The Food and Drug Administration proposed a rule this week that could encourage millions of Americans to quit smoking cigarettes — and prevent millions more from ever developing a habit.
If finalized, the rule would limit the nicotine content of cigarettes to 0.7 milligrams per gram of tobacco — a limit low enough to stop people from developing addictions. The top 100 cigarette brands contain an average of 17.2 milligrams per gram of tobacco, research shows. The FDA estimates that more than 12.9 million people would stop smoking cigarettes one year after the standard takes effect, with that figure rising to 19.5 million after five years. It also could prevent 48 million young people from smoking altogether by 2100.
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"This is probably one of the most significant things that the FDA has done in its history to affect or limit tobacco use," said Dr. Jamie Garfield, a Temple Health pulmonologist and professor of thoracic medicine and surgery at the Lewis Katz School of Medicine. "And it absolutely has the potential to markedly change the way we see tobacco use in our country and reduce the leading cause of preventable death and disease in the U.S."
The impacts on health could be astonishing. FDA modeling suggests 1.8 million tobacco-related deaths would be prevented by 2060. The number would increase to 4.3 million by the end of the century. Along with lives, the rule would also save money. The FDA estimates more than $1.1 trillion would be saved each year due to the diseases and deaths prevented. Cigarette smoking has been linked to numerous conditions, including cancer, heart disease, stroke, type 2 diabetes, chronic obstructive pulmonary disease and fertility issues.
Scientific evidence suggests that cigarettes with lower nicotine levels do not encourage smokers to compensate by smoking more.
"If there's less nicotine in a typical cigarette, the products are gonna be less satisfying," Garfield explained. "They're also going to be less addictive. And so people who currently use cigarettes are going to, unintentionally or not, wean themselves off of their nicotine addiction, and they'll no longer continue to crave these products."
The 0.7 mg/g standard would only apply to cigarettes, cigarette tobacco, roll-your-own tobacco, pipe tobacco and most cigars. Products like e-cigarettes and nicotine pouches would be exempt. As Garfield noted, these items do not contain tobacco, and thus do not pose the same risks of cancer and chronic lung diseases.
"I don't generally recommend patients switch from one tobacco product to another, because I believe it's possible to get people off all of these products all together," Garfield said. "But as a harm reduction strategy, making products that don't contain tobacco or contain very small amounts of tobacco available will likely result in a reduction of some of the significant tobacco-related morbidity and mortality that we see."
These effects are all theoretical until the proposed rule becomes official. The FDA is accepting public comments through Sept. 15; after that date, the FDA will review and factor these messages into its next steps. If the rule becomes final, it would take effect two years after publication.
Garfield said she believes this outcome will require significant public lobbying and support. She noted the FDA previously proposed a rule to ban menthol cigarettes, which has stalled since its 2022 announcement. But if the nicotine in cigarettes is standardized, the ripple effects could be profound.
"More than 16 million Americans currently live with a disease caused by smoking and those diseases," Garfield said. "So if we were able to reduce the incidents of all of these smoking-related diseases, we would see less death, less disease, but even things like less exacerbations, less urgent care visits, less hospitalizations, less loss of work and school time, less medications because of less diseases, less cost (and) less harm to ourselves and to our loved ones."
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