The Biden government is expected to announce on Tuesday that it intends to pass a rule requiring tobacco companies to reduce nicotine levels in cigarettes sold in the United States to low or non-addictive levels, according to a source familiar with the matter. The effort, if successful, could have unprecedented results in reducing smoking-related deaths and threatening a politically powerful industry. The initiative is expected to be unveiled as part of the administration’s “consolidated agenda”, a collection of planned federal regulatory actions issued twice a year, according to the knowledgeable person., who spoke on condition of anonymity because they had no authority to discuss the matter. The policy would be in line with a key White House goal – to reduce cancer deaths. As part of the renewed White House announcement this year, President Biden has promised to reduce cancer mortality rates by 50 percent in 25 years. About 480,000 Americans die from smoking-related causes each year, and tobacco use remains the No. 1 preventable cause of death in the United States. The decision to pursue a policy to reduce nicotine levels marks the first step in a long process and success is not guaranteed. It could take at least a year for a proposed rule from the Food and Drug Administration to regulate cigarettes, experts say. After that, the FDA should consider feedback from the public before issuing a final rule. The opposition could delay or derail the effort – especially if the regulation had not been completed before Biden left. A president elected in 2024 could tell the FDA to stop work on an unfinished rule. The tobacco industry, which is certain to be strongly opposed to such a drastic change in its products, could challenge a final regulation in court. The FDA has supported lowering nicotine levels in cigarettes for years, but has never secured much-needed top-level support, including from the Obama White House. The Trump administration’s first FDA commissioner, Scott Gottlieb, said he wanted to reduce nicotine levels as part of a broader tobacco policy, and the agency took an early step in 2018 by publishing an intelligence gathering statement. The plan to move forward has entered the Trump administration’s regulatory agenda. However, the idea was never fully supported in the White House, according to those familiar with the situation, who spoke on condition of anonymity because they were not authorized to discuss the matter. The effort came to a halt after Gottlieb resigned from the government in the spring of 2019. Given the upheaval on this issue, the Biden government will be under pressure from supporters to point out that it is serious to bring a nicotine reduction demand to the finish line. Proponents say reducing nicotine, the addictive ingredient in cigarettes, would be a public health milestone that would save millions of lives for generations to come. In another major move to reduce smoking-related deaths, the FDA proposed banning menthol cigarettes in April, the only flavored cigarettes still allowed. The Wall Street Journal initially reported that the government planned to pursue a nicotine reduction policy. Mitch Zeller, who recently retired as director of the FDA Tobacco Product Center and has long been a supporter of nicotine reduction in cigarettes, acknowledged that it could take years for such a requirement to take effect. “The most important policies that change the game take a long time, but it’s worth the wait because, at the end of the day, the only cigarettes available will not be able to addict future generations of children,” Zeller said. he said. Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, an anti-smoking group, said lowering nicotine levels “would cause the biggest drop in cancer rates and make the biggest difference” from any public health measure discussed by the administration. Guy Bentley, director of consumer freedom at the Reason Foundation, a libertarian think tank, criticized the plan. “In practice, the proposal would ban most cigarettes currently sold in America,” Bentley said. “Combined with the proposed ban on menthol cigarettes by the Biden government, it would be tantamount to an effort similar to the alcohol ban in the 1920s – and it would ultimately fail,” he said. Bentley said that instead of reducing nicotine levels in cigarettes, management should promote safer alternatives, such as e-cigarettes. The FDA is examining thousands of applications from e-cigarette manufacturers to determine which ones should be allowed to remain on the market. In early 2021, the FDA unveiled its nicotine reduction strategy in tobacco talks with the White House and the Department of Health and Human Services. At the time, the White House gave the green light to the FDA to pursue a policy of banning menthol cigarettes, but senior officials postponed the decision to reduce nicotine levels, according to people familiar with the matter who spoke on condition of anonymity because they were not authorized to discuss internal consultations. Proponents of her case have been working to make the actual transcript of this statement available online. Proponents of her case have been working to make the actual transcript of this statement available online. “There is a great deal of policymaking and the Biden administration’s commitment to promoting this effort will mean that it will be completed,” said Gottlieb, a former FDA commissioner. Combining reduced nicotine levels and properly regulating other nicotine sources for addicted adult smokers, such as e-cigarettes, could be “one of the most important public health efforts in modern times,” he said. Nicotine, a chemical found naturally in the tobacco plant, does not cause cancer. But its highly addictive properties make it difficult for people to quit smoking, whose tobacco contains harmful ingredients that can cause lung cancer and heart disease. Myers, of the Campaign for Children Without Smoke, predicted that the FDA’s demand for a reduction in nicotine in cigarettes would provoke “the biggest reaction from the tobacco industry to any action the government has ever taken.” It is an existential threat despite the allegations [by cigarette companies] that they support a smoke-free future. “ The 2009 Family Smoking Prevention and Control Act gave the FDA the power to regulate cigarettes, including reducing nicotine to low and non-addictive levels. By law, the FDA can not ban cigarettes or reduce nicotine levels to zero. However, it is permissible to set product standards that dictate ingredients, ingredients, additives and nicotine yields for cigarettes, if these standards are required to protect public health. Reynolds American, one of the largest tobacco companies in the country, did not immediately respond to requests for comment. Altria said it would comment after the administration announced plans to reduce nicotine. Altria has previously said that if nicotine levels in cigarettes are set, the FDA must ensure that adult smokers have greater access to non-flammable alternatives and accurate information about switching to them. The company has also argued that reducing nicotine in cigarettes would be catastrophic for tobacco retailers, endangering hundreds of thousands of jobs. Other opponents of such a policy will likely argue, as they have in the past, that reducing nicotine to non-addictive levels is a de facto ban on cigarettes, which is prohibited by law, and that science does not support such a move. It is also possible to say that reducing nicotine would boost demand for black market products. Zeller replied that the science behind nicotine reduction is well established. He said researchers have determined the levels at which nicotine is slightly addictive or non-addictive. And he said they have also come to the conclusion that nicotine reduction should happen “with a drop” because a gradual reduction would encourage smokers to smoke more to compensate for the same amount of nicotine. In its announcement for 2018, the FDA said that reducing nicotine levels to low or non-addictive levels “could give addicted users the option and ability to quit smoking more easily and could help experimenters (mainly young people) to start regular use and become regular smokers. ” A study funded by the service published in 2018 in the New England Journal of Medicine found that lowering nicotine levels could save more than 8 million lives by the end of the century. The number is probably a bit lower now, because the percentage of adult smokers has dropped in recent years from the 15 percent used in the study to about 12 to 13 percent.
