Biden administration expected to change to reduce nicotine in cigarettes

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The Biden administration is expected to announce as soon as Tuesday that it 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 one person. who is familiar with the situation.

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

The initiative is expected to be unveiled as part of the government’s “unified agenda,” a compilation of planned federal regulatory measures released twice a year, according to the knowledgeable person. who spoke on condition of anonymity as they were not authorized to discuss the matter.

The policy would align with a key White House goal: to reduce cancer deaths. As part of the redesigned White House cancer moonshot announced this year, President Biden pledged to reduce the cancer death rate by 50 percent in 25 years. About 480,000 Americans die each year from smoking-related causes, and tobacco use remains the No. 1 cause of preventable death in the United States.

The decision to adopt a policy to lower nicotine levels marks the first step in a lengthy process, and success is not assured. It could be at least a year before the Food and Drug Administration, which regulates cigarettes, issues a proposed rule, experts say. After that, the FDA should review the public’s comments before issuing a final rule.

The opposition could delay or derail the effort, especially if the ordinance was not completed before Biden left office. A president elected in 2024 could tell the FDA to stop working on an unfinished rule. The tobacco industry, sure to vehemently oppose such a drastic change to its products, could challenge a final ordinance in court.

The FDA has supported lowering nicotine levels in cigarettes for years, but has never received the necessary top-level support, including from the Obama White House. Scott Gottlieb, the Trump administration’s first FDA commissioner, said he wanted to lower nicotine levels as part of broader tobacco policy, and the agency took an early step in 2018 by publishing an information-gathering notice. The plan to move forward was on the Trump administration’s regulatory agenda.

But the idea never received full support from the White House, according to those familiar with the situation and who spoke on the condition of anonymity because they were not authorized to discuss the matter. The effort was shelved after Gottlieb left the administration in the spring of 2019. Given the twists and turns of this matter, the Biden administration will be under pressure from lawyers to signal that getting a nicotine-lowering requirement across the finish line is serious.

Proponents say cutting nicotine, the addictive ingredient in cigarettes, would be a public health milestone that would save millions of lives across generations. In another important step 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 government planned to continue its nicotine reduction policies.

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

“The most important, groundbreaking policy is taking a long time, but it’s worth the wait because eventually the only cigarettes that will be available will not be able to make future generations of children addicted,” Zeller said. 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” of any public health measure proposed by the government. discussed.

Guy Bentley, consumer freedom director 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, this would amount to an effort comparable to the ban on alcohol in the 1920s” — and would ultimately fail, he said.

Bentley said that rather than lowering nicotine levels in cigarettes, the government should promote safer alternatives such as e-cigarettes. The FDA reviews thousands of applications from e-cigarette manufacturers to determine which ones can stay on the market.

In early 2021, the FDA presented the nicotine reduction strategy in talks on 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 enact a policy that bans menthol cigarettes, but senior officials postponed a decision to lower nicotine levels, according to people familiar with the matter and who spoke on condition of anonymity because they were not authorized to discuss internal deliberations.

Backers say the idea is a natural fit with the White House’s cancer moonshot, as it would reduce cancer deaths and wouldn’t require a major outlay of government money, given the FDA’s been working on the problem for years.

“There is a long arc to major policy making, and the Biden administration’s commitment to advancing that effort will mean getting it 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 in modern times,” he said.

Nicotine, a chemical naturally occurring in the tobacco plant, does not cause cancer. But their highly addictive properties make it difficult for people to stop using cigarettes, whose smoke contains harmful compounds that can cause lung cancer and heart disease.

Myers, of the Campaign for Tobacco-Free Kids, predicted that an FDA requirement to eliminate nicotine from cigarettes would “provoke the largest tobacco industry response to any action ever taken by the government. It’s an existential threat despite claims [by cigarette companies] that they support a smoke-free future.”

The Family Smoking Prevention and Tobacco Control Act of 2009 gave the FDA the power to regulate cigarettes, including reducing nicotine to a minimal and non-addictive level. By law, the FDA cannot ban cigarettes or reduce nicotine levels to zero. But it is allowed to set product standards that dictate components, ingredients, additives and nicotine levels for cigarettes, if those 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 government 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 greater access to non-combustible alternatives and accurate information about switching to cigarettes. The company has also argued that cutting nicotine in cigarettes would be devastating to tobacco retailers and put hundreds of thousands of jobs at risk.

Other opponents of such policies are likely to argue, as they have in the past, that reducing nicotine to non-addictive levels is a de facto cigarette ban, prohibited by law, and that science does not support such a move. They’re also likely to say that cutting nicotine would boost demand for black-market products.

Zeller objected that the science supporting lowering nicotine levels is well established. He said researchers have determined the levels at which nicotine is minimally addictive or non-addictive. And he said they had also come to the conclusion that reducing nicotine should come in “one blow” because a gradual decrease would encourage smokers to smoke more to compensate for getting the same amount of nicotine.

In its 2018 announcement, the FDA said 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 researchers (primarily young people) from taking regular drugs.” start using and become regular smokers.”

An agency-funded study 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 likely slightly lower now because the percentage of adult smokers has fallen in recent years from the 15 percent used in the study to about 12 to 13 percent.