FDA Seeks Public Comments on Proposal to Limit Nicotine Levels
WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) formally issued a proposed rule on Jan. 15 that would limit the amount of nicotine in cigarettes and certain other combusted tobacco products to non- or minimally addictive levels. If finalized, the rule would make the United States the first country to take such a significant action to prevent and reduce smoking-related disease and death, according to the agency.
A public comment period on the proposed rule will run from Jan. 16 through Sept. 15. Along with general comments, the FDA is specifically soliciting input on certain topics, including the products to be covered by the proposed 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; and the potential for illicit trade resulting from the proposed standard and any related impact to public health.
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The FDA's Tobacco Products Scientific Advisory Committee will also provide input on the proposal.
"Multiple administrations have acknowledged the immense opportunity that a proposal of this kind offers to address the burden of tobacco-related disease," said FDA Commissioner Robert M. Califf, M.D. "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, while also saving huge amounts of money," he continued. "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."
After the FDA submitted the proposed rule to the Office of Management and Budget on Dec. 10, 2024, NACS stated it is paying close attention to the proposed rule, as its implications could significantly impact the convenience store industry, as Convenience Store News previously reported.
The rule would cap the nicotine level at 0.7 milligrams per gram of tobacco in cigarettes and certain other combusted tobacco products, and would not ban cigarettes or any other tobacco products.
It would apply to cigarettes, cigarette tobacco, roll-your-own tobacco, most cigars (including little cigars, cigarillos and most large cigars) and pipe tobacco. It does not include e-cigarettes, nicotine pouches, noncombustible cigarettes (such as heated tobacco products that meet the definition of a cigarette), waterpipe tobacco (hookah), smokeless tobacco products or premium cigars.
"Today, we're taking a critical step in the rulemaking process by providing the public with a proposal they can review and engage on," said Brian King, Ph.D., M.P.H, director of the FDA's Center for Tobacco Products. "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."