The FDA is moving forward with last-minute action to reduce nicotine levels in cigarettes

The Biden administration unveiled the proposal on Wednesday lowering nicotine levels in cigarettes, a last-minute implementation of a plan that could significantly reduce cancer rates nationwide and extend the lives of millions of cigarette smokers.

If finalized, proposal would require cigarette manufacturers to significantly reduce the levels of nicotine in their products to make smoking less addictive and less satisfying. Research suggests the move will assist fewer people take up the habit and assist the country’s roughly 30 million smokers quit or switch to less harmful alternatives such as e-cigarettes.

The policy is a central part of anti-smoking initiatives led by Dr. Robert Califf, commissioner of the Food and Drug Administration, who during his medical career spoke about treating heart patients ravaged by smoking.

“This is the greatest thing I have ever seen in terms of societal benefits, cost savings and lives saved, as well as preventing strokes and cancer,” Dr. Califf said.

The policy’s accompanying effort to ban menthol cigarettes was indefinitely shelved after fierce opposition from cigarette manufacturers and other opponents, including convenience store retailers.

It is unclear whether the nicotine reduction plan will survive the novel administration of President-elect Donald J. Trump. Trump has traditionally been warm to industry and opposed to stringent regulation of businesses. Additionally, he had the backing of tobacco companies, including Reynolds American, which donated at least $8 million to Trump’s main super PAC during the presidential campaign. Reynolds has already expressed his opposition to the proposed requirement.

Susie Wiles, Trump’s campaign co-chair and future chief of staff, was a lobbyist for the cigar company Swisher. The rule applies to cigarettes, roll-your-own tobacco, pipe tobacco and cigars (but not premium cigars).

Some public health advocates are hopeful that the Trump administration will allow the proposal to proceed, given that a previous version was considered by the FDA during his first term. Officials could at least continue to allow the public to comment on the initiative without eliminating it or implementing it.

The FDA’s proposal projects that by 2100, the introduction of nicotine control would prevent approximately 48 million adolescent people from starting smoking. The agency also estimates that 1.8 million tobacco-related deaths will be prevented by 2060 and $30 trillion in benefits will accrue over 40 years, mostly for the generation that doesn’t start smoking.

“We have an extremely toxic and addictive cigarette product that remains on the market that still kills almost half a million people a year,” said Dorothy Hatsukami, a tobacco researcher at the University of Minnesota who has studied low-nicotine cigarettes for about 15 years. “It’s a really unfortunate situation that we haven’t really done anything dramatic about it.”

In 2022, Dr. Califf released an updated proposal for lowering nicotine levels, and opposition began to grow almost immediately.

Tobacco companies considered this initiative a major threat to their business. Luis Pinto, a spokesman for Reynolds American, said the proposal would “effectively eliminate legal cigarettes and fuel an already massive market for illicit nicotine.”

“These actions would also have a significant negative economic impact on farmers, retailers and others,” he added.

Convenience store retailers also opposed earlier versions of the proposal, saying they would suffer significant revenue losses from the projected decline in cigarette sales.

Republicans in Congress have also tried to thwart nicotine restrictions. In 2023, members of the influential Chamber subcommittee passed a certain measure it would prevent the FDA from spending any money on increasing nicotine limits, with almost all votes supporting Republicans. The Senate did not include this provision in the final budget package.

Still, supporters of the plan point to signs that future public health officials may be open to it, including the popularity of Robert F. Kennedy Jr.’s pledge. on fighting chronic diseases and improving the health of Americans if he is confirmed to lead the nation’s most essential health agency. Trump himself has said that he is personally against smoking.

“Given these tremendous benefits, we urge the incoming Trump administration to make progress in finalizing and implementing this rule,” Yolonda C. Richardson, president of the Campaign for Tobacco-Free Kids, said in a statement. “Few actions would make a bigger difference in the fight against chronic diseases like cancer and cardiovascular disease, which significantly threaten health in the United States and which the novel administration has determined should be a priority.”