The Food and Drug Administration advanced its proposed rule to establish a maximum nicotine level in cigarettes and certain finished tobacco products.
The proposed rule, Tobacco Product Standard for Nicotine Level of Certain Tobacco Products, was entered Tuesday into the Office of Management and Budget’s (OMB) Regulatory Information Service Center (ROCIS) system, which is part of the standard OMB review of regulatory documents, the FDA said.
“A proposed product standard to establish a maximum nicotine level to reduce the addictiveness of cigarettes and certain other 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.
This regulation is “misguided as cigarette smoking rates are already declining and at historic lows,” National Association of Tobacco Outlets (NATO) Executive Director David Spross told CSP. Spross said the regulation would “have consequences to licensed retailers which will include significant lost revenue, coupled with job losses across the country.”
Tobacco companies also disagree with the proposal, including Winston-Salem, North Carolina-based tobacco company Reynolds American Inc.
Luis Pinto, vice president corporate communications at Reynolds American Inc., told CSP that smoking rates are at historic lows, and reducing nicotine content in cigarettes will not make these products less risky or improve public health.
“These actions would effectively eliminate legal cigarettes and fuel an already massive illicit nicotine market,” said Pinto. “These actions would also have a significant negative economic impact on farmers, retailers, and others. Instead of focusing on prohibitionist policies, FDA should focus its resources on authorizing potentially reduced risk products that exist today but continue to languish at the agency—many for more than four years. FDA should also refocus its efforts on enforcing against illicit vapor products that are targeted at youth and violate virtually every rule and policy FDA has established.”
The advancing of the rule doesn't mean there would be immediate changes, though. The OMB's approval process generally takes months and involves a public comment period. It's also unclear how President-elect Donald Trump would handle the proposal.
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.
In June of 2022, the administration published plans for future potential regulatory actions, which included FDA Commissioner Robert Califf saying at the time of the announcement that “nicotine is powerfully addictive. Making cigarettes and other combusted tobacco products minimally addictive or non-addictive would help save lives.”
The American Lung Association’s President and CEO Harold Wimmer issued a statement Wednesday on the FDA's move, calling the proposal a game-changer in the country's efforts to eliminate tobacco use.
“Making tobacco products non-addictive would dramatically reduce the number of young people who become hooked when they are experimenting," he said. "To fully address the toll of tobacco on our nation’s health and across all communities, it is critical to reduce nicotine levels to non-addictive levels in all commercial tobacco products, including e-cigarettes. The Lung Association looks forward to reviewing the proposed rule and providing our comments to FDA.”
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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