The goal of the rule is to force the roughly 12% of Americans who still use combustible tobacco products to use less dangerous alternatives, such as electronic cigarette vapors or nicotine lozenges, while reducing the rate of youth smoking traditional cigarettes. is
“The proposed product standard would limit the addictiveness of the most toxic and widely used tobacco products, leading to important public health benefits for all age groups,” the agency wrote. Proposed Rule.
Although vaping rates have increased in recent years, fewer adults vape than smoke traditional cigarettes. Centers for Disease Control and Prevention Estimation That 6% of adults use e-cigarettes.
It is now up to the returning Trump administration to finalize the move. First of all yours During President-elect Donald Trump’s first term. At the time, the head of the FDA called it “one of the most important steps I can take to advance public health.”
The FDA says the proposed rule would apply to traditional cigarettes, roll-your-own tobacco, cigars and pipe tobacco. After it is finalized, cigarette manufacturers will have two years to comply with the rule. Tobacco companies would be required to reduce nicotine levels to 0.7 mg per gram of tobacco, a fraction of the 17.2 mg per gram that averages in most cigarette brands.
A related effort to ban menthol-flavored cigarettes Stopped last year Under the Biden administration, amid political backlash over the measure.
Why didn’t the FDA ban nicotine earlier?
Progress stalled during the Trump administration after then-FDA Commissioner Scott Gottlieb resigned from the agency, according to a former senior official.
“We didn’t have a champion,” said FDA Director Mitch Zeller. “And the day came when the political appointees at the FDA told me to stop talking about menthol and nicotine in my speeches. And we had to basically But they were told to stop working on them.” Tobacco Products Center from 2013 to 2022
The FDA’s tobacco arm turned to other priorities in those years, Zeller said. The agency was faced with an increase in the use of e-cigarettes among young people. Started around 2018.
Zeller credits Gottlieb with advocating for nicotine regulation inside the Trump White House, when the Obama administration failed. Obama officials promised Zeller they would support laws to ban 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. The Biden administration failed to finalize the rule.
“I’m not going to put that timeline forward to you if I don’t believe in good conscience that it can be met, as long as clearance times can be accelerated,” Zeller told White House officials. Remembered telling.
How can nicotine be removed from cigarettes?
Zeller said agency officials carefully studied whether it was possible for the industry to make cigarettes without the addictive levels of nicotine needed.
“In the late 1980s and early 1990s, Philip Morris sold an ultra-low-nicotine cigarette called Next. Now, it wasn’t a commercial success. But I believe Philip Morris sold it for over 30 years. The rest of us answered the question of technical feasibility first,” he said.
Philip Morris cigarettes were produced with a similar process of decaffeinating coffee. At the time, the company was owned by Kraft Foods and its decaf coffee production lines.
A large National Institutes of Health study In 2015 Those who used low-nicotine cigarettes that the NIH contracted to develop showed that reducing the nicotine in cigarettes could significantly prevent addiction, confirming an idea previously described. had gone In the 1990s.
“This study and a number of subsequent confirmatory studies I think provide a very strong scientific basis for this,” Zeller said.
Other companies have explored different ways to reduce nicotine levels. Cigarette company 22nd Century Group receives FDA approval. In 2021 Use of tobacco that is genetically engineered to contain 96% less nicotine.
Despite being enforceable, Zeller predicted that finalizing the rule could face strong opposition from the industry.
If successful, the rule would be an “existential threat,” he said, eliminating the main reason smokers continue to use their products.