FDA Proposes Cap on Nicotine in Tobacco Products

The US Food and Drug Administration (FDA) has issued a proposed rule to limit the amount of nicotine in cigarettes and certain other combustible tobacco products in a bid to curb their addictive properties.

Under the proposed rule, the agency would require manufacturers to limit the amount of nicotine in cigarettes, cigarette tobacco, roll-your-own tobacco, most cigars (including little cigars, cigarillos, and most large cigars), and pipe tobacco to 0.7 mg/g of tobacco. Currently, a cigarette contains 6-12 mg of nicotine.

e-cigarettes and nicotine pouches — the most commonly used tobacco products among American youth — are not included in the proposed rule.

The changes have been in the works since 2017 when the FDA announced its intention to cap nicotine content in certain tobacco products as part of a larger tobacco-related strategy.

The new proposed rule was issued on January 15, in the final days of the Biden administration. It is unclear whether the rule will go into effect as the Trump administration could decide not to act on the proposal or manufacturers could mount legal challenges.

The tobacco industry long ago determined the optimum level of nicotine to hook people and sustain their addiction, the FDA noted in its proposal. The agency is seeking “to set a maximum nicotine level such that cigarettes and certain other combusted tobacco products could no longer create and sustain this addiction,” the agency said.

“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,” FDA Commissioner Robert M. Califf, MD, said in a statement.

Although cigarette smoking has declined in the United States in recent years, tobacco use remains the leading cause of preventable disease and death in the United States, the US Centers for Disease Control and Prevention (CDC) in Atlanta reported. In 2022, nearly 20% of adults used tobacco products, with cigarettes being the most commonly used type, followed by e-cigarettes, the CDC reported.

Tobacco use among youth has also seen steep declines. The National Youth Tobacco Survey reported in 2024 that the use of any tobacco product dropped from 12.6% in 2023 to 10.1% in 2024. e-cigarettes were the most commonly used, followed by tobacco pouches and cigarettes.

The FDA said that its models showed that by 2100, the lower limit on nicotine levels could prevent 48 million youth and young adults from starting smoking. Some 13 million people who smoke cigarettes would stop 1 year after the rule becomes effective, the agency predicted. By 2060, the cap would help prevent 1.8 million tobacco-related deaths, which could lead to savings of more than $1.1 trillion per year over the first four decades, said the FDA.

Anti-tobacco groups hailed the proposal.

“This is a truly game-changing proposal that would accelerate declines in smoking and save millions of lives from cancer, cardiovascular disease and other tobacco-related diseases if it is implemented,” said Yolonda C. Richardson, president and CEO of the Campaign for Tobacco-Free Kids, in a statement.

She urged the Trump administration to implement the rule. “Few actions would do more to fight chronic diseases such as cancer and cardiovascular disease that greatly undermine health,” she said, noting that the incoming administration has indicated that it would prioritize addressing chronic disease.

“We cannot reduce suffering and death from cancer without addressing tobacco use,” said Lisa Lacasse, president of the American Cancer Society Cancer Action Network (ACS CAN), in a statement, adding that tobacco use is responsible for up to a third of cancer deaths. ACS CAN “strongly supports” the rule and FDA making it final, she said.

Action on Smoking and Health also welcomed the proposal. “Reducing nicotine is one of the most impactful ways to help people quit to save their lives,” said Laurent Huber, the organization’s executive director, in a statement. “If addictive levels of nicotine were absent from cigarettes, most users would finally be able to quit,” said Huber.

In addition to the exclusion of e-cigarettes and nicotine pouches, the FDA proposal excludes noncombustible cigarettes, waterpipe tobacco (hookah), smokeless tobacco products, and premium cigars.

The proposal is open for comment through September 15, and the agency said it would ask its Tobacco Products Scientific Advisory Committee to discuss many issues, including the proposed nicotine limit and the potential for the development of a black market of full-nicotine cigarettes. The agency is also proposing to give manufacturers 2 years from the date of a final rule to comply.

Alicia Ault is a Saint Petersburg, Florida-based freelance journalist whose work has appeared in many health and science publications, including Smithsonian.com. You can find her on X @aliciaault and on Bluesky @aliciaault.bsky.social.