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FDA proposes limiting nicotine levels in cigarettes, other tobacco products

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FDA proposes limiting nicotine in cigarettes, other tobacco products
STOCK PHOTO/Adobe Stock
ByMary Kekatos
January 15, 2025, 2:50 PM

The Food and Drug Administration on Wednesday proposed a new rule limiting nicotine levels in cigarettes and other traditional tobacco products.

The FDA said the move could reduce the addictiveness of tobacco products and make it easier to quit, reducing millions of premature deaths.

The federal health agency also said it would help prevent people who experiment with cigarettes or cigars from developing addiction and using those products regularly.

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If the rule is finalized, the United States would be the first country to impose such a limit, the FDA said.

"Multiple administrations have acknowledged the immense opportunity that a proposal of this kind offers to address the burden of tobacco-related disease," FDA Commissioner Dr. Robert Califf said in a statement. "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.

"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," he continued. "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."

A male hand with a cigarette in this undated stock photo.
STOCK PHOTO/Adobe Stock

The FDA announced its intent to propose the rule in 2018, during the first Trump administration, and said this is the next step in the "rulemaking process."

The agency said it will request input via public comment and from the FDA's Tobacco Products Scientific Advisory Committee.

The proposed rule does not ban the sale of cigarettes or other tobacco products, but rather caps the nicotine level at 0.7 milligrams (mg) per gram of tobacco, citing the average amount of nicotine in the top 100 cigarette brands in 2017 was 17.2 mg per gram.

The proposed FDA rule would apply to cigarettes, cigarette tobacco, roll-your-own tobacco, most cigars and pipe tobacco. It would not extend to electronic cigarettes, nicotine pouches, waterpipe tobacco, smokeless tobacco or premium cigars, the FDA said.

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Nicotine, the primary chemical in cigarettes, is highly addictive, and the developing minds of adolescents may be especially vulnerable. The combusted products after lighting a cigarette are toxic, posing a danger to anyone who uses it, including pregnant people and developing fetuses, the FDA and Centers for Disease Control and Prevention say.

The FDA said scientific evidence in the proposed rule suggests the new nicotine cap would not create or sustain addiction and would not lead to smokers compensating for lower nicotine levels by smoking more.

"Today, we're taking a critical step in the rulemaking process by providing the public with a proposal they can review and engage on," Dr. Brian King, director of the FDA's Center for Tobacco Products, said in a statement. "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."

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