The FDA is ready to recommend low levels of nicotine in cigarettes.

According to a notice posted on the US government’s website on Tuesday, the Food and Drug Administration is seeking to reduce the amount of nicotine in conventional cigarettes from tobacco companies by making them less addicted to tobacco. To reduce smoking.

According to the notice, “the proposed principle is the quality of tobacco products that will establish maximum nicotine levels in cigarettes and some manufactured tobacco products. Consumers who repeatedly expose themselves to toxic substances, the FDA will take action to reduce the addiction to certain tobacco products, thus giving addicted consumers a greater chance of quitting. “

The proposal would put the United States at the forefront of global efforts against smoking, taking an aggressive stance on significantly reducing nicotine levels. Only one other country, New Zealand, has taken such a step forward. The headlines, though, are fierce, with a powerful tobacco lobby already signaling that any plan with a significant reduction in nicotine would be intolerable, and with conservative lawmakers considering government overreach. Will spread in the mid-term elections.

Asked about news of a new policy on Tuesday, White House Press Secretary Karen Jane Pierre reminded reporters that agencies routinely post agenda plans on the Office of Management and Budget website. Are And in that case, he said, no policy decision has been made.

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

Similar plans have been put in place to reduce Americans’ addiction to products that coat the lungs with tar, release 7,000 chemicals and cause cancer, heart disease and lung disease. Nicotine is also available in e-cigarettes, chewing gum, patches and lozenges, but this suggestion will not seem to affect these products.

“This is one of the most influential principles of public health in the history of public health,” said Mitch Zeller, director of the recently retired FDA Tobacco Center. “This is the scope and breadth we are talking about here, because tobacco use is the leading cause of preventable disease and death.”

According to the Center for Disease Control and Prevention, approximately 1,300 people die prematurely every day from smoking-related causes, resulting in approximately 480,000 deaths each year.

Obstacles to such a plan, however, are many and may take years to overcome. There are plans to reduce the amount of nicotine in cigarettes by 95%. It could throw an estimated 30 million American smokers into a state of nicotine withdrawal, including irritability, difficulty concentrating and irritability. It will send e-cigarettes to others in search of alternatives, which are not included in the proposal.

Experts say smokers may try to buy cigarettes in illegal markets or across the Mexican-Canadian border with more nicotine.

The FDA will likely have to overcome opposition from the tobacco industry, which has already begun to point out the reasons why the agency cannot maintain its $ 80 billion market. Legal challenges can take years to resolve, and the agency can give the industry five or more years to make changes.

The Tobacco Control Act of 2009 has been slow to take the form of other major tobacco measures. A lawsuit has been filed against tobacco companies for delaying the imposition of graphic warnings on cigarette packets. And the agency recently said it would take a year to finalize key decisions on which e-cigarettes could stay in the market.

Cigarette makers have already warned that the FDA will exceed its authority to regulate cigarettes and require a product that is impossible to produce or unacceptable to consumers.

“Both the express and de facto bans will have exactly the same effect – both will overturn Congress ‘stated goal of’ allowing adults to sell tobacco products, ‘” RJ Reynolds’ parent company, According to a letter from RAI in 2018. Services to the FDA about the earlier proposal.

Efforts to reduce nicotine levels follow a proposed rule announced in April banning menthol-flavored cigarettes, which are popular with black smokers. The proposal was hailed as a potential landmark development for public health, and has already garnered tens of thousands of public comments. The FDA is obliged to review and consider these comments before finalizing the rule.

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

At the time, the FDA said a model predicted that a rapid reduction in nicotine in cigarettes would cause 5 million people to quit smoking a year. .

Out of 8,000 comments on the 2018 proposal, there was opposition 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 consequently an increase in smuggling, crime and other illegal activities.”

RAI Services, the parent company of RJ Reynolds, one of the largest tobacco businesses, said in 2018 that the FDA had no evidence that plans to reduce nicotine levels would improve public health. ۔ The agency will need “decades for tobacco manufacturers to comply,” and find out how to grow low-nicotine tobacco continuously, the RAI said in a letter to the FDA. The letter said the agency had “no authority to force tobacco. Farmers should change their growing methods.”

Tobacco company Altria also warned in 2018 that a standard that lowers tobacco “to the point of being unacceptable to adult smokers” would be considered a cigarette ban that violates tobacco control laws. Will

The 2009 Tobacco Control Act gave the FDA broad powers to regulate tobacco products with “public health protection” standards, although it specifically banned cigarettes or reduced nicotine levels to zero. Declared illegal.

Low-nicotine cigarettes are already available to consumers, albeit in a limited way. This spring, the New York plant biotech company, 22nd Century Group, began selling a low-nicotine cigarette that took 15 years and tens of millions of dollars to manufacture through the plant’s genetic manipulation. The company’s brand, VLN, contains 5% nicotine levels of traditional cigarettes, according to James Mash, the company’s chief executive.

“It’s not a distant technology,” he said.

In order to obtain FDA status 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 K convenience stores in Chicago as part of a pilot program. Mr Mash described the sale as “modest” – retail prices are similar to premium brands such as Marlboro Gold – but said the proposed FDA policy would accelerate national rollout plans in the coming months. The company’s long-term business plan, he said, was largely predicted to license its genomic engineering technology to Big Tobacco.

Dr. Neil Benoitz, a professor of medicine at the University of California, San Francisco who studies tobacco use and its cessation, first came up with the idea of ​​separating nicotine from cigarettes in 1994.

A key concern, he said, is whether smokers will smoke harder, stay in the smoke longer, or smoke more to lower nicotine levels. After several studies, researchers found that the cigarette that stopped these behaviors was the lowest nicotine version, containing 95% less narcotic chemicals.

Dorothy K. Hatsukami, a professor of psychiatry at the University of Minnesota who studies the link between nicotine and smoking behavior, said the growing body of evidence suggests that the rapid and significant reduction in nicotine in cigarettes is more of a public health hazard. Will provide benefits. This is the view that some scientists have been promoting.

A 2018 study led by Dr. Hatsukami, which followed the habits of 1,250 smokers, found that participants who were randomly given extremely low-nicotine cigarettes were less likely to smoke and There were fewer signs of dependence than those who were given cigarettes and had lower levels. Less over 20 weeks.

At the same time, however, there were ups and downs of nicotine reduction: participants dropped out of the study more often than those in the gradual group and experienced severe nicotine withdrawal. Some secretly turned to their regular, complete nicotine brands.

“Most importantly, we have 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 Increases the likelihood that people will try to leave, “he said. .

A recent study offers a cautionary tale, though, about the health benefits lawmakers can expect from a tobacco control policy. Although there is no other nation to experiment with the mandate of low nicotine cigarettes, the taste of menthol is restricted.

Alex Liber, an assistant professor of oncology at Georgetown University’s School of Medicine who studies tobacco control policy, reviewed Poland’s experience with the 2020 ban on menthol cigarettes.

Mr Lieber said the study he and others wrote showed that the ban did not reduce overall cigarette sales, perhaps because tobacco companies reduced cigarette prices and issued flavored infusion cards (each). For a quarter) which consumers can use. Put in a pack of cigarettes to bring back the flavor.

“They know how to sell and make money and they will make as much as they can as long as they have space to move,” he said. “I just don’t expect less.”

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