The Food and Drug Administration is planning to require tobacco firms to slash the quantity of nicotine in traditional cigarettes to make them less addictive and reduce the toll of smoking that claims 480,000 lives annually.
The proposal, which could take years to enter effect, would put america on the forefront of worldwide antismoking efforts. Just one other nation, Recent Zealand, has advanced such a plan.
The headwinds are fierce. Tobacco firms have already indicated that any plan with significant reductions in nicotine would violate the law. And a few conservative lawmakers might consider such a policy one other example of presidency overreach, ammunition that would spill over into the midterm elections.
Few specifics were released on Tuesday, but in keeping with a notice published on a U.S. government website, a proposed rule could be issued in May 2023 in search of public comment on establishing a maximum nicotine level in cigarettes and other products. “Because tobacco-related harms primarily result from addiction to products that repeatedly expose users to toxins, F.D.A. would take this motion to scale back addictiveness to certain tobacco products, thus giving addicted users a greater ability to quit,” the notice said.
The F.D.A. declined to supply further details. But in a statement posted on its website, Dr. Robert M. Califf, the agency’s commissioner, said: “Lowering nicotine levels to minimally addictive or non-addictive levels would decrease the likelihood that future generations of young people develop into hooked on cigarettes and help more currently addicted smokers to quit.”
Similar plans have been discussed to reduce Americans’ addiction to tobacco products that coat the lungs with tar, release 7,000 chemicals and result in cancer, heart disease and lung disease. Nicotine can be available in e-cigarettes, chews, patches and lozenges, but this proposal wouldn’t affect those products.
“This one rule could have the best impact on public health within the history of public health,” said Mitch Zeller, the recently retired F.D.A. tobacco center director. “That’s the scope and the magnitude we’re talking about here because tobacco use stays the leading reason behind preventable disease and death.”
About 1,300 people die prematurely every day of smoking-related causes, in keeping with the Centers for Disease Control and Prevention.
The obstacles to such a plan, though, are immense and will take years to beat. Some plans which were floated would require a 95 percent reduction in the quantity of nicotine in cigarettes. Experts say that would toss U.S. smokers, an estimated 30 million people, right into a state of nicotine withdrawal, which involves agitation, difficulty focusing and irritability and send others in the hunt for alternatives resembling e-cigarettes. Those deliver nicotine without many of the chemicals present in flamable cigarettes.
Experts said that determined smokers might seek to purchase high-nicotine cigarettes on illegal markets or across the borders in Mexico and Canada.
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The F.D.A. would likely need to overcome opposition from the tobacco industry, which has already begun stating the explanations the agency cannot upend an $80 billion market. Legal challenges could take years to resolve, and the agency may give the industry five or more years to make the changes.
The trouble to lower nicotine levels follows a proposed rule announced in April that will ban menthol-flavored cigarettes, that are heavily favored by Black smokers. That proposal was also hailed as a possible landmark advance for public health and has already drawn tens of hundreds of public comments. The F.D.A. is certain to review and address those comments before finalizing the rule.
Other major tobacco initiatives outlined within the landmark 2009 Tobacco Control Act have been slow to take shape. A lawsuit delayed a requirement for tobacco firms to place graphic warnings on cigarette packs. And the agency recently said it might take up to a different yr to finalize key decisions on which e-cigarettes might remain in the marketplace.
A press release from the tobacco company Altria, the maker of Marlboro, offered a preview of arguments that opponents are expected to make against any rule that drastically slashes nicotine levels. “The main target must be less on taking products away from adult smokers and more on providing them a strong marketplace of reduced harm FDA-authorized smoke-free products,” the corporate said in a press release on Tuesday. “Today marks the beginning of a long-term process, which should be science-based and account for potentially serious unintended consequences.”
RAI Services, the parent company of RJ Reynolds, declined to comment on the announcement, but said: “Our belief is that tobacco harm reduction is the easiest way forward to scale back the health impacts of smoking.”
“Each an express and a de facto ban would have precisely the identical effect — each would eviscerate Congress’s expressly stated purpose ‘to allow the sale of tobacco products to adults,’” in keeping with a letter in 2018 from RAI Services to the F.D.A. about an earlier proposal.
