FDA aims to reduce smoking by reducing nicotine levels in cigarettes

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The Food and Drug Administration plans to require tobacco companies to reduce the amount of nicotine in traditional cigarettes to make them less addictive and reduce the toll of smoking that 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 tobacco control efforts. Only one other country, New Zealand, has put forward such a plan.

Headwinds are strong. Tobacco companies have already indicated that any plan with deep reductions in nicotine would violate the law. And some conservative lawmakers might see such a policy as another example of government overreach, ammunition that could spill over into the midterm elections.

Few details were released Tuesday, but according to a notice posted on a US government website, a proposed rule would be released in May 2023 seeking public comment on setting a maximum level of nicotine in cigarettes and others products. “Because tobacco-related harms result primarily from addiction to products that repeatedly expose users to toxins, the FDA would take this action to reduce addiction to certain tobacco products, thereby giving addicted users greater ability to quit smoking,” the notice reads.

The FDA declined to provide 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 reduce the likelihood that future generations of young become addicted to cigarettes and would help more currently addicted smokers to quit.

Similar plans have been discussed to reduce Americans’ addiction to tobacco products that coat the lungs in tar, release 7,000 chemicals and lead to cancer, heart disease and lung disease. Nicotine is also available in e-cigarettes, chews, patches and lozenges, but this proposal would not affect those products.

“This one rule could have the greatest public health impact in public health history,” said Mitch Zeller, director of the FDA’s recently retired Tobacco Center. “That’s the scope and scale we’re talking about here, as tobacco use remains the leading cause of preventable disease and death.”

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

The obstacles to such a plan, however, are immense and could take years to overcome. Some plans that have been launched would require a 95% reduction in the amount of nicotine in cigarettes. Experts say it could send US smokers, around 30 million people, into a state of nicotine withdrawal, which involves restlessness, difficulty concentrating and irritability and send others seeking alternatives such as electronic cigarettes. These deliver nicotine without most of the chemicals found in combustible cigarettes.

Experts said determined smokers may seek to purchase high-nicotine cigarettes from illegal markets or across borders from Mexico and Canada.

The FDA would likely have to overcome opposition from the tobacco industry, which has already begun to point out reasons why the agency cannot upset 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 effort to reduce nicotine levels follows a proposed rule announced in April that would ban menthol-flavored cigarettes, which are heavily favored by black smokers. The proposal has also been hailed as a potential historic breakthrough for public health and has already generated tens of thousands of public comments. The FDA is required to review and respond to these comments before finalizing the rule.

Other major tobacco control initiatives outlined in the landmark Tobacco Control Act of 2009 have been slow to take shape. A lawsuit has delayed requiring tobacco companies to put graphic warnings on cigarette packages. And the agency recently said it would take another year to finalize key decisions on which e-cigarettes might stay on the market.

A statement from tobacco company Altria, the maker of Marlboro, offered insight into the arguments opponents are expected to make against any rule that drastically lowers nicotine levels. “The focus should be less on removing products from adult smokers and more on providing a robust market for lower-risk, FDA-cleared smokeless products,” the company said in a statement Tuesday. “Today marks the start of a long-term process, which must be science-based and consider potentially serious unintended consequences.”

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

“An express ban and a de facto ban would have exactly the same effect – both would eviscerate Congress’s expressly stated goal of ‘allowing the sale of tobacco products to adults,'” according to a 2018 letter from RAI Services to the FDA on an earlier proposal.

Five years ago, Dr. Scott Gottlieb, the agency’s commissioner at the time, released a plan to reduce nicotine levels in cigarettes to minimal or non-addictive levels. The proposal took shape in 2017 but did not result in a formal rule under the Trump administration.

Among the 8,000 comments that poured in on this proposal, opposition emerged from retailers, wholesalers and tobacco companies. The Florida Association of Wholesale Distribution, a trade group, said it could lead to “new demand for black market products and lead to increased trafficking, crime and other illegal activity”.

In 2018, RAI Services said the FDA had no evidence that the plan to reduce nicotine levels would improve public health. The agency “should give tobacco companies decades to comply” and figure out how to regularly grow low-nicotine tobacco, RAI said in the letter to the FDA. The Tobacco Control Act of 2009 gave the FDA broad powers to regulate tobacco products with standards. “appropriate for the protection of public health”, although the law specifically prohibits banning cigarettes or zeroing nicotine levels.

Low nicotine cigarettes are already available to consumers, albeit on a limited basis. This spring, a New York-based plant biotech company, 22nd Century Group, began selling a reduced-nicotine cigarette that took 15 years and tens of millions of dollars to develop through genetic manipulation of the nicotine plant. tobacco. The company’s brand, VLN, contains 5% of the nicotine level of conventional cigarettes, according to James Mish, the company’s chief executive.

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

To gain its designation from the FDA as a “reduced risk” tobacco product, VLN underwent a series of tests and clinical trials by regulators.

For now, the company is selling VLN at Circle K convenience stores in Chicago as part of a pilot program. Mr Mish described sales as “modest” – retail prices are similar to high-end brands like Marlboro Gold – but he said the FDA proposal would most likely speed up national rollout plans within months. coming.

Dr. Neal Benowitz, a professor of medicine at the University of California, San Francisco who studies smoking and withdrawal, first proposed the idea of ​​reducing nicotine from cigarettes in 1994.

He said a major concern was whether smokers puffed harder, held in smoke longer or smoked more cigarettes to compensate for the lower nicotine level. After several studies, researchers found that the cigarette that prevented these behaviors was the lowest nicotine version, one with about 95% 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 a growing body of evidence suggests that a rapid and significant reduction in nicotine in cigarettes would offer greater public health benefits than incremental. approach advocated by some scientists.

A 2018 study led by Dr. Hatsukami that tracked the habits of 1,250 smokers found that participants who were randomly assigned very low nicotine cigarettes smoked less and showed fewer signs of addiction than those who were not. who had been given cigarettes with gradually reduced levels of nicotine over time. the 20 week course.

There were downsides to reducing nicotine all at once, however: Participants dropped out of the study more frequently than those in the gradual group, and they experienced more intense nicotine withdrawal. Some have secretly switched to their regular full-nicotine brands.

“At the end of the day, we’ve known for decades that nicotine is what makes cigarettes so addictive, so if you reduce nicotine, you make the smoking experience less satisfying and you increase the likelihood that people will try to smoke. stop,” she said. said.

A recent study, however, offers a cautionary note about the degree of public health benefit that legislators can expect from tobacco control policy. While there is no other country to turn to for experience with a low nicotine cigarette mandate, there is one for the minty flavor ban.

Alex Liber, an assistant professor in the department of oncology at Georgetown University School of Medicine who studies tobacco control policy, reviewed Poland’s experience with a ban on menthol cigarettes instituted in 2020.

The study he and others authored found that the ban did not lead to a decrease in overall cigarette sales, Liber said, likely because tobacco companies reduced cigarette prices and also started selling flavor infusion cards (for about a quarter each) that users can put in their pack of cigarettes to restore flavor. (Some experts say any move to sell infusion cards in the United States would likely be illegal.)

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

Zolan Kanno-Youngs contributed reporting from Washington.

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