The US FDA has proposed a significant rule to limit nicotine levels in cigarettes and certain combustible tobacco products to 0.7 mg/g, a drastic reduction from the current levels of 6-12 mg.

If implemented, this rule could prevent an estimated 1.8 million tobacco-related deaths by 2060 and save over $1.1 trillion in healthcare costs over the next four decades.

This initiative has been in development since 2017, forming part of a broader strategy aimed at tackling tobacco-related health issues.

The proposed rule was issued on January 15, 2025, during the final days of the Biden administration, leaving its future uncertain with the incoming Trump administration.

Despite a decline in cigarette smoking, tobacco use remains the leading cause of preventable disease and death in the US, with nearly 20% of adults reported using tobacco products in 2022.

The rule specifically targets cigarettes, roll-your-own tobacco, most cigars, and pipe tobacco, but notably excludes e-cigarettes and nicotine pouches, which are increasingly popular among youth.

Anti-tobacco groups have lauded the proposal as a potential game-changer for public health, urging the new administration to enforce it.

The proposal is currently open for public comment until September 15, 2025, and the FDA plans to give manufacturers a two-year period to comply with the final rule.

The FDA's goal with this rule is to reduce nicotine levels to prevent addiction and facilitate cessation among current smokers, with Commissioner Robert M. Califf highlighting its potential impact on youth smoking rates.

The FDA predicts that the rule could prevent 48 million young people from starting to smoke and encourage 13 million smokers to quit within a year of its implementation.

Recent data from the National Youth Tobacco Survey indicates a decrease in youth tobacco use, dropping from 12.6% in 2023 to 10.1% in 2024, with e-cigarettes being the most commonly used product.

Importantly, the FDA's proposal excludes noncombustible cigarettes, waterpipe tobacco, smokeless tobacco products, and premium cigars from the nicotine limit.