FDA proposes cap on nicotine levels in cigarettes
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Key takeaways:
- The FDA is seeking to cap nicotine levels at 0.7 mg per g.
- This new standard would go into effect 2 years after being finalized.
- The proposed rule could avert about 1.8 million tobacco-related deaths by 2060.
The FDA has proposed limiting the level of nicotine in cigarettes and other combusted tobacco products like cigars and pipe tobacco to make them “minimally or nonaddictive,” according to a press release from the agency.
The rule would go into effect 2 years after being finalized. The United States would be the first country to take such action against cigarette smoking, which is estimated to kill nearly half a million people in the U.S. each year, the agency said.
“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 release. “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. This action, if finalized, could save many lives and dramatically reduce the burden of severe illness and disability.”
The FDA’s intent to propose a nicotine rule was first announced in 2018.
The agency is seeking to cap nicotine levels at 0.7 mg per g, which is a steep decrease from the average nicotine levels currently found in combusted tobacco products, and low enough to “no longer create or sustain addiction,” the FDA said.
Using its population health model, the FDA estimated that the rule would result in 12.9 million people quitting smoking within 1 year of going into effect, and 19.5 million people within 5 years.
The agency further projected that the rule would avert 1.8 million tobacco-related deaths by 2060, translating to about $1.1 trillion in savings, and 4.3 million deaths by the end of the century.
In addition to cigarettes, the proposed rule would apply to cigarette tobacco, “roll-your-own” tobacco, most cigars and pipe tobacco. It does not apply to e-cigarettes, premium cigars, nicotine pouches, smokeless tobacco, noncombusted cigarettes or waterpipe tobacco (hookah), according to the release.
The FDA is encouraging the public to comment on the proposed rule starting Jan. 16. The comment period ends Sept. 15. The agency will also seek input from its Tobacco Products Scientific Advisory Committee.
Perspective
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This proposal, if enacted, would represent a landmark effort to reduce the detrimental impact of tobacco on public health in the U.S. The number of lives saved, reduction in tobacco-associated morbidity and cost savings would be substantial. However, achieving its goals is still a long way away as there will be enforcement challenges, responding to the likely proliferation of black markets proliferation and balancing the interests of various stakeholders. Nevertheless, it represents a bold step in tobacco control with far-reaching implications.
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