FDA floats plan to make cigarettes nonaddictive, but its fate rests with Trump

[January 16, 2025]  By MATTHEW PERRONE

WASHINGTON (AP) — Federal officials on Wednesday released a far-reaching proposal to make cigarettes far less addictive by capping their nicotine content, a goal long sought by antismoking advocates that is unlikely to go into effect anytime soon.

The proposed rule from the Food and Drug Administration comes in the final days of President Joe Biden’s term, greatly reducing the likelihood that it will actually be enacted. President-elect Donald Trump and his health nominees have not commented on the measure, but a similar effort led by Trump’s first FDA commissioner, Dr. Scott Gottlieb, was sidelined during his first term.

Trump’s health secretary nominee, Robert F. Kennedy Jr., has said little about how regulating tobacco fits into his plans to overhaul the government's approach to fighting chronic disease. Even if the effort goes ahead under Trump, tobacco companies like Reynolds American and Altria are almost certain to challenge it in court, delaying implementation.

The FDA has spent years studying the issue and said Wednesday that cutting nicotine would help nearly 13 million current smokers quit cigarettes within one year. Roughly 48 million more young people would never take up the habit because cigarettes would essentially become nonaddictive, according to agency projections.

“This action, if finalized, could save many lives and dramatically reduce the burden of severe illness and disability,” FDA Commissioner Robert Califf told reporters Wednesday.

Under the agency's plan, nicotine in cigarettes would be capped at levels that “could no longer create and sustain this addiction among people who smoke.” Companies would have two years to reformulate their products after the publication of a final regulation. The agency posted its 334-page proposal online Wednesday morning and said will take public comments for nine months before taking any further steps.

Antismoking advocates overwhelmingly back the idea and urged Kennedy to help implement it, if he is confirmed.

“Tobacco regulation is a huge part of reaching the goals he’s outlined for reducing chronic disease and a really important part of the conversation we need to have in this country,” said Chrissie Juliano of the Big Cities Health Coalition, which represents the heads of more than 30 metropolitan health departments.

Smoking causes more than 480,000 U.S. deaths each year due to cancer, heart disease, stroke and other smoking-related illnesses. Those conditions often take decades to develop and remain elevated today despite ongoing declines in smoking among adults and teenagers.

The idea of limiting nicotine has its roots in sweeping powers given to the FDA by Congress in 2009 to regulate the tobacco industry. But the FDA’s efforts on nicotine and a host of other tobacco measures — such as adding graphic warning labels to cigarette packs — have been hampered for years by tobacco industry lawsuits.

 A man holds a lit cigarette while smoking in San Francisco, Wednesday, Dec. 2, 2020. (AP Photo/Jeff Chiu, File)

Califf said the expectation of industry lawsuits explains the slow, deliberative pace of FDA's work on the proposal.

“The research has to be airtight to survive the challenges that we know we'll get in court,” Califf said.

Under the law, the agency can regulate nicotine but cannot remove it completely. The limits on nicotine proposed Wednesday would apply to cigarettes, cigars and pipe tobacco, but not electronic cigarettes, nicotine pouches or other lower-risk products. While many e-cigarettes have not undergone extensive testing, the FDA has endorsed several major brands, including NJOY and Vuse, as less harmful alternatives for smokers.

“We anticipate that about 50% of smokers will transition to these other products, whether that’s e-cigarettes or other noncombustibles,” FDA’s tobacco director Brian King told reporters.

Altria, which sells both Marlboro cigarettes and NJOY e-cigarettes, said the FDA’s nicotine proposal will lead to illegal markets.

The plan is “fundamentally flawed," company spokesman David Sutton said in an email.

Currently, there are no U.S. limits on nicotine, which occurs naturally in tobacco plants. There are several techniques for removing it, including chemical extraction and cross-breeding plants.

The latest FDA announcement comes as smoking in the U.S. continues to fall. Last year, the smoking rate hit another all-time low, with 1 in 9 adults saying they currently smoke.

Low-nicotine cigarettes are not a new idea. Several companies, including Philip Morris, experimented with selling the products during the 1980s and 1990s, without much success. In 2019, the FDA authorized a cigarette that contains 95% less nicotine than standard cigarettes.

The FDA has sponsored studies showing that when smokers switch to very low nicotine cigarettes they smoke less and are more likely to try quitting. That research is considered pivotal to establishing that smokers won’t compensate by just smoking more cigarettes or inhaling more deeply. That was sometimes the case with “light” and “low tar” cigarettes marketed in decades past. Those products were subsequently banned as misleading.

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