Five years ago, Dr. Scott Gottlieb, the agency’s commissioner on the time, released a plan to chop nicotine levels in cigarettes to a minimally or non-addictive level. The proposal took shape in 2017 but didn’t result in a proper rule through the Trump administration.
Among the many 8,000 comments that poured in on that proposal, opposition emerged from retailers, wholesalers and tobacco firms. The Florida Association of Wholesale Distribution, a trade group, said it could result in “recent demand for black market products, and lead to increased trafficking, crime and other criminality.”
In 2018, RAI Services said that the F.D.A. had no evidence that the plan to chop nicotine levels would improve public health. The agency “would wish to provide tobacco manufacturers a long time to comply” and determine the right way to consistently grow low-nicotine tobacco, RAI said within the letter to the F.D.A. The Tobacco control law of 2009 gave the F.D.A. broad powers to control tobacco products with standards “appropriate for the protection of the general public health,” although the law specifically outlawed a ban on cigarettes or the reduction of nicotine levels to zero.
Low-nicotine cigarettes are already available to consumers, albeit in a limited fashion. This spring, a Recent York plant biotech company, twenty second Century Group, began selling a reduced-nicotine cigarette that took 15 years and tens of hundreds of thousands of dollars to develop through the genetic manipulation of the tobacco plant. The corporate’s brand, VLN, comprises 5 percent of the nicotine level of conventional cigarettes, in keeping with James Mish, the corporate’s chief executive.
“This just isn’t some far-off technology,” he said.
To earn its F.D.A. designation as a “reduced-risk” tobacco product, VLN was subjected to a raft of testing and clinical trials by regulators.
For now, the corporate is selling VLN at Circle K convenience stores in Chicago as a part of a pilot program. Mr. Mish described sales as “modest” — retail prices are much like premium brands like Marlboro Gold — but he said the F.D.A. proposal would almost definitely speed up plans for a national rollout in the approaching months.
Dr. Neal Benowitz, a professor of drugs on the University of California, San Francisco, who studies tobacco use and cessation, first proposed the concept of paring the nicotine out of cigarettes in 1994.
He said one key concern was whether smokers would puff harder, hold in smoke for an extended time or smoke more cigarettes to compensate for the lower nicotine level. After several studies, researchers discovered that the cigarette that prevented those behaviors was the lowest-nicotine version, one with about 95 percent less of the addictive chemical.
Dorothy K. Hatsukami, a professor of psychiatry on the University of Minnesota who studies the connection between nicotine and smoking behavior, said a growing body of evidence suggested that a rapid and significant reduction of nicotine in cigarettes would supply greater public health advantages than the gradualist approach that some scientists had been promoting.
A 2018 study led by Dr. Hatsukami that followed the habits of 1,250 smokers found that participants who had been randomly assigned cigarettes with ultralow nicotine smoked less and exhibited fewer signs of dependency than those that had been given cigarettes with nicotine levels that were step by step reduced over the course of 20 weeks.
There have been, nevertheless, downsides to slashing nicotine in a single fell swoop: Participants dropped out of the study more incessantly than those within the gradualist group, and so they experienced more intense nicotine withdrawal. Some secretly turned to their regular, full-nicotine brands.
“The underside line is we’ve known for a long time that nicotine is what makes cigarettes so addictive, so in the event you reduce the nicotine, you make the experience of smoking less satisfying, and also you increase the likelihood that individuals will attempt to quit,” she said.
A recent study offers a cautionary tale, though, on the degree of public health profit that lawmakers can expect from tobacco-control policy. While there is no such thing as a other nation to look to for experience with a low-nicotine cigarette mandate, there may be for the menthol flavor ban.
Alex Liber, an assistant professor within the oncology department of Georgetown University’s School of Medicine who studies tobacco control policy, examined Poland’s experience with a menthol cigarette ban instituted in 2020.
The study he and others wrote found the ban didn’t result in a decrease in overall cigarette sales, Mr. Liber said, probably because tobacco firms cut cigarette prices and in addition began selling flavor-infusion cards (for a few quarter each) that users can put of their cigarette pack so as to add back the flavour. (Some experts say any move to sell flavor-infusion cards within the U.S. would likely be illegal.)
“They know the right way to sell and generate profits and they’re going to make increasingly so long as they’ve wiggle room,” he said. “I just expect nothing less.”
Zolan Kanno-Youngs contributed reporting from Washington.