The Biden administration is poised to try to lower the amount of nicotine in tobacco products, an eleventh-hour effort that’s been years in the making.
The move would give the White House one last chance to try to regulate tobacco, as it previously punted on finalizing a long-standing pledge to ban menthol-flavored cigarettes.
The rule has not been made public, so the specific language isn’t known, but it’s expected to require tobacco companies to slash the amount of nicotine in cigarettes and potentially other products to make them less addictive.
It could be published as early as Monday by the Food and Drug Administration (FDA), after it cleared regulatory review earlier this month.
But that would only begin a bureaucratic journey that anti-tobacco advocates worry an incoming Trump administration may derail.
Smoking is the leading preventable cause of disease, death and disability in the United States, according to the Centers for Disease Control and Prevention (CDC), killing more than 480,000 people each year. More than 16 million Americans are living with a smoking-related disease.
Most adults who smoke cigarettes want to quit, and half report trying to quit in the past year, according to a CDC survey from September. Yet less than 1 in 10 adults who smoke cigarettes succeed in quitting, drawn back in because of highly addictive nicotine that changes people’s brain chemistry so they want to smoke more.
“Lowering nicotine levels will help millions of people quit smoking and prevent countless others from becoming addicted, sparing families nationwide from the devastating consequences of tobacco-related illnesses and death,” Nancy Brown, CEO of the American Heart Association, said in a statement to The Hill.
Public health advocates said the policy has enormous potential if the Trump administration follows through. No limits currently exist, so setting any standard would be considered a major step forward.
“If finalized, it would be such a game changer because that would mean kids who experiment with tobacco products, with smoking, are not signing themselves up for a lifetime addiction,” said Erika Sward, assistant vice president of national advocacy for the American Lung Association.
The FDA has been talking about plans to lower nicotine levels since the first Trump administration in 2018.
Under President Biden, the FDA in 2022 announced it was developing a proposed rule on the matter, set for release in May 2023.
More than a year and a half later, the proposal is finally almost ready for publication.
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.
Studies show that cigarettes with lower nicotine content reduce people’s dependence on nicotine and can help alleviate some of the cravings associated with withdrawal.
“Lowering nicotine levels to minimally addictive or nonaddictive 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 in 2022.
There won’t be any immediate changes to tobacco products. The proposal is just the first step.
It will be up to the Trump administration to write, issue and put into effect a final rule, and it could be dialed back.
“We see this as a very important step for public health, but we are clear-eyed and knowing that this is just really the first step, because there’s going to be multiple efforts to try to either make the rule completely ineffective, to roll it back, to cancel it, to delay it. And we’ll be monitoring it at every step,” said Avenel Joseph, interim executive vice president at the Robert Wood Johnson Foundation.
There will also be significant tobacco industry opposition, which has helped to sink numerous other potential regulations.
Tobacco companies donated heavily to President-elect Trump’s campaign, and his chief of staff, Susie Wiles, worked as a tobacco lobbyist.
“The tobacco companies have been fighting every sort of rulemaking from the FDA related to their products, and something that would actually make their products … less effective at being an addictive tool is going to be something that they’re going to throw every ounce of effort and money behind to try to defeat,” Joseph added.
If the rule moves beyond the proposed stage, there will likely be industry lawsuits arguing the government overstepped.
Yet public health advocates said they were not writing off Trump moving forward with the rule.
While it did not happen during his first term, reducing nicotine aligns with the “Make America Healthy Again” movement championed by Robert F. Kennedy Jr., Trump’s pick to be Health and Human Services secretary.
“As a nation, we are having a discussion about chronic disease, and certainly the Trump administration has brought that to the forefront,” Sward said. “Tobacco use is number one when it comes to chronic disease that can be prevented, and how Americans can be healthier.”
“Few actions would do more to fight chronic diseases such as cancer and cardiovascular disease that greatly undermine health in the United States and that the incoming administration has indicated should be a priority to address,” Yolonda Richardson, president and CEO of the Campaign for Tobacco-Free Kids, said in a statement to The Hill.
On the flip side, conservative free market groups and law enforcement associations argue the proposal would amount to a ban on cigarettes, supercharging a black market for illicit products.
“For all intents and purposes, [the rule will] make cigarettes unregulated and throw it back out into the illicit market through a ban,” said Diane Goldstein, executive director of the Law Enforcement Action Partnership.
“Anytime you create a law where you ban something, you put law enforcement in charge of the enforcement of that. And … we’re seeing that bans don’t work for their intended purposes of potentially reducing smoking.”
Goldstein pointed to the proliferation of illicit products that followed FDA efforts to curb youth vaping.
“Bans don’t affect people’s behavior; they just go to the underground market in order to find what they need,” she said.
