FDA issues last-minute proposal to cap nicotine level in cigarettes

The Biden administration on Wednesday proposed capping the amount of nicotine in combustible tobacco at a level that is significantly lower than the current level in cigarettes.

If the Food and Drug Administration’s proposed rule is finalized, the U.S. would be the first country to take this step.

“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 Califf said. “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.”

The last-minute push by President Biden’s team follows a decision not to follow through on its pledge to ban menthol cigarettes, an effort that got tangled in election-year politics.

Smoking is the leading cause of preventable death. It kills over 480,000 Americans each year, according to the Centers for Disease Control and Prevention.

More than 4 in 10 Americans smoked cigarettes in 1965, a rate that declined to 12.5% by 2020.

Capping nicotine would be a major effort to decrease the rate further. While the toxins in combustible tobacco cause health problems, the nicotine is what keeps people hooked.

The FDA proposal would not ban any cigarettes or other tobacco products. However, it would cap the nicotine level at 0.7 milligrams per gram of tobacco in cigarettes and certain other combusted tobacco products.

“For comparison, the average nicotine content in the top 100 cigarette brands for 2017 is 17.2 mg/g of total tobacco,” the proposed rule said.

Public health advocates are cheering the move, though it faces a long regulatory road and could be thwarted or reined in if the incoming administration feels it amounts to governmental overreach.

Tobacco company lobbyists are expected to contest the move.

The proposal is the latest volley in federal rulemaking around tobacco and vape products. 

Earlier in his term, Mr. Biden cracked down on fruit and candy-flavored vape products, saying they appealed to kids and fueled an epidemic of vaping among middle school and high school students.

Mr. Biden did not follow through on a plan to ban menthol-flavored cigarettes. The proposal risked upsetting Black voters, who are crucial to the Democratic base and have the highest percentage of menthol cigarette use among all racial and ethnic groups.

The administration did target menthol cigarettes in an awareness campaign in early 2024.

Critics of tobacco and vaping crackdowns say they amount to government overreach and tend to empower black-market cartels that will offer the products anyway.

President-elect Donald Trump has taken a softer approach, particularly toward vapes, which some adults use to wean off more harmful cigarettes. 

In a September social media post, Mr. Trump said he “saved Flavored Vaping in 2019” and planned to “save Vaping again!”

Mr. Trump, as president, leaned toward a significant crackdown on vapes in the 2018-2019 period but backed off when campaign personnel showed him evidence that his supporters liked the products.

He did, however, sign a law that raised the purchasing age for e-cigarettes and other tobacco products to 21.