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The Biden administration is expected to announce on Tuesday that it intends to issue a rule requiring tobacco companies to reduce nicotine levels in cigarettes sold in the United States to minimal or non-addictive levels, according to someone familiar with the situation.
The effort, if successful, could have an unprecedented effect in reducing smoking-related deaths and threatening a politically powerful industry.
The initiative is expected to be unveiled as part of the administration’s “single agenda”, a compilation of planned federal regulatory actions published twice a year, according to the acquaintance., who spoke on condition of anonymity because they did not have permission to discuss the matter.
The policy would be in line with the White House’s primary goal of reducing cancer mortality. As part of a reorganized lunar attack on the White House for cancer announced this year, President Biden has promised to reduce cancer mortality by 50 percent in 25 years. About 480,000 Americans die from smoking-related causes each year, and tobacco use remains the number one cause of preventable 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 the Food and Drug Administration, which regulates cigarettes, to issue a proposed rule, experts say. The FDA will then have to sift through public comments before issuing a final rule.
The opposition could slow or frustrate efforts – especially if the regulation is not finalized before Biden leaves office. A president elected in 2024 can tell the FDA to stop working on an unfinished rule. The tobacco industry, which is sure to vehemently oppose such a drastic change in its products, may challenge a final ruling in court.
The FDA has supported reducing nicotine levels in cigarettes for years, but has never provided the necessary support from higher levels, including the Obama White House. The first FDA commissioner of the Trump administration, Scott Gottlieb, said he wanted to reduce nicotine levels as part of a broader smoking policy, and the agency took an early step in 2018 by publishing an information gathering notice. The progress plan was on the Trump administration’s regulatory agenda.
But the idea never had the full support of the White House, according to people familiar with the situation, who spoke on condition of anonymity because they were not authorized to discuss the issue. Efforts have been delayed after Gottlieb left the administration in the spring of 2019. Given the twists and turns of the issue, the Biden administration will be under pressure from advocates to show that it is serious about meeting the nicotine reduction requirement across the finish line. .
Proponents say reducing nicotine, an addictive ingredient in cigarettes, will be a cornerstone of public health that will save millions of lives for generations. In another important move to reduce smoking-related deaths, the FDA in April proposed a ban on menthol cigarettes, the only fragrance cigarettes still allowed.
The Wall Street Journal first reported that the administration plans to pursue a policy to reduce nicotine.
Mitch Zeller, who recently retired as director of the FDA’s Tobacco Center and a longtime advocate for reducing nicotine in cigarettes, acknowledged that it could take years before such a requirement takes effect.
“The most important game-changing policies take a long time, but it’s worth the wait, because at the end of the day, the only cigarettes that will be available will not be addictive to future generations of children,” Zeller said.
Matthew L. Myers, president of the Tobacco Free Campaign, an anti-smoking group, said reducing nicotine levels “will lead to the biggest drop in cancer incidence and make the biggest difference” from any measure. for public health, which is being 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 will ban most cigarettes currently sold in America,” Bentley said. “Combined with the Biden administration’s ban on menthol cigarettes, it would be an effort similar to the ban on alcohol in the 1920s,” and it will eventually fail, he said.
Bentley said that instead of reducing nicotine levels in cigarettes, the administration should promote safer alternatives such as e-cigarettes. The FDA is reviewing thousands of applications from e-cigarette manufacturers to determine which ones should be allowed to remain on the market.
In early 2021, the FDA presented a strategy to reduce nicotine in talks on tobacco with the White House and the Ministry of Health and Human Services. At the time, the White House gave the FDA the green light to pursue a policy to ban 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 discussions.
Proponents say the idea naturally coincides with White House cancer, as it would reduce cancer deaths and does not require large expenditures of public money, given that the FDA has been working on the issue for years.
“There is a long way to go about basic policy-making, and the Biden administration’s commitment to making progress in this effort will mean it will be over,” said Gottlieb, a former FDA commissioner. The combination of reduced nicotine levels and proper regulation of other nicotine sources for addicted adult smokers, such as e-cigarettes, could be “one of the most influential public health efforts of our time,” 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 give up cigarettes whose smoke contains harmful ingredients that can cause lung cancer and heart disease.
Myers, of the Tobacco Free Campaign, predicts that the FDA’s requirement to reduce nicotine in cigarettes will provoke “the biggest response from the tobacco industry to any action taken by the government.” This is an existential threat despite the allegations [by cigarette companies] that they support a smoke-free future. “
The Family Law on Smoking Prevention and Control of 2009 gave the FDA the power to regulate cigarettes, including reducing nicotine to minimum and non-addictive levels. By law, the FDA cannot ban cigarettes or reduce nicotine levels to zero. However, it is permissible to set product standards that dictate the components, ingredients, additives and yield of nicotine for cigarettes, if these standards are necessary to protect public health.
Reynolds American, one of the country’s largest tobacco companies, did not immediately respond to requests for comment. Altria said it would comment after the administration announced plans to reduce nicotine.
In the past, Altria said that if nicotine levels are set in cigarettes, the FDA must ensure that older smokers have greater access to non-flammable alternatives and accurate information about switching to them. The company also claims that reducing nicotine in cigarettes would be devastating for tobacco traders, threatening hundreds of thousands of jobs.
Other opponents of such a policy are likely to argue, as in the past, that reducing nicotine to addictive levels is a de facto ban on cigarettes, banned by law, and that science does not support such a move. They are also likely to say that reducing nicotine will increase demand for products on the black market.
Zeller argued that the science supporting the reduction of nicotine levels is well established. He said researchers have identified levels at which nicotine is minimally addictive or non-addictive. And he said they also came to the conclusion that nicotine reduction should happen in one fell swoop, as a gradual reduction would encourage smokers to smoke more to compensate for the same amount of nicotine.
In its 2018 report, the FDA said that lowering nicotine levels to minimal or non-addictive levels “could give addicted users a choice and the opportunity to quit more easily and could help discourage experimenters ( mainly young people) to start regular use and become regular smokers. ”
A study funded by the agency, 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. Now the number is probably slightly lower because the percentage of adult smokers has decreased in recent years from 15 percent used in the study to about 12 to 13 percent.
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