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FDA Proposes Nicotine Cap To Help Curb Cigarette Addiction

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

By India Edwards HealthDay Reporter

THURSDAY, Jan. 16, 2025 -- A rather historic U.S. Food and Drug Administration (FDA) proposal aims to make cigarettes and other tobacco products far less addictive by reducing their nicotine content.

The move could help millions of Americans quit smoking while preventing many more from becoming addicted.

The proposed rule, published Wednesday in a 334-page report, would cap nicotine levels in cigarettes and other tobacco products, potentially, to levels so low they would no longer sustain addiction.

FDA officials believe the policy, if finalized, could save millions of lives over the coming decades.

However, the proposal is unlikely to be enacted anytime soon, as it comes in the final days of President Joe Biden's term. President-elect Donald Trump has not yet commented on the policy, leaving its future uncertain.

“This action, if finalized, could save many lives and dramatically reduce the burden of severe illness and disability,” FDA Commissioner Dr. Robert Califf told the Associated Press.

Details of the proposal

The rule proposes a maximum nicotine level of 0.7 milligrams (mg) per gram of tobacco -- a significant decrease from current levels, which can range anywhere from 6 mg to 28 mg per gram.

The limit would apply to cigarettes, pipe tobacco, and cigars, but not to e-cigarettes, nicotine pouches, or other products.

Research shows that low nicotine levels make it much harder for smokers to maintain their addiction and easier for them to quit.

After years of research, the FDA estimates that, within a year of implementing the proposal, nearly 13 million people could stop smoking, and by the year 2100, about 48 million young people who would otherwise start smoking may never pick up the habit.

Smoking is the leading cause of preventable death in the U.S., accounting for nearly 480,000 deaths annually, according to the U.S. Centers for Disease Control and Prevention.

Conditions linked to smoking include heart disease, stroke, lung cancer, and respiratory illnesses, and reducing nicotine in cigarettes could prevent millions of premature deaths and add millions of years of healthy life for Americans.

However, the policy has faced pushback, unsurprisingly, from tobacco companies, which argue that regulation like this could lead to illegal markets.

The plan is “fundamentally flawed,” David Sutton, company spokesperson for Altria, which sells both Marlboro cigarettes and NJOY e-cigarettes, said in an email to the Associated Press.

While the FDA has the authority to regulate nicotine levels, the process of finalizing the rule could take years.

Once finalized, manufacturers would have two years to comply with the new standards. Tobacco companies are most likely to challenge the rule in court, which could cause even more delays.

This proposal is part of a larger FDA initiative to fight tobacco-related illnesses. Other recent efforts include updated definitions for "healthy" labeling on food and beverages.

The FDA has also endorsed several cigarette brands, like NJOY and Vuse, as less harmful alternatives to traditional smoking.

Anti-smoking and other health advocates have praised the FDA’s proposed nicotine rule as a significant step forward in reducing the use of tobacco.

Sources

  • FDA, proposal, Jan. 16, 2025
  • CDC, Associated Press

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.

© 2025 HealthDay. All rights reserved.

Posted January 2025

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