FDA Announces Plans for Potential Rule to Set Nicotine Limit in Tobacco Products

A cap on nicotine levels in cigarettes and other combustible tobacco products may be enforced sooner rather than later in the US, with the goal to reduce youth use, addiction, and mortality.

The White House published plans on Tuesday for future potential regulatory actions that included the Food and Drug Administration’s (FDA) proposed rule that would establish a maximum nicotine level in cigarettes and certain finished tobacco products.

“Because tobacco-related harms primarily result from addiction to products that repeatedly expose users to toxins, FDA would take this action to reduce addictiveness to certain tobacco products, thus giving addicted users a greater ability to quit,” stated the FDA in the rule notice. The product standard would also help keep nonsmokers interested in trying tobacco, mainly youth, from initiating regular use and becoming regular smokers.

“Nicotine is powerfully addictive,” said FDA Commissioner Robert M. Califf, MD, in an agency statement about the proposed plans. “Making cigarettes and other combusted tobacco products minimally addictive or non-addictive would help save lives. The U.S. Surgeon General has reported that 87 percent of adult smokers start smoking before age 18, and about two-thirds of adult daily smokers began smoking daily by 18 years of age.”

The FDA published a study in 2018 in the New England Journal of Medicine that projected that a potential limit on nicotine in tobacco products could, by the year 2100, prevent 33 million individuals from becoming regular smokers, cut the current smoke rate from 12.5% to 1.4%, and prevent over 8 million mortalities due to tobacco-related illnesses.

Just when could this proposed rule be finalized? In the Spring 2022 Unified Agenda of Regulatory and Deregulatory published today, the White House provided a report on the actions administrative agencies are considering issuing in the short and long term. The report also lists several potential regulatory actions related to tobacco products. However, the dates are, “not intended to be a precise estimate of when the work necessary to complete a proposed rule will be finished nor a final decision regarding whether a rule will be proposed,” noted the FDA.

“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,” stated Califf.