The FDA has set up to suggest lower nicotine levels in cigarettes

According to a notice posted on the US government website on Tuesday, the Food and Drug Administration plans to require tobacco companies to reduce the amount of nicotine in traditional cigarettes to reduce their addiction.

According to the notice, “This proposed rule is a tobacco product standard that establishes maximum nicotine levels for cigarettes and certain finished tobacco products. Tobacco-related harm is primarily reliance on products that repeatedly expose users to toxins. Due to the illness, the FDA will take this step to reduce addiction to certain tobacco products and increase the ability of addicted users to quit. “

This proposal will put the United States at the forefront of global smoking cessation efforts by taking a positive stance on significantly lowering nicotine levels. Only one other country, New Zealand, has pursued such a plan. But headwinds are fierce, and powerful tobacco lobbies have already shown that plans to significantly reduce nicotine are unacceptable, with conservative lawmakers considering government overshoots that could spill over into midterm elections. increase.

White House spokesman Karine Jean-Pierre was asked about news coverage of the new policy on Tuesday and told reporters that government agencies regularly post agenda plans on the Administration and Budget Department’s website. Reminded me. And in this case, she said no policy decisions had been made.

Few details were announced on Tuesday, but expectations are high. Last week, FDA Commissioner Dr. Robert Caliph told the audience that he would talk more about reducing nicotine addiction.

Similar plans have been discussed to cover the lungs with tar, release 7,000 chemicals, and reduce Americans’ reliance on products that cause cancer, heart disease, and lung disease. Nicotine is also available in e-cigarettes, chews, patches and lozenges, but this proposal clearly 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. “That’s the scope and scale we’re talking about here, because tobacco use remains a major cause of preventable illness and death.”

According to the Centers for Disease Control and Prevention, about 1,300 people die early each day from smoking-related causes, and about 480,000 die annually.

However, the obstacles to such a plan are immeasurable and can take years to overcome. A plan has emerged that the amount of nicotine in tobacco needs to be reduced by 95%. It can put an estimated 30 million US smokers into a state of nicotine withdrawal with excitement, out of focus, and irritability. It will send others looking for alternatives like e-cigarettes not included in the proposal.

Experts said resolute smokers may try to buy high nicotine cigarettes in illegal markets or across the Mexican-Canada border.

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.

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.

Cigarette makers have already warned that the FDA will exceed its authority to regulate cigarettes by demanding products that are unmanufacturable or unacceptable to consumers.

According to a 2018 letter from RJ Reynolds’ parent company, RAI, “both explicit and de facto bans have exactly the same effect. Both” allow the sale of tobacco products to adults. ” Reveals the clearly stated purpose of the parliament. Service to the FDA for previous proposals.

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 received tens of thousands of public comments. FDA is obliged to review and address these comments before finalizing the rules.

Five years ago, then agency commissioner Dr. Scott Gottlieb announced plans to reduce nicotine levels in cigarettes to minimal or non-addictive levels. The proposal was materialized in 2017, but did not reach formal rules during the Trump administration.

At the time, the FDA said the model predicted that a sharp reduction in tobacco nicotine would result in 5 million people quitting smoking in a year. ..

Of the 8,000 comments received on the 2018 proposal, retailers, wholesalers and tobacco companies disagreed. The Florida Wholesale and Distribution Association, a trading group, said the proposal “will bring new demand for black market products and may lead to increased trafficking, crime and other illegal activities.”

RAI Services, the parent company of RJ Reynolds, one of the largest tobacco businesses, said in 2018 that there was no evidence in the FDA that plans to reduce nicotine levels would improve public health. Authorities “need to give tobacco manufacturers decades to comply,” and need to understand how to grow low-nicotine tobacco consistently, RAI said in a letter to the FDA. Farmers to change their growth practices. ”

Tobacco company Altria also warned in 2018 that criteria for degrading tobacco “to an unacceptable level for adult smokers” would be considered a tobacco ban that violates tobacco control legislation.

The Tobacco Control Act of 2009 gave the FDA broad authority to regulate tobacco products on “appropriate for public health protection” standards, but explicitly banned the ban on cigarettes or the reduction of nicotine levels to zero. Did.

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 proposed FDA rules will accelerate plans for nationwide expansion in the coming months. Said that it is likely to do. That said, the company’s long-term business plan was primarily premised on licensing its genomic engineering technology to big cigarettes, 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 proposed the idea of ​​removing nicotine from tobacco 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.

In a 2018 study led by Dr. Houjou, who tracked the habits of 1,250 smokers, participants randomly assigned ultra-low nicotine cigarettes were given cigarettes with gradually reduced nicotine levels. It was found that they smoked less and had less signs of addiction than those who smoked, which decreased during the 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 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.

Studies written by him and others have found that the ban did not lead to a decline in overall cigarette sales, Liber said. Add a cigarette pack to restore the flavor.

“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.”

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