Biden Administration Targets Removal of Most Nicotine From Cigarettes: Plan draws on research suggesting very low-nicotine cigarettes are less addictive; tobacco companies say science isn’t conclusive
The Biden administration is moving forward on a plan to mandate the elimination of nearly all nicotine in cigarettes, a policy that would upend the $95 billion U.S. cigarette industry and, health officials say, prompt millions of people to quit smoking.
The plan, unveiled Tuesday as part of the administration’s agenda of regulatory actions, likely wouldn’t take effect for several years. The Food and Drug Administration plans to publish a proposed rule in May 2023, though the agency cautioned that date could change. Then the agency would invite public comments before publishing a final rule. Tobacco companies could then sue, which could further delay the policy’s implementation.
“Nicotine is powerfully addictive,” FDA Commissioner Robert Califf said in a statement Tuesday. “Lowering nicotine levels to minimally addictive or non-addictive levels would decrease the likelihood that future generations of young people become addicted to cigarettes and help more currently addicted smokers to quit.”
The move would be the biggest step by the U.S. government to curb smoking since a landmark legal settlement in 1998, when tobacco companies agreed to pay more than $200 billion to help states pay for healthcare. As part of the settlement, the companies also agreed to various marketing restrictions, including a ban on free product samples and advertising on billboards.
The cigarette smoking rate has been declining in the U.S. for decades, though it rose slightly in 2020 when the pandemic hit. About 12.5% of adults in the U.S., or 30.8 million people, were cigarette smokers in 2020, according to the Centers for Disease Control and Prevention.
U.S. cigarette sales are expected to drop this year to about $95 billion from $99 billion last year, according to Euromonitor International.
The policy would apply to all cigarettes sold in the U.S. Imports of traditional cigarettes would be barred but multinational tobacco companies could continue to sell full-nicotine cigarettes in other countries. New Zealand’s Ministry of Health also has proposed a reduction of nicotine in cigarettes to very low levels as part of a broader plan to curb smoking.
The FDA’s planned rule could sharply decrease U.S. cigarette sales, and tobacco companies intend to fight it. The largest U.S. cigarette makers—Altria Group Inc. MO -9.43%▼ and Reynolds American Inc.—sell alternative products such as nicotine pouches, but revenue for both companies comes predominantly from cigarettes.
Altria shares at market close Tuesday had fallen by 7% since June 10, when The Wall Street Journal reported that the Biden administration planned to mandate a reduction of nicotine in cigarettes.
Reynolds and Altria said Tuesday that encouraging smokers to switch to less harmful options was a better approach to improving public health than reducing nicotine in cigarettes.
“We do actually support the overarching goal here, which is to transition smokers from cigarettes to smoke-free products,” said Murray Garnick, Altria’s general counsel. “We just think that the better way is to create a robust market of FDA-authorized smoke-free products.”
Mr. Garnick said that the policy might not be effective in helping people quit, that it could fuel a surge in demand for black-market cigarettes and that reducing nicotine to very low levels wasn’t achievable on the scale of billions of cigarettes a year. If the policy were effective, he said, it could hurt U.S. tobacco growers and retailers.
Nicotine is the addictive chemical that hooks people on cigarettes. Nicotine itself doesn’t cause cancer or lung disease, according to the FDA. Those diseases are caused by other harmful constituents in cigarette smoke.
The FDA’s nicotine-reduction plan is based on more than a decade of government-funded research showing that when people use cigarettes with about 95% less nicotine than a typical cigarette, they smoke fewer cigarettes and become less dependent on them. Smokers of these cigarettes were more likely to quit or seek their nicotine fix from less-harmful alternatives such as e-cigarettes or gum compared with smokers who continued using regular cigarettes.
Cigarette smoking is the most dangerous way to consume nicotine, according to public health officials. While very low-nicotine cigarettes are less addictive, researchers say, their smoke still contains most of the same carcinogenic compounds as regular cigarette smoke.
According to an FDA study published in 2018, such a rule would prompt an additional 13 million adult smokers to quit within five years of implementation.
Smoking is linked to more than 480,000 deaths in the U.S. each year, according to the CDC. And tobacco use costs nearly $300 billion a year in direct healthcare and lost productivity, the FDA says.
Cigarette industry executives say the science on low-nicotine cigarettes isn’t conclusive. They say that such a rule would expand the illicit market for cigarettes and could lead to consumer confusion around the health risks of very low-nicotine cigarettes. There is widespread misunderstanding in the U.S. about the health risks of nicotine. An FDA study in 2017 found that about 75% of people either were unsure of the relationship between nicotine and cancer or incorrectly believed that nicotine caused cancer.
Big cigarette companies also say it would take years for them to develop a very low-nicotine cigarette and that it wouldn’t be feasible to manufacture at scale. In the past, tobacco companies have made low-nicotine cigarettes by stripping nicotine from the tobacco leaf in a process similar to the way coffee companies make decaffeinated coffee. In anticipation of a federal nicotine-reduction rule, Altria and Reynolds have experimented with other ways, including tobacco-leaf treatments and plant breeding to develop tobacco varieties that contain less nicotine, industry executives say.
22nd Century Group Inc., XXII 25.76%▲ a Buffalo, N.Y., biotechnology company, uses genetic engineering to grow tobacco with about 95% less nicotine than a typical tobacco plant for a cigarette brand called VLN. The product is currently available for sale in Chicago. Through a federal contract, 22nd Century has also supplied more than 30 million cigarettes at varying nicotine levels for scientific research.
22nd Century is willing to partner with other cigarette companies to provide tobacco seeds, Chief Executive James Mish said. “It’s immediately scalable,” he said.
Lowering nicotine in cigarettes has been a subject of discussion inside the FDA since the 1990s. In 2009, the Family Smoking Prevention and Tobacco Control Act gave the agency the authority to mandate a reduction of nicotine in cigarettes, but only if the policy was based on scientific evidence, a caveat that slowed the process for years. The law stipulated that the FDA couldn’t eliminate nicotine in cigarettes entirely.
Scott Gottlieb, who served as an FDA commissioner during the Trump administration, pursued a reduction of nicotine in cigarettes as part of a broader tobacco policy he proposed in 2017. But after he left the agency in 2019, Trump administration officials shelved the plan.
The Biden administration decided to embrace the policy as part of President Biden’s Cancer Moonshot initiative, which aims to reduce the cancer death rate by at least 50% over the next 25 years. His administration is also pursuing a ban on menthol cigarettes, which account for more than a third of all cigarettes sold in the U.S. The FDA published a proposed rule on menthols in April and is now soliciting public comments. That ban also likely wouldn’t take effect for several years.
Separately, the FDA is conducting a review of all e-cigarettes on the market and weighing whether their potential benefit as a less-harmful alternative for adult cigarette smokers outweighs the products’ risk to young people.
Write to Jennifer Maloney at jennifer.maloney@wsj.com
Appeared in the June 22, 2022, print edition as 'FDA Targets the Elimination Of Most Nicotine in Cigarettes'.