The Food and Drug Administration (FDA) is set to propose limits on the levels of nicotine tobacco companies can place in traditional cigarettes in an attempt to make them less addictive, according to a notice published in the agency’s biannual regulatory agenda.
Proponents think the rule could save millions of lives from cancer and other smoking-related diseases if the White House can overcome the expected fierce opposition from the powerful tobacco industry.
Each year, 480,000 people die prematurely from a smoking-attributed disease, which makes tobacco use the leading cause of preventable disease and death in the United States.
According to the notice, the FDA will propose by 2023 “a tobacco product standard that would establish a maximum nicotine level in cigarettes and certain finished tobacco products.”
“Because tobacco-related harms primarily result from addiction to products that repeatedly expose users to toxins, FDA would take this action to reduce addictiveness to certain tobacco products, thus giving addicted users a greater ability to quit,” the agency said.
The FDA said reducing nicotine levels would also help to prevent young people from becoming regular smokers.
“The proposed product standard is anticipated to benefit the population as a whole while also advancing health equity by addressing disparities associated with cigarette smoking, dependence, and cessation,” the agency said in the notice.
No other details were released Tuesday, and it was not clear just how much nicotine would be permitted under the proposal.
The Biden administration will be facing pressure from anti-tobacco advocates to move quickly, as they argue such a measure is long overdue.
The FDA’s plan to set a nicotine threshold follows the agency’s proposed ban on menthol-flavored cigarettes, which was announced at the end of April.
Congress gave the FDA the power to regulate tobacco products in 2009. Scott Gottlieb, who ran the agency under former President Trump, floated a plan in 2017 for reduced nicotine levels in combustible cigarettes, but it was never formalized. Gottlieb left the agency in 2019.
Nancy Brown, CEO of the American Heart Association, said if the move happens, it would be one of “the most consequential actions the FDA could take to change the deadly trajectory of tobacco use in this country.”
Matt Myers, president of the Campaign for Tobacco-Free Kids, called the proposal “game changing” but said the gains will be realized only if the administration and the FDA “demonstrate a full-throated commitment to finalizing and implementing this proposal.”
“There is no other single action our country can take that would prevent more young people from becoming addicted to tobacco or have a greater impact on reducing deaths from cancer, cardiovascular disease and respiratory disease,” Myers added.
But the regulatory process does not usually move quickly, especially if there are legal challenges.
Critics argue people would wind up smoking more just to get the same level of nicotine they have grown accustomed to. They also argue a nicotine ban would lead to a black market of illegal activity and dangerous products.
And if the regulation is not finished before the end of Biden’s term, a new president could stop the agency from implementing it.