Nicotine levels in cigarettes sold in the U.S. would have to be drastically lowered under a proposal released Wednesday by the Food and Drug Administration.
If finalized, the change would mean that cigarettes would lose their ability to hook most people into addiction.
“By reducing the nicotine level of cigarettes and certain other combusted tobacco products to a level low enough to no longer create or sustain addiction, the cycle of exposure to these toxic chemicals can be broken,” Brian King, director of the FDA’s Center for Tobacco Products, said during a briefing with reporters.
Smoking kills more than 480,000 Americans each year. Levels of nicotine in cigarettes vary widely depending on the brand but usually average 13 milligrams a cigarette. The FDA’s plan would limit nicotine in nearly all combustible tobacco products — a category that includes cigarettes, most cigars and pipe tobacco — to 0.07 milligrams. That’s about a 95% reduction.
Although the proposal was released at the 11th hour by the outgoing Biden administration, officials during President-elect Donald Trump’s first term raised the possibility of a federal regulatory plan for nicotine. So it’s possible that the change could move forward in the next four years.
“If there’s a goal to make America healthy again, I can’t imagine anything more important to get done than this,” Dr. Robert Califf, the FDA commissioner, said on the briefing call. Califf, a Biden appointee, will step down when Trump takes office.
If the rule is finalized, companies would have two years to make necessary changes.
The FDA’s proposal does not include e-cigarettes, other vape products, hookahs, smokeless tobacco products or nicotine replacement pouches.
“While my preference would be that use of all of these products goes down, I do think that there is value in reducing harm by helping people avoid becoming addicted to cigarettes,” said Dr. Richard Besser, former acting CDC director and current president of the Robert Wood Johnson Foundation.
When tobacco is burned, it releases toxins known to cause cancer, heart disease and other chronic illnesses. Nicotine is the substance in cigarettes that make them so addictive.
“It’s the tar and everything around the nicotine that poses the greatest risk to people’s health,” Besser said. “But nicotine is what hooks you.”
The proposal was largely welcomed by public health officials, though the American Lung Association’s CEO, Harold Wimmer, suggested it does not go far enough.
“We urge FDA to reduce nicotine levels to non-addictive levels in all tobacco products, including all cigars, hookah and e-cigarettes,” Wimmer said in a statement.
Nearly all adult smokers started as teenagers. The FDA estimates that, if finalized, the cap on nicotine could prevent 48 million kids and young adults from becoming addicted. The agency also predicts that nearly 13 million people would stop smoking within a year.
A 2018 study estimated that a nicotine cap would result in 16 million fewer people becoming addicted to smoking by the year 2060. That number would increase, per the study’s projection, to 33.1 million by 2100.
“Given these enormous benefits, we urge the incoming Trump administration to move forward in finalizing and implementing this rule,” Yolonda C. Richardson, president and CEO of the Campaign for Tobacco-Free Kids, said in a statement.
Dr. Scott Gottlieb, who served as FDA commissioner during the first Trump administration, said the FDA proposal is “an important step in realizing a broader vision” of how the agency can use its authority to help smokers transition away from combustible cigarettes.
Gottlieb added that adults who still want to access nicotine would have a market for “properly regulated, non-combustible products like pouches and e-cigarettes that don’t cause all the death and disease associated with smoking.”
This does not mean that vapes and other products not covered under the new proposal are safe. E-cigarettes, for example, are known to contain other toxic chemicals that can contribute to asthma, lung disease and heart disease.
“Youth should not be using any tobacco products, and adults who do not currently use them should not start now,” King said.
The public will have a chance to weigh in on the FDA proposal until mid-September.
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