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The Food and Drug Administration plans to ask tobacco companies to reduce the amount of nicotine to make traditional cigarettes less addictive and to reduce the consumption of cigarettes, which kills 480,000 people each year.

The proposal, which could take years to take effect, would put the United States at the forefront of global anti-smoking efforts. Only one other nation, New Zealand, has developed such a plan.

The winds are strong. Tobacco companies have already stated that any plan that significantly reduces the amount of nicotine would violate the law. And some conservative lawmakers may view such a policy as another example of government overrun of ammunition that could spill over into midterm elections.

A few details were released on Tuesday, but According to a statement issued by the US government Web site, In May 2023, a proposed rule will be published to seek public opinion on setting the maximum nicotine level in cigarettes and other products. “Since tobacco-related harms are primarily due to addiction to products that repeatedly expose users to toxins, the FDA will take this action to reduce addiction to certain tobacco products, thereby giving addicted users greater quitting ability,” the statement said.

The FDA declined to provide further details. But a statement posted at On his website, the agency’s commissioner, Dr. Robert M. Califf said: “Reducing nicotine levels to minimally addictive or non-addictive levels will make the next generation of youth less likely to become addicted to cigarettes and help smokers who are more addicted now quit. ”

Similar plans have been discussed to reduce Americans’ dependence on tobacco products, which tar the lungs, release 7,000 chemicals, and cause cancer, heart disease, and lung disease. Nicotine is also found in e-cigarettes, chewables, patches, and lozenges, but this offer will not affect these products.

“This single rule may have the biggest impact on public health in the history of public health,” said Mitch Zeller, director of the recently retired FDA tobacco center. “That’s the scope and magnitude we’re talking about here because tobacco use remains the leading cause of preventable disease and death.”

According to the Centers for Disease Control and Prevention, about 1,300 people die prematurely every day from smoking-related causes.

The obstacles to such a plan, however, are enormous and may take years to overcome. Some plans released will require a 95 percent reduction in the amount of nicotine in cigarettes. Experts say this could put U.S. smokers, an estimated 30 million people, into a state of nicotine withdrawal that includes agitation, difficulty focusing, and irritability, sending others to seek alternatives like e-cigarettes. These deliver nicotine without many of the chemicals found in combustible cigarettes.

Determined smokers may try to purchase high-nicotine cigarettes from illegal markets or across borders in Mexico and Canada, experts said.

It will have to overcome opposition from the tobacco industry, which is starting to point to the reasons why the FDA is likely unable to raise an $80 billion market. Legal challenges can take years to resolve, and the agency can give the industry five or more years to make the changes.

The effort to lower nicotine levels follows a proposed rule announced in April that would ban menthol-flavored cigarettes, which are heavily favored by Black smokers. The proposal was also hailed as a potential public health milestone and has already attracted tens of thousands of people. general comments. The FDA must review and address these comments before finalizing the rule.

Other major tobacco initiatives outlined in the landmark 2009 Tobacco Control Act have been slow to take shape. A lawsuit delayed tobacco companies’ obligation to put graphic warnings on cigarette packs. And the agency recently said it will take another year to finalize key decisions about which e-cigarettes will stay on the market.

A statement from tobacco company Altria, the maker of Marlboro, offered a preview of the arguments competitors are expected to make against any rule that drastically reduces nicotine levels. “The focus should be less on removing products from adult smokers, but on providing them with a robust market of FDA-approved smokeless products with reduced harm,” the company said in a statement Tuesday. “Today marks the beginning of a long-term process that must be based on science and take into account potentially serious unintended consequences.”

RAI Services, parent company of RJ Reynolds, declined to comment on the announcement, but said: “It is our belief that reducing tobacco harm is the best way to reduce the health effects of smoking.”

RAI Services’ previous submission to the FDA in 2018.

