• All News
• Consumer
• Pro
• New Drugs
• Pipeline
• Clinical Trials
• FDA Alerts

FDA Asks Biden Administration to Limit Nicotine in Tobacco Products

Medically reviewed by Carmen Pope, BPharm. Last updated on Dec 12, 2024.

By Robin Foster HealthDay Reporter

THURSDAY, Dec. 12, 2024 -- In what appears to be a last-ditch effort to limit the harms of smoking before its term ends, the Biden administration has proposed a rule that would significantly lower the amount of nicotine in tobacco products.

The agency's efforts to counter the dangers of the addictive chemical stretch back to 2018, when it first proposed the idea. Then, FDA Commissioner Dr. Robert Califf went even further in 2022 and announced that the agency was developing a rule that would require tobacco companies to reduce the amount of nicotine in cigarettes.

The next step in that effort took place Tuesday when the FDA finally submitted its refined proposal to the Office of Management and Budget.

“A proposed product standard to establish a maximum nicotine level to reduce the addictiveness of cigarettes and certain combusted tobacco products, when finalized, would be among the most impactful population-level actions in the history of U.S. tobacco product regulation,” the FDA told CNN on Wednesday.

The latest action was welcomed by health experts.

“Once finalized, this rule could be a game-changer in our nation’s efforts to eliminate tobacco use,” Harold Wimmer, president and CEO of the American Lung Association, told CNN. “Making tobacco products non-addictive would dramatically reduce the number of young people who become hooked when they are experimenting."

"To fully address the toll of tobacco on our nation’s health and across all communities, it is critical to reduce nicotine levels to non-addictive levels in all commercial tobacco products, including e-cigarettes,” Wimmer added.

Still, not all smokers would quit if nicotine levels were limited, experts added.

“Certainly, there would be individuals who would benefit from substantially lower nicotine levels and find it easier to quit,” Dr. Rose Marie Robertson, deputy chief science and medical officer at the American Heart Association, told CNN. “It’s really hard to quit. I’ve seen patients over many years who have gotten the wake-up call with a heart attack or a stroke and really want to improve their health and reduce their risk, but it’s just very, very hard to do.”

While the number of people who smoke has been dropping over the past 10 years, smoking remains the leading cause of preventable death, disease and disability, according to the U.S. Centers for Disease Control and Prevention. More than 16 million Americans are living with a smoking-related disease.

Despite the fact that surveys show most smokers want to quit, nicotine is highly addictive and quitting is a challenge.

What could make tobacco products less dangerous? Studies show that when the nicotine content in cigarettes is lowered, people smoke less and try to quit more often.

The FDA has estimated that reducing nicotine levels could keep more than 33 million people from becoming regular smokers, CNN reported, while about 5 million more smokers would quit within a year.

Still, the approval process could take months and the tobacco industry also often sues the government to stop new regulations, CNN reported. It also isn't known how the incoming Trump administration might handle the proposal.

Anti-smoking advocates are ready for whatever comes next.

“We’re hopeful, but we’ll be there if it doesn’t move forward, and we’ll continue to be there,” Robertson said.

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 December 2024

More news resources

• FDA Medwatch Drug Alerts
• Daily MedNews
• News for Health Professionals
• New Drug Approvals
• New Drug Applications
• Drug Shortages
• Clinical Trial Results
• Generic Drug Approvals

Subscribe to our newsletter

Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.