The Food and Drug Administration is moving to cut out addictive nicotine from cigarettes, according to a long-awaited proposed regulation released Wednesday.
The rule aims to force the nearly 12% of Americans still using combustible tobacco products to switch to less dangerous alternatives, like vaping electronic cigarettes or using nicotine lozenges, or quit altogether while ending rates of youth starting to smoke traditional cigarettes.
“The proposed product standard would limit the addictiveness of the most toxic and widely used tobacco products, which would have significant public health benefits for all age groups,” the agency wrote in the proposed rule.
Though vaping rates have climbed in recent years, fewer adults vape than smoke traditional cigarettes. The Centers for Disease Control and Prevention estimates that 6% of adults use e-cigarettes.
It will now be up to the returning Trump administration to decide if and how to finalize this measure, which was first floated during President-elect Donald Trump’s first term. At the time, the head of the FDA called it “one of the most important actions I could take to advance public health.”
“If there is a goal to Make America Healthy Again, I can’t imagine anything more important to get done than this,” FDA Commissioner Robert Califf told reporters on Wednesday.
A related effort to ban menthol-flavored cigarettes stalled out last year under the Biden administration, amid political blowback over the measure.
The FDA says the proposed rule will apply to traditional cigarettes, roll-your-own tobacco, cigars and pipe tobacco. Cigarette manufacturers will have two years to come into compliance with the rule, after it is finalized.
Agency officials stressed that they were not seeking to ban cigarettes or other tobacco products outright. They acknowledged the rule may result in some illegal imports of high nicotine cigarettes, but not enough to outweigh those switching or quitting. Half of smokers are expected to switch within the first years, they estimate.
“Even if some amount of illicit trade develops, we will still have a significantly greater magnitude of benefits that would outweigh any impacts of potential illicit markets,” said Brian King, head of FDA’s Center for Tobacco Products.
Tobacco companies will need to cut nicotine levels to 0.7 milligrams per gram of tobacco, a fraction of the 17.2 milligrams per gram that most cigarette brands have on average.
Why didn’t the FDA ban nicotine earlier?
Progress during the Trump administration halted after then-FDA Commissioner Scott Gottlieb stepped down from the agency, according to a former top-ranking official.
“We had no champion. And the day came when I was told by political appointees at FDA to stop talking about menthol and nicotine in my speeches. And we were basically told to stop working on them,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products from 2013 to 2022.
The FDA’s tobacco arm turned to other priorities in those years, Zeller said. The agency was facing a surge in youth e-cigarette use that began around 2018.
Zeller credited Gottlieb for advocating for the nicotine regulation within the Trump White House, after the Obama administration had fallen short. Obama officials had promised Zeller they would back rules to curb nicotine and menthol.
“If you look back on the record, you’ll see that the Obama administration did absolutely nothing. It was a very frustrating four years,” Zeller said.
Under President Biden, Zeller said the White House asked him to lay out a timeline for how a nicotine rule could be finalized by the end of 2024. Zeller said he delivered the plan in one of his last acts before retiring, and was not sure why the Biden administration failed to finalize the rule.
“I would not be forwarding this timeline to you, if I didn’t believe in good conscience that it could be met, as long as clearance times could be sped up,” Zeller recalled telling White House officials.
Califf defended the agency’s delay in comments to media Wednesday, saying that the FDA needed to lay the groundwork for steep legal fights over the rule. He pointed to ongoing court battles “fighting us tooth and nail” over graphic warnings on cigarettes, saying “we will be sued, on anything that comes into action.”
“The research has to be airtight to survive the challenges that we know we’ll get in court,” he said.
How can nicotine be removed from cigarettes?
Zeller said agency officials carefully studied whether it was possible to require the industry to make cigarettes without addictive levels of nicotine.
“In the late 1980s and early 1990s, Philip Morris sold a very low-nicotine cigarette called Next. Now, it was not commercially successful. But I believe that Philip Morris more than 30 years ago answered the technical feasibility question for themselves and for the rest of us,” he said.
The Philip Morris cigarette had been produced with a similar process to decaffeinating coffee. At the time, the company had owned Kraft Foods and its decaf coffee production lines.
A major study from the National Institutes of Health in 2015 that used reduced-nicotine cigarettes that the NIH contracted to manufacture showed reducing nicotine in cigarettes could substantially curb addiction, proving an idea first outlined in the 1990s.
“That study and a number of confirmatory studies that followed I think provide a very compelling scientific basis for this could be done,” Zeller said.
Other companies have found different ways to cut nicotine levels. Cigarette company 22nd Century Group earned the FDA’s authorization in 2021 using tobacco that is genetically engineered to have 96% lower nicotine.
While feasible to implement, Zeller predicted that finalizing the rule could face steep opposition from the industry.
If successful, the rule would be an “existential threat,” he said, eliminating the main reason that smokers continue to use their products.