Five years ago, the agency’s then commissioner, Dr. Scott Gottlieb published a plan. to cut nicotine levels minimal or non-addictive level in cigarettes. The proposal took shape in 2017, but did not lead to any official rule during the Trump administration.

between 8,000 comments Opposition has emerged from retailers, wholesalers and tobacco companies pouring in on this proposal. Florida Wholesale Distribution Association, a trade group, said that it might “New demand for black market products and increased human trafficking results in crime and other illegal activities.”

In 2018, RAI Services said the FDA had no evidence that the plan to lower nicotine levels would improve public health. The agency will “have to give tobacco manufacturers decades to adapt” and will need to figure out how to grow low-nicotine tobacco consistently. said the RAI In the letter to the FDA, the Tobacco control act of 2009 gave the FDA broad powers regulate tobacco products with standards “conforming to the protection of public health” the law specifically forbade a ban on reducing smoking or nicotine levels to zero.

Low nicotine cigarettes are offered to consumers, albeit on a limited basis. This spring, 22nd Century Group, a New York plant biotechnology company, began selling a reduced-nicotine cigarette that took 15 years and tens of millions of dollars to develop through genetic manipulation of the tobacco plant. According to the company’s CEO, James Mish, the company’s brand, VLN, contains 5 percent of the nicotine level of conventional cigarettes.

“It’s not a very distant technology,” he said.

VLN has undergone a series of testing and clinical trials by regulators to earn FDA designation as a “low-risk” tobacco product.

For now, the company is selling VLN at Chicago’s Circle K convenience stores as part of a pilot program. Mr Mish described sales as “modest” – with retail prices similar to premium brands like Marlboro Gold – but said the FDA proposal would likely accelerate plans for a national rollout in the coming months.

D., a professor of medicine working on tobacco use and cessation at the University of California, San Francisco. Neal Benowitz suggested the first idea Separating nicotine from cigarettes in 1994.

A major concern, he said, is whether smokers breathe harder, hold on to smoke longer, or smoke more to compensate for lower nicotine levels. After several studies, the researchers discovered that it was the lowest nicotine version of cigarettes that inhibited these behaviors, one containing about 95 percent less of the addictive chemical.

Dorothy K. Hatsukami, a professor of psychiatry at the University of Minnesota who studies the relationship between nicotine and smoking behavior, said there is a growing body of evidence to suggest that rapid and significant reduction of nicotine in cigarettes will yield progressively greater public health benefits. approach proposed by some scientists.

2018 study Following the habits of 1,250 smokers, Dr. Led by Hatsukami, she found that participants given random ultra-low nicotine cigarettes smoked less and exhibited fewer signs of addiction than those given cigarettes whose nicotine levels were gradually reduced over time. 20 weeks.

However, there were downsides to nicotine-cutting: Participants stopped working out more often than those in the gradual group and experienced more intense nicotine withdrawal. Some have secretly turned to regular, full-on brands of nicotine.

“Ultimately, we’ve known for years that it’s the nicotine that makes smoking so addictive, so if you reduce the nicotine, you make the smoking experience less satisfying and you make people more likely to quit,” he said. aforementioned.

A recent study provides a cautionary tale about the degree of public health benefit that legislators can expect from tobacco control policy. While there is no other country seeking experience with the low nicotine cigarette mandate, there is a ban on menthol flavoring.

Alex Liber, assistant professor of oncology at Georgetown University School of Medicine and working on tobacco control policy, reviewed Poland’s experience of the menthol cigarette ban, launched in 2020.

Work it and others wrote Mr Liber said the ban did not lead to a decline in overall cigarette sales, possibly because tobacco companies had lowered cigarette prices and also started selling flavor infusion cards (about a quarter each) that users could put in cigarette packs. Add back the flavor. (Some experts say any move to sell flavor infusion cards in the US would likely be illegal.)

“They know how to sell and make money, and as long as they have room to wiggle, they will do more,” he said. “I expect nothing less.”

Zolan Kanno-YoungContributed to reports from Washington.