The Food and Drug Administration on Wednesday proposed curbing the level of nicotine in cigarettes to make the products less addictive in an ambitious effort to help more Americans quit smoking.
The proposal would set a level of 0.7 milligrams of nicotine per gram of tobacco for cigarettes, most cigars, and pipe tobacco, compared to an average nicotine level of 17.2 mg in popular cigarette brands today.
Tamping down on nicotine levels will not make cigarettes less toxic, but research suggests lower levels of the chemical would reduce dependency and ultimately help more smokers quit. The policy change could prevent 8.5 million tobacco-related deaths by 2100, according to a 2018 Journal of the American Medical Association paper supported by the FDA, and reduce the U.S. smoking rate to 1.4% by 2060.
“This would be the single greatest positive impact on public health in the history of public health regulation,” said Mitch Zeller, former director of the FDA’s tobacco center who worked on the rule in 2017.
The rule comes in the twilight of the Biden administration, as the FDA and other agencies scramble to clear their regulation plates. The incoming Trump administration will ultimately decide the fate of the rule, which is not finalized and thus can be withdrawn. The proposal will be open for public comment for 240 days, or about eight months.
The tobacco industry, which has largely opposed the rule, donated heavily to Trump throughout his campaign. But experts also noted that the government’s first serious attempt at cutting nicotine levels began under the first Trump administration. Then-FDA Commissioner Scott Gottlieb unveiled a plan in 2017 to make cigarettes “minimally or non-addictive.”
“I’d like to believe the Trump administration will recognize the same public health benefits that the Biden administration is recognizing. I don’t think those need to be political,” said Eric Donny, a professor at Wake Forest University School of Medicine who has studied the potential impact of reduced-nicotine cigarettes. “I tend to be an optimist.”
Cliff Douglas, head of the nonprofit Global Action to End Smoking, was less certain about the rule’s fate under Trump. “I think it’s easily painted as government overreach, interfering with consumer choices,” said Douglas, whose organization supports e-cigarettes and other products as a harm-reduction strategy. “My fingers are crossed that they will see the value of doing this in a comprehensive way and support the nicotine reduction policy.”
What the FDA rule on nicotine could mean for public health
About 11.6% of Americans smoke cigarettes, which cause more than 490,000 deaths each year, according to the most recent data available from the Centers for Disease Control and Prevention. Because highly educated and higher-income people have largely quit smoking, the majority of those deaths now occur in vulnerable populations such as low-income people, older adults, and people with mental health issues, noted Dorothy Hatsukami, a professor at the University of Minnesota who specializes in research on nicotine addiction and policy. That means the policy could have a major impact on health equity.
“About two-thirds of people who smoke do want to quit smoking, but only 1 in 10 are successful each year,” Hatsukami said, citing CDC data. “Because nicotine is so addictive, sometimes it robs people of being able to quit.”
Reducing nicotine in cigarettes would help people who smoke but want to quit “regain some freedom of choice,” said Donny. “The reality is that the vast majority of smokers regret starting.” One model estimates that 5 million Americans would quit smoking within a year of the introduction of a reduced-nicotine policy.
Reynolds American, which owns cigarette brands like Camel, Newport, Lucky Strike, and Natural American Spirit, pushed back against the FDA’s proposal.
“Smoking rates are at historic lows, and reducing nicotine content in cigarettes will not make these products less risky or improve public health,” Luis Pinto, vice president of corporate communications at the company, said Wednesday. “These actions would effectively eliminate legal cigarettes and fuel an already massive illicit nicotine market. These actions would also have a significant negative economic impact on farmers, retailers, and others.”
The tobacco industry has historically cited two arguments in opposing a change to nicotine standards.
First, the industry has argued that the policy could be rendered moot if people compensate for lower levels of nicotine in their cigarettes by smoking more of them. However, that’s not what happened in clinical trials. One randomized six-week trial, published in 2015 in the New England Journal of Medicine, found that people who smoked cigarettes with lower levels of nicotine smoked 23%-30% fewer cigarettes per day and experienced fewer cravings compared to people in the control group.
