Tobacco

FDA Publishes Proposal to Slash Nicotine in Cigarettes

The public, convenience retailers can provide comments on the rule through Sept. 15
cigarette ashtray
Photograph: Shutterstock

President Joe Biden leaves office in less than a week, but despite the clock winding down, efforts are still being made to cut the nicotine level in cigarettes.

On Wednesday the Food and Drug Administration published a proposed rule that would slash the amount of nicotine allowed in cigarettes and certain finished tobacco products.

“If finalized, the United States would be the first country globally to take such a bold, life-saving action to prevent and reduce smoking-related disease and death,” the FDA said.

The proposed rule, Tobacco Product Standard for Nicotine Level of Certain Tobacco Products, would not ban cigarettes or any other tobacco products, but instead the FDA said it is proposing to cap the nicotine level at 0.7 milligrams per gram of tobacco in cigarettes and certain other combusted tobacco products. The average nicotine content in the top 100 cigarette brands for 2017 was 17.2 milligrams per gram of total tobacco, the FDA said in its proposal. 

“This rule puts the power back in the hands of individuals, enabling those who want to quit to be successful and preventing millions of youths and others from starting in the first place,” according to a White House statement.

The FDA’s proposal would apply to cigarettes, cigarette tobacco, roll-your-own tobacco, most cigars, including little cigars, cigarillos, and most large cigars and pipe tobacco. The proposed rule 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, the agency said.

“Today, we’re taking a critical step in the rulemaking process by providing the public with a proposal they can review and engage on,” the FDA’s Center for Tobacco Products (CTP) Director Brian King said. “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.”

Starting on Thursday, the public will have through Sept. 15 to provide comments, which the FDA will review as it considers future action, the agency said.

In addition to general comments, the FDA said it is requesting input on several topics, including, 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 time frame; and the potential for illicit trade resulting from the proposed product standard and any related impact to public health.

The Biden administration included the initiative in its latest Unified Agenda, a document released twice a year that describes each federal agency’s upcoming regulatory actions. During his 2023 State of the Union Address, Biden addressed his goals to further reduce smoking as part of his Cancer Moonshot Initiative, which was created during the Obama administration. In May of 2024, the White House delayed its planned menthol cigarette ban following “immense” feedback and “historic” attention.

As for how President-elect Donald Trump would handle the proposal, it remains unclear.

During his first presidency, Trump signed legislation amending the Federal Food, Drug and Cosmetic Act, and raised the federal minimum age for sale of tobacco products, including vaping devices from 18 to 21 years. The FDA’s comprehensive plan was first introduced in March 2018 under then-FDA Commissioner Scott Gottlieb. The agency shelved those plans when Gottlieb left the agency in 2019.

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