FDA proposes sweeping limits on nicotine in cigarettes

The Food and Drug Administration (FDA) released a sweeping proposal Wednesday to try to make cigarettes less addictive by lowering the amount of nicotine they contain, an 11th-hour plan from the Biden administration that will take years to go into effect, if it happens at all.

The move gives the White House one last chance to try to regulate tobacco, as it previously punted on finalizing a long-standing pledge to ban menthol-flavored cigarettes amid opposition from cigarette makers and other opponents, including convenience store retailers.

The incoming Trump administration will decide whether the nicotine proposal moves forward or gets scrapped. The proposal will be open for public comment for 240 days, or about eight months.

The FDA in the proposal estimated that if implemented, nicotine reduction would help nearly 13 million additional people to quit smoking cigarettes within one year after implementation. The estimate would rise to 19.5 million additional people within five years of implementation, FDA said.

The proposal would cap nicotine at levels that “could no longer create and sustain this addiction among people who smoke," FDA said.

The proposal would apply to traditional cigarettes, roll-your-own tobacco, most cigars and pipe tobacco, FDA said.

It does not include e-cigarettes, nicotine pouches, non-combustible cigarettes (such as heated tobacco products), hookah tobacco, smokeless tobacco products, or premium cigars.

“Multiple administrations have acknowledged the immense opportunity that a proposal of this kind offers to address the burden of tobacco-related disease," FDA Commissioner Robert Califf said in a statement. “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.”

The proposal would cap the nicotine level at 0.7 milligrams per gram of tobacco. The level of nicotine in cigarettes can vary greatly from brand to brand but on average each cigarette contains roughly 10-12 milligrams of nicotine per gram of tobacco.

Nicotine is the primary addictive chemical in tobacco products that fuels addiction, pushing people to smoke and repeatedly exposing them to a toxic mix of chemicals in the smoke that cause disease and death.

But FDA said extensive research shows reduced nicotine content cigarettes do not lead smokers to compensate by smoking more. Studies show that cigarettes with lower nicotine content reduce people’s dependence on nicotine and can help alleviate some of the cravings associated with withdrawal.

The rule was released online Wednesday, but that only begins a bureaucratic journey that anti-tobacco advocates worry an incoming Trump administration may derail.

There will also be significant tobacco industry opposition, which has helped to sink numerous other potential regulations.

Tobacco companies donated heavily to President-elect Trump’s campaign, and his chief of staff, Susie Wiles, worked as a tobacco lobbyist.

Still, there is some optimism for the Trump administration to act, as reducing nicotine aligns with the “Make America Healthy Again” movement championed by Robert F. Kennedy Jr., Trump’s pick to be Health and Human Services secretary.

“Few actions would do more to fight chronic diseases such as cancer and cardiovascular disease that greatly undermine health in the United States, and that the incoming Administration has indicated should be a priority to address,” Yolonda Richardson, president and CEO of the Campaign for Tobacco-Free Kids, said in a statement

Smoking is the leading preventable cause of disease, death and disability in the United States, according to the Centers for Disease Control and Prevention (CDC), killing more than 480,000 people each year. More than 16 million Americans are living with a smoking-related disease.

The FDA has been talking about plans to lower nicotine levels since the first Trump administration in 2018, but it never moved forward. If finalized, the rule would be the first of its kind in the world.

“This proposal allows for the start of an important conversation about how we meaningfully tackle one of the deadliest consumer products in history and profoundly change the landscape of tobacco product use in the United States,” said Brian King, head of the FDA’s tobacco office.

Public health advocates said the policy has enormous potential if the Trump administration follows through. No limits currently exist, so setting any standard would be considered a major step forward.

The FDA is not allowed to ban cigarettes or reduce nicotine levels to zero, but the 2009 law giving it regulatory authority over tobacco broadly allows the agency to cap nicotine at any other level.

Updated at 11:10 a.m.

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