The Food and Drug Administration is moving to eliminate addictive nicotine from cigarettes, according to a long-awaited proposed regulation released Wednesday.
The rule is intended to force the approximately 12% of Americans who still use combustible tobacco products to switch to less dangerous alternatives, such as using electronic cigarettes or nicotine lozenges, or to discourage youth from starting to smoke traditional cigarettes. Ending the rate is giving up completely.
“The proposed product standard would limit addiction to the most toxic and widely used tobacco products, leading to important public health benefits for all age groups,” the agency wrote. proposed rules,
Although vaping rates have increased in recent years, fewer adults vape than smoke traditional cigarettes. Centers for Disease Control and Prevention Estimate That 6% of adults use e-cigarettes.
It will now be up to the returning Trump administration to decide whether and how to finalize the measure, which was swam first During the first term of newly elected President Donald Trump. At the time, the head of the FDA called it “one of the most important actions I have ever taken to advance public health.”
“If there is a goal make america healthy again“I can't imagine doing anything more important than this,” FDA Commissioner Robert Califf told reporters Wednesday.
A related effort to ban menthol-flavored cigarettes stopped last year Under the Biden administration, amid political blowback over the measure.
The FDA says the proposed rule would apply to traditional cigarettes, roll-your-own tobacco, cigars and pipe tobacco. Once the rule is finalized, cigarette manufacturers will have two years to comply with it.
Agency officials stressed that they are not seeking a complete ban on cigarettes or other tobacco products. He acknowledged that the rule may result in some illegal imports of high nicotine cigarettes, but not enough to compare to those switching or quitting. They estimate that half of smokers will quit within the first years.
Brian King, head of the FDA's Center for Tobacco Products, said, “Even if some amount of illicit trade develops, we will still have substantial profits that will far outweigh any impacts of potential illicit markets.”
Tobacco companies would be required to reduce nicotine levels per gram of tobacco to 0.7 milligrams, a fraction of the average 17.2 milligrams per gram of most cigarette brands.
Why didn't the FDA ban nicotine earlier?
Progress stalled during the Trump administration after then-FDA Commissioner Scott Gottlieb stepped down from the agency, according to a former top official.
FDA Director Mitch Zeller said, “We had no champions. And the day came when I was asked by political appointees at the FDA to stop talking about menthol and nicotine in my speeches. And we basically Told to stop working on them.” Tobacco Products Center from 2013 to 2022.
The FDA's tobacco branch turned to other priorities in those years, Zeller said. The agency was facing an increase in e-cigarette use among youth. Started around 2018,
Zeller credits Gottlieb for advocating for nicotine regulation within the Trump White House, following the waning of the Obama administration. Obama officials promised Zeller that they would support regulations to curb nicotine and menthol.
“If you look at the record, you'll see that the Obama administration did absolutely nothing. It was a very disappointing four years,” Zeller said.
Under President Biden, Zeller said the White House asked him to set a timeline for how the nicotine rule could be finalized by the end of 2024. Zeller said he presented the plan in one of his last acts before retiring, and was not sure why the Biden administration failed to finalize the rule.
Zeller told White House officials, “I would not forward this deadline to you if I did not believe in good conscience that it could be accomplished, as long as the time for approval could be extended.”
Califf defended the agency's delay in media comments Wednesday, saying the FDA needed to lay the groundwork for a tough legal fight over the rule. “Whoever comes into action, we will be sued,” he said, pointing to the ongoing court battle over graphic warnings on cigarettes.
“We know that the research has to be rigorous to survive the challenges we will face in court,” he said.
How can nicotine be removed from cigarettes?
Zeller said agency officials carefully studied whether it was possible to make cigarettes without the addictive levels of nicotine the industry requires.
“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 Philip Morris for 30 years “Even before we answered the technical feasibility question for ourselves and the rest of us,” he said.
Philip Morris cigarettes were produced with a similar process to decaffeinated coffee. At the time, the company owned Kraft Foods and its decaf coffee production lines.
A major study from the National Institutes of Health in 2015 Using low-nicotine cigarettes, which NIH was contracted to make, showed that reducing nicotine in cigarettes could significantly curb addiction, proving the previously mentioned idea. Is. in the 1990s,
“That study and the many confirmatory studies that have followed I think can provide a very compelling scientific basis for doing this,” Zeller said.
Other companies have found different ways to reduce nicotine levels. Cigarette company 22nd Century Group receives FDA authorization in 2021 Using tobacco that has been genetically engineered to have 96% less nicotine.
Even if implementation were possible, Zeller predicted that finalizing the rule would face strong industry opposition.
If successful, the rule would be an “existential threat”, he said, eliminating the main reason that smokers continue to use their products.