Nicotine levels in cigarettes sold in the United States should be significantly reduced under a proposal released Wednesday by the Food and Drug Administration.
If finalized, the change would mean cigarettes would lose their ability to make most people addicted.
“By reducing the level of nicotine in cigarettes and certain other burned tobacco products to a level low enough to no longer create or maintain addiction, the cycle of exposure to these toxic chemicals can be broken,” Brian King, director from the FDA’s Center for Tobacco. Products, said during a briefing with journalists.
Smoking kills more than 480,000 Americans each year. Nicotine levels in cigarettes vary widely by brand, but generally average 13 milligrams per cigarette. The FDA’s plan would limit nicotine in almost all combustible tobacco products — a category that includes cigarettes, most cigars and pipe tobacco — to 0.07 milligrams. This represents a reduction of approximately 95%.
Although the proposal was released at the last minute by the outgoing Biden administration, officials in President-elect Donald Trump’s first term have raised the possibility of a federal plan to regulate nicotine. It is therefore possible that the change will continue over the next four years.
“If there is a goal to make America healthy again, I can’t imagine anything more important to do than this,” Dr. Robert Califf, FDA commissioner, said during the press conference. Califf, a Biden appointee, will resign when Trump takes office.
If the rule is finalized, companies will have two years to make necessary changes.
The FDA’s proposal does not include e-cigarettes, other vaping products, hookahs, smokeless tobacco products, or nicotine replacement packets.
“While I would prefer to see the use of all of these products decrease, I think there is value in reducing harm by helping people avoid becoming addicted to cigarettes,” said Dr. Richard Besser, former director of acting CDC 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 makes them so addictive.
“It’s the tar and everything around nicotine that poses the greatest risk to people’s health,” Besser said. “But it’s the nicotine that gets you hooked.”
The proposal was largely well-received by public health officials, although American Lung Association CEO Harold Wimmer suggested it doesn’t go far enough.
“We urge the FDA to reduce nicotine levels to non-addictive levels in all tobacco products, including all cigars, hookahs and e-cigarettes,” Wimmer said in a statement.
Almost all adult smokers started smoking as teenagers. The FDA estimates that, if finalized, capping nicotine could prevent 48 million children and young adults from becoming addicted. The agency also predicts that nearly 13 million people would quit smoking within a year.
A 2018 study estimated that a nicotine cap would cause 16 million fewer people to be tobacco dependent by 2060. That number would increase, the study projected, 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,” said Yolonda C. Richardson, president and CEO of the Campaign for Children tobacco-free, in a press release.
Dr. Scott Gottlieb, who served as FDA commissioner during the first Trump administration, said the FDA’s proposal is “an important step in realizing a broader vision” of how the agency can use its authority to help smokers give up combustible cigarettes.
Gottlieb added that adults who still want access to nicotine would have a market for “properly regulated non-combustible products, like pouches and e-cigarettes, that do not cause all the deaths and illnesses associated with smoking.”
This does not mean that vapes and other products not covered by 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.
“Young people should not use tobacco products, and adults who are not currently using tobacco products should not start now,” King said.
The public will have the opportunity to provide feedback on the FDA’s proposal until mid-September.
