F.D.A. Set to Propose Lower Nicotine Levels in Cigarettes

The Food and Drug Administration plans to require tobacco companies to reduce the amount of nicotine in traditional cigarettes to make them less addictive, a measure intended to curb smoking, according to a notice posted Tuesday on a government website. American.

According to the notice, “This proposed rule is a tobacco product standard that would establish a maximum level of nicotine in cigarettes and certain finished tobacco products. Since tobacco-related harm primarily results 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 stop.

The proposal would put the United States at the forefront of global tobacco control efforts by taking an aggressive stance to dramatically reduce nicotine levels. Only one other country, New Zealand, has put forward such a plan. The headwinds, however, are fierce, with a powerful tobacco lobby already indicating that any plan with significant nicotine cuts would be untenable and with conservative lawmakers considering government overreach that could spill over to the mid-election. -mandate.

Asked about reports on a new policy on Tuesday, White House press secretary Karine Jean-Pierre reminded reporters that agencies regularly post agenda plans on the Office of Management and budget. And in this case, she said that no political decision had been made.

Few details were released on Tuesday, but an announcement is expected. Last week, FDA commissioner Dr. Robert Califf told an audience that he would soon be talking more about reducing nicotine addiction.

Similar plans have been discussed to reduce Americans’ reliance on 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 apparently 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 each day from smoking-related causes, according to the Centers for Disease Control and Prevention, which amounts to about 480,000 deaths per year.

The obstacles to such a plan, however, are immense and could take years to overcome. Some plans have been launched that would require a 95% reduction in the amount of nicotine in cigarettes. This could send US smokers, around 30 million people, into a state of nicotine withdrawal, which involves restlessness, difficulty concentrating and irritability. This would send others looking for alternatives such as e-cigarettes, which are not included in the proposal.

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.

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.

Cigarette makers have previously warned that the FDA will overstep its authority to regulate cigarettes by requiring a product that is either unproducible or unacceptable to consumers.

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

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 it has already garnered tens of thousands of public comments. The FDA is required to review and respond to these comments before finalizing the rule.

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.

At the time, the FDA said a model predicted that a sharp reduction in nicotine in cigarettes would cause five million people to quit smoking within a year. .

Among the 8,000 comments that poured in on a 2018 proposal, opposition emerged from retailers, wholesalers and tobacco companies. The Florida Association of Wholesale Distribution, a trade group, said the proposal could lead to “new demand for black market products and lead to increased trafficking, crime and other illegal activity.”

RAI Services, the parent company of RJ Reynolds which is one of the biggest tobacco companies, said in 2018 that 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 a letter to the FDA. Additionally, the letter said the agency had no authority “to force tobacco farmers to change their growing practices.

Tobacco company Altria also warned in 2018 that a standard that degrades tobacco “to the point of being unacceptable to adult smokers” would be considered a smoking ban that violates smoke-free laws.

The Tobacco Control Act of 2009 gave the FDA broad powers to regulate tobacco products with standards “appropriate to protect the public health,” although it specifically prohibited banning cigarettes or reducing levels. of nicotine to zero.

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 five percent 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’s proposed rule would most likely speed up national roll-out plans in countries. coming months. That said, the company’s long-term business plan, he said, relied heavily on licensing its genome-engineered technology to Big Tobacco.

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, the one that contained 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. reduced over 20 weeks.

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. .

A recent study, however, offers a cautionary note about the degree of public health benefit lawmakers 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.

“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.”

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