In Biden administration’s final days, FDA advances proposal to set a nicotine limit on tobacco products

By Jen Christensen, CNN

(CNN) — As the Biden administration winds down, the US Food and Drug Administration has submitted a proposed rule that could significantly lower the amount of nicotine in tobacco products and potentially prompt more people to quit smoking.

The FDA has been signaling its intentions to limit nicotine levels at least since 2018, during the first Trump administration. In 2022, President Joe Biden’s FDA commissioner, Dr. Robert Califf, took it a step further and announced that the agency was developing a rule that would require tobacco companies to significantly reduce the amount of nicotine in traditional cigarettes.

The next regulatory step, which the FDA took Tuesday by submitting the proposal to the Office of Management and Budget, would not mean overnight change. But if the government did set a limit on nicotine levels, experts say, it could significantly improve public health.

“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 US tobacco product regulation,” the FDA said in a statement Wednesday.

The number of people who smoke has been declining for more than a decade, but smoking is still the leading cause of preventable death, disease and disability in the country, according to the US Centers for Disease Control and Prevention. More than 16 million Americans are living with a smoking-related disease.

As of 2021, about 28.3 million US adults were considered current smokers, the CDC says. Surveys show that most want to quit, but nicotine is highly addictive, changing the brain in ways that make people want to smoke more. Half of smokers say they’ve tried to quit in the past year, but fewer than 1 in 10 were successful.

Studies show that when the nicotine content of cigarettes is reduced, people smoke less and make more attempts to quit. Cigarettes with lower nicotine levels seem to be effective in alleviating withdrawal, research shows.

When the FDA announced its initial plans to reduce nicotine in 2022, it estimated that reducing nicotine levels could keep more than 33 million people from becoming regular smokers, that about 5 million additional smokers would quit within a year, and that 134 million years of life would be gained.

In the draft proposal from 2018, which the FDA has since refined, it cited a 2013 survey that found that reducing the total nicotine content of cigarettes to 0.5 milligrams per rod would minimize addictiveness, but it also said that questions remain with respect to the precise level of nicotine in cigarettes.

The agency’s proposal was met with high praise Wednesday.

“Once finalized, this rule could be a game-changer in our nation’s efforts to eliminate tobacco use,” said Harold Wimmer, president and CEO of the American Lung Association. “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.”

Not all smokers would quit if nicotine levels were limited, experts say, nor would all smoking-related diseases disappear, since tobacco products contain other chemicals that can be harmful for health.

“Certainly, there would be individuals who would benefit from substantially lower nicotine levels and find it easier to quit,” said Dr. Rose Marie Robertson, a cardiologist and chief science officer at the American Heart Association. “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.”

There won’t be any immediate changes to tobacco products. The Office of Management and Budget’s approval process can take months. There will also be a public comment period, and the tobacco industry often sues the government to stop new regulations.

It’s also unclear what the FDA will do with such a proposal under President-elect Donald Trump. During his first term, the agency signaled that it wanted to limit nicotine, but the tobacco industry donated heavily to Republicans ahead of this year’s elections, and Trump’s pick for chief of staff worked as a tobacco lobbyist.

Robertson says her association wants this last-minute FDA effort to work.

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

CNN’s Deidre McPhillips contributed to this report.

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