The Food and Drug Administration plans to require tobacco companies to reduce the amount of nicotine in traditional cigarettes, reduce addiction, and reduce the number of 480,000 life-threatening smokers each year. ..
The proposal could take years to come into force and will put the United States at the forefront of global smoking cessation efforts. Only one other country, New Zealand, has pursued such a plan.
The headwind is intense. Tobacco companies have already shown that plans to significantly reduce nicotine violate the law. And some conservative lawmakers may see such a policy as another example of government overkill, ammunition that could spill over into midterm elections.
There are few details released on Tuesday, According to a notice issued to the U.S. government Website, The proposed rule was published in May 2023 and seeks public comments on establishing maximum nicotine levels for cigarettes and other products. “Because tobacco-related harm is primarily due to product addiction that repeatedly exposes users to toxins, the FDA is able to take this step to reduce addiction to specific tobacco products and stop addicted users. Will increase, “said the notice.
The FDA has refused to provide further details. but, Statement posted on it Dr. Robert M. Caliph of the website said: “
Similar plans are being discussed to cover the lungs with tar, release 7,000 chemicals, and reduce Americans’ dependence on tobacco products that cause cancer, heart disease, and lung disease. Nicotine is also available in e-cigarettes, chews, patches and lozenges, but this proposal does not affect these products.
“This one rule can have the greatest impact on public health in the history of public health,” said Mitchzeler, director of the recently retired FDA Tobacco Center. “This is the scope and scale we are talking about here, because the use of tobacco remains a major cause of preventable illness and death.”
According to the Centers for Disease Control and Prevention, about 1,300 people die prematurely from smoking-related causes each day.
However, the obstacles to such a plan are immeasurable and can take years to overcome. Some of the plans that have emerged require a 95% reduction in the amount of nicotine in tobacco. According to experts, this will cause an estimated 30 million U.S. smokers to fall into a state of nicotine withdrawal with excitement, out of focus, and irritability, sending others in search of alternatives such as e-cigarettes. There is a possibility. They deliver nicotine with almost no chemicals found in flammable cigarettes.
Experts said resolute smokers may try to buy high nicotine cigarettes in illegal markets or across the Mexican-Canada border.
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The FDA may have to overcome opposition from the tobacco industry. The tobacco industry has already begun to point out why the FDA cannot overturn the $ 80 billion market. Resolving legal issues can take years, and agencies can give the industry more than five years to make changes.
Efforts to lower nicotine levels follow a draft rule announced in April to ban menthol-flavored cigarettes, which are highly favored by black smokers.The proposal has also been welcomed as a potential breakthrough in public health and has already attracted tens of thousands of people. Public comments.. FDA is obliged to review and address these comments before finalizing the rules.
Other major tobacco initiatives outlined in the groundbreaking 2009 Tobacco Control Act have been delayed in materialization. The proceedings delayed the requirement for tobacco companies to display graphic warnings on cigarette packs. And the agency recently said it would take another year to finalize the key decisions about which e-cigarettes will remain on the market.
A statement from Marlboro’s maker, tobacco company Altria, provided a preview of what opponents would expect to do with any rule that would significantly reduce nicotine levels. “The focus should be on providing a strong market for reducing the harm of FDA-approved smokeless products, rather than robbing adult smokers of their products,” the company said in a statement Tuesday. “Today marks the beginning of a long-term process. It is science-based and needs to explain potentially serious unintended consequences.”
RJ Reynolds’ parent company, RAI Services, declined to comment on the announcement, but “our belief is that reducing tobacco harm is the best way to reduce the health effects of smoking. I have. “
According to a 2018 letter from the RAI service to the FDA, “both explicit and de facto bans have exactly the same effect. Both allow the sale of tobacco products to adults.” Reveal a clearly stated purpose. Previous proposal.
