FDA Proposal Aims to Reduce Smoking Addiction and SCLC Cases

This article has been updated.

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.

Update

On January 24, as part of a flurry of executive orders issued during the first week of his second administration, President Donald Trump moved to withdraw a proposed ban on the sale of menthol cigarettes, following the government's failure to issue a final rule on the ban by both December 2023 and March 2024.5 The FDA had sent its final version of the ban to the White House's Office of Management and Budget in October 2023, but the action was stymied by meetings with the ban's many opposers, including business owners and civil rights advocates, with implications for economic losses totaling in the billions and a US market flooded with unregulated products.

In a statement to Reuters, which reported the news, Yolonda Richardson, CEO of Campaign for Tobacco-Free Kids, stated, "It is deeply disappointing that a final rule was not issued in a timely manner ... it is more critical than ever that states and cities step up their efforts to end the sale of menthol cigarettes and other flavored tobacco products."

The FDA first proposed the ban in April 2022, after decades of advocacy claiming menthol cigarettes had a disproportionate negative impact on Black communities and younger individuals, as well as bans already in place in many states.6

Maggie L. Shaw contributed to this article.

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
5. Roy S, Tabassum J. Trump administration withdrawals FDA plan to ban menthol cigarettes. Reuters. January 24, 2025. Accessed January 28, 2025. https://www.reuters.com/business/healthcare-pharmaceuticals/trump-administration-withdraws-fda-plan-ban-menthol-cigarettes-2025-01-24/
6. Banerjee A. U.S. FDA pushed ahead to move to ban menthol cigarettes. Reuters. April 28, 2022. Accessed January 28, 2025. https://www.reuters.com/world/us/us-fda-publish-proposal-ban-menthol-cigarettes-wsj-2022-04-28/