Tobacco Industry Fights Biden’s Proposed Cigarette Nicotine Cut

The future of a Biden-era proposal to slash nicotine levels in cigarettes is uncertain after the Trump administration excluded it from a key regulatory roadmap amid growing industry pressure to scrap the bid.

The Food and Drug Administration’s rule—proposed in the last few days of former President Joe Biden’s term—would cut nicotine levels in cigarettes to make them less addictive. The proposal was floated in President Donald Trump’s first term but never implemented.

The decision to advance or kill the proposed regulation could have a significant impact on the tobacco industry, economy, and public health, according to the nearly 5,000 comments weighing the rule. Leading cigarette manufacturers including Philip Morris USA Inc. and Reynolds American Inc. argued it would upend the tobacco industry and invite legal challenges. Public health groups, meanwhile, said it’s legal and accelerates progress to prevent and reduce smoking, along with the death and disease it causes.

The FDA left the proposal off a semi-annual regulatory agenda posted this month that details its planned rulemaking, raising the question of whether it plans to move forward and finalize the rule.

“The Trump administration needs to answer the question of whether they will allow the FDA to proceed with the final rule,” Mitch Zeller, former director of the FDA’s Center for Tobacco Products in Trump’s first term, said in an interview.

“What the Biden administration did is 1,000% consistent with what the Trump administration had,” Zeller said, now a clinical associate professor at Dartmouth College.

The FDA did not respond to requests for comment on next actions, but Commissioner Marty Makary has discussed efforts to stop children from starting nicotine products, namely vaping.

Tobacco use is recognized by the World Health Organization as one of the biggest public health threats in the world, responsible for over 7 million deaths. Cigarette smoking has declined over the past decades among the overall population, but tobacco use still remains the leading cause of preventable disease and death.

Illegal, Unachievable

Top cigarette makers aggressively argued the rule, if implemented, would violate the Family Smoking Prevention and Tobacco Control Act, the law that grants the FDA the power to regulate the tobacco industry.

It authorizes the FDA to consult broadly and meaningfully with stakeholders who may be affected by a tobacco product standard, but the agency hasn’t widely sought input or shared its thinking about “very low nicotine content” regulation since 2018, opponents said in comments.

The law also forbids the FDA from issuing a regulation that reduces nicotine levels in tobacco products to zero, but companies claimed the agency’s proposed level of 0.70 milligrams of nicotine per gram of total tobacco practically results in that.

“You can imagine a lot of legal fights about what zero means,” Lynn Kozlowski, dean emeritus at the University at Buffalo School of Public Health and Health Professions, said in an interview. “If it doesn’t any longer function as, let’s call it a regular cigarette, is that taking the nicotine level to zero if the nicotine is not enough there to ring the smoker’s bell?”

Altria Client Services, representing Phillip Morris and John Middleton Co., called the proposal a “bad idea” that lacks analytical methods to support a nicotine reduction standard.

Critics also said the rule would be in violation of Trump’s “deregulation” executive order issued in February that requires agencies to identify and rescind regulations that impose significant costs upon private parties that are not outweighed by public benefits.

“This would entail significant costs to private parties, and would very likely take a minimum of eight to twelve years to implement,” said ITG Brands LLC, a leading manufacturer and distributor of tobacco products.

Other industry feedback questioned the FDA’s implementation, another area susceptible to lawsuits, attorneys say.

“Technical achievability is something that FDA is required by law to consider when it implements a tobacco product standard, and it’s not clear to me that they’ve adequately considered that issue,” said Bryan Haynes, head of Troutman Pepper Locke’s tobacco and nicotine practice.

“When you have the evident reasons for this not being great—cigarette smoking rates and use consumption are already at historic lows, coupled with the economic impacts—that strikes me as another area in which a rule, if promulgated, would be vulnerable to challenges,” Haynes said in an interview.

‘End Game Strategy’

Anti-tobacco advocates and public health groups, however, are pushing back on claims that the FDA is overstepping its authority.

The FDA under federal law can issue a product standard that reduces nicotine yields, so long as it doesn’t reduce them to zero, proponents of the rule argued. The FDA can also adopt product standards if shown to be appropriate for the protection of the public health, they said.

“Any administration that moves forward with this rule is completely on the correct side of the law,” Zeller said.

Public health groups including the Campaign for Tobacco-Free Kids and the American Lung Association called on the FDA to broaden the proposal to include all tobacco products, such as hookah, e-cigarettes, and nicotine pouches, to limit the possibility that cigarette smokers will switch to other products to fulfill their addiction.

“Across the tobacco control scientific community, we really see a nicotine standard as the ultimate tobacco end game strategy,” said Jamie Tam, an associate professor at the Rutgers School of Public Health specializing in tobacco studies.

“Maybe it’s being de-prioritized for the current term, but that doesn’t rule out the possibility it would come back onto the unified agenda at a later point in time,” Tam said in an interview.

Michael Bloomberg has campaigned and given money in support of a ban on flavored e-cigarettes and tobacco. Bloomberg Law is operated by entities controlled by Michael Bloomberg.