Biden administration expected to shift to reducing nicotine in cigarettes

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The Biden administration is expected as early as Tuesday to announce plans to enact a rule requiring tobacco companies to reduce nicotine levels in cigarettes sold in the United States to minimal or non-addictive levels, according to a person familiar with the matter.

The effort, if successful, could have an unprecedented effect on reducing smoking-related deaths and threaten a politically powerful industry.

The initiative is expected to be unveiled as part of the administration’s “unified agenda,” a compilation of planned federal regulatory actions released twice a year, according to the person with knowledge., who spoke on condition of anonymity because they were not authorized to discuss the issue.

The policy would align with a major White House goal – to reduce cancer deaths. As part of the revamped White House Cancer Moonshot announced this year, President Biden promised to cut cancer death rates by 50% over 25 years. About 480,000 Americans die each year from smoking-related causes, and smoking remains the number one preventable cause of death in the United States.

The decision to pursue a policy of lowering nicotine levels marks the first step in a long process, the success of which is not guaranteed. Experts say it could take the Food and Drug Administration, which regulates cigarettes, at least a year to release a proposed rule. After that, the FDA should sift through public comments before issuing a final rule.

The opposition could delay or derail the effort — especially if the settlement isn’t completed before Biden leaves office. A president-elect in 2024 could tell the FDA to stop working on an unfinished rule. The tobacco industry, which will certainly vehemently oppose such a drastic change in its products, could challenge a final settlement in court.

The FDA has supported reducing nicotine levels in cigarettes for years, but never got the higher-level support needed, including from the Obama White House. The Trump administration’s first FDA commissioner, Scott Gottlieb, has said he wants to reduce nicotine levels as part of a broader smoke-free policy, and the agency took a first step in 2018 by publishing an information collection notice. But the idea never had the full support of the White House and was scrapped after Gottlieb left the administration in the spring of 2019.

Proponents say reducing nicotine, the addictive ingredient in cigarettes, would be a public health milestone that would save millions of lives over generations. In another big move to reduce smoking-related deaths, the FDA proposed in April to ban menthol cigarettes, the only flavored cigarettes still allowed.

The Wall Street Journal first reported that the administration planned to continue the nicotine reduction policy.

Mitch Zeller, who recently retired as director of the FDA’s Center for Tobacco Products and is a longtime advocate for nicotine reduction in cigarettes, acknowledged that it could take years for such a requirement takes effect.

“The most important game-changing policies take a long time, but it’s worth the wait because ultimately the only cigarettes that will be available will not be capable of creating addiction for future generations of people. kids,” Zeller said. said.

Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, an anti-tobacco group, said reducing nicotine levels would “produce the biggest drop in cancer rates and make the biggest difference” of any measure. public health under discussion by the administration.

Guy Bentley, director of consumer freedom at the Reason Foundation, a libertarian think tank, criticized the plan.

“In practical terms, the proposal would ban most cigarettes currently sold in America,” Bentley said. “Combined with the Biden administration’s proposed ban on menthol cigarettes, it would amount to an effort similar to the banning of alcohol in the 1920s” — and ultimately fail, he said.

Bentley said rather than 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 should be allowed to remain on the market.

In early 2021, the FDA presented the nicotine reduction strategy during discussions of tobacco issues with the White House and the Department of Health and Human Services. At the time, the White House gave the FDA the green light to pursue a policy banning menthol cigarettes, but senior officials postponed a decision on reducing nicotine levels, according to people familiar with the matter who said spoke on condition of anonymity because they were not authorized to discuss internal deliberations.

Backers say the idea fits naturally with the White House’s cancer moonshot because it would reduce cancer deaths and wouldn’t require a big outlay of government money given the FDA is working on the question for years.

“There is a long arc in major policymaking, and the Biden administration’s commitment to advancing this effort will mean it gets done,” said Gottlieb, the former FDA commissioner. The combination of reduced nicotine levels and appropriate regulation of other sources of nicotine for addicted adult smokers, such as e-cigarettes, could be “one of the most impactful public health efforts of modern times”, a he declared.

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, the smoke of which contains harmful components that can cause lung cancer and heart disease.

Myers of the Campaign for Tobacco-Free Kids predicted that an FDA requirement to reduce nicotine in cigarettes would trigger “the biggest tobacco industry reaction of any government action.” It’s an existential threat despite claims [by cigarette companies] that they support a smoke-free future.

The Family Smoking Prevention and Control Act of 2009 gave the FDA authority to regulate cigarettes, including reducing nicotine to minimal, non-addictive levels. By law, the FDA cannot ban cigarettes or reduce nicotine levels to zero. But it is allowed to set product standards that dictate the components, ingredients, additives and nicotine levels of cigarettes, whether these standards are necessary to protect public health.

Reynolds American, one of the nation’s largest tobacco companies, did not immediately respond to requests for comment. Altria said it would comment after the administration announces any nicotine reduction plans.

In the past, Altria has said that if limits are placed on nicotine levels in cigarettes, the FDA must ensure that adult smokers have better access to non-combustible alternatives and accurate information about their transition. . The company also argued that reducing nicotine in cigarettes would be devastating for tobacco retailers, putting hundreds of thousands of jobs at risk.

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, prohibited by law, and that science does not not support such a decision. They are also likely to say that reducing nicotine would increase demand for black market products.

Zeller countered that the science supporting lower nicotine levels is well established. He said the researchers determined the levels at which nicotine is minimally addictive or not. And he added that they also concluded that the reduction in nicotine should happen “all at once”, because a gradual reduction would encourage smokers to smoke more to compensate for getting the same amount of nicotine.

In its 2018 advisory, the FDA said that lowering nicotine levels to minimal or non-addictive levels “could give addicted users the choice and ability to quit more easily, and it could help prevent experimenters (mainly young people) to start regular use and become regular smokers.”

An agency-funded study published in 2018 in the New England Journal of Medicine found that reducing nicotine levels could save more than 8 million lives by the end of the century. The number is probably a little lower now because the percentage of adult smokers has declined in recent years from the 15% rate used in the study to around 12-13%.

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