Janelle Irwin Taylor
As part of his efforts to curb nicotine addiction and reduce harmful smoking habits, President Joe Biden’s administration is moving forward in the final days of his tenure with a proposed rule that would limit the amount of nicotine in cigarettes, a move critics say would effectively ban them altogether.
The rule, the details of which have not yet been made public, would reduce nicotine levels in cigarettes to a less addictive, possibly even non-addictive level, with the goal of pushing smokers to quit or to use less harmful products.
The rule, which has been in the works since 2022, was submitted by the Food and Drug Administration (FDA) to the Office of Management and Budget (OMB) last month, and the OMB cleared it last week.
While the proposal carries with it myriad hopes for reducing harmful smoking — smoking and secondhand smoke exposure cause more than 480,000 deaths in the U.S. each year, according to the Centers for Disease Control and Prevention (CDC) — it has created massive pushback from some who argue such a rule would push cigarette sales into the black market, making products potentially even more harmful and possibly handing the market to dangerous drug cartels.
The FDA announced its plans, under Biden’s administration, “to develop a proposed product standard that would establish a maximum nicotine level to reduce the addictiveness of cigarettes and certain other combusted tobacco products. The goal of the potential rule would be to reduce youth use, addiction and death.”
The announcement claimed “tobacco use costs nearly $300 billion a year in direct health care and lost productivity.” The report notes that it is not nicotine that “makes smoking cigarettes so toxic,” but laments that it is the “ingredient that makes it very hard to quit smoking.”
Further, the announcement also included a citation from an FDA paper published in the New England Journal of Medicine in 2018 that projected a smoking rate of just 1.4% nationwide, from the current 12.5%, by 2100 if such a rule were implemented. That would translate to 8 million fewer deaths from tobacco-related illnesses, the agency said.
Yet as promising as those estimates are, critics are still concerned about what they describe as unintended consequences.
The National Association of Tobacco Outlets in late 2024 commissioned the firm Chmura to prepare a white paper analyzing impacts to the proposed rule. It looks at academic research that researchers say the FDA has previously referenced in establishing a maximum nicotine content of 0.3-0.5 milligrams per gram of tobacco, which would be a 95% reduction in nicotine levels currently used in cigarettes.
Indeed, its research found that such a reduction would lead to approximately just 6% of current legal cigarette sales in the U.S. as a result of demand reduction from users shifting to alternative products, reducing use, participating in illicit markets or quitting altogether.
That reduction to a market that sees more than $90 billion in sales each year, Chmura said, would be a crippling cut to tax revenue among taxing authorities at the federal, state and local levels, or a $24 billion overall reduction to total tax contributions. Its white paper suggests that, under such a rule, as much as 57.5% of future cigarette market sales could be concentrated to illicit providers, which would translate to approximately $43 billion in funding for illicit markets.
Those critical of the proposed rule further define such “illicit markets” as those benefiting transnational criminal organizations, such as cartels.
In a letter in 2023 to Secretary of State Antony Blinken, a bipartisan group of U.S. Senators — Republicans Marco Rubio, Bill Cassidy and Bill Hagerty, and Democrats Bob Casey and Mark Warner — warned of the influence of dangerous drug cartels from Mexico trafficking in black market cigarettes.
“In 2015, the State Department cited activity by terrorist groups, and criminal networks who have used tobacco trafficking operations to finance other crimes, including ‘money laundering, bulk cash smuggling, and the trafficking in humans, weapons, drugs, antiquities, diamonds, and counterfeit goods,’” the Senators wrote.
“Recently, public reporting has also noted these financial linkages between Mexican transnational criminal organizations (TCOs) involved in narcotics and fentanyl trafficking, and these tobacco smuggling activities. Mexican TCOs pose a grave threat to American national security and public health.”
And it’s not just politicians who are concerned. Rich Marianos is a former assistant director of the U.S. Bureau of Alcohol, Tobacco, Firearms and Explosives who specializes in counterterrorism, crime and law enforcement, criminal law, criminal victimization, and intelligence as an adjunct lecturer at Georgetown University. Marianos told Fox News this week that the proposed rule, which he referred to as a ban, “is a gift with a bow and balloons to organized crime cartels,” pointing not just to Mexico, but also Chinese organized crime and the Russian mafia.
“It’s going to keep America smoking, and it’s going to make the streets more violent,” he said.
Critics, including the tobacco industry itself, instead prefer harm-reduction efforts that emphasize a transition to e-cigarettes and other combustible tobacco product alternatives.
And even if the Biden administration approves the rule in its waning days — President-elect Donald Trump will be sworn into office on Jan. 20 — it’s not clear whether the rule would survive the incoming administration.
Trump himself is opposed to smoking, but hasn’t weighed in on this issue specifically. He previously voiced support for the vaping industry, and given the opposition from the tobacco industry and the more than $1 billion impact the rule is expected to have on the economy, Trump may feel pressure to roll back the rule.
There is also public opinion to consider. The Biden administration previously postponed indefinitely its plan to ban menthol cigarettes, a move made amid election-year pushback. Operatives feared political backlash from Black voters in the November Presidential Election had the ban been implemented, according to The Associated Press. The administration gave no timeline for reviving the plan and, with just 11 days left in office, hasn’t revisited it.
