The Food and Drug Administration plans to ask tobacco companies to reduce the amount of nicotine in traditional cigarettes to make them less addictive, a move aimed at reducing smoking, according to a statement posted Tuesday on a U.S. government website.
According to the Communication, “this proposed rule is a standard for tobacco products that will set a maximum level of nicotine in cigarettes and certain finished tobacco products. Because tobacco-related harm is primarily the result of addiction to products that repeatedly expose users to toxins, the FDA will take action to reduce addiction to certain tobacco products, thus giving addicted users greater ability to do so. to give up.
The proposal will put the United States at the forefront of global efforts to combat smoking by taking an aggressive stance on significantly lowering nicotine levels. Only one other nation, New Zealand, has proposed such a plan. However, the headwinds are fierce, with a powerful tobacco lobby already showing that any plan to significantly reduce nicotine would be unsuccessful, and with conservative lawmakers who believe the government’s excesses could carry over into the by-elections.
Asked for news reports on a new policy on Tuesday, White House spokeswoman Karin Jean-Pierre reminded reporters that the agencies routinely publish agenda plans on the Office of Management and Budget’s website. And in this case, she said no political decision had been made.
Little details were released on Tuesday, but an announcement was expected. Last week, FDA Commissioner Robert Calif said to the public that he would soon talk more about reducing nicotine addiction.
Similar plans are being discussed to reduce Americans’ addiction to products that cover the lungs with tar, release 7,000 chemicals and lead to cancer, heart disease and lung disease. Nicotine is also available in e-cigarettes, chewing gum, patches and lozenges, but this offer will obviously not affect these products.
“This one rule may have the greatest impact on public health in the history of public health,” said Mitch Zeller, the recently retired director of the FDA Tobacco Center. “This is the scope and scale we are talking about here, because tobacco use remains the leading cause of preventable disease and death.”
About 1,300 people die prematurely every day from smoking-related causes, according to the Centers for Disease Control and Prevention, which leads to about 480,000 deaths a year.
However, the obstacles to such a plan are enormous and can take years to overcome. Some plans were presented that would require a 95% reduction in the amount of nicotine in cigarettes. This can throw smokers in the United States, about 30 million people, into a state of nicotine withdrawal, which includes agitation, difficulty focusing and irritability. This will send others to look for alternatives such as e-cigarettes that are not included in the proposal.
Experts say determined smokers may seek to buy high-nicotine cigarettes in illegal markets or across borders in Mexico and Canada.
Read more about smoking and vaping
The FDA will probably have to overcome resistance from the tobacco industry, which has already begun to point out the reasons why the agency cannot change the $ 80 billion market. Solving legal challenges can take years, and the agency can give the industry five or more years to make the changes.
Other major initiatives in the field of smoking, outlined in the landmark Tobacco Control Act 2009, are slowly taking shape. A lawsuit delayed a requirement for tobacco companies to put graphic warnings on cigarette packs. And the agency recently said it will take another year to finalize key decisions on which e-cigarettes may remain on the market.
Cigarette manufacturers have already warned that the FDA will exceed its powers to regulate cigarettes by requiring a product that is impossible to produce or unacceptable to consumers.
“Both the explicit and the de facto ban would have exactly the same effect – both would undermine Congress ‘explicitly stated goal of’ allowing the sale of tobacco products to adults ‘,” according to a 2018 letter from RJ Reynolds’ parent company, RAI Services , to the FDA on an earlier proposal.
Efforts to reduce nicotine levels are following a proposed rule announced in April that will ban menthol-flavored cigarettes, which are highly preferred by black smokers. This proposal has also been hailed as a potential landmark for public health and has already attracted tens of thousands of public comments. The FDA is required to review and address these comments before finalizing the rule.
Five years ago, Dr. Scott Gottlieb, the agency’s commissioner at the time, launched a plan to reduce nicotine levels in cigarettes to a minimum or non-addictive level. The proposal took shape in 2017, but did not lead to a formal rule during the Trump administration.