People who smoked reduced-nicotine cigarettes in clinical trials also did not turn to substitutions like cannabis or alcohol, Hatsukami said. They did have a tendency to take up e-cigarettes and other alternative products, as opposed to nicotine patches or lozenges. “In the long term, of course, it’s better not to use any nicotine product,” said Hatsukami. But people who opted for vaping over cigarettes still had a markedly reduced exposure to toxicants and carcinogens. “So the switching can have a beneficial effect.”
The tobacco industry has also argued that the rule would give rise to a black market for cigarettes with higher nicotine content. But nicotine would not be prohibited under the rule, Donny noted. “The drug is widely available in safer forms,” he said, including e-cigarettes and oral nicotine pouches. “So the demand for an illicit market is likely to be greatly reduced as long as the marketplace has alternatives for people to go to.”
Tobacco companies have long had the ability to produce low-nicotine cigarettes, Douglas noted. In the late 1980s, for example, Philip Morris sold a low-nicotine cigarette brand called Next, though it was not marketed as being nonaddictive. The company soon pulled it from the market after disappointing sales.
“Without identification to the public about why it would be valuable or what the whole point of it was, people were not having their dependency satisfied,” Douglas said. And as long as highly addictive conventional cigarettes are available, he said, people won’t be incentivized to turn to the lower-nicotine options and succeed in quitting.
In more recent years, the tobacco industry has invested heavily in e-cigarettes and other cigarette alternatives. Altria acquired the NJOY e-cigarette brand in 2023, Vuse e-cigarettes are owned by Reynolds American, and the oral tobacco pouch Zyn is owned by Philip Morris International. “Those companies that have viable alternatives, have a product to switch people to” if the policy leads more people to quit smoking, Donny said. “They don’t necessarily need to lose revenue.”
The FDA’s long path toward taking on nicotine
The idea that a policy reducing nicotine in cigarettes could prevent addiction and help people quit can be traced back to 1994, when a group of researchers first proposed it in the New England Journal of Medicine. But at the time, the FDA didn’t have the authority to implement such a rule. It was only in 2009 that the agency gained jurisdiction over cigarettes under the Family Smoking Prevention and Tobacco Control Act.
When Gottlieb announced the plan to tackle cigarette addiction in 2017, Zeller, director of the tobacco center at the time, was thrilled. He originally joined the agency in 2013 with the understanding that the Obama administration would support his efforts to ban menthol cigarettes and reduce nicotine levels. Neither came to pass, which Zeller attributes to the administration being politically risk-averse.
His team worked on the rule throughout 2017, but efforts stalled the next year, as use of e-cigarettes like Juul skyrocketed among kids. The center had to shift focus. Then Gottlieb left the agency in 2019, further slow-rolling the proposal.
“I was literally ordered by politicals at FDA to stop talking about menthol and nicotine in my standard speech,” Zeller said.
The Biden FDA then took on the issue in 2022. The agency announced plans to reduce addiction, death, and youth tobacco use by requiring companies abide by a maximum nicotine level, banning menthol cigarettes, and banning flavored cigars. The final versions of the latter two rules are still languishing in White House budget office purgatory.
The FDA has come under fire as not doing enough to help Americans quit smoking. Advocates blame the agency for holding anti-smoking drugs to what some consider an unreasonably high standard, and drug companies for not investing enough in smoking cessation therapies. Public health officials at the FDA and CDC have succeeded in bringing the youth vaping rate down to 6% from a Juul-fueled high of 20% in 2019. But plenty of illegal e-cigarettes remain on the market.
That narrative could start to change with the new rule, which would be the first of its kind in the world. New Zealand in 2022 passed legislation that would have dramatically reduced nicotine levels in cigarettes, but the plan was scrapped under a new government.
“If the U.S. goes forward, it would be a major game-changer, in terms of global influence as well,” said Hatsukami. “It just seems so ludicrous that we’ve had this product that we know kills so many people each year, and yet we have condoned it.”
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