FDA Finally Proposes a Nicotine Crackdown, Years in the Making

On Wednesday, the FDA issued its long-awaited proposal to drastically limit the amount of nicotine in cigarettes and some other tobacco products, with the goal of making them less addictive.

In its proposed rule, the FDA would cap the nicotine level at 0.7 mg/g of tobacco in cigarettes and certain other combusted tobacco products. The FDA’s proposal would apply to cigarettes, cigarette tobacco, roll-your-own tobacco, most cigars, and pipe tobacco — not e-cigarettes, nicotine pouches, noncombusted cigarettes, waterpipe tobacco, and smokeless tobacco products.

This rule, if finalized, would make the U.S. the first country in the world to put a hard cap on nicotine. With a cigarette on the market today currently considered equivalent to 0.9 g of tobacco, the proposed rule would slash the amount of nicotine in each cigarette from 10-15 mg to just under 0.7 mg — low enough to make the tobacco products no longer able to create or sustain addiction, the FDA reasoned.

Nicotine is the primary addictive chemical in tobacco products. Population-level effects of the proposed nicotine product standard would be substantial, according to the FDA’s population health modeling, as it would:

• Prevent approximately 48 million U.S. youth and young adults from starting smoking by the year 2100
• Result in more than 12.9 million cigarette smokers stopping in 1 year after the rule becomes effective (rising to 19.5 million people stopping within 5 years)
• Avert 1.8 million tobacco-related deaths by 2060 (rising to 4.3 million deaths averted by 2100)

“Reducing nicotine levels in cigarettes will be a watershed moment in public health by helping addicted smokers quit and by preventing young people from starting smoking,” said F. Joseph McClernon, PhD, of Duke University School of Medicine in Durham, North Carolina, in a statement. “The policy will save millions of lives, trillions of dollars in healthcare costs, and countless suffering from tobacco-related disease.”

Action on Smoking and Health added that tobacco is also a major contributor to climate change and pollution, citing cigarette butts as the preeminent source of plastic pollution worldwide. “Making cigarettes non-addictive is simple and would result in huge improvements in public health, the economy, and the environment. We do not need to put up with this any longer,” the advocacy group stressed in another press release.

The FDA had first announced its intent to start regulating nicotine levels in tobacco back in 2017.

“Multiple administrations have acknowledged the immense opportunity that a proposal of this kind offers to address the burden of tobacco-related disease,” said FDA Commissioner Robert Califf, MD, in a statement. “Today’s proposal envisions a future where it would be less likely for young people to use cigarettes and more individuals who currently smoke could quit or switch to less harmful products. This action, if finalized, could save many lives and dramatically reduce the burden of severe illness and disability, while also saving huge amounts of money.”

The FDA is welcoming public comments on the proposed nicotine rule from January 16 through September 25 this year. It will also be seeking input from the agency’s Tobacco Products Scientific Advisory Committee.

In the meantime, the agency advises that adults who smoke switch to lower-risk tobacco products, youth abstain from them, and non-smoker adults not start.