FDA aims to reduce nicotine levels in cigarettes

FDA aims to reduce nicotine levels in cigarettes

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 and reduce the toll of smoking, which claims 480,000 lives each year.

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

The headwinds are fierce. Tobacco companies have already indicated that any plan with a significant reduction in nicotine would violate the law. And some conservative lawmakers may consider a policy that is yet another example of government overreach, the ammunition that could spill over into midterm elections.

Few details were released on Tuesday, but a proposed rule will be issued in May 2023 seeking public comment on setting maximum nicotine levels in cigarettes and other products, according to a notice published on the US government’s website. The notice states, “Since tobacco-related harms primarily result from addiction to products that expose users to repeated exposure to toxic substances, the FDA will take this action to reduce addiction to certain tobacco products.” , thus providing addicted users with greater ability to quit,” the notice said.

The FDA declined to provide more details. But in a statement posted on its website, the agency’s commissioner Dr Robert M Califf said: “Reducing nicotine levels to at least addictive or non-addictive levels will help future generations of young people.” K will be less likely to become addicted to cigarettes and to help more current smokers have the addiction to quit.”

Similar plans have been discussed to reduce Americans’ addiction to tobacco products that 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 those products will not be affected by this offer.

“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 causes related to smoking.

However, the obstacles to such planning are enormous and may take years to overcome. Some of the plans that have been introduced will require a 95 percent reduction in the amount of nicotine in cigarettes. American smokers, experts say, could throw an estimated 30 million people into a state of nicotine withdrawal that includes agitation, difficulty concentrating and irritability and send others looking for alternatives such as e-cigarettes. They deliver nicotine without most of the chemicals found in flammable cigarettes.

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

The FDA will have to overcome opposition from the tobacco industry, which has already 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.

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 already attracted thousands of public comments. The FDA is obligated to review and address those comments before finalizing the rule.

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.

A statement from tobacco company Altria, the maker of Marlboro, offered a preview of the arguments opponents are expected to make against any rules that significantly reduce nicotine levels. “The focus should be on taking the products away from adult smokers and providing them with a strong market for low-harm FDA-authorized smoke-free products,” the company said in a statement Tuesday. “Today marks the beginning of a long-term process that must be science-based and account for potentially serious unintended consequences.”

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

“Both an express and an actual ban would have the same effect—both would clarify Congress’s clearly stated purpose of ‘allowing the sale of tobacco products to adults’,” according to a letter to the FDA from RAI Services in 2018 According to a prior proposal about.

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 become a formal rule during the Trump administration.

That proposal drew 8,000 comments, which were opposed by retailers, wholesalers and tobacco companies. The Florida Association of Wholesale Distribution, a trade group, said this could result in “new demand for black market products, and could result in an increase in smuggling, crime and other illegal activities.”

In 2018, RAI Services said 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 develop low-nicotine tobacco more consistently, RAI said in a letter to the FDA. Gave wide powers to regulate tobacco products with standards. “Appropriate to protect public health,” although the law specifically banned cigarettes or reduced nicotine levels to zero.

Low-nicotine cigarettes are already 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. The company’s brand, VLN, contains 5 percent of the nicotine level of conventional cigarettes, according to the company’s chief executive officer, James Misch.

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

To earn its FDA designation as a “low-risk” tobacco product, VLN was subjected to a raft of trials 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. Mr Misch described sales as “moderate” – retail prices similar to premium brands like Marlboro Gold – but added that the FDA proposal will accelerate plans for a national rollout in the coming months.

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 swell more vigorously, 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 percent less 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 Dr. 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 did not. Those who were given cigarettes with nicotine levels that gradually decreased showed fewer symptoms of dependence. 20 week course.

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. Told.

A recent study presents a cautionary tale on the degree of public health benefit that lawmakers can expect from tobacco control policy. While there is no other country to look out for to experience the low-nicotine cigarette mandate, there is one for the menthol flavor restriction.

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, Mr. Lieber said, probably because tobacco companies cut cigarette prices and added flavor-infusion cards (about a quarter). each), which users can insert into their cigarette packs to add back the flavor. (Some experts say any move to sell flavor-infusion cards in the US would be illegal.)

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

Zolan Kanno-Youngs contributed reporting from Washington.

Leave a Reply