Biden Releases 11th-Hour Plan to Lower Nicotine in Cigarettes

Cornell Watson for The Washington Post
VLN cigarettes, made by a company in North Carolina, have ultralow levels of nicotine. They haven’t proved popular with smokers.

The Biden administration released a proposal Wednesday to dramatically reduce nicotine levels in cigarettes, a move that anti-smoking advocates believe would save millions of lives even as it threatens the powerful tobacco industry.

The Food and Drug Administration’s plan to slash nicotine to minimally or nonaddictive levels represents a last-ditch effort by President Joe Biden to influence tobacco policy. The agency is proposing the policy in the waning days of his term, leaving it up to President-elect Donald Trump to finalize the effort – or scrap it – once he takes office.

Under the plan, tobacco companies would be required to cut nicotine in cigarettes to no more than 0.7 milligrams per gram of tobacco, which the FDA says is significantly lower than the average concentration in products on the market. The agency’s proposal would also apply to most cigars and pipe tobacco, but not to e-cigarettes or nicotine pouches.

FDA Commissioner Robert M. Califf, a cardiologist, has been a champion of the nicotine reduction plan, referring to it as “the number one priority” in an interview last month. The effort also aligns with Biden’s goal of cutting U.S. cancer rates by half.

“Multiple administrations have acknowledged the immense opportunity that a proposal of this kind offers to address the burden of tobacco-related disease,” Califf said in a statement. He added: “I hope we can all agree that significantly reducing the leading cause of preventable death and disease in the U.S. is an admirable goal we should all work toward.”

Nicotine – which is found naturally in tobacco plants – releases feel-good chemicals that fuel addiction and push people to smoke. Cigarettes, in turn, expose smokers to toxic carcinogens that can cause lung cancer and heart disease.

About 480,000 Americans die of smoking-related causes each year. The FDA estimates that more than 19 million people who smoke cigarettes would quit within the first five years after such a rule was implemented.

“Given these enormous benefits, we urge the incoming Trump Administration to move forward in finalizing and implementing this rule,” Yolonda C. Richardson, president of the Campaign for Tobacco-Free Kids, said in a statement. “Few actions would do more to fight chronic diseases such as cancer and cardiovascular disease that greatly undermine health in the United States.”

Cigarette companies have long recognized that lower levels of nicotine could threaten their business, and the industry has argued that such a plan would effectively ban cigarettes and fuel an illicit market.

“Smoking rates are at historic lows, and reducing nicotine content in cigarettes will not make these products less risky or improve public health,” Luis Pinto, vice president of corporate communications at Reynolds American, the maker of popular cigarette brands including Camel, Lucky Strike and Newport, said in a statement.

Anti-tobacco advocates have been frustrated that other tobacco-related policies, notably a ban on menthol cigarettes, stalled under Biden. But cutting nicotine in cigarettes has also been a long-held goal of advocates who have called the policy the “death knell” for smoking in America.

The proposal is also aimed at helping adults who smoke switch to lower-risk alternatives – such as e-cigarettes – which would reduce exposure to the chemicals contained in cigarettes, FDA officials said. But some experts have contended the FDA has failed to authorize a robust selection of vaping products, denying applications for more than 1 million flavored vaping products and only recently approving a handful of menthol vapes.

Researchers have concluded that slashing cigarette nicotine levels should essentially be all or nothing, saying a moderate cut would spur smokers to light up more. Cigarettes with very low nicotine levels would not pose that risk, researchers have said.

“My initial reaction is the FDA got it right – targeting combusted products which cause the vast majority of the death and disease and leaving non-combusted products alone as viable alternative sources of nicotine,” Eric Donny, a Wake Forest University School of Medicine nicotine researcher, wrote in an email.

The plan released Wednesday is only a draft, and the public will be able to comment until Sept. 15. Advocates are hoping Trump follows through. A similar plan emerged early in his first administration but languished. The Trump transition team did not immediately respond to a request for comment.

Scott Gottlieb, Trump’s first FDA commissioner, announced he was pursuing an ambitious plan to reduce nicotine levels in cigarettes in summer 2017, and the agency sought public feedback the following year.

The plan lost momentum after Gottlieb left the agency in spring 2019. Mitch Zeller, director of the FDA’s Center for Tobacco Products at the time, recalled he was later told by FDA political staff members to stop working on efforts to reduce nicotine as well as efforts to ban menthol in cigarettes, The Washington Post reported this week. Zeller declined to identify the officials. A former federal health official, who spoke on the condition of anonymity to be candid, confirmed that the instructions came from the White House.

The Biden administration resurrected the effort in summer 2022, but it took more than two years for the agency to issue a proposed rule. As the agency drafted the rule, officials were aware of the potential for the tobacco industry to file lawsuits if the plan is finalized.

“The research has to be airtight to survive the challenges that we know we’ll get in court,” Califf told reporters Wednesday. He invoked Robert F. Kennedy Jr.’s Make America Healthy Again agenda – an effort to tackle chronic disease and childhood illnesses – in urging the incoming Trump administration to pursue the plan. Trump has selected Kennedy to lead the federal health department.

“If there is a goal to make America healthy again, I can’t imagine anything more important to get done than this,” he said.

A 2009 federal law gave the FDA the power to regulate cigarettes. The agency is not allowed to ban cigarettes or impose a zero-nicotine requirement, but it can dictate standards for tobacco products – such as nicotine and ingredient levels – if needed to protect public health.

In the heart of North Carolina tobacco country, 22nd Century manufactures cigarettes with ultralow nicotine levels. VLN cigarettes – the only smokable tobacco products the FDA allows to be marketed as lower-risk for nicotine exposure – are available in about 5,100 stores in 26 states.

Sales are not exactly sizzling. The company’s struggles underscore the challenges advocates have long faced in their quest to slash nicotine levels and the difficulties of competing with Big Tobacco even though fewer Americans are smoking.

“It’s a David-and-Goliath story,” said 22nd Century CEO Lawrence Firestone, who likens the company’s cigarettes to decaf coffee or low-alcohol beer.