FDA Targets Nicotine to Reduce Lung Cancer and Other Tobacco-Related Diseases

On Wednesday, the FDA announced a proposed a rule that would significantly reduce nicotine levels in cigarettes and other combusted tobacco products, making them minimally or non-addictive, a groundbreaking move that could drastically reduce smoking-related illnesses and deaths in the US.¹

Image credit: Nopphon | stock.adobe.com

Nicotine, the addictive substance in tobacco products, particularly in combusted forms like cigarettes, exposes users to harmful chemicals that cause disease and death. The proposed rule aims to reduce nicotine levels in these products as research indicates that lower nicotine content does not lead to increased smoking.¹

“Today’s proposal envisions a future where it would be less likely for young people to use cigarettes and more individuals who currently smoke could quit or switch to less harmful products,” Robert M. Califf, MD, commissioner of the FDA, said in a news release.¹

Rather than banning cigarettes or tobacco products, the FDA is proposing to cap the nicotine level at 0.7 mg per gram of tobacco in cigarettes and certain other combusted tobacco products.¹ This is a significant decrease as the current average concentration of nicotine per cigarette is around 10 mg to 12 mg. However, 1 mg to 2 mg is absorbed by the smoker when inhaled.²

The FDA reported that the proposed rule would apply to cigarettes, cigarette tobacco, roll-your-own tobacco, most cigars (including little cigars, cigarillos, and most large cigars), and pipe tobacco. However, the proposed rule will not apply to e-cigarettes, nicotine pouches, noncombusted cigarettes (such as heated tobacco products that meet the definition of a cigarette), waterpipe tobacco (hookah), smokeless tobacco products, or premium cigars.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. I hope we can all agree that significantly reducing the leading cause of preventable death and disease in the US is an admirable goal we should all work toward,” Califf said in a news release.¹

Cigarettes and other combusted tobacco products are the most harmful forms of tobacco, with cigarette smoking being the leading preventable cause of death and a major contributor to chronic diseases in the US, resulting in an estimated half a million deaths and over $600 billion in annual costs.¹

According to the CDC, cigarette smoking is also the leading risk factor for lung cancer and is linked to about 80% to 90% of lung cancer deaths. Additionally, individuals that smoke cigarettes are 15 to 30 times more likely to develop lung cancer or die from the disease compared to individuals who do not smoke. Occasional smoking is also reported to increase lung cancer risk; however, individuals that quit smoking have a lower risk than if they continued to smoke. Despite eliminating cigarette use, the risk is still higher among individuals that quit compared to individuals who never smoked. The use of other tobacco products such as cigars and pipes also increase an individual’s risk of developing lung cancer.³

The FDA noted that the proposed rule is projected to have immense public health benefits, preventing approximately 48 million US youths from starting to smoke by the year 2100. Additionally, it will aid 12.9 million current smokers to quit, with a predicted estimate of 19.5 million individuals within 5 years of the rule being finalized which could avert 1.8 million tobacco-related deaths. The decrease in fatal smoking outcomes could generate over $1.1 trillion annually over the next 4 decades.¹

“Today, we’re taking a critical step in the rulemaking process by providing the public with a proposal they can review and engage on,” Brian King, PhD, MPH, director of the FDA’s Center for Tobacco Products, said in the news release. “This proposal allows for the start of an important conversation about how we meaningfully tackle one of the deadliest consumer products in history and profoundly change the landscape of tobacco product use in the United States."¹

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 17, 2025. https://www.fda.gov/news-events/press-announcements/fda-proposes-significant-step-toward-reducing-nicotine-minimally-or-nonaddictive-level-cigarettes?utm_medium=email&utm_source=govdelivery

2. NIH. Tobacco, Nicotine, and E-Cigarettes Research Report How does tobacco deliver its effects? National Institute on Drug Abuse. January 2020. Accessed January 17, 2025. https://nida.nih.gov/publications/research-reports/tobacco-nicotine-e-cigarettes/how-does-tobacco-deliver-its-effects

3. CDC Lung Cancer Risk Factors. October 15, 2024. Accessed January 17, 2025. https://www.cdc.gov/lung-cancer/risk-factors/index.html#