According to the announcement, “this proposed rule is a standard for tobacco products that would set a maximum nicotine level in cigarettes and certain finished tobacco products. Because tobacco-related harms result primarily from addiction to products that repeatedly expose users to toxins, the FDA will take steps to reduce addiction to certain tobacco products, giving addicted users a greater chance of quitting. smoking. The proposal would put the United States at the forefront of global anti-smoking efforts by taking an aggressive stance to significantly reduce nicotine levels. Only one other nation, New Zealand, has promoted such a plan. Opposite winds, however, are strong, with a strong tobacco lobby already indicating any plan with significant nicotine reductions would be unfounded and conservative lawmakers considering a government overrun that could extend to midterm elections. Asked about news of a new policy on Tuesday, White House spokeswoman Karine Jean-Pierre reminded reporters that agencies regularly post agenda plans on the Office of Management and Budget website. In this case, too, he said no political decision had been made. A few details were released on Tuesday, but an announcement is expected. Last week, FDA Commissioner Dr. Robert Califf told an audience that he would talk more about reducing nicotine addiction soon. Similar plans have been discussed to reduce Americans’ addiction to products that coat 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 proposal obviously will not affect these products. “This rule could have the biggest impact on public health in public health history,” said Mitch Zeller, the recently retired director of the FDA Tobacco Center. “This is the extent and magnitude we are talking about here, because tobacco use remains the leading cause of preventable disease and death.” About 1,300 people die prematurely each day from smoking-related causes, according to the Centers for Disease Control and Prevention, adding up to about 480,000 deaths each year. The obstacles to such a plan, however, are enormous and may take years to overcome. Some designs have been launched that require a 95 percent reduction in the amount of nicotine in cigarettes. This could plunge US smokers, some 30 million people, into a nicotine deprivation state that includes arousal, difficulty focusing and irritability. It would send others in search of alternatives such as e-cigarettes, which are not included in the proposal. Experts say determined smokers may seek to buy nicotine-rich cigarettes in illegal markets or across borders in Mexico and Canada.
Read more about smoking and steaming
The FDA will probably have to overcome the opposition from the tobacco industry, which has already begun to point out the reasons why the organization can not overturn a $ 80 billion market. Legal challenges can take years to resolve and the organization can give the industry five or more years to make the changes. Other major tobacco initiatives outlined in the 2009 Landmark Tobacco Control Act were slow to take shape. A lawsuit delayed the requirement for tobacco companies to place graphic warnings on cigarette packs. And the agency recently said it would take another year to finalize key decisions about which e-cigarettes might remain on the market. Cigarette manufacturers have already warned that the FDA will go beyond its authority to regulate cigarettes by requiring a product that is impossible to produce or unacceptable to consumers. “Both an explicit and a de facto ban will have exactly the same effect – both will undermine the explicitly stated purpose of Congress ‘to allow the sale of tobacco products to adults,’” according to a 2018 letter from its parent company. RJ Reynolds, RAI Services. , to the FDA on a previous proposal. The effort to reduce nicotine levels follows a proposed rule announced in April that would ban menthol-flavored cigarettes, which are strongly favored by black smokers. This proposal has also been hailed as a potential milestone in public health and has already garnered tens of thousands of public comments. The FDA is committed to reviewing and addressing these comments before finalizing the rule. Five years ago, Dr. Scott Gottlieb, the service commissioner at the time, published a plan to reduce nicotine levels in cigarettes to a minimum or non-addictive level. The proposal was formulated in 2017, but did not lead to a formal rule during the Trump administration. At the time, the FDA said a model predicted that a sharp drop in nicotine in cigarettes would push five million people to quit smoking in one year. Among the 8,000 comments that came out of a 2018 proposal, opposition emerged from retailers, wholesalers and the tobacco industry. The Florida Wholesale Association, a trade group, said the proposal could lead to “new demand for black market products and lead to increased trafficking, crime and other illegal activities.” RAI Services, the parent company of RJ Reynolds, one of the largest tobacco companies, said in 2018 that the FDA had no evidence that the plan to reduce nicotine levels would improve public health. The agency “should give tobacco manufacturers decades to comply” and find out how to consistently grow low-nicotine tobacco, RAI said in a letter to the FDA. farmers to change their cultivation practices “. Tobacco company Altria also warned in 2018 that a standard that degrades tobacco “to the point of being unacceptable to 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 to standards “appropriate to protect public health,” although it specifically banned smoking or reduced nicotine levels to zero. Low nicotine cigarettes are already available to consumers, albeit in a limited way. This spring, a New York-based plant biotechnology company, the 22nd Century Group, began selling a low-nicotine cigarette that took 15 years and tens of millions of dollars to grow through the genetic manipulation of the tobacco plant. The company’s brand, VLN, contains five percent of the nicotine level of conventional cigarettes, according to James Mish, the company’s chief executive officer. “This is not a distant technology,” he said. To earn its FDA rating as a “reduced risk” tobacco product, the VLN has undergone a series of trials and clinical trials by regulators. The company is currently selling VLNs at Circle K convenience stores in Chicago as part of a pilot project. Mr Mish described sales as “mediocre” – retail prices are similar to premium brands like Marlboro Gold – but said the proposed FDA rule was likely to accelerate plans for a nationwide launch in the coming months. That said, the company’s long-term business plan, he said, relied heavily on licensing its genomic engineering technology to Big Tobacco. Dr. Neal Benowitz, a professor of medicine at the University of California, San Francisco who studies tobacco use and smoking cessation, first proposed the idea of eliminating nicotine from cigarettes in 1994. He said a key concern was whether smokers would inhale harder, hold on to the tobacco for longer or smoke more cigarettes to compensate for lower nicotine levels. After several studies, the researchers found that the cigarette that prevented these behaviors was the version with the lowest nicotine content, one with about 95 percent less than the addictive chemical. Dorothy K. Hatsukami, a professor of psychiatry at the University of Minnesota who studies the relationship between nicotine and smoking behavior, said a growing body of evidence suggests that a rapid and significant reduction in nicotine in cigarettes would provide greater public health benefits. their gradual approach promoted by some scientists. A 2018 study led by Dr. Hatsukami, who followed the habits of 1,250 smokers, found that participants who were given extremely low nicotine cigarettes smoked less and showed fewer signs of dependence than those who were given nicotine cigarettes at nicotine levels. reduced over a period of 20 weeks. There were, however, drawbacks to reducing nicotine in one go: participants dropped out of the study more often than those in the gradual group and experienced more intense nicotine withdrawal. Some secretly turned to their regular brands with complete nicotine. “The bottom line is that we have known for decades that nicotine is what makes cigarettes so addictive, so reducing nicotine makes your smoking experience less satisfying and increases the likelihood that people will try to quit,” he said. . A recent study offers a warning story, however, about the degree of public health benefit that lawmakers can expect from tobacco control policy. While there is no other nation to seek experience with a mandate for low nicotine cigarettes, there is a ban on the taste of menthol. Alex Liber, an assistant professor in the oncology department at Georgetown University School of Medicine who studies tobacco control policy, looked at Poland’s experience with banning the menthol cigarette introduced in 2020. The study written by him and others found that the ban did not lead to a reduction in total cigarette sales, Mr.
