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FDA Proposes Nicotine Limits on Combustible Tobacco Products

Medically reviewed by Carmen Pope, BPharm. Last updated on Jan 16, 2025.

By Stephanie Brown HealthDay Reporter

THURSDAY, Jan. 16, 2025 -- The U.S. Food and Drug Administration has issued a proposed rule to lower the level of nicotine in cigarettes and certain other combustible tobacco products in an effort to make the products minimally addictive or nonaddictive.

Scientific evidence suggests the nicotine level for cigarettes and certain other combustible tobacco products proposed in the regulation would be low enough to no longer create or sustain addiction. The FDA emphasizes that lowering the amount of nicotine in cigarettes does not lead smokers to compensate by smoking more.

"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, M.D., said in an agency news release. "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 U.S. is an admirable goal we should all work toward."

Based on data from a population health model, the FDA believes the benefits of this new standard for nicotine levels -- 0.7 mg/g of tobacco -- will be manifold. The model projects that ~48 million U.S. youth and young adults would be prevented from ever starting smoking by 2100; ~19.5 million cigarette smokers would quit within five years of rule enactment; and during the first four decades, cost savings would be more than $1.1 trillion per year.

"It is crucial for the FDA to establish nicotine reduction levels that maximize quitting and reduce initiation of youth smoking," Nancy Brown, CEO of the American Heart Association, said in a statement. "The public must also be made aware that even reduced-nicotine cigarettes remain harmful and deadly products. Education about reduced nicotine products will be important to optimize the impact of this rule on public health."

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Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.

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