FDA proposes to reduce nicotine levels in cigarettes

According to a notice posted Tuesday on the US government website, the Food and Drug Administration is planning to ask tobacco companies to reduce the amount of nicotine in traditional cigarettes to make them less addictive, to reduce smoking. A step with intention.

According to the notice, “This proposed rule is a tobacco product standard that would establish maximum nicotine levels in cigarettes and certain finished tobacco products. As tobacco-related harms primarily arise from addiction to products that are repeatedly toxic to users, When exposed to substances, the FDA will take this action to reduce addiction to certain tobacco products, thus giving addicted users a greater ability to quit.

The proposal would put the United States at the forefront of global anti-smoking efforts while taking an aggressive stance on significantly reducing nicotine levels. Only one other country, New Zealand, has developed such a plan. However, the adverse conditions are dire, with a powerful tobacco lobby indicating that any plan with a significant reduction in nicotine would be unsustainable and with conservative lawmakers who consider it an overreach of the government that could spill over into midterm elections.

When asked about news reports on a new policy on Tuesday, White House press secretary Karine Jean-Pierre told reporters that agencies regularly post agenda plans on the website for the Office of Management and Budget. Huh. And in this case, it said no policy decision had been taken.

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

Similar plans have been discussed to reduce the addiction of Americans who cover the lungs with tar, release 7,000 chemicals and cause cancer, heart disease and lung disease. Nicotine is also available in e-cigarettes, chews, patches and lozenges, but this offer will not explicitly affect those products.

“This one rule could have the biggest impact on public health in the history of public health,” said recently retired FDA Tobacco Center director Mitch Zeller. “That’s the scope and magnitude of what 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 each day from smoking-related causes, with approximately 480,000 deaths per year.

However, the obstacles to such planning are enormous and may take years to overcome. Some plans have been introduced that would require a 95% reduction in the amount of nicotine in cigarettes. It can put American smokers, an estimated 30 million people, into a state of nicotine withdrawal, which includes agitation, difficulty concentrating, and irritability. This will send others looking for alternatives such as e-cigarettes, which are not included in the offer.

Experts said determined smokers may want to buy cigarettes with high nicotine in illegal markets or across borders in Mexico and Canada.

The FDA has to overcome opposition from the tobacco industry, which has begun to pinpoint reasons the agency can’t grow the $80 billion market. Legal challenges can take years to resolve, and the agency may give the industry five or more years to make changes.

Other major tobacco initiatives outlined in the Tobacco Control Act of 2009 have been slow to take shape. One lawsuit delayed a requirement for tobacco companies to put graphic warnings on cigarette packs. And the agency recently said it would take another year to finalize major decisions on which e-cigarettes could stay on the market.

Cigarette makers have warned that the FDA will go beyond its authority to regulate cigarettes, requiring a product that is impossible or unacceptable to consumers.

According to a letter from RJ Reynolds’ parent company in 2018, “both an express and a de facto ban would have the same effect—both of Congress’s explicitly stated purpose ‘to allow the sale of tobacco products to adults'”. will end. RAI Services, regarding an earlier proposal to the FDA.

The effort to reduce nicotine levels follows a proposed rule announced in April that would ban menthol-flavored cigarettes, much favored by black smokers. That proposal was also seen as a potential milestone advance for public health, and has attracted thousands of public comments. The FDA is obligated to review and address those comments before finalizing the rule.

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

At the time, the FDA said a model predicted that rapidly reducing nicotine in cigarettes would motivate 5 million people a year to quit smoking.

Amid 8,000 comments on the 2018 proposal, protests emerged from retailers, wholesalers and tobacco companies. The Florida Association of Wholesale Distribution, a trade group, said the proposal could result in “new demand for black-market products, and could result in an increase in smuggling, crime and other illegal activities.”

RAI Services, one of the largest tobacco businesses, said in 2018 that the FDA had no evidence that a plan to cut nicotine levels would improve public health. The agency would need to “give tobacco manufacturers decades to comply,” and figure out how to consistently develop low-nicotine tobacco, RAI said in a letter to the FDA. Furthermore, the letter said, the agency had no authority to “force tobacco farmers to change their growing practices”.

Low nicotine cigarettes are available to consumers, though in a limited way. This spring, 22nd Century Group, a New York plant biotech company, began selling a low-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 Misch, the company’s brand, VLN, contains 5% of the nicotine level of conventional cigarettes.

“It’s not some far-fetched technology,” he said.

To earn its FDA designation as a “low-risk” tobacco product, VLN was subjected to testing and clinical trials by regulators.

For now, the company is selling VLNs at Circle’s convenience stores in Chicago as part of a pilot program. Misch described sales as “moderate” — retail prices similar to those of premium brands like Marlboro Gold — but added that the proposed FDA rule would accelerate plans for a national rollout in the coming months. That said, the company’s long-range business plan, he said, was based largely on licensing its genomic engineering technology to Big Tobacco.

Dr. Neil Benowitz, a professor of medicine at the University of California, San Francisco who studies tobacco use and cessation, first proposed the idea of ​​phasing out nicotine from cigarettes in 1994.

He said a major concern was whether smokers would puff more vigorously, stay in smoke longer or smoke more cigarettes to compensate for the low levels of nicotine. After several studies, the researchers found that the cigarette that inhibited those behaviors was the lowest-nicotine version, with about 95% fewer addictive chemicals.

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 rapid and significant reduction of nicotine in cigarettes is more public than gradualism. will provide health benefits. The approach that some scientists were promoting.

A 2018 study led by Hatsukami that followed the habits of 1,250 smokers found that participants who were randomly given cigarettes with ultralow nicotine smoked less and compared to those who didn’t. Those who were given cigarettes with nicotine levels that gradually decreased, displayed fewer signs of dependence. of 20 weeks.

However, there were downsides to reducing nicotine all at once: Participants quit the study more often than those in the gradual group and they experienced more intense nicotine withdrawal. Some secretly turned to their regular, full-nicotine brands.

“The bottom line is that 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 leave,” she said. ,

A recent study offers a cautionary tale, however, on the degree of public health benefit lawmakers can expect from tobacco control policy. While there is no other country to watch for experiences with low-nicotine cigarette mandates, there is one for menthol flavor restrictions.

Alex Lieber, an assistant professor in the Department of Oncology at Georgetown University’s School of Medicine who studies tobacco control policy, examined Poland’s experience with the menthol cigarette ban established in 2020.

The study he and others wrote found that the ban did not reduce overall cigarette sales, Lieber said, probably because tobacco companies cut cigarette prices and added flavor-infusion cards (about a quarter of each). for) which users can enter. To add back the flavor of their cigarette packs.

“They know how to sell and make money and they will make more and more as long as they have wiggle room,” he said. “I just don’t expect anything less.”

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