The US is planning to develop a rule requiring tobacco companies to reduce nicotine levels in cigarettes to minimally or non-addictive levels, an effort that, if successful, could slash smoking-related deaths and threaten a politically powerful industry.
By May 2023, the US Food and Drug Administration (FDA) intends to implement a proposed standard “that would establish a maximum nicotine level in cigarettes and certain finished tobacco products”, reports The Washington Post.
In a statement this week, the FDA said the goal was “to reduce youth use, addiction and death”. If nicotine were reduced, many addicted users would have a greater ability to quit, and young people could be prevented from becoming regular smokers, the agency said.
The administration also said a nicotine-reduction requirement could advance “health equity by addressing disparities associated with cigarette smoking, dependence and cessation”.
However, Guy Bentley, director of consumer freedom at the Reason Foundation, a libertarian think tank, has criticised the plan.
“In practical terms, the proposal would ban most cigarettes sold in America,” he said. “Combined with the proposed ban on menthol cigarettes, this would amount to an effort similar to the prohibition of alcohol in the 1920s, and would ultimately fail.”
Bentley said rather than cutting cigarettes’ nicotine levels, they should promote safer alternatives like e-cigarettes. The FDA is reviewing thousands of applications from e-cigarette manufacturers to determine which should be allowed to remain on the market.
But the Biden administration says reducing nicotine levels in cigarettes would would fit with a major goal – to cut cancer deaths. As part of the country’s retooled cancer moonshot announced this year, President Joe Biden promised to reduce cancer death rates by 50% over 25 years. About 480,000 Americans die of smoking-related causes each year, and tobacco use remains the leading cause of preventable deaths in the US.
The decision to pursue a policy to lower nicotine levels marks the first step in a lengthy process, and success is not assured. It could take at least a year for the FDA, which regulates cigarettes, to issue a proposed rule, experts say. After that, it would have to sift through comments from the public before issuing a final rule.
Opposition could delay or derail the effort, especially if the regulation is not completed before Biden leaves office. A President elected in 2024 could tell the FDA to stop work on an unfinished rule. The tobacco industry, bound to be fiercely opposed to such a drastic change in its products, could challenge a final regulation in court.
The FDA has supported reducing nicotine levels in cigarettes for years but has never secured the necessary upper-level support, including from the Obama White House. The Trump administration’s first FDA commissioner, Scott Gottlieb, said he wanted to lower nicotine levels as part of a broader tobacco policy, and the agency took an early step in 2018 by publishing an information-gathering notice. The plan to move forward was listed on the Trump administration’s regulatory agenda.
But the idea never had full White House backing. Now, the government will be under pressure to indicate it is serious about getting a nicotine-lowering requirement across the finish line.
Supporters say slashing nicotine, the addictive ingredient in cigarettes, would be a milestone in public health that would save millions of lives over generations. In another significant move to reduce smoking-related deaths, the FDA in April proposed banning menthol cigarettes, the only flavoured cigarettes still permitted.
Mitch Zeller, who recently retired as director of the FDA’s Centre for Tobacco Products and is a longtime advocate of reducing nicotine in cigarettes, acknowledged it could take years for such a requirement to take effect.
“The most important, game-changing policies take a long time, but it is worth the wait because, at the end of the day, the only cigarettes that will be available won’t be capable of addicting future generations of kids,” Zeller said.
Matthew Myers, president of the Campaign for Tobacco-Free Kids, said slashing nicotine levels “would produce the greatest drop in cancer rates”.
The American Heart Association called it “one of the most consequential actions the FDA could take to change the deadly trajectory of tobacco use in this country”.
In early 2021, the FDA pitched 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 go-ahead to pursue a policy banning menthol cigarettes, but senior officials postponed a decision on reducing nicotine levels.
Backers say the idea is a natural fit with the White House cancer moonshot because it would slash cancer deaths and does not require a big outlay of money, given that the FDA has been working on the issue for years.
Nicotine, a chemical that occurs naturally in the tobacco plant, does not cause cancer. But its highly addictive properties make it hard for people to quit using cigarettes, which produce smoke containing harmful constituents that can cause lung cancer and heart disease.
Myers, of the Campaign for Tobacco-Free Kids, predicted an FDA requirement to slash nicotine in cigarettes would trigger “the greatest reaction from the tobacco industry of any action ever taken by the government”.
The 2009 Family Smoking Prevention and Tobacco Control Act gave the FDA the authority to regulate cigarettes, including cutting nicotine to minimally and nonaddictive levels. Under the law, the FDA may not ban cigarettes or reduce nicotine levels to zero. But it is permitted to set product standards that dictate components, ingredients, additives and nicotine yields for cigarettes, if those standards are needed to protect the public health.
Aaron Williams, senior vice-president for scientific and regulatory affairs at Reynolds American, one of the nation’s biggest tobacco companies, said the company is reviewing the proposal.
“Our belief is that tobacco harm reduction is the best way forward to reduce the health impacts of smoking,” Williams said.
Other opponents of such a policy will probably argue, as they have in the past, that reducing nicotine to nonaddictive levels is a de facto ban on cigarettes, prohibited by law, and that science does not support such a move. They also are likely to say that slashing nicotine would boost demand for products on the black market.
An agency-funded study published in 2018 in the New England Journal of Medicine found that lowering nicotine levels could save more than 8m lives by the end of the century. The number probably is a little lower now because the percentage of adult smokers has declined in recent years from the 15% rate used in the study to about 12% to 13%.
See more from MedicalBrief archives:
Tobacco use declines globally, strategies for cessation – WHO tobacco report
Smoking cessation treatment for patients with depression could save 203,000 US lives
JAMA editorial: Research strengthens case for e-cigarettes for smoking cessation