increase to 19.5 million within 5 years.

This new standard could also prevent approximately 48 million Americans from beginning to smoke by the end of the century, according to projections.

Cigarette smoking is responsible for nearly 500,000 deaths annually in the US and imposes an estimated economic burden exceeding $600 billion each year in health care expenses and lost productivity. Due to the lives saved and diseases averted, the estimated benefits of the proposed rule are more than $1.1 trillion per year over the first 40 years. Additional savings related to medical cost savings, productivity gains, and other impacts are anticipated as well.

SCLC is rarely seen in individuals who have never smoked, underscoring the critical role of tobacco in its development.³ The risk of lung cancer increases with the duration of smoking and the number of cigarettes consumed daily, and cigar and pipe smoking, as well as menthol cigarettes, are nearly as harmful as traditional cigarettes in contributing to lung cancer risk. Even exposure to secondhand smoke significantly increases the likelihood of developing lung cancer, making it the third most common cause of overall lung cancer in the US. By targeting the addictive properties of tobacco products, the FDA's proposal could have far-reaching implications for reducing the risk of SCLC and other smoking-related cancers.

The proposal also acknowledged significant challenges, including the potential for illicit trade and concerns over the compliance timeline for tobacco companies.¹ The FDA plans to review public comments and consult with its Tobacco Products Scientific Advisory Committee as part of the decision-making process. This rule would apply to cigarettes, cigarette tobacco, roll-your-own tobacco, most cigars, and pipe tobacco; it would not apply to e-cigarettes, nicotine pouches, noncombusted cigarettes, hookah, smokeless tobacco products, or premium cigars.

References

1. FDA proposes significant step toward reducing nicotine to minimally or nonaddictive level in cigarettes and certain other combusted tobacco products. News release. FDA. January 15, 2025. Accessed January 16, 2025. https://www.fda.gov/news-events/press-announcements/fda-proposes-significant-step-toward-reducing-nicotine-minimally-or-nonaddictive-level-cigarettes
2. Small cell lung cancer. Cleveland Clinic. Updated September 28, 2022. Accessed January 16, 2025. https://my.clevelandclinic.org/health/diseases/6202-small-cell-lung-cancer
3. Lung cancer risk factors. American Cancer Society. Updated January 29, 2024. Accessed January 16, 2025. https://www.cancer.org/cancer/types/lung-cancer/causes-risks-prevention/risk-factors.html
4. Prochaska JJ, Benowitz NL. Current advances in research in treatment and recovery: nicotine addiction. Sci Adv. 2019;5(10):eaay9763. doi:10.1126/sciadv.aay9763