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FDA Proposes Substantial Nicotine Limitation

A newly submitted rule would set a maximum nicotine level for tobacco products.
Angela Hanson
Tobacco Deep Dive

WASHINGTON, D.C. — The U.S. Food and Drug Administration opened the door to significantly cutting down on the amount of nicotine in tobacco products through a newly proposed rule it submitted to the Office of Management and Budget on Dec. 10.

"A proposed product standard to establish a maximum nicotine level to reduce the addictiveness of cigarettes and certain combusted tobacco products, when finalized, would be among the most impactful population-level actions in the history of U.S. tobacco product regulation," the FDA said in a statement.

[Read more: Massachusetts Lawmakers to Propose Phasing Out Nicotine Sales]

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This regulatory step does not mean overnight change, but experts say it could significantly improve public health, according to a CNN report.

The FDA first discussed the possibility of lowering nicotine in cigarettes in 2018. Four years later, FDA Commissioner Robert Califf announced the agency was developing a rule requiring tobacco companies to lower nicotine levels to no higher than a designated maximum level.

Health experts told CNN that adopting the rule could have a positive effect on public health by making it less likely that people would become addicted to nicotine and make it easier for those who want to quit to do so, but not all smokers would quit, and smoking-related diseases would still exist, as other chemicals in tobacco products can be harmful.

The timeline for the proposed rule is expected to be long. The Office of Management and Budget's approval process can take months and would include a public comment period. Litigation from the tobacco industry is also possible, as is a course change for the agency upon the upcoming change in presidential administration.

NACS stated that it is paying close attention to the proposed rule, as its implications could significantly impact the convenience store industry. 

"NACS is closely following the Biden Administration's plans to reduce the nicotine content in cigarettes, and we will review the proposal once it is published," stated Anna Ready Blom, director of government relations for NACS. "NACS has long expressed concerns that any changes to tobacco policy must address the growing illicit tobacco market in the U.S. for it to be effective. Unfortunately, as we most recently saw with the menthol proposal, FDA failed to consider how illicit sellers would seize the opportunity to lure current tobacco users to buy counterfeit, unregulated products, an unintended consequence that would cause great harm."

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