FDA to draft and publish proposal, which likely wouldn’t take effect for several years
THE WALL STREET JOURNAL // JUNE 10, 2022
The Biden administration intends to pursue a policy requiring tobacco companies to reduce the nicotine in all cigarettes sold in the U.S. to minimally or nonaddictive levels, according to people familiar with the matter, a move that would upend the tobacco industry.
The policy, which the administration is expected to announce as early as next week, likely wouldn’t take effect for several years. The Food and Drug Administration first must publish a proposed rule, then invite public comments before publishing a final rule, according to the people familiar with the matter. Tobacco companies could then sue, which could further delay the policy’s implementation.
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.
Altria Group Inc. and Reynolds American Inc., the two largest U.S. cigarette companies, didn’t immediately comment Friday. A White House spokesman declined to comment.
Nicotine is an addictive chemical found in cigarettes and other tobacco products. While nicotine hooks people on cigarettes, nicotine itself doesn’t cause cancer, heart disease or lung disease, according to the FDA. It is other harmful compounds in cigarette smoke that are associated with more than 480,000 deaths in the U.S. each year, according to the Centers for Disease Control and Prevention.
Nicotine levels in cigarettes can be reduced in different ways. Manufacturers can adjust the blend of tobacco leaves or use different types of paper or filters. Nicotine can also be stripped from the leaf in the manufacturing process. One company uses genetic engineering to grow tobacco with 95% less nicotine than a typical tobacco plant.
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 authorized the FDA to mandate such a change—with the stipulation that the policy be based on scientific evidence, a caveat that slowed the process for years.
FDA officials have said reducing nicotine in cigarettes to very low levels would prevent future generations from becoming addicted to cigarettes, and prompt current smokers to quit.
Research funded by the FDA and National Institutes of Health has shown that when nicotine was nearly eliminated in cigarettes, smokers 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 cigarettes with normal nicotine levels.
The tobacco industry has rejected these findings. Cigarette companies have said that such a rule would lead people to smoke more, not less, and would expand the illicit market for cigarettes.
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 FDA’s current commissioner, Robert Califf, has also long supported the move. In a 2017 interview, when Dr. Gottlieb was pursuing the policy, Dr. Califf said: “If it works, it will save more lives than anything else the FDA could do.” Dr. Califf declined to comment Friday through a spokesman.
The Biden administration for more than a year has been considering whether to advance a plan to reduce nicotine in cigarettes. According to the people familiar with the matter, the 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.
The 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.
The cigarette smoking rate has been declining in the U.S. for decades, though it ticked up 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 CDC.
According to estimates published in the New England Journal of Medicine, mandating a reduction of nicotine levels in cigarettes to very low levels would prompt an additional 5 million adult smokers to quit within a year of implementation.
Tobacco use costs nearly $300 billion a year in direct healthcare and lost productivity, according to the FDA.
Write to Jennifer Maloney at email@example.com