Five years ago, then agency commissioner Dr. Scott Gottlieb announced the plan. Lower nicotine levels To a minimal or non-addictive level with tobacco. The proposal was materialized in 2017, but did not reach formal rules during the Trump administration.
Among 8,000 people comment As the proposal was poured, retailers, wholesalers, and tobacco companies disagreed. Florida Wholesale and Distribution Association, Industry Association, Said it could result “There is new demand for black market products, and trafficking, crime and other illegal activities are on the rise.”
In 2018, the RAI service said the FDA had no evidence that plans to reduce nicotine levels would improve public health. The agency “needs to give tobacco manufacturers decades to comply”, understands how to grow low nicotine tobacco consistently, RAI said In a letter to the FDA, the Tobacco Control Act of 2009 gave the FDA broad authority. Regulate tobacco products Although it has “appropriate for public health protection” standards The law specifically outlawed bans Decrease in tobacco and nicotine Set level to zero..
Low nicotine tobacco is already available to consumers, albeit in a limited way. This spring, New York’s plant biotechnology company, 22nd Century Group, began selling reduced nicotine tobacco, which cost 15 years and tens of millions of dollars to develop by genetic engineering of tobacco plants. According to the company’s CEO, James Mish, the company’s brand, VLN, contains 5% of traditional cigarette nicotine levels.
“This is not a distant technique,” he said.
To obtain the FDA’s designation as a “risk-reducing” tobacco product, VLN has undergone numerous regulatory and clinical trials.
The company is currently selling VLN at the Circle K Convenience Store in Chicago as part of its pilot program. Mish described sales as “modest.” Retail prices are similar to premium brands like Marlboro Gold, but the FDA’s proposal is likely to accelerate plans for nationwide expansion in the coming months, he said.
Dr. Neal Benowitz, a professor of medicine at the University of California, San Francisco, who studies the use and discontinuation of tobacco, First suggested an idea To get rid of nicotine from cigarettes in 1994.
He said one important concern was whether smokers smoked harder, retained smoke for longer, or smoked more cigarettes to compensate for lower nicotine levels. After several studies, researchers found that cigarettes that interfered with these behaviors were the lowest nicotine version, with about 95% less addictive chemicals.
Dorothy K. Hatskami, a professor of psychiatry at the University of Minnesota who studies the relationship between nicotine and smoking behavior, found that the rapid and significant reduction of nicotine in tobacco has greater public health benefits than gradualists. An approach promoted by some scientists who said there was increasing evidence to suggest it.
2018 survey Participants led by Dr. Houjou, who followed the habit of 1,250 smokers, were more randomly assigned to use ultra-low nicotine cigarettes than those given cigarettes with gradual nicotine levels. We found less smoking and less signs of addiction. 20 weeks.
However, reducing nicotine all at once had its drawbacks. Participants dropped out of the study more often than participants in the gradualist group and experienced more severe nicotine withdrawal. Some people secretly turned to their regular full nicotine brand.
“The bottom line is that we’ve known for decades that nicotine makes tobacco addictive, so reducing nicotine can reduce the satisfaction of your smoking experience and encourage people to quit smoking. Will increase, “she says. she said.
However, recent research provides a warning story about the extent of public health benefits that legislators can expect from tobacco control policies. No other country is looking for an experience of low nicotine tobacco obligations, but there is a menthol flavor ban.
Alex Lieber, an assistant professor of oncology at Georgetown University School of Medicine and studying tobacco control policy, investigated Poland’s experience with the 2020 menthol ban on tobacco.
Study with him Written by others This ban did not reduce overall tobacco sales, probably because tobacco companies have lowered tobacco prices and started selling flavored infusion cards (about a quarter each) that users can put in cigarette packs. Liber said. Add flavor. (Some experts say the move to sell flavored cards in the United States is likely to be illegal.)
“They know how to sell and make money, and as long as they have room to wiggle, they will make more and more,” he said. “I don’t expect anything more than that.”
Zoran Kanno-YoungContributed to the report from Washington.