At the time, the FDA said the model predicted that a sharp drop in nicotine in cigarettes would prompt five million people to quit smoking in one year.
Among the 8,000 comments pouring in on the 2018 proposal, opposition emerged from retailers, wholesalers and tobacco companies. The Florida Wholesale Distribution Association, a trade group, said the proposal could lead to “new demand for products on the black market and lead to increased trafficking, crime and other illegal activities.”
RAI Services, the parent company of RJ Reynolds, one of the world’s largest tobacco businesses, said in 2018 that the FDA had no evidence that a plan to reduce nicotine levels would improve public health. The agency will “have to give tobacco growers decades to comply” and figure out how to grow low-nicotine tobacco permanently, RAI said in a letter to the FDA. Moreover, the letter states forces tobacco farmers to change their cultivation practices. ”
Tobacco company Altria also warned in 2018 that a standard that worsens tobacco “to the point that it is unacceptable for adult smokers” would be considered a cigarette ban that would violate tobacco control laws.
The 2009 Tobacco Control Act gave the FDA broad powers to regulate tobacco products with standards “appropriate to protect public health,” although it explicitly prohibited a ban on cigarettes or a reduction in nicotine levels to zero.
Low-nicotine cigarettes are now available to consumers, albeit in a limited way. This spring, a New York-based biotechnology company, the 22nd Century Group, began selling a nicotine-reduced cigarette that took 15 years and tens of millions of dollars to grow through genetic manipulation of the tobacco plant. The company’s brand, VLN, contains five percent of the nicotine level in conventional cigarettes, according to James Mish, the company’s chief executive.
“It’s not some distant technology,” he said.
To earn its FDA name as a low-risk tobacco product, VLN has undergone numerous tests and clinical trials by regulators.
For now, the company is selling VLNs at convenience stores Circle K in Chicago as part of a pilot program. Mr Mish described sales as “modest” – retail prices were similar to premium brands such as Marlboro Gold – but said the FDA’s proposed rule was likely to accelerate plans for national deployment in the coming months. However, the company’s long-term business plan, he said, is largely based on licensing Big Tobacco’s genomic engineering technology.
Dr. Neil Benowitz, a professor of medicine at the University of California, San Francisco, who studied the use and cessation of smoking, first proposed the idea of removing nicotine from cigarettes in 1994.
He said one major concern is whether smokers will smoke more, hold back smoke longer or smoke more cigarettes to compensate for lower nicotine levels. After several studies, researchers found that the cigarette that prevents this behavior is the version with the lowest nicotine content, about 95 percent less than the addictive chemical.
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 a rapid and significant reduction in nicotine in cigarettes will provide greater public health benefits. than the gradual approach that some scholars have encouraged.
A 2018 study led by Dr. Hatsukami, which followed the habits of 1,250 smokers, found that participants who were randomly assigned to ultra-low nicotine cigarettes smoked less and showed fewer signs of addiction. of those who have been given cigarettes with nicotine levels that are gradually declining. decreases over 20 weeks.
However, there were downsides to reducing nicotine in one fell swoop: participants dropped out of the study more often than those in the progressive group and experienced more intensive nicotine withdrawal. Some have secretly turned to their regular, all-nicotine brands.
“After all, 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 increase the likelihood that people will try to quit,” she said. .
However, a recent study offers a warning story about the degree of public health benefits that lawmakers can expect from tobacco control policy. Although there is no other nation looking for experience with the mandate of low-nicotine cigarettes, there is a ban on the taste of menthol.
Alex Lieber, an assistant professor in the Department of Oncology at Georgetown University School of Medicine who studies tobacco control policy, reviewed Poland’s experience with the 2020 ban on menthol cigarettes.
The study, which he and others wrote, found that the ban did not reduce overall cigarette sales, Mr …
Add Comment