The FDA approved the release of low nicotine levels in cigarettes

Food and Drug Administration plans to ask tobacco companies to cut down on nicotine in traditional cigarettes to make them less addicted, with the aim of reducing smoking, according to an announcement posted Tuesday on the government website. US.

According to the announcement, “The proposed law is that tobacco products will produce the highest nicotine levels in cigarettes and some tobacco products will expire. Since tobacco-related injuries result from drug use of products that repeatedly expose its users to toxins, the FDA will do this to reduce the drug use of certain tobacco products, thus giving the addicted workers a greater chance of quitting. “

The plan puts the United States at the forefront of efforts to stop global smoking by stepping up and reducing nicotine levels significantly. Only one other country, New Zealand, has made such a plan. However, severe headaches, as well as severe smoking cessation have already shown any plans with significant reductions in nicotine are impossible as well as with conservative lawmakers who will consider a possible end to the government. to enter the midterm elections.

Asked about the news report on the new forecast on Tuesday, White House press secretary Karine Jean-Pierre reminded reporters and companies that publish the plan on the website for the Office of Management and Budget. In this case, he said no legal decision had been made.

A few details were released on Tuesday, but an official announcement is expected. Last week, Drs. Robert Califf, the FDA director, told the audience that he would talk more about reducing nicotine use in the near future.

Such plans are being considered to reduce American addictive drugs and tar-containing products, release 7,000 chemicals and lead to cancer, heart disease and lung cancer. Nicotine is also found in e-cigarettes, cigarettes, patches and lozenges, but this plan will not affect those products.

“This same law could have the greatest impact on public health and the history of public health,” said Mitch Zeller, a retired FDA chief executive. “That is the extent and magnitude we are talking about here, because smoking is still the leading cause of disease and preventable death.”

About 1,300 people die every day as a result of smoking, according to the Centers for Disease Control and Prevention, adding up to 480,000 deaths each year.

The obstacles to such a plan, however, are enormous, and it can take years to overcome them. Some plans have been put in place that would require a 95 percent reduction in nicotine in cigarettes. That could put smokers in the US, about 30 million people, at risk of nicotine withdrawal, which includes irritability, the ability to focus on the irritants. It will send to other demanding parties such as e-cigars, which are not included in the plan.

Experts say smokers may want to buy nicotine-containing cigarettes on the market illegally or overseas in Mexico and Canada.

The FDA is likely to overcome opposition from the tobacco industry, which has already begun to explain why the company is unable to boost its $ 80 billion market. The legal challenge could take years to resolve, the company could provide housing the service for five years or more to make the change.

Other key tobacco initiatives outlined in the 2009 Tobacco Control Act are fast approaching. A lawsuit captures a requirement for tobacco companies to include graphic warnings on cigarette packs. The company recently said that it will take about another year to finalize the major decisions that e-cigarettes will have on the market.

Smokers have warned that the FDA will go beyond its control over cigarettes by looking for products that are unlikely to be produced or approved by consumers.

“Both the ban and the de facto will have the same effect – they will both overturn Congress’s stated stated objective ‘to allow the sale of tobacco products to adults'” according to a letter in 2018 from the mother company and father RJ Reynolds, RAI. Service, inform the FDA about the original plan.

The move to lower nicotine levels follows a proposed law in April that would ban menthol sweeteners, much to the chagrin of black smokers. The plan is also hailed as a potential breakthrough for public health, it has already attracted tens of thousands. public speech. The FDA must review and review the terms before completing the policy.

Five years ago, Dr. Scott Gottlieb, the company’s director at the time, developed a plan for bee nicotine levels in cigarettes to a lesser degree or less addictive. The plan took place in 2017, but did not lead to legislation during the Trump administration.

At the time, the FDA said the model predicted that a significant reduction in nicotine and smoking would motivate five million people to quit smoking each year. .

