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FDA looks to curb nicotine levels in cigarettes, other products with new rule

The Food and Drug Administration (FDA) is seeking to curb the level of nicotine that cigarettes and other combusted tobacco products can contain. 

The agency is looking to do so through a rule proposed Wednesday that FDA Commissioner Dr. Robert Califf said “could save many lives and dramatically reduce the burden of severe illness and disability, while also saving huge amounts of money” if finalized. 

Cigarettes and “certain other combusted tobacco products” would not be allowed to have more than 0.7 milligrams of nicotine per gram of tobacco under the proposed rule, per the FDA. The agency said that lower nicotine level would “be low enough to no longer create or sustain addiction.” 

FDA HQ sign in Marylnd

The Food and Drug Administration (FDA) is seeking to curb the level of nicotine that cigarettes and other combusted tobacco products can contain.  (Sarah Silbiger/Getty Images / Getty Images)

Cigarette tobacco, roll-your-own tobacco, most cigars and pipe tobacco are among the combusted tobacco products that would be subject to the nicotine limit in addition to cigarettes. 

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The FDA wants the rule to come into force two years after the publication of a final rule on the matter. 

Citing public health models, the agency forecast the rule could “prevent approximately 48 million U.S. youth and young adults from starting smoking” by the start of the next century. 

If finalized, it could also prompt over 12.9 million smokers to ditch cigarettes, “including those who would completely switch to noncombusted tobacco products” a year after it would potentially go into effect, the FDA said. 

Smoking a cigarette

Cigarette tobacco, roll-your-own tobacco, most cigars and pipe tobacco are among the combusted tobacco products that would be subject to the nicotine limit in addition to cigarettes. (iStock / iStock)

The agency said a switch to “lower-risk tobacco products” would “reduce exposure to the many harmful chemicals present in cigarettes and other combusted tobacco products” among smoking adults.

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The limit has the potential to help avoid 1.8 million tobacco-related deaths by 2060, according to the agency. 

“This proposal allows for the start of an important conversation about how we can meaningfully tackle one of the deadliest consumer products in history and profoundly change the landscape of tobacco product use in the United States,” FDA Center for Tobacco Products Director Brian King said in a statement.

The FDA has previously indicated it wanted to pursue limiting tobacco levels in cigarettes. 

Citing public health models, the agency forecast the rule could “prevent approximately 48 million U.S. youth and young adults from starting smoking” by the start of the next century. (Michael Macor/The San Francisco Chronicle via Getty Images / Getty Images)

Wednesday’s proposed rule “would not ban” cigarettes or other similar products, according to the agency. 

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A survey published by Gallup in August 2024 found 11% of U.S. adults had smoked cigarettes in the past week. Meanwhile, 7% reported electronic cigarette usage, it said. 

E-cigarettes, nicotine pouches, noncombusted cigarettes, waterpipe tobacco smokeless tobacco products and premium cigars would not be impacted by the proposed rule, according to the FDA. 

The rule will be open to public comment starting Thursday through Sept. 15, the agency said.

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