The FDA knows nicotine is addictive. It wants to regulate it for the first time

The Food and Drug Administration has called cigarettes "the only legal consumer product that, when used as intended, will kill half of all long-term users."

But the agency has never regulated nicotine, cigarettes' notoriously addictive ingredient — and for years, it has been wanting to change that. Now, it seems, the time has come.

The FDA is poised to set a maximum nicotine level in cigarettes and some other tobacco products, looking to make them less addictive and wean smokers away from the habit. Despite an overall trend away from smoking, tobacco use remains the No. 1 cause of preventable deaths in the United States.

"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," FDA Commissioner Robert M. Califf said as the agency announced its plan.

Outlining the potential benefits, the FDA notes that 480,000 people die each year from disease attributed to smoking. Overall, it says, "tobacco use costs nearly $300 billion a year in direct health care and lost productivity."

The FDA plans to issue its proposed rule in May 2023.

Advocates welcome a "historic" move

In an email to NPR, the Campaign for Tobacco-Free Kids applauded what it called "a truly historic proposal." Combined with the FDA's recent push to ban menthol cigarettes and flavored cigars, the changes would "greatly reduce the appeal of cigarettes, especially to kids, and ensure these products can no longer create or sustain addiction," the group said.

For their part, cigarette companies have been working to adapt to shifts in regulations and in consumer tastes. For instance, the tobacco conglomerate Altria (which includes Philip Morris USA) has previously said it agrees with the FDA that addicted smokers need less harmful alternatives than cigarettes.

But rather than quitting smoking — and nicotine — altogether, Altria and other tobacco companies want those smokers to become customers for other tobacco products.

It's been a long time coming

The tobacco industry fought for decades to block federal efforts to regulate cigarettes and tobacco.

"Cigarettes had less federal oversight than both pet food and makeup," as NPR's Fresh Air has reported, "in part because of a 2000 Supreme Court decision that ruled that the Food and Drug Administration was not allowed to regulate nicotine without congressional approval."

But in 2009, Congress finally approved a bill giving the FDA authority over cigarettes and tobacco products. The FDA seemed to be on the cusp of new regulations in 2017, and it published a proposed rule in 2018. But that rule died, as the agency dropped the proposal in 2019.