The Biden administration proposal cleared an Office of Management and Budget review at the end of last week.
The 11th hour effort from the Biden administration would require tobacco companies to slash the amount of nicotine in cigarettes and other products to make them less addictive.
The rule has not been made public, so the specific language isn't known; the rule is likely to be released in the coming days.
The move would give the Biden administration one last chance to try to regulate tobacco, as it previously punted on finalizing a plan to ban menthol-flavored cigarettes.
The FDA has been talking about plans to lower nicotine levels since the first Trump administration in 2018. Under Biden, the FDA in 2022 announced it was developing a proposed rule on the matter, set for release in May 2023.
The FDA in 2022 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 collective life would be gained.
"Lowering nicotine levels to minimally addictive or non-addictive levels would decrease the likelihood that future generations of young people become addicted to cigarettes and help more currently addicted smokers to quit," FDA Commissioner Robert Califf said at the time.
More than a year-and-a-half later, the proposal is set for publication.
The proposal is just the first step. There won't be any immediate changes to tobacco products. It would be up the Trump administration to write and issue a final rule and put it into effect, and it could be dialed back—if the administration releases it at all. There will be significant tobacco industry opposition.
Tobacco companies donated heavily to President-elect Trump's campaign, and his chief of staff worked as a tobacco lobbyist.
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