FDA Proposed Rule Would Limit Nicotine Content in Cigarettes, Cigars, Other Combusted Products
The agency estimates that limiting nicotine levels could lead to 1.8 million fewer tobacco-related deaths by 2060 and health care savings of $1.1 trillion a year over the next 40 years.
Nicotine levels in cigarettes and cigars would be reduced to nonaddictive levels under a new rule proposed by the FDA.
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Currently there is no limit on nicotine, the substance that makes combusted smoking products so addictive. If the United States adopts the rule, it would be the first country in the world to take that action against the leading cause of preventable death in the nation, and a contributor to chronic disease.
“Multiple administrations have acknowledged the immense opportunity that a proposal of this kind offers to address the burden of tobacco-related disease,” FDA Commissioner Robert M. Califf, MD, said in the agency’s January 15 announcement.
“Today’s proposal envisions a future where it would be less likely for young people to use cigarettes and more individuals who currently smoke could quit or switch to less harmful products,” Califf said. “This action, if finalized, could save many lives and dramatically reduce the burden of severe illness and disability, while also saving huge amounts of money. I hope we can all agree that significantly reducing the leading cause of preventable death and disease in the U.S. is an admirable goal we should all work toward.”
While the national rate of smoking has plummeted in the last few decades, FDA reported smoking is estimated to kill almost 500,000 people a year. Health care costs and lost productivity tally up to approximately $600 billion a year.
No ban on smokes
FDA noted the rule is not a ban of cigarettes or any smoking products. Rather, nicotine would be capped at 0.7 milligrams per gram of tobacco in cigarettes, roll-your-own tobacco, pipe tobacco and most cigars. That level of nicotine would be low enough that cigarettes and the other products would no longer create or sustain addiction. FDA said research also indicates that when nicotine content is lower, smokers do not compensate by smoking more.
“Today, we’re taking a critical step in the rulemaking process by providing the public with a proposal they can review and engage on,” Brian King, PhD, MPH, director of the FDA’s Center for Tobacco Products, said in the announcement. “This proposal allows for the start of an important conversation about how we meaningfully tackle one of the deadliest consumer products in history and profoundly change the landscape of tobacco product use in the United States.”
Health effects over time
FDA researchers have projected a potentially massive health effect for the nation if nicotine is limited. By year 2100, an estimated 48 million youth and young adults will not start smoking. Within one year, a projected 12.9 million current smokers will stop, with that number rising to 19.5 million within five years of the finalized rule. By 2060, there will be 1.8 million fewer deaths due to tobacco, and that number will rise to 4.3 million by the end of the century.
That, in turn, leads to health savings: $1.1 trillion a year over the next 40 years, according to FDA.
Public comments
A public comment period will run from January 16 to September 15. The FDA announced it specifically is requesting data on:
- The products covered by the proposed product standard.
- The proposed limit to the nicotine level.
- The proposed two-year effective date and likelihood that companies will be able to comply within that timeframe.
- The potential for illicit trade resulting from the proposed product standard and any related impact to public health.
The notice of proposed rule is published online in the Federal Register with the draft rule. Additional details on the commenting process are expected soon.
Key Messages
- The FDA proposes reducing nicotine in cigarettes and cigars to nonaddictive levels, aiming to curb tobacco-related diseases and deaths.
- The rule would cap nicotine at 0.7 mg per gram of tobacco, not banning smoking products but reducing addiction potential.
- Projections suggest significant health benefits, including millions fewer smokers and deaths, with substantial healthcare savings.
- Public comments on the proposal are open until September 15, focusing on product coverage, nicotine limits, compliance timelines, and potential illicit trade impacts.
