The U.S. Food and Drug Administration is taking action to ban addictive nicotine from cigarettes, under a long-awaited proposed rule released Wednesday.
The rule aims to force the nearly 12% of Americans who still use combustible tobacco products to switch to less dangerous alternatives, such as e-cigarettes or using nicotine lozenges, while reducing the rate of young people starting smoking traditional cigarettes.
“The proposed product standards would limit the addictive properties of the most toxic and widely used tobacco products, which would have significant public health benefits for all ages,” the agency wrote in the proposed rule.
Although the rate of vaping has increased in recent years, fewer adults smoke e-cigarettes than traditional cigarettes. The Centers for Disease Control and Prevention estimates that 6% of adults use e-cigarettes.
It will now be up to the Trump administration to decide whether and how to finalize the measure, which was first proposed during President-elect Donald Trump's first term. At the time, the FDA chief called it “one of the most important actions I can take to promote public health.”
The proposed rule would apply to traditional cigarettes, hand-rolled cigarettes, cigars and pipe tobacco, the FDA said. Once the rule is finalized, cigarette manufacturers will have two years to comply. Tobacco companies are required to reduce nicotine levels to 0.7 milligrams per gram of tobacco, while the average nicotine level for most cigarette brands is 17.2 milligrams per gram.
Efforts to ban menthol cigarettes stagnant last year The measure faced political backlash under the Biden administration.
Why didn’t the FDA ban nicotine sooner?
Progress during the Trump administration stalled after then-FDA Commissioner Scott Gottlieb resigned, according to a former senior official.
“We had no advocates. One day I was told by political appointees at the FDA not to talk about menthol and nicotine in a speech. We were basically told to stop studying them,” said FDA Director Mitch Zeller. Tobacco Products Center 2022.
Zeller said the FDA's tobacco division moved on to other priorities during those years. The agency faces a surge in teen e-cigarette use that began around 2018.
Zeller praised Gottlieb for advocating for nicotine regulation in the Trump White House after the Obama administration failed to do so. Obama officials had promised Zeller they would support rules limiting nicotine and menthol.
“If you look back at history, the Obama administration did absolutely nothing. It was a very frustrating four years,” Zeller said.
Under President Joe Biden, Zeller said the White House asked him to lay out a timeline for how the nicotine rules would be finalized by the end of 2024. It’s uncertain why the Biden administration failed to finalize the rule.
“If I believed in good conscience that this requirement could be met if the clearance time could be expedited, I would not forward this schedule to you,” Zeller recalled.
How to remove nicotine from cigarettes?
Zeller said agency officials carefully studied the possibility of requiring the industry to produce cigarettes that do not contain addictive levels of nicotine.
“In the late 1980s and early 1990s, Philip Morris sold a very low-nicotine cigarette called Next. Now, it's not a commercial success. But I believe that Philip Morris has The question of technical feasibility was answered for myself and for the industry more than 30 years ago.
The production process for Philip Morris cigarettes is similar to that of decaf coffee. At the time, the company owned Kraft Foods and its decaf coffee line.
A major 2015 National Institutes of Health study using lower-nicotine cigarettes contracted by the NIH showed that reducing the nicotine content in cigarettes can significantly curb addiction, as evidenced by 20 An idea first proposed in the 1990s.
“I think this study and the series of confirmatory studies that followed provide a very compelling scientific basis for doing that,” Zeller said.
Other companies have found different ways to lower nicotine levels. Cigarette company 22nd Century Group received FDA authorization in 2021 to use genetically engineered tobacco with 96% lower nicotine content.
While implementation is feasible, Zeller predicted that finalizing the rule would likely face strong opposition from the industry.
If successful, he said, the rule would become an “existential threat” and remove a major reason why smokers continue to use its products.
