FDA Plans to Slash Nicotine Levels in Cigarettes and Other Products

(UPDATED) The US government announced this week that they plan to slash nicotine levels in cigarettes to nonaddictive levels.

The proposed rule, which was published in a government report listing actions the Biden-Harris administration wants to take, would allow the US Food and Drug Administration to set maximum nicotine levels in cigarettes and other tobacco products. In lowering the amount of nicotine, the government hopes to stop those experimenting with smoking from becoming regular smokers and to help addicted users to quit.

“Making cigarettes and other combusted tobacco products minimally addictive or nonaddictive would help save lives,” FDA Commissioner Robert M. Califf, MD, said in a statement. “The US Surgeon General has reported that 87% of adult smokers start smoking before age 18, and about two-thirds of adult daily smokers began smoking daily by 18 years of age.”

Just a day after the proposal went public, the FDA banned Juul Labs, the maker of e-cigarettes and electronic nicotine delivery systems (ENDS), from the US market. The FDA issued several marketing denial orders, which means Juul must stop selling and distributing their device and four types of tobacco- and menthol-flavored pods. Anything currently for sale in stores must also be removed.

Based on a yearslong review, the FDA decided that there wasn’t enough toxicological evidence to show that marketing the Juul products would be appropriate for the protection of the public’s health.

Much like the agency’s goal in lowering nicotine standards to nonaddictive levels, the Juul ban reflects concerns about the rise in youth smoking and vaping. In the statement, the FDA states that they’ve dedicated significant resources to reviewing products that have large shares in the US market, including Juul. “We recognize these make up a significant of the available products and many have played a disproportionate role in the rise in youth vaping,” said Califf.

The American Heart Association issued a statement supporting the market ban. Nancy Brown, chief executive officer, criticized Juul’s history of marketing their products, including flavored e-cigarettes with high nicotine concentrations, directly to children. She pointed out that by including tobacco-flavored e-cigarettes as part of the ban, which other companies continue to sell, the FDA is sending an “unmistakable message that Juul cannot be trusted with any product in the marketplace,” according to Brown.

In 2020, the FDA restricted flavors in cartridge-based cigarettes to just menthol and tobacco in an effort to make the products less appealing to young people.  

Not the First Attempt to Cap Nicotine Levels

Each year, approximately 480,000 people die in the United States from diseases attributable to smoking, which is the leading cause of preventable morbidity and mortality there. The World Health Organization (WHO) says that 1.9 million people die every year from coronary heart disease brought on by smoking. Of all coronary heart disease deaths, smoking is responsible for at least one out of every five. Within a year of quitting, however, the risk of myocardial infarction among former smokers can be cut roughly in half, according to the WHO.   

In 2018, the FDA published a paper in the New England Journal of Medicine showing that capping nicotine levels could help 33 million people from becoming regular smokers by 2100. In setting a nicotine standard, the agency said smoking rates could be reduced to 1.4% as opposed to the current rate of 12.5%. Based on their modeling, it’s predicted that this would translate into 8 million fewer deaths from tobacco-related illnesses.  

The US government issued their plan to set maximum nicotine levels in the Spring 2022 Unified Agenda of Federal Regulatory and Deregulatory Actions. This report highlights their priorities and lists actions they are considering in both the near and long term. There is no time line on the changes, but a proposed rule from the FDA seeking public comment would be expected in spring 2023. However, as several media outlets have reported, there are concerns that any changes could be delayed by lawsuits from the tobacco industry.

This isn’t the first time an attempt has been made to make cigarettes less addictive. In 2018 under FDA Commissioner Scott Gottlieb, MD, the agency issued an advanced noticed on a proposed rule limiting the amount of nicotine in cigarettes and other tobacco products. Despite the proposal, there was no formal rule brought forward by the previous White House administration in support of the change.  

This past April, the FDA announced plans to ban menthol cigarettes and flavored cigars as part of their ongoing efforts to reduce the burden of tobacco-related disease and premature deaths.