Over 8,000 said which spilled over into the 2018 plan, opposition from retailers, retailers and tobacco companies. Members of the Florida Association of Wholesale Distribution, a trade union, said The plan could lead to “new demand for black products, and increase trade, crime and illegal activity.”

The RAI project, the parent company of RJ Reynolds is one of the largest tobacco businesses, said in 2018 that the FDA has no evidence that nicotine reduction plans will improve public health. The agency “would like to give tobacco producers more decades to follow,” and found out how to grow low-nicotine tobacco, RAI. said in a letter and FDA What’s more, the letter said, the company does not have the authority to “force tobacco farmers to change their young behavior.”

Altria Tobacco Company too warned In 2018, a banner that degrades tobacco “to the point of being an adult who does not smoke” will be considered a smoking cessation. tobacco control laws.

2009 Tobacco Control Act provided by the FDA broad powers to regulate tobacco products under “appropriate public safety standards,” even though it prohibits smoking or the reduction of nicotine. level to zero.

Cigarettes containing low nicotine are already popular among consumers, despite its high fashion trends. This spring, the New York biotech plant company, 22nd Century Group, began selling 15 to 10 million dollars worth of nicotine cigarettes to grow from tobacco plant genes. The company’s logo, VLN, contains 5 percent of the nicotine levels of cigarettes smoked, according to James Mish, the company’s chief executive.

“This is not far-fetched technology,” he said.

To get its FDA name as a “risk-reducing” tobacco product, regulators conducted the VLN in several clinical trials and tests.

For now, the company sells VLN and convenience stores Circle K in Chicago as part of its pilot program. Mr Mish described sales as “modest” – retailers’ prices seem less favorable than Marlboro Gold – but said FDA-recommended regulations would make it faster. for national migration in the coming months. That said, the company’s long-term business plan, he said, is aimed at licensing its genomic engineering technology to Big Tobacco.

Dr. Neal Benowitz, a professor of pharmacology at the University of California, San Francisco, is studying tobacco use and quitting, first. suggested the idea of ​​removing nicotine from cigarettes in 1994.

He said one of the main concerns was whether smokers would smoke, hold longer cigarettes or smoke more cigarettes to pay for nicotine lower. After several studies, researchers found that smoking cessation was the lowest form of nicotine, containing about 95 percent of the addictive chemicals.

Dorothy K. Hatsukami, a professor of psychiatry at the University of Minnesota who studies the relationship between nicotine and smoking behavior, said that growing body of evidence suggests that a rapid reduction in nicotine and smoking will offers greater public health benefits than graduates. the way some scientists have been promoting.

A 2018 study Dr. A study conducted by Hatsukami following the behavior of 1,250 smokers found that participants with low nicotine levels smoked less and showed fewer signs of dependence than those who had been given high nicotine levels. gradually reduced more. Course of 20 weeks.

However, there are disadvantages to nicotine withdrawal at the same time: Participants dropped out of study more frequently than those in the graduating group who received stronger nicotine withdrawal . Some secretly turned to their usual nicotine form.

He said: “The reason is that we have known for decades that nicotine is a addictive substance, so if you reduce the nicotine level, you increase the experience. smoking is not satisfying, you increase the chances that people will try to quit, ”he said. .

A recent study provides a cautionary tale, however, that the level of public health benefits can be expected from tobacco control forecasts. While no other country would require experience in the regulation of low nicotine smoking, there is a ban on menthol flavors.

Alex Liber, an assistant professor in the oncology department of the Georgetown University School of Medicine who studies tobacco control, examines the Polish experience and the menthol ban imposed in 2020.

His birth to others wrote found that the ban did not reduce the overall tobacco market, Mr. Liber said, probably because the tobacco industry cuts the price of cigarettes and also starts selling infusion cards of sweetness (about a quarter) that employees can put in their cigarette packs. add sweet fish.

“They know how to sell and earn money and they will increase as long as they have a wiggle room,” he said. “I expect nothing less.”

The FDA approved the release of low nicotine levels in cigarettes

Source link The FDA approved the release of low nicotine levels in cigarettes

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